Medivir´s licensee, Tango Therapeutics, has dosed the first patient with TNG348, a novel USP1 inhibitor, in a phase 1/2 clinical study
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Insights
The initiation of patient dosing with TNG348 marks a pivotal step for Medivir and Tango Therapeutics in advancing a novel therapeutic option for HRD+ cancers. The ubiquitin-specific protease 1 (USP1) inhibitor TNG348 targets a critical pathway in DNA damage response, aiming to exploit the vulnerability in BRCA1/2-mutant and other HRD+ cancers. The potential synergy with PARP inhibitors could position TNG348 as a significant addition to the current oncology arsenal, particularly for patients who have developed resistance to existing treatments.
Given the prevalence of HRD+ cancers across various cancer types, the successful development and subsequent approval of TNG348 could lead to considerable market penetration. The royalty structure and milestone payments stipulated in the licensing agreement between Medivir and Tango suggest a substantial financial incentive for Medivir, contingent on the clinical success and commercialization of the drug. The financial outcomes for both companies, however, hinge on the results of ongoing clinical trials and regulatory approvals.
The clinical evaluation of TNG348, both as a monotherapy and in combination with olaparib, a PARP inhibitor, is significant for patients with HRD+ cancers. This subset of cancers, characterized by mutations in BRCA1/2 or other deficiencies in homologous recombination, are particularly aggressive and often develop resistance to current standard treatments. The ability of USP1 inhibitors to potentially restore sensitivity to PARP inhibitors could be transformative for treatment protocols and patient outcomes.
Moreover, the clinical trial's design to assess the efficacy of TNG348 in multiple cancer types broadens the potential impact on the patient population. The therapeutic landscape for HRD+ cancers could be reshaped if TNG348 demonstrates a strong safety profile and efficacy, addressing a high unmet medical need and potentially improving survival rates for a significant portion of the oncology patient population.
For investors, the dosing of the first patient in Tango's clinical trial is a noteworthy milestone that could influence both Medivir's and Tango's stock valuations. The progression of TNG348 into clinical trials not only triggers a milestone payment for Medivir but also serves as a risk-reduction event for stakeholders. While the short-term financial impact is limited to milestone payments, the long-term revenue potential through royalties could be substantial if TNG348 reaches the market.
Investors will closely monitor the drug's clinical progress and safety data, as these will be key determinants of its commercial viability. The addressable market for HRD+ cancers is significant and a successful USP1 inhibitor could capture a sizeable share, driving revenue growth for both Medivir and Tango. However, investors must also weigh the inherent risks of drug development, including trial outcomes, regulatory hurdles and competition from other therapies in development.
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
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.
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: magnus.christensen@medivir.com
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. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
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SOURCE Medivir
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