Shasqi Announces Click Chemistry Breakthrough with First-Ever Human Application in Launch of Clinical Program

First Patients Dosed in Phase 1 Clinical Study of SQ3370 for Advanced Solid Tumor MalignanciesShasqi is First Y-Combinator Biotech Company to Reach First-in-Human Clinical Studies

SAN FRANCISCO, Oct. 14, 2020 /PRNewswire/ -- Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, announced today the first-ever application of click chemistry in humans, with the launch of the Company's lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development. 

The first two patients have been dosed in Shasqi's Phase 1 clinical study of SQ3370 for the treatment of advanced solid tumors. SQ3370 is a novel investigational product that activates a non-toxic protodrug into a powerful chemotherapy agent, doxorubicin, precisely at a pre-injected tumor. SQ3370 is designed to allow substantially higher drug doses to be given to the patient, increasing tumor destruction while minimizing toxicity in the rest of the body.

"Shasqi is founded on the belief that one day we will be able to beat cancer without poisoning our bodies. We are excited to reach this milestone with our CAPAC Platform and the launch of Shasqi's first clinical program," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi.

The CAPAC Platform is a new therapeutic modality based on click chemistry, which leverages biocompatible chemical reactions, to activate protodrugs at a selected tumor that has been pre-injected with a biopolymer. The CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity, rendering it applicable to a broad array of tumor types. Additionally, the CAPAC Platform is highly modular and can be applied to a wide variety of cancer therapeutics in addition to doxorubicin.

"Doxorubicin has been proven effective for dozens of cancers, but severe side effects limit its use. Guiding it directly to the tumor while avoiding damage to the rest of the body may allow us to use doxorubicin and potentially many other drugs in a completely new and effective way for patients," commented Wayne Saville, M.D., Chief Medical Officer of Shasqi. "Shasqi has taken a novel concept through a rigorous preclinical regulatory path all the way to treating patients in near-record time."

"Shasqi was Y Combinator's first therapeutic biotechnology investment and now the first of our life sciences companies to reach clinical development," said Jared Friedman, Partner, Y Combinator. "We are extremely impressed by the team's rapid advancement and capital-efficient execution. SQ3370 and CAPAC are not just a standard new small molecule, but rather a broad and powerful new platform leveraging state of the art science and materials to transform the treatment of cancer." 

SQ3370-001 (NCT04106492) is a multicenter, first-in-human, dose-escalation, Phase 1 clinical trial evaluating the safety and tolerability, pharmacokinetics, immune effects, and preliminary anti-tumor efficacy of SQ3370 in patients with locally advanced or metastatic solid tumor malignancies ineligible for standard-of-care therapy. The study is being conducted in the United States and Australia at multiple cancer centers, including MD Anderson Cancer Center and Stanford University. The study is expected to be completed in 2021. More information about the trial is available at: https://clinicaltrials.gov/ct2/show/NCT04106492. 

About SQ3370
SQ3370 is designed to enhance anti-tumor efficacy and decrease systemic toxicity of doxorubicin by restricting activation of the protodrug to a pre-injected malignant tumor and its peripheral tumor environment. Pre-clinical data show that SQ3370 leads to tumor reduction and reduced systemic toxicity. SQ3370 consists of two components, both of which are proprietary new molecular entities: a protodrug of doxorubicin (SQP33) with attenuated cytotoxic activity and a biopolymer (SQL70) made of sodium hyaluronate which activates the protodrug at the tumor site.

About Shasqi's CAPAC Platform
Shasqi's Click Activated Protodrugs Against Cancer (CAPAC) Platform is a new therapeutic modality based on click chemistry, which utilizes the biocompatible chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely captures and activates an infused protodrug. The CAPAC Platform and it is designed to increase anti-tumor efficacy while minimizing systemic toxicity. The platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity. Shasqi's CAPAC Platform is highly modular and can be applied to a wide variety of cancer therapeutics.

The technology originally conceived and developed at the University of California, Davis and at the Royzen Lab at the University at Albany, SUNY, served as the foundation for the CAPAC Platform.

About Y Combinator
Y Combinator (YC) is a startup fund and program. Since 2005, YC has invested in over 2,000 companies including Airbnb, Dropbox, Stripe, Reddit, Doordash, and Brex. The combined valuation of YC companies is over $155B. YC has programs and resources that support founders throughout the life of their company. Startup School teaches the basics of starting a company. The YC batch program helps founders as they build their product, talk to their customers, and raise funding. Work at a Startup makes it easy for founders to find their first engineers. YC Series A helps founders launch their A round. YC Growth Program provides founders with resources to scale their companies and hire an executive team, and YC Continuity invests in their later stage rounds.

About Shasqi
Shasqi is a privately held, clinical stage biotechnology company whose mission is to enable patients to beat cancer without poisoning their bodies. Shasqi leverages its proprietary Click chemistry Activated Protodrugs Against Cancer (CAPAC) Platform to develop precision activated oncology therapeutics designed to improve efficacy while decreasing systemic toxicity. Shasqi's CAPAC Platform is highly modular and can be applied to a broad range of drugs that are otherwise limited by toxicity, enabling the exploration of therapeutic biology in ways that were not previously possible. For more information, please visit: http://www.shasqi.com

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