Kite to Acquire Tmunity Therapeutics to Pursue Next Generation CAR T-Cell Therapy Advancements in Cancer

-- Acquisition Complements Kite's Existing In-House Research Capabilities --

-- Provides Kite with Rapid Manufacturing Processes, ‘ Armored' CAR T Technology Platform, and Access to Certain Future Innovations Through a Sponsored Research and License Agreement with the University of Pennsylvania --

-- Cell Therapy Researchers Who Founded Tmunity to Consult as Senior Scientific Advisors for Kite --

Kite, a Gilead Company (Nasdaq: GILD), and Tmunity Therapeutics (Tmunity), today announced that the companies have signed an agreement in which Kite will acquire Tmunity, a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies. The acquisition of Tmunity complements Kite's existing in-house cell therapy research capabilities by adding additional pipeline assets, platform capabilities, and a strategic research and licensing agreement with the University of Pennsylvania (Penn).

The acquisition will provide Kite with pre-clinical and clinical programs, including an ‘armored' CAR T technology platform, which potentially could be applied to a variety of CAR T's to enhance anti-tumor activity, as well as rapid manufacturing processes. Tmunity's prostate-specific membrane antigen (PSMA) and prostate stem cell antigen (PSCA) assets are not part of the Kite acquisition and will be spun-out by Tmunity as part of the transaction.

As part of the acquisition, Kite will assume responsibility for continuing the research and development collaboration between Tmunity and Penn, also known as the Amended Research License Agreement (ARLA), which includes research funding to Penn along with options and licenses to certain cell engineering and manufacturing technologies invented and developed in certain Penn laboratories. Upon closing, the ARLA will be extended until 2026 with an option to extend further.

"Kite has demonstrated an ability to globally scale cell therapy and address the unique challenges and opportunities that cell therapy represents, which are quite different in material ways than traditional pharmaceutical or biotech approaches," said Tmunity Founder Carl June, MD, who is also the Richard W. Vague Professor of Immunotherapy in Penn's Perelman School of Medicine and director of Penn's Center for Cellular Immunotherapies. "Kite's singular focus on cell therapy makes them unique and particularly nimble."

Tmunity was formed in 2015 by some of the early innovators in the cell therapy field, the University of Pennsylvania's Dr. June, Bruce Levine, PhD, James Riley, PhD and Anne Chew, PhD. The company was formed to rapidly advance early-stage cell therapy research and innovation done in academia into the clinic, to produce new treatments for patients with unmet needs. As part of Kite's acquisition, the Tmunity founders will become senior scientific advisors for Kite.

"We believe that the impact cell therapy is making for patients today is just the start of what is possible," said Christi Shaw, Chief Executive Officer of Kite. "The Kite team is thrilled to be joining forces with the researchers at Tmunity who are rapidly advancing cell therapy research from the labs into the clinic through their unique partnership with the University of Pennsylvania. Together, we bring a deep understanding of cell therapy as an effective platform, and combined with Kite's industry-leading global scale, we collectively have a singular focus: to use cell therapy to develop potential cures, and to get them to patients as quickly as possible."

Dr. June, a visionary researcher who helped shape the development of innovative cell therapies beginning in the 1980s, leads a team at Penn which, working across basic and clinical research settings, helped ignite the promise of cell therapy.

"The Tmunity team is excited by the potential to become part of Kite and see what we can accomplish together to write the next chapter on what cell therapy is capable of," said Beth Seidenberg, MD, Non-Executive Chairwoman of Tmunity and Founding Managing Director of Westlake Village BioPartners. "This acquisition is about unlocking ways to help more patients, and do so more quickly, than either team could do alone."

The transaction is expected to close in the first quarter of 2023, and after closing, Tmunity's employees will join Kite. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

The financial terms of the agreement were not disclosed. Kite will acquire all outstanding shares of Tmunity other than those already owned by Kite. Beginning in the first quarter of 2022, consistent with guidance from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures and expects the transaction with Tmunity to reduce Gilead's GAAP and non-GAAP 2023 EPS by approximately $0.18-$0.22.

Drs. June, Levine, Riley, and Chew are all individual equity holders in Tmunity and as part of this agreement will become paid scientific advisors to Kite. Penn receives sponsored research funding from Tmunity, and as inventors of some of the licensed technology, Drs. June, Levine, Riley, and Chew, along with Penn, may receive additional financial benefits under the license in the future. Penn is also an investor in Tmunity and holds equity interests.

The other major investors in Tmunity include Westlake Village Biopartners, Andreessen Horowitz (also known as "a16z"), Parker Institute for Cancer Immunotherapy, Gilead Sciences, Kleiner Perkins, Resilience, Lilly Asia Ventures, Crystal South, Be The Match, and BrightEdge, the philanthropic impact fund of the American Cancer Society.

