Amazon Announces New Fulfillment Center in Missouri City, TX

Amazon Announces New Fulfillment Center in Missouri City, TX

New one million square-foot site to create over 500 new, full-time jobs

SEATTLE–(BUSINESS WIRE)–Amazon.com, Inc. (NASDAQ: AMZN) plans to open its first fulfillment center in Missouri City, Texas. The new fulfillment center, which is anticipated to launch in 2021, will create over 500 new full-time jobs with industry-leading pay and comprehensive benefits starting on day one.

See Our Fulfillment Centers in Action

“We’re excited to be expanding our network of operations in Missouri City,” said Alicia Boler Davis, Amazon’s vice president of global customer fulfillment. “We are grateful for the strong support we’ve received from local and state leaders as we broaden our footprint throughout Texas. Every day at Amazon, incredible employees come together to deliver magical experiences for customers and we look forward to creating over 500 jobs for the local community, with industry-leading pay and comprehensive benefits starting on day one.”

In the new one million square-foot fulfillment center Amazon associates will work to pick, pack, and ship bulky or larger-sized customer items such as patio furniture, outdoor equipment, or rugs.

“Missouri City and Amazon are alike when it comes to success, diversity, customer service and community. We are looking forward to this new business model, which focuses on customer service and expands the economy as this is another partnership that will build on our commercial tax base, helping to ease the property tax burden on residents,” said Missouri City Mayor Yolanda Ford. “Expanding the economic base is a citizen and City Council priority, and this new Amazon center helps to achieve that goal. It’s just another step in moving Missouri City’s economy forward into the future.”

On top of Amazon’s industry-leading minimum $15 per hour wage, the company offers full-time employees comprehensive benefits including full medical, vision, and dental insurance as well as a 401(k) with 50 percent match starting on day one. Amazon prioritizes the safety and health of its employees and has invested millions of dollars to provide a safe workplace. The company also offers up to 20 weeks of maternal and parental paid leave and innovative benefits such as Leave Share and Ramp Back, which give new parents flexibility to support their growing families.

Amazon leverages its scale to help support local communities. Amazon has also pledged to invest over $700 million to provide upskilling training for 100,000 U.S. employees for in-demand jobs. The programs will help Amazon team members from all backgrounds access training to move into highly skilled roles across the company’s corporate offices, tech hubs, fulfillment centers, retail stores, and transportation network, or pursue career paths outside of Amazon.

“We welcome Amazon to Missouri City and are excited that this piece of the City’s long-term economic development plan has come to fruition,” said City Manager Odis Jones. “Our teams have been working hand-in-hand the last few weeks to finalize the deal and we are looking forward to continuing our corporate-community partnership with this industry giant for years to come.”

Amazon in Texas:

  • Since 2010, Amazon has created more than 43,000 jobs in Texas and invested more than $16.9 billion across the state, including infrastructure and compensation to its employees.
  • Amazon’s investments have contributed more than $18.8 billion in GDP to the Texas economy and have helped create over 49,000 indirect jobs on top of Amazon’s direct hires – from jobs in construction and logistics to professional services.
  • More than 116,000 independent authors and small and medium businesses in Texas are selling to customers in Amazon’s store, creating thousands of additional jobs across the state.

Additional Resources:

About Amazon: Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. Customer reviews, 1-Click shopping, personalized recommendations, Prime, Fulfillment by Amazon, AWS, Kindle Direct Publishing, Kindle, Fire tablets, Fire TV, Amazon Echo, and Alexa are some of the products and services pioneered by Amazon. For more information, visit https://www.aboutamazon.com/ and follow @AmazonNews.

Amazon.com, Inc.

Media Hotline

[email protected]

www.amazon.com/pr

KEYWORDS: Texas Washington United States North America

INDUSTRY KEYWORDS: Retail Online Retail

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Middlesex Water Company CEO Dennis Doll to Present at BofA Securities 2020 Water Conference

ISELIN, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Middlesex Water Company (NASDAQ:MSEX) announced today that its Chairman, President and CEO Dennis W. Doll will be among water industry leaders presenting at the BofA Securities 2020 Virtual Water Conference on Thursday, December 10, 2020. 

Mr. Doll’s remarks are expected to include an overview of the Company’s financial performance and operational highlights, comments on consistent service delivery during the pandemic, progress on the largest capital program in the company’s history and its expanded commitment to Environmental, Social and Governance oversight and disclosure. The event will bring together water industry leadership, regulators, investors and other key industry stakeholders for an in depth discussion on the state of the water industry, sustainable infrastructure investing and the current regulatory landscape.

Middlesex Water’s webcast presentation from the BofA Securities 2020 Water Conference will be available in the Investors section of the company’s website www.middlesexwater.com under News & Events/Presentations and at this link within 24 hours of the conclusion of the Water Conference.


About Middlesex Water Company

Established in 1897, Middlesex Water Company (NASDAQ:MSEX) serves as a trusted provider offering life-sustaining high quality water service for residential, commercial, industrial and fire protection purposes. The Company offers a full range of water, wastewater utility and related services. An investor-owned public utility, Middlesex Water is a professional services provider specializing in municipal and industrial contract operations and water and wastewater system technical operations and maintenance. The company and its subsidiaries form the Middlesex Water family of companies, which collectively serve a population of nearly half a million people in New Jersey and Delaware.  Named a 2020 Top Workplace in New Jersey and a 2020 Superstar in Business in Delaware, Middlesex is diligently focused on meeting and balancing the needs of our employees, customers, and shareholders. We invest in our people, our infrastructure and the communities we serve to support reliable and resilient utility services, economic growth and quality of life.  To learn more, visit our website and follow us on Facebook, Twitter and LinkedIn.

