- Medicenna (MDNA) announces submission of a clinical trial application to a Human Research Ethics Committee (HREC) in Australia for a Phase 1/2 study of MDNA11
- Medicenna expects to initiate this study in the third quarter of 2021
- The planned study is designed to assess the safety, PK, PD, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumors
- It includes both, an MDNA11 monotherapy arm as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor
- Following its progress in Australia, Medicenna intends to expand the study to the United Kingdom, the United States and Canada
- Medicenna Therapeutics Corp. (MDNA) is down 3.05 per cent and is trading at C$4.45 at 12:09 pm ET
Medicenna Therapeutics Corp. (MDNA) has submitted a clinical trial application to initiate a Phase 1/2 clinical study of MDNA11
MDNA11 is Medicenna’s selective, long-acting and novel IL-2 super-agonist.
Medicenna expects to initiate this study in the third quarter of 2021.
Additionally, pending successful patient recruitment, the company intends to provide a preliminary update on safety, pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data by year-end.
“Submission of this dossier for Human Research Ethics Committee (HREC) approval is an important milestone that keeps us on track to execute our broader clinical and corporate strategy,” said Fahar Merchant, Ph.D., President and Chief Executive Officer of Medicenna.
“We look forward to the initiation of this trial and reporting results that could support MDNA11’s best-in-class potential as a “beta-only IL-2” instead of “not-alpha IL-2″ agents currently in the clinic,” added Merchant.
The planned Phase 1/2 ABILITY study is designed to assess the safety, PK, PD, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumors.
It includes both, an MDNA11 monotherapy arm as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor.
Following its progress in Australia, Medicenna intends to expand the study to the United Kingdom, the United States and Canada.
Mann Muhsin, MD, Chief Medical Officer of Medicenna, commented,
“MDNA11 has the attributes to overcome the limitations of competing IL-2 therapies and the filing of this application represents a crucial step in exploring the pan-tumor potential of MDNA11 and its ability to treat multiple tumor types spanning a wide immunogenicity spectrum.”
The preliminary efficacy readout from the monotherapy arm is expected in 2022 and most notably will evaluate MDNA11’s anti-tumor activity in expansion cohorts comprised of subjects with metastatic melanoma and advanced renal cell carcinoma,” concluded Muhsin.
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines for the treatment of a broad range of cancers.
Medicenna Therapeutics Corp. (MDNA) is down 3.05 per cent and is trading at C$4.45 at 12:09 pm ET.
