Alzinova establishes scaled-up manufacturing process for ALZ-101 ahead of Phase 2
Alzinova AB (publ) (“Alzinova” or “the Company”) announces today that the Company has successfully verified that the manufacturing process for vaccine doses of ALZ-101, the Company’s vaccine candidate against Alzheimer’s disease, can be scaled up to deliver larger production volumes required for clinical phase 2 trials.
Preparations for clinical phase 2 development are progressing successfully and the Company has now verified that the manufacturing process can produce larger volumes of Alzinova's Alzheimer's vaccine candidate ALZ-101. Earlier this year, Alzinova announced that it had already optimized the production of the active ingredient in the vaccine. Now, the Company has also validated that the manufacturing process for the drug can be scaled up for larger production volumes. The previous manufacturing process of the vaccine had a limit of about 1,100 vials, or doses, per clinical batch, while the limit of the improved process at the contracted manufacturer is now about 3,300 units per batch, with the possibility of even larger volumes at a drug manufacturer with higher capacity. This is an important step towards the long-term goal of being able to cost-effectively produce and offer a vaccine against Alzheimer's on the global market.
Anders Sandberg, Chief Scientific Officer at Alzinova, comments, “Optimising manufacturing is crucial to ensure that a pharmaceutical product can be produced cost-effectively, on time and with high quality. We are therefore pleased that we have been able to ensure that the manufacturing capacity of ALZ-101 and meet the requirements to enter into clinical phase 2 studies. A strategically important step in our plan to prepare the vaccine for clinical phase 2.”
During the third quarter of 2021, Alzinova initiated a clinical phase 1b study with the vaccine candidate ALZ-101, in patients with Alzheimer's disease. Research shows that the peptide "amyloid-beta", a type of protein that is found naturally in the brain, clumps together into toxic assemblies, so-called oligomers, in those who get Alzheimer's. The vaccine that Alzinova is now testing in a clinical phase 1b study, has been developed so that the body itself can produce antibodies which then will specifically target and neutralise these toxic assemblies. In this way, the antibodies produced by Alzinova's vaccine removes these toxins in the brain with the goal of stopping the course of the disease. Unlike other companies, Alzinova has already in pre-clinical studies, been able to identify and target these specific cell-killing protein assemblies without removing other assemblies in the brain. The goal is now for the clinical phase 1b study to be able to show safety and tolerability in patients. Topline data for the ongoing phase 1b study are expected to be presented during the second half of 2023.
For more information, please contact:
Kristina Torfgård, CEO
Tel. +46 708 46 79 75
E-mail: kristina.torfgard@alzinova.com
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company specialising 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 preclinical development, and the ambition is to expand the pipeline further. The company’s Certified Advisor on Nasdaq First North Growth Market is Corpura info@corpura.se +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com.