Alzinova improves manufacturing process of ALZ-101 to meet phase 2 requirementsDate: 2022-03-30
Alzinova AB (publ) (FN STO: ALZ), a Swedish biopharma company developing disease-modifying treatments for Alzheimer’s, today announces that the manufacturing process for its oligomer-specific vaccine, ALZ-101, has been further improved to facilitate large-scale production.
Alzinova’s drug substance manufacturing partner, Bachem (Bubendorf, Switzerland), has optimised the manufacturing process of the active ingredient in ALZ-101 – a vaccine in clinical development for the treatment of Alzheimer’s disease. Process optimisations have resulted in a more efficient and scalable manufacturing process enabling supply of ALZ-101 in the amounts required for phase 2 clinical trials. Furthermore, a more robust manufacturing process was obtained, which is beneficial for future reliable, cost-effective and GMP (Good Manufacturing Practice) compliant manufacturing.
“We are very pleased to have reached this important milestone, which is part of making the therapeutic vaccine, ALZ-101, phase 2-ready and more attractive to potential partners,” says Kristina Torfgård, CEO of Alzinova AB.
In the third quarter of 2021, Alzinova initiated a phase 1b clinical study with ALZ-101, in patients with Alzheimer’s disease. The vaccine is developed to specifically target the neurotoxic soluble forms of amyloid-beta42, i.e. oligomers. Oligomers are considered to be a key factor in the development of Alzheimer´s disease. Top line data for the study is anticipated in the second half of 2023.
For more information, please contact:
Kristina Torfgård, CEO
Tel. +46 708 46 79 75
The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CEST on March 30, 2022.
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer’s disease targeting neurotoxic amyloid beta oligomers. The lead candidate, ALZ-101, is being developed as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova’s proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that target the toxic amyloid beta oligomers involved in the onset and progression of the disease with high precision. Alzheimer’s is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201 is in early preclinical development, and the ambition is to expand the pipeline further. The company’s Certified Advisor on Nasdaq First North Growth Market is Corpura email@example.com +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com