Moderna’s clinical and business update at the JP Morgan Healthcare Conference led the newly public company shares to pop 4.2 percent, a welcome change.
Moderna’s clinical and business update at the JP Morgan Healthcare Conference led the newly public company shares to pop 4.2 percent, a welcome change. The Cambridge, Mass.-based company, which focuses on mRNA therapies, had a record initial public offering (IPO) in December, raising $604.3 million. Since that heady IPO, shares have slipped 26.3 percent.
In his update, Moderna’s chief executive officer, Stephane Bancel, stated, “This year we are focused on making significant advances to our pipeline as we work to bring multiple programs into Phase II clinical trials, move programs within our rare disease portfolio toward the clinic and leverage our mRNA platform to create both new development candidates and potential new modalities where we believe there is an opportunity to develop therapies for a broad range of diseases.”
Bancel went on at the JP Morgan conference to outline three new drug candidates that are moving into Phase II this year. He also spent some time, oddly enough, convincing the audience that the company was undervalued, saying, “What if one drug got to market? What if two drugs got to market? What if a few more drugs got to market? This is what we’re working hard to make happen.”
The three new drugs bring the company’s tally of drugs in clinical trials to 13. The company recently discontinued testing a Zika vaccine, mRNA-1325, after it failed to stimulate antibodies to the virus.
One is mRNA-2752. Moderna has dosed the first patient in a Phase I study for treating advanced or metastatic solid tumor malignancies or lymphoma. The study is evaluating the safety and tolerability of the triplet combination as a single agent and in combination with either AstraZeneca’s durvalumab or tremelimumab.
A Phase II trial for mRNA-4157 is being planned with Merck. The trial will compare the Personalized Cancer Vaccine (PCV) and Merck’s Keytruda against Keytruda alone. An interim Phase I PCV trial in 24 patients hasn’t shown dose-limiting side effects.
Merck will also head a dose-expansion and dose-escalation Phase I trial of mRNA-5671, a KRAS vaccine. mRNA-5671 will be dosed as an intramuscular injection as a monotherapy and in combination with Merck’s Keytruda. KRAS is a mutated oncogene found in epithelial cancers, primarily in non-small cell lung, colorectal and pancreatic cancers.
Moderna has also submitted an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to start a Phase II cohort of mRNA-2416 as a monotherapy in advanced ovarian carcinoma within its current Phase I trial. This was based on clinical observations in two patients in its Phase I trial that had advanced ovarian carcinoma.
The company has also submitted an IND for mRNA-3704 for methylmalonic acidemia (MMA), a rare pediatric disease. The FDA also granted its mRNA-3927 Orphan Drug Designation in December 2018 and Rare Pediatric Disease Designation this month, for propionic acidemia (PA), a rare, life-threatening, inherited metabolic disorder.
With all this activity, Bancel still had his work cut out for him convincing investors the company was worth its market valuation, particularly after the IPO it lost $2 billion of that valuation. Eden Rahim, a portfolio manager at Next Edge Capital, told STAT, “Moderna holds the blue-sky possibility of turning protein therapeutics on its head, but it’s still a long way to establishing that.”
Two other unidentified investors told STAT that they see the value of the company’s science, but not its $5 billion valuation. They planned to hold off on investing until the company either showed promising human data or share prices became more affordable.
