Gotistobart

iStock, U. J. Alexander Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year. BioNTech released its third-quarter earnings report on Monday, finally stemming its losses this year and reporting strong year-over-year growth driven by its variant-adapted COVID-19 vaccine. In Q3, the company generated $1.36 billion in sales, up from nearly $940 million during the same period in 2023—and far ahead of the consensus forecast, which expected that BioNTech would bring in nearly $652 million in Q3, according to analytics firm Zacks Equity Research. BioNTech reported net profit in the quarter of $216 million—the first time it’s done so this year, after sustaining more than $340 million and almost $885 million in losses in the first and second quarters, respectively. On a per-share basis, BioNTech’s profit was $0.88, while analysts forecasted a loss of $2.01 per share The biotech attributed the strong performance in Q3 to the “earlier” approval for its variant-adapted COVID-19 shot, compared with the later regulatory nod the company secured in 2023. The FDA greenlit BioNTech’s vaccine in August 2024, allowing its use for the Omicron KP.2 variant for the 2024–2025 season. Last year, the FDA’s approval came in September . Still, 2024 has been difficult for BioNTech overall, reflected in its nine-month revenue of $1.7 billion, down from $2.55 billion during the same period last year. And despite recording its first quarterly profit this year, the biotech has still suffered more than $1 billion in losses in 2024 so far. Reflecting its financial challenges, BioNTech on Monday lowered its total revenue guidance for the year. The company now expects it to be in the lower end of its previously announced forecast range of $2.73 billion to $3.38 billion. BioNTech’s adjusted guidance reflects expectations regarding the uptake of its updated COVID-19 vaccine, as well as potential inventory write-downs and other charges associated with its partnership with Pfizer. In an investor call on Monday, CEO Ugur Sahin struck an optimistic note and focused on the company’s prospects in the coming years, touting the biotech’s progress in oncology development—particularly regarding its lead cancer candidate BNT327, a bispecific antibody that binds to PD-L1 and VEGF-A, both validated targets in cancer. “BioNTech was established with the ambition to revolutionize cancer treatment through the development of mRNA-based immunotherapies, particularly personalized cancer vaccines” Sahin said during the call. With its oncology pipeline, the biotech is looking to leverage its COVID-19 success to advance a portfolio of next-generation cancer treatments, “aiming to tailor therapies to the individual genetic make-up of each patient tumor.” Last month, BioNTech dosed the first patient in the Phase II study testing BNT327, in combination with chemotherapy, for the first- and second-line treatment of patients with locally advanced or metastatic triple-negative breast cancer. Data from this study will help the biotech launch a Phase III program for the bispecific, set to begin in 2025. BioNTech is also developing BNT327 for non-small cell lung cancer and at the 2024 European Society for Medical Oncology Congress in September 2024, the biotech unveiled Phase II data showing a 57.8% confirmed objective response rate in patients carrying EGFR mutations. In addition to BNT327, BioNTech is working on the anti-CTLA-4 monoclonal antibody BNT316, dubbed as gotistobart, for the treatment of NSCLC and platinum-resistant ovarian cancer. The company is also advancing a portfolio of mRNA cancer vaccines, which are in mid-stage studies. “We are entering a catalyst-rich period for our company, in particular for our oncology portfolio,” Chief Strategy Officer Ryan Richardson said during Monday’s earnings call, noting that BioNTech currently has more than 10 Phase II and III trials ongoing across various cancer types. “In the next 18 months, we expect multiple clinical data updates from these trials and we’ll initiate several additional trials with registrational potential.”

The partial clinical hold only applies to the Phase III PRESERVE-003 trial of gotistobart. Image credit: Andrii Yalanskyi / Shutterstock. The US Food and Drug Administration (FDA) has placed a partial clinical hold on the registrational Phase III PRESERVE-003 trial of BioNTech and OncoC4’s gotistobart. The study was placed on partial hold after the therapy showed “varying results between the squamous and non-squamous non-small cell lung cancer (NSCLC) patient populations”, as per an SEC filing by BioNTech. The companies have also “proactively” paused the enrolment of new patients and have informed the US regulator “of the possible variance for further alignment.” The companies were adamant that clinical hold does not affect other gotistobart trials, including a Phase II trial (NCT05446298) in ovarian cancer indication, a Phase I/II trial (NCT05682443) in prostate cancer and a Phase I/II trial (NCT04140526) of gotistobart and MSD’s Keytruda (pembrolizumab) in advanced solid tumours. Additionally, whilst the companies are not enrolling new patients in the Phase III PRESERVE-003 study , the ones that have already enrolled in the trial will continue to receive treatment. The trial was expected to enrol 600 participants with metastatic NSCLC who have progressed on anti-programmed death ligand 1 (PD1) antibodies, according to ClinicalTrials.gov . The participants were randomised to receive either gotistobart or a chemotherapy docetaxel. The trial’s primary endpoint is overall survival over 36 months. The study also measures objective response rate, progression free survival and treatment emergent adverse events as part of secondary endpoints. See Also: Gilead and MSD to advance once-weekly HIV treatment to Phase III Editas and Genevant team up to develop gene editing therapies Gotistobart is an antibody that targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which regulates the body’s immune responses. BioNTech licenced the therapy from OncoC4 in March 2023. As part of the agreement, the companies will jointly develop the gotistobart in solid tumour indication both as a monotherapy and in combination with anti-PD1 antibodies. Whilst BioNTech holds sole rights to develop the therapy as a combination, other than with PD-1 inhibitors. Another anti-CTLA-4 antibody being developed as a treatment for solid tumours is Xilio Therapeutics’ XTX101 . It is currently being evaluated as a combination treatment with Roche’s Tecentriq (atezolizumab) in an open-label Phase I/II trial (NCT04896697). The study is co-funded by Roche and Xilio and investigates the combination in advanced solid tumours.