Fahar Merchant, President and CEO of Medicenna: Amendment Means Clinical Trial Changes | Summary and Q&A

TL;DR

Many Santherapeutics is developing a unique drug to target glioblastoma, delivering it directly into the tumor to bypass the blood-brain barrier and also targeting tumor microenvironment cells that protect it from the immune system.

Key Insights

• 🧠 Many Santherapeutics is developing a unique drug to target recurrent glioblastoma, a highly aggressive brain tumor.
• 🎯 The drug targets a specific biomarker found in 75% of glioblastoma patients.
• 🧠 Delivery of the drug directly into the tumor bypasses the blood-brain barrier, improving efficacy.
• 🎯 The drug also targets tumor microenvironment cells that protect the tumor from the immune system.
• 🏁 The company expects significant milestones in 2018 and 2019, including completing enrollment in a Phase two clinical trial and obtaining data on ongoing trials.
• 😀 Many Santherapeutics has familiarity with the FDA process but may face liquidity challenges for Canadian investors.
• 👻 Protocol changes in their clinical trial aim to improve patient outcomes and allow for better monitoring of tumor response.

Transcript

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Questions & Answers

Q: What sets Many Santherapeutics apart from other companies in the glioblastoma treatment space?

Many Santherapeutics' drug targets a specific biomarker found in glioblastoma patients, delivers the drug directly into the tumor by bypassing the blood-brain barrier, and also targets the tumor microenvironment cells that protect the tumor from the immune system. These unique approaches differentiate it from other therapies.

Q: What milestones can investors look forward to in 2018 and 2019 for Many Santherapeutics?

The company expects to complete enrollment in a Phase two clinical trial by the end of 2018, with interim data expected in the fall of this year. Final data is anticipated in early 2019. Following this, there will be further news regarding meetings with the FDA, planning for additional studies, and potential approval.

Q: Are there any barriers being based in Canada when dealing with the FDA and Health Canada?

Many Santherapeutics has primarily filed with the FDA and the European Medicines Agency, with no filings in Canada yet. However, familiarity with the FDA process is not a barrier, but being a Canadian-listed stock may pose liquidity challenges for Canadian investors.

Q: What are the highlights from your presentation at the conference?

The company announced protocol changes in their ongoing clinical trial to improve patient outcomes. These changes include allowing patients to have a second dose, setting the dosage to the maximum tolerated dose, and monitoring tumor response more extensively to differentiate between tumor progression and other factors. Additionally, the company revealed their early stage program on interleukin 2, a promising immunotherapy approach.

Summary & Key Takeaways

• Many Santherapeutics is focused on finding a treatment for recurrent glioblastoma, a type of brain tumor that is highly aggressive.

• The company's drug targets tumors that overexpress a biomarker called interleukin 4 receptor, found in 75% of glioblastoma patients.

• Unlike other therapies, Many Santherapeutics delivers the drug directly into the tumor and targets both tumor cells and the cells that protect the tumor from the immune system.