| Item 7.01. | Regulation FD Disclosure |
On November 3, 2023, Werewolf Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary first-in-human clinical data from initial monotherapy dose-escalation cohorts in the Company’s Phase 1/1b clinical trial of WTX-124. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Investor Presentation
On November 3, 2023, the Company made available a presentation to be used with investors to discuss the preliminary first-in-human clinical data from the Company’s Phase 1/1b clinical trial of WTX-124. A copy of the presentation is filed as Exhibit 99.2 hereto and is incorporated herein by reference.
Preliminary Data from Phase 1/1b Clinical Trial of WTX-124
On November 3, 2023, the Company announced preliminary first-in-human clinical data from initial monotherapy dose-escalation cohorts in the Company’s lead clinical program, WTX-124x2101. This clinical program is an ongoing, multi-center Phase 1/1b clinical trial of WTX-124, the Company’s interleukin 2 (IL-2) INDUKINE molecule, in patients with advanced or metastatic solid tumors.
Study WTX-124x2101 is evaluating WTX-124 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. The preliminary data include data collected as of October 18, 2023 from 16 heavily pretreated patients from the first four monotherapy dose escalation cohorts (1, 3, 6 and 12 mg). The preliminary data established proof of mechanism for WTX-124 and proof of concept for Werewolf’s INDUKINE design.
The preliminary data include assessments of safety and tolerability, pharmacokinetics, relevant biomarkers and preliminary antitumor activity. Data as of the October 18, 2023 cutoff date are summarized as follows:
| | • | | WTX-124 was generally well-tolerated at all doses tested, up to and including 12 mg, in the outpatient setting. |
| | • | | All treatment-emergent adverse events (“TEAEs”) were Grade 1 or Grade 2, and arthralgias and fatigue were the most common TEAEs. Vascular leak syndrome was not observed, and there were no dose limiting toxicities, treatment-related serious adverse events (“SAEs”) or treatment-related study discontinuations. |
| | • | | WTX-124 was delivered intravenously once every two weeks. |
| | • | | WTX-124 showed expected pharmacokinetics with evidence of wide therapeutic index allowing for continued dose escalation. |
| | • | | WTX-124 demonstrated both translational biomarker activity and early evidence of monotherapy antitumor activity at 6 mg and 12 mg doses. |
| | • | | CD8+ T and NK cell proliferation and activation in the tumor microenvironment and immune cell gene expression changes were seen at 6 mg and 12 mg dose levels. |
| | • | | Among five patients treated at 12 mg, one patient achieved an unconfirmed partial response, one patient had a restaging scan that was consistent with a partial response as of November 1, 2023, and one other showed evidence of anti-tumor activity. |
Dose escalation is ongoing in the monotherapy and combination therapy arms of the trial, with cohort 5 (18 mg) fully enrolled. Additional data from monotherapy dose-escalation cohorts will inform declaration of recommended dose for expansion and opening of the monotherapy expansion arms expected in the first half of 2024.
