Life Science News

-- Viral Vector Facility Further Strengthens Vertical Integration of Kite's Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company's Blood Cancer Treatments --

-- Kite is the Only Cell Therapy Company with In-House Viral Vector Manufacturing Capabilities for Both Commercial Products and Clinical Trials --

-- In-house Viral Vector Supply Supports Continued Reliable Delivery of Kite's CAR T-cell Therapy Products --

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved the company's retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production. Viral vectors are key components needed to manufacture Kite's cell therapies to treat certain blood cancers. Kite is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities, augmenting its strong external supply partners.

CAR T-cell therapies are one-time treatments individually made starting from a patient's own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite's specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). During this process, a viral vector is used to encode the CAR in the patient's T-cells so the engineered T-cells can recognize and attack the patient's cancer cells in certain types of blood cancers. Once an individual therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Over 10,000 patients have been treated with Kite's CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 of the leading cancer hospitals in the U.S.

"The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow," said Christi Shaw, Chief Executive Officer of Kite. "This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients."

The Oceanside site is part of Kite's global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, Netherlands, and a recently FDA-approved Maryland site. This forms the largest dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Kite has continued to increase its manufacturing network capacity to meet increasing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

"The cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in ‘engineering' a patient's own T-cells to recognize and attack their cancer. The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments," said Chris McDonald, Global Head of Technical Operations, Kite.

The company continues to invest in its cell therapy workforce, employing approximately 100 employees at the 100,000-square-foot space. The capabilities and operations are fully scalable and will allow Kite to accommodate additional vector manufacturing as cell therapy science advances.

For more information on how cell therapy is manufactured, including the use of viral vectors, please click here .

About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com .

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 Kite's ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies or produce an amount of supply sufficient to satisfy demand for such therapies; Kite's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all; the possibility of unfavorable results from ongoing or additional clinical trials; Kite's ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 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 Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

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

For more information on Kite, please visit the company's website at www.kitepharma.com . Follow Kite on social media on Facebook , Twitter ( @KitePharma ), LinkedIn and YouTube .

Jacquie Ross, Investors
investor_relations@gilead.com

Tracy Rossin, Media
trossin@kitepharma.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 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:

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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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Gilead Sciences: U.S. Military Veteran Battles Lymphoma With Car T-Cell Therapy: Marcus' Story

Marcus arrived home to Mississippi from his military assignment overseas, excited to see his 20-month-old son, when he realized something was wrong

"I started noticing that I had a little growth right here on my neck. About two weeks later, I had a growth in my left groin area, the size of a softball," recalls Marcus. "I was like, this isn't right. I'm 36 years old, and I had never been sick in my life."

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Sirona Biochem Announces Start of Clinical Trial for Anti-Aging Compound TFC-1326

Sirona Biochem Announces Start of Clinical Trial for Anti-Aging Compound TFC-1326

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce that the clinical trial, for novel anti-aging compound TFC-1326, started on December 5 th 2022.

The trial, which will take place in Paris, is designed to assess the compound's efficacy in reversing aging facial skin, including restoring lost volume (plumping) and reducing fine wrinkles. The formulation is a cream base with TFC-1326 at a concentration of 1% and no other active ingredients.

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Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan

Daiichi Sankyo to Transfer Yescarta Marketing Authorization in Japan to Gilead Sciences K.K. –

Kite Cell Therapy Business Unit at Gilead Sciences K.K. Will Manage the Sales and Promotion Activities in Japan After the Marketing Authorization Transfer –

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Aptose to Hold Clinical Update and Data Review of AML Drug Tuspetinib on Sunday, December 11th

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that the company's management team will provide a corporate update on Sunday, December 11, 2022, at 10:00 AM EST 9:00 CST, in conjunction with poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held in New Orleans, LA. The webcast event will include a comprehensive review of current clinical data for Aptose's lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose's oral, dual lymphoid and myeloid kinase inhibitor.

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The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

  • Purchase Order from 5-star luxury hotel in Austin, Texas marks the achievement of another milestone in The Gummy Project's ongoing highly strategic multi-channel sales strategy
  • The Peachy Bees and Watermelon Sharks are expected to be for sale in each of the hotel's guest room private bars

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order for its Peachy Bees and Watermelon Sharks from a 5-star luxury hotel located in Austin, Texas (the "Luxury Hotel").

"Entering an additional US state and having our gummies for sale at this Luxury Hotel is another significant achievement for the Company as we continue to expand in both Canada and the US," said Charlie Lamb, President and CEO of GUMY.

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New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer

Late-Breaking TROPiCS-02 Analysis Shows that Trodelvy Demonstrates Consistent Efficacy Across Trop-2 Expression Levels –

Trop-2 is Highly Expressed in 90% of Breast Cancers

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