As the Covid-19 pandemic continues to wreak havoc in the U.S., the CEO of BioNTech that received the first emergency use authorization for a vaccine presented his vision to transform ther German company into an immunotherapy powerhouse at the all-virtual 39th Annual J.P. Morgan Healthcare Conference. BioNTech and Pfizer jointly received the EUA from the Food and Drug Administration back on Dec. 11.
On Monday, Ugur Sahin, CEO of BioNTech, shared more details about the mRNA vaccine platform, its ability to be used across other infectious diseases as well as in the development of cancer vaccines. Here are some key takeaways from Sahin’s presentation.
2B vaccine doses to be readied in 2021
While the vaccine rollout has been an abject failure in most states, it’s not because of lack of supply. Sahin declared that BioNTech has already delivered 32.9 million doses as of Jan. 10 and is ramping up its manufacturing capability to be able to deliver 2 billion doses this year. That’s double the 1 billion dose commitment the company has made but Sahin’s confidence comes from the company’s alliance with Pfizer under which a total of six manufacturing sites will produce the Cominarty vaccine. Further, the company is working with contract manufacturing organizations to be able to deliver the 2 billion doses this year.
mRNA platform is easily re-engineered
While BioNTech’s Cominrnaty vaccine has been tested in more than 43,000 people, has shown to be more than 95% effective (94% in those over 65) and is approved under emergency/temporary/conditional use in 45 countries, it’s an open question whether the vaccine is going to be effective in mutations of the novel coronavirus.
Sahin noted that the company is closely following variants that have arisen over the last few months.
“We knew that this virus mutates and there will be new strains coming up,” he said. “We will monitor these strains and we will evaluate whether our vaccine is still active against these new strains and we have the ability to create a re-engineered vaccine in and make it available within six weeks. This is one of the key advantages of messenger RNA”
Later in the Q&A session, Sahin responded to a question voicing concern that the vaccine may ultimately prove ineffective against a significant mutation.
“We have evaluated two of the mutations which are present in the U.K. variant and both seem not to be affecting our vaccine efficacy,” noting that BioNtech will release data in the next seven days for the U.K. variant and the next 10 days for the South African variant. “At a certain time, if we get variance that requires adaptation of the vaccine, we can do it.”
So far, scientists have said that the approved vaccines in the U.S. — including Moderna’s — are working well to counter the variants of the novel coronavirus. But should further review reveal otherwise, the six-week time frame that Sahin offered should be heartening.
Expect re-vaccinations in the future
Despite high efficacy, Sahin made it a point to stress that immune response of the vaccine will wane over time.
“We consider that revaccinations will be necessary at certain time points,” he said. “We do not know [for sure] but we are prepared. Again, messenger RNA technology is well-suited for revaccination purposes. We know from our oncology trials where we have re-vaccinated some of the cancer patients more than 25 times ….”
BioNTech is developing mRNA-based vaccines for different infectious diseases
Sahin emphasized that mRNA’s potential applications are far and wide. He said BioNTech is developing mRNA vaccines for three infectious diseases— influenza, tuberculosis and HIV.
This is a smart move considering the annual influenza vaccine efficacy is less-than-stellar – per CDC, “during seasons when the flu vaccine viruses are similar to circulating flu viruses, flu vaccine has been shown to reduce the risk of having to go to the doctor with flu by 40 percent to 60 percent.”
Compare that to the 90% plus efficacy rate that BioNTech’s vaccine has demonstrated
Separately, there are six other infectious disease programs — that Sahin would not identify – where the company is developing vaccines.
“In the United States in the last three years … only seven vaccines have been approved, so there is room for further improvement and for acceleration,” he said.
BioNTech’s cancer vaccines are advancing
Aside from infectious diseases, BioNTech is also leveraging its mRNA platform in the field of oncology to develop cancer vaccines.
Here’s a slide that Sahin shared that showed the programs the company is currently pursuing using the FixVac approach. [click image below to enlarge]
Through this approach being tested in Phase 1 trials in melanoma, head and neck cancers as well as prostate cancer, the focus is on “leveraging antigens to break tumor tolerance.” Sahin said.
Aside from Fixvac, the company has also developed a separate n cancer vaccine program that can target 20 neo-antigens per patient.
“This is a complementary vaccine approach – iNeST – though here the targets are individual mutations, so that means this is a fully individualized vaccine approach,” Sahin explained. “The vaccine is customized to each individual patient and targets up to 20 neoantigens per patient which have been identified by next-generation sequencing.”
Further, Sahin noted that the company is also using the same vaccine technology to “amplify and promote the activity of CAR-T cells” in cancer.
BioNTech and Moderna have become household names as they raced to create a vaccine in record time (10 months for BioNTech). But BioNTech is not resting on its laurels. Through his presentation, Sahin laid out the company’s ambition to harness the power of the immune system to bring about a wholesale change in how patients have been vaccinated and treated.
“We believe that by harnessing the full potential of the immue system, we might be able to really address medical needs in multiple disease areas,” he said.
The company’s stock has jumped 170 percent to $108.20 in afternoon trading up from $40.05 on Jan 3, a year ago.
Photo: BioNTech
