On January 28, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose-limiting toxicity, reported that it has secured a $30 million financing to advance the development of LUT014, an innovative topically applied gel aimed at reducing EGFRi-induced rashes, a common adverse side effect of these cancer-fighting therapies (Press release, Lutris Pharma, JAN 28, 2025, View Source [SID1234649916]). The round was led by Columbus Venture Partners and Pontifax Venture Capital, an existing investor, with Peregrine Ventures and aMoon Fund also participating.
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While EGFRi therapies are highly effective for the treatment of cancer, they have dose-limiting skin toxicities, leading to substantial discontinuation of patients’ treatment in less than three months due to intolerable acneiform rashes. LUT014, a novel B-Raf inhibitor, is used for patients who develop dose-limiting rashes, potentially allowing them to continue EGFRi treatment with an improved quality of life.
"We are grateful to these investors who recognize the potential of LUT014 to address the significant unmet need caused by the toxicity of EGFRi therapies, which are otherwise effective therapeutic regimens. This financing will enable us to continue the clinical development of LUT014 with the goal of treating the acneiform rash to improve life quality and enabling adherence to EGFRi therapies," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "The development and ultimate commercialization of LUT014 aligns with our mission to improve anti-cancer therapy effectiveness and to meaningfully impact the quality of life for patients."
In October 2024, Lutris successfully completed enrollment in the international phase 2 trial of LUT014 in patients with metastatic colorectal cancer (mCRC) treated with EGFRi therapy who develop dose-limiting acneiform rash. The company expects to report top-line results from this trial during the first half of 2025 at a major medical meeting.
"Based on the broad use of EGFRi’s to treat cancer and the dermal toxicity that often emerges, many of these patients do not receive the optimal treatment against their cancer, either due to dose reduction or outright discontinuation in response to the intolerable dermal toxicity," stated Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma. "Despite extensive research efforts in the past, no standard of care has emerged to deal with this prevalent issue, leading to a significant unmet medical need. By reversing the inhibitory effect of EGFRi therapy on downstream signaling in the skin cells, we believe that LUT014 has the potential to become an important therapeutic for EGFR inhibitor induced skin toxicity and can have a tremendous impact for patients who currently have no other effective treatment options."
"Acneiform rash is the most common side effect of EGFRi therapies, with up to 90% of patients experiencing an adverse dermatologic event, taking a toll which can be detrimental to their therapy. It is all too common that patients terminate treatment due to these effects, leading to continued disease progression and prolonged treatment. The need to manage this condition is crucial and Lutris is doing just that with the advent of LUT014," said Dr. Yael Gruenbaum-Cohen, DMD, PhD, Partner at aMoon Fund. "As development of LUT014 proceeds, we can foresee a paradigm shift wherein EGFRi treatment will be regularly coupled with LUT014 as a valuable adjunct. This aligns with aMoon’s mission of helping people live longer, healthier lives, and we are proud to support Lutris on their journey towards success."
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.
Drugs called EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have failed prior chemotherapy. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy. Accordingly, LUT014 has the potential to impact not only on quality of life but also on oncologic outcome.
About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to reactivate the MAPK pathway and reverse the rash induced by the inhibition of this signaling pathway.