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Safety Profile of New IL-2 Molecule Better Than Like Drugs'

Source: Andres Maldonado


November 3, 2023 ( Newswire) First clinical data of this investigational interleukin-2 cytokine show it lacks the degree and rates of adverse events typically seen with treatments of this kind, noted an H.C. Wainwright & Co. report.

Werewolf Therapeutics Inc.'s (HOWL:NASDAQ) WTX-124 was shown, in initial clinical trial results, to have a favorable safety profile, reported H.C. Wainwright & Co. analyst Dr. Andres Maldonado in an October 31 research note.

"WTX-124's initial safety profile looks to be in complete divergence of native IL-2 therapies and represents a step forward in derisking Werewolf's masking technology (PREDATOR platform)," Maldonado wrote.

Conference Call on Nov. 3

These first data became available through the release of abstracts for the in-progress annual meeting of the Society for Immunotherapy of Cancer (SITC).

Werewolf management will review the WTX-124 data to be presented at SITC at 8:30 a.m. EDT on Friday, November 3, 2023, in a conference call.

495% Return Implied

H.C. Wainwright maintained its US$15 per share target price on the Massachusetts-headquartered biopharma company, trading now at about US$2.52 per share in comparison. The gap between these prices suggests a potential return for investors that is significant: 495%.

Werewolf is a Buy.

About the Data

These first results are from the monotherapy dose-escalation cohorts in the ongoing Phase 1/1b study of WTX-124, an interleukin-2 (IL-2) Indukine molecule, in solid tumors. Doses were 1 milligram (1 mg), 3 mg, and 6 mg.

Data, cut off on June 22, 2023, is for 11 patients. Of these, four had nonsmall cell lung cancer, three had cutaneous melanoma, and two had renal cell carcinoma.

"In line with our positive thesis towards Werewolf's masking technology, investors garnered a first small positive look at the potential of systemically delivering a masked native IL-2 cytokine to patients," Maldonado wrote.

Better Safety Profile

Trial results indicated that no dose-limiting toxicities were reported, Maldonado relayed. Treatment-related adverse effects (TRAEs) occurred in 26% of patients but were not severe and categorized as Grade 1 or 2. The most common TRAEs were fatigue and arthralgias, with three patients reporting each.

The analyst noted that this paucity of TRAEs overall and severe TRAEs is unusual for IL-2 therapies, Maldonado noted. He indicated that initial studies by Rosenberg et al. done in 1985 of native IL-2 reported rates of 80-100% for each TRAE plus the occurrence of 15 additional severe TRAEs.

IL-2 therapies have caused high rates of neurologic toxicities and cytokine storm symptoms, such as pulmonary edema, noted Maldonado. Less severe capillary leak syndrome occurred in some patients systemically treated with aldesleukin, for instance. None of these TRAEs was reported with WTX-124 treatment in the first data set.

"We believe it's clear that WTX-124 is exhibiting dose-proportional pharmacokinetics, which thus far has yielded low levels of active IL-2-which is responsible for the improvement of the safety profile," the analyst purported.

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