SQ3370

SAN FRANCISCO--(BUSINESS WIRE)-- Shasqi, Inc. (“Shasqi”), a clinical-stage biotech company, whose mission is to revolutionize cancer treatment with click chemistry, announced today it has entered into a research collaboration with Johnson & Johnson Enterprise Innovation Inc. Through the collaboration, Shasqi will apply its novel tumor-targeted Click Activated Protodrugs Against Cancer (CAPAC®) platform to the development of new cancer therapies. Shasqi’s CAPAC® platform relies on chemistry, not biology, for activation of drugs at the tumor. The platform is made up of two separate components: a tumor-targeting agent and a cancer therapeutic. These come together at the site of the tumor, and the cancer therapeutic is activated via click chemistry, a Nobel Prize winning technology. Using this platform, Shasqi is targeting high doses of cancer drugs directly to the site of the tumor, while minimizing toxicity to healthy cells. Shasqi is the first company to use click chemistry in humans. “This is a compelling opportunity to expand our platform,” said José M. Mejía Oneto, MD, PhD, founder and chief executive officer of Shasqi. “We are excited to collaborate and apply click chemistry for potential new therapies in areas of significant unmet medical need." The use of click chemistry to activate cancer drugs at the tumor has been clinically validated. In a phase 1 study, click chemistry was used to activate a dose of doxorubicin that is 12-times a conventional dose, with a favorable toxicity profile. Tumor localization of click chemistry was achieved through an intratumorally injected biopolymer. A phase 2a study is currently enrolling patients with soft tissue sarcoma and head and neck cancer.[1] The collaboration will focus on Shasqi’s intratumorally injected biopolymer (SQL70) and a co-development committee has been formed with the aim of identifying the next clinical candidate. “This marks the start of Shasqi’s ambition to advance our platform and collaboratively develop the next generation of tumor-targeted therapies, expanding on the foundation built by antibody drug conjugates,” said Mukul Agarwal, chief business officer at Shasqi. “The reliance on chemistry, not biology for drug activation, allows for the use of small molecules, peptides, and antibody fragments to target tumor antigens, creating unprecedented flexibility.” References: [1] Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors , Accessed on May 31, 2023. About Shasqi and CAPAC® Shasqi is a clinical-stage biotech company, located in San Francisco, whose mission is to revolutionize cancer treatment with click chemistry, a 2022 Nobel Prize winning technology. Our unique CAPAC® (Click Activated Protodrugs Against Cancer) platform uses click chemistry to target high doses of cancer drugs directly to the site of the tumor while minimizing toxicity to healthy cells, potentially improving the therapeutic index. Over the past decade, antibody-drug conjugates (ADCs) have transformed tumor-targeted drug delivery. CAPAC® builds on this foundation, changing what’s possible with an approach that expands on the advances achieved by ADCs. Shasqi has developed an expansive and diverse library of antigen targeting agents and cancer therapeutic payloads. These are decoupled from each other and reunited at the site of the tumor via a click chemistry reaction. We are the first company to use click chemistry in humans. For more information, please visit: Follow Shasqi on social media:

Shasqi's lead asset, SQ3370 is designed to activate doxorubicin at the tumor site and established click chemistry in humans Phase 1 data presented at ESMO Congress 2022 show SQ3370 is well-tolerated among patients receiving up to approximately 12 times the standard dose of doxorubicin (Dox); dose escalation continues The unprecedented therapeutic index of SQ3370, the first agent that allows the administration of over 5 times conventional Dox, unlocks the opportunity to exploit the full potential of the target High dose levels of SQ3370 show novel immune-regulatory effects that could treat both local and metastatic lesions SAN FRANCISCO, Sept. 12, 2022 /PRNewswire/ -- Shasqi, a clinical-stage biotechnology company developing oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC ®) platform announced today it has opened the Phase 2 of their Phase 1/2a clinical study to further assess SQ3370 in anthracycline- naïve patients. The Phase 2 study follows the company's presentation at the European Society for Medical Oncology (ESMO) Congress, held September 9-13, 2022, evaluating the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose for SQ3370 in patients with locally advanced and/or metastatic solid tumors (NCT04106492). "We are encouraged by the promising results from our Phase 1 study and preclinical data which indicate that click chemistry in humans has the potential to revolutionize cancer care by expanding the therapeutic index of anti-cancer therapies such as doxorubicin," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "We look forward to further exploring the safety and efficacy of our lead candidate SQ3370 at unprecedented dose levels in the Phase 2 study." The Phase 1 clinical data were presented as a poster during the congress: Abstract Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors Presentation Number: 1499P Poster Session Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors Link to full poster details here. Key Phase 1 study findings include: SQ3370 was well tolerated among 27 DLT evaluable patients receiving up to 12x (1x equals 75mg/m2/cycle of Dox molar equivalents); maximum tolerated dose has not been reached Among patients treated with a least one cycle of SQ3370, no protocol defined dose-limiting toxicities, including anthracycline myelosuppression and gastrointestinal (GI) toxicity, were observed and no treatment emergent adverse events (TEAEs) that led to death were considered related to SQ3370; the most frequent Grade ≥3 TEAE was anemia The highest doses tested of SQ3370 led to immune activation in soft tissue sarcomas which are considered immunologically cold tumors, validating preclinical findings of SQ3370 previously published: Increased cytotoxic T-cell activity observed at higher dose levels of SQ3370 indicate immune activation and a trend toward increase in tumor cell death in heavily pretreated patients Immune activation has the potential to improve systemic activity of intra-tumoral administration of SQ3370 which will be explored in Phase 2 "Early data has shown that click chemistry allows for the release of doxorubicin at the tumor site to generate anti-tumor responses. Phase 1 results showing that SQ3370 is well-tolerated among a heavily pretreated patient population further validate this clinical approach and the importance of investigating SQ3370 as a potential treatment option in patients with anthracycline-sensitive- and other solid tumors," said Sant P. Chawla, M.D., FRACP, Principal Investigator, and Head, Sarcoma Oncology Center in Santa Monica, California." Shasqi is excited to open the Phase 2 study of SQ3370 in anthracycline-naïve patients with advanced soft tissue sarcomas, relapsed or recurrent squamous-cell head and neck cancer, platinum refractory ovarian cancer recurrent and/or metastatic uterine carcinoma, or uterine sarcoma. For more information, visit About Shasqi and the CAPAC Platform Shasqi is a privately held, clinical-stage biotechnology company whose mission is to enable patients to beat cancer with tumor-localized therapies by pioneering the use of click chemistry in humans. Click chemistry is a term that describes chemical reactions in which 2 compounds rapidly react with each other; ignoring everything else around them. Shasqi's proprietary CAPAC platform enables precise oncology therapeutics to reach unprecedented doses at the tumor site with a strong safety profile in two steps. First, the CAPAC platform localizes a click chemistry reagent (activator) to the tumor. Then protodrugs (attenuated drugs activated by click chemistry) are infused systemically. When the protodrug reaches the activator, the payload is released at the tumor site. The lead asset, SQ3370 has established click chemistry in humans and uses a powerful chemotherapeutic, doxorubicin, as the payload. Shasqi's CAPAC Platform, when applied to a broad range of existing and experimental cancer drugs, is designed to reach unprecedented doses and unlock novel beneficial biological effects. SOURCE Shasqi, Inc.