Dacomitinib

Celcuity (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy. "There is an urgent need for better treatment options for HR+/HER2- metastatic breast cancer patients whose disease progressed after treatment with a CDK4/6 inhibitor and endocrine therapy," said Brian Sullivan, CEO and co-founder of Celcuity. "We are very encouraged by the clinical data for gedatolisib and believe that Fast Track designation will facilitate our efforts to advance its development for patients as quickly as possible." Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions and which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and to ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application. Celcuity remains on track to obtain feedback from the FDA and to finalize the design and protocol of its Phase 3 clinical trial in the first quarter of 2022. Site identification and feasibility activities for the Phase 3 clinical trial are on-going. Additionally, Celcuity announced plans to initiate two Phase 2 clinical trials to evaluate gedatolisib in HR+/HER2- breast cancer patients selected with a CELsignia PI3K Pathway Test. One trial will evaluate gedatolisib in combination with fulvestrant in up to 25 patients with metastatic breast cancer. The second trial will evaluate up to 15 patients with early-stage breast cancer with gedatolisib in combination with palbociclib and letrozole. These clinical trials will be initiated at sites which are already participating in a trial that is screening patients with the CELsignia HER2 Pathway Test. Screened patients who provide a tumor biopsy will receive a CELsignia HER2 and PI3K Test. Patients found to have hyperactive HER2 signaling will be eligible to receive treatment with an anti-HER2 therapy and those with hyperactive PI3K signaling will be eligible to receive gedatolisib in combination with other targeted therapies. Patient enrollment is expected to begin for the two trials in late 2022. Celcuity believes that conducting these CELsignia studies in parallel will enhance screening activities for potentially eligible patients. Based on the prevalence of hyperactive HER2 and PI3K signaling, Celcuity estimates that approximately 40%-45% of patients receiving a CELsignia test would potentially be eligible to enroll in one of the clinical trials. Patients providing tumor for CELsignia testing would thus be twice as likely to be eligible for participation in a CELsignia clinical study, potentially a significant benefit. "Initiating clinical trials to evaluate gedatolisib in CELsignia selected patients in parallel with other CELsignia studies is very synergistic," stated Brian Sullivan. "First, we believe this will enhance the enrollment activities for each study. Secondly, these studies provide an efficient opportunity for Celcuity to evaluate gedatolisib in CELsignia PI3K test selected patients. Finally, it allows optimization of our overall CELsignia trial strategy. We concluded that the patients eligible for PI3K therapies may significantly overlap with the patients eligible for our clinical trial evaluating the pan-HER inhibitor, dacomitinib, and the c-MET inhibitor, crizotinib. In addition, a gedatolisib based regimen offers, we believe, a significantly more favorable safety pro the combination of dacomitinib and crizotinib. Since we have another clinical trial evaluating a pan-HER and c-MET inhibitor, we concluded the FACT-3 clinical trial was redundant, and we have decided to discontinue it." About Celcuity Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic and companion diagnostic and strategy. The company's therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver its companion diagnostics can identify. Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. About Gedatolisib Gedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Inhibiting all four Class I PI3K isoforms, as gedatolisib does, limits the potential development of drug resistance compared with isoform-specific PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the absence of mTOR inhibition. A robust response rate and a well-tolerated treatment with manageable side effects were observed in an on-going Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with ER+/HER2- advanced breast cancer. Based on these results, a Phase 3 clinical trial is planned.

