Biotech Unicorn Moderna Details Game Plan, Reveals Infectious Disease Programs


Moderna Therapeutics unleashed a torrent of updates yesterday. Moderna is noted for several things, mostly its ability to raise money, almost $2 billion so far. Its focus is on synthetic mRNA, with the plan being to inject that engineered mRNA into patients that will cause the patients’ cells to manufacture their own drugs. For a company with so much money, it doesn’t have any products on the market yet.

The advances announced at the J.P. Morgan Healthcare Conference in San Francisco include:

· The company’s first Phase IIa trial, of mRNA AZD8601, for vascular endothelial growth factor (VEGF-A) in partnership with AstraZeneca.

· mRNA-3927, a new candidate for a rare disease, propionic acidemia (PA).

· Moderna filed an investigational new drug (IND) application for mRNA-5671, a KRAS cancer vaccine.

· It launched two Phase I prophylactic vaccine studies for mRNA-1647, a cytomegalovirus (CMV) vaccine, and mRNA-1653, a human metapneumovirus and parainfluenza virus type 3 combination vaccine.

· mRNA-1944, a new development candidate that directs the liver to express an antibody to potentially neutralize chikungunya virus in the blood. It also has a Phase I trial ongoing for a prophylactic vaccine, mRNA-1388, to prevent infection from the chikungunya virus.

“We are proud of the progress we have made over the past year as we continue to see real development pipeline momentum and productivity from our platform, and continue to deliver to the clinic important advances in mRNA sciences,” said Stephane Bancel, the company’s chief executive officer, in a statement.  “We have achieved critical milestones in R&D, having gone from four clinical programs at the beginning of the year to now having 10 medicines in human testing, and our intention is to continue to rapidly advance our pipeline with an array of new development programs.”

In addition, Moderna announced that John Mendlein will join the company as president, Corporate and Product Strategy. Mendlein is vice chairman of the board and founder of Fate Therapeutics. He also serves on the boards of Editas Medicine and Axcella Health For the last six years, he was chief executive officer of aTyr Pharma.

John Carroll, writing for Endpoints News, notes, “For Bancel, a prominent new hire like this underscores the many moving parts associated with a fast-growing portfolio of pipeline projects, the introduction of combination approaches, major league partners, the creation of a full fledged manufacturing operation for products like a personalized cancer vaccine and a blockbuster investment effort designed to make Moderna a pioneer in messenger RNA.”

“This is very powerful stuff,” Bancel told Carroll, “thinking about all these products with $900 million in cash on the balance sheet. How do you weigh those products? That takes an amazing amount of work.”

As such, Bancel and Mendlein will be splitting the strategy, which, given the size of its funding and the breadth of its programs, sounds like a good idea. Mandlein, for his part, told Bancel, “I’ve been associated with companies with great platforms and science. The science here is absolutely terrific and the breadth of the applications is stunning.”

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