Briefing documents were disclosed relating to the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC), which will convene July 17 on the matter of London-based GSK plc’s Blenrep (belantamab mafodotin) as a therapy for multiple myeloma (MM). The antibody-drug conjugate was pulled from the global marketplace by GSK in November 2022 after a phase III confirmatory study failed to meet accelerated-approval requirements. In May of this year, the EMA’s Committee for Medicinal Products for Human Use recommended clearance of the drug as combination therapy for the treatment of adults with relapsed or refractory MM. GSK hopes to make a comeback in the U.S. as well. ODAC panelists will deliberate on whether the Blenrep’s profile justifies its go-ahead as a treatment for relapsed or refractory MM two settings: when paired with bortezomib and dexamethasone for adults who have received at least one previous therapy; and when used as a combo with Pomalyst (pomalidomide) from Bristol Myers Squibb Co. (BMS) plus dexamethasone for patients given at least one prior treatment, including Revlimid (lenalidomide), also from BMS. The PDUFA date for the compound is July 23.

Hengrui/Kailera obesity asset delivers solid weight loss in phase III

A GLP-1/GIP receptor agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose with no plateau over 48 weeks in a phase III trial conducted in China. As a result of the top-line results, Hengrui now plans to file an NDA in China, while Kailera prepares to launch global trials evaluating higher doses and a longer duration of treatment.

Proteomics finds surprise commonalities as well as differences in neurodegenerative diseases

The switch will be flicked today to make the world’s largest dementia-related proteomics dataset freely available to researchers, at the same time as members of the consortium which compiled it publish the proteomics signatures of major neurodegenerative diseases that they uncovered in a first trawl of the data. To set the scene, researchers from the Global Neurodegeneration Proteomics Consortium (GNPC) outline the features of the dataset, which includes around 250 million unique protein measurements from over 35,000 blood and cerebrospinal fluid samples, and associated clinical data, that has been contributed by 23 research groups from around the world. From this resource, GNPC researchers have identified specific protein signatures associated with Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia and amyotrophic lateral sclerosis. They also have detected proteins that the diseases have in common.

Renasant launches with $54.5M to develop drugs for a genetic kidney disease

Launched out of 5AM Ventures’ 4:59 Initiative, Renasant Bio has secured $54.5 million in seed funding to support development of treatments for autosomal dominant polycystic kidney disease (ADPKD), a genetic disease caused by mutations to an ion channel. The newco sees parallels between ADPKD and cystic fibrosis with the potential to develop both corrector molecules that help stabilize misfolded proteins and potentiators that enhance the function of mutated proteins. The big difference? There's estimated to be more than 12 million people globally affected by ADPKD, a couple of orders of magnitude larger than the approximately 100,000 people living with cystic fibrosis globally.

Imugene’s allogeneic CD19 CAR T sees 75% response rate

Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate. Patients enrolled in the trial have previously failed at least three lines of therapy, with many patients failing four to six lines of therapy, including autologous CAR T therapies.

Illimis $42M series B to spur study of Aβ-clearing fusion protein

Illimis Therapeutics Inc. raised ₩58 billion (US$42 million) in a series B financing round. The funds will support development of ILM-01, its lead bispecific fusion protein candidate, into preclinical development for Alzheimer’s disease by the second half of 2025, along with the company’s neuroimmunology portfolio. Seoul, South Korea- and Boston-based Illimis expects to submit an IND application for ILM-01 by the end of 2027.

Also in the news

Amylyx, Astrazeneca, Atara, Bayer, Biodexa, Boehringer Ingelheim, Bonus Biogroup, Corcept, Crinetics, Daré, Disc, Essa, Gero, GSK, Imugene, Leo, Nanoscope, Neurocrine, OS Therapies, Recludix, Rhythm, Simris, Takeda, Ultragenyx, Uniquity, Valneva, Verastem, Xeno, Zenith