The partnership will help advance the development of drugs aimed at treating the underlying cause of uncontrolled inflammation in autoimmune diseases
Alma Bio Therapeutics SAS (Alma) and Delphi Genetics SA are intending to use the strategic alliance to take the development of plasmid DNA drugs to the next level.
Alma focuses on developing therapies to cure autoimmune diseases. It is tackling Crohn’s disease, one of the two major types of Inflammatory Bowel Disease (IBD), as its first clinical application.
Currently prescribed IBD treatments aim to manage disease symptoms, they suppress inflammation and extend intervals between flare-ups, improving the patients’ quality of life.
Alma’s treatments go beyond the symptoms, treating the underlying cause of autoimmune disease without suppressing the function of the immune system.
Alma and Delphi Genetics have been collaborating since 2014 on generating a plasmid DNA drug for Alma’s preclinical efficacy studies.
Under the terms of this alliance, Delphi Genetics will produce the plasmid DNA drugs needed to advance Alma’s pipeline and complete the regulatory studies necessary to submit an Investigational New Drug (IND).
Binah Baum, CEO of Alma, said: “Delphi Genetics is an ideal partner. It has scientific excellence, high quality bioproduction services and an established track record with big pharma.
We are delighted with the strong vote of confidence its management has given our game changing therapeutic approach to treating autoimmune diseases. With their expertise, we believe our programme to demonstrate safety and efficacy of our therapies in patients should move rapidly.
Alma’s pipeline consists of a product family of plasmids DNA encoding Heat Shock Proteins. HSPs are body molecules that serve as self-antigens to regulatory T-cells; they have been shown to possess pro-resolution activity.
Pro-resolution therapies are sought after in autoimmune disease treatments due to their ability to restore the delicate balance between healthy cells (regulatory T-cells) and the rogue cells (pro-inflammatory effector T-cells) the immune system is designed to eliminate.
Activating the immune system to better regulate itself would mark a significant improvement over the way autoimmune diseases are currently treated.
Alma’s first target is Crohn’s disease, a chronic debilitating autoimmune disease of the gastrointestinal tract and one of the two subtypes of IBD. IBD affects an estimated 3.5 million people in the US and Europe. Its prevalence is rising on every continent.1
A second target is rheumatoid arthritis, affecting an estimated 1% of all Caucasians (totalling roughly 7 million people across North America, North Africa and Europe).2
This partnership places Alma in a stronger position to attract longer term investment with the aim of preparing entry into a phase 1 clinical trial for Crohn’s disease in H2 2018. It gains access to Delphi Genetics’ bioproduction manufacturing capabilities, including Staby, its antibiotic-free plasmid DNA production technology.
Cédric Szpirer, Executive and Scientific Director at Delphi Genetics, said: “Having received validation of our technologies by several big pharmaceutical companies for protein production, this partnership with Alma will be an additional milestone for Delphi Genetics.
“It advances our Staby technologies in clinical phases to produce plasmid DNA in GMP grade according to regulatory guidelines. We are one of a very few manufacturers able to produce plasmid DNA and recombinant proteins without antibiotics and antibiotic resistance genes. We achieve this at higher yields than classic bioproduction.”
Marc Dechamps, Managing Director of Delphi Genetics, said: “Our partnership with Alma Bio Therapeutics represents an important next step in Delphi Genetics’ development and strategic direction. It allows us to accelerate our development as a key player in Europe for the bioproduction of plasmid DNA for human use. It also strengthens the company’s dimension as a credible partner for companies involved in developing gene therapies and DNA vaccines.”
1. Gilaad G. Kaplan, "The global burden of IBD: from 2015 to 2025," Nature Reviews Gastroenterology & Hepatology 12, 720-727 (2015).
2. S.E. Gabriel and C.S. Crowson, "Epidemiology of, risk factors for, and possible causes of rheumatoid arthritis," UpToDate, www.uptodate.com/contents/epidemiology-of-risk-factors-for-and-possible-causes-of-rheumatoid-arthritis