BioNTech has dosed the first participant in a Phase 1 trial for BNT163, a herpes simplex virus (HSV) vaccine candidate for HSV-2 and potentially HSV-1.
Replay, the genome writing company formed in July, has launched its third product company, Kaleibe, which will use HSV gene therapy to target genetic brain disorders.
GSK and genetic medicines company, Wave Life Sciences, have announced a strategic collaboration to advance oligonucleotide therapeutics across multiple disease areas.
Calidi Biotherapeutics, a clinical-stage biotech developing allogeneic stem cell-based platforms for oncolytic virus immunotherapies, has been awarded a $3.1m grant from the California Institute for Regenerative Medicine (CIRM).
Annogen has begun a research project with Pfizer to functionally test tens of thousands of disease-related non-coding sequence variants for their effect on gene regulation.
ExPLoRNA Therapeutics, a Polish biotech developing mRNA vaccines and therapeutics with improved translational efficiency, has received funding from the Bill & Melinda Gates Foundation to further develop its mRNA technology.
Emmes has announced the creation of a dedicated center for cell and gene therapy research: which will focus on supporting clinical trials for the Clinical Research Organization’s (CRO) clients.
The US Food and Drug Administration (FDA) has accepted Pfizer’s RSV vaccine Biologics License Application (BLA) for priority review: with a decision expected in May.
Rani Therapeutics, which is aiming to orally deliver the osteoporosis drug, PTH, for the first time, has shared positive clinical data from part two of its Phase 1 trial for RT-102, its RaniPill capsule.
Intravacc has enrolled the first participant in a phase I first in-human clinical trial of Avacc 10, the company’s SARS-CoV-2 intranasal subunit vaccine, as a booster shot.
Infinimmune, a biotech pioneering new methods for antibody drug discovery and development, has closed a $12 million seed round: helping it develop its R&D capabilities.
Vaxxas has completed a financing round which raised US$23m (A$34m) in new funds: allowing the company to progress multiple vaccine programs in the clinic and ramp up manufacturing capabilities towards commercial scale.
The phase 3 trial results for lecanemab and gantenerumab presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference demonstrate why optimal treatment of Alzheimer’s will require drugs that do more than clear amyloid plaques, says the Alzheimer’s...
BigHat Biosciences, a US biotech with a machine learning-guided antibody discovery and development platform, has announced a collaboration with Merck to apply its technology to design candidates for up to three drug discovery programs.
A new experimental mRNA-based vaccine could give a baseline level of immune memory against diverse flu strains: and thus might serve one day as a general preventative measure against future flu pandemics, according to researchers.
A new biotech incubator, which will be located at CSL’s new Global Headquarters in Melbourne, Australia, is welcoming expressions of interest ahead of its 2024 launch.
Blue Water Vaccines has signed an exclusive, global license agreement for the development of a live attenuated, oral Chlamydia vaccine candidate from The University of Texas Health San Antonio.
GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.
A Phase 3 trial for Northwest Biotherapeutics’s DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.
NextCure and LegoChem Biosciences have announced a collaboration and co-development agreement focused on generating a B7-H4 antibody drug conjugate (ADC) and options for two additional targets.
EncOVac, a consortium led by Poolbeg Pharma, has been awarded €2.3m ($2.37m) in non-dilutive grant funding to progress its Oral Vaccine Platform under the Irish Government’s Disruptive Technologies Innovation Fund (‘DTIF’).
Gene therapy company Kriya Therapeutics is acquiring Redpin Therapeutics, a privately held biotech developing regulatable gene therapies for intractable diseases of the nervous system.
The US Food and Drug Administration (FDA) has approved Provention Bio’s Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes: with the American Diabetes Association welcoming it as a 'tremendous accomplishment'.
Roche announced yesterday that Phase 3 studies for its Alzheimer’s drug gantenerumab failed to meet the primary endpoint of slowing clinical decline. Although disappointed, Alzheimer’s associations are hopeful there is still a lot that can be learned...
Apollo Therapeutics and The Institute of Cancer Research in London have entered into a strategic collaboration to discover and develop new cancer medicines.
Cue Biopharma has released positive data at SITC 2022 from its ongoing Phase 1 trial evaluating its lead interleukin 2 (IL-2)-based biologic, CUE-101, in combination with KEYTRUDA, as a first line therapy for patients with recurrent/metastatic HPV+ head...
EdiGene Biotechnology USA has moved into a new Research & Development Center in Waltham, Mass. to advance its proprietary LEAPER tech into in vivo RNA editing therapies: with an initial focus on ophthalmology and the central nervous system.
Sanofi and Insilico Medicine have announced a multi-year, multi-target strategic research collaboration: leveraging Insilico’s ‘Pharma.AI’ platform to advance drug development for up to six new targets.
Chameleon Biosciences, a Berkeley-based biotech aiming to enable safer and more effective gene therapies, has won the Immunomodulatory Solution of the Year in the Biotech Breakthrough Awards, run by the Tech Breakthrough organization.
One dose of an antibody drug protected from malaria infection during the malaria season in Mali, showing up to 88% effectiveness: demonstrating for the first time that a monoclonal antibody can prevent malaria in an endemic region.
BioNTech is set to take several mRNA candidates into clinical trials over the coming months: including vaccines for shingles, malaria and tuberculosis.
Sensorion, a biotech specializing in therapies for hearing loss disorders, has been granted Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for its lead gene therapy candidate, OTOF-GT.
Harro Höfliger and leon-nanodrugs GmbH (LEON) are teaming up on a manufacturing device to encapsulate mRNAs or active pharmaceutical ingredients (APIs) into lipid nanoparticles (LNPs).
IGM Biosciences is teaming up with ADC Therapeutics on a clinical trial collaboration and supply agreement to assess the combination of an IgM antibody and an ADC for the treatment of patients with relapsed/refractory (R/R) B cell non-Hodgkin’s lymphoma...
CSL Limited has entered into a collaboration and license agreement with Arcturus Therapeutics Holdings to access its late stage, next-generation self-amplifying mRNA (sa-mRNA) vaccine tech: prepared to spend more than $4bn on the deal to accelerate its...
Lonza is to increase the size of the cell and gene therapy (CGT) development space at its Houston facility; the expansion will include viral vector-based process development and analytical development laboratories.
CPhI Frankfurt takes place next week: covering the full supply chain from research and manufacturing to packaging and finished products. Here’s five ideas on how to make the most of the event.
A ‘significant shift’ is under way in global outsourcing strategies: with the sector moving away from phase-appropriate development in favor of a more forward-looking model – with experts advising starting the search for an outsourcing partner as early...
Acumen Pharmaceuticals believes ACU193 – the first clinical-stage monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers (AβO) – offers the promise of an effective treatment with a better safety profile than other Alzheimer's...
London investment fund Syncona will acquire retinal gene therapy company Applied Genetic Technologies Corporation (AGTC): with AGTC noting it had been facing ‘significant challenges’ in funding operations beyond 2022.
