NEW YORK – Massachusetts-based biotech Bicara Therapeutics officially launched on Monday with $40 million in seed funding from Indian pharma company Biocon and a pipeline of bifunctional antibody cancer immunotherapy candidates.
Bicara's lead candidate, BCA101, is a bifunctional antibody targeting EGFR and TGF-beta. The company is evaluating BCA101 in a Phase I/II study as a monotherapy and in combination with pembrolizumab (Merck's Keytruda) as a treatment for advanced EGFR-driven solid tumors that no longer respond to standard treatments. The company started the dose-escalation portion of the trial at US and Canadian cancer centers in July 2020 and expects to begin the dose-expansion portion in the second half of 2021.
In the dose-expansion portion, Bicara will enroll four cohorts investigating BCA101 as a single agent in PD-L1 negative, EGFR-amplified squamous cell lung cancer; RAS wild-type, microsatellite stable colorectal cancer; EGFR-amplified triple-negative breast cancer; and any solid tumor with either a KRAS G12D or G13D mutation. In this part of the study, researchers will also explore the activity of BCA101 and pembrolizumab in head and neck cancer and anal cancer.
"Resistant tumors often survive because they have manipulated the complex biochemistry of the tumor microenvironment to suppress an immune response," Thomas Tan, CSO of Bicara, said in a statement. "Bicara's bifunctional antibodies are expertly designed to overcome this defense system and spark a strong, highly localized immune attack. They have real potential to make a difference for patients with intractable cancers."
Bicara will operate as a subsidiary of Biocon, a pharma company focused on treatments for cancer, diabetes, and autoimmune diseases. In addition to CSO Tan, Claire Mazumdar, one of the founders of the immune-metabolism-focused firm Rheos Medicines and a senior associate at Third Rock Ventures, will serve as Bicara's CEO; and Liviu Niculescu, previously the head of clinical development for oncology and global medical affairs at Bluebird Bio, will be chief medical officer.