March Biosciences is a clinical-stage cell therapy company with a mission to transform patient care in the most challenging hematological malignancies. Pulse 2.0 interviewed March Biosciences co-founder and CEO Sarah Hein to learn more about the company.
Sarah Hein’s Background
“I was originally trained as a PhD in Molecular Biology, but during that time, I realized that I was fascinated with biotech commercialization as a means of translating bench science to the clinic. I plugged into the local startup ecosystem and that led me to becoming a venture fellow with Mercury Fund and helping launch Courier Therapeutics, which was a retargeted cytokine company.”
“I learned a lot about startups and biotechnology development through that process, including strategically derisking real and perceived risk in a cost-effective way. We tend to focus on the big chunky milestones in biotech (preclinical validation, clinical trial initiation, and first clinical results) but there is a significant amount of work and capital required to get to those points and the ability to do that is really dependent on the perceived risk along the way.”
Formation Of The Company
“After Courier, I helped launch the Texas Medical Center Innovation’s Accelerator for Cancer Therapeutics. It was there that I first met Dr. Max Mamonkin and later Dr. Malcolm Brenner and saw the earliest clinical results for the CD5-targeted chimeric antigen receptor (CAR) T cell therapy that later became the core of March Biosciences. The product had clear potential but had reached the limits of academic development, so we worked together on the first plans to resource and develop the company.”
Favorite Memory
“During the process of getting ready for the Phase 2 trial of our CD5-targeted CAR lead asset, we started speaking with clinicians across the country, many of whom were already aware of the Phase 1 trial at Baylor College of Medicine. It was extremely humbling to see the enthusiasm from the clinicians looking for new opportunities for their patients, which helped us push through a rougher fundraising environment.”
Clinical Assets And Pipeline
“Our lead asset, MB-105, is a CD5-targeted CAR-T cell therapy that has been granted orphan drug designation by the FDA and is currently in a Phase 2 trial for T cell lymphoma.”
“CAR-T therapies represent a breakthrough class of living therapeutics engineered from patients’ own immune cells to combat cancer. While these therapies have revolutionized treatment of B-cell lymphomas and leukemias, with many patients achieving durable remissions lasting a decade or more, they have yet to address rarer T cell lymphomas and leukemias, and that is what we are going after with our therapy.”
“The patients with T cell lymphoma currently face a truly dismal prognosis, especially when the disease becomes relapsed or refractory to primary care. There is no true standard of care at this point, and patients cycle through a number of relatively ineffective salvage therapies. So we are really trying to change the standard of care for this disease.”
Challenges Faced
“Biotech in general has been down over the last couple of years, with limited funding available to new companies. On top of that, a few high-profile failures in cell therapies led to a lot of negative sentiment across the board which increases the difficulty for a new company.”
“We addressed this by focusing on the key element – manufacturing – that had caused some of the prior challenges in the sector. By partnering with experts such as Cell Therapy Manufacturing Center (CTMC) and Volnay Therapeutics, we were able to address this high-risk point even as a new and very small startup company. We also focused on the extreme patient need and truly promising clinical data in the Phase 1 trial to highlight the unique opportunity to create real patient benefit, which resonated with our investors.”
Significant Milestones
“Moving our lead asset MB-105 out of the academic setting, completing a Phase 1 study, receiving orphan drug designation from the FDA, and launching a Phase 2 trial were significant milestones for us. We closed our Series A in October 2024 and have just dosed the first patient in our Phase 2 trial of MB-105, so it’s an exciting year ahead of us as we continue enrolling new patients.”
Funding
When asking Hein about the company’s funding, she revealed:
“March Biosciences has raised over $52 million to date including both dilutive (venture capital) and non-dilutive sources (grants). Our recent Series A was over $29 million and combined with our Cancer Prevention and Research Institute of Texas (CPRIT) funding, leaves us with sufficient resources to complete the company-sponsored Phase 2a and conduct additional pipeline development.”
Total Addressable Market
“In the US alone, we estimate a $6 billion annual market. Our initial indication, relapsed and refractory T cell lymphoma, is about half of that at $3B. There is a significant lack of therapies available to these patients and so we believe a large proportion would ultimately benefit from our therapy, if approved.”
“And of course, we are excited to continue building our pipeline into new opportunities.”
Differentiation From The Competition
“We are the most advanced cell therapy product in the T cell lymphoma space and our target is quite differentiated, and we believe more broadly applicable, than other approaches. We have also focused diligently to create a manufacturing process for our CAR-T therapy that is shorter, simpler, and more robust in comparison to alternative manufacturing approaches.”
Future Goals
“At the moment, we are highly focused on enrolling patients in our Phase 2 trial in T cell lymphoma. We are looking forward to being able to report our first clinical readouts potentially in late 2025.”
Additional Thoughts
“Our biggest hope in the coming year is that we can make a real impact in T cell lymphoma with a first and best in class option for patients. And there is still a lot of work to be done before we can get there, so we are always looking for new partners and champions to our work who see that same vision.”
