Tango Therapeutics' TNG462 Receives Orphan Drug Status for Pancreatic Cancer as Company Advances PRMT5 Inhibitor Programs
Key Insights
Tango Therapeutics' lead candidate TNG462 has been granted Orphan Drug Designation by the FDA for pancreatic cancer (search) treatment, providing seven years of market exclusivity upon approval.
The company's second PRMT5 inhibitor, TNG456, received FDA clearance for its IND application and will begin Phase 1/2 trials in early 2025, including a collaboration with Eli Lilly combining it with Verzenio.
Key clinical data for TNG462 monotherapy focusing on pancreatic and lung cancers is expected later in 2025, with plans to initiate a registrational study in pancreatic cancer (search) by 2026.
Tango Therapeutics (NASDAQ: TNGX) has achieved a significant milestone in its precision oncology program with the FDA granting Orphan Drug Designation to TNG462 for pancreatic cancer (search) treatment in November 2024. This designation, awarded to therapies targeting conditions affecting fewer than 200,000 people annually in the United States, provides important benefits including seven-year marketing exclusivity upon approval and access to federal grants and tax credits.
Advancing Dual PRMT5 Inhibitor Programs
The company is making substantial progress with its PRMT5 inhibitor pipeline, led by TNG462, which is currently enrolling patients in a Phase 1/2 clinical trial with a strategic focus on pancreatic and lung cancers. Simultaneously, Tango has secured FDA clearance for the Investigational New Drug (IND) application of TNG456, their next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, with Phase 1/2 trials scheduled to begin in the first half of 2025.
Strategic Collaboration with Eli Lilly
In a significant development for its clinical program, Tango Therapeutics has established a clinical collaboration with Eli Lilly to evaluate TNG456 in combination with the CDK4/6 inhibitor Verzenio® (abemaciclib). This partnership represents an important step in exploring potential combination therapies for MTAP-deleted cancers.
Clinical Development and Future Outlook
"We are starting 2025 with momentum in TNG462, our lead PRMT5 program, with fulsome data focused on pancreatic and lung cancer (search) expected before the end of the year," stated Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "PRMT5 is a clinically well-validated target, and we believe that TNG462 and TNG456 are both potentially best-in-class oral small molecules for multiple MTAP-deleted cancers."
The company plans to leverage upcoming clinical data to inform its development strategy, with aims to initiate its first TNG462 monotherapy registrational study in pancreatic cancer (search) in 2026. With a strong financial position of $258 million as of December 31, 2024, Tango projects sufficient funding to support operations into the third quarter of 2026.