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Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.
On April 3, 2018, Pfizer and Allogene Therapeutics, a biotechnology company, announced that they have entered into an asset contribution agreement, under which Pfizer will transfer assets related to allogeneic chimeric antigen receptor T-cell (CAR-T) therapy in its portfolio to Allogene.
Under the agreement, Allogene will receive from Pfizer the rights to 16 preclinical CAR-T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR-T therapy that is being developed for treating CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I development. UCART19 utilizes TALEN gene-editing technology pioneered and owned by Cellectis.
Allogene and Servier intend to initiate Phase II studies in 2019. Under terms of an original development agreement, Allogene will have exclusive rights to develop and commercialize UCART19 in the United States, while Servier will retain exclusive rights for all other countries.
The new agreement with Pfizer poses an opportunity for Pfizer to support the continued development of allogeneic CAR-T therapy in a more focused way. The company will continue to participate financially in the development of the CAR-T portfolio through a 25% ownership stake in Allogene. Separately, Pfizer continues to have an 8% ownership stake in Cellectis through an equity agreement entered into in 2014.
Allogene, a Two River portfolio company, was co-founded and led by former executives of Kite Pharma and is positioned to catalyze the development of this allogeneic cell therapy portfolio. Arie Belldegrun, MD, founder and former chairman, president, and CEO of Kite, will serve as executive chairman of Allogene, and David Chang, MD, PhD, former executive vice president, research and development, and chief medical officer of Kite, will serve as Allogene’s president and CEO.
Allogene was formed with Series A financing of $300 million from an investment consortium that includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others. TPG, Vida Ventures, BellCo Capital, and Pfizer will be represented on the Allogene board of directors. Closing is expected in the second quarter of 2018, subject to closing conditions.
“The allogeneic CAR-T platform represents a potentially transformative approach to treating cancer, and we are very excited about what the future may hold for this area of research,” said Robert Abraham, senior vice president and group head, Oncology Research & Development, Pfizer, in a company press release. “We believe that under the strong scientific, clinical development, and regulatory expertise of Allogene’s leadership team, the portfolio of CAR-T assets contributed by Pfizer will be well-positioned to rapidly advance into potential innovative new therapies, and ultimately to reach patients in need more quickly.”
“While there is important work underway across the industry for next-generation autologous cell therapy, Allogene hopes to bring about the next revolution in the field with the successful development of allogeneic cell therapy and the potential for greater and faster patient access,” said Belldegrun in the release. “Under the direction of David Chang, an extraordinary scientist, physician, and life-sciences business executive with [more than] 30 years of unprecedented experience in developing cancer treatments, Allogene is poised to potentially lead the development of one of the most exciting opportunities in our industry today.”
“Last year, Kite’s anti-CD19 CAR-T therapy became the first autologous CAR-T treatment to be approved by [FDA] for adult patients with aggressive non-Hodgkin lymphoma. Many believed the idea was rooted in science fiction, but science fiction became a reality,” said Chang in the release. “We believe that this partnership among leaders in the field-visionaries, industry forerunners, venture capitalists, and researchers-has the potential to accelerate the development of allogeneic T cell therapy, making it a reality and forever changing how cancer is treated.”
“Investing in innovation and R&D has long been a hallmark of who we are as investors, and for many years, we’ve been partnering with dynamic companies that are driving meaningful change in healthcare,” said Todd Sisitsky, managing partner, TPG Capital, in the company press release. “We believe CAR-T is one of the most exciting spaces within the pharmaceutical landscape today, and we are thrilled to partner with a best-in-class management team and industry leaders to invest in this potentially groundbreaking opportunity.”
“As a pioneer of the allogeneic approach and expert in gene editing, the Cellectis team is excited by this agreement and eager to continue this groundbreaking work with Allogene’s experienced team, striving to accelerate the development of the portfolio and to continue along the path of making these treatments available to patients as soon as possible,” said Dr. André Choulika, Cellectis CEO.
“I believe that the recognized expertise of the Allogene team in the field of CAR-T will be of benefit to the development of UCART19, for which Servier is the sponsor of two clinical studies,” commented Olivier Laureau, President of Servier Group. “The development of off-the-shelf allogeneic CAR T therapy in the field of oncology initiates a revolution that could potentially expand access of such innovative treatment to a larger number of oncologists and their patients.”
Pfizer reports that allogeneic CAR-T cell therapies have the potential to become the next advancement in anti-cancer agents, eliminating the need to create personalized therapy from a patient’s own cells. Allogeneic CAR-T cell therapies are developed from cells of healthy donors and stored for “off-the-shelf” use in patients. This is expected to simplify the manufacturing process and reduce waiting time for patients, according to the company.