This press release contains “forward‐looking statements” within the meaning of U.S. federal securities laws regarding Middlesex Water Company “MSEX” or the “Company”, its financial condition, and its results of operations that reflect the Company’s current views and information currently available. This information is, where applicable, based on estimates, assumptions and analysis that the Company believes, as of the date hereof, provides a reasonable basis for the information contained herein. Forward‐looking statements can generally be identified by the use of forward‐looking words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates,” “foresees” or the negative version of those words or other comparable words and phrases, and include statements relating to the Company’s beliefs or expectations regarding its future performance, strategic plans and cash flows, as well as any other statements that do not directly relate to any historical or current facts. Actual results, performance or achievements may differ materially from forward‐looking statements, and the assumptions on which forward-looking statements are based. There can be no assurance that the information contained herein is reflective of future performance, and investors are cautioned not to place undue reliance on forward‐looking statements as a predictor of future performance. Unless otherwise specified, all information contained in this press release speaks only as of the date hereof. The Company undertakes no duty to update or revise the information contained herein, publicly or otherwise, whether as a result of new information, future events or otherwise.

Media Contact:

Bernadette Sohler, Vice President – Corporate Affairs
Middlesex Water Company
(732) 638-7549
[email protected]



Founded by Chaos Engineering Pioneer, Jeli.io Launches First Incident Analysis Platform With $4 Million in Funding

Jeli Uses Incidents as a Catalyst for Understanding Pain Points in Organizations so They Can Improve the Collaboration and Communication Between Engineering and Business Units

SAN FRANCISCO, Dec. 07, 2020 (GLOBE NEWSWIRE) — Today at SREcon20 Americas, Jeli.io formally launched and unveiled the first incident analysis platform. The platform uses incidents as a catalyst for understanding how their company is doing so they can stay focused on what really matters and improve response, prevention and long-term reliability. The product is in private beta with brand name companies like Indeed, the world’s number one job site. 

Indeed Head of SRE Jason Koppe said: “Jeli is our new secret sauce for learning from incidents and increasing trust, collaboration, initiative, creativity, on-the-job training and effectiveness in eliciting insightful information from others. Jeli’s unique approach is unmatched, and we’re making everything better about the way we work together, grow together and succeed together. I’m ecstatic to partner with Jeli.”

Today most companies look for how much their incidents cost from customer revenue loss. However, the wildly overlooked area is the hidden coordination costs within teams which can cost hundreds of hours of engineering time without delivering a better customer experience ultimately repeating the same broken processes. Companies find that they are increasingly having the same incidents, not getting their action items completed and driving a wedge between engineering and business units.

Jeli highlights incident coordination costs, uncovers organizational issues and generates recommendations to help companies address these issues before they become irreparable. Jeli coalesces disparate systems involved in incidents and directs users’ attention to areas that are costing companies the most during incidents so that users can not only improve the collaboration and process aspects of incident response but improve on-call rotations and strengthen the capability of getting your action items complete.

“Jeli gives companies the visibility and critical focus to ensure their chaos engineering and incident response practices continue to optimize. Their action items actually get followed through on because they are useful, all while safeguarding companies from making the same mistakes twice,” said Nora Jones, founder and CEO of Jeli.io. She has held senior technical leadership roles at Netflix, Slack, Jet.com and Alarm.com. She pioneered chaos engineering in 2017, created and founded the https://www.learningfromincidents.io movement and co-authored two O’Reilly books on chaos engineering. 

With Jeli, companies no longer have to painstakingly go through every detail of every incident. Jeli proactively does it for them in a way that makes them faster and enhances the quality of the output. Through Jeli’s incident analysis and timeline, organizations can start their postmortems with shoulders to stand on, rather than starting from scratch and missing opportunities to improve. Jeli enables users to slice and dice their incidents in a way that shows how responders can better coordinate.

Today Jeli.io also announced $4 million in seed funding led by Boldstart Ventures with participation from Harrison Metal and Heavybit.

“Jeli’s incident analysis platform provides a whole new view into ‘what happened’ that unlocks not only a faster response but a clear path to improving software to generate a ‘return on incidents’. There’s no other product on the market that does this. We are thrilled to be partnered with the team at Jeli and lead their series seed,” said Eliot Durbin, General Partner at Boldstart Ventures.

About Jeli.io

Jeli.io is an incident analysis platform company that allows users to not only address incidents but learn everything they can from them. Jeli aggregates systemic incident data such as on-calls and incident response transcripts combined with team and responder information to find clear, actionable recommendations and insights to reveal organizational issues and continuously improve. For more information, go to https://www.jeli.io or follow @Jeli_io.

Media and Analyst Contact:

Amber Rowland
[email protected]
+1-650-814-4560

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c92c3c91-e309-47e1-8ffb-28e2fb9e6cfa

 



Affimed Announces Updated AFM13 Clinical Data Presentation at the American Society of Hematology Annual Meeting, Demonstrating Good Tolerability and a High Objective Response Rate in Patients with Recurrent/Refractory CD30-positive Lymphoma

  • AFM13 monotherapy was well tolerated and reached an Objective Response Rate of 42 percent among heavily pretreated patients with R/R CD30-positive lymphoma with cutaneous presentation
  • Immunological analyses revealed that innate cell engagers modulate NK and T cell populations in peripheral blood and tumors

Heidelberg, Germany, December 7, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the presentation of a clinical data set on AFM13 at the 62nd American Society of Hematology Annual Meeting and Exposition. Dr. Ahmed Sawas, Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, and principal investigator presented the updated results of a phase 1b/2a study in patients with CD30-expressing lymphoma with cutaneous involvement.

