Mural Oncology presented clinical data from ARTISTRY-3 trial ahead of ASCO

CLINICAL AND REGULATORY

Mural Oncology presented clinical data from ARTISTRY-3 ahead of ASCO.

In ARTISTRY-1, the company sought to recapitulate the results of high-dose IL-2 by mimicking its dosing regimen with five daily IV infusions (days 1-5) per three-week cycle. In the ARTISTRY-3 trial, the company evaluated escalating LFIV infusions, all of which were generally well tolerated. The safety profile in all dosing schedules evaluated was consistent with nemvaleukin’s known mechanism of action, and no dose limiting toxicities were observed. Despite administering higher doses per three-week dosing cycle than in previous trials evaluating nemvaleukin with daily infusions, no new safety signals were identified. The desired PD effects were also seen across all evaluated doses. Expansion of antitumor CD8+ T cells and NK cells was observed concurrent with minimal expansion of immunosuppressive regulatory T cells. 

Werewolf to present updated data from Phase 1 trial of WTX-124 in solid tumors at ASCO 

Werewolf Therapeutics announced the upcoming presentation of clinical data from dose-escalation arms of the Phase 1/1b trial evaluating WTX-124, its conditionally activated IL-2 INDUKINE molecule, as monotherapy and in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors after checkpoint inhibitor therapy. Highlights from the data as of January 28, 2024, were published in an abstract for the upcoming poster presentation at ASCO. The updated single agent dose escalation data continues to demonstrate that WTX-124 is well tolerated and clinically active. Preliminary data on WTX-124 administered in combination with pembrolizumab show similar tolerability to monotherapy. 

ImmunityBio completed GMP drug substance manufacturing for 170,000 doses of Anktiva 

ImmunityBio announced that the drug substance (DS) has been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg Anktiva (nogapendekin alfa inbakicept-pmln). Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of Anktiva for commercial and clinical trial use in advance of the full operation of the company’s own drug substance and fill-finish manufacturing plants in California and New York. In 2020, the company began construction of a state-of-the-art biological manufacturing plant in California with large-scale bioreactors for Anktiva drug substance and it is anticipated to be completed in the next 12-18 months. The large-scale equipment needed for GMP biological manufacture, with long-lead times, are on site and will be installed in the next 12 months. Upon completion, this 100,000 square foot manufacturing site will have the capacity to manufacture drug substance sufficient for a million doses of ANKTIVA a year. The drug product will be filled at the Dunkirk, New York facility, a 400,000 square foot state-of-the-art GMP facility in which the fill-finish equipment has been purchased and is in the process of being installed.