Alligator sells cancer antibody for $750,000 upfront after abandoning development
Swedish biotech Alligator Bioscience has agreed to sell its CD40-targeting cancer immunotherapy mitazalimab to Canadian drug developer Biossil for $750,000 (€670,000) upfront, with up to $108 million (€97 million) in contingent milestones and additional royalties. The deal follows Alligator's decision in July to discontinue independent development of the drug and concentrate its resources on another oncology program.
Why it matters: In the Phase 1b/2 OPTIMIZE-1 trial, mitazalimab combined with modified FOLFIRINOX chemotherapy achieved a 42.1% confirmed response rate and median overall survival of 14.9 months in previously untreated metastatic pancreatic cancer, although the absence of a randomized comparator leaves its added benefit uncertain.
“Mitazalimab has shown promising data in pancreatic cancer, and with this agreement it gets an owner that can take mitazalimab forward towards registrational trials. Importantly, Alligator, and thus our shareholders, keep a stake in the future value of the program,” said Søren Bregenholt, CEO of Alligator Bioscience, in a press release.
Zoom in: Under the agreement announced on October 31, Biossil will acquire worldwide rights to mitazalimab across all indications and assume responsibility for future development costs.
- Although pancreatic cancer has been the drug’s main development focus, it has also been investigated in other cancers, including an investigator-initiated study in early-stage breast cancer.
- Alligator could receive up to $3 million (€2.7 million) in total upon the drug’s first regulatory approvals in the EU and U.S. and up to another $105 million (€94 million) linked to worldwide net sales, alongside “mid-single-digit” royalties, with the agreement specifying a $250 million (€224 million) cap. It would also receive an unspecified share of the proceeds if Biossil sells or licenses the drug to another company within two years.
- Biossil specializes in using AI to identify and advance previously discontinued drug candidates. The Toronto-based company raised $153 million (€137 million) in September to expand its clinical development capabilities and acquire additional assets, but has not disclosed a budget or development timeline for mitazalimab.
Backstory: Alligator explained in its October financial report that emerging RAS inhibitors, drugs that block cancer-growth signals from mutated RAS proteins, are expected to change the standard of care for pancreatic cancer, eliminating the commercial rationale for a Phase 3 trial combining mitazalimab with chemotherapy.
The company considers a combination with RAS inhibitors scientifically relevant, but said this would require a new randomized clinical study and a development partner.
Reality check: Most of the potential sale proceeds depend on future approvals and commercial sales.
- The competitive landscape is already changing: the European Medicines Agency recommended approving Revolution Medicines’ RAS inhibitor daraxonrasib in October for metastatic pancreatic cancer after at least one prior treatment, following U.S. approval in August that also covers patients who are not candidates for multiagent systemic therapy.
- Alligator’s shares rose 88% in Monday morning trading in Stockholm, but the sale offers limited immediate financial relief to the company, which reported SEK 41.3 million (€3.8 million) in cash at the end of September following a heavily dilutive rights issue. The company warned in the same report that it lacked secured financing for the next 12 months, which “indicates a material uncertainty that may cast significant doubt on Alligator’s ability to continue as a going concern.”
What’s next: The sale is expected to close within 30 days of signing. Alligator says it will concentrate on its financial interest in dulpatatug (HLX22), a HER2-targeting antibody that China’s Shanghai Henlius Biotech is testing in a Phase 3 trial for gastric and gastroesophageal junction cancer, and expects topline results in the second half of 2027 and potential royalty income from around 2030.
