Milestone Achievement for Consortium Seeking Solutions Against AMR
NOSO-502, discovered by Nosopharm from a Xenorhabdus bacteria, is intended for the treatment of the main hospital-acquired infections caused by the multidrug-resistant Enterobacterales: Escherichia coli, Klebsiella pneumoniae and Enterobacter spp. Inhibiting the bacterial ribosome with a new mechanism of action, NOSO-502 was found to be active against the Carbapenem-Resistant Enterobacterales (CRE), regardless of the profi le of carbapenemase production, including polymyxin-resistant isolates. As these have been classifi ed by the World Health Organisation (WHO) as critical priority pathogens, the results of the GLP toxicology studies, combined with other results in clinical microbiology, effi cacy and pharmacokinetics/pharmacodynamics studies, enable preparation of a Clinical Trial Authorisation application, which if granted would see the entry of this candidate into fi rst-in-human clinical studies.
Philippe Villain-Guillot
The European-funded GNA NOW Consortium and Nosopharm, a biotechnology company exploring unconventional sources of antibiotics with potential in the fi ght against antimicrobial resistance, have announced a milestone development following completion and positive results of toxicology studies for a fi rst-in-class antibiotic for the treatment of multidrug-resistant infections.
“The results of these GLP toxicology studies are very encouraging. Combined with the other results acquired with the GNA NOW Consortium, they allow us to carry out further development of the program to Phase 1, provided we receive regulatory authorisation. This is an important milestone. These results demonstrate the quality and the innovativeness of NOSO-502, which has the potential to treat life-threatening multidrug-resistant infections,” said Philippe Villain-Guillot, co-founder and CEO of Nosopharm.
Established in 2019, the GNA NOW Consortium (Gram-Negative Antibacterials NOW), led by Evotec as a European Federation of Pharmaceutical Industries and Associations (EFPIA) representative,
is focused on addressing this gap in the AMR space by progressing new classes of Gram-negative antibiotics from lead optimisation to the completion of Phase 1 clinical trials.
Commenting on this milestone, Lynn Silver, an expert in antibacterial drug discovery and preclinical development, also a member of the general project review group for the Innovative Medicines Initiative (IMI) said: “The positive results of the NOSO-502 program demonstrate the importance of discovery and development partnerships like the GNA NOW Consortium. It proves that this kind of work can be done collaboratively by partners from academia, industry and big pharma. Together, it is possible to achieve positive results during the notoriously challenging early stages of antibiotic development.”
GNA NOW is a joint initiative of 11 partners from industry and academia, coordinated by Lygature, with the goal of developing novel antibacterial agents. The Consortium hopes to bring one of the three simultaneously developed compounds through completion of Phase I studies, with the aim of one compound reaching Investigational New Drug (IND) stage and/or up to two compounds reaching clinical development candidate stage, by 2024. The project received funding from the IMI 2 Joint Undertaking (JU) under grant agreement No 853979. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and the EFPIA.
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Queen’s Award Recognises Global Support for Life Sciences
A prestigious Queen’s Award for Enterprise (2022) presented in the International Trade category, has been awarded to sample management specialists Ziath Ltd, an exporter of scientifi c instruments contributing to furthering drug development and life sciences research worldwide.
UK Small Business Minister Paul Scully said: “This country is renowned for its entrepreneurial achievements and there is no greater showcase for it than The Queen’s Awards. It is vital we celebrate the success of our businesses and recognise the contributions they make to communities across the country.”
Steve Knight, Commercial Director of Ziath said: “We are incredibly pleased and excited to have gained this award, which is personally approved by Her Majesty, Queen Elizabeth the Second. From our
Cambridge, UK, base we export 85% of our production which helps us serve the major drug discovery and life science communities around the world. Our dedicated offi ces in Maastricht, San Diego, Boston and Tokyo, together with a global Distributor network are poised to support our wonderful customers in forensics, diagnostics, biobanking and pharma who have contributed so greatly to our success.
We will cherish this award and strive to produce even more innovative sample management products and software to ensure that Ziath customers always know exactly where their samples are stored.”
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Azhar Khan, Steve Coteman and Sabina Czyz with a Ziath Cube 2D bar code reader
Expanded Supply Line Options for Clinical Diagnostics Industry
Global life science industry critical materials supplier Biosynth Carbosynth has acquired Aalto Bio Reagents, a leading developer and provider of biological materials to the in-vitro diagnostic (IVD) and vaccine development industry in the fi eld of emerging disease.
Dr Urs Spitz, CEO and President of Staad-based Biosynth said: “This acquisition marks the next phase of our ambitious journey to become a leading global supplier and partner to the biopharma and diagnostics industries. It allows us to offer an expanded range of products to our IVD customers including complex biochemicals, peptides and biological materials. We are pleased to welcome Aalto and its employees and look forward to working with them to continue to grow our offering to the diagnostics industry.”
Philip Noone, CEO of Aalto, added: “We are delighted to be joining forces with Biosynth, a world-renowned supplier with a broad portfolio of critical products and services across biopharma and diagnostics. Aalto’s industry leading products and key focus on emerging disease are an excellent fi t with Biosynth’s product and we see huge opportunities for the platform to be at the forefront of developing new innovative products and supplying our customers with an even greater scale and diversity of products they need to solve the diseases of the future.”
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Rodolphe Clerval Patrick Mahieux
Clinical-stage biotech Coave Therapeutics focused on treatments for diseases of the eyes and central nervous system (CNS) is combining its expertise with that of contract development and manufacturing organisation ABL, a specialist in viruses for vaccine candidates, gene and cancer therapies, to co-develop manufacturing technologies for AAV-based gene therapy products.
Both companies will initially work together in ABL’s GMP facility in Lyon, France, with the second stage of the collaboration providing Coave with an option to secure its own process development capacity and laboratory space within ABL’s facility. This will enable the biotech to further develop and scale-up manufacturing
CDMO Provides Facilities Option for Integration Capability
technologies for AAV-based products, including its proprietary next- generation AAV-Ligand Conjugate vectors (ALIGATOR) platform.
“Our collaboration with ABL, a best-in-class and complementary partner for Coave, is a major step in our strategy towards the vertical integration of our R&D capacities, which will be crucial in enabling us to control the development and manufacture of our pipeline products in an end-to-end manner. The manufacturing processes developed through this partnership will be critical on the path to achieving our future clinical and commercial development milestones, in particular for our CNS programs addressing large patient populations,” said Rodolphe Clerval, CEO, Coave Therapeutics.
Patrick Mahieux, General Manager, ABL Europe, said: “We are delighted to join forces with Coave, a fellow French company. This exclusive partnership aims to bring together our knowledge and expertise to co-develop a state-of-the-art manufacturing process for viral vectors used in cell and gene therapies. We are excited to welcome Coave’s team of expert scientists to our facilities in Lyon to jointly accelerate the development of an AAV manufacturing platform. We look forward to a long-term partnership enabling the development and manufacturing of innovative cell and gene therapy treatments in France.”
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