Celcuity to Host Virtual Science Day for Investors
September 07 2023 - 4:05PM
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today announced that it will host a Virtual Science Day for
analysts and investors from 10:00 a.m. – 12:00 p.m. ET on Thursday,
September 21, 2023. During this informative event, Celcuity will
provide an in-depth overview of its lead compound, the equipotent
pan-PI3K/mTOR inhibitor gedatolisib, discuss the importance of
comprehensive, rather than selective, inhibition of the PI3K/mTOR
pathway, and review its anticipated clinical development strategy
in breast and prostate cancer.
The Phase 3 (VIKTORIA-1) global registration trial with
gedatolisib is currently enrolling patients with HR+/HER2- advanced
breast cancer whose disease progressed while receiving a CDK4/6
inhibitor. In early 2024, Celcuity expects to initiate the Phase
1b/2 CELC-G-201 trial of gedatolisib in combination with the
androgen receptor inhibitor Nubeqa® (darolutamide) in metastatic
castration resistant prostate cancer.
“We look forward to providing additional insights about
gedatolisib’s highly differentiated mechanism of action and how, we
believe, this MOA can enable gedatolisib to potentially obtain
several blockbuster indications,” said Brian Sullivan, Chief
Executive Officer and co-founder of Celcuity.
Key opinion leaders speaking at Celcuity’s Virtual Science Day
will include two leading oncologists:
- Sara Hurvitz, M.D., Head of the Division of
Hematology and Oncology at the University of Washington Department
of Medicine, Senior Vice President, Clinical Research Division at
Fred Hutchinson Cancer Center. Formerly, she was the Director of
the Breast Cancer Clinical Trials Program at UCLA.
- Karim Fizazi, M.D., Ph.D., Professor of
Oncology at the University of Paris-Saclay, and former head of the
department of oncology medicine at Gustav Roussy specializing in
the treatment of prostate cancer.
Registration Information
Celcuity’s Virtual Science Day for analysts and investors will
take place on Thursday, September 21, 2023, from 10:00 a.m. to
12:00 p.m. ET. To register for the event, please click here. A
replay of the webcast will be available on the “Events &
Presentations” section of Celcuity’s website following the
event.
About the Phase 1b/2 CELC-G-201 Trial
The CELC-G-201 Phase 1b/2 clinical trial is designed to evaluate
gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor,
in patients previously treated with an AR inhibitor as a first-line
treatment for metastatic castration resistant prostate cancer
(mCRPC). In the Phase 1b portion of the study, Celcuity expects
that 36 participants will be randomly assigned to receive 600 mg
darolutamide combined with either 120 mg gedatolisib in Arm 1, or
180 mg gedatolisib in Arm 2. An additional 12 participants will
then be enrolled in the Phase 2 portion of the trial at the
recommended Phase 2 dose (RP2D) to enable evaluation of 30
participants treated with the RP2D of gedatolisib. The primary
objectives of the Phase 1b portion of the trial include assessment
of the safety and tolerability of gedatolisib in combination with
darolutamide and determination of the RP2D of gedatolisib. The
primary objective of the Phase 2 portion of the trial is to assess
the radiographic progression-free survival (rPFS) at six months of
patients who received the RP2D.
About Gedatolisib
Gedatolisib is a potent 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 PI3K isoforms, as
gedatolisib does, limits the potential confounding effect of
isoform interaction that may occur 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.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing
development of targeted therapies for oncology. The company's lead
therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR
inhibitor. 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. A Phase 3 clinical trial, VIKTORIA-1, evaluating
gedatolisib in combination with fulvestrant with or without
palbociclib in patients with HR+/HER2- advanced breast cancer is
currently enrolling patients. More detailed information about the
VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2
clinical trial, CELC-G-201, evaluating gedatolisib in combination
with darolutamide in patients with metastatic castration resistant
prostate cancer, is planned to begin enrolling patients in the
first quarter of 2024. The company’s 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. Further information about Celcuity can be found at
Celcuity.com. Follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains statements that constitute
"forward-looking statements" including, but not limited to, the
timing of initiating and enrolling patients in, and receiving
results from, clinical trials, such as Celcuity's Phase 3
VIKTORIA-1 and Phase 1b/2 CELC-G-201 clinical trial, the costs and
expected results from ongoing and planned clinical trials, the
impact on gedatolisib and Celcuity of preliminary clinical trial
results, the market opportunity for gedatolisib in the prostate and
breast cancer markets, and other expectations with respect to
Celcuity's lead product candidate, gedatolisib, and Celcuity’s
CELsignia platform. In some cases, you can identify forward-looking
statements by terminology such as "may," "should," "expects,"
"plans," "anticipates," "believes," "estimates," "predicts,"
"potential," "intends," “goal,” or "continue," 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 are subject to numerous
risks, uncertainties, and conditions, many of which are beyond the
control of Celcuity. These include, but are not limited to, delays,
disruptions or adverse results in our clinical trials and those
risks set forth in the Risk Factors section in Celcuity's Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the Securities and Exchange Commission on March 23, 2023, and
our subsequent Quarterly Reports on Form 10-Q. 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 press release, except as required
by law.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc.Brian Sullivan, bsullivan@celcuity.comVicky Hahne,
vhahne@celcuity.com763-392-0123
ICR Westwicke Robert Uhl,
robert.uhl@westwicke.com619-228-5886
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