Bicara Therapeutics Presents Promising New Preclinical Data for Lead Immunotherapy Program BCA101 at the Society for Immunotherapy of Cancer 2021 Annual Meeting

CAMBRIDGE, Mass., November 12, 2021 – 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 that a poster highlighting promising new preclinical data for BCA101, a bifunctional antibody designed to localize the TGF-β trap to EGFR+ tumors currently in an ongoing Phase 1/2 study, will be presented on Saturday, November 13, 2021 at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting in Washington, D.C.

“These data show that BCA101, our first-in-class bifunctional antibody, has strong potential to improve anti-tumor response versus historical EGFR inhibitors by leveraging the interplay between the EGFR and TGF-β signaling pathways. It also suggests synergy in combination with PD-1 inhibitors with the potential to delay and overcome PD-1 resistance,” said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. “These preclinical data are very encouraging for our ongoing clinical trial aimed at giving cancer patients a treatment option with better efficacy and safety than currently available options. We look forward to reporting data from the Phase 1/2 clinical trial in the second half of 2022.”

Details of the poster are as follows:

Title: Development of BCA101, a Bifunctional Antibody Capable of Simultaneously Disabling EGFR and TGF-β Signaling, as a Novel Single-agent Immunotherapy

Poster Number: 874

Category: Novel Single-Agent Immunotherapies
Presentation Date and Time: Friday, November 12, 2021, at 7:00 a.m.

Authors: Srinivas R. Boreddy, Ph.D.; Reshmi Nair; Arindam Banerjee; Anshu Kuriakose; Prashant Kumar Pandey; Chaitali Dey; Meena Shri; Shruthi Rao; Bhadravathi Marigowda Shivakumar; Moni Abraham Kuriakose; Ram Bhupal Reddy; Amrita Suresh; Praveen Reddy Moole; Usha Bughani; Seng-Lai Tan, Ph.D.; Pradip Nair

Key findings: 

• Improved retention of BCA101 in tumor microenvironment compared to TGF-bRII-Fc alone
• BCA101 inhibits TGF-β-induced epithelial to mesenchymal transition and rescues from TGF-β-mediated immune inhibition
• BCA101 demonstrates superior anti-tumor efficacy compared to cetuximab + TGF-bRII-Fc in vivo
• BCA101 demonstrates sustained tumor regression compared to cetuximab in HNSCC-PDX models
• BCA101 exhibited improved efficacy in combination with anti-PD-1 inhibitor in checkpoint-resistant HuNOG-EXL humanized model

BCA101 is currently being evaluated in a Phase 1/2 study as both a monotherapy in patients with EGFR-driven tumors and in combination with pembrolizumab (anti-PD-1) in squamous cell carcinoma of the head and neck (SCCHN) and squamous cell carcinoma of the anal canal (SCCAC). The study is currently enrolling patients in dose escalation and will open dose expansions in 2022.

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 1/2 clinical trial of BCA101, initiated in July 2020, has dosed the first six cohorts of patients in a dose-escalation study with BCA101 as a single agent. A second arm of the study began enrolling patients for combination treatment with BCA101 and pembrolizumab, a PD-1 inhibitor, in January 2021. For more information, please visit www.clinicaltrials.gov.

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 1/2 study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy.

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