SHY is a private, clinical-stage company developing small molecule therapeutics that non-covalently modulate the activity of ATPases and GTPases.
ATPases and GTPases are essential proteins that regulate 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, neurodegeneration and cardiovascular diseases.
SHY is conducting a Phase 1 trial called Luca-1 for the treatment of solid tumors with SHY-ONC6, a novel proteasome inhibitor.
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
SHY-ONC6 Phase 1 Trial 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.
Luca-1, SHY's Phase 1 trial for SHY-ONC6, is now underway to study its safety in people for the first time.
A unique platform portfolio
ATPases and GTPases are ubiquitous across species and critical cellular proccesses. SHY has developed and is expanding a unique, proprietary portfolio of pharmacophores (chemical core structures) and compounds that non-covalently modulate the activity of ATPases and GTPases. This portfolio is proving to be a highly productive platform for Hit to Lead to Clinical Candidate generation by SHY. SHY has already selected compounds from it demonstrating high specificity, efficacy, and tolerability in a growing set of in vivo models of critical unmet medical needs.
First-in-class pre-clinical pipeline
A growing portfolio of patient-focused programs that meet and surpass standards of care in models of critical underserved disease. SHY programs that have demonstrated positive in vivo outcomes with novel compounds and mechanisms of action include proteasome inhibition, Ras Superfamily of Small GTPases multi-target cancer therapeutics, anti-fungals, anti-bacterials, and neuromuscular disease therapeutics.
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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