Medivir’s Partner Tango Therapeutics received FDA clearance to start the TNG348 phase 1/2 clinical study

On September 11, 2023 Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that Medivir’s partner Tango Therapeutics has received FDA clearance on its Investigational New Drug application for TNG348 (Press release, Medivir, SEP 11, 2023, View Source [SID1234635078]).

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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 Therapeutics intends to initiate a phase 1 / 2 study with TNG348 in first half of 2024, both as single agent and in combination with a PARP-inhibitor. Preclinical data has shown synergistic effect with PARP inhibitors in PARP naïve models and that TNG348 is active in models with resistance to PARP inhibitors. These data suggest that TNG348 may benefit patients both as single agent or in combination with PARP inhibitors.

TNG348 is a USP-1 inhibitor developed from the preclinical USP-1 program in-licensed from Medivir in 2020.

Under the licensing agreement, Medivir is entitled to multiple development and commercial milestone payments as well as royalties on future sales.

"It is very encouraging to see another preclinical molecule developed by Medivir being evaluated in patients. The preclinical data generated by Tango Therapeutics looks very promising and we will be following the clinical development of TNG348 with great anticipation," says Jens Lindberg, CEO of Medivir.

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100. E-mail: [email protected]