Study will evaluate BCA101 in patients with head and neck squamous cell carcinoma, squamous cell carcinoma of the anal canal and cutaneous squamous cell carcinoma

Preliminary results expected in H2 2022

CAMBRIDGE, MA, USA I February 22, 2022 I Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, today announced the initiation of dose expansion cohorts of the Phase 1/1b study evaluating BCA101 in patients with head and neck squamous cell carcinoma (HNSCC), squamous cell carcinoma of the anal canal (SCAC) and cutaneous squamous cell carcinoma (cSCC).

BCA101 is a bifunctional antibody designed to target a TGF-β trap to EGFR-positive tumors by inhibiting epidermal growth factor receptor (EGFR) and disabling TGF-β directly at the site of the tumor, ideally achieving superior anti-tumor efficacy with an improved therapeutic window.

“This is the first-in-human trial of the first bifunctional molecule targeting EGFR and TGF-β. We are pleased that the observed safety, pharmacokinetic, pharmacodynamic and efficacy profiles of BCA101 to date have enabled us to declare a recommended dose for expansion,” said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. “The results thus far from this early clinical study have been very encouraging in our efforts to offer new potential treatment options to patients with cancer, and we are grateful to the study’s patients, their families, and investigators whose trust, time, dedication and hard work have been crucial in reaching this milestone.”

The dose expansion arm of the study follows the successful completion of a Phase 1/1b open-label, multicenter dose escalation study of BCA101 in patients with EGFR-driven advanced solid tumors that identified a recommended dose. It will assess the efficacy, safety and tolerability of BCA101 at 1500mg intravenously weekly in three initial expansion cohorts. BCA101 will be administered in combination with the immune checkpoint inhibitor pembrolizumab as first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cSCC who have received previous anti-PD-1 therapy will be treated with BCA101 as a single agent. Data from the dose escalation part of the study will be presented at a future scientific conference later in 2022.

“While these are early clinical trials, we have observed an intriguing efficacy signal for BCA101 in both the preclinical and interim phase 1 clinical data, including among those with highly refractory cancers,” said Dr. Glenn J. Hanna, Assistant Professor of Medicine at Harvard Medical School, principal investigator of the BCA101 study. “We look forward to evaluating the efficacy of BCA101 in the selected expansion cohorts and to subsequently exploring ways to bring this potential therapeutic option to our patients.”

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b clinical trial of BCA101, initiated in July 2020, has enrolled cohorts of patients in a dose-escalation study with BCA101 as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor and a recommended dose for expansion has been declared. For more information, please visit study number NCT04429542 at

About Bicara Therapeutics

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of immunotherapy. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy.

SOURCE: Bicara Therapeutics