Before the year is out, the first mRNA-based shingles candidate – a collaboration between BioNTech and Pfizer – is expected to enter clinical trials; as is the Phase 1 trials for BioNTech’s BNT163 against herpes simplex virus type 2 (HSV 2).
Furthermore, a first-in-human clinical trial for BNT165 against malaria is due to start either in Q4, 2022 or early 2023.; while BioNTech’s mRNA tuberculosis candidate (BNT164) is expected to start clinical trials in early 2023.
In 2023, BioNTech expects to initiate up to five vaccine clinical trials in infectious diseases.
Commenting as the German biotech released its Q3, 2022 results this morning, Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said: “We are working to leverage our experience [with COVID-19 vaccines] and apply the lessons learned from the development of Omicron-adapted vaccines to other disease areas and product candidates.
“The next chapter of BioNTech’s evolution is becoming tangible; we continue to expand our COVID-19 vaccine and infectious disease portfolio and advance our oncology pipeline.
"We reaffirm our commitment to improving the health of people worldwide by developing immunotherapies that utilize the full potential of the immune system to fight cancer, infectious and other serious diseases.”
Beyond its commercialized COVID-19 vaccine, BioNTech has one candidate in Phase 3 trials: namely its influenza candidate BNT161 developed in collaboration with Pfizer. A trial of 25,000 US adults for the quadrivalent modRNA influenza got under way in September.
BioNTech also has 5 candidates in Phase 2 development, 16 in Phase 1, and 11 in the preclinical phase: which notably includes a Phase 1 trial for a combined flu/COVID-19 candidate, incorporating the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and Pfizer’s quadrivalent modified RNA (modRNA) influenza vaccine candidate, both based on BioNTech’s mRNA platform.
While COVID-19 remains an important part of the company's strategy, BioNTech is continuing to strengthen its immuno-oncology strategy: not least through carving out key collaborations in the space with Germany's Medigene and the UK's Crescendo Biologics this year.
BioNTech already has multiple candidates which may have the potential to tackle tumors using complementary strategies, either by targeting tumor cells directly or by modulating the immune response against the tumor.
These drug classes include mRNA therapeutic vaccines, cell therapies (CAR-, TCR-, and neoantigen-specific T-cell therapies), mRNA-encoded effector molecules (RiboMabs and RiboCytokines), next generation immune checkpoint inhibitors and agonists, anti-tumor antibodies and immune-modulatory small molecules. And BioNTech says many product candidates have the potential to be combined with other pipeline assets or already approved therapies.
BioNTech’s clinical stage oncology pipeline includes a total of 19 product candidates in 24 ongoing clinical trials including five randomized Phase 2 clinical trials: two FixVac programs (BNT111 and BNT113), two indications for the iNeST product candidate autogene cevumeran (BNT122/RO7198457) and the bispecific antibody immune checkpoint modulator BNT311 (GEN1046).
In the third quarter of 2022, BioNTech started three first-in-human clinical trials: BNT116, a FixVac program for non-small cell lung cancer (NSCLC), BNT142, a bispecific RiboMab targeting CD3 on T cells and Claudin-6 (CLDN6) in solid tumors and, most recently, BNT313, a HexaBody targeting CD27, a new product candidate from BioNTech’s collaboration with Genmab A/S being evaluated in solid tumors.
In 2023, BioNTech expects to provide up to ten clinical trial updates in oncology.
BioNTech announced this morning that it has raised its COVID-19 vaccine revenue target to the upper end of its original guidance: now coming in at €16bn – €17bn ($16 - $17bn) - up from previous estimates of €13bn – €17bn.
BioNTech's Q3 revenues in 2022 dropped considerably from Q3 2021 - from €6bn to €3.4bn ($6bn - $3.4bn); attributed to fluctuations in COVID-19 vaccine demand as the 'course of the pandemic remains dynamic'
But revenues for the year to date compare to 2021: for the 9 months ended September 30, 2022, BioNTech reported revenues of €13bn (compared to €13.4bn for the same period in 2021) and net profit of €7.2bn (compared to €7.1bn).
“The updated guidance reflects the shipment of the Omicron-adapted bivalent vaccine boosters, which started early in September and is expected to continue throughout the fourth quarter of 2022 as well as higher prices and a positive foreign currency effect.”
In volume terms, BioNTech expects to invoice up to 2.1 billion doses of the COVID-19 vaccine in 2022.
BioNTech and Pfizer now have three commercial stage COVID-19 vaccine products on the market: the original COVID-19 vaccine and two Omicron adapted vaccines, Original/BA.1- and BA.4/5.-adapted bivalent vaccines (around 300 million doses of the bivalent vaccines had already been invoiced as of mid-October)
BioNTech credits the flexible mRNA platform and production infrastructure as key supports for the ‘rapid development and manufacturing of variant-adapted vaccines at an unprecedented speed’.
Like Pfizer and Moderna last week, BioNTech continues to champion the long-term potential of COVID-19 vaccines.
“BioNTech will continue to innovate to advance a diverse pipeline of follow-on and next generation product candidates; and we believe the COVID-19 vaccine franchise will remain a long-term sustainable business opportunity,” says the company.
As part of this long-term plan, BioNTech and Pfizer are investigating novel next generation vaccine approaches to with the goal of maintaining a broad and longer lasting immune response against COVID-19 as SARS-CoV-2 evolves.
“The long-term strategy takes a multipronged approach devised to develop multiple engineered vaccine candidates with the aim of delivering a pan-SARS-CoV-2-type vaccine that will help to better manage future variants of concern. The companies expect that scientific data derived from those different approaches will support the selection of the vaccine candidate for evaluation in a pivotal trial.
“BioNTech and Pfizer plan to test several novel vaccine constructs that have been engineered to engage multiple arms of the immune system, including antibodies and T cells.”
In July 2022, BioNTech and Pfizer started a Phase 2 study with a first enhanced spike antigen vaccine candidate.
And the first T cell enhancing SARS-CoV-2 vaccine product candidate (BNT164b4) in combination with the Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is expected to enter the clinic in the fourth quarter of 2022.