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Celcuity to Present Preclinical Data for Gedatolisib at the 2023 San Antonio Breast Cancer Symposium

Key Takeaway: Celcuity Inc. will present new preclinical data on gedatolisib at the 2023 San Antonio Breast Cancer Symposium. The poster presentation will highlight the drug's enhanced potency and efficacy as a pan-PI3K/mTOR inhibitor compared to other approved PAM inhibitors, particularly in breast cancer cell lines. These promising results may inform ongoing clinical trials, including the Phase 3 VIKTORIA-1 trial assessing gedatolisib in combination therapies for advanced breast cancer. Presentation is scheduled for December 6, 2023.

Market Sentiment Analysis

POSITIVE FACTORS

  • Gedatolisib shows superior potency and efficacy compared to other PAM inhibitors.
  • The ongoing VIKTORIA-1 trial could further validate gedatolisib's clinical potential.
  • Presentation at a prestigious cancer symposium highlights the relevance of the findings.

Full Press Release Details

MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- 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: PO1-24-04
Poster Session: Poster Session 1
Presentation 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/.
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
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com

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San Antonio Breast Cancer

Frequently Asked Questions

What is the focus of Celcuity Inc. in oncology?

Celcuity Inc. is focused on developing targeted therapies for oncology.

When is the 2023 SABCS being held?

The 2023 SABCS is scheduled for December 5-9, 2023.

What is gedatolisib's mechanism of action?

Gedatolisib is a pan-PI3K/mTOR inhibitor that affects DNA and protein synthesis.

What type of cancer is being targeted in the VIKTORIA-1 trial?

The VIKTORIA-1 trial targets HR+, HER2- advanced breast cancer.

Where can the poster presentation be accessed?

The poster will be available on Celcuity's website after its presentation.

Last updated: Dec 1, 2023