Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial
August 22 2023 - 4:05PM
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today announced that it has entered into a clinical trial
collaboration and supply agreement with Bayer AG for Celcuity’s
Phase 1b/2 clinical trial of gedatolisib and Nubeqa®
(darolutamide) in patients with metastatic castration resistant
prostate cancer (mCRPC). As part of the supply agreement,
Bayer will provide Nubeqa to Celcuity at no cost.
Celcuity expects to initiate a Phase 1b/2 clinical trial in the
first quarter of 2024 to evaluate gedatolisib, the company’s
pan-PI3K/mTOR inhibitor, in combination with darolutamide, an
androgen receptor inhibitor, in patients with mCRPC who progressed
on their first line of androgen receptor treatment for mCRPC.
“We are excited that Bayer is providing darolutamide for this
important Phase 1b/2 clinical trial,” said Brian Sullivan, Chief
Executive Officer and co-founder of Celcuity. “Darolutamide is
structurally unique to other ARI’s, with an excellent efficacy and
differentiated tolerability profile coupled with minimal drug-drug
interactions, making it an ideal combination partner for
gedatolisib. Our goal is to address the significant need for new
therapeutic options for patients with metastatic castration
resistant prostate cancer.”
About GedatolisibGedatolisib 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 CelcuityCelcuity 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
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," "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, Bayer’s
continued performance under the terms of our clinical trial
collaboration and supply agreement 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 Westwicke Robert Uhl, robert.uhl@westwicke.com
(619) 228-5886
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