Much of the broader life sciences community has been waiting to see what Doug Williams has been up to since leaving his position as R&D head at Biogen this past July.
Now we know: Williams is launching Codiak BioSciences, a biotech startup that is using exosomes as a new tool for therapeutics and diagnostic development for a wide range of diseases, beginning with pancreatic cancer.
The startup just closed out the first tranche of an $80 million Series A and B round – enough, Williams said in a phone interview, to potentially commercialize an exosome-based pancreatic cancer diagnostic. He also anticipates bringing an exosome-based therapeutic to clinical trial as early as next year.
The underlying technology comes from the labs of Raghu Kalluri, chairman of the department of cancer biology at MD Anderson. It’s cofounded by Eric Lander, president and founding director of Harvard and MIT’s Broad Institute.
Williams said that Kalluri has found a protein that’s specifically expressed om the surface of exosomes from pancreatic cancer. He’s developed an assay that’s worked in animal models and also humans that’s “100 percent specific and 100 percent sensitive” for pancreatic cancer detection, Williams said. “It’s a true statement.”
Exosome analysis yields wide-ranging possibilities for liquid biopsy, Williams said – because “what’s inside exosomes is really a reflection of what’s going on inside a cell.”
It’s fairly simple to produce exosomes, as they can be created from virtually any cell culture. Exosomes, which are small lipid particles that work as extracellular vessels to allow intracellular communication, are produced naturally by all cells. So it’s just a matter of harvesting them, purifying them, and then loading them with an inhibitory RNA or other payload, Williams said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“We have quite a bit of preclinical data that hasn’t been published yet that provides the proof of concept,” Williams said.
After all, when an exosome from one cell fuses with the membrane of another cell, it dumps these contents into the cytoplasm – changing the biology of the recipient cell. So if messenger RNA is in the exosome, it’ll be translated into protein in the receiving cell – which is the general concept behind Codiak’s new therapeutic line.
Williams enjoyed success in the four years he held the top R&D spot at Biogen. This came thanks to an R&D overhaul led by Williams – he cut 17 R&D programs he believed were flailing, and added others he believed had strong market potential. Since, the company has done well with its Alzheimer’s and multiple sclerosis pipelines, and its stock has grown accordingly.
“We’re not working with Biogen at the moment, but one of the areas that exosomes could be very valuable in is neurodegeneration – particularly Alzheimer’s disease,” Williams said.
Funding was led by ARCH Venture Partners and Flagship Ventures, with other investors including Fidelity Management, the Alaska Permanent Fund and Alexandria Venture Investments.
“We have enough funding now that our goal is to demonstrate some significant proof of concept,” Williams said. “From there, that could be enough to allow the company to go public, or broaden opportunities for partnerships. That $80 million we have to start out with will carry us a far distance.”
