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BioNTech has seen phenomenal success during the COVID-19 pandemic, with its Pfizer-partnered mRNA vaccine propelling the company to new heights. But now, with demand for the vaccine falling sharply and revenues dropping sharply in the first half of 2024, the pandemic darling is betting that its oncology pipeline will be profitable in the coming years.
BioNTech’s rapid growth is expected to be followed by a decline in revenue in 2023 and a continued decline in 2024. Total revenue for the first half of this year was It reached $347 million.That’s down 119% from $1.6 billion for the same period in 2023, according to the company’s most recent revenue report.
As COVID-19 vaccine sales peak in 2021 and 2022, BioNTech expects annual revenues to grow by nearly $21 billion and $19 billionThe company’s total losses for the first half of 2024 reached $885 million.
As vaccine revenues tumble, BioNTech is beefing up its pipeline to find new blockbuster candidates and plans to increase research and development spending by 55% to $1.2 billion in the first half of 2024 compared with the first half of 2023. The biotech currently has more than 40 candidates. In the PipelineFour of them are in Phase 3 trials and are betting big on mRNA. mRNA Production Facility In Rwanda earlier this year, BioNTech Approval for 10 cancer indications Launches are scheduled to begin from 2026 onwards, with completion planned by 2030.
BioNTech CEO Ugur Sahin
Used with permission from BioNTech
But the focus on COVID-19 isn’t over yet. CEO Ugur Sahin said on an earnings call with investors that BioNTech has “begun rolling out a ‘new variant-adapted vaccine’ that we expect to be approved and distributed in the coming weeks and months.” Chief Strategy Officer Ryan Richardson stressed that COVID-19-related products “remain a driver of our total profits.”
mRNA Cancer Pipeline
Among the drugs in BioNTech’s pipeline, the leading candidate is BNT111, an mRNA cancer vaccine being studied in melanoma, according to Lee Brown, global leader of healthcare at research firm Third Bridge. The vaccine, which triggers an immune response in patients with advanced melanoma, has received fast track and regulatory designation from the FDA. The company recently Positive Top-Line Results Brown said the Phase 2 trial in July met its primary endpoint and also improved overall response rates when combined with Regeneron’s Libtayo.
The vaccine is a proof of concept for BioNTech’s off-the-shelf mRNA platform, FixVac, which Chief Medical Officer Dr. Ozlem Tureci said has the flexibility to target multiple non-mutated antigens in most patients with a given tumor type. The company’s other mRNA vaccine platform, iNeST, produces vaccines on demand and tailored to each patient.
“These preliminary results mark an important milestone for the company and underscore our belief in the transformative potential of this new class of medicine and mRNA vaccine technology, a key pillar of our oncology strategy,” Sahin said in the earnings call.
The cancer vaccine market also has room for growth. $30 billion Consulting firm Towards Healthcare predicts that a skin cancer vaccine will be in development by the end of 2033. But BioNTech isn’t the only pharmaceutical company working on a skin cancer vaccine: Merck & Co. and mRNA biotechnology company Moderna also recently announced mid-stage research results for their skin cancer vaccines. Cancer Vaccines Combined with Keytruda, the vaccine was found to significantly improve survival rates.
Oncology Strategies
Also in the pipeline is BNT323, a candidate antibody-drug conjugate that targets the HER2 protein in metastatic breast cancer. Late-stage testing has begun It began a progression-free survival trial in January. BioNTech is working with DualityBio to develop the candidate, and Richardson said the company expects to have data from a Phase 3 trial next year, with a potential launch in 2026. The drug has also been given breakthrough therapy designation.
Another candidate in BioNTech’s R&D division is a novel immuno-oncology drug, BNT327, an anti-VEGF-A antibody candidate developed in collaboration with Biotheus. The company is currently evaluating it as a combination therapy against multiple cancers and plans to initiate further trials, including in combination with chemotherapy, within the next 12 months. BNT327 combines two validated mechanisms of action that inhibit tumor angiogenesis and reduce tumor cell proliferation and survival.
“These novel BNT327 combinations have the potential to open up new areas of activity for our anti-VEGF-A and anti-PD-L1 molecules,” Tureci said on the earnings conference call.
But while BioNTech plans to expand its trials, Summit Technologies is moving forward with a similar drug candidate, ibonecimab, which targets both the PD-1 and VEGF pathways. Already in the third stage The company is moving its drug candidates through clinical trials, and BioNTech plans to begin late-stage studies later this year.
BioNTech is pursuing a broader approach with BNT327.
“Our approach here is to be broad in terms of indications and potentially pursue them in registrational trials,” Tureci said. “We’re well positioned for that. … We already have a wealth of data and can select indications and expand on that as we mature.”
Despite the promising candidates in development, not all of the pipeline has yet advanced: BioNTech has terminated its collaboration with Danish biopharmaceutical company Genmab to advance acasunlimab, a PD-L1x4-1BB bispecific antibody, into Phase 3 trials, which Genmab is further developing. AloneThe drug, the company announced earlier this month, is designed to activate 4-1BB on T cells and natural killer cells through simultaneous binding to the PD-L1 arm, inducing an anti-tumor response.
