Celcuity to Present Preclinical Data for Gedatolisib at the 2023 San Antonio Breast Cancer Symposium
December 01 2023 - 11:02AM
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today announced that an abstract accepted for a poster presentation
at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now
available on the SABCS website. The 2023 San Antonio Breast Cancer
Symposium (SABCS) is being held virtually and in-person from
December 5-9, 2023.
The presentation will include potency and efficacy data
evaluating the effects of gedatolisib, a pan-PI3K/mTOR (PAM)
inhibitor, and approved PAM inhibitors (PAMi) on breast cancer cell
lines with mutated or non-mutated PAM pathway genes. Compared to
the other PAMi, gedatolisib exhibited more potent and efficacious
anti-proliferative and cytotoxic effects, regardless of the cell
lines’ PI3K pathway mutational status. Mechanistically, gedatolisib
decreased both DNA and protein synthesis more effectively than the
other PAMi tested.
These findings demonstrate that gedatolisib may more effectively
address potential drug resistance mechanisms associated with the
approved PAM inhibitors. A Phase 3 VIKTORIA-1 trial evaluating
gedatolisib plus fulvestrant with and without palbociclib is
underway in in adults with HR+, HER2- advanced breast cancer.
Poster presentation details are provided below.
Poster Title: “Gedatolisib, a pan-PI3K
inhibitor shows superior potency & efficacy relative to other
PI3K/AKT/mTOR pathway inhibitors in breast cancer
models”Author: Rossetti S et
al.Poster ID: PO1-24-04Poster
Session: Poster Session 1Presentation
Time: December 6, 2023, 12:00 p.m. - 2:00 p.m. CT
(1:00 p.m. - 3:00 p.m. ET)
Additional data will be presented at the Poster Discussion, and
the poster will be available on Celcuity's website after the poster
is presented.
For more details about SABCS please
visit: https://www.sabcs.org/.
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
efficacy and potential applications of Celcuity’s lead product
candidate, gedatolisib, the timing of clinical trial activities,
and other expectations with respect to 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" 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,
unexpected delays or results relating to our clinical trials or
regulatory approvals, and the 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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