Medicenna Therapeutics (MDNA) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Pipeline overview and development strategy

• Advancing IL-2, IL-4, and IL-13 superkines, primarily in oncology, with additional opportunities in autoimmune diseases and other areas.

• Focus on achieving proof of concept in humans for oncology and robust preclinical data for non-oncology, with potential for partnerships.

• Platform enables use as single agents, in combination therapies, and in cell-based therapies, including bispecific superkines (BiSKITs).

• MDNA11 and MDNA55 are the most advanced assets, with MDNA11 in phase I/II and MDNA55 showing efficacy in GBM.

• BiSKITs platform fuses superkines with antibodies for immunotherapy applications.

MDNA11 clinical program and study design

• MDNA11 engineered to avoid alpha domain binding, reducing Treg stimulation and improving safety by avoiding eosinophilia.

• Enhanced affinity for beta gamma receptor increases selectivity for effector T and NK cells.

• Albumin fusion extends half-life and promotes tumor accumulation.

• ABILITY study includes monotherapy and combination arms, with dose escalation and expansion in select tumor types (melanoma, MSI-high, non-melanoma skin cancer).

• Combination with pembrolizumab (Pembro) is being evaluated, with no overlapping toxicities observed so far.

Efficacy and safety data

• In 14 heavily pretreated patients, response rate was nearly 30%, including one complete response and three partial responses.

• Responses observed in tumor types (pancreatic, small bowel) where IL-2 has not shown activity before, especially in MSI-H patients.

• Potential to expand study in MSI-H patients who failed checkpoint inhibitors if response rates remain above 30%.

• Safety profile favorable: 95% of drug-related events were grade 1 or 2, transient, with no immune-related adverse events or treatment discontinuations.

• No observed immune-mediated adverse events in combination with Pembro; patients become more tolerant with subsequent doses.