TNG348 First Patient Dosing - Medivir Milestone

Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir’s licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has dosed the first patient with TNG348, a novel USP1 inhibitor. Tango received U.S. Food and Drug Administration clearance on its Investigational New Drug application for TNG348 in September 2023.

TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers. HRD+ cancers, including BRCA1/2 mutations, represent up to 50% of ovarian cancers, 25% of breast cancers, 10% of prostate cancers and 5% of pancreatic cancers. Tango is developing TNG348 from the preclinical USP1 program licensed from Medivir in 2020.

In the study, TNG348 will be evaluated both as single agent and in combination with olaparib (PARP-inhibitor) in patients with BRCA1/2-mutant and other HRD+ cancers. Preclinical data has shown synergistic effect with PARP inhibitors in PARP naïve models, including models with resistance to PARP inhibitors.

–     “The preclinical data generated by Tango for TNG348 is promising and dosing the first patient in a clinical study is encouraging for patients with HRD+ cancers. The efforts undertaken by Tango to develop TNG348 into a clinical-staged drug are impressive and we will continue to follow the clinical development of TNG348 with great anticipation,” says Jens Lindberg, CEO of Medivir.

Under the licensing agreement, Medivir is entitled to multiple development and commercial milestone payments as well as royalties on future sales. Dosing the first patient in a clinical trial triggers a milestone payment.