– TNG908 IND cleared by FDA, Phase 1/2 trial expected to start in 1H 2022

– Additional pipeline programs progressing throughout 2022

CAMBRIDGE, MA, USA I January 24, 2022 I Tango Therapeutics, Inc. (NASDAQ: TNGX), a biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced progress updates across its pipeline and recent corporate highlights.

“Last year we achieved a critical milestone, becoming a publicly-traded company with a sufficient cash balance that we believe will fund operations into the second half of 2024. We are excited to start 2022 with important corporate updates, including recent achievements and anticipated milestones in our research and development programs,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “With the IND cleared for our lead program, TNG908, an MTA-cooperative PRMT5 inhibitor selective for cancers with MTAP deletions, we expect to initiate a Phase 1/2 clinical trial in the coming months. Additionally, we have accelerated the timeline for our Target 3 program and continue to progress our USP1 program. We look forward to providing additional updates throughout the year.”

Pipeline Progress Updates

  • TNG908 IND cleared and first-in-human clinical trial expected to start in 1H 2022. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company’s lead program, TNG908, a synthetic lethal small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) designed to selectively kill cancer cells with an methylthioadenosine phosphorylase (MTAP) deletion. MTAP deletions occur in 10% – 15% of all human cancers, including non-small cell lung cancer, mesothelioma, pancreatic cancer and cholangiocarcinoma. Tango expects to initiate a Phase 1/2 clinical trial in the first half of 2022, with preliminary safety and efficacy data expected in the first half of 2023. Enrollment will be limited to patients with confirmed MTAP-deleted tumors. In preclinical studies TNG908 demonstrated strong selectivity for MTAP-deleted tumors with robust anti-tumor effects in vitro and in vivo.
  • Target 3 inhibition reverses immune evasion in STK11 mutant cancers; development candidate planned for 1H 2022. Target 3, an undisclosed synthetic lethal target, reverses the immune evasion effect of serine-threonine kinase 11 (STK11) loss-of-function mutations. Target 3 was discovered using our novel in vivo target discovery platform. In syngeneic mice, Target 3 inhibition, in combination with an anti-PD1 antibody, resulted in complete regressions in all treated mice, and the induction of immune memory against re-implantation of tumors in the majority. Tango expects to advance a development candidate in the first half of 2022 and file an IND in 2023.
  • USP1 development candidate anticipated in 2H 2022. Tango anticipates advancing a development candidate for their ubiquitin-specific protease 1 (USP1) program, a synthetic lethal target for BRCA1-mutant breast, ovarian and prostate cancer, in the second half of 2022. USP1 inhibition is synergistic with poly (ADP-ribose) polymerase (PARP) inhibition in BRCA1 mutant cancer cell lines and murine xenograft models. Clinical trials of the USP1 inhibitor will be conducted both as a single agent and in combination with PARP inhibitors in BRCA1-mutant cancers. Tango expects to advance a development candidate in the second half of 2022 and file an IND in 2023.

Recent Corporate Highlights

  • Michael Palmieri, PhD, Head of Chemistry, Manufacturing, & Controls (CMC). Today, Tango is announcing the addition of Dr. Palmieri to the leadership team as Head of CMC, where he will be responsible for leading all CMC-related activities for the Company, including process chemistry, drug substance, drug product, analytical, and formulation activities. Dr. Palmieri has more than 20 years of experience, most recently at Alkermes, where he led small molecule CMC activities from the lead optimization phase through to commercialization.

About Tango Therapeutics

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. For more information, please visit www.tangotx.com.

SOURCE: Tango Therapeutics