Langer-backed cancer, fibrotic upstart XTuit takes on ex-Forum chief as CEO

Deborah Dunsire hopes to have XTuit's lead product in the clinic early next year.

Deborah Dunsire, M.D., has achieved the rare feat, on International Women’s Day no less, of becoming CEO of an early-stage biotech after being officially named as XTuit Pharmaceuticals’ leader today.

Dunsire, who also becomes president and a board member of the young cancer and fibrotic startup, comes from a long career in the biopharma world after serving for 8 years as president and CEO of Millennium Pharmaceuticals (which became part of Takeda Oncology in a near-$9 billion deal in 2008), while before that working out of Novartis’ North American Oncology Business for over a decade.

Her most recent role was at the troubled CNS biotech Forum Pharmaceuticals (formerly known as EnVivo Pharmaceuticals), but in May of last year she left the private company, coming after the FDA put a hold on two of its Alzheimer’s trials for its lead candidate, which also flubbed two late-stage schizophrenia studies.

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Originally, Xconomy reported that Dunsire left Waltham, Massachusetts-based Forum, three years after becoming its chief, to form a biotech consulting company called Southern Cross Biotech Consulting.

But today, Dunsire has resurfaced as the new lead of XTuit, an upstart focused on creating new meds targeting the disease-promoting microenvironment in fibrotic diseases and cancer.

Why choose a small, early-stage biotech after her early career at larger biopharmas? “What’s clearly different at a smaller biotech is that I’ll be closer to the frontier of science, and I was drawn to that frontier at this point in my career and at this time of breakthroughs in medical research. At a company like XTuit, I can make a contribution on the leading edge of drug development where new science gets transformed into medicines that change lives,” she tells FierceBiotech.

“One thing that’s exhilarating and rewarding at a smaller company is that there is ‘real time’ information that defines a company’s direction and progress.

“Yet there are some things that will be similar for me between small and large drug companies. You see, I have always been a builder. No matter what the size of a drug development company, there are unexpected challenges and course corrections that come with the territory. And yet, this risky path yield opportunities and has been the focus of my building efforts: to build great teams, great markets and great medicines that culminate in making a difference in the lives of patients.”

The company, which now has 30 staffers and expects to expand this year, had been in stealth mode for around 4 years until the summer of 2015, when it gained a $22 million Series A round led by New Enterprise Associates, with founding investor Polaris Partners, CTI Life Sciences, Arcus Ventures, and Omega Funds also taking part.

Its work is preclinical for now, but it is poised to enter the clinic early next year with a focus on fibrotic diseases, which is supported by XTuit’s tissue-based biomarker platform, with a cancer candidate a little further up the road.

Dunsire would not say exactly what areas it was focused on in the fibrotic space (NASH may be a good bet, however, given the major interest across the field), explaining: “We are not disclosing the specific targets and indications quite yet; there are multiple that we are pursuing with our therapeutics. But, I can say we are taking a distinct approach to others in the fields of cancer and fibrosis. We expect important data to come through from our preclinical work in the next 4 to 6 months, and this will guide our decision-making about the indications for the first clinical candidates.”

She said that one of her first areas of focus is to find the “product road map” for XTuit. “I am working with the team to architect this strategy and further define the clinical path and timeline for our pipeline. Data from ongoing preclinical studies will be the guide for this. 

“At this point, the programs in fibrotic diseases are very slightly ahead of the ones in cancer. Importantly, all our programs include the development of multiplex biomarkers through XTuit’s biomarker platform. We expect our first product candidate to go into the clinic in 2018, and I am aiming for the earlier part of that year.”

In terms of corporate/financing strategy, she said there was “a broad range of possibilities,” including a pharma collab on the cards, but things would become clearer in the coming months as early data are generated.  

She added, however, that “I am always keen to carve out core proprietary assets for the companies I lead, as this creates strong value. With XTuit’s leadership in the microenvironment space, I am confident we will have strong opportunities to build value with proprietary assets, but given the number of possible opportunities that are emerging, we may also seek to partner on a strategic few, to progress more in parallel.”

Dunsire said one of the things that attracted her to lead XTuit was its founders and its founding science.

“Before joining XTuit, I spent the most considerable time with our founder, Dr. Rakesh Jain, of Mass General Hospital’s Edwin L. Steele Laboratory for Tumor Biology. Key aspects of XTuit’s unique approach were incubated in Dr. Jain’s lab, and he has incredible insights into cancer biology related to the microenvironment that are impressive and captured my attention and imagination. 

“Ron Evans was very generous with his time, taking me through the outstanding work done in his laboratory at the Salk Institute. The work is incredibly elegant and elucidates a range of targets in the microenvironment.

“I also spent significant time with Bob Langer (Professor at MIT and a perennial startup backer) to discuss the work done at that institution and which we have licensed. Rakesh Jain and Bob Langer sit on our board of directors and are fully engaged! It is astonishing to me that such busy scientists are so consistently thoughtful about how the company can be successful and so responsive to any question we have of them.”