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

STOCKHOLM, Sept. 11, 2023 /PRNewswire/ -- 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 partner Tango Therapeutics has received FDA clearance on its Investigational New Drug application for TNG348.

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]

About Medivir

Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (NASDAQ: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.

About Tango Therapeutics

Tango Therapeutics is a clinical-stage 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.

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SOURCE Medivir