Jan. 27, 2021 22:31 UTC Celcuity Announces Breast Cancer Clinical Trial Collaboration with Sarah Cannon and Pfizer to Study New Drug Regimen - Trial will evaluate the efficacy and safety of Pfizer’s targeted therapies, VIZIMPRO® and XALKORI®, in patients with metastatic HER2-negative breast cancer selected by Celcuity’s CELsignia Multi-Pathway Activity Test - First clinical trial to treat patients diagnosed with hyperactive HER2 and c-Met signaling breast cancers with matching targeted therapies MINNEAPOLIS--(BUSINESS WIRE)-- Celcuity Inc. (Nasdaq: CELC), a clinical stage biotechnology company utilizing its 3rd generation companion diagnostics to identify new targeted therapeutic options for cancer patients, today announced a clinical trial collaboration with Sarah Cannon Research Institute, the research arm of Sarah Cannon, and Pfizer Inc., a global biopharmaceutical company, to conduct a Phase II clinical trial. This open-label Phase II trial will evaluate the efficacy and safety of two Pfizer targeted therapies, VIZIMPRO®, a pan-HER inhibitor, and XALKORI®, a c-Met inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity’s CELsignia Multi-Pathway Activity Test. Under the agreement, Sarah Cannon Research Institute will serve as the sponsor and Erika Hamilton, MD, a medical oncologist and Director of the Breast Cancer and Gynecologic Cancer Research Program for Sarah Cannon Research Institute at Tennessee Oncology, will serve as the principal investigator of this study. Sarah Cannon Research Institute, one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom, has been a clinical trial leader in the majority of approved cancer therapies over the last decade. “This clinical trial could lay the groundwork for a new treatment paradigm for patients with metastatic HER2-negative breast cancer who stop responding to current standard-of-care drug regimens,” said Dr. Hamilton. Added Dr. Hamilton, “We are eager to begin working with Celcuity and exploring their novel CELsignia technology to identify patients whose tumors may respond to these targeted therapies.” Pfizer will supply VIZIMPRO and XALKORI, targeted therapies currently approved by the U.S. Food and Drug Administration to treat metastatic non-small cell lung cancer. Celcuity will provide its CELsignia Multi-Pathway Activity Test to select patients with HER2-negative metastatic breast cancer who have hyperactive HER2 and c-Met signaling pathways for the trial and will fund the patient-related trial costs. Based on Sarah Cannon’s estimate of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after the protocol is activated and final results 12-15 months later. Celcuity expects enrollment to begin in the second quarter of 2021. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for patients with metastatic HER2-negative breast cancer whose disease progressed on prior therapies. The anti-tumor effect of blocking EGFR/HER1, HER2, HER3, and c-Met pathways when the HER2 and c-Met pathways are hyperactive has been demonstrated in animal models.1 This study represents Celcuity’s fourth clinical trial collaboration with a leading cancer research organization and a pharmaceutical company, and the second one announced in the past month. In December, Celcuity announced a clinical trial collaboration with Massachusetts General Hospital, UCLA, and Vanderbilt to evaluate Puma Biotechnology’s pan-HER inhibitor, NERLYNX, in patients with hormone receptor-positive, HER2-negative breast cancer. Each of the four collaborations rely on a CELsignia Pathway Activity test to select patients who have a dysregulated oncogenic pathway not associated with a corresponding genomic or proteomic mutation. “We are excited about the opportunity to collaborate with Dr. Hamilton, Sarah Cannon Research Institute, and Pfizer on this important clinical trial,” said Brian Sullivan, CEO and co-founder of Celcuity. “This will be our first collaboration that uses our CELsignia Multi-Pathway Activity Test to select patients who have both HER2 and c-Met hyperactive signaling tumors for a clinical trial. According to our studies, approximately 20% of HER2-negative breast cancers have hyperactive HER2 and c-MET signaling. For this group of patients, this trial represents a critical step towards a potential new therapeutic option.” About Celcuity Celcuity is a clinical stage biotechnology company translating discoveries of new cancer sub-types into pioneering companion diagnostics and expanded therapeutic options for cancer patients. Celcuity’s 3rd generation diagnostic platform, CELsignia, analyzes living tumor cells to untangle the complexity of the cellular activity driving a patient’s cancer. This allows Celcuity to discover new cancer sub-types molecular diagnostics cannot detect. Celcuity is driven to improve outcomes for patients and to transform how pharmaceutical companies define the patient populations for their targeted therapies. Celcuity is headquartered in Minneapolis, MN. Further information about Celcuity can be found at . About Sarah Cannon Research Institute Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. A leader in drug development, Sarah Cannon has led more than 450 first-in-human clinical trials since its inception in 1993 and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years. Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. Forward-Looking Statements This press release contains statements that constitute “forward-looking statements.” In some cases, you can identify forward-looking statements by terminology such as “may,” “can,” “could,” “expects,” “estimates,” or “plans,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward looking statements in this release include, without limitation, expectations with respect to commencement of patient enrollment, patient enrollment rates and timing of expected results, and beliefs regarding clinical interest of the trial, the use of new diagnostic tests and targeted therapies in treating cancer patients, and the potential role of the trial and the CELsignia Multi-Pathway Activity Test in developing new treatment options for cancer patients. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, those set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 13, 2020. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Laing, L, et al., Evaluating contribution of hyperactive c-Met and ErbB signaling to tumor progression in mouse breast tumor xenografts: an in vivo study of c-Met and ErbB targeted therapies. Cancer Research;79 (4 Supplement) P3-10-15 VIZIMPRO and XALKORI are registered trademarks of Pfizer Inc.