Alpine Immune's Davoceticept Monotherapy Reduces Tumors In Early Stage Study

Alpine Immune Sciences Inc ALPN announced the oral presentation of results from the dose-escalation portion of NEON-1 study of davoceticept monotherapy in advanced malignancies.

• The data were shared at the 2022 Annual Meeting of the American Association for Cancer Research (AACR).
• Data showed that a heavily pretreated, advanced solid tumor population demonstrated tumor volume reduction.
• 26 (54%) achieved clinical benefit as defined as a best response of stable disease or better. Three (6%) remained on treatment beyond six months. Two partial responses were observed in colorectal and renal cell carcinoma.
• Last month, the FDA placed a partial clinical hold on Alpine Immune's NEON-2 trial of davoceticept / pembrolizumab combo in advanced malignancies.
• Davoceticept was well-tolerated with no reported events of cytokine release syndrome. Adverse events included mild to moderate immune-related adverse events and infusion-related reactions.
• Single dose-limiting toxicity of gastritis was observed at 3 mg/kg, but a maximum tolerated dose was not reached.
• Immunophenotyping demonstrated favorable increases in activated and central memory T cells and reductions in regulatory T cells. Pharmacodynamic analyses suggest 1 or 3 mg/kg every 3 weeks as the optimal biological dose.
• Monotherapy expansion cohorts in metastatic cutaneous melanoma, renal cell carcinoma, and PD-L1-positive tumors are planned.
• Price Action: ALPN shares are down 2.19% at $7.60 during the market session on the last check Wednesday.