Volastra Therapeutics

Volastra Therapeutics

Clinical-stage biopharma developing CIN-targeting cancer drugs

Overview

Volastra Therapeutics develops cancer therapies focused on chromosomal instability (CIN), a feature present in many tumors and linked to aggressive disease. Its core strategy is discovering and developing drugs that inhibit KIF18A, a protein essential for cancer-cell division, with two lead programs in Phase I/II for KIF18A inhibitors such as VLS-1488. The company advances drug candidates through clinical trials and aims to bring them to patients with aggressive cancers, building its pipeline through ongoing preclinical work and data sharing from conferences like AACR. Compared with competitors, Volastra combines a CIN-targeted approach with KIF18A inhibition to address tumors characterized by chromosomal instability, seeking to translate preclinical findings into clinically tested therapies. The goal is to provide effective treatments for patients with CIN-associated cancers and to progress multiple candidates through development toward commercialization."

About Volastra Therapeutics

Simplify's Rating
Why Volastra Therapeutics is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

11-50

Company Stage

Early VC

Total Funding

$119M

Headquarters

New York City, New York

Founded

2019

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Simplify's Take

What believers are saying

  • VLS-1488 Phase I/II shows tumor reduction in 7 of 17 pretreated ovarian cancer patients.
  • FDA Fast Track designations for both inhibitors accelerate HGSOC development timelines.
  • Partnerships with Microsoft and Function Oncology enable AI-driven biomarker expansion.

What critics are saying

  • Insilico Medicine skips Phase Ib, eroding Volastra's first-mover advantage in 6-12 months.
  • Sovilnesib Phase Ib triggers dose-limiting toxicities, halting Phase 2 by June 2025.
  • p16 biomarker fails validation, confining strategy to ovarian niche within 12 months.

What makes Volastra Therapeutics unique

  • Volastra pioneers KIF18A inhibitors targeting chromosomal instability in 80% of solid tumors.
  • Identifies p16 loss as predictive biomarker for Rb pathway-driven pan-cancer response.
  • Advances dual clinical assets: internally-discovered VLS-1488 and Amgen-inlicensed sovilnesib.

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Funding

Total Funding

$119M

Above

Industry Average

Funded Over

4 Rounds

Early VC funding comparison data is currently unavailable. We're working to provide this information soon!
Early VC Funding Comparison
Coming Soon

Benefits

Remote Work Options

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

2%

1 year growth

2%

2 year growth

5%
Volastra Therapeutics
May 27th, 2025
Volastra Therapeutics Announces Appointment of David P. Southwell as Chief Executive Officer

NEW YORK - may 27, 2025 - Volastra Therapeutics, a clinical-stage cancer biotechnology company, today announced the appointment of David P. Southwell as Chief Executive Officer.

Business Wire
May 22nd, 2025
Volastra Announces Initial Data from First-in-Human Phase I/II Trial of Novel KIF18A Inhibitor VLS-1488 to be Presented at 2025 ASCO Annual Meeting

Volastra announces initial data from first-in-human Phase I/II trial of novel KIF18A inhibitor VLS-1488 to be presented at 2025 ASCO Annual Meeting.

Fierce Biotech
Oct 16th, 2024
Chromosomal instability biotech Volastra taps CSO as it looks to 'expand the operation'

As it transitions from a discovery- to a clinical-stage biotech, Volastra Therapeutics is bringing longtime adviser Samuel Bakhoum, M.D., Ph.D., on board as its chief scientific officer.

Securities and Exchange Commission
Jun 1st, 2024
SEC FORM D

The Securities and Exchange Commission has not necessarily reviewed the information in this filing and has not determined if it is accurate and complete.The reader should not assume that the information is accurate and complete.

Business Wire
Apr 16th, 2024
Volastra Therapeutics Announces First Patient Dosed In Phase Ib Clinical Trial Of Sovilnesib

NEW YORK--(BUSINESS WIRE)--Volastra Therapeutics, a clinical-stage biotechnology company, today announced it has dosed the first patient in its Phase Ib clinical trial evaluating sovilnesib in patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC). This trial (NCT06084416) is a randomized dose optimization study of once-daily oral sovilnesib at different dose levels to establish the recommended Phase 2 dose. Sovilnesib was granted Fast Track designation in this indication by the U.S. Food and Drug Administration (FDA) based on its initial clinical data as well as the high unmet need in this population. Volastra in-licensed sovilnesib (formerly AMG-650) from Amgen in February 2023. The company is also progressing its internally developed KIF18A inhibitor, VLS-1488, in an ongoing Phase 1 clinical trial (NCT05902988)

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