Lilly-Backed Volastra Enters Clinic with Amgen’s KIF18A Inhibitor


Pictured: scientists looking into microscope/Getty Images

Volastra Therapeutics announced Tuesday it has in-licensed Amgen’s Phase I candidate sovilnesib, a KIF18A inhibitor being studied for high-grade ovarian cancer, triple-negative breast cancer and other solid tumors.

Concurrently, the New York-based biotech has secured $60 million in Series A funding. The financing round was led by Eli Lilly, along with founding investors Polaris Partners and ARCH Venture Partners. Droia Ventures, Vida Ventures, Meyers ventures, Cornell University and Catalio Capital Management also participated in the Series A.

Under the terms of the deal, Volastra will put forth an upfront payment of cash and equity and pledge downstream milestones and royalties. In exchange, it will receive exclusive rights to sovilnesib worldwide, except for China.

Designed to be orally available, sovilnesib is a first-in-class small molecule inhibitor of the protein KIF18A. In cancers, KIF18A is central to the proliferation of chromosomally unstable tumor cells. Disrupting the action of this protein could interrupt the process of cell division and might hold therapeutic potential in oncology.

Sovilnesib is currently in Phase I studies for platinum-resistant high-grade serous ovarian cancer, for which the FDA has granted the drug Fast Track designation. The investigational drug is also being assessed as a potential treatment for triple-negative breast cancer and solid tumors with TP53 mutations.

Adding sovilnesib to its array of assets will help Volastra accelerate development of therapies against a promising new target,” said Scott Drutman, M.D., Ph.D., chief medical officer, Volastra, in a statement.

Targeting Chromosomal Instability

At its core, Volastra is focused on a phenomenon called chromosomal instability (CIN).

In healthy cells, chromosomes are divided in an orderly manner during cell division, and any mitotic errors lead to cell death. Cancer cells, however, lose the ability to detect and deal with errors in cell division, resulting in generation after generation of daughter cells that carry unstable chromosomes.

CIN is present in 60% to 80% of all cancers and has been shown to compromise patient survival.

Tuesday’s Amgen deal will add another promising asset to Volastra’s “growing pipeline of CIN-targeted therapeutics,” which includes VLS-1488, another KIF18A inhibitor discovered in-house using the company’s proprietary CINtech platform.

Volastra will advance both sovilnesib and VLS-1488 through clinical development in 2023.

Aside from Amgen and Lilly, Volastra’s focus on CIN has also garnered the interest of Bristol Myers Squibb, with which it forged a drug discovery and development deal for more than $1 billion in March 2022. The agreement was for access to Volastra’s CINtech platform and covers undisclosed oncology targets.

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