VLS-1488 / Volastra Therap - LARVOL DELTA

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Volastra Therapeutics, Inc. | N=120 ➔ 200

Enrollment change • Breast Cancer • Carcinosarcoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uterine Cancer • CTCs

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Volastra Therapeutics, Inc. | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Breast Cancer • Carcinosarcoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uterine Cancer • CTCs

Preliminary results from a first-in-human, phase I/II study of VLS-1488, an oral KIF18A inhibitor, in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "VLS-1488 was found to be safe and tolerable, with encouraging anti-tumor activity observed in heavily treated HGSOC pts. VLS-1488 will be evaluated further in the Dose Expansion phase of the study. Clinical trial information: NCT05902988."

Clinical • Metastases • P1/2 data • Carcinosarcoma • Fatigue • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • KIF18A

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 (Businesswire) - P1/2 | N=120 | NCT05902988 | Sponsor: Volastra Therapeutics, Inc. | "As of the January 10, 2025 data cutoff, 52 patients with advanced solid tumors were enrolled to the dose escalation portion of the trial across dose levels ranging from 50 mg to 800 mg. Drug exposures exceeded preclinically-defined efficacious thresholds for anti-tumor activity. No dose limiting toxicities were observed and a maximum tolerated dose was not reached. Less than 45% of patients experienced treatment-related adverse events (TRAEs) of any grade and less than 16% of all patients experienced G3 TRAEs. No patients experienced >G3 TRAEs. Of the 20 patients with advanced high grade serous ovarian cancer, the majority were platinum resistant and heavily pretreated with a median of 5 prior lines of therapy."

P1/2 data • Platinum resistant • High Grade Serous Ovarian Cancer

Volastra Therapeutics Granted FDA Fast Track Designation for Novel KIF18A Inhibitor in Ovarian Cancer (Businesswire) - "Volastra Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VLS-1488, the company’s internally discovered KIF18A inhibitor. The designation has been granted for the treatment of patients with platinum-resistant high-grade serous ovarian cancer (HGSOC)....The Phase I/II trial for VLS-1488 is evaluating safety, tolerability and preliminary efficacy in patients with advanced tumors, including HGSOC."

Fast track • Ovarian Cancer

A phase I/II, first-in-human study of VLS-1488, an oral KIF18A inhibitor, in patients with advanced cancer. (ASCO 2024) - P1/2 | "Subjects enrolled to specific tumor type cohorts may be randomized to DLs of interest. Enrollment to Dose Escalation began in September 2023 and is ongoing."

Clinical • Metastases • P1/2 data • Bladder Cancer • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Serous Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • KIF18A

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Volastra Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Bladder Cancer • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • CTCs • MUC16

Volastra Therapeutics Announces First Patient Dosed in Phase I/II Clinical Trial of VLS-1488, One in a Portfolio of Novel and Differentiated KIF18A Inhibitors (Businesswire) - "Volastra Therapeutics...announced the dosing of the first patient in a Phase I/II clinical trial evaluating VLS-1488. VLS-1488 and sovilnesib (formally AMG650) make up Volastra’s innovative clinical portfolio of differentiated KIF18A inhibitors specifically designed for the treatment of solid tumors characterized by high levels of chromosomal instability (CIN). The Phase I/II trial (NCT05902988) evaluates safety, tolerability and preliminary efficacy of VLS-1488 in patients with advanced tumors....Phase Ib trial for sovilnesib, Volastra’s second KIF18A inhibitor, is anticipated to open in Q1 2024."

Trial status • Ovarian Cancer

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Volastra Therapeutics, Inc.

Metastases • New P1/2 trial • Bladder Cancer • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • CTCs • MUC16

Preclinical Data on Volastra Therapeutics’ Two Novel and Differentiated KIF18A Inhibitors Presented at AACR 2023 (Businesswire) - "Volastra Therapeutics...released preclinical data from the company’s portfolio of KIF18A inhibitors at the 2023 American Association for Cancer Research (AACR) Annual Meeting....Sovilnesib findings, presented in a poste...demonstrate robust anti-cancer activity with evidence of durable tumor regressions in a subset of human ovarian and breast tumor models at well-tolerated doses....Findings for one of Volastra’s internally-developed KIF18A inhibitors are shown in a second poster....In this, in vivo data shows substantial, dose-dependent inhibition of tumor growth in multiple tumor models....Volastra will advance clinical development of both sovilnesib and the Volastra-developed KIF18A inhibitor VLS-1488 in 2023."

Clinical • Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Volastra Therapeutics In-Licenses Clinical Stage KIF18A Inhibitor and Secures $60 Million in Series A Funding to Further Advance Cancer-Focused Pipeline (Businesswire) - "Volastra Therapeutics...announced completion of the in-license of Amgen’s sovilnesib (AMG650), an oral, first-in-class small molecule inhibitor of KIF18A. In parallel, the company has closed a $60 million Series A financing. Under the terms of the licensing agreement, Volastra receives an exclusive worldwide license (ex-China) to develop and commercialize sovilnesib. In return, Amgen receives an upfront mix of cash and equity, as well as downstream milestones and royalties. The drug is currently in Phase 1 for the treatment of platinum-resistant high-grade serous ovarian cancer, triple-negative breast cancer and other solid tumors with TP53 mutations....Volastra will advance clinical development of both sovilnesib and VLS-1488 in 2023."

Financing • Licensing / partnership • Pipeline update • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer