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

SPECIAL REPORT #21.3

COVID 19 Treatments Update #2

In spite of the numerous announcements made at the JP Morgan Healthcare Conference this week, COVID-19 treatments remain the main topic of the Biopharmaceutical companies’ agenda At the dawn of the year 2021, the most important issue for many countries around the world is the one addressing supplies of already approved vaccines and negociations with companies close to getting an approval for their “soon to come” vaccines.  Following the end of year holidays and the rapid emergence of new SARS-COV-2 variants, the sanitary conditions have dramatically degraded in many countries and there is now an ongoing race to vaccinate as many people as possible in order to reach herd immunity as soon as possible. Vaccination plans have been disclosed by several health officials, but as stated previously supply of vaccines might be the major hurdle to achieve successful vaccination campaigns.

According to the Johns Hopkins University, the global death toll from COVID-19 topped 2 million today, just one year after the coronavirus was first reported in Wuhan. The number of dead is about equal to the population of Brussels or Vienna.

The report of this week is a timely and unique opportunity to take stock of the current situation as we know it.

Vaccine News

• Moderna has received a conditional marketing authorisation (CMA) from the European Commission for its COVID-19 vaccine on January 6, after a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

• AstraZeneca has filed a CMA with the European Medicines Agency (EMA) for its AZD1222 vaccine and expects an approval by January 29. The company has not formally applied for an Emergency Use Application (EUA) with the U.S. FDA .

• According to Pfizer and the University of Texas Medical Branch, COMINARTY or BNT122b, the Pfizer/BioNTech COVID-19 vaccine, appears to work against key mutations in the variants recently uncovered in the U.K. and in South Africa.

• CureVac, a German biotechnology company, based in Tübingen, which develops CVnCOV, also a mRNA vaccine, has entered a partnership with compatriot Bayer in order to speed up the clinical development, boost manufacturing and prepare for a possible launch. CVnCOV has just entered phase 3 testing in the last days of 2020. Bayer’s expertise should help to supply “hundreds of million” doses once the vaccine is approved. The collaboration between CureVac and Bayer is alike the one between BioNTech and Pfizer. CureVac had no late stage clinical candidate prior to the pandemic.

• China Sinovac’s COVID19 vaccine, CoronaVac received  an EUA from the Indonesia’s Food and Drug Authority, making it the first country to approve the vaccine outside of China. The Indonesia FDA said it found the vaccine to be 65.3% ,effective based on interim data from a phase 3 trial.

• At the JPMorgan Healthcare Conference, Alex Gorsky, Johnson & Johnson CEO, said Ad26.COV2.S, its COVID19 vaccine is in the “final stages” of data analysis gathered from around 45,000 patients and the company hopes “to have that information very soon”. Ad26.COV2.S is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding  a full length and stabilised SARS-COV2 spike (S) protein based vaccine given as a one-dose regimen, which, when approved, could help an immunisation push in many countries. J&J could receive a EUA by next month according to an unofficial source. Preliminary phase 1/2b results were published in the NEJM of January 13. Ad26.COV2.S induced an immune response and was generally well tolerated across all study participants “producing neutralizing antibodies after a single vaccination, in participants aged 18-55”.

• Open Orphan (Dublin) and Codagenix (Long Island, New York),  have received approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a phase 1 study with their nasal vaccine candidate COVI-VAC in 48 young healthy volunteers. COVI-VAC uses the entire virus in a weakened form and has the potential to induce broad antibody, cellular and mucosal immunity with a single intra-nasal dose.

• In the French newspaper “Le Monde” reporters stated that the Sanofi vaccine developed with GSK was late because of “an error in the dosing of antigens”.

• Moderna’s leaders indicated that one should stick to the approved EUA dosing regimen and there were no data available to consider that approved doses could be halved in order to administer them to more people. Moderna’s CEO, Stephane Bancel, said COVID19 is likely to become an endemic disease. “SARS-COV-2 is not going away. We are going to live with this virus for ever” he said at the JPMorgan Healthcare Conference earlier this week.

Vaccine Supplies

• In spite of a slow rollout in the U.S., Moncef Slaoui, the Head of Operation Warp Speed, believes the country has responded to the crisis and is on track for herd immunity.

• BioNTech announced that it expects to produce 2 billion doses of COMINARTY in 2021 with ramped-up manufacturing facilities.

• The European Union has announced that it has secured an additional 300 million doses of COMINARTY from Pfizer and BioNTech.

• India, is preparing to become the world’s largest vaccination drive and is ready to rollout AstraZeneca’s vaccine at a non-profit price. Serum Institute of India says it will charge 200 rupees ($2.75) for the first 100 million doses.

Other treatments

• Regeneron’s R&D chief George Yancopoulos said “We, as a society have to do a much better job in getting antibody therapies to patients”. Eli Lilly and Regeneron have both received EUAs for their antibody cocktails in mild-to-moderate patients who are not hospitalised but are at high risk of progressing to  severe COVID-19. “Right now the vaccine is not helping any of these people” Yancopoulos said. “The only thing that can really help these people… are antibody therapies”. Janet Woodcock, the current Center for Drug Evaluation and Research (CEDR) head also claimed that these drugs are “underutilised” and should receive a greater attention.  “If we don’t do this, the likelihood is that we will have even more overwhelmed hospitals and healthcare workers”. One of the hurdle of these antibody cocktail treatments comes from the fact that they need to be infused at an infusion center. The Regeneron cocktail treatment (casirivimab and imdevimab) is currently only available in the U.S but is being evaluated in the U.K.’s RECOVERT trial of multiple COVID-19 treatments. So far Regeneron has sold an initial 300,000 doses but the U.S. government has ordered an additional 1.25 millions doses through June 30, in a deal potentially worth $2.6 billion.

• U.K. government found that RoActerma, or tocilizumab, an IL-6 selective antibody, approved for the treatment of rheumatoid arthritis was effective in reducing risk of death as well as hospitalisation time for COVID19 patients. In a press release the U.K. National Health Services (NHS) said tocilizumab was among two drugs that “reduced the relative risk of death by 24% when administered to patients within 24 hours of entering intensive care and left intensive care between 7 and 10 days earlier on average”.

• Synairgen, a Southampton (U.K.) based company, has treated its first patient in the U.K. with its COVID-19 treatment SNG001, an inhaled formulation of interferon beta-1a, a protein believed to stimulate the body’s antiviral responses.

Miscellaneous

• Moncef Slaoui, the Head of Operation Warp Speed has submitted his resignation at the request of the incoming Biden administration, earlier this week. He will be replaced  by former U.S. FDA commissioner David Kessler, acting Medicare head Andy Slavitt will also join the Operation group.

• Janet Woodcock, a veteran regulator and longtime director of the CEDER, has been appointed as interim chief of the FDA by the Biden administration after the one year term of Stephen Hahn has been terminated. Woodcock and former FDA principal deputy commissioner Joshua Sharfstein are vetted for the permanent job.

 Paris, January 15, 2021

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