Researchers at Vivace Therapeutics discussing mesothelioma treatment
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News Summary

Vivace Therapeutics raises $35 million to advance VT-3989, a promising mesothelioma treatment, securing a future Phase III clinical trial.

Vivace Therapeutics Secures $35 Million for Mesothelioma Drug VT-3989

In a significant development for the biotechnology industry, Vivace Therapeutics Inc., a small firm located in San Mateo, has successfully raised over $100 million across four funding rounds, with the latest round—Series D—bringing in an impressive $35 million. This round closed recently and stands as a pivotal achievement for the company as it prepares to trial a promising drug targeting mesothelioma.

Funding Details and Future Plans

The Series D funding was bolstered by participation from major investment firms, including RA Capital Management, Canaan Partners, and Cenova Capital. With a focus on advancing their late-stage clinical trial for the oral drug VT-3989, the infusion of capital is a critical step for Vivace. The company first plans to engage with the Food and Drug Administration (FDA) within the year to discuss a randomized Phase III study specifically for mesothelioma—an aggressive cancer primarily linked to asbestos exposure.

While the current funding round positions Vivace to move forward with the Phase III clinical trial, securing additional investments will be crucial for its completion. This investment comes at a time when the biotechnology sector is becoming increasingly cautious, as many venture capital firms are opting to invest in more established companies. Despite this trend, the market potential for VT-3989 presents a compelling opportunity for investors.

VT-3989: A Beacon of Hope for Mesothelioma Patients

VT-3989 has garnered attention for its mechanism of action, designed to block TEAD proteins involved in the Hippo signaling pathway—integral in tumor suppression across various cancers. This pathway has been recognized as altered in approximately 10% of cancers, including kidney cancer and sarcoma, hinting at a broad spectrum of potential applications. The company claims that the timeline for its clinical trial will be shorter and less expensive than typical randomized studies due to the unique characteristics of mesothelioma.

To date, Vivace has dosed and evaluated over 150 patients and boasts a “compelling data package.” In a recent presentation at the AACR Annual Meeting 2023, the company unveiled first clinical proof of concept data showing durable anti-tumor responses for VT-3989. Of 69 treated patients, 7 experienced significant tumor size reductions lasting up to 21 months, particularly highlighting cases among mesothelioma patients.

The Path Ahead for Vivace

As clinical trials advance, Chief Medical Officer Neelesh Sharma will oversee the necessary hiring to expand the staff, currently comprised of just six full-time employees. Plans are in motion for a randomized Phase III study targeting not just mesothelioma, but also assessing potential applications in fibrotic diseases and other solid tumors, particularly those carrying NF2 mutations.

The ongoing Phase I trial has yielded promising results, with participants having a median of three prior lines of therapy and reporting no dose-limiting toxicities from the drug. This positions VT-3989 not merely as a singular treatment option but as part of more extensive trials in combination with other therapies.

The Competitive Landscape

The race to develop effective treatments for mesothelioma sees competitors like SpringWorks Therapeutics and Novartis AG, with SpringWorks enrolling patients in a Phase I trial and Novartis initiating studies on their own targeted therapies. As the number of diagnosed mesothelioma cases remains around 3,000 annually in the U.S., the urgency for groundbreaking therapies has never been higher.

With the latest funding, Vivace Therapeutics stands at the precipice of significant strides in the fight against mesothelioma, as their drug VT-3989 shows early promise that could one day change the lives of many affected by this devastating disease.

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