AFM13 is a bispecific tetravalent Innate Cell Engager (ICE®) targeting CD30 on tumor cells and CD16A on NK cells and macrophages.

2971: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)

This updated analysis of the AFM13 monotherapy study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation showed an Objective Response Rate (ORR) of 42 percent (6/14) and demonstrated clinical activity after brentuximab vedotin failure in two of four patients. Flow cytometry of peripheral blood revealed decreased circulating NK cell numbers during therapy and tumor biopsies of responders exhibited an increased pre-therapy CD56+ NK cell infiltration versus non-responders. Granzyme B expression was detected in responders, indicating NK cell cytotoxicity. Together, these data suggest that AFM13 may initiate NK cell tumor infiltration and recruit and engage NK cells. In addition, AFM13 was well tolerated.

“The therapeutic need for this heavily pretreated patient group is extremely high. We are therefore happy to see that AFM13 monotherapy was well tolerated and demonstrated a promising ORR,” commented Dr. Ahmed Sawas. “Our biological evaluation is the first to demonstrate that innate cell engagers modulate NK cell populations in patient peripheral blood and tumors, which seems to be associated with patient benefit.”

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis
Head of Investor Relations
E-Mail: [email protected]

Media Contact

Mary Beth Sandin
Head of Marketing and Communications
E-Mail: [email protected]



Nurix Therapeutics Presents Preclinical Data at 62nd American Society of Hematology (ASH) Annual Meeting and Exposition

Data support a planned clinical trial of NX-2127 in B-cell malignancies

SAN FRANCISCO, Dec. 07, 2020 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced the presentation of key preclinical data from its lead program, NX-2127, for the potential treatment of B-cell malignancies, at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Supported by these data, Nurix plans to initiate a Phase 1 clinical trial of orally administered NX-2127 in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in the first half of 2021.

“The data presented at ASH demonstrate the unique dual properties of NX-2127 which is designed to overcome treatment failures including resistance to approved agents while simultaneously activating additional cancer-fighting immune cells,” said Robert Brown, M.D., vice president of clinical development of Nurix. “We look forward to advancing our novel targeted protein dual degrader to the clinic for patients with B-cell malignancies who have failed to respond to currently available therapies.”

NX-2127 catalyzes proteasomal degradation of Bruton’s tyrosine kinase (BTK), an enzyme involved in B-cell development, differentiation and signaling that is critical for proliferation and survival of lymphoma and leukemia cells in many B-cell malignancies, including NHL and CLL. Inhibitors of BTK, such as ibrutinib, are approved for treatment of B-cell cancers, however specific mutations can arise in the BTK protein that confer resistance to these agents, thereby reducing their efficacy. Degradation of BTK has the potential to overcome resistance in patients harboring such mutations in BTK. In addition, NX-2127 catalyzes degradation of a transcription factor involved in regulating T-cell function, resulting in T-cell activation in a similar fashion to immunomodulatory imide drugs (IMiD) that have demonstrated efficacy in some aggressive B-cell malignancies.

The data presented at ASH demonstrate that NX-2127 catalyzes potent and selective degradation of both wild type and ibrutinib-resistant mutant BTK (BTKC481S) in lymphoma cell lines and inhibits their growth. In addition, NX-2127 treatment of normal human T-cells results in their activation with similar potency to commercially available IMiDs, pomalidomide and lenalidomide, as measured by degradation of the transcription factor Aiolos and production of IL-2. Notably, orally administered NX-2127 results in potent anti-tumor effects in mouse xenograft models and rapid and near complete BTK degradation in preclinical testing in non-human primates with once-daily dosing.

About Nurix Therapeutics, Inc.

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurix.com.

Forward Looking Statement

Any statements made in this press release relating to future business performance, conditions, plans, prospects, trends, or strategies and other business matters, including statements regarding our plans to file an IND and initiate clinical trials to develop NX-2127 for the treatment of B-cell malignancies, our ability to advance multiple wholly owned drugs into clinical development are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions regarding the future of the Company’s business, future plans and strategies, its development plans, its preclinical results and other future conditions. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, performance or events and circumstances could differ materially from those expressed or implied in our forward-looking statements due to a variety of factors, including the risks and uncertainties described under the heading “Risk Factors” in our final prospectus pursuant to Rule 424(b)(4) filed with the Securities and Exchange Commission (SEC) on July 24, 2020, our Quarterly Report on Form 10-Q filed with the SEC on October 14, 2020 and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.

Contacts:

Investors: Media:
Jason Kantor, Ph.D. Elizabeth Wolffe, Ph.D.
Nurix Therapeutics, Inc. Wheelhouse Life Science Advisors

[email protected]

[email protected]



Equitable Bank looks to grow USD GIC market in Canada with launch of new products

Canada NewsWire

Foreign currency GIC investments provide a unique, secure and stable option for diversified portfolios

TORONTO, Dec. 7, 2020 /CNW/ – Equitable Bank, a wholly owned subsidiary of Equitable Group Inc. (TSX: EQB) (TSX: EQB.PR.C), today announced it has launched U.S. currency GICs, further building out its suite of competitive investment options for Canadians. These new GICs are available exclusively through Investment Advisors and provide investors with high-rate U.S. dollar investment options — from cashable to 10-year – that challenge the limited offering that’s traditionally been available in the advisor market.

