We are initiating coverage of Medicenna Therapeutics Corp. (TSX:MDNA.TO) (OTC:MDNAF) with a valuation of $3.50. Medicenna is a clinical stage immunotherapy company developing novel versions of the cytokines Interleukin (IL)-2, IL-4, and IL-13, which they term ‘Superkines’. The Superkines can be utilized as monotherapies, used in combination with other immune modulating agents (e.g., checkpoint inhibitor antibodies), or fused with toxic agents to generate ‘Empowered Cytokines’ (EC) that precisely deliver cell-killing moieties to tumors. The company’s lead EC is MDNA55, which has completed enrolment in a Phase 2b clinical trial for the treatment of recurrent glioblastoma (rGBM), the most common and deadly form of brain cancer. In addition, the company has a rich pipeline of pre-clinical assets, including its lead Superkine MDNA109, an enhanced version of IL-2.
Targeting a Very Difficult Cancer to Treat
While relatively rare, GBM is the most common form of brain cancer and also the deadliest. Standard of care for an initial diagnosis is surgery, in order to remove as much of the tumor as possible, followed by radiation therapy and chemotherapy with temozolimide. Unfortunately, essentially all patients with GBM suffer recurrence, and there is currently no standard of care for rGBM, although drugs such as Avastin® and lomustine are typically used. The five-year survival rate for GBM is less than 5%, one of the most dismal for any cancer.
Encouraging Early Clinical Data
In Feb. 2019, Medicenna presented encouraging preliminary results from the company’s ongoing Phase 2b clinical trial of MDNA55 in patients with rGBM at first or second relapse. Results showed that IL-4 receptor (IL-4R) positive patients had a median overall survival (mOS) of 15.2 months, compared to 8.5 months for patients that were IL-4R negative. In addition, survival rates at 6, 9, and 12 months for IL-4R positive patients were 100%, 67%, and 55%, compared to 73%, 40%, and 30%, respectively, in the IL-4R negative group. These results compare quite favorably to those seen with Avastin® and lomustine (mOS of 8 months for each with 6, 9, and 12-month survival rates of 62%, 38%, 26%, and 65%, 43%, 30%, respectively).
Possibility for Accelerated Approval
MDNA has already been granted Fast Track designation by the FDA and Orphan Drug designation by both the FDA and EMA for the treatment of rGBM and other high-grade gliomas. Based upon the Phase 2b data presented thus far, which shows patients treated with MDNA55 having substantially higher mOS and survival rates compared to other treatments, the company will be conducting an ‘end-of-Phase 2’ meeting with the FDA in the second half of 2019 to determine if the drug potentially qualifies for accelerated approval, which could allow MDNA55 to reach the market prior to conducting a Phase 3 clinical trial.
Modulating Cytokine Activity an Intense Area of Focus
As an example of Big Pharma’s interest in modulating cytokine activity, in 2018 Nektar Therapeutics entered into a $3.8 billion collaboration with Bristol-Myers Squibb for its lead development candidate (NKTR-214), which is a long acting version of IL-2 conjugated to polyethylene glycol (PEG) chains and stimulates immune cells through slow release of PEG to generate active IL-2. NKTR-214 is being studied in combination with Opdivo® and/or Yervoy® in more than 20 indications. Medicenna’s lead Superkine development product (MDNA109) is an enhanced long acting IL-2 Superkine that has increased affinity for IL-2Rβ for improved selectivity and safety and has shown synergism with both anti-PD-1 and anti-CTLA-4 monoclonal antibodies in pre-clinical studies.
Near-Term Milestones Including Interim Phase 2b Clinical Data in June 2019
The most important near-term milestone for Medicenna will be the release of interim top-line data from the company’s Phase 2b rGBM trial, which we anticipate in June 2019. Another important milestone will be the second half, ‘end-of-Phase 2’ meeting with the FDA to determine the potential for accelerated approval for MDNA55.
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