CLINICAL TRIALS

OUR COMMITMENT

At Werewolf Therapeutics, we’re working to create a new kind of cancer treatment—one that turns 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.

Two of our investigational INDUKINE™ molecules, WTX-124 and WTX-330, employ distinct conditionally activated cytokines. WTX-124 is designed to use IL-2 to directly activate cancer-attacking immune cells. WTX-330, an IL-12 INDUKINE molecule, is designed to orchestrate a broader immune response by engaging a range of immune cells to unleash a rapid, innate defense and address diverse and challenging cancers often resistant to other immunotherapy approaches.

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: NCT05479812).

“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

WTX-330: A PHASE 1B/2 TRIAL IN ADVANCED SOLID TUMORS OR LYMPHOMA

This is a Phase 1b/2 multisite expansion study of WTX-330 evaluating the safety and tolerability of WTX-330 when administered using a fixed-dose regimen or a step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma.

For further study details on eligibility and contact information for participating sites, please visit ClinicalTrials.gov (trial identifier: NCT06939283).

Disease Areas of Focus

Early immunotherapies such as high-dose Interleukin-2 (IL-2) showed potent anti-tumor effects, but severe toxicities limited their use, paving the way for checkpoint inhibitors (CPIs) to become a treatment cornerstone. Yet CPIs are not universally effective; many patients either fail to respond or develop resistance, highlighting the urgent need for superior therapeutic options. Innovative immunotherapies are crucial to overcome these limitations, delivering enhanced efficacy and safety with broader patient benefit.

WTX-124 is engineered to directly activate cancer-attacking immune cells, with a focus on historically IL-2– responsive solid tumors

Our investigational WTX-124 is a conditionally activated IL-2 INDUKINE molecule designed to unleash IL-2’s proven ability to stimulate cancer-attacking immune cells. By focusing its action in the tumor, WTX-124 aims to deliver potent anti-tumor activity and overcome the historical toxicity of IL-2. It is being investigated in solid tumors such as cutaneous melanoma (CMM), cutaneous squamous cell carcinoma (cSCC), renal cell carcinoma (RCC), and non–small cell lung cancer (NSCLC).

WTX-330 is designed to produce a broad and comprehensive anti-tumor immune response, primarily targeting difficult-to-treat and resistant cancers

Our investigational INDUKINE molecule WTX-330 is designed to employ conditionally activated Interleukin-12 (IL-12) to orchestrate a broader, more comprehensive immune assault. IL-12 activates a wider array of critical immune cells—including antigen-presenting dendritic cells and rapid-response innate immune cells, alongside T cells—to tackle difficult-to-treat cancers and those resistant to other immunotherapies. WTX-330 is currently being studied in adults with selected advanced or metastatic solid tumors.

About Cutaneous 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.

About Non-Small Cell Lung Cancer^¶

~85%

of lung cancer cases worldwide are NSCLC.

~197K

new cases of NSCLC each year in the U.S.

~112K

new cases of PD-L1 positive NSCLC diagnosed annually in the U.S.

^¶Statistics from the American Cancer Society and Nature Communications.

Have questions about our trials?

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Email us at [email protected]