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BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1 Trial for SHP2 Inhibitor BBP-398 in Combination with Bristol Myers Squibb’s OPDIVO® (nivolumab)
– BBP-398, an investigational SHP2 inhibitor, is a potentially best-in-class therapy for use in combination approaches, which is shown by preclinical findings
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"– BBP-398, an investigational SHP2 inhibitor, is a potentially best-in-class therapy for use in combination approaches, which is shown by preclinical findings demonstrating its safety profile, continuous, once-daily dosing regimen and synergistic efficacy to treat cancers driven by KRAS mutations – If successful, the combination of investigational therapy BBP-398 and OPDIVO has the potential to address the serious unmet need for patients with KRAS-mutated non-small cell lung cancer (NSCLC) and other advanced solid tumors with KRAS mutations PALO ALTO, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc., (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient with non-small cell lung cancer (NSCLC) has been dosed in its Phase 1/2 clinical trial of BBP-398, an investigational SHP2 inhibitor, with Bristol Myers Squibb’s OPDIVO® (nivolumab) in advanced solid tumors with KRAS mutations (NCT05375084). KRAS mutations occur in approximately 27% of NSCLC cases and approximately 17% of malignant solid tumors. By combining SHP2 inhibition with KRAS inhibition in patients, there is potential to prevent oncogenesis and overactive cellular proliferation. “SHP2 has been shown to be a key regulator of both tumor and immune cell signaling. In KRAS mutant tumors, SHP2 promotes survival, proliferation and decreased immunogenicity by driving the active form of KRAS, while in immune cells, it associates with PD-1 which leads to immunosuppression in the tumor microenvironment,” said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio. “By partnering with Bristol Myers Squibb on this trial, we hope to show that targeting PD-1 with a two-prong approach can unlock the potent benefits of immunotherapy against this cancer and provide new treatment options for patients who need them.” The Phase 1 study will include a dose escalation period followed by dose expansion, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with OPDIVO. Both the dose escalation and expansion periods will enroll patients who were unresponsive to standard of care with advanced NSCLC with a KRAS mutation. The dose expansion period will evaluate the antitumor activity o...