In a significant development for the biopharmaceutical company, Werewolf Therapeutics, its stock experienced a notable surge following the release of preliminary results from the initial monotherapy dose-escalation cohorts of an ongoing Phase 1/1b trial of WTX-124. The trial is focused on patients grappling with advanced or metastatic solid tumors.
At the time of this publication, Werewolf Therapeutics Inc stock (HOWL) has witnessed a surge.
Werewolf Therapeutics Inc
Current Price: $2.78
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These preliminary findings, set to be unveiled at the upcoming Society for Immunotherapy of Cancer’s Annual Meeting, encompass data gathered up until October 18, 2023, derived from 16 heavily treated patients spanning the first four monotherapy dose escalation cohorts, ranging from 1 to 12 mg.
All observed treatment-emergent adverse events (TEAEs) were confined to Grade 1 or Grade 2, with joint stiffness (arthralgias) and fatigue being the most frequently reported. Notably, there were no instances of Vascular Leak Syndrome, dose-limiting toxicities, treatment-related serious adverse events (SAEs), or study discontinuations due to treatment.
WTX-124 exhibited anticipated pharmacokinetics, revealing a broad therapeutic index that facilitates ongoing dose escalation.
At doses of 6 mg and 12 mg, WTX-124 demonstrated both translational biomarker activity and initial signs of monotherapy antitumor efficacy. Noteworthy enhancements were observed in the proliferation and activation of CD8+ T and NK cells within the tumor microenvironment, accompanied by alterations in immune cell gene expression.
Within the subset of patients administered the 12 mg dose, promising outcomes emerged. One patient achieved an unconfirmed partial response, while another displayed a restaging scan consistent with a partial response as of November 1, 2023. A third patient exhibited encouraging signs of antitumor activity.
Dose escalation remains underway in both the monotherapy and combination therapy arms of the trial. Further data from monotherapy dose-escalation cohorts will play a pivotal role in determining the recommended dose for expansion, with the anticipation of opening the monotherapy expansion arms in the first half of 2024.
