ImmunityBio and Beigene to run Phase 3 of Anktiva plus PD-1 in NSCLC

CLINICAL AND REGULATORY 

ImmunityBio presented positive long-term OS data in NSCLC 

The Phase 3 trial design is based on the synergistic potential already demonstrated in the QUILT 3.055 study that a PD-1 and Anktiva, an IL-15 superagonist, prolongs OS in the study population compared to historical controls in this setting. In Phase 1 and 2 studies, Anktiva demonstrated the capability of rescuing T cells, and thus CPI efficacy, through the molecule’s unique mechanism of action. Anktiva is the first FDA approved molecule that has demonstrated the ability to increase lymphocytes via its proliferative IL-15 stimulatory action.

Medicenna reported MDNA11’s compelling anti-cancer activity in ABILITY-1 study

Medicenna Therapeutics announced the presentation of new clinical data from its ongoing ABILITY-1 study evaluating MDNA11 alone or in combination with Keytruda in patients with advanced solid tumors. The data was presented in a late-breaking abstract at the inaugural AACR-IO. MDNA11 significantly expands a unique population of ‘stem-like’ CD8+ T cells that leads to more persistent and effective anti-tumor activity. MDNA11 has shown durable single agent activity, with a 30% (3 of 10) ORR in the monotherapy dose expansion cohort in checkpoint-resistant patients. Disease control rate of 78% (7 of 9) in combination with Keytruda includes one complete response, one partial response and five stable disease.