May 2023 • PharmaTimes Magazine • 9
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Moderna cancer vaccine takes positive step
Moderna has announced that mRNA-4157/V940 – its investigational cancer vaccine – in combination with Keytruda, Merck's anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA).
It concerns the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The vaccine mRNA-4157/V940 stimulates an immune response by generating specific T-cell responses based on the unique mutational signature of a patient's tumour.
The EMA awarded the PRIME scheme designation following positive data emerging from the phase 2b KEYNOTE-942/mRNA-4157-P201 clinical trial. The results from this research were shared at the American Association for Cancer Research in mid-April.
PRIME is a regulatory system run by the EMA that provides support for the development of medicines that target unmet medical needs. Through PRIME, the EMA offers proactive and early support to help enhance the generation of data on a drug’s benefits and risks, while accelerating the development and evaluation of applications.
Meanwhile, the companies are continuing to analyse the results of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial with regulatory authorities with a view to initiating a phase 3 study later this year.
The aim is to expand the therapy to additional tumour types, including non-small cell lung cancer.
Biomodal releases genetics and epigenetics solution
Biomodal has launched a new ‘duet multiomics’ solution, which reveals both genetic and epigenetic data from a single, low volume sample.
The company – formerly known as Cambridge Epigenetix – releases the dual-action solution as the world’s first single-base-resolution sequencing technology with one workflow. In addition, it can involve the use of any sequencer.
Furthermore, the product delivers more epigenetic information from a single low-input DNA library without medical treatment or resource-intensive bioinformatics. Meanwhile, it also provides a more thorough assessment of information stored in genomes, yielding new insights from biomedicine applications.
Indeed, by incorporating cell-free DNA through liquid biopsy, duet multiomics can at once detect powerful genetic and methylation biomarkers in an individual’s blood, providing unique disease analysis in the process.
Notably, the use of liquid biopsy in oncology, to profile circulating tumour DNA in blood, is a promising, minimally invasive approach for early cancer detection and minimal residual disease monitoring.
Professor Sarah-Jane Dawson, clinician-scientist at the Peter MacCallum Cancer Centre, reflected: “We gain new insight when measuring the interaction of genetics and epigenetics on the same read, allowing us to better understand the biology behind disease development and treatment responses.”
She added: “We look forward to progressing our research with this technology and affecting a paradigm shift in the way that cancer can be treated and monitored in the clinic.”
HOT & NOT
A malaria vaccine – R21/Matrix-M – developed by the University of Oxford and Serum Institute of India PvT Ltd (SIIPL) has been licensed for use in Ghana by its Food and Drugs Authority.
The vaccine, which leverages adjuvant technology from Novavax, and is manufactured by SIIPL, has been awarded national licensure for use across Ghana.
It becomes the first clearance for R21/Matrix-M malaria vaccine for use in any specific country.
Adcendo – a company that concentrates on the development of breakthrough antibody-drug conjugates (ADCs) for treating cancers with high unmet medical needs – has revealed that it has successfully completed vital funding.
The series A extension financing raised a further €31m, following the €51m series round two years ago. Funds will be used to ensure the broad pan-sarcoma development of lead ADC candidate uPARAP and further progress a second ADC asset.
Avacta – a company developing targeted oncology drugs and diagnostics – has announced that the first individual has been dosed with its AVA6000 candidate.
The patient was among the fifth cohort of the first-in-human phase 1 trial involving the therapy. It comes after the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency, which allows higher levels of dosing.
Immutep – a company concentrating on novel LAG-3 immunotherapies for cancer and autoimmune conditions – has announced the beginning of an open-label phase 2 trial researching eftilagimod alpha.
The therapy is a soluble LAG-3 protein and MHC Class 2 agonist used in tandem with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma patients within the pre-surgery setting.
Ipsen has expressed its disappointment regarding the National Institute for Health and Care Excellence’s preliminary guidance, which does not recommend Cabometyx – also known as cabozantinib.
The treatment involves patients with previously treated differentiated thyroid cancer (DTC), which is unsuitable for radioactive iodine and has progressed after systemic treatment. The outlook remains good for most DTC patients, but there are a few patients with advanced disease where radioiodine does not work, who then require chemotherapy treatment.
With nurses, their unions and the government unable to reach an agreement on pay and working conditions, further strikes are planned. There is even a suggestion that, unless a compromise or deal is struck imminently, the industrial action could continue until – or even after – Christmas.
Ministers have warned that more strikes are unsustainable and the increased pressure could lead to the collapse of the NHS.