Life Science News

-- Enrolled Patients in These Studies May Continue Receiving Study Medicine --

-- Studies Outside of Combination with Azacitidine Unaffected --

Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab."

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.

The studies impacted by this partial clinical hold include:

  • Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881 )
  • Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397 )
  • Phase 3 ENHANCE-3 study in unfit AML ( NCT05079230 )
  • Phase 1b study in MDS ( NCT03248479 )
  • Phase 2 study in myeloid malignancies ( NCT04778410 ) * only the azacitidine combination cohorts

The studies not impacted include:

  • Phase 2 study in diffuse large B-cell lymphoma ( NCT02953509 )
  • Phase 2 study in multiple myeloma ( NCT04892446 )
  • Phase 2 study in head and neck squamous cell carcinoma ( NCT04854499 )
  • Phase 2 study in solid tumors ( NCT04827576 )
  • Phase 2 study in triple-negative breast cancer ( NCT04958785 )
  • Phase 2 study in colorectal cancer, planned and not currently recruiting

About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.

More information about clinical trials with magrolimab is available at www.clinicaltrials.gov .

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving the combination of magrolimab plus azacitidine, and the possibility of unfavorable results from ongoing or additional trials; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not remove the clinical holds on studies evaluating the combination of magrolimab plus azacitidine; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter ( @GileadSciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Jacquie Ross, Investors
investor_relations@gilead.com

Marian Cutler, Media
marian.cutler1@gilead.com

News Provided by Business Wire via QuoteMedia

GILD
abigail echo-hawk

CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
"investingnews.com"

Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

As quoted in the press release:

Keep reading...Show less

Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors

Kite, a Gilead Company (Nasdaq: GILD), today announced results from an ongoing Phase 1 study conducted by the National Cancer Institute (NCI) showing that clinical responses were observed with investigational T cell receptor (TCR) cell therapy targeting human papillomavirus type 16 (HPV-16) E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).

As quoted in the press release:

Keep reading...Show less

Gilead Sciences Announces Promotion in Oncology Division

Gilead Sciences (NASDAQ:GILD) shared the promotion of Dr. Alessandro Riva to executive vice president of Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs.
As quoted in the press release:

Dr. Riva will become a member of Gilead’s senior leadership team.
Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutic Area Head. He has been instrumental in expanding Gilead’s oncology program with the recent acquisition of Kite Pharma, establishing the company as a leader in the field of cellular therapy. He has also guided the strategy and development of Gilead’s broader oncology pipeline during his tenure.

Keep reading...Show less

CLASS ACTION UPDATE for AUPH, AMZN and UPST: Levi & Korsinsky, LLP Reminds Investors of Class Actions on Behalf of Shareholders

Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court. Further details about the cases can be found at the links provided. There is no cost or obligation to you

AUPH Shareholders Click Here: https://www.zlk.com/pslra-1/aurinia-pharmaceuticals-inc-information-loss-submission-form?prid=27309&wire=1
AMZN Shareholders Click Here: https://www.zlk.com/pslra-1/amazon-com-inc-loss-submission-form?prid=27309&wire=1
UPST Shareholders Click Here: https://www.zlk.com/pslra-1/upstart-inc-loss-submission-form?prid=27309&wire=1

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

All Clinical Studies Evaluating Injectable Lenacapavir to Resume –

– Decision Based on Review of Vial Compatibility Data –

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

ROSEN, A Top Ranked Law Firm, Encourages Aurinia Pharmaceuticals Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action - AUPH

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) between May 7, 2021 and February 25, 2022, inclusive (the "Class Period"), of the important June 14, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Aurinia securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

ROSEN, GLOBAL INVESTOR COUNSEL, Encourages AbbVie Inc. Investors With Losses to Secure Counsel Before Important June 6 Deadline in Securities Class Action - ABBV

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

IBM, ABBV, & TWTR Class Actions: Bronstein, Gewirtz & Grossman, LLC, A Leading Class Action Firm Reminds Shareholders to Actively Participate

Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss, you can request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff

Bronstein, Gewirtz and Grossman, LLC, Monday, May 16, 2022, Press release picture

International Business Machines Corporation (NYSE:IBM)
Class Period: April 4, 2017 - October 20, 2021
Deadline: June 6, 2022
For more info: www.bgandg.com/ibm.

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

SHAREHOLDER ALERT: CELH AUPH MULN: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Celsius Holdings, Inc. (NASDAQ:CELH)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/celsius-holdings-inc-loss-submission-form?prid=27287&wire=1
Lead Plaintiff Deadline: May 16, 2022
Class Period: August 12, 2021 - March 1, 2022

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×