Tisotumab Vedotin-tftv

Genmab binned three antibody programmes as part of a pipeline reprioritisation disclosed during the biotech's quarterly earnings call on Wednesday. The culled assets include GEN1047, a CD3/B7H4 bispecific that was in Phase I/II testing for solid tumours; GEN3017, a CD3/CD30 bispecific that had been in a Phase I study for relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma; and GEN1056, a Phase I antibody that was being evaluated for solid tumours in partnership with BioNTech. "These programs simply didn't meet the high bar we have set internally for really having a truly differentiated therapeutic candidate," CEO Jan Van De Winkel said on the call. "We actually intend to focus more on the winners, and expand the breadth of the winners in the future."The company also said it will no longer launch a Phase III trial of Tivdak (tisotumab vedotin) in second and third line squamous cell carcinoma of the head and neck. The antibody-drug conjugate (ADC) won full FDA approval for cervical cancer in April."We continuously evaluate our clinical pipeline to ensure we are prioritising our resources in the best and most effective way possible," Van De Winkel explained. The pruned pipeline "means we are very focussed on maximising the potential of our Phase III programmes," he added, listing cancer assets Tepkinly/Epkinly (epcoritamab), rinatabart sesutecan (Rina-S), and.The former is in five late-stage studies for various cancers, while acasunlimab, a bispecific directed against PD-L1 and 4-1BB, is expected to enter Phase III by year-end for solid tumours. Rina-S is an ADC that targets folate receptor alpha (FRα) and is in development for tumours that express the protein, with a Phase III trial slated to start this quarter. Autoimmunity up next?Despite the slimdown, Van De Winkel assured investors that they "will again see new programmes added to the pipeline."He pointed to the $1.8-billion buyout of ProfoundBio as another source of candidates; Genmab gained Rina-S via the acquisition, along with two other clinical assets. Van De Winkel also commented that, while mainly oncology-focussed now, the biotech has "a very active number of programmes in preclinical development for autoimmune indications… but they are not yet ready for clinical introduction.""The majority of the work at Genmab over the coming years will still be in cancer, where we have our dominant focus, but we are clearly very interested in exploring innovative ways to move towards autoimmune with the T-cell engager programmes, potentially ADCs, and all our next-generation antibody technologies," he said.

The Medicare rebate program, under the Inflation Reduction Act, keeps chugging along. The Biden administration is once again trumpeting the Medicare Prescription Drug Inflation Rebate Program to prove to voters it is lowering drug prices.Through the program, 54 drugs will be less expensive for Medicare enrollees because of a lower Part B coinsurance rate from Oct. 1 through the end of the year. This is because drug companies raised the price of these 54 drugs faster than the rate of inflation, affecting 822,000 beneficiaries.“The President’s lower cost prescription drug law continues to put money back in the pockets of seniors and people with disabilities,” said Department of Health and Human Services (HHS) Secretary Xavier Becerra in a statement. “President Biden and Vice President Harris promised to lower prescription drug costs—and they have delivered.”The program has been in effect since April 2023. Each quarter, a new selection of drugs is discounted through the Inflation Reduction Act. This time, the program could could save patients $3,000 on the drug Kymriah, which treats cancer, the administration said. Other drugs included in this round are Briumvi for multiple sclerosis, Krystexxa for chronic gout and Tivdak used to treat cervical cancer.It is expected enrollees could save as much $3,854 depending on the prescription drug they need.HHS discounted drugs for bladder cancer, osteoporosis, infections and more this year. Starting next year, Medicare Part D enrollees will have a $2,000 cap on annual out-of-pocket prescription drug costs. In August, the feds announced savings on 10 prescription drugs through the drug negotiation program, which drastically reduces the price of drugs like Enbrel, Jardiance and Januvia, starting in 2026. A new list for negotiation in 2027 will be announced in February.The Centers for Medicare & Medicaid Services will start invoicing prescription drug companies for rebates owed to Medicare by fall 2025. These rebates are deposited to the Federal Supplementary Medical Insurance Trust Fund.