In the area of oncology, EGFR inhibitors have proven to be one of the most powerful treatments against cancer. The therapeutic efficacy is generally undermined by a dermatological adverse effect such as acneiform rash, resulting in treatment cessation. Lutris Pharma is therefore seeking solutions that help improve the tolerance of anticancer treatments to prevent patients from losing their therapeutic programs with a detrimental effect on quality of life.

Founded with a mission to improve anti-cancer therapy effectiveness, Lutris Pharma focuses on developing treatments that reduce cutaneous dose-limiting toxicities. Their lead product, LUT014, is a novel topical B-Raf inhibitor designed to alleviate EGFRi-induced rashes. By allowing patients to continue their cancer treatments with minimal dermatological side effects, Lutris will set a new standard in supportive oncology care.

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The recent $30 million financing round was led by Columbus Venture Partners and Pontifax Venture Capital, with participation from Peregrine Ventures and aMoon Fund. This substantial investment underscores the confidence these investors have in Lutris Pharma’s innovative approach and the potential impact of LUT014 on cancer care

EGFR inhibitors are essential in the treatment of several cancers, including metastatic colorectal cancer and non-small cell lung cancer. Though these drugs have proven therapeutic benefits, up to 90% of patients develop dermatological adverse events, mainly acneiform rashes. 

These can be severe enough to require dose reductions or discontinuation of therapy, thus undermining the effectiveness of the treatment. To date, there is no standard of care for this common problem, which underscores a significant unmet medical need. PRNEWSWIRE.COM

LUT014: A New Therapy

LUT014 is an intradermal gel, and it is the B-Raf inhibitor. This drug is able to reduce the severity of acneiform rashes in patients undergoing cancer treatment with the help of its action on the pathways responsible for EGFRi-induced skin toxicities. As a result, patients are left free to undergo their treatments, free from these debilitating skin side effects, improving adherence and probably the treatment results.

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Lutris Pharma successfully completed the enrollment of an international, Phase 2 trial on LUT014 for the treatment of patients with metastatic colorectal cancer who had dose-limiting acneiform rashes related to EGFRi therapy in October 2024. 

The firm expects that it will present top-line results for this trial at a major medical meeting sometime in 2025’s first half. Favorable data from this trial may result in the further pursuit of this product toward potential regulatory approval and advance the availability of LUT014 to help patients around the world.

Dr. Noa Shelach, Chief Executive Officer of Lutris Pharma said, “We are thankful to these investors that understand the promising potential of LUT014 for addressing the considerable unmet medical need caused by the toxicity of the otherwise effective EGFRi therapeutic regimens.” She added, “The funds will allow Lutris Pharma to carry on with clinical development of LUT014 so that it might improve the quality of life and be able to sustain adherence to the EGFRi therapies.

Dr. Antoni Ribas, Chairman and Founder of Lutris Pharma said, “In reversing the inhibition of downstream signaling in skin cells by EGFRi therapy, we believe that LUT014 will become an important therapeutic for skin toxicity induced by EGFR inhibitors and will be of great significance for patients for whom no alternative effective treatment options are available at present.”

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The investors participating in this round of financing bring significant experience and strategic support to Lutris Pharma. Their investment reflects a common view of the development of innovative solutions for oncology supportive care. The partnership is set to streamline the development and commercialization of LUT014, making it accessible to all patients across the global 

With the secured funding, Lutris Pharma will be able to move forward the clinical development of LUT014. The report of Phase 2 trial results is going to be released and will be the most important milestone: it could help validate the effectiveness of LUT014 and subsequently pave the way for regulatory submission. The company continues to pursue its objective of improving tolerability of cancer treatment and patients’ quality of life.