Celcuity Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Breast Cancer Models at the 2023 San Antonio Breast Cancer Symposium
December 06 2023 - 8:30AM
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today presented data from preclinical studies evaluating
gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast
cancer cell lines during a poster session at the 2023 San Antonio
Breast Cancer Symposium (SABCS).
The preclinical studies evaluated gedatolisib, a pan-PI3K/mTOR
inhibitor, and PAM inhibitors that selectively target single PAM
nodes (PI3Kα, AKT, and mTORC1) to compare the functional effect of
inhibiting multiple vs. single PAM pathway nodes in a panel of
breast cancer cell lines. In cell viability and proliferation
analyses, gedatolisib was found to be more cytotoxic and at least
300-fold more potent, on average, compared to the single node PAM
inhibitors. Mechanistically, gedatolisib decreased cell survival,
DNA replication, protein synthesis, glucose consumption, lactate
production and oxygen consumption more effectively than the other
PAM inhibitors. In vivo studies confirmed that pan-PI3K/mTOR
inhibition by gedatolisib reduced tumor cell growth more
effectively than single node inhibitors in breast cancer patient
derived xenograft models with and without PAM pathway
mutations.
“These findings indicate that gedatolisib is more effective than
single node PAM inhibitors at controlling key cellular functions
required by cancer cells for energy production, molecule
biosynthesis, and cell proliferation,” said Brian Sullivan,
Celcuity’s Chief Executive Officer and co-founder. “We believe this
data reinforces the relevance of gedatolisib’s highly
differentiated mechanism of action.”
The poster will be available in the publications page of
the Celcuity website after the poster session.
About Gedatolisib
Gedatolisib is a potent, reversible dual inhibitor that
selectively targets all Class I PI3K isoforms 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 and mTOR limits the potential
development of drug resistance compared with isoform-specific PI3K
or mTOR specific inhibitors. A robust response rate and a
manageable side effect profile were reported for the Phase 1b
clinical trial that evaluated gedatolisib in combination with
palbociclib and endocrine therapy in patients with HR+/HER2-
advanced breast cancer.
About Celcuity
Celcuity is a clinical-stage biotechnology company focused on
development of targeted therapies for treatment of multiple solid
tumor indications. 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 expected
to be initiated 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. 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
adequacy of Celcuity’s cash on hand to fund research and
development expenses and other general corporate expenses, the
timing of initiating and enrolling patients in, and receiving
results from, clinical trials, such as Celcuity's Phase 3
VIKTORIA-1 clinical trial and Phase 1b/2 CELC-G-201 clinical trial,
the costs and expected results from any ongoing or planned clinical
trials, the impact on gedatolisib and Celcuity of preliminary
clinical trial results, any potential benefits resulting from
Breakthrough Therapy designation for gedatolisib, and other
expectations with respect to Celcuity's lead product candidate,
gedatolisib and its 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" 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, 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, as may be updated by our 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.com Vicky Hahne,
vhahne@celcuity.com (763) 392-0123
ICR Westwicke Maria Yonkoski,
maria.yonkoski@westwicke.com (203) 682-7167
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