Pharmaceutical Market Europe • May 2024 • 8-9
NEWS
AI drug discovery biotech Xaira Therapeutics launches with $1bn funding
Xaira Therapeutics, a new biotech aiming to “re-engineer” drug discovery and development using artificial intelligence, has launched with more than $1bn in committed funding.
The US-based company was jointly incubated by ARCH Venture Partners and Foresite Labs, and co-founded by David Baker, professor of biochemistry and director of the Institute for Protein Design at the University of Washington School of Medicine.
It will combine machine learning, data generation and therapeutic product development to help “transform” the drug discovery and development process and provide more effective therapies to patients faster.
Xaira employs a group of researchers who developed models for protein and antibody design, RFdiffusion and RFantibody, in Baker’s lab, with the company’s broader team now set to advance these models and develop new methods that can “connect the world of biological targets and engineered molecules to the human experience of disease”.
It is led by Marc Tessier-Lavigne, former chief scientific officer of Genentech, with the executive team also comprising co-founder Hetu Kamisetty, previously of Meta and the Institute for Protein Design, as well as former Genentech executives Arvind Rajpal and Don Kirkpatrick.
Novartis’ blood cancer therapy Kymriah recommended by NICE for routine NHS use
The National Institute for Health and Care Excellence has recommended that Novartis’ personalised immunotherapy, Kymriah (tisagenlecleucel), be made routinely available on the NHS to treat children and young adults with a form of leukaemia.
The recommendation means that an estimated 40 children and young adults will become eligible for the new treatment in England.
The new draft guidance recommends the CAR-T therapy for children and young adults aged 25 years and under with B-cell acute lymphoblastic leukaemia who have not responded to treatment, relapsed after a stem-cell transplant, or relapsed for a second time or later.
Administered as a one-off infusion into the bloodstream, Novartis’ CAR-T therapy works by taking a patient’s own immune cells and modifying them so that they attach to and eliminate cancer cells.
Since December 2018, Kymriah has been available within the NHS’ Cancer Drugs Fund, which has allowed people to have access to the treatment on the NHS while collecting efficacy data.
The data revealed that the 24-month overall survival was 72% following treatment, improving overall survival for people compared with standard treatment without experiencing disease recurrence or progression.
Merck’s adult-specific pneumococcal vaccine shows promise in late-stage study
Merck & Co – known as MSD outside the US and Canada – has announced positive results from a late-stage study of its investigational, adult-specific 21-valent pneumococcal conjugate vaccine.
Merck’s V116 is specifically designed to address the strains of Streptococcus pneumoniae that are responsible for the majority of adult pneumococcal disease, including eight strains that account for approximately 30% of adult disease but are not included in any currently approved pneumococcal vaccine.
The phase 3 STRIDE-10 trial has been comparing V116 against PPSV23 in adults aged 50 years and older who had not previously received a pneumococcal vaccine.
According to results from the study presented at this year’s European Society of Clinical Microbiology and Infectious Diseases, V116 elicited immune responses that were non-inferior to PPSV23 for the 12 strains common to both vaccines, as measured by serotype-specific opsonophagocytic activity geometric mean titres at day 30.
Merck’s vaccine also induced superior immune responses for its nine unique strains on the same measure, and superior immune responses for eight of these, as measured by the proportions of participants with at least a four-fold rise in immune responses.
AstraZeneca begins global withdrawal of COVID-19 vaccine following decline in demand
AstraZeneca (AZ) has begun the global withdrawal of its COVID-19 vaccine, citing a “surplus” of vaccines that have been updated to target new variants of the virus.
The company said in a statement that this has led to a decline in demand for the vaccine, Vaxzevria, which is no longer being manufactured or supplied.
According to the Telegraph, AZ’s application to voluntarily withdraw its European marketing authorisation was made on 5 March and came into effect on 7 May.
Similar applications in the UK and other countries where the vaccine holds approvals will be made in the coming months, the Telegraph noted.
AZ said: “We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the COVID-19 pandemic.”
The withdrawal comes just months after the Telegraph reported that AZ had admitted in court documents that the vaccine can, in “very rare” cases, cause thrombosis with thrombocytopenia syndrome.
The company outlined in its recent statement that the withdrawal of Vaxzevria was made for commercial reasons.
European Parliament approves pharma reform compromise for equal access to new medicines
The European Parliament has voted through the pharmaceutical reforms as legislation, despite the industry previously claiming that they could compromise competitiveness and patient care.
The European Parliament has said that the file will be finalised after the European elections in June 2024.
The new directive and regulation, which include a reduction in the minimum regulatory data protection period for new medicines, will be set to seven and a half years, with a further two years of market exclusivity, during which generic or biosimilar products cannot be sold.
Drug developers will be able to extend this to a maximum of eight and a half years if new therapies address an unmet medical need, are tested in comparative clinical trials or have research and development carried out within the EU.
For orphan drugs for rare diseases, drug developers could benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
The proposal has previously proved controversial, with members of the European Parliament divided over how best to achieve improved patient access while encouraging innovation.
WHO reveals ‘extensive’ worldwide overuse of antibiotics during COVID-19 pandemic
The World Health Organization (WHO) has revealed the “extensive” worldwide overuse of antibiotics in hospitalised patients during the COVID-19 pandemic, which could have contributed to the spread of antimicrobial resistance (AMR).
WHO used a repository of standardised individual-level anonymised clinical data from around 450,000 patients hospitalised with COVID-19 in 65 countries between January 2020 and March 2023.
WHO classifies antibiotics as per the access, watch and reserve classification in accordance with the risk of AMR. The report revealed that ‘watch’ antibiotics with higher resistance potential were most frequently prescribed globally.
The report revealed that while 8% of hospitalised COVID-19 patients had bacterial co-infections requiring antibiotics, 75% were treated with antibiotics ‘just in case’ they helped.
Antibiotic use ranged from 33% in patients in the Western Pacific region, to 83% in those from the Eastern Mediterranean and the African regions.
The highest rate of antibiotic use was seen in patients with severe or critical COVID-19, with a global average of 81%. There was a considerable variation across regions for mild or moderate cases, with the highest use in the African region at 79%.