Interview with CEO of Stemson Therapeutics, Geoff Hamilton – Updates and the Future

Follicle Thought is pleased to present a recent interview we conducted with Geoff Hamilton, the CEO of Stemson Therapeutics. Stemson Therapeutics is a biotech company founded in 2018 that aims to revolutionize hair regrowth through stem cell technology. So, let’s get into the interview.

FT: Hi Geoff, Thank you for coming back to Follicle Thought for a second conversation. Our last interview was in September 2021. Could you give us an overview of the progress you and Stemson have made since that time?

GH: Thank you for your continued interest in Stemson. Being able to share our news with the extended hair loss community is mission-critical to Stemson’s ultimate commercial success. When we last spoke in 2021, Stemson had just completed a $15 million Series A financing led by DCVC-Bio and supported Genoa Ventures, AbbVie Ventures, and other investors, bringing our total funds raised to over $22 million. Since then, Stemson has been expanding our scientific staff and management team as well as developing technological solutions for hair regeneration and conducting experiments in support of our iPSC hair loss program. Most recently, we expanded our product line to include Aderans’ proprietary cell therapy technology to address androgenetic alopecia (AGA), a synergistic development program that is expected to complement our iPSC cell therapy development program for hair loss.

Expanding our scientific expertise.

Since Stemson’s 2021 Series A financing, one of our key goals has been to expand the scientific team at Stemson. Stemson’s management team includes three experts in their field. Chief Development Officer Megan Samberg, Ph.D., is experienced in the fields of biomedical engineering and regenerative medicine with specialties in skin wound healing, tissue engineering, animal model development and testing, nanoparticle toxicology, and biomaterial fabrication. Chief Scientific Officer Kevin D’Amour, Ph.D. has over 20 years of experience in cell therapy R&D with a specific background in stem cell biology, stem cell differentiation, gene editing, immunology, and cell therapy development. Vice President of Data Science and Bioinformatics Nick Wisniewski, Ph.D., has over a decade of experience applying machine learning to frontier problems in biology and medicine. His passion is building biotech startups that leverage artificial intelligence in diagnostics, devices, and drug discovery to address unmet needs in healthcare technology. Stemson’s executive team is well positioned to move Stemson into the final stages of product development with an emphasis on leveraging bioengineering, big data, and machine learning approaches to create a highly controlled and reproducible therapeutic outcome for hair growth. These key individuals are supported by a scientific staff that has expanded to over 20 scientists, up from just 5 in 2021.

Technological solutions and scientific advancements.

1. Identifying the best animal model
   Once we had the funding in place and the development team on board, we conducted pre-clinical research with in vivo animal models to determine how our product might behave in a human being. We tested a few different animal models, from mice to pigs. We have chosen a human skin xenograft model in an immunocompromised mouse, which we believe is the best model to mimic the natural human skin environment and test how our therapeutic solution will behave. We refer to this model as a humanized mouse. Furthermore, we confirmed with the FDA this is an acceptable model for IND-enabling studies.
2. Developing and designing engineered follicular units
   Much of Stemson’s development activities have been focused on developing engineered follicular units, which are constructed through a proprietary bioprinting process combining hair follicle cells and biomaterials into a three-dimensional biomimetic design resembling the hair follicle shape. The engineered follicular units are designed to provide an unlimited source of hair follicle replacements capable of treating a range of hair loss indications, including AGA, scarring alopecia, and chemo-induced alopecia.
3. Pre-clinical testing
   From there, we combined the two development efforts and began testing our product design on the xenograft mouse model. Upon transplantation, the engineered follicular units will engraft with the human skin and develop into mature natural hair follicles, replacing those that have been lost. The design of the engineered follicular units enables handling and precision delivery into the skin using common hair transplantation tools and techniques available in the field today, which will enable easy clinical adoption by hair transplant surgeons. In addition, the design facilitates healthy follicle development with proper directionality and the emergence of a hair shaft out of the skin.
   

In February 2024, Stemson reported the successful creation of human hair follicles in humanized mice using engineered follicular units. Stemson’s development team has demonstrated that an all-human bioengineered cell solution can generate brand-new human hair follicles in human skin.

Stemson is now moving into the final development of the engineered follicular units before testing in human trials.

FT: The most recent news from Stemson is that you have signed an exclusive licensing agreement with Aderans. Can you explain how this came about and what you hope will come from this deal?

GH: As you may know, Aderans halted their therapeutic development program of a promising proprietary hair regeneration cell therapy technology that had already completed Phase 2 clinical trials with over 400 patients. When Stemson met with Aderans in 2022, they were investigating possibilities of resurrecting the hair regeneration program because they had invested so much time and effort and had achieved promising results in the Phase 2 trials. We at Stemson believe the Aderans cell therapy product has tremendous potential to treat early-stage AGA in men and women. In discussions between us, both parties agreed that Stemson is very well positioned to carry the program forward, given the strong synergies and complementary nature of our iPSC-based program and the Aderans program. Stemson’s goal is to take the Aderans program back into clinical trials and earn regulatory approval to commercialize the product. It will become the first-ever cell therapy for hair loss.

