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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #20.16

Moderna Announces Positive Interim Phase 1 Results with mRNA-1273 Against COVID-19

Moderna, a Cambridge, Massachusetts (USA) based biotechnology company announced positive interim clinical data of mRNA-1273, its vaccine candidate against SARS-Cov-2) from the phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID).

Immunogenicity data for the 25 µg, the 100 µg and the 250 µg levels were made available.  The bottom line indicates that the 25 µg and the 100 µg triggered immune responses in 8 patients after two doses at day 43 and at the 250 µg after one dose at day 29 in subjects aged 18-55 years old. Levels of binding antibodies were at the levels seen in convalescent sera from people who have recovered from COVID-19, although no figures were presented. The company stated that at the 100 µg dose, levels of binding antibodies significantly exceeded the level seen in convalescent sera. Right now, neutralizing antibodies data are only available for the first four patients in each of the 25 µg and the 100 µg dose level cohorts.

“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 “ said Tal Zalks, Moderna’s Chief Medical Officer.

mRNA-1273 is considered to be safe and well tolerated at the 25 µg and 100 µg doses. The most notable adverse effects were seen at the 250 µg dose level, with three patients with grade 3 systemic episodes.

These results are from 3 cohorts of patients aged 18 to 55. Two other cohorts : 55 to 79 and 71 and above are now being tested, which represent the most vulnerable group and where  efficacy and safety will be critical to assess the value of the vaccine.

“I could not be happier” about that data said Moderna CEO Stéphane Bancel in a call with analysts on May 18, 2020.

Based on these results, Moderna will initiate a Phase 2 study with two dose levels, 50 µg and 100 µg with the aim of selecting a dose for the pivotal Phase 3 study expected to start in July and, if successful, Moderna expects to file an Biologic Licence Application (BLA)  with the US FDA, at the end of summer. With the support of BARDA, Moderna has already invested in scale up manufacturing through a partnering with Lonza.

According to Moderna latest Press Release, mRNA-1273 is an mRNA vaccine against SARS-COV-2 encoding from a prefusion stabilized form of the Spike (S) protein, completed on February 7, 2020, shipped to NIH on February 24 and tested in a first participant of a Phase 1 study on March 16, 63 days after sequence selection.

Right now, more than 100 different vaccine candidates against COVID-19 are in development and at least eight have started testing in humans.

On Friday May 15, Moncef Slaoui, a Belgian-American, was appointed by the Trump administration as Chief Scientist, to lead the “COVID-19 Warp Speed Operation”. Moncef Slaoui is a worldwide recognized expert in the vaccine field. He was in charge of GlaxoSmithKline Vaccine Business for several years before joining various activities as a Board Member, including one at Moderna. As soon as he was appointed in that position by the White House, Slaoui appeared at a Rose Garden Press Conference in presence of Donald Trump and said “Mr. President, I have recently seen early data from a clinical trial with a coronavirus vaccine. And this made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020.” It is now clear that Slaoui knew about the Moderna data, a company from which he resigned as a Board Member upon his appointment as the “Operation Warp Speed “ head. The bemoaning issue is linked to the fact that Slaoui still holds 155,438 options in Moderna, a stake worth $12,575 000 at Moderna current share price of $80.90 at the time of publication (an increase of 19.96% since his appointment).

We, like many others, consider that this stock options holding should be called a conflict of interest and should be thoroughly investigated by the appropriate authorities.

Paris, May 19, 2020

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