GICs are an effective cash management solution for a range of needs, including currency diversification for Canadians who also hold U.S. assets. GICs act as a strong risk mitigation tool that ensure stability and earnings potential, while simultaneously providing a guaranteed investment option that instills confidence — and grows wealth.

“This year, we have considerably grown our suite of wealth management products and, in turn, helped to create an entirely new market for foreign currency investments in Canada,” said Damon Knights, Head of Wealth Solutions at Equitable Bank. “With the addition of U.S. dollar GICs, along with our U.S. high interest savings accounts that were introduced in April, we’re helping forge a new wealth path for Canadians – one that provides secure, guaranteed and competitive options for foreign currency investments.” 

The addition of U.S. GICs to Equitable’s portfolio follows the expansion of deposit insurance coverage announced by Canada Deposit Insurance Corporation (CDIC) in April 2020, which allows eligible deposits held in foreign currencies at member institutions to be covered for CDIC insurance. For more information, visit https://www.cdic.ca/your-coverage/.

The Equitable Bank U.S. High Interest Savings Account (HISA) launched in April and provides a competitive U.S. dollar cash alternative for Investment Advisors to offer their clients. It’s also a way for snowbirds, investors and small businesses to ensure their U.S. cash balances are always earning a safe, reliable return while remaining easily accessible. 

“The appetite for change and growth in the foreign investment market is stronger than ever and we seized the opportunity to really challenge the status quo,” said Mahima Poddar, SVP of Personal Banking at Equitable Bank. “With the addition of U.S. dollar GICs to our mix, we’ve introduced a huge opportunity for Canadian investors; one that helps us lead the way for our wealth management partners.”

Investors can access the new Equitable Bank U.S. GICs through select wealth management dealer firms on the CANNEX network; the U.S. HISA can be accessed in the same way via the FundSERV network.

About Equitable Bank Wealth Solutions

Equitable Bank offers a suite of solutions tailored to individual clients’ financial needs, for every stage in life. From a wide range of Canadian and U.S. dollar deposit products, including short- and long-term GICs, one-year cashable GICs, and high interest savings accounts, to asset decumulation through reverse mortgages and CSV lines of credit, Equitable helps investor clients reduce portfolio volatility, grow savings, and find solutions that work for them.

About Equitable Group Inc.

Equitable Group Inc. is a growing Canadian financial services business that operates through its wholly owned subsidiary, Equitable Bank. Equitable Bank, Canada’s Challenger BankTM, has grown to become the country’s ninth largest independent Schedule I bank through its proven branchless approach and customer service focus in providing residential lending, commercial lending, wealth management, and savings solutions to Canadian consumers and investors. EQ Bank, the digital banking platform offered by Equitable Bank, provides state-of-the-art digital banking services. Equitable Bank is a member of Canada Deposit Insurance Corporation (CDIC) and employs over 900 dedicated professionals across the country. For more information about Equitable Bank and its products, please visit equitablebank.ca.

SOURCE Equitable Bank

Sutro Biopharma Presents Data from Ongoing Phase 1 Dose-Escalation Study for STRO-001 for the Treatment of B-cell Non-Hodgkin Lymphoma at the 62nd American Society of Hematology Annual Meeting

– STRO-001 was generally well-tolerated in patients with late-line NHL with no ocular or neuropathy toxicity signals; MTD has not been reached –

– 1 CR & 2 PRs observed in heavily pretreated patients with DLBCL; 1 SD in marginal zone lymphoma; 2 SDs in follicular lymphoma

– Fred Hutchinson preclinical models with STRO-001 identifies CD74 as a potential target for the treatment of AML

PR Newswire

SOUTH SAN FRANCISCO, Calif., Dec. 7, 2020 /PRNewswire/ — Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, today announced a poster presentation at the virtual 62nd American Society of Hematology (ASH) Annual Meeting for the ongoing Phase 1 dose-escalation clinical trial for its CD74-targeted antibody drug conjugate (ADC) STRO-001 for patients with late-line Non-Hodgkin Lymphoma (NHL). Additionally, data were presented from preclinical studies conducted in collaboration with researchers from the Fred Hutchinson Cancer Research Center.

“With three product candidates in the pipeline actively enrolling patients—STRO-001, STRO-002, our folate receptor alpha- (FolRα) targeting ADC, and CC-99712 in partnership with Bristol Myers Squibb, a BCMA-targeting ADC—Sutro is working on addressing unmet needs via targeted therapies that can tackle cancer evolution,” said Bill Newell, Sutro’s Chief Executive Officer. “The encouraging safety and preliminary efficacy clinical data presented at ASH on STRO-001 for the treatment of late-line NHL further validates our platform and unique approach to ADC design, creating potential first-in-class and/or best-in-class therapeutic candidates.”

