Backed by Indian biosim giant Biocon, bispecifics player Bicara debuts with $40M and solid tumors on the radar
Best known stateside for its biosimilars pact with Mylan, Indian generics player Biocon has long run a much smaller R&D unit for in-house oncology drugs. Now, with at least one of those candidates showing promise, Biocon is propping up a US-based biotech to get things off the ground.
Biocon will shell out $40 million and spin off bispecific antibody player Bicara — headquartered in Cambridge, MA — which is currently testing its lead compound alongside Merck’s Keytruda against solid tumors, the company said Monday.
Bicara’s lead candidate, an EGFR/TGFβ-trap bispecific antibody dubbed BCA101, entered Phase I/II testing in July in the US and Canada for patients with advanced EGFR-driven solid tumors who have not responded to standard of care.
BCA101 works by targeting both EGFR proteins on the surface of cells and also “trapping” TGFβ — a multifunctional cytokine implicated in immune suppression — in the tumor microenvironment. Bicara is testing the bispecific as a solo therapy and in combination with Keytruda for patients previously treated with chemotherapy, immune checkpoint inhibitors or targeted therapies, the biotech said. The company expects to launch the dose-escalation phase of that study in the back half of the year.
Seeing an oncology spinoff from Biocon may strike US market watchers as odd given its reputation for biosims. But according to CEO Claire Mazumdar, the Indian multinational has long been dedicating resources to its R&D branch.
“For as long as they’ve been around, (Biocon has had) a dedicated R&D group focused on novel antibodies and novel large molecules,” Mazumdar said. “The idea was to build out a separate company to really get the resources and attention it deserved with the idea that building the leadership team in the US and bringing the clinical development to the US would be a really great strategy. We very much view Biocon as our lead strategic investor, and they’re really interested in bringing the molecule with us side by side and as far as we can bring it.”
In a working arrangement perhaps well suited for the pandemic, Bicara’s executive team is housed in Cambridge, with a research team working under contract from Biocon back in Bangalore. It’s an unusual setup for a nimble, early-stage biotech but one modeled on Big Pharma’s global setup and well suited for Bicara’s mission, COO Ryan Cohlhepp told Endpoints News.
“It’s a unique situation for a Cambridge startup, but it’s not necessarily unique in the Big Pharma model,” Cohlhepp said. “What we’re doing is taking those models — sort of the best of Biocon — and thinking through the site head model, how we’re going to be able to build the culture between the two organizations, taking the innovation of a Cambridge startup and leveraging some of the work practices of a multinational.”
The Bangalore team currently sports 65 scientists working across the development spectrum, Mazumdar said. The wet labs there are working on building Bicara’s bispecifics pipeline, and Mazumdar said that team is on track despite the 10-hour time zone difference from its leadership team.
“Moving into a remote and virtual world, we were very well set up to do that when Covid hit and despite the pandemic we’ve been able to achieve some real milestones along the way,” Mazumdar said.
The company scored its first IND in February 2020 right as the pandemic was taking off and dosed its first patient at MD Anderson Cancer Center in Houston in July, just as the virus locked down the city.
“Despite the fact we haven’t been able to go see the team all the time in India, our CSO would say we’re moving with the urgency that we want to have,” she said.
Mazumdar, a former founder at Rheos Medicines and Third Rock senior associate, is joined by a senior leadership team that includes Cohlhepp, another Rheos veteran who formerly worked with Takeda Oncology. The company’s science will be led by CSO Seng-Lai “Thomas” Tan, a veteran of Elstar Therapeutics and Forma Therapeutics, while bluebird bio and Pfizer veteran Liviu Niculescu will take the clinical lead as CMO.
The company’s board features Biocon founder Kiran Mazumdar-Shaw — also Claire Mazumdar’s aunt — as well as F. Stephen Hodi, a Harvard professor and Dana-Farber Cancer Institute professor, and Nils Lonberg, formerly VP of oncology biology discovery at Bristol Myers Squibb.