• 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 of BBP-398 in combination with OPDIVO.

In May 2022, BridgeBio entered into an exclusive license agreement with Bristol Myers Squibb to develop and commercialize BBP-398 in oncology worldwide, except for in mainland China and other Asian markets. These territories are part of BridgeBio’s separate strategic collaboration with LianBio announced in 2020. The 2022 agreement with Bristol Myers Squibb expands upon the earlier agreement between the companies signed in 2021 to investigate the combination of BBP-398 with OPDIVO^® (nivolumab) in patients with advanced solid tumors with KRAS mutations.

Additionally, BridgeBio has a non-exclusive clinical collaboration with Amgen to evaluate the combination of BBP-398 with LUMAKRAS in patients with advanced solid tumors with the KRAS^G12C mutation.

BBP-398, as a monotherapy or in combination with other targeted therapies, could potentially be a promising therapy for patients with KRAS mutations. Initial Phase 1 data from the ongoing BBP-398 trial is expected in 2023.

OPDIVO^® (nivolumab) is a trademark of Bristol-Myers Squibb Company.

About BBP-398

BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers and was founded through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. In May 2022, BridgeBio entered an exclusive license with Bristol Myers Squibb to develop and commercialize BBP-398, a potentially best-in-class SHP2 inhibitor. Additionally, BridgeBio has a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal and pancreatic cancer, in mainland China and other Asian markets and clinical collaborations; with Bristol Myers Squibb for combination with OPDIVO^® (nivolumab) in patients with advanced solid tumors with KRAS mutations; and with Amgen for combination with LUMAKRAS^® (sotorasib), Amgen’s KRAS^G12C inhibitor, in patients with advanced solid tumors with KRAS^G12C mutations.

About BridgeBio Pharma, Inc.

BridgeBio Pharma (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.

BridgeBio Pharma, Inc. Forward-Looking Statements

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding the clinical and therapeutic potential of our clinical development program for BBP-398 in multiple oncology indications, the timing and success of this clinical development program, the progress of our ongoing and planned clinical trials of BBP-398, the frequency of occurrence of KRAS mutations, the ability of combining SHP2 inhibition with KRAS^G12C inhibition in patients with the KRAS^G12C mutation to prevent oncogenesis and overactive cellular proliferation, the availability of initial Phase 1 data from the ongoing BBP-398 trial expected in 2023, our ability to provide substantial relief for cancer patients in need, the promise of targeted therapies for patients with KRAS mutations, the success and status of current and future relationships with third-party collaborators and academic partners, including the continuing success of our clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398 with OPDIVO^® (nivolumab), and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our clinical trials not being indicative of final data, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, the FDA or other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the continuing success of our collaboration with Bristol Myers Squibb, Amgen and other third parties, our ability to enter into future collaboration agreements, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, as well as those risks set forth in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K and BridgeBio’s other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Contact:
Vikram Bali
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