Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
Charles River Laboratories International has signed a multi-programme collaboration agreement with Related Sciences (RS) for the artificial intelligence (AI)-powered drug platform, Logica. Last year, Charles River and Valo Health unveiled Logica, a solution that leverages the AI-powered Valo Opal Computational Platform, along with Charles River’s preclinical expertise. Logica will be used on multiple previously undrugged targets within the RS portfolio. RS will collaborate with the teams from both Charles River and Valo Health to deploy Logica to discover significant new medicines. These medicines will be used to meet unmet requirements across disease areas including autoimmunity, cancer immunotherapy and inflammatory diseases. Charles River senior vice-president and chief scientific officer Julie Frearson stated: “Logica’s unique platform, which combines AI/machine learning (ML)-enabled in silico discovery, high-powered DNA-encoded libraries and traditional screening techniques, has the capability to accelerate the drug discovery and development pipeline, transforming a target to a candidate in just over two ...
Moderna and Immatics have announced a collaboration agreement aimed at developing ‘novel and innovative’ cancer therapies, with the deal potentially worth over $1.7bn. The multi-platform partnership will combine Moderna’s mRNA technology with Immatics’s T-cell receptor platform and cover various therapeutic modalities such as bispecifics, cell therapies and cancer vaccines. The companies outlined in a statement that their research will focus on three main pillars, including applying the mRNA technology for in vivo expression of Immatics’s half-life extended TCR bispecifics (TCER) targeting cancer-specific HLA-presented peptides. They will also leverage Moderna’s mRNA experience alongside Immatics’s tumour and normal tissue data included in its Xpresident target discovery platform and Xcube bioinformatics and AI platform to develop mRNA-based cancer vaccines, as well as evaluate Immatics’s IMA203 TCR-T therapy targeting preferentially expressed antigen in melanoma (PRAME) in combination with Moderna’s investigational PRAME mRNA-based cancer vaccine. Under the terms of the agreement, Immatics will receive an ...
Depicting the plight of patients with chronic and potentially fatal diseases is always a challenge for pharma companies, but Gilead Sciences has quite literally found a novel way forward.Teaming up with British historian, presenter and writer Professor David Olusoga, OBE, Gilead is launching “From the Margins,” (PDF) in what is intended to be one of the most difficult books to read. That’s because the book has every word printed entirely in the margins of the pages in what Gilead and Prof. Olusoga see as a direct inversion of a normal book. The idea is simple: “To tell the profoundly moving personal stories of marginalized people living with HIV, Hepatitis C and cancer,” according to a statement sent to Fierce Pharma Marketing. Gilead markets drugs for all three diseases. The book is specific to Britain and being run to “to raise awareness of the issue of marginalization and health inequality in ...
By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
By Tristan Manalac Pictured: AbbVie corporate office in California/iStock, vzphotos AbbVie will not exercise its exclusive licensing option for Harpoon Therapeutics’ HPN217 program, being developed for the treatment of multiple myeloma, the immuno-oncology biotech announced Wednesday. Harpoon will retain exclusive ownership over HPN217, for which it is running a Phase I clinical trial. The company will complete the study and plans to advance the candidate through its next phases of development. Despite AbbVie’s decision, Harpoon CEO Julie Eastland said in a statement that the biotech remains “confident in HPN217’s potential” to offer multiple myeloma patients “a differentiated treated option.” The company will share interim results from the candidate’s Phase I study at the upcoming International Myeloma Society (IMS) Annual Meeting, scheduled for Sept. 28, Eastland said. Developed using Harpoon’s proprietary TriTAC technology, HPN217 targets the B-cell maturation antigen, a protein highly and specifically expressed on myeloma cells. TriTAC, which stands ...
Kuano, a drug discovery company combining quantum mechanics with AI to design the next generation of medicines, today announced the close of its £1.8M seed funding round, led by Mercia Ventures, and including ACF Investors, Ascension Ventures, o2h Ventures, Meltwind Advisory LLP, and other Angel investors. The investment will facilitate further validation of Kuano’s quantum simulation platform for the design of more effective drug candidates targeting enzymes, as well as continued Company growth through strategic partnerships and recruitment. Dysfunctional enzymes are implicated in many human diseases and are therefore a prevalent target in today’s drug market. However, until now scientists have only been able to view enzymes in their ‘resting’ state, and not in their fully functioning ‘dynamic’ states. As different enzymes may appear very similar in a resting state, drugs designed to target one may also affect others, potentially impacting drug safety and efficacy. Kuano’s quantum simulation platform enables ...
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