As part of WuXi AppTec’s ongoing efforts to collaboratively foster new thinking and actionable approaches in advancing breakthroughs for patients, we have launched a new interview series in 2022 – “Delivering on the Promise of New Modalities” – so leading voices of R&D can share how their approaches are addressing the barriers standing in the way of breakthroughs.
Up next in our interview series, Ray Tabibiazar, M.D., a seasoned executive in the healthcare and biopharma industries, imparts his perspective as CEO & Chairman of SalioGen Therapeutics. SalioGen is advancing a new category of genetic medicine through its unique Gene Coding approach, a genome engineering technology that leverages proprietary mammal-derived enzymes. Earlier this year, SalioGen closed a $115 million Series B financing to advance the company’s goals of transforming the treatment paradigm for patients with inherited diseases and beyond.
Thank you for taking the time to sit down with us, Ray. What major bottlenecks or barriers is SalioGen aiming to address?
Ray: At SalioGen, we aim to address inherited disorders by addressing some of the limitations of currently available approaches. Current therapeutic approaches include gene editing and viral vector-based gene therapies. These modalities, however, often have limited clinical applicability. Many of the inherited disorders are caused by many different mutations and oftentimes involve a large gene (>5 kb sequence). Gene editing is designed to fix only a few point mutations at a time, and viral gene therapies can only accommodate gene sequences of a few thousand base pairs at most. Additionally, viral gene therapies carry the risk of causing potentially severe immune responses in patients and gene editing carries the risk of causing damage to the DNA that it changes. Altogether, the field of genetic medicine is limited in the number of inherited disorders it can address effectively and safely.
How is SalioGen’s approach differentiated and what might be advantages of the approach?
Ray: SalioGen is developing a new category of genetic medicine called Gene Coding, which is designed to turn on, turn off or modify the function of any gene in the genome. The cornerstone of Gene Coding is SalioGen’s portfolio of mammal-derived enzymes collectively called Saliogase, which can take a DNA sequence of any length and integrates it into the genome at a precise, pre-defined location. To our knowledge, SalioGen is the only company developing a mammalian genome engineering enzyme.
Gene Coding machinery is delivered using a cell specific lipid nanoparticle; therefore, we don’t anticipate any risk of causing the virus-related immune responses that some gene therapies can cause. Furthermore, Saliogase works without causing double-stranded breaks when it inserts new DNA to the genome. It therefore doesn’t trigger any of the error-prone DNA repair pathways that may cause DNA damage and other unwanted downstream effects. Saliogase can also insert DNA sequences of any length, unlocking the potential to address most inherited disorders regardless of the size of the gene or genes involved in the disease.
All these features are designed to make Gene Coding applicable to a broad range of inherited disorders. The physical components of the technology are also easily reproducible and scalable, ensuring they can be manufactured to reach large patient populations with prevalent inherited disorders.
What challenges are you facing currently and how are you addressing these?
Ray: With the recent explosion of new biotech companies, there has been a shortage across the sector including limited capacity at partner CDMOs and a shortage of non-human primates for GLP toxicology studies. We are working to develop in-house CMC capabilities to maintain control over our manufacturing process.
Pipelines of genetic medicines are on the rapid rise. What trends do you see coming in the next few years?
Ray: There has been a clear trend toward the accelerated development timeline for the new fields in genetic medicine. RNA-based therapeutics were largely developed over the course of roughly the past twenty years, with siRNA therapeutics and recently with mRNA therapeutics. On the other hand, the more recent newcomer of gene editing has taken hold in about half the time, in the past 11 years since the first papers on the CRISPR-Cas9 system as we know it were first published.
We anticipate that by 2030, we’ll see increased availability of different modalities of genetic medicine for inherited disorders. In addition to currently available products like viral vector-based gene therapies, RNAi and antisense oligonucleotides, perhaps modalities like Gene Coding and other non-viral genome modification platforms, mRNA-based gene therapies and epigenetic therapies will be further advanced and available for patients.
Definitely a great outlook and great opportunities for patients. Any closing thoughts you like to share with our audience?
Ray: Looking forward, we expect to see a shift in drug approvals away from single-purpose compounds and toward therapies based on platform technologies. Successful platform technologies will each be capable of yielding multiple successful therapies, each of which can be developed in parallel. Platform technology-based development is becoming more common and is significantly more streamlined than the historically more common trial-and-error, one-molecule-at-a-time path of drug development, and that may push us toward a greater volume of drug approvals by 2030.
Thank you Ray, it’s been an insightful discussion into the new breakthroughs SalioGen is bringing to the field of genetic medicine. We wish you luck in your future endeavors.
Ray: Thanks for having me.
Ray is a seasoned executive with leadership experience in the healthcare and biopharma industries, including venture capital, pharmaceuticals and diagnostics. As a clinician-entrepreneur and as managing director of 526 Ventures, he has focused on creating new ventures in the form of new companies or spinouts to translate innovative science into commercially viable products. Previously, Ray led Aravive Biologics as President and CEO, served as Senior Vice President, Corporate Development and Business Strategy at Twist Bioscience, a venture partner at Bay City Capital, and other senior executive roles.
Prior to moving to industry, Ray was a practicing cardiologist and an adjunct faculty member at Stanford University, having trained as a physician scientist at Harvard Medical School and a cardiologist at Stanford Medical Center. Ray graduated with his medical degree from Harvard Medical School.