We recently spoke with Nikole Kimes, PhD, CEO and Co-Founder at Siolta Therapeutics, a clinical-stage biopharmaceutical company developing targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need.
Its lead program, STMC-103H is currently in phase 2 development to prevent atopic diseases in at-risk newborns. Siolta has successfully scaled up a multi-strain LBP drug product STMC-103H, completed a First-In-Human descending-age clinical trial (STMC-103H-101), and was recently awarded a $2.7M NIH grant to further advance its proprietary mixed-strain LBP manufacturing methods. By leveraging its Precision Symbiotics Platform™ the company is expanding its product pipeline into additional pediatric and women’s health indications.
Driving Siolta’s early-stage development, Dr. Kimes heads a talented team of scientists, blending microbiology, immunology, and bioinformatics expertise to leverage microbiome data for the improvement of patient stratification and the development of precision microbial therapeutics. Nikole has over a decade of experience in microbial ecology and host/microbe interactions, supported by the National Science Foundation (NSF), the European Commission FP7, and the University of California San Francisco (UCSF).
As an inventor of Siolta’s technology, her research in Dr. Susan Lynch’s lab at UCSF provided the foundation for the company’s translational research program. Dr. Kimes is also the Chairman of the Microbiome Therapeutics Innovation Group (MTIG), an independent coalition of companies leading the research and development of FDA-approved microbiome therapeutics to address unmet medical needs, improve clinical outcomes, and reduce healthcare costs.
Business News Tribune: What prompted you to pursue a career in Life Sciences? Was there a specific moment in time or influence that you can remember? What drives you to work in this space?
Nikole Kimes: I have always had two loves from an academic and career perspective: human health and environmental science. These concepts were often presented as competing interests despite my intuitive sense suggesting that they are intrinsically and inextricably linked. Thus, my early academic career was a bit meandering as I attempted to find ways to combine both passions into a single career objective. Early in my career, I obtained a BS in science and a MA in holistic health, followed by a stint in the Peace Corps teaching human health, environmental education, and basic business principles, after which I returned to human health doing neurobiology research. Although each of these events was vital to my development, I had not yet successfully integrated my interests in a meaningful manner.
As a result, I kept searching for something I could not yet name or fully describe. I eventually found myself with a unique opportunity to participate in a PhD program at the Medical University of South Carolina (MUSC) that combined environmentally focused molecular and cellular biology with translational human health. Although the genesis for this program was more of a small molecule drug discovery approach, my exposure to systems biology was life-altering and afforded me the “ah ha” moment that I had been seeking.
BNT: Can you tell us a little bit about your background & career thus far? What were you doing before you started leading a startup?
NK: My doctoral work focused on characterizing environmental microbiomes (e.g., the coral microbiome) both taxonomically and functionally. My particular focus was on how these amazing microbial systems were influenced by changing environmental parameters and consequently impacted the health of the entire ecosystem. During this time, I learned to appreciate not only the intricacies of specific molecular interactions but also the complexity of interdependent networks driving a given ecosystem’s functionality.
This grand awakening in my own education occurred in parallel with the broader microbiome revolution that has changed our understanding of all ecosystems, including the human holobiont. A term that references the co-evolution of human beings with their complex microbial counterpart, the human microbiome. It was always my belief that if we could unlock the connection between our environment and our health, we would be able to address health conditions that had to date remained significant unmet clinical needs due to their complexity and recalcitrant nature (e.g., chronic inflammatory diseases and multi-factorial infections). At this point in my education, I had the tools to elucidate more specifically how the human microbiome connected our environmental exposures to our long-term health. This revelation and knowledge provided a much clearer vision of my future from an academic and career perspective.
Importantly, my family and I chose to return to San Francisco where I sought to find an innovative scientist as a mentor in the human microbiome space. This was a critical step in which I had the privilege of working with an amazing scientist, Dr. Susan Lynch at UCSF. She had incorporated an ecological perspective into her understanding of the human microbiome and more specifically its impact on systemic health through immunomodulation in early life development. This approach and years of scientific research coming out of Sue’s lab were eventually the foundation on which we have built Siolta Therapeutics.
BNT: What is your company’s founding story?
NK: The founding of Siolta Therapeutics at its very foundation is a scientific story. Dr. Lynch is a pioneer in the human microbiome field, and her work has moved far beyond the early characterization studies. In fact, her work has provided a greater understanding of the gut microbiome’s systemic modulation of immune development and overall health. As a result of her work at UCSF, Sue worked with influential people, such as Marc Benioff, and eventually interacted with the different players in biotech, including venture capitalists such as Samir Kaul. As a result in 2016, there was a fortuitous alignment of factors. First and most importantly, the science proved to be compelling in a more mature manner than previously. Second, the interest in backing an innovative approach that would truly transform our approach to healthcare existed. Finally, although I had never previously considered becoming an entrepreneur, I was open to the unique opportunity at hand.
