Medicenna Updates on 2024 ASCO Annual Meeting Presentations

Medicenna Therapeutics Corp. ("Medicenna"), a clinical-stage immunotherapy company focusing on the development of Superkines, recently announced that the American Society of Clinical Oncology (ASCO) has reversed its decision and withdrawn Medicenna’s abstract from its 2024 Annual Meeting. The abstract, titled “Results from ABILITY-1 Monotherapy Dose Escalation Study with MDNA11, an Engineered Long-acting IL-2 agonist, in patients with advanced solid tumors,” was initially accepted for an oral podium presentation.

ASCO's decision was based on the assertion that Medicenna allegedly violated the “Prior Publication Policy” due to previously reporting results at the 2024 Annual Meeting of the American Association of Cancer Research (AACR). Medicenna, however, disputes this claim, arguing that the data presented at AACR were interim and ongoing, while the ASCO abstract focused on a completed Phase 1 study with no interim cut-off date. Medicenna emphasizes that no other issues were raised by ASCO regarding the submitted data or the clinical trial's aspects.

Dr. Fahar Merchant, President and CEO of Medicenna, expressed disappointment over ASCO’s decision, noting that the opportunity to present at ASCO would have been significant for showcasing promising developments in cancer treatment. Dr. Merchant highlighted the potential of MDNA11 in demonstrating deep and durable responses in advanced solid tumors, marking a notable achievement in cancer therapeutics.

Despite this setback, Medicenna is committed to sharing the full data set from the ABILITY-1 trial through a special virtual event within the next two to four weeks, details of which will be announced shortly. The data will include comprehensive results from the monotherapy dose-escalation arm, updated data from the monotherapy dose-expansion arm, and preliminary data from the combination study with pembrolizumab (KEYTRUDA®).

MDNA11 is a long-acting interleukin-2 (IL-2) super-agonist, engineered to address the limitations of aldesleukin and other next-generation IL-2 variants. It activates immune effector cells responsible for attacking cancer cells while minimizing stimulation of immunosuppressive Tregs. MDNA11’s unique properties are achieved through seven specific mutations and genetic fusion to a recombinant human albumin scaffold, enhancing its pharmacokinetic profile and activity in tumor sites.

The ABILITY-1 study is a global, multi-center, open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MDNA11 both as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. The study aims to identify an appropriate dose regimen for the combination therapy, which will then proceed to a dose expansion cohort.

Furthermore, Medicenna will present new data analyses for bizaxofusp (formerly MDNA55), a Phase-3 ready immunotherapy for recurrent glioblastoma, at the 2024 ASCO Annual Meeting. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and EMA, underscoring its potential in treating this aggressive form of brain cancer.

Medicenna continues to focus on developing novel, selective versions of IL-2, IL-4, and IL-13 Superkines and Empowered Superkines. The company’s early-stage BiSKITs™ and T-MASK™ programs aim to enhance the therapeutic capabilities of Superkines, particularly in treating immunologically “cold” tumors.

In conclusion, while ASCO's withdrawal of Medicenna’s abstract is a setback, the company remains steadfast in its efforts to advance cancer treatment and looks forward to sharing their significant findings through upcoming virtual events.