ImmunityBio announced insurance coverage of Anktiva across multiple states

CLINICAL AND REGULATORY 

ImmunityBio announced insurance coverage of Anktiva across multiple states 

Anktiva was approved by the FDA on April 22 for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors. The intravesical therapy employs a combination of Anktiva, an IL-15 agonist in combination with BCG. The first patients to receive commercial doses are located throughout the US and several are being treated by community urologists, as the therapy does not require any special handling or equipment that would limit its use to specialty medical centers. Anktiva received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of CR and DOR in BCG-unresponsive NMIBC CIS. The 77 evaluable patients in this single-arm, multicenter trial received Anktiva with BCG maintenance therapy for up to 37 months. 

Werewolf highlighted initial safety and efficacy data from its ongoing Phase 1 trial evaluating WTX-330 

Werewolf announced initial results from the Phase 1 clinical trial evaluating WTX-330, its conditionally activated IL-12 INDUKINE molecule, as monotherapy in patients with immunotherapy insensitive or resistant locally advanced or metastatic solid tumors or NHL. IL-12 therapy holds tremendous promise for immune-resistant cancer patients but has been historically limited by severe toxicity, like many cytokines. Werewolf is developing a novel, conditionally activated IL-12, WTX-330, in order to overcome this key limitation with its systemically administered, tissue-targeted technology, optimizing its therapeutic index so that efficacious doses can be delivered for clinical impact. Early WTX-330 dose-escalation data demonstrated encouraging clinical activity and evidence of immune biomarker activity including an unconfirmed partial response in a metastatic melanoma patient. As of the cutoff date of June 12, 2024, the study had dosed eleven patients in dose escalation with solid tumors relapsed or refractory to all standard of care therapies with at least one dose of WTX-330 across three dose escalation cohorts, 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), or 0.032 mg/kg (n=5) and two patients in dose expansion at 0.024 mg/kg. 

Medicenna announced EMA approval of its clinical trial application to expand its Phase 1/2 to Europe 

Medicenna announced that EMA has approved the Clinical Trial Application for the conduct of the Phase 1/2 ABILITY-1 study with MDNA11 either alone or in combination with pembrolizumab thereby expanding the clinical trial in the EU. MDNA11 is the Company’s long-acting, “beta-enhanced not-alpha” IL-2 super-agonist and is currently enrolling patients with advanced solid tumors in the ABILITY-1 trial at clinical trial sites in U.S.A., Canada, Australia, and Korea.