Tango Therapeutics has dosed the first patient in the Phase I/II clinical trial investigating ubiquitin-specific protease 1 (USP1) inhibitor TNG348.
The multi-centre, open-label study (NCT06065059) will evaluate the safety, tolerability, and preliminary antitumour activity of TNG348 alone, and in combination with AstraZeneca’s PARP inhibitor Lynparza (olaparib) in patients with BRCA1/2 mutant or HRD+ solid tumours.
The study will enrol 140 subjects with an estimated completion date of June 2026, as per the ClinicalTrials.gov registry. The primary endpoints will determine the TNG348 dose as a monotherapy and in combination in the Phase I part of the trial and measure anti-tumour activity in the Phase II portion. Secondary endpoints include safety and tolerability.
In March 2020, Tango entered a licensing agreement with pharma company Medivir to develop the asset. Under the contract, Medivir is entitled to multiple development and commercial milestone payments, as well as royalties on future sales of this candidate.
Medivir’s CEO Jens Lindberg said: “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.”
USP1 inhibitors target a protein that plays a role in DNA repair processes within cells. Inhibiting USP1 can impact the repair mechanisms in cancer cells, potentially making them more vulnerable to other treatments, or hindering their ability to metastasise.
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Several other companies have USP1 inhibitors in the pipeline, including Roche and its KSQ-4279 for the treatment of ovarian cancer.
In April 2021, Tango went public with the signing of a definitive merger agreement with the Boxer Capital-sponsored special purpose acquisition company BCTG Acquisition worth up to a total of approximately $353m.