Biose Industries takes pride in showcasing its partners and drawing attention to the fantastic work they are doing. We sat down with Alveolus Bio with whom we are working to bring their inhalable live biotherapeutic (LBP) to market. Read on to understand the challenges in developing an LBP for lung indications, the origins of Alveolus’ work, and their thoughts on choosing the right CDMO partner.
To start with could we get some background on Alveolus Bio?
Alveolus Bio is developing a first-of-its-kind inhaled live biotherapeutic, a little over a decade in the making. We’re a clinician-scientist led team that is trying to address neutrophilic inflammation in chronic lung disease, which in simple terms is severe and persistent inflammation.
We started as a university spin-out from the University of Alabama at Birmingham Heersink School of Medicine, which is renowned for its pulmonary research. Our founder, Dr. Vivek Lal, a physician scientist, studied the causative factors behind chronic lung inflammation and bacteria. His initial seminal findings, that of downregulation of neutrophilic inflammation by specific bacteria, encouraged him to further explore the involvement of bacteria in lung development, injury and health.
His line of research led to a collaboration with our Chief Medical Officer, Dr. Amit Gaggar. Dr. Gaggar is a renowned pulmonologist with a clinical and background in COPD and cystic fibrosis. Their work together implicated changes in bacteria populations in adult and pediatric lung diseases. When they dug into it, they found not only are certain bacteria types lacking, but neutrophilic inflammation and tissue damage was also running rampant. With Alveolus’ lead asset for COPD, we’re specifically targeting this neutrophilic inflammation present in the lungs.
How is Alveolus going about targeting neutrophilic inflammation?
Based off Dr. Lal’s work we identified a few different strains that are effective in reducing inflammation. This raised the question; how can you inhale them to reach distal parts of your lungs? We partnered with the folks who made inhalable biologics including inhalable insulin. We encapsulate the strains into a capsule, which you break and inhale using an off the shelf, FDA cleared inhaler. When inhaled, the bacteria produce anti-inflammatory metabolites and are then cleared by the lungs.
What advantages does approaching COPD using LBPs have over standard of care treatments?
The current standard of care for COPD includes steroids. These come with a whole host of side effects, especially with use over an extended period. Given the fact that we’re using natural, non-GMO bacteria, we don’t anticipate those steroid-like side effects. What we’ve found in a lot of the animal data is that our asset is performing just as well as the standard steroids, if not better, in significantly reducing a lot of these inflammatory biomarkers. We’re also seeing lung structure improving as well. Of course, human trials will be the real test, but it’s a step in the right direction.
What led to the decision to engage with the CDMO versus manufacturing in-house for your candidate?
As a start-up, the simple answer is we don’t have the capital funds to establish in-house manufacturing, especially at scale. More so we wanted work with somebody who has a track record in producing bacteria, somebody who is not doing it just for us, but also has for other companies. We realized that if we engage with a CDMO, not only will it be more cost favorable in getting to market, but we would also have the know-how and the resources to get us there faster.
And why, of all the CDMOs, did you engage with Biose Industrie?
Biose has a great reputation as far as producing Live Biotherapeutics that’s currently used in numerous clinical trials for microbiome companies, and we wanted to work with the best.
What advice would you give to other biotech’s selecting a partner with whom to develop their products?
You want to go with a company that has the know-how from a GMP standpoint and can reliably scale you up. Thinking ahead, you want to select a partner who is active and knowledgeable in that space too, to eventually have a successful pre-approval inspection for the BLA. I can’t stress that enough because companies can fail by picking the wrong partners. It’s incredibly important to pick somebody who has worked with companies through every stage of the approval process, even if it comes with a premium.
What is the biggest manufacturing challenge for your product?
One challenge is making our bacteria in a pathogen-free setting. I would say it’s also making it in quantity.
What is a highlight of collaborating with Biose Industrie on your candidates?
Biose knows how to work with bacteria. Not many CDMO’s want to introduce bacteria into their manufacturing operations. They have the expertise to really help us scale up and to make sure that we are a priority. They help us find ways to think outside of the box to reduce our overall costs or reduce our overall time to production.
What does the future hold for Alveolus? When do you expect to enter the clinic?
Alveolus is getting ready for prime time here. We are filing the IND in the next year and planning to enter into the clinic shortly after – it all depends on funding.
To find out more about the work Alveolus is doing please feel free to visit their website here.