3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, and the American biotech company, Zhittya Genesis Medicine (Zhittya), have successfully accomplished a tech transfer.
3P and Zhittya began their relationship at the beginning of 2019 with 3P being selected as the CDMO to transfer the process for scaling up and performing cGMP manufacturing for clinical studies.
After successfully achieving the transfer of the process, 3P anticipates manufacturing of the first cGMP batch by the second quarter of 2020.
The candidate protein selected by Zhittya is human FGF-1, which is a growth factor involved in stimulating new blood vessel growth (angiogenesis) and new neuron growth (neurogenesis). These properties make FGF-1 an excellent therapeutic candidate for treating neurodegenerative diseases, such as Parkinson’s disease, Zhittya’s lead drug development program. Phase I clinical trials are being planned for this indication in the US, Mexico and Europe.
Recent research from several medical centers has indicated that a number of neurodegenerative diseases, including Parkinson’s disease, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS), are initiated by vascular dysfunction in the brain leading to defective blood perfusion and loss of neurons in selected regions of the brain.
Due to the stimulating effects of FGF-1 on cell division, it could represent a promising candidate for improving vascular and neuronal regeneration, thereby preventing or improving the devastating symptoms seen in these neurodegenerative diseases. Importantly, this novel therapeutic strategy has the potential to deliver an excellent solution to patients suffering from medical conditions that currently have no cures.
Dámaso Molero, 3P Biopharmaceuticals CEO, explained: “it is a pleasure to work with Zhittya and be part of a project whose goal is to obtain a candidate capable of alleviating neurodegenerative diseases through regenerative medicine“. In addition, Molero added that “this collaboration demonstrates the experience and knowledge that 3P provides as a partner to develop complex and stimulating projects, even those starting at the tech transfer phase.”
Dr Jack Jacobs, President and Chief Science Officer at Zhittya, explains “we are very pleased to partner with 3P Biopharmaceuticals to produce high-quality biological products that can be tested in patients with severe, life-threatening diseases. We look forward to working with 3P on our clinical development projects which hopefully will also include the future commercial production of our drug candidates.”
This partnership once again demonstrates the knowledge and capacity of 3P to carry out process development and manufacturing that is adapted to the needs of each client using mammalian and/or microbial systems. Furthermore, this collaboration supports 3P´s strategic goal to further expand its presence in the US market.