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.

We recently sat down with Geoff Hamilton, Co-Founder & CEO of Stemson Therapeutics, an early-stage company focused on hair regeneration using stem cells to generate healthy new follicles as part of our interview series. Last year, the company secured $15 million in Series A Financing to create a hair loss treatment that makes net-new hair follicles. Stemson’s vision is to provide a solution to all patients battling the emotional trauma or social stigma of hair loss through a novel approach using the patient’s own cells.

Thank you for taking the time to join us, Geoff. For cell therapies, what are the challenges in current therapeutic intervention in general?

Geoff: The primary industry-wide challenge that cell therapy companies like Stemson face is the fact that we are working with cells as the therapeutical modality. The challenge of working with cells as the actual therapy is the ability to safely and scalability control these cells for the therapeutic endpoints. Cells are alive and have their own activities with a high degree of variability, which can pose huge challenges in establishing a level of control and reproducibility to have the cells perform the functions that we need on a consistent basis. Having tools, processes, and methods for making those cells more uniform, controllable and reproducible are probably the biggest challenges that not only face us here at Stemson, but also folks across the industry working on cell therapy solutions which are now widely in development across the whole industry. A large number of big pharma and biotechs are developing cell therapy-based solutions in their pipeline.

What is your new modality approach helping to address these challenges? How is it different from existing approaches?

Geoff: Stemson’s new modality uses a cell therapy approach to address the broad problem of hair loss across the human population. Hair loss affects all races, ethnicities, nationalities and genders; it’s very widespread, and has a tremendously negative effect on mental health, self-confidence and well-being. Until now, the therapeutic products brought forward to treat this condition were all small molecule or biologics-based approaches. Hair loss is a degenerative disease in the skin. Much like other degenerative diseases across the body, a cell therapy approach makes a lot of sense in terms of regenerating the tissue that’s been lost in hair. So, the uniqueness of our approach is that we are capable of making the cell types required to regenerate hair follicles. We leverage these cells as the starting materials to bioengineer a new supply of hair follicles to treat folks who have lost their hair. That’s novel. And there is no therapeutic solution available today capable of generating de novo hair follicles.

What are critical challenges in realizing the full potential of your regenerative cell therapy? Key milestones anticipated?

Geoff: The biggest challenge for Stemson in realizing the full potential of cell therapy to treat hair loss is how we use cells as the building blocks to engineer a functionable, durable hair follicle tissue that can survive once transplanted into the skin. Engineering cells is hard enough but directing that population of cells to work together to form a functional tissue that’s capable of engrafting successfully into a patient’s skin and surviving over the long term is the next big challenge. So, the key milestone driving Stemson’s focus will be the first-in-human clinical trial which we expect to begin following successful completion of our pre-clinical trials. Our initial animal data shows tremendous promise, but we need that first-in-human proof of concept to prove that this is possible and reproducible in humans.

With many new modalities advancing into the clinic and getting closer to patients, how will the 2030 class of FDA new approvals look compared to those of today?

Geoff: With many new modalities advancing into the clinic, there is a strong push forward across the cell therapy front. Cell therapy, rather than other types of biologics or other drug molecules, is going to prove to be a better approach to treating a number of degenerative diseases. With a robust pharma pipeline of cell therapies in development across many indications, I would expect the 2030 class of FDA new approvals to have a much larger share of these cell therapies making their way out into commercialization to treat broader patient populations. This will be true not just for companies targeting degenerative diseases but for companies attempting to modulate and tune immune cells to unleash the immune system on certain types of diseases such as cancer.

For cell therapy development, do you see novel data technologies, AI, or machine learning being used in the next couple of years?

Geoff: I do see machine learning and AI being put to heavy use specifically on cell therapies. The challenge of understanding the basic biological mechanisms with which we need to control broad populations of cells is a daunting challenge of biological variability. The complex genetic and proteomic interactions driving cellular behavior is such an enormous amount of data to consume even for a single individual cell. Typical analytical approaches to understand the drivers of cell function and behavior cannot be addressed effectively without the use of big data tools like machine learning and Artificial Intelligence. At Stemson, we collect large amounts of molecular data to tell us what is happening in the cells that we are engineering and what is happening in the tissues that we are engineering. The complexity of this data requires that we write and leverage algorithms with machine learning and AI to pick out patterns and correlations and statistical significance to help us understand what is going on across a broad population of cells and across many molecular mechanisms existing within those cells.

 

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Geoff Hamilton

Co-Founder & CEO, Stemson Therapeutics

Geoff Hamilton is co-founder and Chief Executive Officer of Stemson Therapeutics. He brings 20 years of product commercialization and business executive experience in life science and biotech companies. Prior to founding Stemson Therapeutics, Geoff spent five years at Illumina, a Fortune 500 company and world leader in DNA sequencing technology, where he held leadership positions in marketing, product management, and strategic partnerships. During his time at Illumina, Geoff launched three instrument platforms and helped the company grow from $1.4B to $3.8B in annual sales. Prior to Illumina, Geoff spent ten years at Life Technologies (now a part of ThermoFisher Scientific) where he held various leadership roles in marketing, global commercial operations, and acquisition integration. He helped build the company from $1.2B to $3.6B in annual sales before the ThermoFisher Scientific acquisition. Geoff earned a Bachelor of Science in Business Administration from the University of North Carolina, Chapel Hill.