David Dalvey's Contact Details

David Dalvey's Company Details

Celcuity

Plymouth, MN, US • 50 - 99 Employees
SaaS

Celcuity is a clinical-stage public biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic (Rx) and companion diagnostic (CDx) strategy that leverages our CELsignia CDx platform. Our therapeutic strategy aims to utilize CELsignia's unique insights into tumor cell biology to develop potential first-in-class or best-in-class targeted therapies that treat the same cancer driver a CELsignia CDx can identify. Our CELsignia CDx platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies. Our first drug candidate is gedatolisib, a potent, well-tolerated, small molecule that selectively targets all Class 1 isoforms of PI3K and mTORC1 and mTORC2. Gedatolisib's unique mechanism of action, pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved and investigational therapies that target PI3K or mTOR alone or together. We intend to initiate a Phase 3 study in the first half of 2022 evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022. Additional clinical development programs are expected to focus on other tumor types that involve the PI3K/mTOR pathway, such as prostate, lung, and ovarian cancer.