MDNA: Encouraging CD8+ T Cell and NK Cell Responses in the ABILITY Assay…

By NASDAQ: MDNA Company Update Encourage CD8 T cell and NK cell responses in the ABILITY assay On June 22, 2022, Medicenna Therapeutics Corp. MDNA has provided an update on the Phase 1/2 ABILITY study (an IL-2 beta-only immunotherapy study) of MDNA11 in patients with advanced solid tumors (). So far, the company has completed dosing in the first three dosing cohorts. Cohorts 1 and 2 received 10 g/kg of MDNA11 while cohort 3 received 30 g/kg of MDNA11. Although it is too early to determine the potential efficacy of MDNA11, the company noted that tumor control was achieved in three out of eight patients, with some patients seeing tumor shrinkage in target lesions. Importantly, MDNA11 exhibited an acceptable safety profile and there were no dose-limiting toxicities (DLTs) or evidence of immunogenicity. One of the things noted during the early dosing cohorts is the development of fever after the initial dose of MDNA11. Thus, Medicenna decided to implement a “step-up” dosing strategy, which involves first treating patients with two priming doses of MDNA11 before moving to the highest fixed dose. For example, in the fourth cohort, patients will receive two 30 g/kg doses of MDNA11 with all subsequent doses at 60 g/kg. While this strategy is likely to improve patient outcomes, the company will now monitor patients for DLT for eight weeks (instead of the current four weeks). Thus, we anticipate that Cohort 4 data will be available in Q3 of calendar year 2022, followed by a full set of efficacy data for all dosing cohorts in Q4 of 2022. In May 2022, Medicenna announced new clinical data from the ABILITY trial that included pharmacodynamic data related to T cell and natural killer (NK) cell activation. Key findings reported at the time by the first three dosing cohorts included: MDNA11 treatment at 30 g/kg resulted in a 17-fold and 10-fold increase over baseline in Ki67 expression in CD8 T cells and NK cells, respectively. Expansion of CD8 T cells and NK cells was significantly greater at the 30 g/kg dose than at the 10 g/kg dose, with CD8 T cell and NK cell levels increasing by 3 and 6, respectively. times compared to the initial value. Treatment with MDNA11 at 30 g/kg increased CD8 T cells and NK cells preferentially over pro-tumor T regulatory (Treg) cells, with the average peak CD8 T cell/Treg ratio increasing from the line of baseline and the average peak NK/Treg ratio increasing above baseline. There was no significant increase in eosinophil count from baseline after MDNA11 treatment. This is important because an extremely high eosinophil count is associated with severe toxicity and is a known side effect of high dose recombinant IL-2 treatment. MDNA11 treatment resulted in a dose-dependent 3-fold increase in immune cells expressing granulysin. Granulysin is a potent effector molecule that induces cytotoxic effects against tumor cells (). The clinical and pharmacodynamic results observed so far for the ABILITY trial are very encouraging and we look forward to continued updates as the study progresses. At this point, we believe the most important data is the absence of any dose-limiting toxicity, which has plagued other IL-2 treatments. Although some patients experienced fever after initial administration of MDNA11, we believe that the company's "stepped up" dosing strategy will help ease the burden of side effects on patients and lead to better outcomes. Financial update On June 22, 2022, Medicenna announced its financial results for fiscal year 2022, which ended March 31, 2022. As expected, the company reported no revenue for fiscal year 2022. Net loss was millions Canadian dollars, or $ per share, compared to a net loss of millions of Canadian dollars, or $ per share, for the fiscal year ending March 31, 2021. R&D expenses for fiscal 2022 were approximately million Canadian dollars, compared to approximately million Canadian dollars in fiscal year 2021. The increase was primarily due to costs associated with the development of MDNA11, which included preclinical studies, manufacturing of GMP materials and regulatory costs associated with the launch of the ABILITY test. General and administrative expenses for fiscal year 2022 were millions of Canadian dollars, compared to millions of Canadian dollars for fiscal year 2021. The increase is primarily due to a full year of costs associated with enrollment in the Nasdaq and corresponding D&O insurance, compared to just nine months the previous year. period. As of March 31, 2022, Medicenna had approximately million Canadian dollars in cash and cash equivalents. We estimate the company is funded through the end of the second quarter of calendar year 2023. As of March 31, 2022, Medicenna had approximately one million common shares outstanding and, including warrants and options on shares, a fully diluted number of shares of one million. Conclusion We are very encouraged by the early results of the ABILITY trial, with pharmacodynamic and clinical data showing that, although early, MDNA11 appears to have a positive therapeutic effect while exhibiting no dose-limiting toxicity or immunogenicity so far. The fact that tumor control was observed in three out of eight patients is a good sign, especially since it was observed at low doses. We look forward to additional updates to the ABILITY trial later in 2022. We made a change to our model of reducing the probability of success of MDNA55, as a partnership seems to take longer than initially expected, which reduced our valuation to $10. However, we remain very excited about the future of Medicenna and the potential of the Superkine platform and see the stock's current downtrend caused by the overall negative sentiment in the biotech sector as a great buying opportunity for investors. long-term. to receive our articles and reports directly by e-mail each morning. Please visit our for more information on Zacks SCR. DISCLOSURE: Zacks SCR received compensation from the issuer directly, an investment manager or an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period at least one year. Research papers, as seen here, are part of the service provided by Zacks SCR and Zacks SCR receives quarterly payments totaling a maximum royalty of $40,000 per year for such services provided to or relating to the issuer. Full disclaimer. 2022 Benzinga does not provide investment advice. All rights reserved.