Werewolf has aligned with the U.S. Food and Drug Administration (FDA) on a
WTX-124 recommended phase two dose (RP2D) of 18 mg IV Q2W for both monotherapy and combination with pembrolizumab. The Company believes the data support compelling opportunities for further development of WTX-124 in non-small cell lung cancer, melanoma, CSCC and gastroesophageal junction adenocarcinoma.
The Phase 1b/2 clinical trial of WTX-330 was designed to evaluate WTX-330,
administered intravenously every two weeks in fixed-dose and step-up regimens, in patients with relapsed/refractory, locally advanced or metastatic solid tumors. The presentation at SITC reported data from 24
patients treated at doses ranging from 0.016 mg/kg to 0.032 mg/kg.
Data for the Phase 1b/2 clinical trial of
WTX-330 as of the May 14, 2026, clinical database lock date are summarized as follows:
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WTX-330 was well tolerated and was administered primarily in the
outpatient setting. |
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WTX-330 showed high systemic prodrug exposure with low exposure to free
(active) IL-12. |
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The frequency of treatment-related adverse events was dramatically reduced at equivalent dose levels compared to
what was observed with first-in-human WTX-330 material. |
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WTX-330 produced evidence of intratumoral IL-12/STAT4 signaling in 7 of 9 patients contributing paired tumor
biopsies. |
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WTX-330 produced a confirmed partial response per RECIST 1.1 in a patient
with gallbladder cancer whose best response to all prior standard-of-care therapy had been progressive disease, as well as multiple additional tumor regressions in
patients with late-line refractory solid tumors. |
These findings are summarized in a poster titled, “A Phase 1b/2 study of the
tumor-activated IL-12 prodrug WTX-330 in patients with relapsed/refractory solid tumors”. The poster was presented at SITC on November 7, 2026.
Werewolf believes WTX-330 is poised for further development as a monotherapy, in combination with an ICI, or in a
sequenced combination with WTX-124.
About Werewolf Therapeutics:
Werewolf Therapeutics, Inc., is an innovative 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 has designed conditionally activated INDUKINETM 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.
The Company’s clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated
Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the
treatment of solid tumors. To learn more visit www.werewolftx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical
facts, contained in this press release, including statements regarding Werewolf’s strategy, future operations, prospects, plans, and objectives of management, the availability of data from such clinical development; the potential activity and
efficacy of product candidates in preclinical studies and clinical trials; the anticipated safety profile of product candidates; and the potential further development of WTX-124 and WTX-330, including in specific tumor types and in combination with other therapies, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words
“aim,” “anticipate,” “approach,” “believe,” “contemplate,” “continue,” “could,” “design,” “designed to,” “engineered,”
“estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,”
“project,” “promise,” “should,” “target,” “will,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: risks and
uncertainties inherent in the development of Werewolf’s product candidates, including the conduct, timing, progress and results of preclinical studies and clinical trials; Werewolf’s ability to successfully advance the clinical
development of WTX-124 and WTX-330; whether preliminary or interim clinical will be predictive of final results or results from subsequent clinical trials; whether the
safety, tolerability and antitumor activity observed in clinical trials of WTX-124 and WTX-330 will be observed in additional patients or with longer follow-up; Werewolf’s ability to obtain regulatory approvals for its product candidates; Werewolf’s ability to obtain sufficient funding to continue the development of its product candidates; and
Werewolf’s ability to obtain and maintain intellectual property rights and regulatory exclusivities; as well as the risks and uncertainties identified in the “Risk Factors” section of the