Cowen is acting as financial advisor to Kite. Centerview Partners is acting as financial advisor and Cooley and Ropes & Gray are acting as legal advisors to Tmunity.

About Tmunity Therapeutics

​Tmunity is a private, clinical-stage biotechnology company focused on transforming the future of CAR-T therapies by developing the next generation of engineered T-cell therapies, innovative manufacturing process and technologies. Programs are multi-armored with broader therapeutic-index to benefit patients with hematologic malignancies and advanced solid tumors, including those who have relapsed after receiving CAR-T treatment. Integrating the research and development collaboration with the University of Pennsylvania (Penn) with the expertise and demonstrated track record of its founders with Tmunity teams' scientific experience enables efficient implementation of cutting-edge insights in T-cell engineering, manufacturing, clinical development and patient management. Headquartered in Philadelphia -- for more information, visit www.tmunity.com .

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. 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. Gilead acquired Kite in 2017.

Gilead 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 the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived; difficulties or unanticipated expenses in connection with the acquisition and the integration; the risk that Kite and Gilead may not realize the expected benefits of this transaction and the ARLA, including the ability of Kite to further advance the pipeline through the ARLA; the potential effect of any of the foregoing on Gilead and Kite's earnings; 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 September 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 Gilead and Kite, and Gilead and Kite 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 .

Kite Contacts:

Gilead Investor Relations:
Jacquie Ross
investor_relations@gilead.com

Kite Public Affairs/Media:
Tracy Rossin
trossin@kitepharma.com

Tmunity Media Contact:
Kathy Vincent
Greig Communications
Kathy@greigcommunications.com

News Provided by Business Wire via QuoteMedia

GILD
The Conversation (0)
CHMP Adopts Positive Opinion Recommending Hepcludex®  for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

-- If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Gilead Sciences Announces First Quarter 2023 Financial Results

Gilead Sciences Announces First Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 15% Year-Over-Year to $5.7 billion

Biktarvy Sales Increased 24% Year-Over-Year to $2.7 billion

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences recently released its inaugural Environmental, Social and Governance (ESG) Impact Report. This is an evolution of our traditional Year in Review, and uses the ESG framework to highlight the successes and achievements of the prior year

Though the report itself is new, our commitment to practicing ESG is not: We've been guided by Environmental, Social and Governance principles for more than 35 years.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
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

AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024

Planning Underway for Phase 3 Development of Tezepelumab in COPD

Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE ® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20 from 9:15-11:15 a.m. PDT .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Close up 3D rendering of DNA strands.

Biotech Stocks: 5 Biggest Companies in 2024

What are the top biotech companies? The following five stocks have market capitalizations worth billions of dollars and operate in countries all around the globe.

Plus, these big-name biotech players have pipelines stuffed with potentially disruptive products — and enough revenue to recover should some of those products fail.

This means that investors can experience the excitement of biotech investing while minimizing risk. Although returns are never guaranteed, company size can insulate investors from volatility.

Keep reading...Show less
SIRONA BIOCHEM Corporate Update April 2024

SIRONA BIOCHEM Corporate Update April 2024

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") provides the following update:

Dear shareholders,

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Announces Close of Private Placement

Sirona Biochem Announces Close of Private Placement

Vancouver, British Columbia – April 4, 2024 Sirona Biochem Corp . (TSX-V: SBM) (Frankfurt: ZSB) (" Sirona ") has closed its private placement (Private Placement") for gross proceeds of $132,500 CAD. The Private Placement consists of 1,325,000 units, (the "Units") at a price of $0.10 per Unit. Each Unit consists of one common share and one transferable share purchase warrant, each whole warrant exercisable into one additional common share of the Company for a period of 2 years from the date of issue at a price of $0.15 per Share in year one and $0.25 per Share in year two. All securities issued under the Private Placement are subject to statutory hold periods expiring on August 4, 2024.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Need injecting into red and white cell.

How to Invest in Biotechnology (Updated 2024)

Investors interested in the life science sector are well aware of the importance of biotechnology.

From finding cures for diseases to feeding future generations, many areas of day-to-day life are influenced by players in the biotechnology space, and expert projections show the industry's future looks bright.

But how can investors gain exposure to biotechnology? Here’s a brief overview of how to invest in the expanding biotechnology market, from stocks to watch to exchange-traded funds (ETFs).

Keep reading...Show less
Sirona Biochem Announces 2023 Annual Meeting Results

Sirona Biochem Announces 2023 Annual Meeting Results

Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") announces the voting results from its Annual General Meeting of Shareholders (the "Meeting"), held in Vancouver, British Columbia on March 28, 2024. The total number of shares represented by shareholders present in person and by proxy at the Meeting was 26,722,196, representing 10.52% of Sirona's issued and outstanding Common Shares.

All matters put forward to shareholders for consideration and approval, as set out in the Company's Management Information Circular dated 22nd of February, 2024, were approved by the requisite majority of votes cast at the Meeting. These were:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×