Just months after negotiating the sale of autologous CAR-T pioneer Kite Pharma to Gilead for $11.9 billion, two of the executives who led Kite to success are back with a new company, a clinical-stage asset, and a portfolio of 16 preclinical therapeutic candidates, as well as substantial financing. This time, the focus is the development of “off-the-shelf,” allogeneic CAR-T treatments in an attempt to provide patients with faster access, lower-cost versions of the immuno-oncology therapies addressed by Kite.
In collaboration with Pfizer, Arie Belldegrun, former Kite CEO, and David Chang, former Kite EVP, R&D and CMO, have created Allogene Therapeutics. Their aim: to expedite the development of Pfizer’s extensive allogeneic CAR-T portfolio, in-licensed from and partnered with Cellectis in 2014.
The assets acquired from Pfizer include rights to Cellectis’ UCART19, which is currently in Phase 1 testing in CD19+ hematologic malignancies, with Phase 2 trials slated for next year in both Europe and the United States. To fund technology and product development, Allogene has raised a $300 million Series A investment from a syndicate that includes Belldegrun and Chang, and includes a 25% ownership stake from Pfizer. While Allogene assumes the full development responsibilities for the CAR-T assets that Pfizer licensed from Cellectis, Pfizer remains eligible to receive clinical and commercial milestones on the same originally negotiated terms of $185 million per target and tiered, high single-digit, royalties on eventual net commercial sales.
Allogene’s aim is to perfect a gene-editing process that can efficiently enable the creation of 50-100 allogenic CAR-T doses from a single, healthy immune cell donor. Such CAR-Ts could be processed ahead of time in batches and stored at treatment sites, ready to be administered to any patient; in contrast, the current autologous CAR-T manufacturing processes requires shipping cells from the patient treatment center to processing facilities and back as activated CAR-Ts, which adds substantial time and expense to the therapy. Belldegrun and Chang believe they will have a good shot at initiating serious commercialization work for their technology by late 2021 or 2022. As part of Allogene’s formation, the new company has gained a team of over 50 Pfizer scientists and investigators, and they are busy lining up a string of other top-notch scientists in the cell therapy space.
Allogene is far from alone in developing allogeneic CAR-Ts. Gilead transacted its own deal with Sangamo Therapeutics back in February, to use Sangamo’s gene-editing technology in the development of 10 or more allogeneic CAR-T products. And there are a number of smaller companies pursuing such off-the-shelf approaches, as cited by BioInformant News. But clearly the resources and financial power behind Allogene immediately position this start-up among the leaders in the development of off-the-shelf CAR-T treatments.