Oct 31, 2020 | News
Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, congratulates client company Shasqi on the announcement of 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.
San Francisco-based Shasqi said in the announcement:
First Patients Dosed in Phase 1 Clinical Study of SQ3370 for Advanced Solid Tumor Malignancies
Shasqi is First Y-Combinator Biotech Company to Reach First-in-Human Clinical Studies
Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPACtm) 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.
See the announcement here. https://www.shasqi.com/news/2020/10/14/shasqi-announces-click-chemistry-breakthrough-with-first-ever-human-application-in-launch-of-clinical-program
Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.
Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.
Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex also offers pharmacodynamics servicesthat include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
- Receptor occupancy
· Cytokine release assays (whole blood or PBMC stimulation assays) and
- PBMC assays and cellular mechanism of action assays (eg: ADCC)
Agilex Biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs companies from US, Europe and APAC.
About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.
Agilex Biolabs Media Contact:
Shasqi media contact:
David Rosen, Argot Partners
+1 (212) 600-1902