Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these trailblazers who continue to shape the landscape of the biotech industry. This week we are recognizing:
Stanley Lewis, MD MPH, Founder and Chief Executive Officer
Dr. Stanley Lewis is Founder and Chief Executive Officer of A28 Therapeutics. Previously serving as Chief Medical Officer of Ansun Biopharma. Lewis is a proven leader in life sciences, with 25 years of experience in clinical research, drug development, patient care and teaching. Prior to Ansun, Dr. Lewis was CMO at TaiMed Biologics where he led the company to US FDA approval of the first long-acting agent and the first monoclonal antibody treatment for multi-drug resistant HIV disease. He was instrumental in securing additional regulatory designations and grant funding, as well as manufacturing and commercial licensing for TaiMed development programs. He serves on multiple scientific and medical advisory boards for both for-profit and non-profit organizations focused on improving healthcare, clinical research, and education.
Please summarize your career in your own words, noting some of the most pivotal moments or decisions throughout:
I’m an internal medicine physician by training. I attended University of Texas Medical School at Houston for my internship, residency and fellowship. I joined the faculty there for about six years. I saw patients, taught residents and students, and conducted clinical research. My primary area of interest was HIV disease, and I participated as Principal Investigator on dozens of clinical trials.
I was recruited to become a medical director for Tanox, a small, publicly-traded biotech company in Houston. After a couple of years, Tanox was acquired by Genentech. After a portfolio review, Genentech decided against pursuing a medication in the HIV field, and they asked me to stick around and help out-license the product. So, I helped them out-license the product to TaiMed Biologics, a company co-founded by David Ho. David asked me to be the Chief Medical Officer of TaiMed. During my time at TaiMed we continued to develop the monoclonal antibody for the treatment of HIV and ultimately the drug was approved and now marketed as TROGARZOTM.
Shortly after approval, I received a call from my former CEO, who asked me to come out to California because she had a new company, Ansun Biopharma. Ansun was developing a new treatment for hospitalized parainfluenza and influenza. Just as she had convinced me to leave the University before, she persuaded me to come to Ansun as Chief Medical Officer. We had gotten a breakthrough therapy designation for the product and started enrollment for a Phase 3 clinical trial, when COVID-19 emerged and derailed our plans. All the distancing, hand-washing, and masking are very effective at preventing people from getting the flu.
In addition to conducting global clinical trials, I was also asked to help identify and evaluate new assets for the pipeline. Ansun was a single asset company, and we had just raised $100 million. Most of the candidates were not that great, but one product I reviewed was particularly interesting to me because it was a lytic peptide, similar to an antibiotic, but it had been retooled to target cancer instead of bacteria. Ansun decided to go in another direction and ultimately passed on in-licensing the product. After leaving Ansun, I was approached by the company attempting to out-license this product and was asked to join the leadership team.
Unfortunately, the company wasn’t in great shape, and it was going to be very difficult to raise money to get that program moving forward. Instead, I offered to create a company and take the asset off their hands. Sure enough, they said yes, and I ended up purchasing all of their assets, including the lead compound in Phase 2 as well as a pipeline of three other preclinical products. I founded A28 Therapeutics along with my co-founder, Tom Kottler, and we began raising a Series A to get back into the clinic and conduct a clinical trial to position the product for Accelerated Approval.
What are some of your proudest professional accomplishments?
That’s a tough question. There have been so many proud moments. I really enjoyed being a Clinician. That part of my career was very rewarding. It was an honor and a privilege to be allowed to care for so many patients. I am very grateful for that opportunity. On the drug development side, I am very proud to see the HIV drug, TROGARZOTM all the way through the development process from Phase 1 as an investigator to full market approval was quite a journey and an incredible learning experience. I am very proud of that accomplishment. .
With rapid advancements in areas like gene editing, personalized medicine, and synthetic biology, what do you see as the most promising technologies in biotech over the next 10 years?
Well, I think it’s easy enough to say AI is poised to change everything about the drug development process; I think that’s going to have a huge impact on the way that we approach the challenge of developing new drugs, understanding the biology and chemistry of those agents, and how they work together. But there are two things I think are very important. First, we need to integrate more physiology into our pursuit of chemical interventions and understanding biology, because I think in a lot of ways our body is already capable of repairing itself. If we can make our interventions more consistent with the physiology of what the body is trying to do, rather than looking at targets where we can inhibit a molecule or antagonize some receptor. I think those types of approaches tend to be less in harmony with the way the body wants to work.
I think the other thing that we need to do is to take a step back. I think we spend too much time worshiping at the altar of the complex. When I look across the drug development landscape, it reminds me of when you’re on the plane; and the flight attendant is giving you the safety briefing, and they say “in case of emergency, isle-path lighting will guide you to an exit; but keep in mind that the closest exit may be behind you.” I think that’s also good advice for us in medicine – the closest exit could actually be behind us. We keep going down these paths of greater and greater complexity, when maybe some simple solutions are available to us that we’ve just overlooked or underappreciated. That’s one of the reasons why I really like the drug that I’m working on now; it is a very elegant yet very simple solution.
What companies and innovations are you following right now, what do you find most exciting or disruptive?
What I think would be absolutely game changing for the field of oncology, is if we can borrow some of the same corporate cooperation that we’ve seen in the area of infectious diseases. Particularly when I was working in HIV, one of the things that was very instrumental in helping us to transform that disease from being universally fatal into a chronic disease that you could live with, was when companies realized that HIV was the enemy, not each other. So we worked together to combine medications, create cross company co-formulations, to work together in a collaborative way for the benefit of patients and ultimately put HIV on the run.
That was, quite frankly, very different from how you see corporations work in any other therapeutic area. So I’d love to see oncology embrace that same sort of attitude. I think, in a lot of ways, there are lots of parallels between where oncology care is today, and where HIV care was 30 years ago. You’ve got patients with terrible malignancies that shorten their lives; you’ve got medications that cause lots of side effects, and you’ve got a clear need for combination therapy. To get cancer under control, we need to collaborate.
With the experience and insights you have gained, what advice would you give to young people aspiring to work in the biotech industry?
First, I’d say there is no blueprint. So be aware that in many ways, you’ll have to blaze your own path. And that can be a great thing but also very challenging. Don’t feel like there’s necessarily a right way or wrong way to get there. Having integrity and working hard are some things that are universal. This field is certainly not for the faint of heart; there’s not going to be a very clear and paved path. That’s why they call it ‘innovation’.
Also remember that you can’t do it alone, you’re going to need help. So strengthen those networks. Don’t be afraid to ask for help or ask for additional input or feedback from those that you work with. I think there’s strength in our diversity and having diverse inputs can make us better.. I think there’s strength in our collaborations. If we try to do this alone, it’s going to be much more difficult, if not impossible. The challenges that we face are just too big. So those two things I think are really important: don’t expect a paved path and remember to take some friends with you on the journey.
Can you tell me a little about your involvement in Life Science Cares?
Oh, absolutely. Giving back is one of my favorite things to do. Life Science Cares is a nonprofit organization that was founded by a friend, Rob Perez, and I am a member of the Board of Advisors. The mission is to leverage the resources of the life science industry to fight some of the big problems such as poverty, that we have in the communities where we live and work. Our industry is full of great people and great companies. We want to give back and show that beyond just creating great medicines and devices, we also want to impact the broader social determinants of health. Another area of interest is to help the youth, particularly from underrepresented and underserved areas of our community, and make them aware of the life sciences industry as a potential career path. Things like mentoring and supporting STEM programs are just a couple of ways that Life Science Cares gives back.
