TORONTO and HOUSTON - Medicenna Therapeutics Corp. (TSX: MDNA), an immunotherapy-focused clinical-stage company, announced positive results from their ongoing Phase 1/2 ABILITY-1 study of MDNA11, a novel interleukin-2 (IL-2) super-agonist, at the American Association for Cancer Research Annual Meeting on April 9, 2024. The therapy is designed for patients with advanced solid tumors who have not responded to checkpoint inhibitor therapies.
The study reported an encouraging response rate of 29% and a clinical benefit rate of 50% among high-dose phase-2 eligible patients. Notably, two patients—one with melanoma and another with pancreatic cancer—experienced a 100% reduction in target lesions. Additionally, three melanoma patients maintained stable disease for periods ranging from 6 to 18 months while also showing tumor shrinkage.
MDNA11 has been generally well-received, with no dose-limiting toxicities or vascular leak syndrome observed across various dosing cohorts. The majority of treatment-related adverse events were of low severity and resolved quickly. The findings support Medicenna's claims of MDNA11's potential as a differentiated therapy with a favorable safety and pharmacodynamic profile.
The study's expansion includes new enrollment sites in the U.S. and Korea, with further data expected to be presented in the first half of 2024. MDNA11 is being evaluated as a monotherapy as well as in combination with pembrolizumab (Keytruda®).
MDNA11 is engineered to preferentially activate immune effector cells, such as CD4+ T, CD8+ T, and NK cells, which are responsible for killing cancer cells, while minimally stimulating immunosuppressive Tregs. This selectivity is achieved through specific mutations and fusion to a human albumin scaffold, enhancing the drug's pharmacokinetics.
Medicenna is dedicated to developing novel IL-2, IL-4, and IL-13 Superkines, and MDNA11 is one of their leading candidates. The company's portfolio also includes bizaxofusp and early-stage programs aimed at treating immunologically "cold" tumors.
The information in this article is based on a press release statement from Medicenna Therapeutics Corp.
InvestingPro Insights
Amidst the promising results from Medicenna Therapeutics' ABILITY-1 study, investors and industry observers are closely monitoring the company's financial health and stock performance. With a market capitalization of approximately $76.9 million, Medicenna operates in a highly competitive and capital-intensive field. Despite recent clinical successes, the company is grappling with financial challenges, as indicated by an adjusted P/E ratio of -7.68, reflecting investors' concerns about profitability.
InvestingPro data shows a striking 295.35% three-month price total return, coupled with a significant six-month price total return of 347.37%. This performance suggests a robust investor response to Medicenna's recent developments and future potential. However, the InvestingPro Tips highlight that Medicenna's stock has experienced a notable decline over the past week, with a 12.37% drop in price total return. This volatility underscores the risks inherent in investing in clinical-stage biotech companies.
Furthermore, Medicenna's financials reveal a challenging path ahead. The company's operating income stands at a negative $12.82 million, and with weak gross profit margins, the path to profitability appears steep. Analysts do not anticipate the company will be profitable this year, and net income is expected to drop. These financial headwinds are crucial for investors to consider when evaluating the company's long-term prospects.
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