Innovative Solutions for Managing Skin Rash in Targeted Cancer Therapy

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Targeted therapies have revolutionized cancer treatment by specifically attacking cancer cells while sparing normal cells, thus reducing side effects compared to traditional treatments. Despite these advancements, one significant side effect remains: a prominent facial rash that resembles acne. This adverse reaction has deterred some patients from continuing their treatment regimen, compromising the effectiveness of their therapy.

Israeli startup EMRIS Pharma has addressed this issue with a new ointment designed to mitigate this side effect. According to the American Cancer Society, rashes are the most common side effect of targeted therapies, with their occurrence and severity depending on the type and dose of treatment. These rashes usually appear on the face and, in some cases, on other visible areas such as the neck, scalp, and upper back. While the rash subsides after completing the treatment, it can be so traumatic for some patients that they avoid public appearances, reduce their treatment frequency, or halt it altogether.

Dr. Sharon Merims, EMRIS’s Chief Scientific Officer and co-founder, explains that around 90% of patients receiving targeted therapies experience some form of skin toxicity. Dr. Merims, a dermatologist who leads the Dermato-Oncology and Skin Toxicity Clinic at the Sharett Institute of Oncology at Hadassah University Hospital-Ein Kerem in Jerusalem, emphasizes the significant impact of the rash due to its facial involvement, affecting patients’ quality of life.

The development of the EMRIS ointment began eight years ago when Dr. Merims, alongside co-founder and Chief Technology Officer Professor Ofra Benny, a specialist in drug delivery systems at the Hebrew University of Jerusalem, started exploring a solution to this problem. They aimed to create a topical therapy to manage the side effects of targeted therapy, a concept that seemed paradoxical at first. Dr. Merims envisioned a blocking agent that could be applied topically to prevent the cancer drug from affecting the skin cells.

Through extensive research, the team identified a potent lead molecule forming the basis of the EMRIS ointment. This molecule prevents the targeted cancer therapy, specifically an epidermal growth factor receptor (EGFR) inhibitor, from affecting the skin cells. EGFR inhibitors block the activity of EGFR, a protein related to cell growth found in many cells, to prevent cancer cells from growing. However, this action also affects normal skin cells, causing the rash. The ointment works by blocking the EGFR inhibitor from binding to the skin cells, thus preventing the rash while allowing the cancer treatment to proceed unhindered.

EMRIS Pharma was established in 2023 with Dr. Lyora Aharonov, an expert in biological research and R&D management, as its third co-founder. Funding from the Israel Innovation Authority, which supports the nation’s high-tech sector, and assistance from Yissum, the Hebrew University’s technology transfer company, helped license EMRIS and advance its development.

Dr. Aharonov highlights the ointment’s targeted action as a key advantage, describing it as a game changer for patients. Unlike current treatments, which involve avoiding the sun, using emollients, topical steroids, and a regimen of antibiotics, the EMRIS ointment addresses the root cause of the rash, preventing it from developing in the first place.

In the past year, EMRIS Pharma has achieved significant milestones, including formulating the topical ointment to reach the necessary skin layer. Animal testing has shown very positive safety results, and human trials are scheduled to begin at Hadassah in early 2026, with plans for further clinical trials in the United States to gain approval from the US Food and Drug Administration.

The ointment is primarily designed for patients undergoing targeted therapy for advanced colon and head and neck cancers. The company’s priority is to keep patients on their cancer treatment regimen while improving their quality of life. Dr. Merims notes that many patients skip doses or reduce their treatment due to the rash, but the EMRIS solution aims to support patients in completing their therapy.

In summary, the innovative approach by EMRIS Pharma offers a promising solution to the significant problem of skin rash in targeted cancer therapy. By addressing the root cause of the rash, the ointment not only improves patients’ quality of life but also supports the continuation of their essential cancer treatment, potentially enhancing overall treatment outcomes.

Detailed Scheme Table for Skin Toxicities and EGFR Inhibitors

DescriptionCategoryAdditional Notes
Specific “on-target” toxicities cause damage to tissues that highly express the molecular targetToxicity TypeMany antineoplastic molecular targeting agents, particularly those that disrupt signal transduction, such as EGFR inhibitors, are associated with severe skin toxicity
Papulopustular eruption, an acne-like rash, is the most common cutaneous reactionCutaneous ReactionLesions typically appear on the face, scalp, and upper trunk, prompting many patients to withhold or reduce treatment
Mutations causing EGFR overexpression linked to various cancersCancer LinkEGFR inhibitors developed to treat these cancers have major improvements in patient outcomes, but also cause normal keratinocyte proliferation inhibition resulting in skin toxicities
Treatment protocols for EGFRi-induced skin toxicities are of limited benefitTreatment ProtocolsCurrent treatments do not effectively address the underlying mechanisms of skin toxicities caused by EGFRi
New skin-directed treatments are needed to prevent keratinocyte damageTreatment NeedHypothesized that blocking EGFRi binding to EGFR in keratinocytes could prevent initial triggers of skin toxicity without compromising anticancer treatment
Molecule screening identified small molecules that block EGFR monoclonal antibodies binding to EGFRMolecule ScreeningDesigned lead compounds with high potency to block and reverse anti-EGFR monoclonal antibody–related skin damage
Developed a topical compound with slow-release biodegradable nanoparticlesTopical CompoundTargets hair follicles with minimal systemic effects; effective in in vitro cell line assays and an ex vivo model of human skin, found to be safe in an animal study
Specific on-target side effects of new targeted biological drugsOn-Target Side EffectsExample: on-target skin toxicity caused by EGFRi can affect patients’ quality of life, leading to dose reductions or discontinuation of treatment
Identified SDT-011 as a potent candidate to block anti-EGFR monoclonal antibodies binding to EGFRSDT-011 IdentificationSDT-011 showed significant reduction in the binding affinity of cetuximab to EGFR, reactivating the EGFR pathway in keratinocyte cell lines and improving keratinocyte cell proliferation
Vitamin K derivatives and BRAF inhibitors as previous efforts to treat EGFRi-induced skin toxicitiesPrevious EffortsVitamin K-based creams showed no improvement in clinical trials; BRAF inhibitors raised concerns due to their carcinogenic effects
Systemic antibiotics used for EGFRi-induced skin toxicity have limited effect and contribute to antibiotic resistanceSystemic AntibioticsThere is a need to reduce the use of antibacterial agents to prevent antibiotic resistance and maintain optimal response to cancer treatment
Developed biodegradable nanoparticles to deliver SDT-011 to pilosebaceous unit and hair folliclesNanoparticle DeliveryPLGA polymer used as a biodegradable carrier with tunable degradation properties; nanoparticles showed accumulation in high EGFR expression sites and maintained the ability to block and reverse EGFRi damage
Study presents a method for reducing skin toxicity by blocking EGFRi locally in keratinocytesStudy FindingsSDT-011 as a potential treatment for skin toxicities caused by anti-EGFR monoclonal antibodies without affecting systemic anticancer therapy

reference : https://www.emris-pharma.com/


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