Lutris Pharma Receives Notice of Allowance for Patent Covering the Use of B-Raf Inhibitors in MEK Inhibitor induced rash

Notice of Allowance of Patent Application for the Use of B-Raf Inhibitors for Treating Cutaneous Reactions Caused by Treatment with a MEK Inhibitor Further Expands Lutris' Comprehensive Intellectual Property Portfolio Until 2038

TEL AVIV, Israel, Sept. 14, 2022 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that the company, together with Memorial Sloan Kettering Cancer Center (MSK), has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application No. 16/636,974, entitled, "Use of BRAF Inhibitors for Treating Cutaneous Reactions Caused by Treatment With a MEK Inhibitor." The company has licensed exclusive rights to the patent from MSK. When issued, Lutris will have a total of 24 issued national patents covering 18 countries, as well as 19 patents pending.

The allowed claims cover Lutris' novel compositions of B-Raf inhibitors and uses thereof for treating and/or preventing MEK inhibitor-associated cutaneous conditions through a multitude of methods of administration, including, but not limited to, local administration to the skin, orally or systemically. The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The patent resulting from this application will have an expiration date of not earlier than August 8, 2038. 

"The receipt of this Notice of Allowance from the USPTO for method-of-use claims related to B-Raf inhibitors, significantly strengthens our intellectual property portfolio and broadens the potential indications," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "While the usage of MEK inhibitors in the treatment of certain diseases and cancers may significantly improve patient prognosis, such treatments hold the risk of serious adverse reactions, including acneiform rashes. The use of B-Raf inhibitors in treating these MEK inhibitor-associated cutaneous reactions could potentially help improve the treatment by reducing the associated dose limiting toxicities. This patent is synergistic to our portfolio including lead compound, LUT014, a proprietary, topical, first-in-class, novel B-Raf inhibitor for the treatment of EGFR inhibitor-induced acneiform lesions."

About Lutris Pharma
Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects and enable patients' adherence to anti-cancer treatment.

Lutris Pharma is currently assessing the effectiveness of LUT014 in two clinical studies: a randomized, double-blind, placebo-controlled efficacy and safety study of topically administered LUT014 in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions (NCT04759664), and a Phase 1/2 open-label followed by blinded study evaluating the safety, tolerability and efficacy of topically administered LUT014 (LUT-RD) in breast cancer patients with radiation induced dermatitis (RD) (NCT04261387). Top-line results in RD showed that 75% of patients in part 1 experienced complete resolution of RD, while part 2 data showed a clinically relevant treatment effect in 100% of patients treated with LUT014.

For more information, please visit www.lutris-pharma.com.

Contacts:

Lutris Pharma
Noa Shelach, Ph.D. 
Chief Executive Officer 
ir@lutris-pharma.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

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