What felt random at the moment proved to make perfect sense in reflection. Much like Systems biology is not a linear process; founding a successful company requires an almost mystical confluence of events in a complex, yet systematic way that is not always obvious initially.
BNT: How did you get your training, if any, to be able to build your company?
The early days consisted of a lot of on-the-job learning. The amazingly supportive early biotech support systems available in the Bay area, MBC BioLabs and California Life Sciences, for example, were also essential to our initial success. I learned the vast majority of what I needed to know through a welcoming community that openly and willingly shared their experiences and resources. I was willing to ask questions about all the things I never even knew I needed to know to develop therapeutics, everything from business licenses to intellectual property to accounting practices. The skills for building a team were a bit more intuitive, although they needed to be fostered through mentoring and guidance. Interestingly for me, I found all the new aspects of daily life to be just as compelling as science, and eventually, it became clear that I was actually the perfect person to lead this company on such a unique journey.
BNT: What problem is your company solving?
NK: Traditional drug development often utilizes screened molecules to target specific pathways in the body that help alleviate the symptoms of the disease. Although effective in many ways, this approach does not alleviate the underlying cause of disease and often is associated with unwanted side effects. In contrast, our microbiome-based therapeutics are designed to work with the body’s natural systems to stop diseases before they start. We know that the human microbiome plays essential roles across a broad spectrum of critical functionalities in healthy individuals, including proper metabolism, immune modulation, inflammatory signalling, and even neurophysiology. This provides a natural reservoir of synergistic therapeutic agents that can work together to address the underpinnings of complex and multifactorial diseases, and we founded Siolta to develop targeted microbiome-based therapeutics that have the potential to be more efficacious with fewer side effects.
BNT: How did you become motivated to tackle this particular problem?
NK: Through our work at USCF, we recognized that the gut microbiome plays a critical role in regulating the immune system and that modulating it could potentially provide a novel approach to treating inflammatory-related diseases. Our team at Siolta Therapeutics have been working on developing therapeutics that can restore the balance of the human microbiome in infants at risk of developing atopic diseases (i.e., atopic dermatitis, food allergy, and allergic asthma) as well as other indications. Most simply stated we are harnessing the human microbiome to develop a new class of drugs that will address the underlying causes of disease. To do this, we are integrating sophisticated bioinformatics with complex biology to develop targeted therapeutics and diagnostics across a number of indications.
BNT: Why does your solution matter for the world when you get it right?
NK: Imagine holding your newborn baby and knowing that they are at risk for developing a life-long chronic disease. Now imagine being provided with a relatively low-cost solution that you provide in the first months of life that would alleviate that outcome. Siolta’s approach is to target multiple mechanisms of action simultaneously in order to solve for the underlying “root” cause of disease, rather than simply addressing individual symptoms. This approach has the potential to provide more comprehensive and long-lasting treatment outcomes for patients. This approach of addressing disease before it causes permanent damage is a fundamentally different way of thinking about healthcare. Not only would it transform health outcomes, it would also dramatically reduce the cost burden of such diseases.
Deciding to start a company, I imagine is never an easy task. We are focused on a solution that involves emerging technology; we are integrating a transformative approach focused on prevention; and we believe that we will be most impactful if we start with our children. Although traditional drug development norms would readily argue against our approach, science is telling us something different. At Siolta we are compelled by the science to follow a different path, and we are proud of the team we’ve built both internally and externally to support such a unique endeavour. Although we have had to build each stepping stone along the way, we have successfully navigated a path from academic ideation into clinical trials to test this potentially groundbreaking approach in an amazingly efficient manner having added significant value and de-risked our future efforts substantially.
BNT: Throughout the journey, what have been some of your biggest takeaways thus far?
NK: Systems, whether they are ecosystems, biological systems or even human systems, are always complex, multifactorial, and powerful. From this perspective rarely is anything a simple linear equation. One of the greatest lessons I’ve absorbed along this journey has been to accept a systems perspective for my own life trajectory. Often, we like to think of successful leaders as being visionaries who knew from day one what the solution needed to be. When in reality there is a complex web of experiences, knowledge and serendipity that occurs over time driving the greatest outcomes. As an entrepreneur, do not be fooled into thinking there is “a right path” because there are always alternatives and it’s more important to find the path that is uniquely suited for you. As long as you have an idea, determination, and resources, it can be done in many different ways.
For more information, log on to www.sioltatherapeutics.com