Alkermes announced the initiation of ARTISTRY-7, a global Phase 3, open-label, randomized trial evaluating the anti-tumor activity and safety of intravenously administered nemvaleukin alfa, in combination with Keytruda, compared to investigator's choice chemotherapy, in patients with platinum-resistant ovarian cancer. Nemvaleukin, Alkermes' lead immuno-oncology candidate, is a novel, investigational, engineered IL-2 variant immunotherapy. As previously announced, ARTISTRY-7 is being conducted in collaboration with Merck & Co, which is providing Keytruda for the study. In addition, Alkermes is working with The GOG Foundation and ENGOT to conduct the study. FDA recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.
Alkermes initiated Phase 3 evaluating nemvaleukin alfa combined with Keytruda in ovarian cancer
CLINICAL
NCI selects N-803 to combine with Keytruda in 700-site Lung-MAP clinical trial of chemo-free therapy
ImmunityBio announced the Lung Cancer Master Protocol (Lung-MAP) public-private partnership, which includes the National Cancer Institute (NCI), the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health (FNIH), will study the company’s IL-15 receptor superagonist complex, N-803 (Anktiva), in the Lung-MAP trial. Anktiva will be given in combination with Merck’s Keytruda to participants with NSCLC who have failed previous treatments. The combination therapy will be offered as a treatment to patients with tumors that do not have mutations targetable with a drug, which is the case for the majority of NSCLC patients.The Lung-MAP trial is open at more than 700 sites in the US When fully enrolled, this trial group will include 478 patients.
Kadmon will present data from the ongoing Phase 1 clinical trial of KD033
Kadmon Holdings announced it will present data from the ongoing Phase 1 clinical trial of KD033, its anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors, in addition to other IL-15 preclinical work, at the SITC 2021 36th Annual Meeting, taking place virtually November 10 - 14, 2021.
DEALS AND FINANCING
Xilio Therapeutics completed its IPO raising $118 million
Xilio completed initial public offering selling 7,353,000 shares of its common stock at a price to the public of $16 per share. The aggregate gross proceeds to Xilio from the offering were approximately $117.6 million. Xilio plans to use around $35 million to advance the development of IL-2 program XTX202 through Phase 1 dose escalation and Phase 2 efficacy cohorts of planned Phase 1/2 trial in patients with solid tumors, and approximately $15 million to advance the CTLA-4 antibody XTX101 through Phase 1 dose escalation and to initiate activities for Phase 2 development. The company also develops tumor selective IL-15 XTX401.
