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Operating Through Covid



Moderna posts 'positive' early data for COVID-19 vaccine

With eyes on a phase 3 study this summer, Moderna posted promising early data for its COVID-19 vaccine. The jab prompted an immune response similar to those seen in patients who have recovered from the disease.

The study, being run by the National Institute of Allergy and Infectious Diseases (NIAID), is testing three dose levels of the vaccine, mRNA-1273, given in two injections a month apart. Eight patients who received the two lowest dose levels—25 micrograms and 100 micrograms—developed neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, two weeks after receiving their second dose.

These antibody levels mirrored those seen in patients who have recovered from infection. The study also found that all 45 patients developed binding antibodies against the virus—so-called because they identify and bind to viruses but do not attack them—within two weeks of receiving the first dose.

The data are early and come from a group of patients aged 18 to 55. The study is testing the vaccine in adults aged 56 to 70 and those 71 and older.

Of the 30 patients who received the two lowest doses, only one reported a side effect considered to be grade 3: redness around the injection site. Three people who got the highest dose, 250 mcg, developed grade 3 “systemic symptoms,” including fever, muscle pain and headache, Moderna Chief Medical Officer Tal Zaks, M.D., Ph.D., said on a call discussing the data. Although the side effects were temporary and went away on their own, Moderna won’t carry the highest dose into future trials.

Based on the data, the company will tweak its phase 2 study to test two dose levels, 50 mcg and 100 mcg, while the NIAID will test a 50-mcg dose in all three age groups. Moderna thinks the phase 3 dose will land somewhere between 25 mcg and 100 mcg.

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” Zaks said in a statement. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”

The company plans to start its phase 3 study in July. Last week, it picked up fast-track status from the FDA, which will help speed up the time a new drug or vaccine takes to hurdle the normal regulatory barriers.

“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Moderna CEO Stéphane Bancel said in the statement. Last month, the Biomedical Advanced Research and Development Authority committed up to $483 million to fund late-stage trials and scale up manufacturing for the vaccine.

In a pandemic world, the biotech funding environment couldn’t look brighter, and today Pfizer shone its own light.

The Big Pharma giant is committing $500 million through the Pfizer Breakthrough Growth Initiative to a series of biotechs alongside access to its “scientific expertise” in order to keep the “most promising clinical development programs” ongoing during a pandemic that is hitting so many new trial starts.

The expertise access includes being able to tap Pfizer’s resources in research, clinical development and manufacturing.

Specific details are a little thin, but the areas Pfizer will target will need to dovetail with its own focuses including oncology, rare diseases, internal medicine, inflammation and immunology and vaccines.

This will add to the $5 billion-plus already sloshing around for biotechs after a series of major venture capital raises in 2020, a year that has seen financial chaos almost everywhere except biotech funds and IPOs, which appear to be impervious to the affects of COVID-19.

Two years back, Pfizer ran a $600 million VC fund—setting aside 25% for investments in neuroscience startups—after its retreat from in-house R&D.

“There has never been a more important moment to pursue new collaborations in our industry," said John Young, Pfizer's chief business officer. “The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”



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