PRO-1286

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.

GEN1160 joins another spoil from the ProfoundBio buy, GEN1107, on Genmab’s scrap heap.\n Genmab has shed another antibody-drug conjugate from its April 2024 acquisition of ProfoundBio. The Danish pharma has dropped development of GEN1160, a company spokesperson confirmed to Fierce Biotech, halting a phase 1/2 trial of the asset.“GEN1160 has been discontinued due to low enrollment in the clinical trial and in line with our portfolio prioritization strategy,” the Genmab spokesperson said. “This approach ensures we focus our resources on developing innovative antibody medicines with the greatest potential to make a meaningful impact for patients.”The trial had been testing GEN1160 in patients with renal cell carcinoma, nasopharyngeal carcinoma and non-Hodgkin lymphoma.GEN1160 joins another spoil from the ProfoundBio buy, GEN1107, on Genmab’s scrap heap. The drugmaker scuttled its solid tumor candidate, GEN1107, in September after a phase 1/2 trial revealed a subpar risk-benefit profile.Genmab is still pursuing rinatabart sesutecan (Rina-S), ProfoundBio’s star asset, in ovarian and endometrial cancers, the spokesperson said, along with GEN1286 in solid tumors. The pharma is currently enrolling patients with advanced solid tumors in a phase 1/2 trial for GEN1286, formerly known as PRO1286. Rina-S is a potential competitor to AbbVie’s Elahere, but the Chicago pharma has taken legal steps to interrupt Genmab’s ADC development. AbbVie alleged in a March lawsuit that ProfoundBio built its ADC tech on stolen trade secrets from a former AbbVie employee.Genmab said it would “vigorously defend” itself against AbbVie’s claims, and noted that numerous other companies—such as Adcentrx, Alvotech, BeiGene and Revance—have come under fire from the American pharma in similar cases.In May, Rina-S beat analyst expectations with a 50% unconfirmed response rate in advanced endometrial cancer, fueling a phase 3 push in the indication that is set to begin this month, according to clinicaltrials.gov. In October, Genmab released further phase 1/2 data showing Rina-S achieved a 50% objective response rate, including two patients whose cancer completely disappeared.Though it is winnowing down its assets from ProfoundBio, Genmab is still building up its cancer pipeline overall. At the end of September, Genmab shelled out a hefty $8 billion for Netherlands-based biotech Merus and its bispecific antibody, petosemtamab.The antibody previously notched a 79% 12-month survival rate in a phase 2 trial of patients with PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma, with analysts hailing its “best-in-disease profile.”