University of Oxford

GSK’s MenABCWY vaccine application was supported by the results from two Phase III trials. Credit: MAXSHOT.PL/Shutterstock. GSK has secured approval from the US Food and Drug Administration (FDA) for its new vaccine, Penmenvy, to protect against five meningococcal serogroups for individuals aged ten to 25. The vaccine is designed to target serogroups of Neisseria meningitidis (A, B, C, W and Y), which are the known causes of invasive meningococcal disease (IMD). GSK’s MenABCWY vaccine is an injectable suspension intended for intramuscular use. It comes with a vial of lyophilised MenACWY powder, mixed with a prefilled syringe of MenB liquid before use. Penmenvy is a combination of antigens from GSK’s established vaccines: Bexsero (Meningococcal Group B vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The company’s regulatory application for the vaccine was supported by data from two Phase III trials involving 4,800 participants. The studies confirmed that the vaccine has a safety profile consistent with the licensed meningococcal vaccines of GSK. The integration of the MenABCWY vaccine into healthcare practices is expected to streamline the vaccination process. GSK chief scientific officer Tony Wood stated: “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the US, especially for IMD caused by serogroup B. “Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.” The CDC [Centers for Disease Control]’s Advisory Committee on Immunization Practices (ACIP) is set to vote on the use of GSK’s MenABCWY vaccine on 26 February 2025. In January 2025, GSK embarked on a new research partnership with the University of Oxford for an immuno-prevention programme to explore cancer prevention through vaccination. The partnership will invest in translational research to understand pre-cancer biology and potentially develop new vaccination strategies for cancer prevention.

The vaccines were made to target mutant proteins identified from each patient’s tumor. The researchers used an algorithm to determine which of these neoantigens would be most likely to fire up an immune response. \n After their advanced kidney tumors were surgically removed, nine patients were protected from the cancer returning thanks to an experimental, personalized cancer vaccine, researchers reported Feb. 5.The small, phase 1 trial was carried out by the Dana-Farber Cancer Institute, with the results published in Nature on Wednesday. Even more than three years after surgery, none of the patients saw their tumors recur.The vaccines boosted cancer-targeting T cells 166-fold, the scientists wrote, and these immune cells persisted in the body throughout the study’s duration.Patients were given the vaccine on days 1, 4, 8, 15 and 22 after surgery, with boosters following at weeks 12 and 20. Five patients also received the checkpoint inhibitor antibody Yervoy (ipilimumab) along with the vaccine.One patient in the study died from mental health complications that were unrelated to the cancer and treatment, the researchers wrote in their paper. Otherwise, the most common side effects were local reactions to the vaccine injection and flu-like symptoms.All nine patients had stage 3 or 4 clear-cell renal cell carcinoma, the most common form of kidney cancer. This cancer has a high risk of recurrence, study author Toni Choueiri, M.D., director of Dana-Farber’s Lank Center for Genitourinary Oncology, said in a statement. The vaccines were made to target tiny, mutant proteins identified from each patient’s surgically removed tumor. The researchers used an algorithm to determine which of these proteins, called neoantigens, would be most likely to fire up an immune response, according to the release.The personalized neoantigen approach has found success in melanoma, a cancer which has many more mutations that can be targeted. The findings support the idea that the technique can also work in cancers with fewer mutations, such as kidney cancer, according to the release.“These results support the feasibility of creating a highly immunogenic personalized neoantigen vaccine in a lower mutation burden tumor,” study author Patrick Ott, M.D., Ph.D., director of Dana-Farber’s Center for Cancer Vaccines, said in the release. “Though larger scale studies will be required to fully understand the clinical efficacy of this approach.”One such larger study is already underway with a similar personalized vaccine in combination with Merck’s Keytruda (pembrolizumab). That randomized phase 2 trial is currently recruiting and seeks to enroll about 272 patients with renal cell carcinoma.Merck is keen to partner Keytruda with vaccines. The Big Pharma has been collaborating with Moderna on an mRNA-based cancer vaccine that’s currently in a phase 3 trial of high-risk melanoma, while IO Biotech is testing a Keytruda-vaccine combo in squamous cell carcinoma of the head and neck.Others are also starting to look more closely at neoantigens, with GSK recently inking a research pact with the University of Oxford.

Oxford Science Enterprises (OSE) and Cedars-Sinai Intellectual Property Company announced a partnership to support health-tech startups expanding from the United Kingdom to the United States. The collaboration will provide funding, resources and market access to emerging companies developing healthcare technologies to accelerate the adoption of AI-driven healthcare tools by combining Oxford's research expertise with Cedars-Sinai's clinical and commercial network. The initial step in this initiative is a $2 million investment by OSE and Cedars-Sinai in Neu Health, a University of Oxford startup focused on neurology care. Neu Health's smartphone-based platform helps clinicians monitor and manage Parkinson's disease and dementia patients by analyzing motor and cognitive symptoms using artificial intelligence. AI and machine learning are used to remotely monitor disease progression, predict clinical outcomes and optimize medication management for Parkinson's and dementia patients. The app enables clinician-guided care, provides educational support and offers personalized in-person and digital therapies to help patients live independently and reduce the need for higher-acuity care. OSE, which previously participated in a Cedars-Sinai accelerator program, will pilot its digital platform at Cedars-Sinai, enrolling 150 neurology patients in a six-month trial as part of its U.S. expansion. Heather Roxborough, senior partner of health tech at Oxford Science Enterprises, told MobiHealthNews that neurology care suffers from a lack of objective data on what happens between doctor visits. "Neurologists typically see their patients once or twice a year and must make complex treatment decisions based on a short consultation and a handful of tests," Roxborough said. She explained that finding the right product-market fit in the U.S. healthcare system is not always straightforward, as the system is highly fragmented. "While clinical needs are similar across different markets, the incentive structures for healthcare businesses vary significantly," she said. Roxborough said partnering with Cedars-Sinai at an early stage allows companies like Neu Health to gain rapid market feedback and tailor their solution to the needs of a U.S. partner. "This is particularly valuable for understanding workflow, data integration and commercial requirements –often significant hurdles for early-stage companies," she said. THE LARGER TREND Partnerships aimed at matching startup brainpower with access to capital are off to a strong start this year, including AMD's $20 million equity investment to boost Absci's drug-discovery efforts. Significant investments are also being made to leverage AI technology, as evidenced by drug discovery startup Insilico Medicine's deal with Italian pharmaceutical company Menarini Group to deepen their AI partnership – worth a potential $550M.