- BeyondSpring Inc announced data from a poster presentation at the ESMO Congress 2022, including a new analysis from the Phase 2/3 PROTECTIVE-1 and PROTECTIVE-2 trials of plinabulin.
- Plinabulin, the company's lead asset, is a selective immunomodulating microtubule-binding agent, a potent antigen-presenting cell (APC) inducer being developed as an anticancer agent.
- The data provides evidence of protection of bone marrow granulocyte-monocyte progenitor (GMP) stem cells within 24 hours after chemotherapy based on an evaluation of peripheral immature and mature neutrophil counts.
- The absolute neutrophil count (ANC) with and without plinabulin was comparable at pre-dose C1D1 (p=0.96) but was significantly higher at 24 hours post-chemo dose with plinabulin vs. control.
- At 24 hours post-chemo dose, the mean ANC had increased by 3.2 x 109/L with plinabulin, whereas the mean ANC had decreased by 0.55 x 109/L with the control due to the myelosuppressive effect of TAC chemotherapy.
- Alpine Immune Sciences Inc announced clinical updates from ALPN-303 and davoceticept programs. Key highlights from the announcement include:
- ALPN-303
- Well tolerated in healthy adults when administered intravenously or subcutaneously at doses up to 960 mg.
- Pharmacodynamic analyses further support the feasibility of convenient subcutaneous therapeutic dosing every four weeks.
- Initial data from the basket studies in renal, hematologic, and dermatologic autoimmune diseases are expected in 2H of 2023.
- The company plans to conduct a phase 2 proof-of-concept study in systemic lupus erythematosus.
- Davoceticept (ALPN-202)
- Preliminary analyses of the NEON-2 trial of davoceticept plus pembrolizumab show a 37.8% reduction in prostate-specific antigen in castrate-resistant prostate cancer and a 25.5% reduction in tumor volume in poorly differentiated renal cell carcinoma (RCC).
- A third subject, with clear cell RCC, including prior primary resistance to nivolumab, achieved a durable confirmed partial response (-30%).
- Across the NEON-1 davoceticept monotherapy and NEON-2 studies, 2/5 (40%) and 3/5 (60%) of subjects have achieved a confirmed partial response or stable disease, respectively.
