Celcuity Announces Worldwide Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib, a First-in-Class PI3K/mTOR Inhibitor for Breast Cancer - Seite 2

To evaluate the efficacy and safety of this new treatment strategy, gedatolisib is currently being evaluated in combination with palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or fulvestrant in the expansion portion of a Phase 1b clinical trial in patients with ER+/HER2-negative advanced or metastatic breast cancer. A total of 103 patients were enrolled in one of four different arms according to their prior treatment history for metastatic breast cancer. A preliminary analysis of the objective response rates as of the January 11, 2021 data cut-off demonstrated that gedatolisib combined with palbociclib and an endocrine therapy achieved superior objective response rates relative to historical control data. Gedatolisib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs were neutrophil count decrease and stomatitis.

Added Art DeCillis, M.D., Celcuity’s Chief Medical Officer, “In light of the data reported as of the January 11, 2021 data cut-off, we intend to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial 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.”

Webcast Presentation and Conference Call Information

The Celcuity management team will host a webcast/conference call today, April 8, 2021, at 5:00 p.m. ET to discuss the gedatolisib license agreement. To participate in the call, dial 1-877-407-8035. A live webcast presentation can also be accessed using this weblink at: https://www.webcaster4.com/Webcast/Page/2678/40570 or via Celcuity’s website at https://celcuity.com/home/investors/events-webcasts/. A replay of the webcast will be available on the Celcuity website for a limited time following the event.

About Celcuity

Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated companion diagnostic and therapeutic strategy. Our CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies. This enables a CELsignia CDx to support advancement of new indications for already approved targeted therapies. Our therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver our companion diagnostics can identify. By pursuing an integrated companion diagnostic and therapeutic strategy, we believe we are uniquely positioned to achieve our goal of helping cancer patients receive the therapeutic best suited to treat their cancer driver. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com.