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Noticias de BBOT
Eventos de BBOT
BBOT Reports Progress on Three Clinical Programs
"In the first quarter, we reported meaningful progress across all three clinical programs, including encouraging preliminary antitumor activity and a potentially differentiated safety profile for BBO-8520 in lung cancer; anti-tumor activity and a partial response (PR) in pancreatic cancer with BBO-11818 as monotherapy; and confirmation of full target engagement without hyperglycemia for BBO-10203," said Pedro J. Beltran, PhD, Chief Executive Officer of BBOT. "In addition, we announced the publication of BBO-11818 in Cancer Discovery, highlighting its role as a potent and selective pan-KRAS inhibitor. These results and our cash runway into 2028 position us well as we continue advancing our differentiated pipeline to provide new treatment options for patients with limited choices."
BridgeBio Oncology Appoints Pedro Beltran as CEO
BridgeBio Oncology announced the appointment of Pedro Beltran as CEO and Idan Elmelech as COO effective April 20. This transition reflects BridgeBio Oncology entering a new phase of development as the company's three clinical assets enter expansions and combinations across multiple RAS-driven cancers. Beltran joined BridgeBio Pharma in 2020 as senior VP of biology and became chief scientific officer of BridgeBio Oncology in July 2023.
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.
BridgeBio Announces Positive Preliminary Antitumor Data Across Three Programs
BridgeBio Oncology Therapeutics announced positive preliminary safety and antitumor data across its three orally bioavailable, differentiated small molecule RAS and PI3Kalpha programs. The data updates include BBO-8520, a direct inhibitor targeting both the ON and OFF states of KRASG12C; BBO-11818, a panKRAS inhibitor targeting mutant KRAS in both the ON and OFF states, and BBO-10203, a RAS-PI3Ka breaker with a novel mechanism of action designed to inhibit the physical interaction between RAS and PI3Kalpha. BBO-8520 monotherapy in patients with KRASG12C non-small cell lung cancer showed a 65% objective response rate and a 66% 6-month progression-free survival, with 83% of patients eligible for 6-month follow-up remaining on treatment for greater than or equal to6 months. BBO-8520 in combination with pembrolizumab, at active dose levels, demonstrated promising efficacy data and a distinct, differentiated safety profile. BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer and 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. BBO-10203 demonstrated a potentially differentiated safety profile without any observed events of hyperglycemia and without any enrollment restrictions on baseline HbA1c and glucose levels
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