Medicenna Receives Amendment to Revamp Clinical Trial

At the beginning of May, Medicenna (TSX:MDNA) successfully amended the protocol of its Phase 2b recurrent glioblastoma study of MDNA55 in response to strong safety data and early efficacy read-outs.

This means that due to the safety profile to date, the trial is able to make some changes to give it the best chance for success at reaching its trial endpoints.

The Investing News Network (INN) was able to speak with Medicenna’s CEO Fahar Merchant about the amendment at the Bloom Burton & Co. Healthcare Investment Conference, which was held in Toronto from May 2-3. To listen to the full interview, watch the video above.

Other highlights from the interview with Merchant are company milestones for investors to look out for this year and 2019 regarding Medicenna’s pipeline, which includes preclinical data on the interleukin-2 (IL-2) project as well as the candidate MDNA109.

Prior to the the amendment, the trial previously only dosed patients once on a low dose. The amendment now allows the trial to dose patients twice and set the dose at the maximum tolerated dose—based on its safety profile. The third change is due to pseudo-progression of the tumor, meaning the tumor has the tendency to look larger resulting from necrosis, inflammation, edema and other factors, but limits the trials ability to see if the tumor is actually shrinking.

This amendment allows patients to undergo further screening to identify if the tumor size is actually growing or not. The screening includes advanced imaging techniques or the patient will have a biopsy before withdrawn from the trial.

This allows the patient to stay in the study longer and monitor the patients better by assessing the tumor rather than leaving prematurely, Medicenna CEO Fahar Merchant told INN.

Medicenna is among many companies working on glioblastoma treatments. While other companies often focus on recurring or newly diagnosed glioblastoma, Medicenna’s MDNA55 is for both—in addition to other gliomas—and is taking a different approach from competitors in the industry.

“Our drug is designed to target the tumors that overexpress a biomarker called interleukin-4 (IL-4) receptor,” said Merchant. This is important as the company identified 75 percent of glioblastoma patients overexpress that receptor.

Merchant said the drug is delivered directly to the tumor bypassing the blood-brain barrier which other drugs administered through IV and orally are challenged with.

“Our drug also has the ability to target and kill not just the tumor cells but also the cells that are protecting the tumor from our immune system,” Merchant added. It can do this by identifying  the same IL-4 receptor expressed in the microenvironment which surrounds and protects the tumor. “It’s something unique that no one else is looking at,” he said.

Looking ahead, milestones to look out for regarding MDNA55 include completing enrollment for its Phase 2 clinical trial with 52 patients by the end of the year. The company also expects to share some interim data as well as final data in the fall and final clinical trial results in early 2019.

Aside from steady news flow regarding its glioblastoma treatment, Merchant said the company expects announcements from regulatory meetings with the US Food and Drug Administration (FDA) planning for other studies–potentially with fast-track approval in 2019–and hopefully submitting an investigational new drug application with MDNA109 to start a Phase 1 trial late 2019.

While still in the early stage program, the Canadian-based immuno-oncology company Medicenna is also developing cytokines such as the IL-2 which was exclusively licensed from a lab at Stanford University. Bristol-Myers Squibb (NYSE:BMY) and Nektar Therapeutics (NASDAQ:NKTR) announced in February a global development and commercialization collaboration for Nektar’s drug candidate NKTR-214 using a potential approach to the IL-2 pathway—proving the industry is growing quickly.

Investor Takeaway

Since the company’s news about the amends protocol for its trial Medicenna’s share price saw a 5.14 percent decrease to a $1.69 as of market close Thursday (May 10).

Merchant said, from a “Canadian investor perspective we have less liquidity from being a Canadian-listed stock company, but also we have a smaller share of the investment capital being in Canada.”

Looking ahead to the rest of the year, Medicenna’s share price may see a change with a big news flow, especially towards the end of the year with the interim data from MDNA55 Phase 2 clinical trial as well as the up and coming preclinical IL-2 research.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.