CLINICAL TRIALS

OUR COMMITMENT

At Werewolf Therapeutics, we’re working to create a new kind of cancer treatment—one that is designed to turn on the immune system only where it’s needed most: inside the tumor. Our clinical trials are studying these targeted therapies, called INDUKINE™ molecules, in multiple solid tumor types to see if they can help fight cancer while reducing the risk of side effects. Learn more information about our currently enrolling clinical trials below and at www.clinicaltrials.gov.

WTX-124: Phase 1/1b Trial in Advanced Solid Tumors

This is a Phase 1/1b, open-label, multicenter, dose-escalation, and dose-expansion clinical trial designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of WTX-124, a conditionally activated IL-2 INDUKINE™ molecule, in adults with selected advanced or metastatic solid tumors.

For further study details on eligibility and contact information for participating sites, please visit ClinicalTrials.gov (trial identifier: NCT05660384).

“I haven’t had any cancer since [the trial]. I don’t have any pain, other than the nerve damage done by the radiation. 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.”

Male, 73 | Phoenix, AZ

For this patient, achieving a complete response was his “Full Moon Moment”—the powerful turning point in his cancer journey made possible by a treatment designed to awaken only when and where it’s needed most.

Read more in our press release with HonorHealth.

VIEW PRESS RELEASE

Disease Areas of Focus

Cutaneous malignant melanoma (CMM), cutaneous squamous cell carcinoma (cSCC), renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC) among others, are cancers where immunotherapy has become a critical component of treatment—particularly in high-risk or advanced/metastatic settings. High-dose IL-2 therapy was associated with long-term patient benefit and was the first immunotherapy approved for metastatic melanoma and RCC. However, its use has been hindered by significant safety issues.

The next wave of immunotherapies—checkpoint inhibitors (CPIs)—are considered to be part of standard of care regimens for a number of cancer indications. Yet the majority of patients either don’t respond to CPIs or develop resistance, underscoring the urgent need for additional therapeutic options. A differentiated IL-2 therapy has the potential to harness this powerful immunotherapeutic mechanism while avoiding the toxicity that has historically limited its use.

About Cutaneous Malignant Melanoma*

5th

most common cancer diagnosed in the U.S., and the most common form of melanoma.

years ago, the melanoma landscape looked very different—today, new cases have more than doubled in the U.S.

~90%

of cutaneous melanomas are caused by ultraviolet radiation from the sun or indoor tanning devices.

*Statistics from the Melanoma Research Alliance.

About Cutaneous Squamous Cell Carcinoma^†

2nd

most common form of skin cancer and 5 times more prevalent than melanoma in the U.S.

1.8M

U.S. estimated cases diagnosed every year—205 cases every hour.

~40K

U.S. cases each year progress to advanced stages, when the cancer spreads or recurs and becomes difficult to treat. At this point, CSCC can become life-threatening.

^†Statistics from the Skin Cancer Foundation.

About Renal Cell Carcinoma^‡

~90%

of kidney cancers are renal cell carcinomas, making it the most common form in the U.S.

81K

people in the U.S. were diagnosed with renal cell carcinoma at all stages in 2023.

~70%

of people diagnosed with renal cell carcinoma have the clear cell subtype.

^‡Statistics from the American Cancer Society and JAMA.

Have questions about our trials?

We’re here to help.

Email us at clinicaltrials@werewolftx.com