The small, Lexington, MA-based biotech Curis ($CRIS) is jumping onto the increasingly popular immuno-oncology bandwagon, handing over a chunk of its stock and promising more than $100 million in milestones to Bangalore-based Aurigene if they can successfully take a small molecule approach to the cancer field and advance a new program through preclinical and clinical development and on into the market. And it's getting a second targeted small molecule for cancer that is intended to hit IRAK4.
Curis's new deal centers on one of the hottest drug targets in the industry: PD-L1. Pharma giants Roche ($RHHBY) and AstraZeneca ($AZN) are both hustling along their own pioneering drugs for this target, which has shown great promise in spotlighting cancer cells for destruction by the immune system. Merck ($MRK) and Bristol-Myers Squibb ($BMY), meanwhile, have achieved breakthrough approvals for their own checkpoint inhibitors, which target PD-1. But with analysts touting the emergence of a $30 billion market for IO drugs, there's a whole host of companies jumping into the field. And little Curis, with a market cap of $120 million, is hoping to pick up some positive attention for its oral approach.
Curis CEO Ali Fattaey hit that theme hard in a call with analysts this morning, citing plans to file INDs for the two small molecule programs, including the checkpoint inhibitor, later this year. Curis is giving Aurigene 17 million shares, or 20% of its common stock (worth about $24 million), for the partnership. Then there's a bunch of biobucks on the table: Up to $52.5 million for each of the first two preclinical drugs, up to $50 million each for the next two and up to $140 million for each new therapy after that.
"We also have an eye on commercializing these drugs on our own," Fattaey said in the call.
If so, the biotech has a long way to go and faces some tough odds. And Curis has had a number of setbacks along the way. The FDA temporarily put its lead R&D program on partial hold due to safety concerns following the death of a patient in a Phase I study of solid tumors and lymphoma. Regulators then lifted the hold on CUDC-427 last spring. The company snagged the drug in late 2012, paying Genentech $9.5 million up front and promising to pay milestones based on the first sales of an approved product.
Fattaey also noted in today's call that Debiopharm is returning the tumor drug Debio 0932. Its web site notes that its partner is punting the program after terminating a Phase I/II study.
"Our scientists at Aurigene have established a novel strategy to address immune checkpoint targets using small molecule chemical approaches, and have discovered a number of candidates that modulate these checkpoint pathways, including PD-1/PD-L1," noted Aurigene CEO CNS Murthy in a statement. "We have established a large panel of preclinical tumor models in immunocompetent mice and can show significant in vivo anti-tumor activity using our small molecule PD-L1 antagonists. We are also in the late stages of selecting a candidate that is a potent and selective inhibitor of the IRAK4 kinase, demonstrating excellent in vivo activity in preclinical tumor models."
- here's the release