San Diego, June 12, 2019.

Alpine BioTherapeutics Corporation and Allele Biotechnology and Pharmaceuticals, Inc. entered into a research agreement for developing iPSC-derived cell therapy for treating retinal diseases. Both companies are based in San Diego, California.

Alpine BioTherapeutics has developed a patented stem cell differentiation technique to robustly generate human retinal stem cells from pluripotent stem cells.  Alpine’s cell therapy products will be used to treat blindness caused by Retinitis Pigmentosa, Stargardt Disease, and dry age-related macular degeneration (AMD) etc. The technique is the most efficient known process in the manufactured retinal cell category by far and is expected to yield the highest quality retinal cell in the industry. This translates into much lower variability and cost while also minimizing regulatory risk.  

iPSCs (induced pluripotent stem cells) have the potential to differentiate into all human tissue types and play an increasingly important role in regenerative medicine. Approximately a dozen clinical trials using iPSCs are currently underway around the globe.

Allele Biotechnology has been developing technologies to produce GMP grade human iPSCs and high-quality tissue-specific cells derived from them for 10 years. Allele’s core capabilities in this area include its proprietary and patented technologies utilizing mRNA for generation and differentiation of footprint-free iPSCs in its state-of-the-art commercialization-ready cGMP facility.

"This collaboration with Allele Biotechnology provides us a clear path forward for clinical use of our technology. There are only a handful of clinical grade iPSC lines available in the world and we are fortunate that we will now have access to one of the best. Moreover, the support of Allele’s cell scientists and cGMP experts will be of great advantage to enable us to move to IND and into clinical trials quickly”, said Dr. Jack J. Zhao, CEO of Alpine BioTherapeutics.

The agreement will provide Alpine BioTherapeutics priority access to Allele’s cGMP facility and will involve licensing one or more of Allele’s cGMP-grade human iPSC lines to generate cell therapy products for vision loss.  

Dr. Jiwu Wang, Founder and CEO of Allele Biotechnology, said “We are excited that our technology synergizes Alpine’s to make novel products with the potential to make a difference to millions of lives affected with debilitating eye disorders”.