Allogene Therapeutics, a biotech developing a cell therapy made from donor cells, is laying out IPO plans to finance more tests of its experimental cancer treatment.
South San Francisco, CA-based Allogene made waves this year when it launched with a huge $300 million Series A round. It has now set a preliminary $100 million IPO target in documents filed with securities regulators Friday. The company has applied for a listing on the Nasdaq exchange under the stock symbol “ALLO.”
Allogene is aiming to advance cancer cell therapy by using donated human immune cells to treat the disease. The current cell therapy for cancer, CAR-T therapy, involves engineering a patient’s own T cells to better recognize and kill tumors, then reintroducing those cells back into the patient. Novartis (NYSE: NVS) and Gilead Sciences (NASDAQ: GILD) received FDA approvals last year for their respective CAR-T therapies to treat advanced forms of blood cancers. Allogene—founded by former executives from CAR-T pioneer Kite Pharma, which was bought by Gilead—is developing an “off-the-shelf” CAR-T, in which the T cells come from donors. This approach is meant to be easier and less expensive than the one used to produce the Novartis and Gilead treatments.
The lead Allogene cell therapy, UCART19, has been tested in a Phase 1 clinical trial that enrolled patients with acute lymphoblastic leukemia (ALL). The company is now planning to advance the therapy into Phase 2 studies in the second half of 2019 in adult and pediatric patients with ALL that has relapsed or has not responded to initial treatment.
Allogene says in the prospectus that this study could be a registrational trial, meaning it could be enough to support a filing for FDA approval. But the company adds that it has no agreement or guidance from the regulator that these trials will be sufficient for regulatory review.