Quay Pharma is taking on the formulation, development and clinical manufacture of a targeted release formulation containing lyophilized microbial cells suitable for phase one clinical trials.
The drug substance is being supplied by Australia-based Luina Bio.
Established last year, Liveome, a subsidiary of Medytox, is a company specializing in the development of next-generation new drugs. It has two live biotherapeutic product (LBP)-related technologies – N-LBP, a natural microbiome-based platform technology, and E-LBP, which maximizes gene-editing treatment efficacy.
Liveome says it is rapidly expanding its new drug pipeline for intractable diseases based on the two platforms. LIV001 is a candidate for the treatment of inflammatory bowel disease (IBD), which has applied Liveome’s E-LBP platform technology. The drug has been designed to have maximized therapeutic efficacy by regulating immune function to ensure safety as a therapeutic agent, it explained.
The Korean frim recently confirmed the therapeutic efficacy of LIV001 for acute and chronic enteritis in a preclinical trial.
“Starting with these CDMO contracts for LIV001, we plan to build a cell bank, develop a production process and produce clinical samples,” commented Liveome CEO Song Ji-yoon. “We aim to complete a nonclinical toxicity test this year and start a global clinical trial by 2023.”
SGS said Quay Pharma was selected for the project because of its "proven expertise" in the product development and clinical supply of therapies derived from the microbiome.
Its manufacturing facilities in Deeside, UK include a suite of laboratories with a compartmentalized design to containment level 2, enabling it to work on a variety of projects and different microbes simultaneously.
Swiss group, SGS, only acquired that UK-based CDMO back in December 2021.
Quay Pharma CEO, Maireadh Pedersen, said back then, that as part of SGS, the CDMO would be able to accelerate its growth strategy and further develop its range of services, with the introduction of additional capabilities such as biopharmaceutical analysis and specialist microbiological capabilities.
“At the same time, we will retain our existing management and dedicated specialist teams to ensure we continue to offer our clients the highest levels of service, expertise and technical focus.”
In particular, said the parties, the deal would enhance the continuing development of Quay's “pioneering” work in LPBs.
The SGS subsidiary, which works with both small and large molecules, claims it has built a strong reputation for the formulation development and clinical manufacture of unusual and difficult to handle drug substances.
In terms of live biotherapies, the CDMO claims capabilities in formulation development across many delivery routes, along with an understanding of isolation and containment techniques to protect the environment during the manufacturing process. “In particular, we have introduced procedures to effectively handle many types of microbes during the development and manufacture of drug products in order to maintain their potency.”