Lutris Pharma Expands Intellectual Property Portfolio Surrounding its Novel B-Raf Inhibitors Including Lead Asset LUT014

Broad Patents Include Compositions of Novel B-Raf Inhibitors and Use for the Treatment of Cutaneous Reactions Caused by Treatment with EGFR Inhibitors and/or PI3K Inhibitors

TEL AVIV, Israel, Dec. 8, 2021 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that it has expanded the intellectual property (IP) surrounding its novel B-Raf inhibitors, including lead compound LUT014, a topically applied, novel B-Raf inhibitor for the treatment of cutaneous reactions caused by treatment with epidermal growth factor receptor (EGFR) inhibitors and/or PI3K inhibitors and treatment of radiation dermatitis (RD) caused by radiation therapy, in both the U.S. and internationally. Within its patent portfolio, Lutris currently has a total of 13 issued national patents covering eight countries, as well as 17 patents pending.

The company's patent portfolio includes compositions comprising BRaf inhibitors and uses thereof for treating and/or preventing, by topical or systemic administration, cutaneous conditions caused by treatment with EGFR inhibitors and/or PI3K inhibitors, which have been granted in the U.S. Israel, Canada Russia, Australia, Japan, Mexico and Korea, with other applications still in active prosecution. Additional non-U.S. applications have been accepted for expedited examination based on the allowed U.S. applications under the Patent Prosecution Highway program.

The company noted that a patent has been filed in the U.S., Australia, Brazil, Canada, China, EP (regional), Israel, India, Japan, Mexico, Russian Federation, South Korea and South Africa for the treatment of radiation dermatitis (RD) with B-Raf inhibitors. Lutris also has additional provisional patents for dosing and novel indications. A broad U.S. patent has been granted for a method of screening a population of B-Raf inhibitors in order to identify the best candidates for clinical development.

"The expansion of our patent portfolio, for which we have filed broadly and have received key levels of protection, is a critical focus for the company, as we seek to continually strengthen the position around LUT014," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma, "Our pipeline programs are based on novel technology, backed by compelling data, illustrating the potential ability to harness the paradoxical effect of B-Raf inhibitor therapy with a topical treatment (LUT014) that can both reverse the inhibitory effect of EGFR inhibitors on downstream proteins in the skin cells in order to reduce dose-limiting acneiform lesions caused by EGFR therapy, and stimulate proliferation of basal keratinocytes to treat cancer patients afflicted with radiation dermatitis. Our current phase 2 trial of LUT014 in metastatic colorectal cancer patients (mCRC) being treated with EGFR inhibitor therapy who have developed dose-limiting acneiform lesions is progressing and we expect to report rolling data, as appropriate. Additionally, we look forward to announcing data from our blinded phase 1/2 study of LUT014 for the treatment of RD in breast cancer patients, during the first half of 2022. We are dedicated to making an impact on these patients,  for whom there are currently no approved treatment options." 

Additional information on the patent portfolio can be found on "Intellectual Property" section of the Lutris website at: www.lutris-pharma.com/intellectual-property.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. The B-Raf protein is part of the EGFR pathway and has shown to be mutated in some human cancers such as melanoma cancer. Blocking the B-Raf pathway in B-Raf mutated cancer cells leads to tumor shrinkage, but when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAP Kinase pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses this paradoxical effect in order to reverse the effect of EGFR inhibitors on downstream proteins in the skin cells, thereby reducing dose-limiting acneiform lesions associated with EGFR inhibitor treatment.

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. Lutris Pharma's lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients. 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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