BridgeBio Announces Clinical Collaboration with Bristol Myers Squibb to Study BBP-398, a Potentially Best-in-class SHP2 Inhibitor, in Combination with OPDIVO® (nivolumab) in Advanced Solid Tumors ...

PALO ALTO, Calif., July 27, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with OPDIVO® (nivolumab) in patients with advanced solid tumors with KRAS mutations with the hope of providing an effective new treatment option for patients with difficult-to-treat cancers. 

The collaboration will also include the initiation of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRAS^G12C inhibitor as triplet therapy in non-small cell lung cancer (NSCLC) with KRAS mutations, as first- and second-line treatment options. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Bristol Myers Squibb will provide nivolumab. Both BridgeBio and Bristol Myers Squibb will share the cost of clinical development activities for the combination trial.

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. Overactivity of the SHP2 pathway, often driven by distinct genetic mutations, is a critical contributor to many forms of cancer, and is a mechanism of resistance to several targeted therapies.

"Cancers that are driven by hyperactive MAPK signaling, including certain RAS mutations such as KRAS^G12C, may be sensitive to SHP2 inhibition," said Frank McCormick, Ph.D., chairman of oncology at BridgeBio.  "With this collaboration, we hope to better elucidate our SHP2 inhibitor's ability to enhance immuno-oncology and other targeted therapies to potentially provide options for patients with difficult-to-treat cancers as quickly and safely as possible."

KRAS mutations occur in approximately 27% of NSCLC cases and approximately 17% of malignant solid tumors. Combination of anti-PD-1 treatment with BBP-398, and other targeted therapies, could be promising for patients with KRAS mutations.

"A priority of ours is to develop innovative medicines that target tumor intrinsic mechanisms including the MAPK pathway," said Emma Lees, senior vice president, oncology research at Bristol Myers Squibb. "We look forward to beginning the clinical exploration of the mechanistic rationale and therapeutic benefit from combining robust MAPK pathway inhibition and PD-1 blockade in KRAS mutant NSCLC."

"We are pleased to collaborate with Bristol Myers Squibb and advance BridgeBio's larger strategy to fully interrogate BBP-398, a potentially best-in-class SHP2 inhibitor, as an ideal combination agent for certain cancer patients given its profile and potential for once daily dosing," said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio.  "By partnering with one of the strongest oncology players in the industry, we hope to provide a new therapeutic approach to cancer patients in need."

BridgeBio is currently advancing its Phase 1 clinical trial in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes.

OPDIVO® is a trademark of Bristol-Myers Squibb Company. 

About BBP-398

BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division. BridgeBio previously entered into a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as NSCLC, colorectal and pancreatic cancer, in mainland China and other major Asian markets.

About BridgeBio Pharma, Inc.

BridgeBio Pharma (BridgeBio) is a 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 over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's two approved therapies. 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.

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 and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding the success of our non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb, the timing and success of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRAS^G12C inhibitor as triplet therapy in non-small cell lung cancer with KRAS mutations, as first- and second-line treatment options, the ability of our SHP2 inhibitor's ability to enhance immuno-oncology and other targeted therapies to potentially provide options for patients with difficult-to-treat cancers as quickly and safely as possible, the incidence of KRAS mutations and the promise of targeted therapies for patients with such mutations, the success of current and future relationships with third-party collaborators and academic partners, 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, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with Bristol Myers Squibb, 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. 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:
Grace Rauh
BridgeBio Pharma, Inc.
Grace.rauh@bridgebio.com
(917) 232-5478

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