Medicenna to Present MDNA11 Phase 1/2 Study Results at Oncology Innovation Forum

Medicenna Therapeutics Corp., a clinical-stage immunotherapy firm specializing in the development of Superkines, has announced promising results from their Phase 1/2 ABILITY-1 study evaluating MDNA11 in patients with advanced solid tumors. The results were presented at the 10th Annual Oncology Innovation Forum in Chicago.

One significant highlight is the durable response observed in a pancreatic cancer patient. The individual exhibited 100% regression of both target and non-target lesions for over 104 weeks and continues to show remission four months after ceasing treatment. In parallel, a melanoma patient also demonstrated sustained 100% regression of target lesions, maintaining the positive response over time.

Dose Escalation and Combination Therapy

The study also reports the current enrollment for dose escalation in combination with KEYTRUDA® at the next higher dose of 90g/kg, following no dose-limiting toxicities at 60g/kg. This is a significant step considering the safety profile of MDNA11. Notably, MDNA11 has shown marked increases in stemness, central and effector memory, and markers of enhanced effector function in circulating CD8+ T cells and NK cells, which are pivotal for a durable anti-cancer response.

Gene Expression Insights

Analysis of gene expression signatures from biopsies before and during treatment indicated a suppression of cancer-promoting pathways and enhancement of immune-related pathways following MDNA11 administration. These findings underscore MDNA11’s potential in modulating the tumor microenvironment favorably.

Safety and Efficacy in Monotherapy

Medicenna's CEO, Dr. Fahar Merchant, expressed satisfaction with the partial responses seen so far, especially in the dose-escalation cohort. He highlighted one pancreatic cancer patient who achieved complete regression of all lesions and remains in remission even after stopping MDNA11 treatment. Additionally, a melanoma patient continues to show deepening tumor shrinkage over successive scans, with complete resolution of target lesions and ongoing regression of non-target lesions.

The monotherapy segment of the study demonstrated a favorable safety profile. No dose-limiting toxicity (DLT) was noted, and the majority of treatment-related adverse events (TRAEs) were mild and resolved quickly. Repeat doses of MDNA11 improved tolerability, and no severe adverse events were reported.

Pharmacodynamic Effects

Detailed pharmacodynamic analyses revealed a potent, durable systemic immune response triggered by MDNA11. The study observed sustained expansion of CD8+ T cells and NK cells, without a significant increase in immunosuppressive Tregs. These cells showed enhanced characteristics, such as high proliferative potential and diverse immune effector functionalities, essential for potent anti-tumor activity.

Combination Therapy with KEYTRUDA®

In the combination therapy phase, the initial dose level involved MDNA11 at 30 and 60g/kg, paired with 400mg of KEYTRUDA® every six weeks. No dose-limiting toxicities were observed, allowing the progression to a higher dose level. The study continues to enroll patients with advanced solid tumors who have not responded to previous treatments.

Future Prospects

The expansion part of the ABILITY-1 study is actively enrolling patients with metastatic melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors. The combination dose escalation part is focused on patients with advanced solid tumors.

About MDNA11 and the ABILITY-1 Study

MDNA11, an intravenously administered, long-acting IL-2 Superkine, is designed to selectively activate immune effector cells responsible for killing cancer cells. The ABILITY-1 study is a global, multi-center, open-label trial evaluating MDNA11’s safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity, both as a monotherapy and in combination with pembrolizumab (KEYTRUDA®).

Conclusion

Medicenna's advances with MDNA11 highlight the potential of this novel IL-2 Superkine in offering a new therapeutic avenue for patients with advanced solid tumors. The ongoing clinical trials and future data will further elucidate its role in cancer treatment.

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