The US company has also announced several funding milestones supporting the development of its therapeutics to prevent serious diarrheal diseases.
It says its drug development and manufacturing platform offers the potential to transform the biologics industry.
Lumen discovers, develops, and manufactures biologic drug candidates for highly prevalent diseases—many of which currently lack effective treatments.
Despite the challenging start to 2022 following the Russian invasion of Ukraine, waning investor sentiment in the biotech sector, and layoffs announced by other industry players, Lumen managed to do better than many when it came to financing last year, its chief executive, Brian Finrow, told us.
The company secured $36m in new funding in the second half of 2022, including major new research grants and equity.
The Seattle-based oral biologics innovator also built out a second GMP plant last year and doubled its lab space.
Coupled with that, the company has been expanding headcount, reporting growth across the clinical, GMP manufacturing, R&D, and quality teams.
“We face 2023 with tremendous optimism,” said Finrow.
Commercial pipeline
Lumen’s drug development environment is rapid and cost effective compared to other pharma players, he stressed.
“That, in turn, means that the non-dilutive grant funding we get from foundations and government agencies goes a lot further.
“On top of that grant funding and the business development financing, we have managed to run the company on a break-even basis. [That operational strategy] gives us the time to get some of our products approved and out there into the market, which is a much more stable way of funding an organization.”
Supporting that goal of marketplace entry, Lumen’s lead investigational commercial product, LMN-201, which is orally delivered and doesn’t require refrigerated distribution, has been cleared for a pivotal trial in 2023.
It is aimed at the prevention of C. difficile infection, which, potentially, has a very large commercial market behind it.
“We want to produce something that is cheap to make and scale with the idea that we can price it at a level that enables everyone to get access, regardless of how good their insurance is,” said Finrow, citing the high cost and challenges of IV administration linked to Merck’s Bezlotoxumab, a monoclonal antibody commercially available for the prevention of C. difficile infection recurrence.
LMN-201 combines four therapeutic proteins—manufactured and orally delivered in the edible microorganism spirulina—that are designed to work synergistically to neutralize both the C. difficile bacterium and the toxin that causes its virulence.
“By delivering the product to the gastrointestinal tract, we can get much more drug to where it can do its work.”
The US Food and Drug Administration (FDA) cleared Lumen’s IND application last year, supporting a Phase 2/3 multi-center, placebo-controlled trial to evaluate the efficacy of LMN-201 in preventing C. difficile recurrence.
In addition, Lumen completed a Phase 1 pharmacokinetics study in 2022, continued Finrow.
That validated drug delivery of enteric capsules into the gut. “That data came out beautifully, and we are preparing a manuscript on that now.”
The company also initiated preclinical development of an orally delivered biologic cocktail for the treatment of inflammatory bowel disease (IBD) - Crohn’s disease and ulcerative colitis - in 2022.
That program remains on track for initial regulatory filings by the end of 2023.
Charitable (ESG) clinical development pipeline
The scalability, low GMP COGS, and easy distributability of Lumen products make them applicable for a variety of neglected diseases, according to the CEO.
Where public research funding is available, Lumen is committed to opening its platform for these diseases.
Earlier this month, the developer announced that it had secured major funding for two additional mid-stage clinical trials in 2023 – the first is a $5m grant from the Bill & Melinda Gates Foundation for a second Phase 2 study of an improved anti-campylobacter therapeutic, LMN-101.
That randomized, double-blind, placebo-controlled study will evaluate LMN-101 at several dose levels in healthy volunteers challenged with Campylobacter jejuni CG8421.
The trial design is similar to the first Phase 2 trial of LMN-101 but with enhancements to shed light on the unexpectedly low placebo attack rate that made that earlier trial uninterpretable.
It also won a $4m award from the US Army Medical Research and Development Command (USAMRDC), operating through the Medical Technology Enterprise Consortium (MTEC), for further clinical evaluation of Lumen’s anti-campylobacter/anti-ETEC VHH cocktail product.
Building on foundational work at Lumen that was originally funded by CARB-X, the new funds will support clinical evaluation of a tablet form of the product; it is expected to have favorable cost and distribution characteristics compared to a capsule format that was tested in past trials.
The grant will also be used to further characterize the product’s gastrointestinal pharmacokinetics in study volunteers.
Moreover, CARB-X renewed its funding support with an additional award of up to $2.8m for lead optimization of an anti-campylobacter/anti-ETEC VHH cocktail to prevent serious diarrheal diseases.
Looking to other work backed by federal agencies, and in December last year, Lumen reported “strong” preclinical data from a Biomedical Advanced Research and Development Authority (BARDA)-supported effort to develop an intranasal formulation of its drug candidate, LMN-301.
This drug, produced in spirulina, contains an antibody cocktail for SARS-CoV-2, the virus that causes COVID-19. The program is on track to initiate human clinical trials in mid-2023, said Finrow.
