Alkermes announced durable and deepening responses of its nemvaleukin in Phase 1/2

The presentations include updated efficacy and safety data from ARTISTRY-1, an ongoing Phase 1/2 study investigating IV nemvaleukin, which showed anti-tumor activity of IV nemvaleukin monotherapy in checkpoint inhibitor-experienced melanoma and RCC patients, and anti-tumor activity of IV nemvaleukin in combination with pembrolizumab in a range of difficult-to-treat tumors, including in CPI-unapproved tumor types, and in CPI-approved tumor types among both CPI treatment-naïve and pretreated patients. Durable and deepening responses have been observed with IV nemvaleukin, as monotherapy or in combination with pembrolizumab, in platinum-resistant OVCA and mucosal melanoma. Treatment-related AEs were mostly transient and manageable, and the maximum tolerated dose had not yet been reached. Alkermes' presentations also include data from ARTISTRY-2, an ongoing phase 1/2 study evaluating subcutaneous nemvaleukin. Findings include a pharmacodynamic response and safety profile that support the recommended phase 2 dose (RP2D), and encouraging early signs of anti-tumor activity.

FINANCING

Cytokine companies Synthekine, Bright Peak each tap crossovers for megarounds

Engineered cytokine companies Synthekine and Bright Peak each raised nine-figure crossover rounds, setting both companies up as candidates for public offerings in the coming months. Synthekine banked $107.5 million in series B funding from a syndicate led by Deerfield Management and Janus Henderson Investors. Bright Peak Therapeutics raised $107 million in its series B round, with RA Capital as the leader. Along with their near-identical amounts raised, the two share RA Capital as a crossover investor, and IL-2 as a target of interest. Both companies are also among a growing group of biotechs developing next-generation cytokine therapies designed to boost cytotoxic immune responses against cancer while sidestepping the toxicity limitations of past candidates.

Synthekine intends to submit an IND this year for its partial agonist of IL-2, which is designed to selectively agonize cancer antigen-activated T cells. The company’s other lead program, also due for an IND submission this year, is SYNCAR-001, a CAR T cell therapy engineered to express a modified IL-2 receptor that recognizes Synthekine’s “orthogonal IL-2” STK-009. Based on the structural biology work of Stanford synthetic cytokine pioneer K. Chris Garcia, Synthekine is seeking to develop molecules from a broad platform that could generate therapeutic cytokine signals never seen in nature.

Bright Peak’s lead program IL-2 inhibitor BPT-143, is in IND-enabling studies for immuno-oncology. The cytokine is engineered to bind preferentially to IL2RB with modifications that block binding to IL2RA, with an extended half-life.

The presence of crossover investors suggests that the companies could be headed for the public markets soon. RA Capital in particular has stepped up its pace of investment this year; the firm has participated in 33 venture deals already in 2021, after investing at least once in 33 private biotechs last year.