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LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
LONDON – In the largest-ever series A for a Spanish biotech, Splicebio S.L. has raised €50 million (US$56.9 million) to apply its protein splicing technology to the delivery of large genes that do not fit into existing vectors. The company claims its approach will overcome the capacity constraints of adeno-associated viral vectors (AAVs), by splitting genes into parcels and reconstituting the proteins they express in vivo.
伦敦——曲线治疗有限公司直接去了from £4.5 million (US$6.1 million) in startup funding to signing a $1.7 billion drug discovery agreement with Merck & Co. Inc. The deal will see Curve apply its mammalian cell discovery technology to five oncology and neuroscience targets nominated by Merck.
LONDON – Neuromuscular disease specialist NMD Pharma A/S has raised €35 million (US$39.7 million) in a new financing, as it awaits initial data from its first clinical trial, in the treatment of myasthenia gravis. The new money enables NMD to complete that phase IIa study and to launch another trial of the same compound, NMD-670, in spinal muscular atrophy. The Aarhus, Denmark-based company is preparing the IND and aims to treat the first patient before the end of 2022.
The overwhelming focus of research into the cellular immune response to SARS-CoV-2 has been investigating the reaction of vaccinated people, in an effort to establish correlates of protection required to fight off infection. But with a majority in many African and Asian countries still unvaccinated, it also is important to understand the natural cellular immune response, and to track the emergence of SARS-CoV-2 variants with the potential to escape immunity in these populations.
LONDON – Orthox Ltd. is primed for an assault on the mountain that is knee cartilage repair after raising $12.5 million in a series A funding round. After more than a decade of translational and preclinical research, these funds will allow the company to start a trial of Fibrofix, a tissue regeneration product derived from silk, in the middle of this year. An initial cohort of six patients in the U.K. will be treated for sports injury-related cartilage damage, with six months follow up to demonstrate safety. Assuming positive results, that will be followed by treating a further 75 patients in the U.K., Hungary and elsewhere in mainland Europe.
LONDON – Three patients with complete spinal cord injury are able to walk independently after having specialized electrodes implanted below their lesions. The details were published inNature Medicineon Feb. 7. This is a significant new milestone for the researchers at École polytechnique fédérale de Lausanne (EPFL), Switzerland, who in 2018 delivered proof that electrical stimulation can reactivate spinal neurons, in that case in three patients with partial spinal cord injury. “Here for the first time, we have developed purpose-made technology in order to precisely stimulate the spinal cord to restore movement after paralysis,” said Gregoire Courtine, professor of spinal cord repair at EPFL.
LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published inNatureFeb. 2.
LONDON – Another month, another deal for antibody-drug conjugate (ADC) specialist Synaffix BV, which has sealed a $586 million, three-target agreement with Macrogenics Inc. No details of the targets or the indications were disclosed, but Synaffix CEO Peter van de Sande said this is “an important milestone” because it will be the first time the company’s linkers and payloads have been attached to a bispecific antibody.
LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published inNatureFeb. 2.
