Biocon Launches Bifunctional Antibody IO Subsidiary Bicara with $40 Million

Bicara CEO Claire Mazumdar, Courtesy of Bicara The

Bicara CEO Claire Mazumdar, Courtesy of Bicara The

Cambridge-based Bicara Therapeutics launched with a $40 million investment from its parent company, Biocon, to advance its bifunctional antibodies targeting both tumors and the immune system in cancer patients who are refractory to checkpoint inhibitors.

Bicara CEO Claire Mazumdar, Courtesy of Bicara Therapeutics

Cambridge-based Bicara Therapeutics launched with a $40 million investment from its parent company, Biocon, to advance its bifunctional antibodies targeting both tumors and the immune system in cancer patients who are refractory to checkpoint inhibitors.

The company’s lead asset, which inhibits both EGFR on tumors and the immunosuppressive cytokine TGFβ, began first-in-human testing last year as both a monotherapy and in combination with Keytruda (pembrolizumab) for patients with EGFR-driven solid tumors. According to the company, TGFβ promotes tumor growth in the presence pf EGFR, and lead asset BCA101 disables TGFβ in the tumor microenvironment. BCA101 is currently in the early dose escalation part of a 292-patient Phase 1 trial in patients with standard-of-care-refractory squamous cell carcinomas, and Bicara is planning to move into the dose expansion part in patients with other solid tumors by the end of this year.

Although they are designed differently, bifunctional antibodies are similar to bispecific antibodies, which are showing promise in the clinic. Last month, Immunocore announced it was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for its bispecific tebentafusp, a T-cell receptor fused to an anti-CD3 antibody fragment, following the release of interim results from a Phase III trial in patients with metastatic uveal melanoma (mUM). The company said tebentafusp met statistical significance on its primary endpoint of overall survival, the first such Phase III data showing a survival benefit for any bispecific antibody in solid tumors.

There have been at least 38 clinical trials for cancer patients receiving immune cell-engaging bispecific antibodies.

India-based Biocon’s interest in immune-targeted hybrid molecules dates back to at least 2013, when the company partnered with Johns Hopkins University spinout IATRICa to codevelop immunoconjugates for cancer and infectious diseases. IATRICa scientific cofounders and Johns Hopkins researchers Atul Bedi and Rajani Ravi published preclinical data in Nature Communications in 2018 showing bifunctional antibody-ligand traps that fused either anti-CTLA-4 or anti-PD-L1 antibodies to a TGFβ receptor II ectodomain had stronger antitumor effects in mice than checkpoint inhibitors Yervoy (ipilimumab), Opdivo (atezolizumab), or Bavencio (avelumab).

Bedi also cofounded Y-Trap, which announced a deal in 2019 to codevelop antibody-ligand traps with Merck KGaA. A spokesperson for Bicara said its molecules were developed in-house and Bicara owns all rights and licenses.

According to the spokesperson, although Biocon is the only current investor in Bicara, it will look to add other investors in a financing syndicate in the future. The $40 million investment from Bicara will fund BCA101 and at least three other bifunctional antibody cancer immunotherapies in preclinical development.

MORE ON THIS TOPIC