When Donald Hayden, a 25-year veteran of Bristol-Myers Squibb, joined WindMIL Therapeutics as its executive chairman, he figured he would steer the ship until the company’s board picked a permanent CEO. But as he got to know the company and the marrow-infiltrating lymphocytes from which it takes its name, he “threw his hat into the ring” and came out the other side four months later as WindMIL’s full-time chief.
It is his first full-time executive role since leaving Bristol-Myers back in 2006.
“I left BMS almost exactly 13 years ago, in March 2006, and I did continue to work full-time, it’s just been a different type of employment,” he told FierceBiotech. He’s advised a number of companies over the years, including Regenxbio, Amicus Therapeutics and the VC firm Prospect Venture Partners, and estimates that he has chaired about 15 boards.
“Over the last few years, I’ve concentrated my focus on a few companies and a few boards, and have really wanted to play a much more complete role in those companies,” he said. “I had created some space to do other things and that effort coincided with moving into the interim CEO role at WindMIL.”
WindMIL, which is based in Baltimore and Philadelphia, was founded upon the work of Ivan Borrello, M.D., and Kimberly Noonan, Ph.D, of Johns Hopkins University. It is working to develop what it calls marrow infiltrating lymphocytes (MILs); its approach involves extracting, activating and expanding T cells taken from a patient’s bone marrow.
WindMIL wants to develop MILs both as a pipeline of treatments and as a platform that can be tweaked to create new types of T-cell treatments.
“Memory T cells derived from bone marrow have a specific set of characteristics that we believe makes them particularly effective in the treatment of both hematological and solid tumors,” Hayden said. These are what WindMIL refers to as unmodified MILs.
On the other hand, modified MILs are T cells that have been genetically modified such as by attaching a chimeric antigen receptor (CAR). WindMIL reckons that combining its technology with CAR-T—making “MIL CARs”—could improve the success rate of CAR-T therapies. The company’s MIL CAR work is in the preclinical stage.
CAR-T treatments like Kymriah and Yescarta use T cells taken from a patient’s blood, Hayden said. Though CAR-Ts have shown promising results in blood cancers, the response they elicit can be short-lived, and they have seen limited success in solid tumors. Using marrow-derived T cells rather than T cells from peripheral blood could address those issues, he said.
Johns Hopkins has done a small phase 1 study in 25 patients with high-risk multiple myeloma—that is, patients who have relapsed and are difficult to treat—and is running a larger phase 2 trial in the same type of patients. The phase 2 study will read out in the second half of 2020. Meanwhile, WindMIL will focus on bringing its unmodified MILs into the clinic for solid tumors.
“We will, this quarter, file an IND seeking approval to begin a phase 2 clinical trial of MILs in non-small cell lung cancer later this year. We will be looking at patients who are either refractory to, or relapsed on, PD-1 therapy,” Hayden said. The company expects to generate data for that study in the middle of next year.
As for MIL CARs, WindMIL is in talks with a number of companies in the CAR-T space who’ve already developed CAR-T technology. It wants to move as quickly as possible, developing CAR MILs, moving them into the clinic and ultimately to patients, and it thinks the best way to do so is “through a partnership of some sort,” Hayden said.
Founded in 2016, WindMIL has been building out its leadership team lately, adding a chief development officer, vice president of operations and a vice president of process science and manufacturing all in the past few months. Its headcount is 15—“hopefully soon to be 16,” Hayden said—with its staffers divided evenly between Philadelphia and Baltimore.