Shasqi Awarded a Second NCI Grant of $1.9M to Accelerate the Development of SQ3370

- The Small Business Innovation Research (SBIR) ‘Direct to Phase 2’ grant will fund a Phase 1b dose-expansion cohort to test the safety and efficacy of the recommended Phase 2 dose of SQ3370 in patients with advanced sarcoma

- SQ3370 is a click-activated protodrug therapy currently in a Phase 1 clinical study in advanced sarcomas and other solid tumors

SAN FRANCISCO--(BUSINESS WIRE)--Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC™) Platform, announced today that it has been awarded a second ‘Direct to Phase 2’ Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI). The $1.9 million grant will support a Phase 1b dose-expansion cohort in the company’s ongoing development program for its click-activated prodrug therapy, SQ3370. The safety and efficacy data from this cohort will support dose selection for the planned Phase 2 study of SQ3370 in patients with advanced soft tissue sarcoma.

"The NCI has made two investments in our Phase 1 clinical studies of SQ3370, which will enable us to accelerate the development of SQ3370 and gather additional efficacy and safety data to inform our Phase 2 clinical trial design. We are grateful for the vision of the NCI and their support of SQ3370 and our click chemistry platform," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "The early data from our Phase 1 study of SQ3370 provides initial validation for our platform in humans, with an encouraging safety profile and initial hints of clinical activity. We believe we can improve the efficacy, safety, and biological effects of many existing cancer therapies and various modalities which are currently either too toxic to be used widely, have significant safety burden, or have limited efficacy due to a limited therapeutic window."

About CAPAC and SQ3370:

SQ3370 is the first click chemistry-based treatment to be tested in humans, and utilizes Shasqi's proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the site of the tumor. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing drugs and various modalities that have a limited therapeutic window.

About Shasqi:

Shasqi is a privately held, clinical-stage biotechnology company whose mission is to enable patients to beat cancer with tumor-localized therapies. Shasqi leverages its proprietary CAPAC Platform to develop precision oncology therapeutics designed to deliver unprecedented doses precisely focused at the tumor with an uncharacteristically mild safety profile - breaking through the historic ceiling of dose-limiting toxicities. Shasqi's CAPAC Platform is highly modular and can be applied to a broad range of cancer drugs that are otherwise limited by toxicity, enabling the exploration of therapeutic biology in ways that were not previously possible.