BridgeBio Oncology Therapeutics Inc (BBOT) News & EventsBBOTBridgeBio Oncology Therapeutics Inc

BridgeBio Oncology's BBO-11818 Receives FDA Fast Track Designation

BridgeBio Oncology Therapeutics announced that the FDA has granted Fast Track designation to BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma. "Receiving Fast Track designation from the FDA for BBO-11818 in KRAS-mutant pancreatic ductal adenocarcinoma reflects the importance and urgency of accelerating the development of our pan-KRAS inhibitor in this serious disease," said Yong Ben, MD, Chief Medical and Development Officer. "Pancreatic cancer remains one of the most difficult-to-treat malignancies. KRAS mutations are present in the vast majority of cases, yet patients have had few targeted options. This designation will help us collaborate closely with the FDA to advance BBO-11818 as efficiently as possible for patients who need new options." This designation follows preliminary data, first released in January 2026, in which BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer. In addition, anti-tumor activity was observed across dose levels and tumor types with tumor reductions at higher dose levels with a generally favorable, differentiated safety profile in dose escalation.

BridgeBio Announces Preclinical Data for BBO-11818

BridgeBio Oncology Therapeutics announced the publication of preclinical data describing the discovery and characterization of BBO-11818, a panKRAS inhibitor targeting KRAS in both the ON and OFF states, with significant therapeutic potential for patients with KRAS mutant cancers. The publication, titled "Discovery of BBO-11818, a Potent and Selective Non-covalent Inhibitor of (ON) and (OFF) KRAS with Activity Against Multiple Oncogenic Mutants" was published in the peer-reviewed journal Cancer Discovery, a journal of the American Association for Cancer Research's. The preclinical findings in this publication highlight the key properties BBO-11818 and its potential to address critical limitations associated with other compounds targeting mutant KRAS. Unlike several existing inhibitors that primarily target the inactive GDP-bound state, BBO-11818 potently binds and inhibits KRAS in both its ON and OFF states, as demonstrated through structural analysis, surface plasmon resonance, and functional assays. By targeting the active state of KRAS, BBO-11818 may overcome a critical resistance mechanism observed with current KRAS inhibitors, in which tumors upregulate KRAS expression or activate upstream signaling to sustain pathway activation. Data demonstrate potent activity against multiple clinically relevant KRAS mutants, including KRASG12D, KRASG12V, and KRASG12C, with high selectivity for KRAS, exhibiting greater than500-fold selectivity over other RAS isoforms. BBO-11818's activity across a broad range of KRAS mutants is designed to help prevent the emergence of resistance driven by secondary activating KRAS mutations that can limit the efficacy of allele-specific inhibitors. In addition, its high specificity for KRAS may support improved tolerability and greater potential for combination with other therapeutic agents. Monotherapy studies show robust anti-tumor activity across multiple in vitro and in vivo models of KRAS mutant solid tumors, including colorectal, pancreatic, and lung cancers. BBO-11818 also demonstrated strong combination potential with immune checkpoint inhibitors, anti-EGFR antibodies, and BBO-10203, the company's RAS:PI3Kalpha breaker compound. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. Initial Phase 1 monotherapy data were announced in January 2026, demonstrating encouraging early anti-tumor activity across dose levels and tumor types, including a confirmed partial response in a patient with pancreatic ductal adenocarcinoma with a 56% tumor reduction. The company plans to provide additional data updates in the second half of 2026 and to study the combination of BBO-11818 with BBO-10203 later in 2026. The discovery and preclinical characterization of BBO-11818 is the result of a collaborative effort between BBOT, the RAS Initiative at Frederick National Laboratory, and Lawrence Livermore National Laboratory.