PRO-1107

GSK's RSV vaccine wins broader EU approvalGenmab halts recruitment for ProfoundBio ADC studyCormorant's third SPAC reels in $150MUCB to invest £500M in R&D, manufacturing at UK siteUK drug cost watchdog backs Dupixent for COPDGSK's RSV vaccine wins broader EU approvalThe label of GSK's adjuvanted recombinant respiratory syncytial virus (RSV) vaccine Arexvy has been expanded in the EU to cover all adults 18 years and older. The shot was previously approved for use in adults aged 60-plus, as well as in those aged 50 to 59 years at increased risk for RSV disease.Arexvy's broadened indication matches that previously awarded to Pfizer's RSV vaccine Abrysvo. Despite bringing in considerable first-year sales following its initial approval in 2023, GSK was forced to scale back long-term forecasts for Arexvy when it became apparent that re-vaccination was not required on an annual basis, and after a move by US authorities to narrow their recommendations for RSV shots.Genmab halts recruitment for ProfoundBio ADC studyGenmab has halted enrollment in a Phase I/II advanced solid tumour trial of GEN1286, an EGFR/cMet-targeting antibody-drug conjugate (ADC). According to a ClinicalTrials.gov update dated Jan. 15, the study stopped recruiting after enrolling just 23 patients, far short of the roughly 260 participants originally planned.Genmab did not respond to a request for comment from FirstWord at the time of publication. If the company has no further plans for development, GEN1286 would be the third ADC from its $1.8-billion ProfoundBio takeout in 2024 to be scrapped.Last September, Genmab terminated development of GEN1107, a Phase I/II PTK7-targeted ADC, after concluding that its overall benefit-risk profile no longer supported continuation. Roughly two months later, it also pulled the plug on the CD70-targeted ADC GEN1160, which was in Phase I/II testing for relapsed/refractory non-Hodgkin lymphoma, saying it was ending clinical development "due to slow enrolment."Meanwhile, another investigational compound from the ProfoundBio acquisition — an FRα-targeted ADC called rinatabart sesutecan (Rina-S, GEN1184) — remains in the pipeline. It is in a Phase III trial for endometrial cancer and platinum-resistant ovarian cancer, according to the company's website.Cormorant's third SPAC reels in $150M Cormorant Asset Management's third blank-cheque company, Helix Acquisition III, raised $150 million in an IPO on Friday through the sale of 15 million shares at $10 apiece. The deal exceeded the firm's original goal of $125 million.The crossover investor will now be looking to merge its SPAC with a private biotech.Cormorant's latest SPAC follows the success of two prior public vehicles, which merged with MoonLake Immunotherapeutics and BridgeBio Oncology Therapeutics in 2022 and 2025, respectively. UCB to invest £500M in R&D, manufacturing at UK siteUCB confirmed an investment of £500 million ($684 million) in R&D and manufacturing at its site in Windlesham, Surrey, further strengthening claims of a recovery in the UK life sciences sector. The commitment is supported by the government's Life Sciences Innovative Manufacturing Fund (LSIMF)."The LSIMF grant strengthens our collaboration with government to support the life sciences sector and we are delighted to be able to deliver a campus and scientific capability that…cements drug discovery here," said Alistair Henry, UCB's chief scientific officer. The investment means the biopharma will continue developing a range of medicines for immunological diseases in the UK.A recent report by the Medicines and Healthcare products Regulatory Agency (MHRA) showed that clinical trial applications in the UK rose by 9% between January and November last year, suggesting that efforts by the government to reignite the country's life sciences sector may be starting to pay off.UK drug cost watchdog backs Dupixent for COPDThe National Institute for Health and Care Excellence (NICE) has recommended Sanofi and Regeneron Pharmaceuticals' Dupixent (dupilumab) for patients with chronic obstructive pulmonary disease (COPD) who have raised blood eosinophil levels. NICE said the injectable therapy could benefit nearly 30,000 people in England whose COPD remains uncontrolled despite standard inhaler treatment, particularly those with elevated eosinophils.In the Phase III BOREAS and NOTUS trials, Dupixent reduced COPD flare-ups by about a third and improved lung function, outcomes that could translate into fewer hospitalisations and less reliance on steroid treatments. NICE estimates that if half of eligible patients receive the drug, that could avoid about 3600 flare-ups annually, saving the National Health Service (NHS) roughly £16.5 million ($22.6 million).NHS England has negotiated a commercial agreement with Sanofi to support rollout of the therapy, which patients self-administer at home every two weeks using a pre-filled pen.

iStock, Ekaterina Chergik Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in late-stage studies for ovarian and endometrial cancer. Genmab has scrapped another antibody-drug conjugate picked up in its $1.8 billion acquisition of ProfoundBio last year, continuing the pruning of that company’s molecules. The asset, dubbed GEN1160, was in a Phase I/II study assessing its safety and efficacy for blood cancers and solid tumors. The trial was cut “due to slow enrollment,” according to an update to a federal clinical trials database. Confirming the move to Fierce Biotech , a Genmab spokesperson added that GEN1160 is being shelved “in line with our portfolio prioritization strategy.” “This approach ensures we focus our resources on developing innovative antibody medicines with the greatest potential to make a meaningful impact for patients,” the spokesperson said. Monday’s news comes after Genmab in September discontinued the development of GEN1107, another antibody-drug conjugate (ADC) that was in Phase I/II development, but this time for advanced solid tumors, including ovarian, endometrial and triple-negative breast cancer. According to its own Clinical Trials.gov page , GEN1107 was abandoned because its “overall benefit-risk pro longer supports continuation.” GEN1160 and GEN1107 are two of the three clinical-stage cancer assets obtained by Genmab in its $1.8 billion acquisition of ProfoundBio in April 2024. The remaining clinical molecule from that deal, rinatabart sesutecan (Rina-S), the centerpiece of the acquisition, remains in development. Rina-S is in late-stage development for platinum-resistant ovarian cancer and endometrial cancer. The drug had a readout last month in endometrial cancer at the 2025 meeting of the European Society for Medical Oncology. In the Phase I/II RAINFOL-01 study, Rina-S, which was dosed every 3 weeks, elicited a 50% confirmed objective response rate over a median follow-up of 1 year. RAINFOL-01 enrolled heavily pretreated patients with endometrial cancer whose disease had progressed even after platinum-based chemotherapy and immune checkpoint inhibition. The study also documented two complete responses. Meanwhile, in March, Genmab released Phase I/II data for Rina-S in ovarian cancer, touting a confirmed objective response rate of 55.6% in heavily pretreated patients, with median duration of response not yet reached. Elsewhere in its oncology push, Genmab in September acquired rising cancer star Merus for $8 billion. The buyout, which represented a 41% premium to Merus’ closing price the day before the deal was announced, will give Genmab the bispecific antibody petosemtamab that binds both EGFR and LGR5 markers. In May, petosemtamab plus Keytruda treatment resulted in a 79% overall survival rate at 12 months in a Phase II study of head-and-neck squamous cell carcinoma. The overall response rate was 63%.