Shelton biotech prepares to restart late-stage cancer trial after...

Intensity Therapeutics, a Shelton-based biotech company, is preparing to resume patient enrollment in a late-stage cancer drug trial that was paused due to funding constraints. The broader restart remains dependent on securing additional capital.

About the Role

Intensity Therapeutics is seeking to expand its clinical research efforts, focusing on the resumption and completion of a Phase 3 study for an experimental cancer treatment. The role involves contributing to the advancement of this innovative therapy, which is injected directly into tumors to target soft-tissue sarcoma and other cancers.

Responsibilities

• Support the resumption of patient enrollment in the Phase 3 clinical trial for an experimental tumor-injected cancer treatment.
• Assist in expanding enrollment and adding study locations once additional funding is secured.
• Collaborate on the preparation and execution of clinical trial protocols, ensuring compliance with regulatory requirements.
• Contribute to the ongoing treatment of patients already enrolled in the study.
• Participate in the management of a separate Phase 2 trial for triple-negative breast cancer, including revised dosing regimens and international site coordination.
• Engage in strategic discussions with potential partners to secure funding and advance drug development programs.

Requirements

• Experience in clinical research, particularly in oncology or biotech drug development.
• Knowledge of Phase 2 and Phase 3 clinical trials, including patient enrollment, regulatory filings, and trial management.
• Ability to work in a dynamic environment with evolving funding and operational challenges.
• Strong collaboration skills to work with cross-functional teams, including researchers, clinicians, and strategic partners.
• Familiarity with regulatory requirements for clinical trials, including FDA and international guidelines.

About the Trials

The Phase 3 study focuses on an experimental treatment that combines two cancer-killing drugs with a compound designed to enhance tumor penetration. The therapy is injected directly into tumors to kill cancer cells locally while stimulating an immune response. The trial targets patients with certain types of soft-tissue sarcoma, a rare form of cancer.

• Enrollment was paused in March 2025 after 21 patients were signed up, though treatment for existing participants continued.
• Enrollment is expected to resume in the third quarter of 2026 at a limited number of U.S. locations.
• The company estimates needing $30 million to enroll and treat an additional 300 patients to complete the study.

A separate Phase 2 trial involves triple-negative breast cancer, studying the tumor-injected treatment in combination with standard immunotherapy and chemotherapy. This trial was paused due to skin irritation near the injection site but resumed in July 2026 after revising the dosing regimen. The company opened its first international site in France in August 2026 and aims to complete enrollment by the end of 2027.

Company Status

• Intensity Therapeutics had $9.5 million in cash as of June 30, 2026, and raised an additional $1.3 million through stock sales.
• The company reported a $3 million net loss in the second quarter of 2026, compared to a $2.5 million loss in the same period the prior year.
• Research and development spending increased to $1.8 million from $1.5 million, driven by preparations to resume the Phase 3 trial.
• The company met with potential strategic partners at the BIO International Convention in June 2026 and expects discussions to continue.