STRO-001 Phase 1 Dose Escalation Interim Data
STRO-001-BCM1 is an ongoing first-in-human, phase 1 dose-escalation study evaluating the safety, tolerability, and preliminary antitumor activity of STRO-001 in adults with B-cell malignancies. The study is ongoing, and data presented at ASH included results from the NHL cohort. There were 21 NHL patients treated and 18 evaluable patients for response. Patients had a median of 5 prior therapies. 6/21 patients (29%) had previous stem cell transplant or CAR-T therapy. Data as of October 30, 2020 are as follows:

  • Most (90%) treatment-emergent adverse events (TEAEs) were grade 1 or 2 and no ocular or neuropathy toxicity signals have been observed
  • Following a previously announced protocol amendment last year requiring pre-treatment screening imaging for patients at risk for thromboses, no additional thromboembolic events have been observed
  • In the 7 patients with diffuse large B-cell lymphoma (DLBCL), 1 complete response (CR) and 2 partial responses (PRs) were observed
  • Out of other NHL types, 2 patients with follicular lymphoma had stable disease (SDs), of which one is still on treatment at 9 weeks. One patient with marginal zone lymphoma had SD and is still on treatment at 39 weeks

“These results continue to demonstrate the potential clinical benefit of STRO-001 treatment in patients with NHL who are heavily pretreated, with a median of five prior lines of treatment,” said Dr. Arturo Molina, Sutro’s Chief Medical Officer. “We are especially pleased for the patients who responded to STRO-001 after previously progressing on CAR-T treatments and an additional post- CAR-T regimen to which they had no response, seeing comparable duration of disease control to the duration on a cell therapy. STRO-001 has been well tolerated.  We look forward to continuing the dose-escalation study to learn more about the potential for STRO-001 for patients with NHL.”

Maximum tolerated dose (MTD) was not reached at 2.5 mg/kg. Active enrollment in the NHL cohort continues at the 3.5 mg/kg dose level and additional higher dose levels may be explored. The trial, registered with clinicaltrials.gov identifier NCT03424603, continues to enroll patients in dose escalation in both multiple myeloma (MM) and NHL cohorts.

The virtual poster titled “Preliminary Results of an Ongoing Phase 1 Dose Escalation Study of the Novel Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with B-cell Non-Hodgkin Lymphoma,” presented by Nirav N. Shah, M.D., Associate Professor of Medicine at Medical College of Wisconsin, is accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com.

Preclinical Data from Fred Hutchinson Cancer Research Center in Collaboration with Sutro
Fred Hutchinson Cancer Research Center, in collaboration with Sutro, presented preclinical models showing the potential of CD74-targeted therapies, and in particular STRO-001, for the treatment of acute myelogenous leukemia (AML). The research is out of the lab of Soheil Meshinchi, M.D., Ph.D., Professor, Clinical Research Division at Fred Hutchinson Cancer Center and Professor of Pediatrics at University of Washington School of Medicine.

“My team at Fred Hutchinson Cancer Research Center has built a robust computational platform leveraging our large AML transcriptome dataset to identify highly expressed antigens on leukemic cells that are being targeted by agents in early phase trials or preclinical development with the goal of repurposing these therapeutics for use in AML,” said Soheil Meshinchi, M.D., Ph.D. “One of these therapies was the STRO-001 ADC which targets the cell surface protein CD74. We have demonstrated that CD74 is highly expressed in a significant proportion of patients with AML. Our initial studies of STRO-001 ADC in AML cell lines demonstrated robust in vitro cytotoxicity on AML cell lines expressing high- to moderate-levels of CD74, with no cytotoxicity in cells with no CD74 expression. This in vitro data, which identifies CD74 as a viable target in AML, coupled with the 27% incidence of CD74 in nearly 1,000 pediatric AML patients from our clinical trial with bortezomib, strengthens the notion that targeting CD74 with STRO-001 represents a viable targeted therapy in this patient population. In addition to AML, CD74 is highly expressed in high risk acute lymphoblastic leukemia (ALL), including Ph-positive and Ph-like ALL, thus providing rationale for exploring the efficacy of STRO-001 in all leukemias.

  • A virtual poster titled “Target-Informed Repurposing of Immunotherapies in AML – a Transcriptome Based Approach for Identifying Immediately Available Therapeutics,” will be presented Amanda Leonti, MS, Computational Biology, Meshinchi lab, Fred Hutchinson Cancer Research Center, and include in vitro cytotoxicity data for STRO-001 in AML cell lines. See the abstract here.
  • A virtual oral session titled “Newly Diagnosed Childhood AML Patients Treated with Bortezomib Show Superior Survival If CD74 Is Expressed: A Report of 991 Patients from the Children’s Oncology Group AAML1031 Protocol,” will be presented by Lisa Eidenschink Brodersen PhD HCLD, Director, Flow Cytometry, Hematologics, Inc in Seattle Washington, and will highlight the potential of CD74 targeted therapies in pediatric AML. See the abstract here.

About Sutro Biopharma

Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.

Sutro’s proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™ led to the discovery of STRO-001 and STRO-002, Sutro’s first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018. STRO-002 is a folate receptor alpha (FolRα)-targeting ADC, currently being investigated in a Phase 1 clinical trial of patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF® and XpressCF+™ technology platforms. A third program, CC-99712 (BCMA-targeting ADC), which is part of Sutro’s collaboration with Bristol Myers Squibb (formerly Celgene Corporation), is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma. Sutro’s proprietary technology was responsible for the discovery and manufacturing of CC-99712, for which Bristol Myers Squibb has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Bristol Myers Squibb for this BCMA ADC. Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need.

To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal. The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.

Additional multimedia content from Sutro regarding STRO-001 and STRO-002 can be found here and here.

Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, timing of clinical trials and announcements of clinical results, potential benefits of the company’s product candidates and platform and potential market opportunities for the company’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact

Annie J. Chang

Sutro Biopharma
+1 650-255-8806
[email protected]

Media Contacts

David Schull

Russo Partners
(212) 845-4271
[email protected] 

 

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SOURCE Sutro Biopharma

Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for LOXO-305 in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma at the American Society of Hematology Annual Meeting

62% overall response rate in BTK pre-treated CLL/SLL patients, rising to 84% in patients followed for 10 or more months; consistent response rates regardless of reason for prior BTK discontinuation or BTK mutation status

Similar overall response rates observed in patients previously treated with all classes of available therapy (chemotherapy, anti-CD20 antibodies, BTK inhibitors, BCL2 inhibitors, PI3K-delta inhibitors)

94% of responding patients remain in response and on therapy

Phase 3 program in CLL/SLL to be initiated in 2021, including a superiority head-to-head trial comparing LOXO-305 vs. ibrutinib

PR Newswire

INDIANAPOLIS, Dec. 7, 2020 /PRNewswire/ — Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced clinical data from the LOXO-305 global Phase 1/2 BRUIN clinical trial in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).  LOXO-305 is an investigational, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. These data are being presented in an oral presentation at the 2020 American Society of Hematology (ASH) Annual Meeting (abstract 542).

“The data presented at ASH reveal an incredibly encouraging and consistent safety and efficacy profile for LOXO-305 in heavily pre-treated CLL and SLL patients, regardless of previous therapies, reasons for discontinuations of those therapies, or presence of resistance mutations”, said Anthony Mato, M.D., director of the CLL Program at Memorial Sloan Kettering Cancer Center and the presenting author. “We are increasingly in need of new therapies for patients that have been previously treated with a covalent BTK inhibitor, and LOXO-305 may allow us to continue treating patients in the same biologic class before attempting more complicated therapeutic approaches.”

“The LOXO-305 data continue to surpass our expectations, and we are very excited for what these data could mean for patients with CLL and SLL”, said David Hyman, M.D., chief medical officer of Loxo Oncology at Lilly. “These emerging data further substantiate our thesis that the drug’s reversible binding mode, high selectivity, and robust pharmacology offer a differentiated treatment option across B-cell leukemias and lymphomas. We are eager to initiate a Phase 3 program in 2021.”

Key Data Presented at ASH

As of September 27, 2020, 323 patients were enrolled in the study, including 170 with CLL/SLL, 61 with mantle cell lymphoma (MCL), 26 with Waldenström’s macroglobulinemia, and 66 with other B-cell lymphomas. The CLL/SLL patients had received a median of three prior lines of therapy with 86% receiving a prior BTK inhibitor, 90% an anti-CD20 antibody, 82% chemotherapy, 34% venetoclax, 21% a PI3K inhibitor, 6% CAR-T therapy and 2% an allogeneic transplant.

Pharmacokinetic analyses during the dose escalation demonstrated consistent dose-proportional exposures with low inter-patient variability across the entire dosing range of 25mg to 300mg daily. Doses of 100mg QD and greater exceeded BTK IC90 target coverage for the entirety of the dosing interval. Responses were observed starting at the first dose level.

The efficacy data presented at ASH are based on investigator response assessments. Patients were considered efficacy-evaluable if they had at least one post-baseline response assessment or if they discontinued treatment prior to their first post-baseline response assessment. In 139 efficacy-evaluable patients with CLL/SLL treated across all dose levels, 88 responded including 69 partial responses (PR), 19 partial responses with ongoing lymphocytosis (PR-L), 45 stable disease (SD), one progressive disease (PD), five discontinued prior to their first response assessment and were considered non-evaluable (NE), resulting in an overall response rate (ORR) of 63% (95% CI: 55-71). The ORR was consistent in various subsets of patients, including:

  • In the 121 efficacy-evaluable BTK-pretreated patients, the ORR was 62% (95% CI: 53-71), rising to 84% (21/25) for those followed 10 months or more. This deepening of response over time is consistent with other BTK inhibitors and suggests the overall efficacy profile of LOXO-305 will continue to strengthen with additional follow-up.
  • The ORR was similar in patients who previously discontinued a covalent BTK inhibitor for progression (67% [53/79]) versus toxicity or another reason (52% [22/42]).
  • The ORR was also similar in those with a BTK C481 mutation (71% [17/24]) and those without (66% [43/65]).
  • In patients who previously received prior chemoimmunotherapy, a covalent BTK inhibitor and a BCL-2 inhibitor the ORR was 69% (27/39).
  • In patients who previously received all five classes of available CLL/SLL therapy including prior chemoimmunotherapy, a covalent BTK inhibitor, a BCL-2 inhibitor, and a PI3K inhibitor the ORR was 58% (7/12).
  • In the 28 patients with a 17p deletion, TP53 mutation, or both, the ORR was 79% (22/28).

As of the data cut-off, 88% of all CLL/SLL patients remain on LOXO-305. Median follow-up for efficacy-evaluable CLL/SLL patients was six months. Of the 88 responding CLL/SLL patients, all except five remain on therapy (four progressed and one achieved a PR and electively discontinued to pursue a transplant). The longest-followed responding patient continues on treatment at 17.8 months.

