SHY is a clinical-stage company developing small molecule therapeutics that non-covalently modulate the activity of ATPases and GTPases.
ATPases and GTPases are essential proteins involved in the regulation of virtually every major cellular process, including metabolism, signal transduction, adhesion, and proliferation. Dysregulation of ATPases and GTPases underlies a broad spectrum of human diseases, including cancer, infectious diseases, and neurodegeneration.
SHY is conducting a Phase 1 trial called Luca-1 for the treatment of solid tumors with SHY-ONC6, a novel small molecule inhibitor of proteasome ATPases.
SHY’s other development programs include:
a multi-target of the Ras Superfamily of Small GTPases cancer therapeutic in lead optimization
fungal anti-infectives in lead optimization
bacterial anti-infectives in lead optimization
The compounds in these programs show promising preclinical efficacy and tolerability, matching or surpassing current treatment standards in cancer and infectious disease models.
PHASE 1 TRIAL
Luca-1, a Phase 1 Trial of SHY-ONC6 Initiated in Solid Tumors
Approved proteasome inhibitors have transformed treatment for certain blood cancers, but none have succeeded in solid tumors. SHY-ONC6 is an investigational oral drug targeting the proteasome with a unique and novel mechanism of action, distinct from current FDA approved drugs, that may unlock its potential across a broad range of cancers.
First-in-class pipeline
SHY is advancing a preclinical pipeline of first-in-class patient-focused programs designed to meet or surpass current standards of care in critical, underserved diseases. These programs include novel compounds and mechanisms of action spanning proteasome inhibition, multi-target Ras Superfamily inhibitors, anti-fungals, anti-bacterials, and neuromuscular disease therapeutics, most of which have already demonstrated positive in vivo outcomes.
A unique platform portfolio
SHY’s pipeline is built on a unique, proprietary platform of pharmacophores and compounds that non-covalently modulate the activity of ATPases and GTPases. It has proven to be highly productive. SHY-ONC6 has advanced to the clinic, and SHY anticipates designating further clinical candidates over the next 12-24 months that demonstrate high specificity, efficacy, and tolerability in a growing set of in vivo disease models.
Our purpose
SHY’s priorities are set by the benefits we believe our work can ultimately deliver for significantly ill patients. We are here to generate clinically and scientifically significant results, not biobucks, biotech bravado, or false hopes.
We will measure our success by the therapeutics we develop; the contributions we make to basic science and medical innovation; and our balanced fulfillment of the expectations of patients, clinicians, shareholders, our employees, and other stakeholders.
Our strategic approach
SHY’s strategy is to focus on the discovery and early clinical-stage development of impactful, valuably differentiated therapeutic programs and intellectual property based on its GTPase and ATPase modulator portfolio and expertise. We are an intentionally lean, focused company. Critical in vitro and in vivo experiments are conducted in our laboratories on the campus of the New York Medical College. We outsource other activities to collaborators including pharmacokinetic studies, computational chemistry, compound synthesis and scale-up, toxicology studies, and BSL-3 pathogen testing. To ensure tight oversight and quality control, we are managing our Luca-1 Phase 1 trial directly.
SHY welcomes opportunities to explore collaborations with similarly minded scientists, clinicians, investors, and companies. We may partner early-stage programs and anticipate undertaking late-stage clinical development and product commercialization with experienced pharmaceutical and biotechnology partners.
SHY is the first company to focus on developing small-molecules that non-covalently modulate the activity of ATPases and GTPases – well-recognized but traditionally very difficult drug development targets.
SHY has built a highly productive, targeted, proprietary pharmacophores (chemical core structures) and compound portfolio based on novel cell free assays, machine learning analyses of traditional and in-silico libraries, proprietary screens, and inspired SAR (structure activity relationship) drug design work.
SHY is continuing to expand its compound portfolios and, as our resources permit, to test its efficacy and safety to treat a growing number of diseases.
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