Werewolf Therapeutics has dosed the first participant in a Phase I clinical trial of its conditionally activated Interleukin-12 (IL-12) INDUKINE molecule, WTX-330.

The multi-centre, first-in-human, open-label Phase I trial will assess WTX-330’s safety, tolerability, and clinical activity in people with advanced or metastatic solid tumours or lymphoma that is resistant to checkpoint inhibitors, or for which checkpoint inhibitors are not approved.

WTX-330 is being developed for reducing the severe toxicities and increasing the clinical benefit when given as monotherapy or along with checkpoint inhibitors in refractory and/or immunologically unresponsive tumour patients.

It was designed to mediate robust anti-tumour activity through innate and adaptive antitumor immune response stimulation.

The responses include maturation and cross-presentation of dendritic cells, Th1 differentiation, and amplification of antitumour T effector cell responses.

WTX-330 showed better anti-tumour activity, as well as a favourable tolerability and pharmacokinetic profile in preclinical trials.

Werewolf Therapeutics founder and CEO Daniel Hicklin said: “Dosing the first patient in our Phase I trial of WTX-330 marks the second INDUKINE molecule arising from our PREDATOR protein engineering platform to enter the clinic.

“Our continued transition into a clinical stage company comes at an exciting time for Werewolf following the initiation of a Phase I/Ib clinical study of WTX-124 last year.

“WTX-330 serves as another example of our team’s capacity to expand our clinical pipeline and validates our novel approach of developing conditionally activated cytokines as cancer therapies to improve outcomes for patients with hard-to-treat tumours.”

The company develops therapeutics for stimulating the immune system of the body to treat cancer.