Safety data were presented for the entire enrolled BRUIN population. Across all 323 patients enrolled in the study, the most commonly reported adverse events, regardless of attribution, were fatigue (20%), diarrhea (17%), and contusion (13%). In addition, rates of two adverse events commonly associated with BTK inhibitors, atrial arrythmias and hemorrhage, were low, experienced by two patients and one patient respectively, and considered by investigators as unrelated to LOXO-305. Dose interruptions, reductions and permanent discontinuations for drug-related adverse events were observed in 8%, 2.2%, and 1.5% of patients, respectively. No dose limiting toxicities were reported and a maximum tolerated dose (MTD) was not reached.

LOXO-305 Development Program Update

In addition to the previously announced Phase 3 MCL trial, Loxo Oncology at Lilly is preparing to initiate two global, randomized, Phase 3 clinical trials in BTK pre-treated patients with CLL/SLL. The trials will explore LOXO-305, alone and in combination as follows:

  • BRUIN CLL-321: CLL/SLL patients who progressed or were intolerant to covalent BTK inhibitor treatment will be randomized to receive continuous LOXO-305 therapy or investigator’s choice of either Idelalisib plus Rituximab or Bendamustine plus Rituximab. This trial is expected to start in the first quarter of 2021.
  • BRUIN CLL-322: CLL/SLL patients who progressed or were intolerant to covalent BTK inhibitor treatment will be randomized to receive a time-limited combination of either LOXO-305 plus venetoclax and Rituximab or venetoclax and Rituximab. This trial is expected to start in the second quarter of 2021.

In addition, Loxo Oncology at Lilly is planning to study LOXO-305 in treatment-naïve CLL/SLL, including a global, randomized Phase 3 superiority clinical trial to study LOXO-305 versus ibrutinib, expected to start later in 2021.

About LOXO-305
LOXO-305 is an investigational, oral, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, and marginal zone lymphoma. Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition. LOXO-305 was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. Interested patients and physicians can contact the Loxo Oncology at Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Trial
This first-in-human, global, multi-center Phase 1/2 trial evaluates LOXO-305 as a single agent in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL). The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase. The Phase 1 dose escalation enrolls patients with CLL/SLL or NHL who have received at least two prior lines of therapy and have progressed or are intolerant to standard of care. The dose escalation phase followed a “3+3” design with LOXO-305 dosed orally in 28-day cycles. As dose cohorts were cleared, additional patients could enroll in cleared cohorts and intra-patient dose escalation was permitted. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose and recommended Phase 2 dose. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria). In the Phase 2, patients are enrolled across various cohorts, depending on disease type and prior therapy. The primary endpoint for Phase 2 is ORR. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK).

About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.


About Eli Lilly and Company

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

Disclosure: Dr. Mato has provided consulting and advisory services to Loxo Oncology at Lilly and Eli Lilly and Company.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly’s LOXO-305 for the potential treatment of previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma and non-Hodgkin lymphoma and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that studies will complete as planned, that future study results will be consistent with the results to date, or that LOXO-305 will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Refer to:

Lauren Cohen; [email protected]; 617-678-2067 – media

Kevin Hern; [email protected]; 317-277-1838 – investors

 

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SOURCE Eli Lilly and Company

Cigna Global Health Benefits(R) Partners with InterNations to Offer a Scholastic Solution for Students, Chaperones and Faculty Participating in a Study Abroad Program

PR Newswire

The new, flexible Cigna StudyWell offering makes it simple, predictable and affordable for populations studying abroad to access whole person health care.   

BLOOMFIELD, Conn., Dec. 7, 2020 /PRNewswire/ — Cigna Global Employer Health (CGEH) Americas, a division of global health service company Cigna, announced today that it is partnering with German-based InterNations, the leading independent network and resource for expatriates across 420 cities and with 4 million members worldwide.

To provide students and faculty with access to comprehensive health benefits wherever they are in the world, CGEH is associating with InterNations to be the group sponsor of Cigna StudyWell™ plans. Through this relationship, CGEH provides students, chaperones, and faculty members participating in study-abroad programs with services and solutions that help improve their health, well-being, and peace of mind. Benefits include medical coverage including telehealth access, mental health and substance abuse treatment, and prescription and maintenance drugs.

Student-centric, Whole Person Care

This collaboration responds to the need for flexible insurance cover for globally mobile students and scholastic-affiliated populations. “The Cigna StudyWell™ solution was specifically designed to meet demand among this population for adequate cover that is tailored to the unique needs of the primarily student population,” said Ann Asbaty, CEO, Americas.

With two Cigna StudyWell™ plan options, one for students traveling outbound from the U.S. and another for students traveling inbound to the U.S. for their studies, the solutions are tailored to the unique needs of each population. With outbound students typically traveling for shorter periods of time, often only several weeks, the population typically requires unexpected illness and injury cover. Students coming to the U.S. to study typically remain in-country for longer periods of time and, as a result, require more comprehensive cover.

“Typically younger, student populations that are far away from their home countries may experience stresses and mental health issues for which coverage has been previously lacking,” said Asbaty. “With Cigna StudyWell™, we provide this and the peace of mind that comes from knowing that whole person support and care is available.” And Cigna StudyWell™ makes seeking care simple for students by providing access to 24/7 medical advice via its telehealth offering. 

CGEH takes holistic mental and emotional care further by offering Cigna StudyWell™ covered members access to an in-the-moment support Service. Provided by Workplace Options (WPO), this new solution enables a student or faculty member covered under the Cigna StudyWell™ solution to speak with a clinician regarding a non-urgent matter (e.g., stress, anxiety, relationship conflict, or bereavement/loss) by telephone or chat function 24/7.  

