The Cell and Gene Therapy (CGT) Catapult has announced the formation of a consortium of over 20 organisations, which will aim to accelerate technology development in cell and gene therapy manufacturing. The consortium consists of pharmaceutical companies, technology providers, therapy developers and charities. It will aim to assess the application and combination of a number of process analytic technologies (PAT) with the aim of developing cell and gene therapy specific PAT. In a statement, the CGT Catapult said the development of cell and gene therapy industry-specific PAT is key to enabling monitoring and control during the manufacturing process. The partners will utilise a collaborative work model, sharing data from each of their own research, to accelerate expertise in this area and develop industry-specific knowledge. This knowledge, according to the CGT Catapult, will enable technology providers and manufacturers to potentially develop lower cost and ‘more robust’ manufacturing processes for cell and ...
Novartis has received green lights from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab). The drug is a fully human anti-CD20 monoclonal antibody (mAb) thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion. It enables faster repletion of B cells versus other anti-CD20 monoclonal antibodies and so may offer flexibility in the management of RMS, according to the drugmaker. As per its licence, Kesimpta can be used to treat adults with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features. Novartis says it has the potential to become a recognised treatment option for eligible UK patients that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen. Initial ...
GlaxoSmithKline (GSK) is set to leverage the Cell and Gene Therapy (CGT) Catapult’s facility in Stevenage to expand its own clinical trial manufacturing capacity for cell and gene therapy. GSK will use the Stevenage facility to perform GMP cell processing to accelerate its pipeline of cell and gene therapy for clinical trials and streamline technical transfer. “The UK already has significant capabilities in cell and gene therapy, and this agreement illustrates how strategic investments by GSK can make them even stronger,” said Tony Wood, senior vice president, medicinal science and technology, GSK. “Working more closely with CGT Catapult will help us advance our promising cell and gene therapy programmes, and bring these transformative medicines more quickly to the patients who desperately need them,” he added. There has been a 48% increase in the UK GMP manufacturing space for cell and gene therapies in 2020, according to CGT Catapult. It added that ...
The UK’s National Institute for Health and Care Excellence (NICE) has recommended selective internal radiation therapy (SIRT) for the treatment of advanced liver cancer in final draft guidance. NICE’s draft guidance recommends the use of SIR-Spheres – made by SIRTEX – and TheraSphere – made by Boston Scientific – for treating advanced liver cancer that can’t be removed surgically and when transarterial therapy is not appropriate. The recommendation also specifies that these two therapies should only be considered for people with Child-Pugh grade A liver impairment. Despite limited clinical trial data for SIRTs compared with other treatment options, NICE’s appraisal committee concluded that SIRT may have fewer and more manageable side effects compared to systemic therapy sorafenib. Although SIR-Spheres and TheraSphere are slightly less clinically effective than sorafenib, they cost less. The cost savings mean that these two therapies can be recommended as cost-effective options for people with Child-Pugh grade ...
The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium). The marketing authorisation indicates Trimbow for use as a maintenance treatment for adult asthma patients, whose condition is not adequately controlled with a combination of long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS). Patients must have also experienced one or more asthma exacerbations in the previous year. Chiesi’s triple asthma therapy has been shown to reduce exacerbations and improve lung function in patients with uncontrolled asthma, compared to ICS/LABA. Both the CHMP’s recommendation and the EC’s approval are based on efficacy and safety data from four clinical studies, involving almost 3,000 patients. “This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, chief commercial officer of Chiesi Group. “The European Commission’ ...
New research has revealed ‘dramatic changes’ in the delivery of radiotherapy treatments for cancer during the first wave of the COVID-19 pandemic in England. The study – led by the University of Leeds with Public Health England and the Royal College of Radiologists – is the first to evaluate the impact of the pandemic on radiotherapy services in England. Researchers discovered that the use of much shorter radiotherapy courses increased – in particular for breast cancer patients. The use of a shorter treatment course went from 0.2% of all breast cancer radiotherapy courses in April 2019, up to 60.0% of all courses in April 2020. The change to shorter courses of treatment was also observed in other types of cancer, with clinicians likely making the switch to keep patients safe and services running during the pandemic. According to the researchers, this change was made possible in part by results of ...
4th December 2020 Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab. Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours. The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI). An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy. In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy. The median progression-free survival was 8.3 months for all patients and ...
3rd December 2020 Johnson & Johnson’s pharmaceuticals division Janssen has purchased rights to acquire an investigational gene therapy asset for geographic atrophy from Hemera Biosciences. Geographic atrophy is an advance and severe form of age-related macular degeneration (AMD) which affects five million people globally. Hemera’s investigational gene therapy, HMR59, is administered as a one-time intravitreal injection to aid vision preservation in patients with geographic atrophy. HMR59 is designed to increase the ability of retina cells to produce a soluble form of CD59, a protein that protects the retina from damage. Patients with wet AMD often have low levels of this protein, which is an essential component of the body’s natural immune response. “Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & ...
By Ludwig Burger FRANKFURT (Reuters) – Bayer <BAYGn.DE> agreed to acquire unlisted U.S. biotech firm Asklepios BioPharmaceutical Inc for as much as $4 billion in a bet on gene therapy with the help of modified viruses. Germany’s Bayer will pay $2 billion upfront and up to an additional $2 billion in milestone payments contingent on development achievements, it said on Monday. The North Carolina-based takeover target, also known as AskBio, is trying to use the harmless adeno-associated virus as a delivery device to bring genetic repair kits against a range of diseases into the body.Drugs and farming pesticides maker Bayer needs to upgrade its drug development pipeline amid a weaker outlook for agricultural sales and as it seeks to finalise an $11 billion settlement over claims its Roundup weedkiller causes cancer. Among AskBio’s most advanced projects are early tests on volunteers of prospective treatments against Pompe disease – a ...
Roche is paying more than $1 billion upfront for the ex-U.S. rights to Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy SRP-9001. The deal comes days after Roche advanced its push into gene therapies by closing the takeover of Spark Therapeutics. Sarepta has linked SRP-9001 to microdystrophin expression levels of up to 96% in early clinical tests, leading it to start a 24-patient placebo-controlled trial that is due to deliver data next year. Coupled to a safety profile that so far makes SRP-9001 look a better prospect than rival gene therapies from Pfizer and Solid Biosciences, the efficacy data have put Sarepta at the forefront of efforts to develop a one-shot treatment for DMD. That has attracted the attention of Roche. The Swiss drugmaker is set to pay $750 million in cash and $400 million in equity upfront for the ex-U.S. rights to SRP-9001. Sarepta is also in line to ...
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