On May 19, 2021 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to spur a potent and durable immune response in the tumor microenvironment, reported that a digital presentation with clinical data from its ongoing Phase 1/2 study of BCA101, a bifunctional antibody designed to target the TGFβ trap to EGFR+ tumors, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, to be held virtually from June 4-8, 2021 (Press release, Bicara Therapeutics, MAY 19, 2021, View Source [SID1234580318]).

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"We’re excited to share clinical data on our lead therapeutic candidate BCA101, a first-in-class antibody with strong potential to achieve superior anti-tumor efficacy by promoting immune response directly at the tumor site," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "Data from the ongoing Phase 1/2 clinical trial of BCA101 support our biologic rationale and point to the potential to provide treatment options for patients who have not benefitted from other approaches within the standard of care."

Details of the digital presentation are as follows:

Abstract: 3074
Title: First-in-human phase I study of the bifunctional EGFR/TGFβ fusion protein BCA101 in patients with EGFR-driven advanced solid cancers
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Lead Authors: Filip Janku, M.D. and Philippe Bedard, M.D.

Key findings:

BCA101 demonstrates target engagement at the tumor site and decreases SMAD2 phosphorylation as a proximal PD endpoint.
A partial response has been observed in combination with pembrolizumab in a PD-(L)1 naïve subject.
BCA101 achieves dose-proportional PK and exhibits encouraging biomarkers in both plasma and tissue.
Dose escalation currently continues at the 1250mg dose level in single agent and 750mg dose level in combination with pembrolizumab.
The ASCO (Free ASCO Whitepaper) e-poster website will be launched on Friday, June 4, 2021, and will remain available for viewing through Tuesday, July 6, 2021. Bicara’s presentation will also be available on the Bicara website.

About BCA101

BCA101 is a first-in-class EGFR / TGFβ-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 TGFβ, 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 four 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.