FT: How do Aderans’ hair regeneration cell therapy technology and Stemson’s iPSC technology complement each other? 

GH: Stemson’s iPSC technology and the Aderans technology both target the same types of hair follicle cells, but they are used for different purposes and hair loss disease indications. The iPSC technology is best suited to generate true de novo hair follicles where an entire follicle replacement is needed, such as in late-stage AGA or scarring alopecia. In contrast, the Aderans approach is best suited to capture follicles in active shrinkage and rejuvenate the endogenous follicle tissue through cell injections, which is best suited for early-stage AGA. There is a tremendous benefit to having both technical solutions under one company because the R&D for both programs centers on the same hair follicle cell types. Learnings from one program can directly translate to learnings from the other program.

FT: With the incorporation of Aderans’ technology, what unique benefits do you foresee for patients suffering from androgenic alopecia (and other types of hair loss)?

GH:  Aderans’ proprietary hair regeneration platform is a cell therapy system that utilizes patient-derived hair and skin cells to durably rejuvenate shrinking hair follicles in patients with AGA by repopulating functional hair follicle cells into early-to-mid-stage hair loss areas. Aderans conducted Phase 2 clinical testing in the United States on 445 human patients to treat early-to-mid-stage AGA in men and women. Initial clinical data suggest a single dose of functional hair follicle cells in the target scalp area can safely produce long-lasting and durable hair growth results. Because this product is in late-stage clinical testing, our goal is to win commercial approval as soon as possible and make this the first-ever approved cell therapy to treat hair loss. We believe a solution that can functionally restore healthy hair follicle tissue with long-lasting, durable hair growth results will be a tremendous breakthrough for men and women suffering from the early-stage effects of AGA. We expect the solution to be especially important for women where there are truly no solutions available for their condition. 

FT: In February, Stemson also announced a technological breakthrough in hair growth. Can you describe this and explain a bit about what this means for future hair regeneration treatments?

GH: The results we achieved were using the actual product, the engineered follicular unit, into human skin grafted on the back of a mouse, whereas previous results were taking components of the product and testing them in mouse skin, which is a poor model and poor predictor for human skin results. We believe this is the first-ever demonstration of successful de novo human hair formation in a human skin patch using transplantable engineered follicular units. This result represents the strongest possible evidence, other than directly testing in humans, that our product concept can successfully generate de novo hair follicles. The implication is that hair transplant surgeries will become a practice of the past, and Stemson’s engineered follicular units will become standard treatments for hair loss patients. It is important to note the difference in translatable clinical use of our product versus other concepts that have demonstrated hair growth results in mice. Our product is designed to be an individual unit transplanted into otherwise healthy skin, very similar to an excised follicular unit in current hair transplant surgeries. Hair growth results demonstrated in other labs have typically used either wound healing environments or mouse skin injections, neither of which can translate to a clinical procedure one would perform on a person with AGA or other forms of alopecia. 

FT: What are the next steps toward transitioning from successful murine trials to human clinical trials? 

GH: The path forward is now clear. We’re focused on finishing the final adjustments of the product and the process to make the cells such that we can move the development program into official IND enabling studies, which are a more formal, governed approach that the FDA requires for a third party to conduct tests in an animal model. Because we are designing an autologous product, meaning we will use each individual patient’s own cells to create the product, we will need to demonstrate that our process can be consistent from patient to patient to patient. As a result, we must develop and finalize a process that is robust across dozens of cell lines. We may need to make some additional adjustments to the process to make it more robust and address some of the patient-to-patient variability. Our end goal is to develop a strong cell differentiation process from iPSC to hair follicle cells that can handle any variability from patient to patient, and that ends with the right cell identity and cell purity. From there, we can initiate the IND-enabling studies as quickly as possible.

FT: Do you have a timeline for this transition?

GH: We are not commenting specifically on timelines at this point, but I can say that IND-enabling studies for the FDA typically take up to one year to complete once initiated. In addition, we need to build and validate a GMP-compliant manufacturing environment before submitting a clinical trial application. 

FT: Would you like to tell our readers anything else about yourself, your work, or the company as a whole?

GH: The Stemson team is passionate about our mission to bring highly effective new treatments to many forms of hair loss where new solutions are desperately needed. We are on the precipice of a new era for hair loss therapies with the development of cell therapy approaches that hold the promise to restore functional follicle tissue to grow hair. The team is working tirelessly to lead the way and usher in this new era of breakthrough medicines for hair loss.

Reflections

You can find our previous interview with Stemson here. This interview gives us unique insight into Stemson Therapeutics’ progress and explains the process from laboratory to clinic. We are excited to see what news Stemson will share in the coming months and years and want to thank Geoff Hamilton for taking the time to answer our questions.

Let us know what you think in the comments below.