MD Anderson and BridgeBio Pharma launch Navire Pharma to develop targeted therapy for patients with difficult-to-treat cancer

The University of Texas MD Anderson Cancer Center and BridgeBio Pharma today announced the launch of Navire Pharma, a biopharmaceutical company aimed at developing novel small-molecule inhibitors of a tyrosine-protein phosphatase called SHP2 for genetically driven and treatment-resistant cancer.

BridgeBio has committed $30 million and a team of senior business managers to the company, while MD Anderson, through its Institute for Applied Cancer Sciences (IACS), provides intellectual property and an oncology drug development team to advance SHP2 inhibitors toward clinical studies.

SHP2, encoded by the PTPN11 gene, links growth factor signaling with the downstream RAS/ERK/MAPK pathway to regulate cell growth and division. Over-activity of this pathway, often driven by distinct gene mutations, causes or contributes to many human cancers. Inhibiting SHP2 offers a new approach to treat tumors relying on this pathway.

Shafique Virani, M.D., joins BridgeBio as CEO in residence, and will serve as CEO of Navire. Virani was most recently officer and vice president of Business Development, Licensing, and M&A at Roche/Genentech where he assumed several leadership roles across the globe over 13 years.

“Navire’s compounds potently bind SHP2 and prevent activation of the protein, blocking its ability to promote tumor growth,” said Virani. “Directly inhibiting SHP2 could provide patients and physicians a new, transformative approach to treat RTK-driven cancers at their source.”

Navire Pharma’s lead compounds were discovered and developed by the IACS team led by Phil Jones, Ph.D., executive director and head of drug discovery at IACS, together with Benjamin G. Neel, M.D., Ph.D., director of the Laura and Isaac Perlmutter Cancer Center at New York University (NYU).

“Resistance mechanisms that cause many patients to stop responding to therapy rely on SHP2 activity,” said Jones, a scientific co-founder of Navire. “Our ‘molecular glue’ inhibitory approach inactivates SHP2 and could help overcome these resistance pathways.”

SHP2 also suppresses T-cell activity against growing tumors through regulation of the adaptive immune response by binding to PD-1 and dephosphorylating CD28 and the protein LCK. SHP2 inhibition may relieve this negative effect, enhancing the patient’s immune response to fight cancer proliferation.

“SHP2’s role in oncogenic signaling has been known for decades, but effective approaches for inhibiting the protein were only recently discovered,” said Neel, Navire scientific co-founder and chairman of the company’s scientific advisory board. “These novel approaches have demonstrated compelling efficacy in pre-clinical disease models, which we hope will translate into benefit for patients.”

Other members of Navire’s scientific advisory board, comprised of leaders in cell signaling and hematological and solid tumors, include:

  • Kwok Kin-Wong, M.D., Ph.D., chief of Hematology and Medical Oncology, NYU
  •  Scott Kopetz, M.D., Ph.D., associate professor, Gastrointestinal Medical Oncology, MD Anderson;
  • Frank McCormick, Ph.D., director of the University of California, San Francisco (UCSF) Cancer Center and associate dean of the UCSF School of Medicine, and co-founder, Onyx Pharmaceuticals;
  • Lillian Siu, M.D., professor of Medicine, Princess Margaret Cancer Centre, Toronto.

BridgeBio also has added pharmaceutical and biotechnology executives to the Navire team, including Uma Sinha, Ph.D., and Brian Metcalf, Ph.D., who together have advanced more than 30 drug candidates into human trials, and have brought nine safe and effective drug products to market. The BridgeBio team will closely collaborate with MD Anderson through IND filing and prosecute subsequent clinical trials.

“Navire combines MD Anderson’s clinicians and drug development scientists with our veteran biotechnology team to create a focused organization to develop SHP2-targeted therapies,” said Neil Kumar, Ph.D., chief executive officer of BridgeBio Pharma. “Together, we aim to bring these novel treatments to patients at the soonest possible opportunity.”