On November 7, 2022 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, reported 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) (Press release, Bicara Therapeutics, NOV 7, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-presents-preclinical-data-for-precision-immunocytokine-bca356-at-society-for-immunotherapy-of-cancer-sitc-2022-annual-meeting [SID1234623224]). These data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, Massachusetts from November 8-12, 2022.

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"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, PhD 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.