Microbiotica, a biopharma company developing a pipeline of
orally-delivered precision microbiome medicines called live
biotherapeutic products (LBPs), announces that Adam Wilkinson, its
Vice President of Pre-Clinical Development, will present an
overview of the company’s successful product manufacturing
campaigns ahead of its forthcoming melanoma and ulcerative colitis
clinical studies at the 9th Microbiome Movement Drug Development
Summit, on 11 July, in Boston, USA, together with Claire Derlot,
CBO from its GMP manufacturing partner Biose Industrie.
Microbiotica is a leading company developing
LBPs based on the gut microbiome. Its lead programs, MB097 for
advanced melanoma and MB310 for ulcerative colitis, are on track to
enter clinical studies this year. In preparation, to scale
processes for the production of cGMP-compliant clinical trial
batches, Microbiotica entered into a manufacturing contract with
Biose Industrie, a world-leading CDMO for microbiome
therapeutics.
Each of Microbiotica’s LBPs comprise defined
consortia of multiple bacterial strains, identified using its
precision microbiome discovery platform which analyses the gut
microbiome composition of patients and identifies bacterial species
associated with clinical response. Manufacturing processes are
developed for each individual bacterium, resulting in the
production of freeze-dried stable powders which are combined into
bespoke capsules for oral dosing.
Microbiotica has established expertise in the
isolation and culturing of novel bacteria from the human gut
microbiome, which it has leveraged, together with GMP manufacturing
partner Biose, in the development of robust GMP manufacturing
processes to produce batches for their multi-strain LBPs. Biose has
provided its knowledge and experience in the industrialisation of
bacterial manufacturing processes to scale-up the growth of these
therapeutic bacteria, preserving them in stable freeze-dried state.
GMP manufacturing processes for both programs have been developed
at Biose.
“Working in partnership with the Biose team, we
are delighted to have successfully navigated the challenges of
process development and scale-up of two LBPs in parallel.
Manufacturing of biologics can be challenging at the best of times,
but the development of multiple processes to be scaled up to cGMP
standard poses significant challenges, and seamless open
collaboration between our project teams has been essential to
success,” said Adam Wilkinson, Vice President of
Pre-Clinical Development at Microbiotica.
Tim Sharpington, Microbiotica’s CEO,
added, “Adam and his team, together with the Biose team,
have done an amazing job to ensure that we are ready to start both
of our clinical trials in the second half of this year. These
first-in-patient trials will be a major milestone for the
company.”
Microbiotica has a clinic-led, purpose-built,
proprietary, microbiome profiling platform to support drug
discovery based on clinical data, which enables precision
identification of bacteria associated with favourable clinical
trial outcomes in specific patient populations. The company has
significant expertise in microbiology, bioinformatics,
translational biology and LBP manufacturing and development.
Details of the presentation
Event: 9th Microbiome Movement Drug Development
Summit
Date: Thursday 11 July
Time: 09.00-09.30
Place: Boston, USA
Session: Bringing the Cutting-Edge from the
Clinic: Redefining Standards in Disease Management
Title: “Microbiotica & Biose Industrie:
Developing & Manufacturing Two multi-strain Live Biotherapeutic
Products for Clinical Studies”
Speakers: Adam Wilkinson, Vice President of
Pre-Clinical Development, Microbiotica, and Claire Derlot, Chief
Business Officer, Biose Industrie
About Microbiotica
Microbiotica is a private, clinic-ready,
biopharma company developing a pipeline of oral precision
microbiome medicines called live biotherapeutic products (LBPs)
with lead programs in immuno-oncology and inflammatory bowel
disease (IBD).
The Company has a clinic-led, purpose-built,
proprietary, microbiome profiling platform to enable precise
identification of bacteria associated with favourable clinical
trial outcomes in specific patient populations. The company has
significant expertise in microbiology, bioinformatics,
translational biology and LBP manufacturing and
development.
Microbiotica is creating a novel pipeline of
programs in immuno-oncology (MB097 for advanced melanoma), and
inflammatory bowel disease (MB310 for ulcerative colitis), both of
which have data read-outs in 2025.
- The company has a supply agreement
with MSD (Merck & Co., Inc., Rahway, NJ, USA) for use of
KEYTRUDA® in evaluating MB097 in melanoma patients with primary
resistance to anti-PD-1 immunotherapy.
- MB310 was developed in collaboration
with the University of Adelaide.
Microbiotica also has a major partnership with
Cancer Research UK and Cambridge University Hospitals in
immuno-oncology.
Spun out of the Wellcome Sanger Institute in
2016, the Company is based in purpose-built facilities at the
Chesterford Research Park near Cambridge, UK.
Microbiotica has raised £62M equity investment,
including a £50 M Series B in 2022, with venture investors
including British Patient Capital, Cambridge Innovation Capital,
Flerie Invest, IP Group plc, Seventure Partners and Tencent. The
company has also received financial support from the US-based
Crohn’s and Colitis Foundation.
For more information, please
visit www.microbiotica.com, and follow us on
LinkedIn.
Media contacts
Microbiotica
Ro Gardner, rgardner@microbiotica.com, +44 7801
480569
Scius Communications
Sue Charles, sue@sciuscommunications.com, +44
7968726585Katja Stout, katja@sciuscommunications.com, +44
7789435990Daniel Gooch, daniel@sciuscommunications.com, +44
7747875479