-No observed dose-limiting toxicity to date when SQ3370 is administered at doses up to 12 times higher than conventional doxorubicin; dose escalation is ongoing-

Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC™) platform, will present interim data from its Phase 1 clinical study of SQ3370 in advanced solid tumors, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held at McCormick Place in Chicago, IL, on June 3-7, 2022.

Presentation details:

• Abstract Title: Interim Phase 1 results for SQ3370 in advanced solid tumors
• Abstract Number: 3085
• Poster Number: 77
• Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
• Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

Key highlights include:

• 26 patients received treatment with SQ3370 and as of the data cutoff date, 21 patients were evaluable
• 77% of patients had metastases with a median number of 2 metastatic sites (1-5); most frequently lung (50%) and more than 50% being previously treated with doxorubicin
• Escalating doses of SQP33 protodrug ranging from 0.38x to 12x the molar equivalent of conventional doxorubicin per cycle along with a dose of 10 or 20 mL of SQL70 were administered
• SQ3370 was well tolerated with 62% of patients receiving more than 500 mg/m² cumulative doxorubicin equivalents given as SQP33
• The most common treatment emergent adverse events reported were nausea, fatigue, anemia, and constipation
• At a median follow-up of 9.2 weeks, of the 21 evaluable patients, 71% had stable disease, with a median duration of 80 days
• Dose escalation continues as the maximum tolerable dose has not yet been reached
• SQ3370 demonstrates proof of concept for the CAPAC platform

About CAPAC™ and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It 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 tumor site. 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 therapeutics across various modalities with 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 historical 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.

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