Medicenna Therapeutics Corp. (MDNA) experienced a decrease of 10.67% in the aftermarket. However, the last trading session closed at $2.25.
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FDA Clearance of IND to Expand the Phase 1/2 ABILITY Study of MDNA11
On 27th October 2021, MDNA announced that FDA has approved the application of Medicenna’s investigational new drug (IND). This is done in order to expand the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study of MDNA11. Patients are now being enrolled in the ABILITY Study at clinical trial locations in Australia, and regulatory filings which are supposed to expand the trial to sites in Canada and the United Kingdom are expected to end this year.
The ABILITY Study aims to evaluate the stability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of varying concentrations of intravenously administered MDNA11 in patients. Moreover, it will include an MDNA11 monotherapy arm as well as a combination arm that will evaluate MDNA11 in combination with a checkpoint inhibitor. The ABILITY Study will enroll around 80 participants. Last but not least, Medicenna expects to recruit patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combined settings for a dose growth stage.
MDNA11 Data by Medicenna
The company presented preclinical findings from its MDNA11 program at a virtual session on 7th October 2021. MDNA11’s anti-tumor effectiveness in the MC38 tumor model was studied in mice as a single agent and in conjunction with anti-PD1 checkpoint suppression. Three successive doses of 0.15 mg/kg, 0.3 mg/kg, or 0.6 mg/kg MDNA11 were delivered intravenously 14 days apart in NHP trials to assess the safety, pharmacokinetics, and pharmacodynamics of the drug.
Moreover, these preclinical findings confirm MDNA11’s benefits of its distinct ‘beta alone’ strategy to targeting the IL-2 receptor. The company thinks that the data about MDNA11 enhanced the long-term proliferation and expansion of anti-cancer immune cells. Treatment with MDNA11 alone or in combination with anti-PD-1 drugs in mice resulted in full responses and a strong immunological memory effect that protected animals from tumor re-challenge.
New Appointment to the Board of Directors
MDNA announced that the company has appointed John H. Sampson to the Board of Directors on 23rd September 2021. John is also the President of Duke’s medical practice, Private Diagnostic Clinic, which has a revenue of over $1 billion, and a member of the prestigious National Academy of Medicine. Moreover, he also has participated in the Scientific and Governance Boards of a number of publicly listed biotechnology businesses as well as large non-profit healthcare delivery organizations.
Dr. Sampson is the best neurosurgeon at the National Institutes of Health. Not only this but he also has helped create a number of immune-based medicines and has led scores of early or late-stage clinical testing. The company genuinely thinks that his considerable experience leading new clinical trials, interacting with regulators, and translating immuno-oncology competence will be extremely valuable to collaborate to further and advance the MDNA55 program. Lastly, MDNA is looking forward to the advice and insights as they plan to move their pipeline closer to the clinic.