Emerging from the tsunami of abstracts from the nearly here American Society of Hematology (ASH) annual meeting in Orlando, Fla., were data that sent some stocks upward on Wednesday.
Most notably, Constellation Pharmaceuticals Inc. (NASDAQ:CNST) was a huge winner as its shares nearly doubled in value as they closed at $28,10, up $13.33, for a gain of 90.25%. The company posted two abstracts with preliminary data from its MANIFEST phase II trial indicating CPI-0610 showed signs of activity in JAK inhibitor-naïve myelofibrosis. In the third arm of the trial, CPI-0610, a small molecule designed to promote antitumor activity by inhibiting BET protein function that would decrease abnormally expressed genes in cancer, was evaluated in combination with Jakafi (ruxolitinib, Incyte Corp.) in a first-line setting in JAK inhibitor-naïve patients.
The data showed four patients had at least a 35% reduction in spleen volume and at least a 50% drop in total symptom score. Both those measures are the primary endpoints.
In the first and second arms of MANIFEST, CPI-0610 was evaluated as part of a combination therapy with ruxolitinib and as a monotherapy in a second-line setting in ruxolitinib-resistant or -intolerant patients. The new data showed continued signs of activity across a range of parameters, including spleen volume reduction, patient-reported symptom improvement, hemoglobin increases, conversion to transfusion independence in transfusion-dependent patients, and bone marrow fibrosis score improvement. That was consistent with preliminary data.
Precision Biosciences Inc. (NASDAQ:DTIL) also shot higher on the abstract release but by a more modest 17.88%. The company's abstract showed initial phase I data supporting the safety and clinical activity of PBCAR-0191, its CD19-targeted allogeneic CAR T therapy candidate for treating diffuse large B-cell and other aggressive B-cell non-Hodgkin lymphomas. The data indicated preliminary evidence of cell-mediated antitumor activity. Two of the three patients had an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. Both patients progressed due to new lesions (on day 28 and day 60, respectively). The third patient, who had previously progressed following treatment with Yescarta (axicabtagene ciloleucel, Gilead Sciences Inc.), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but had shown evidence of central necrosis, decreased tumor size and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild cytokine release syndrome symptoms.
J.P. Morgan analysts called Precision's data "encouraging" and said "we continue to believe that Precision has a best-in-class allogeneic CAR T platform centered on its ARCUS gene editing technology."
H.C. Wainwright analysts were similarly impressed Wednesday: "These data also indicate the potentially higher quality product from Precision, compared with Allogene [Therapeutics Inc.], considering that Allogene's UCART19 product generated no responses without alemtuzumab. This activity at the low-dose, somewhat unexpectedly is encouraging from our perch."
ASH's annual conference, Dec. 7-10, typically attracts more than 5,000 scientific abstracts each year but only roughly 3,000 are accepted.