A Shared Commitment

“With a shared commitment to the well-being and successful adjustment of those we serve, the collaboration between InterNations and Cigna is a natural one,” shared Philipp von Plato, Founder and Co-CEO at InterNations. “We’re delighted to expand the support we provide to students, chaperones and faculty participating in a study abroad program with such a reputable, globally mobile-focused organization by our side,” said Asbaty. CGHB Vice President Sales, Russ Hyde, added, “Our common values and complementary services make this a great fit, and we’re excited about this endeavor.”

Commenting on the relationship, Malte Zeeck, Founder and Co-CEO of InterNations said, “Reputable and robust globally mobile scholastic coverage remains a growing need. Together with Cigna, we are bringing to market a comprehensive and competitive offering that aligns with our values and mission of enhancing the health of the scholastic population traveling.”

For more information on CGEH, visit cignaglobalhealth.com.

About Cigna

Cigna Corporation (NYSE: CI) is a global health service company dedicated to improving the health, well-being and peace of mind for those we serve. Cigna delivers choice, predictability, affordability and quality care through integrated capabilities and connected, personalized solutions that advance whole person health. All products and services are provided exclusively by or through operating subsidiaries of Cigna Corporation, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Life Insurance Company of North America, Cigna Life Insurance Company of New York, Express Scripts companies or their affiliates. Such products and services include an integrated suite of health services, such as medical, dental, behavioral health, pharmacy, vision, supplemental benefits, and other related products including group life, accident and disability insurance.

Cigna maintains sales capability in over 30 countries and jurisdictions, and has more than 160 million customer relationships throughout the world. To learn more about Cigna®, including links to follow us on Facebook or Twitter, visit www.cigna.com.

About InterNations

With more than 4 million members in 420 cities around the world, InterNations is the largest global community and a source of information for people who live and work abroad. InterNations offers global and local networking and socializing, both online and face to face. At around 6,000 events and activities per month, expatriates have the opportunity to meet other global minds. Online services include discussion forums and helpful articles with personal expat experiences, tips, and information about life abroad. Membership is by approval only to ensure we remain a community of trust. InterNations is part of the New Work SE, a group of brands that offer products and services for a better working life.

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SOURCE Cigna

Protagonist Announces Results of Large-Scale Analysis of Current Treatment Patterns Revealing Significant Opportunity to Improve the Standard of Care for Patients with Polycythemia Vera Across Broad Population Categories

— Treatment options did not provide hematocrit control consistent with NCCN guidelines for up to 78 percent of patients as presented at the American Society for Hematology (ASH) 2020 annual meeting —

— Company to host conference call to provide research update on December 9, 2020, at 8:30 a.m. EST —

PR Newswire

NEWARK, Calif., Dec. 7, 2020 /PRNewswire/ — Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced the results of a large-scale analysis of real world treatment patterns for polycythemia vera, demonstrating that treatment incorporating existing options failed to achieve hematocrit control for a majority of patients and across broad categories of patient groups over the course of two years of observations. The analysis included patients in both high risk and low risk groups, as well as patients receiving phlebotomy alone or phlebotomy as a component of combination treatment. Details will be presented today at the American Society for Hematology (ASH) 2020 annual meeting.

“This analysis shows that patients with polycythemia vera are often not receiving appropriate treatment, thereby potentially exposing these patients to life-threatening risks such as the risk of experiencing thrombotic events,” commented Srdan Verstovsek, M.D, Ph.D., research co-author and Director of the Clinical Research Center for Myeloproliferative Neoplasms at the MD Anderson Cancer Center. “Improving treatment patterns would likely help avoid risks, improve quality of life, and potentially avoid unnecessarily utilization of health care resources associated with adverse outcomes.”

The large scale analysis with 4,264 patients analyzed indicated that only 22 percent of a representative population of patients had hematocrit values maintained below the NCCN recommended guideline level of 45 percent. A majority of patients in the high risk population received treatment with phlebotomy alone, and hematocrit levels were often above recommended levels, and nearly half (49 percent) of patients had hematocrit levels substantially above recommended levels (above 50 percent) at least once during the observation period. Consistent with inadequate hematocrit control, a high incidence of thrombotic events was observed in patients receiving treatment.

“Our interpretation of these results is that there is a significant unmet need for effective treatment options for patients with polycythemia vera,” commented Samuel Saks, M.D., Protagonist Chief Medical Officer. “Patients are being poorly treated, resulting in excessive risk.”

A Phase 2 study of PTG-300 in patients with polycythemia vera is currently enrolling subjects. Additional information is available at http://ptg300pvstudy.com/.

About Polycythemia Vera

Polycythemia vera is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. There are an estimated 100,000 patients with polycythemia vera in the U.S. and approximately 100,000 patients in major EU countries.

Conference Call and Webcast Information

Protagonist management will host a conference call at 8:30 a.m. EST on December 9, 2020, to provide a research update including Andrew Kuykendall, M.D., PTG-300 study investigator and member of the Department of Malignant Hematology at the Moffitt Cancer Center. To access the call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 8794865. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn’s disease as the initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates from a collaboration with Janssen Biotech, Inc., are in development and have been selected for advancement into clinical studies. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.

Protagonist is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential benefits of polycythemia vera treatments. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

 

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SOURCE Protagonist Therapeutics, Inc.