Cellares: Shuttling in a New Era of Cell Therapy
By Justin Kao, Jocelyn Kinsey, and Rob Ciechowski
One of our core investment themes at DFJ Growth is Machine Assist, which is characterized by the trends in modern industrial automation, autonomous systems, and advanced robotics. Over the past 15 years, we’ve invested heavily in these trends, seeking out companies that epitomize the evolution toward smart systems across multiple industries, including Anduril, Formlabs, SpaceX, and Tesla. At the core of these systems are product architectures that rely on a unique combination of hardware intertwined with specialized, proprietary software that together create a co-dependent and durable advantage.
In surgical robotics, we see the elegance of tightly integrated hardware and software designs through our investments in Neocis and Neuralink. Now in cancer treatment, we see a similar opportunity to apply an engineering-first approach to a new class of breakthrough therapeutics called cell therapies. Cell therapies can be life-saving but face a major challenge in scaling to millions of patients due to the lack of scalable manufacturing technologies. Even with FDA-approved cell therapies on the market, about 20 percent of eligible patients are dying on the waiting list due to the industry’s inability to meet patient demand.
Cellares is on a mission to accelerate access to life-saving cell therapies by deploying its automated manufacturing platform, called the Cell Shuttle, in its own Smart Factories around the world. We are excited to join them as part of their $255 million Series C financing.
Cell therapy is transforming cancer care. In healthy people, the immune system routinely detects and kills cells that have begun to exhibit properties of cancer. Starting in the early 1990s, researchers began to harness this insight to genetically engineer patients’ immune cells to detect and kill cancer cells. What sounds like science fiction is now a reality. Today, there are six FDA-approved cell therapies for patients with various types of blood cancers. These therapies, which are called CAR-T cell therapies, work by extracting a specific type of immune cell from a patient’s own blood, re-engineering the cells to target specific cancer cell receptors, and then re-infusing the edited cells to attack the patient’s cancer. Cell therapies can be curative, with some patients remaining cancer-free more than a decade after their treatment.
With more than 1,000 clinical trials ongoing, the future of cell therapy is bright. Scientists are now using CRISPR and other gene editing techniques to engineer different types of immune cells and target additional cancer types, including solid tumors. Yet in 2022, only around 6,000 patients were able to receive an FDA-approved cell therapy. The key bottleneck has been manufacturing these individualized therapies. Unlike traditional methods of manufacturing biologic drugs, which rely on large batches made in bioreactors, cell therapy manufacturing remains an artisanal process that requires clean rooms, multiple pieces of equipment made by different companies, and highly specialized human labor. Because each dose is custom-made for the individual patient, manufacturing cell therapies is expensive — with a single patient dose costing up to $300,000 to make — and very challenging to scale, which severely limits access.
We have been following Cellares closely over the past three years. From our first meeting, we were inspired by the vision of co-founders Fabian Gerlinghaus and Omar Kurdi.
They envisioned the Cell Shuttle as a completely closed, end-to-end system with true walk-away automation, enabling up to 16 individual doses to be manufactured in parallel. From centrifuges to electroporators, Cellares took a first-principles engineering approach to every step of the manufacturing process. Because cell therapy developers are innovating so rapidly, Cellares designed the Cell Shuttle to be flexible so it can support a wide variety of cell therapy processes, building modularity into the system both in the hardware and deeply integrated software. Unlike legacy systems, software and data are a core component of the Cell Shuttle. Cellares’ hardware-software integration enables researchers to iterate quickly, including customizing workflows and optimizing parameters; it also enables Cellares to manufacture multiple batches on the same instrument, a breakthrough compared to current approaches. Lastly, Cellares also integrates in-process quality control, a critical component of cell therapy manufacturing that is typically done manually.
The engineering challenge that Fabian and Omar set out to conquer was daunting, which makes their execution all the more impressive as they consistently deliver on ambitious milestones.
In our diligence, we heard repeatedly from experts that the Cellares value proposition is exactly what they need, but that it’d be “just a little crazy” to pull this off. Unanimously, we also heard (and agreed!) that the Cellares team continually surprises industry leaders with how fast they build and execute.
In just four years, Cellares is now the world’s first Integrated Development and Manufacturing Organization (IDMO) and is taking on customers big and small.
To bring scale to the cell therapy market, Cellares is building a 118,000-square-foot IDMO Smart Factory in Bridgewater, New Jersey. This facility will be capable of manufacturing 40,000 cell therapy doses every year, more than 5x the total worldwide commercial doses delivered in 2022. Powered by their Cell Shuttle technology, Cellares expects to manufacture 10x the number of doses as a traditional manufacturer with the same workforce and physical footprint, at a significantly lower cost.
We believe Cellares is well on its way to revolutionizing the way in which cell therapies are brought to market and manufactured at scale. Most importantly, Cellares will play a key role in getting transformative therapies to the patients that need them.
From SpaceX to Tesla, we have seen firsthand the power of vertically integrated approaches. When you combine “just a little crazy” with a world-class team and a product that literally saves lives, you have a company that we are proud to partner with. With our portfolio company Delfi detecting cancer early, and Cellares making the treatments to cure it, the future of cancer care is looking up!