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Bicara Therapeutics Raises $165M in Oversubscribed Series C Financing

NEW YORK – Bicara Therapeutics on Tuesday said it completed an oversubscribed $165 million Series C financing round to support development of its EGFR/TGF-β inhibitor BCA101 as a treatment for human papillomavirus (HPV)-negative cancers.

Braidwell and TPG co-led the financing, in which all of Bicara's Series B investors also participated as well as new investors Deerfield Management, Fairmount, and Aisling Capital. Bicara has raised $273 million in 2023 with the completion of this Series C round.

The Massachusetts-based company is studying BCA101 in a Phase I/II trial as a monotherapy and in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab). In the initial dose-escalation portion of the study, researchers tested single-agent BCA101 in EGFR-driven solid tumors that do not respond to standard treatments, and the BCA101-Keytruda combination in refractory patients with squamous cell head and neck or anal cancers. In the dose-expansion portion of this study, researchers are testing single-agent BCA101 at the recommended dose in various solid tumors and in combination with Keytruda in squamous cell head and neck cancer and anal cancer. Patients also have to provide tumor samples for PD-L1 biomarker analysis.

At a medical conference earlier this year, Bicara reported that in the dose-expansion phase of this trial, BCA101-Keytruda demonstrated clinically meaningful anti-tumor activity and a tolerable safety profile in patients with HPV-negative, relapsed and metastatic, squamous cell head and neck cancer.

"Our proof-of-concept data in frontline HPV-negative [head and neck cancer], a very difficult patient population to treat, underscore the promise of BCA101 as a new precision therapeutic option for these patients," Bicara CEO Claire Mazumdar said in a statement.

Bicara said it intends to continue developing BCA101 in other HPV-negative cancers, including advanced squamous non-small cell lung cancer and cutaneous squamous cell cancer. Next year, the company is expecting additional readouts of the drug's activity in other tumor types from the ongoing Phase I/Ib trial.