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Chief Executive Officer Stéphane Bancel said a successful Covid vaccine would be the company’s first approved product.
Chandan Khanna / AFP / Getty Images
Since Wednesday
Modern
had enrolled more than 25,000 people in the pivotal trial of the vaccine that is pioneering the race to stop Covid-19.
That brings it closer to the 30,000 the company will need to know for sure whether the vaccine prevented enough Covid cases to warrant approval. The reading could come in about a month.
Speaking to investors in an online review of Moderna’s research (ticker: MRNA) on Thursday morning, CEO Stéphane Bancel said that a successful Covid vaccine would be the company’s first approved product: funding the business and validating the messenger RNA technology behind the rest of Moderna. pipeline. That portfolio includes vaccines for common but still untreatable childhood diseases, as well as treatments for cancer, cystic fibrosis, and an inherited disease that causes heart failure in young women.
Moderna’s leadership in the development of a Covid vaccine is at the same level as the team of
Pfizer
(PFE) and
BioNTech
(BNTX): It soared its shares nearly five times this year, to a July high of $ 95, before hitting $ 60 again. Thursday morning’s research filings did not electrify investors. Moderna shares were down 2.8%, to $ 66.94, in recent trading, compared with a 2.1% drop in the
Nasdaq compound.
Still, Moderna’s $ 26 billion market cap is not a paltry valuation for a company that has no sales yet. In presentations Thursday, Moderna executives told investors that the company will be ready to produce 1 billion doses annually if its Covid vaccine receives the green light.
With the help of manufacturing partners like
Catalent
(CTLT) and Switzerland
Lonza Group
(LZAGY), Moderna can package the vaccine in 10-dose vials that are kept for six months while frozen and one week in a refrigerator, Moderna’s chief of technical operations, Juan Andrés, said. That fits perfectly into the world’s existing infrastructure for vaccine distribution.
Moderna believes that success against the SARS-CoV-1 coronavirus will position it to develop vaccines against the coronavirus that causes seasonal flu. On Thursday, she told investors that she intends to get into the flu vaccine business.
On Wednesday, Moderna announced two new research programs. Help to
Vertex Pharmaceuticals
(VRTX) explores gene-editing treatments for cystic fibrosis, in parallel with its existing Vertex collaboration that attempts to get messenger RNA to provide a critical protein that is missing from the lungs of cystic fibrosis patients. Moderna could get up to $ 455 million in the gene-editing partnership, plus royalties on any product.
A second new research partnership with Italy’s Chiesi Group will seek mRNA treatments for pulmonary arterial hypertension, which damages the lungs and hearts of those who inherit it, mostly young women. Moderna expects to get $ 425 million in the collaboration, as well as royalties from sales.
The company has just started a clinical trial of a vaccine against the RSV virus, which infects the lungs of children and sends more than 3 million a year to the hospital worldwide. Earlier this year, a phase 1 study of another vaccine against two other viruses that cause pediatric lung infections began.
There is still no approved vaccine against these childhood respiratory infections. Moderna’s Phase 3 study will combine preventives against all three respiratory viruses into a single vaccine. The company’s mRNA technology is suitable for combination vaccines, said Allison August, who leads the infectious disease clinical studies at Moderna.
Moderna will begin a Phase 3 trial next year of its vaccine against cytomegalovirus, which causes birth defects in about 25,000 American newborns each year. CMV is transmitted by infected mothers, so the phase 3 trial will test the vaccine in about 8,000 women. In previous studies, the CMV vaccine seemed safe and effective in boosting immunity, said Lori Panther, another clinical development executive at Moderna.
Along with its work on vaccines, Moderna is testing various cancer treatments aimed at enhancing the effect of widely used products such as Keytruda, the
Merck
(MRK) drug released by a patient’s immune system on tumors.
Although immuno-oncology drugs can stop cancer without the side effects of traditional chemotherapy, only about 20% of patients benefit, said University of Colorado oncology professor Antonio Jimeno, who addressed the audience as one of Moderna’s research collaborators. Furthermore, this benefit is transitory in most of these patients, because the tumors acquire resistance to the immuno-oncological drug.
Jimeno’s patients are participating in clinical trials in which Moderna’s experimental treatments are injected directly into solid tumors to stimulate cells to produce chemicals that amplify the tumor’s immune targeting. Tumors shrunk in a third of the patients who received one of Moderna’s products, in combination with the immuno-oncological drug Imfinzi from
AstraZeneca
(AZN), in a phase 2 study.
Moderna is conducting a separate Phase 1 trial that is studying a treatment that generates three immune system chemicals simultaneously. Administered with and without immuno-oncological drugs, about 40% of the 22 patients showed a response.
Write to Bill Alpert at [email protected]
