Patented combination technology aligns with recent American Academy of Dermatology guidelines on the benefits of field-directed therapy for Actinic Keratosis which include the potential to reduce the risk of squamous cell carcinoma

FORT LAUDERDALE, Fla., July 22, 2026 /PRNewswire/ -- SKNV, a leader in dermatologic innovation and customized prescription medications, has been granted exclusive commercialization rights under a sub-license to the patent portfolio owned by Washington University in St. Louis covering the combination of Fluorouracil and Calcipotriene therapies, which is currently available through SKNV as Kefunova^TM Cream (Fluorouracil 5% / Calcipotriene 0.005%), SKNV has the exclusive right to produce and distribute this highly researched and established patented combination technology to further its portfolio of novel medications.

The patented combination is commonly used by clinicians to treat some of the most prevalent dermatologic conditions caused by sun exposure, including Actinic Keratosis (AK), a known precursor to squamous cell carcinoma (SCC), and low-risk superficial skin cancers. SKNV will continue to support prescriber needs by manufacturing the combination in its Fort Lauderdale FDA-Registered 503B Outsourcing Facility ensuring Current Good Manufacturing Practices, medication consistency, availability, and access for dermatology practices nationwide.

"At SKNV, we are committed to advancing innovative dermatologic therapies that address meaningful unmet needs for providers and patients. Since its introduction in 2025, Kefunova rapidly became the most prescribed medication across our portfolio of more than 100 formulations, underscoring the strong clinical interest in this patented treatment approach. The recent publication of expert consensus recommendations in the Journal of the American Academy of Dermatology further highlights the growing recognition of 5-FU/calcipotriene as an important option in the management of actinic keratosis and related skin cancers. We are proud to partner with Washington University to help advance the next phase of commercialization and access for this technology," said Dr. Spencer Malkin, Founder and CEO of SKNV.

"When treating patients with AKs, it's not just about targeting the visible lesions. It's also about getting ahead of the unseen actinic damage that has yet to manifest - subclinical AKs harbor a mutational profile indicative of a potentially cancerous state - that is why field-directed therapy offers the most efficacious approach for the treatment of widespread actinic damage in keratinocytes," said Lynn A. Cornelius, MD, Division Chief and Winfred and Emma Showman Professor of Dermatology at Washington University in St. Louis. "Although field therapy has been studied by many investigators over the years, our team initiated the study of this topical combination treatment and has additionally conducted follow-up studies for over a decade. We have collected clinical data not only demonstrating the efficacy of treating AKs using the combination therapy over shorter time-course than conventionally used with other topical regimens but have additionally shown a novel immunopreventive effect by reducing the risk of developing squamous cell carcinoma." 

Dr. Shawn Demehri, Director of High Risk Skin Cancer Clinic at Massachusetts General Hospital and Professor of Dermatology at Harvard Medical School, and Dr. Cornelius demonstrated the therapeutic benefits of the combination technology in a randomized, placebo-controlled clinical trial, the results of which were published in two peer-reviewed studies. The first study showed the combination technology clinically reduced AK lesion counts compared with a Fluorouracil monotherapy control. The standard treatment duration for Fluorouracil monotherapy is 2-4 weeks, but the combination was effective with just 4 days of treatment, which has meaningful implications for patient convenience, adherence, and overall treatment experience.¹ Based on these data, in April 2026 the International Immunosuppression and Transplant Skin Cancer Collaborative (ITSCC) recommended treating AK with a short course of the combination technology.² Dr. Demehri and Dr. Cornelius are co-inventors of the combination technology.

A second published study, which followed the clinical trial cohort for over 1,500 days, showed the short course of treatment with the combination technology of Fluorouracil and Calcipotriene reduced the risk of squamous cell carcinoma development on treated face and scalp sites within three years. This reduced risk was associated with the persistence of tissue-resident memory T (T_RM) cells in the skin.¹

The two studies also established a dual mechanism of action for the combination immunotherapy. Fluorouracil, a well-established cytotoxic agent, induces tumor-antigen release from sun-damaged cells that is associated with immunogenic cell death, while Calcipotriene, a vitamin D analog, induces thymic stromal lymphopoietin (TSLP)-driven CD4⁺ T cell infiltration into the skin to target those damaged cells. Together, the agents work synergistically to target abnormal skin cells by activating a potent immune response in the skin.¹

"Previously, topical field therapy with Fluorouracil monotherapy was impractical for many AK patients, due to the lengthy treatment regimen and harsh side effects. The combination technology allows more patients to experience the potential benefits of topical field therapy in reducing the risk of developing new AKs, limiting AK recurrence, and mitigating subclinical damage, and is aligned with the treatment paradigm already acknowledged as a likely superior standard of care in recent guidelines from the American Academy of Dermatology. Importantly, the combination therapy is an important advance in topical field therapies for AK, which are directed at a continuous cancerization field across the sun-damaged skin—including unseen, subclinical AK—rather than the individual, visible lesions,¹" said Shawn Demehri, MD, PhD. 

About Actinic Keratosis and Squamous Cell Carcinoma
Actinic Keratosis (AK) is caused by long-term exposure to ultraviolet (UV) radiation from the sun or indoor tanning beds that results in skin damage over time. Approximately 40 million new cases of AK are diagnosed in the US annually, accounting for more than 8 million visits to dermatologists and primary care providers, and the risk of developing AK increases with age.^1-3

Left untreated, actinic keratosis (AK) can progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. The incidence of SCC has increased substantially in recent decades, with some studies reporting increases of up to 200%.⁵

In 2025, SKNV launched Kefunova Cream, a prescription-only topical therapy developed in direct response to the needs of dermatology providers and is most commonly used in treating conditions related to sun damaged skin, including AK.

For more information, visit www.sknv.com.

DISCLAIMER: Kefunova cream is made by SKNV LLC, an FDA-Registered 503B Outsourcing Facility. The FDA does not review or approve drugs made by Outsourcing Facilities for safety, efficacy, quality, or indications for use. The Federal Food, Drug, and Cosmetics Act exempts customized drugs from such approval requirements. Although other parties have conducted clinical studies on Fluorouracil and Calcipotriene, SKNV's customized medications are exempt from clinical studies.

References

1. Cunningham TJ, et al. Randomized Trial of Calcipotriol Combined with 5-Fluorouracil for Skin Cancer Precursor Immunotherapy. The Journal of Clinical Investigation. 2017;127(1):106-116.
2. Loranger et al. Journal of the American Academy of Dermatology. Published online April 22, 2026.
3. Rosenberg AR, et al. Skin Cancer Precursor Immunotherapy for Squamous Cell Carcinoma Prevention. JCI Insight. 2019;4(6).
4. Eisen DB, et al. Guidelines of Care for the Management of Actinic Keratosis. Journal of the American Academy of Dermatology. 2021;84(4):e209-e233.
5. Que SKT, Zwald FO, Schmults CD. Cutaneous Squamous Cell Carcinoma: Incidence, Risk Factors, Diagnosis, and Staging. Journal of the American Academy of Dermatology. 2018;78(2):237-247.

Mary Conway | mconway@mkcstrategies.com | 516-606-6545

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