Trailhead Biosystems Raises $6.6 Million in Series A Financing

Trailhead Biosystems is a biotechnology company that came out of Case Western Reserve University in 2015 and optimizes industrial-grade cell culture recipes relevant to cell therapy. Currently, it is pioneering the application of machine-enabled science towards understanding and controlling biology. On November 10th, the company announced that it successfully raised $6.6 million in a Series A funding round. This funding is intended to develop specialized human cells and the expansion of the company’s High Dimensional Design of Experiments platform (HD-DoE). Yale Law School’s Entrepreneurship & Innovation Clinic was critical in closing the Series A financing round.

Trailhead’s Technology

The HD-DoE platform is meant to support creating a variety of specialized human cells with therapeutic properties and their pilot scale manufacturing. Trailhead conducts the largest dimensioned experiments in biology, using machine learning. The company has developed its platform for a systems-level inquisition into biological problems. These problems range from the generation of industrially-scalable human cell bio-manufacturing to combinatorial drug discovery for therapies ranging from cancer to anti-viral. These experiments are meant to discover critical process parameters and combinatorial inputs that explain biological responses. Trailhead’s methods depart from the limited explorative power of traditional hypothesis-driven research.

“Biology is complex, but conventional science is not,” says Jan Jensen, Ph.D., Chief Executive Officer and founder of Trailhead Biosystems. “We created Trailhead Biosystems to address key limitations in the scientific process, unlocking a deeper understanding of the biology that will enable us to better control it.”

Quality-by-Design

The company spearheads the application of Quality-by-Design principles and has converted the traditional discovery process into one centered on systematic engineering to determine critical process parameters for the manufacturing of human cells. Quality by Design is a principle laid out by the FDA’s Office of Biotechnology Products that attempts to guide pharmaceutical development to facilitate the design of products and processes that maximizes the product’s efficacy and safety while enhancing product manufacturability.

Cell culture optimization is often done using single-factor (one factor held constant while another is modified) techniques. The most positive cell response of both experiments then dictates the optimized condition. Most cell culture differentiation media formulations contain 3-6 factors, and so using this method results in 23-26 experiments that need to be done before the best growing conditions for cells can be found. Trailhead can perform 12-factor, simultaneously tested experiments using their methods and rapidly cut down on R&D and manufacturing time as a result.

Trailhead Biosystems uses strong developmental biology knowledge to interpret the results and devise optimized cell culture recipes to differentiate itself from other companies. Many methods are used in the pharmaceutical industry to develop new drugs but have never before been applied in animal cell culture.

Goals and Partnerships

Trailhead aims to develop industrial-scale therapeutics by creating specialized human cell types at high purity for regenerative medicine. This will address the current industry needs for highly specialized cells used in drug discovery and modeling of human diseases. Trailhead’s current products include those targeting Multiple Sclerosis, Parkinson’s, type I diabetes, Alzheimer’s, and blood disorders, along with others.

Along with manufacturing for the private market, Trailhead participates in public-private partnerships. “Trailhead is a key enabling technology developer who works closely with the Advanced Regenerative Manufacturing Institute (ARMI),” through the BioFabUSA program, Tom Bollenbach, Chief Technical Officer, says. ARMI is a U.S. Department of Defense-funded manufacturing innovation institute focused on enabling the scalable, consistent, and cost-effective manufacturing of cell therapies and tissue-engineered medical products.

“I am extremely proud to have helped put Trailhead Biosystems on a path to enable Jan’s extraordinary out-of-the-box science to discover therapeutics that could potentially alleviate conditions that lack a cure today. This Series A financing round is a great vote of confidence in our cutting-edge technology and will allow the company to progress its programs to benefit patients. We are excited to realize our future objective of becoming a key provider of therapeutic human cells to the regenerative medicine industry.” – Magnus Persson, M.D., Ph.D., a seasoned biotech entrepreneur and Chairman of the Board of Trailhead Biosystems.

As the COVID-19 pandemic continues and various treatments are developed, various cell lines will be needed in higher quantities to supply research facilities. It is highly likely that Trailhead’s HD-DoE platform services could be incredibly useful in the coming months.

By Eduardo Longoria

Related Article: Scorpion Therapeutics Scores $108 Million Series A Funding for Oncological Research

References

1. https://www.trailbiosystems.com/news

Author

Eduardo Longoria