Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
has been notified by the U.S. Food and Drug Administration (FDA)
that its Investigational New Drug (IND) submission has been
reviewed, and Celcuity can proceed with the clinical development of
gedatolisib in combination with Nubeqa® (darolutamide), an approved
androgen receptor inhibitor, for the treatment of patients with
metastatic castration resistant prostate cancer (mCRPC). Celcuity’s
Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants
with mCRPC who progressed after treatment with an androgen receptor
inhibitor as first-line treatment for mCRPC. The Company
anticipates initiating this Phase 1b/2 clinical trial in the first
quarter of 2024.
“We are excited to initiate the clinical development of
gedatolisib in prostate cancer,” said Brian Sullivan, Chief
Executive Officer and co-founder of Celcuity. “Gedatolisib’s highly
differentiated mechanism of action makes it uniquely suited to
address the complex PI3K/mTOR activity involved in this
disease.”
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 study at the RP2D
level 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 recommended
Phase 2 dose 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.
“Treatment options for patients with mCRPC whose disease
progressed on or after treatment with an androgen receptor
inhibitor are limited, and there is an urgent need for new drugs to
treat this patient population,” said Karim Fizazi, MD, PhD,
Professor of Medicine at Institute Gustave Roussy and GETUG
President. Professor K. Fizazi, who is one of the primary principal
investigators for this study, further stated: “Since PI3K/mTOR and
androgen receptor signaling are commonly aberrantly activated in
mCRPC, combining gedatolisib with the approved androgen receptor
inhibitor darolutamide represents a potentially promising treatment
option for these patients.”
Registration Information for the Virtual Science
Day
Celcuity will host a Virtual Science Day for analysts and
investors on Thursday, September 21, 2023, from 10:00 a.m. – 12:00
p.m. ET, featuring presentations by key opinion leaders and
Celcuity’s leadership. During this meeting, Celcuity will provide
an in-depth scientific overview of gedatolisib, the importance of
comprehensive, rather than selective, inhibition of the PI3K/mTOR
pathway, and review its clinical development strategy, including a
discussion about its Phase 1b/2 study in mCRPC.
A live chat-based Q&A session will follow the formal
presentations. 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 for a limited time
following the event.
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 scope,
protocol, costs and expected results from ongoing and planned
clinical trials, the skills and experience of investigators
involved with Celcuity’s Phase 1b/2 CELC-G-201 clinical trial, the
impact on gedatolisib and Celcuity of preliminary clinical trial
results, the market opportunity for gedatolisib in the prostate
cancer market, 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," “will,” "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 the
CELC-G-201 clinical trial 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.
Contacts:
Celcuity Inc.Brian Sullivan, bsullivan@celcuity.comVicky Hahne,
vhahne@celcuity.com763-392-0123
ICR WestwickeRobert Uhl, robert.uhl@westwicke.com
(619) 228-5886
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