Bicara Therapeutics Presents Preclinical Data for Precision Immunocytokine, BCA356, at Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting

Data show BCA356 targets CAIX-expressing tumors cells via safe delivery of the pro-inflammatory cytokine IL-12

IND submission anticipated in 2023

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, today presented preclinical data for BCA356, a bispecific designed to deliver safe and efficacious concentrations of an attenuated version of the pro-inflammatory cytokine IL-12 directly to the tumor microenvironment by targeting the tumor antigen carbonic anhydrase IX (CAIX). These data will be presented at the Society for Immunotherapy of Cancer’s (SITC) 37^th Annual Meeting, being held in Boston, Massachusetts from November 8-12, 2022.

“These data demonstrate BCA356’s potential to engage more difficult to treat, less immunogenic solid tumors by leveraging our engineered IL-12’s ability to locally activate the innate and adaptive immune system while avoiding the challenges seen with systemic IL-12 administration, such as cytokine release syndrome,” said Claire Mazumdar, Ph.D. MBA., Chief Executive Officer of Bicara Therapeutics. “These findings support our hypothesis that leveraging CAIX and attenuating IL-12 can offer a potentially safe and efficacious avenue for local IL-12 delivery because if its high expression in various tumor types and minimal expression in healthy tissues.”

Bicara intends to continue advancing BCA356 through Investigational New Drug (IND)-enabling studies and expects to submit an IND application by the end of 2023.

BCA356 Data Highlights:

• Immunohistochemistry studies confirm high CAIX expression across tumor types, notably in clear cell renal carcinoma.
• BCA356 specifically targets CAIX-expressing tumor cells, and similar to wild type IL-12 cytokine, has the potential to reduce tumor proliferation with optimal activation of additional pro-inflammatory cytokines.
• BCA356 attenuated IFNγ release by stimulated peripheral blood mononuclear cells (PBMCs), activated NK cell and pSTAT4 expression in CD8 T cells as compared to IL-12 wild type.
• In co-culture assays, BCA356 demonstrated comparable cytotoxicity to wild type IL-12 without significant cytokine release.
• Efficacy studies in humanized and transgenic mice models confirmed that BCA356 is efficacious and safe in CAIX-overexpressing tumor bearing mice.

SITC Presentation Details:

Presentation type: Poster
Title: A novel bispecific BCA356 targeting tumor antigen CAIX conjugated to an attenuated IL12 demonstrates pre-clinical efficacy with potential for limited systemic toxicity
Presenting author: Pradip Nair, Ph.D.
Session: Novel Single-Agent Immunotherapies – Poster #1368
Session Date and Time: Friday, Nov 11: 9:00 AM to 8:30 PM

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. More information is available at www.bicara.com.

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