COVID-19, Vaccine Development Trends at JPM21

Johnson & Johnson’s COVID-19 Vaccine

At this year’s virtual conference, Alex Gorsky, chairman and CEO of Johnson & Johnson, kicked off the conversation with Chris Schott, managing director of J.P. Morgan, touching on company’s journey of developing lead COVID-19 vaccine candidate, Ad26.COV2.S. 

“We had several different options but once we became confident on the candidate based on our best projections on efficacy on manufacturing, volume production, and yields, we selected our candidate. We quickly went into Phase 1, where we were able to garner very encouraging information about antibody response and even cellular response,” Gorsky said.

He then went onto talk about Johnson & Johnson’s larger clinical trial that was initiated shortly after the Phase 1 trial. This trial aimed to target over 60,000 patients, but the company decided to close enrollment at 45,000 due to positive numbers of infection rate and various other parameters. 

“Because of the diversity of the recruitment that we were able to do and the quality information, we were able to gather in that timeline. We're in the final stages of that analysis as we speak, we hope to have that information very soon,” Gorsky continued. 

Gorsky also touched on the other top pharmaceutical companies in the race to develop a COVID-19 vaccine, including Pfizer, BioNTech, GSK, and AstraZeneca.

“What’s really important here is that we're cheering for all of those companies right now, especially as we see variants mutations,” he said. “What's really incumbent upon all society around the world is to get these vaccines not only distributed, but administered to try to minimize of the adaptations that we're seeing with the virus, as soon as possible.” 

Moderna Vaccines Currently in Development 

Cory Kasimov, a biotechnology analyst at J.P. Morgan, interviewed Stephane Bancel, CEO of Moderna about the company’s mRNA COVID-19 vaccine, mRNA-1273, and other products currently in development. 

Bancel began by addressing the doubts surrounding the legitimacy of the 95 percent efficacy for the company’s vaccine candidate after just 11 months. 

“mRNA is an information molecule. Once you get a medicine to work in humans for a given modality and once you have optimized the technology to do that, then you can scale very quickly within that modality,” Bancel explained. 

“We know that genomics information of human genome has been sequenced. And because it's very quick and cheap to get the genomic information of a virus, you can turn into a new product very quickly, like we’ve shown with COVID-19. We have created nine vaccines in humans before the COVID-19 vaccine was born. If you do it for one modality, you can replicate the same model for many more modalities over time,” he continued. 

Moderna’s COVID-19 vaccine is currently authorized in over 30 countries. Last week, the company received approval from Israel, and then days later it gained approval from the EU and the UK. 

Most recently, Moderna initiated another study of mRNA-1273 with the goal to potentially vaccinate adolescents before going back to school in the fall. 

Bancel also touched on a few vital products coming down the pipeline for Moderna, including a potential best in class vaccine for influenza. As recommended by the World Health Organization, Modera will cover the fall seasonal virus and then improve the product from there. Currently, the company is on track to start Phase 1 in 2021. 

Moderna is also developing antigen treatments for CMV and EBV. 

After a successful Phase 1 trial and more recently a successful Phase 2 trial, the company is on track to start a Phase 3 trial for CMV this year.  And while there is currently no vaccine on the market for EBV, Moderna is on track to start a Phase 1 study of a treatment for the virus this year as well. 

Along with Biomedical Advanced Research and Development (BARDA), Bancel also announced a new program to develop an HIV treatment. 

“I've been working for many years to try to understand HIV better and try to find the best antigen to drug, a vaccine against HIV. Well, we are very pleased to partner with them. And we are on track to start, also in the clinic, an HIV vaccine this year,” he said.

The last vaccine Moderna is currently developing is for the Nipah virus, which is transmitted from animals to human and has a very high mortality rate. This virus is mainly found in Southeast Asia. 

BioNTech COVID-19 Vaccine, Company Milestones

BioNTech’s COVID-19 vaccine, BNT162b2, is one of the two FDA-approved vaccines currently being allocated to individuals globally.

At the J.P. Morgan Conference, Ugur Sahin, MD, CEO and co-founder of BioNTech, presented on the company’s vaccine candidate and the milestones that he anticipates in 2021.

First, Sahin explained that BNT162b2 has had many positive impacts on the company as a whole, such as generating cash flow that BioNTech can then invest in and advancing its pipeline of already existing infectious disease drug candidates.

So far, the vaccine candidate has proven over 90 percent effective in clinical trials, with maximum benefit observed seven days after vaccination. Additionally, BNT162b2 has gained approval in over 45 countries and about 33 million doses of the vaccine have shipped so far.

“So we have these neutralizing antibodies, T-cell responses, and we have best in class. These different types of immune responses correlate to provide, control, and prevent disease,” Sahin said.  

In 2021, BioNTech plans to manufacture nearly 1.3 billion doses of BNT162b2, with vaccine production capacity up to 2 billion doses. This will be done in seven manufacturing sites in the US, Europe, and Germany, through the Pfizer and BioNTech partnership.

“What is important is that we had that label change in the United States and in Europe and various other regions, from a five dose to six doses, which increases the number of vaccine doses 20% overnight,” Sahin explained.

Sahin closed out his interview with the key milestones that BioNTech is expecting to see in 2021.

First, there will be clinical trial updates across the company’s portfolio as a whole, including updates for bi-specific antibodies, BNT311 and BNT312, updates for multiple tumor antigens, CLDN6 and CARVac, and an update for the company’s small molecule, BNT411.

There will also be three programs moving into randomized Phase 2 trials, such as FixVac for melanoma, BNT113 for head and neck cancer, and BNT122 for iNeST in melanoma and other indications.

And lastly, BioNTech will progress six pre-clinical programs to Phase 1, including RiboMabs RiboCytokines, CARVac, and NEOSTIM neoantigen-based T cell therapy programs.