HOWL Werewolf Therapeutics Inc

A common and unsightly skin cancer that can turn deadly has been undetectable for more than a year in a patient treated with a new targeted immune-therapy in a clinical trial at HonorHealth Research Institute.

Wayne Futch, 73, of Phoenix, developed a type of skin cancer known as cutaneous squamous cell carcinoma, following a career in pool-maintenance that regularly exposed him to hours of strong sunlight. Despite wearing sunscreen and protective clothing, Mr. Futch’s face was disfigured by skin cancer. He lost his right eye following more than 60 radiation treatments that ultimately failed to rid him of the malignancy. “It disfigured my face,” Mr. Futch said of the cancer and radiation treatment. “I knew I needed to take some different action, because the radiation was not getting rid of it.”

It was then that Mr. Futch said he learned of a new clinical trial for his type of skin cancer at HonorHealth Research Institute. He enrolled in the clinical trial in September 2023. Mr. Futch was infused with a new type of drug that substantially shrunk his tumor in just 8 weeks and left him with no detectable cancer after 12 weeks.

“I haven’t had any cancer since (the trial). I don’t have any pain, other than the nerve damage done by the radiation,” said Mr. Futch, who after high school hitchhiked to Phoenix from southern California, married and has remained in the Valley of the Sun ever since. “I feel confident that if (the cancer) ever comes back again, that they’ll detect it and get rid of it, because they did it once already.”

The investigational drug is an engineered derivative of the long-proven, but highly toxic, anti-cancer drug known as Interleukin-2 (IL-2). The drug is designed to remain inactive in the periphery until it selectively releases fully potent IL-2 in the tumor microenvironment to stimulate antitumor immunity with reduced toxicity.

The clinical trial (NCT05660384) is evaluating the investigational drug as a monotherapy and in combination with pembrolizumab in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care treatment, including checkpoint inhibitor therapy.

“This drug is designed to be inactive upon infusion and only activated within the tumor, which means that we have the potential to get all of the benefit of IL-2 with much better safety,” said Justin Moser, M.D., an associate clinical investigator in HonorHealth Research Institute’s Cancer Research Division and Associate Research Professor at Arizona State University School of Medicine and Advanced Medical Engineering. “We are overjoyed with the benefit that this patient received, especially given the very limited treatment options available for patients with immunotherapy refractory squamous cell carcinoma.”

1 million Americans diagnosed annually

Cutaneous squamous cell carcinoma is a cancer of the outer layer of skin, though it can also develop in other parts of the body. More than 1 million U.S. patients across all stages are diagnosed annually, and nearly 7,000 succumb to this disease when it becomes advanced or metastatic. When detected early, cases of cutaneous squamous cell cancer can be treated effectively with surgery, radiation, curettage (scraping), or cryotherapy (freezing with liquid nitrogen). For cases that progress to advanced disease, systemic therapy is required. Checkpoint inhibitors are approved for these cases, but for patients whose disease fails this treatment, there are currently no consistently effective therapies.

Incidence tripled in three decades

The incidence of cutaneous squamous cell carcinoma has tripled over the past three decades, owing to an aging population and cumulative sun damage, but also because of improved methods of skin cancer screening and detection.

HonorHealth Research Institute in Scottsdale is one of 10 national clinical trial sites for this new drug. Other sites are: Tampa; Atlanta; Chicago; Indianapolis; Hackensack, N.J.; Buffalo; Portland; Dallas and San Antonio. Patients, caregivers, and healthcare providers can learn more about the clinical trial by visiting clinicaltrials.gov.

As Skin Cancer Awareness Month in May shines a spotlight on the growing burden of this disease, as well as other forms of skin cancer, like cutaneous melanoma, this clinical trial offers new hope to patients who previously had few or no remaining treatment options.

For more about HonorHealth Research Institute clinical trials: call 833-354-6667; or email clinicaltrials@HonorHealth.com.

For more about Werewolf Therapeutics clinical trials: call 617-675-1865; or email clinicaltrials@werewolftx.com.

About the HonorHealth Research InstituteHonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through its clinical trials and innovative treatment options. Headquartered in Scottsdale, Arizona, the institute’s team of physicians and researchers collaborate with experts from across the nation to offer life-changing therapies, drugs and devices. At HonorHealth Research Institute, patients have access to tomorrow’s health innovations, today. Learn more at: HonorHealth.com/research.

About Werewolf TherapeuticsWerewolf Therapeutics, Inc., is a biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions. The Company is leveraging its proprietary PREDATOR® platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Werewolf’s INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. To learn more visit www.werewolftx.com.

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HonorHealth Research Institute Media Contact:Steve YozwiakSenior Research Science WriterHonorHealth Research Institute602-620-4749syozwiak@honorhealth.com

Werewolf Media Contact:Amanda SellersDeerfield Group 301-332-5574amanda.sellers@deerfieldgroup.com