a small patient study of ublituximab consisting of 12 patients with advanced relapsed/refractory chronic lymphocytic leukemia. Of the 12, half of them saw their tumors shrink by more than 50 percent.
“[That’s] pretty remarkable activity, and it certainly doesn’t occur by chance in cancer,” he says. “If we didn’t see the activity that we saw even before we took in this drug, TG wouldn’t exist today.”
Indeed, the drug presented an opportunity for Weiss, who had learned from his previous experiences at Keryx: start with a low-risk asset you are confident will work, and then build a portfolio behind it.
So Weiss pounced. LFB spun out TG and handed it the rights to ublituximab in return for an equity stake, plus royalties and milestones tied to the drug’s success. Weiss then raised $25 million from unspecified investors and reverse-merged the company with a publicly-traded biotech known as Manhattan Pharmaceuticals.
Much like he did when stacking ferric citrate on top of perifosine, Weiss then moved quickly to add a drug he could offer in tandem with ublituximab, specifically searching for either PI3K inhibitors, or Btk inhibitors—both of which scientists say are likely to work in combination with CD20 inhibitors such as ublituximab. Ultimately, TG grabbed the rights to a PI3K inhibitor from Switzerland-based Rhizen Pharmaceuticals in August.
Weiss’ thesis for TG going forward is this: almost all of the patients that take rituximab end up taking something else after the drug stops working. Weiss expects this market, which contains a lot of old generic chemotherapies, to triple over the next 10 to 15 years with the introduction of newer, more effective, and more expensive drugs such as PI3K inhibitors and Btk inhibitors. His plan is for TG’s cancer drugs to find a niche among the several potential treatment cycles after patients stop responding to rituximab. For a small company like TG, even a small portion of that market could change its value dramatically.
“You’re most likely to see an anti-CD20 plus a Btk inhibitor, or an anti-CD20 plus a PI3K inhibitor, than any of those drugs given alone in those third, fourth, and fifth- line settings,” he says. “We hope that every time someone thinks of taking a Btk inhibitor off the shelf, they’re going to pick our anti-CD20.”
The next year will go along way towards proving it. At the American Society of Clinical Oncology’s annual meeting in June, TG will present the data from the early-stage portion of its study of ublitximab in patients with non-Hodgkin’s lymphoma who either haven’t responded to rituximab or have relapsed. TG will release the data from the mid-stage portion of the study at the American Society of Hematology’s yearly meeting in December, as well as early-stage data from a separate study combining the treatment with Celgene’s lenalidomide (Revlimid). In the meantime, it is trying to get as many patients onboard as it can to prove to the world that its drug’s promise is real.
“That’s exactly what Pharmacyclics did, that’s exactly what Infinity has done,” he says. “The more patients you’ve put on, the more confidence you can give around the activity level of your drug, and the valuation increases.”
