Life Science News

Recommendation is Based on Week 26 Data from the CAPELLA Trial Showing Twice-Yearly Lenacapavir Achieved High Rates of Virologic Suppression in Heavily Treatment-Experienced People with HIV –

– If Authorized, Lenacapavir Could Offer a New, Every Six-Month Treatment Option for People with Limited Treatment Choices

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year.

"Treatment options are extremely limited for people living with HIV whose virus is no longer effectively controlled by their current regimen. We are encouraged by this CHMP positive opinion for lenacapavir, as it is an important step toward a potential new treatment option for individuals with multi-drug resistant HIV," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "We look forward to the final decision by the European Commission and the potential for lenacapavir to help fill a critical unmet need for persons living with HIV with complex prior treatment histories."

The positive opinion is supported by data from the Phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load ( Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection . Through Week 26, lenacapavir was generally well tolerated, with no serious adverse events related to lenacapavir as determined by the study investigator. The most common adverse events observed in the trial were injection-site reactions.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

About Lenacapavir

Lenacapavir is Gilead's potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection. The safety, efficacy and dosing of Gilead's investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If authorized, lenacapavir would be the only HIV-1 treatment option administered twice yearly.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. CAPELLA includes men and women with HIV-1 and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo in a 2:1 ratio for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The primary endpoint was the proportion of participants randomly allocated to receive lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

Following the 14-day functional monotherapy period, participants randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068 .

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.

For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications , including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

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 and complete clinical trials involving lenacapavir in the anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the EC may not grant marketing authorization for lenacapavir for the treatment of HIV-1 infection in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir 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 March 31, 2022, 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. All other trademarks are the property of their respective owners.

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

Jacquie Ross, Investors
jacquie.ross@gilead.com

Brian Plummer, Media
brian.plummer@gilead.com

Sarah Swift, Media (Europe)
sarah.swift@gilead.com

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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.

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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.

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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:

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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:

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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.

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First Data From LUMAKRAS Plus Immunotherapy and LUMAKRAS Plus SHP2 Inhibitor Combinations Show Clinical Activity and Support Ongoing Investigation

Updated Phase 1 Tarlatamab Data Reinforce Potential of BiTE ® Therapy in Small Cell Lung Cancer

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Boosh Settles $190,000 In Debt

Boosh Settles $190,000 In Debt

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") announces that it has entered into a settlement agreement with an arm's length third party for the settlement of $191,428.52 in debt for services previously provided through the issuance of 1,519,274 common shares at a deemed price of $$0.126 per share.

All securities issued in the debt settlement are subject to a four month and one day hold period expiring on December 04, 2022.

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AMGEN REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2022. Key results include:

  • Total revenues increased 1% to $6.6 billion in comparison to the second quarter of 2021, resulting from 3% growth in global product sales partially offset by lower Other Revenue from our COVID-19 manufacturing collaboration.
    • Volumes grew double-digits for a number of products including Repatha ® (evolocumab), Prolia ® (denosumab), LUMAKRAS ® /LUMYKRAS™ (sotorasib) and EVENITY ® (romosozumab-aqqg).
  • GAAP earnings per share (EPS) increased from $0.81 to $2.45 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired In-Process Research & Development (Acquired IPR&D) associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022, partially offset by an impairment charge related to the divestiture of GENSENTA, a generics subsidiary in Turkey .
    • GAAP operating income increased from $0.8 billion to $2.2 billion , and GAAP operating margin increased 21.1 percentage points to 34.6%.
  • Non-GAAP EPS increased from $1.77 to $4.65 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired IPR&D associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022.
    • Non-GAAP operating income increased from $1.6 billion to $3.3 billion , and non-GAAP operating margin increased 26.8 percentage points to 53.1%.
  • The Company generated $1.7 billion of free cash flow for the second quarter versus $1.7 billion in the second quarter of 2021.
  • 2022 total revenues guidance revised to $25.5 - $26.4 billion ; EPS guidance revised to $11.01 - $12.15 on a GAAP basis, and reaffirmed at $17.00 - $18.00 on a non-GAAP basis.

"We are focused on delivering our long-term objectives by serving an ever-increasing number of patients around the world with our medicines," said Robert A. Bradway , chairman and chief executive officer. "We are advancing our pipeline and look forward to important readouts over the next few months."

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The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

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  • Partnership with Flair rapidly accelerates The Gummy Project's growth across Canada with GUMY products being featured for sale on all Flair flights.
  • As the "Better for You" gummy company, The Gummy Project, through its Flair Airlines partnership, will extend the reach and effectiveness of its purpose driven mission to support endangered keystone species.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that the Company has received a repeat order from its existing customer Flair Airlines ("Flair").

"We are very pleased to receive our second repeat order from an existing customer. We view this as another vote of confidence that our customers are very much enjoying our gummies and strongly embracing our mandate to support endangered keystone species," said Charlie Lamb, President & CEO of The Company. "We look forward to building upon the momentum that the Company has created as we continue to accelerate revenue generation and brand awareness."

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Gilead Sciences to Acquire MiroBio

Acquisition Provides Gilead with MiroBio's Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform –

– MiroBio's Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead's Inflammation Research and Development Strategy –

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AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH

Acquisition Includes TAVNEOS ® (avacopan), a First-in-Class Medicine for Patients With Serious Autoimmune Disease

Tavneos Adds to Amgen's Decades-Long Leadership in Inflammation and Nephrology

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