The American Society of Hematology conference kicked off Saturday and has driven several directional moves in the stock market.
The annual event is a four-day meeting attended by hematologists from around the world where advances in the field of hematology and clinical programs are discussed at length.
ASH Winners:
Syros Pharmaceuticals Inc SYRS: The company presented new data from the fully enrolled Phase 2 trial of SY-1425 in combination with Bristol-Myers Squibb Co's BMY Vidaza in newly diagnosed acute myeloid leukemia, or AML, patients, showing an overall response rate of 67%, with a complete response rate of 61% as of Oct. 1.
The median duration of response was 10.8 months, and the median overall survival was 18 months. The combo was also found to be generally well-tolerated.
The company also released data from the study of relapsed/refractory RARA-positive AML patients, showing overall response rate of 19% as of Oct. 1 and median overall survival of 5.9 months.
Gamida Cell Ltd GMDA: Presenting updated and expanded results from a Phase 1 study of GDA-201, an investigational natural killer cell-based immunotherapy for the treatment of non-Hodgkin Lymphoma, or NHL, and multiple myeloma, the Boston-based biopharma said the pipeline asset was well-tolerated and no dose-limiting toxicities were observed in 35 patients.
Of the 19 NHL patients, 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%.
Constellation Pharmaceuticals Inc CNST: The company announced data pertaining to the Phase 2 and Phase 3 studies of CPI-0601 in myelofibrosis.
In the first-line arm, where CPI-0610 is being evaluated with Incyte Corporation's INCY Jakafi, about 42 of the 63 evaluable patients achieved more than 35% reduction in spleen volume at 24 weeks, which is the primary endpoint. The median spleen volume reduction was 50%. Thirty-four of the 60 evaluable patients achieved more than 50% reduction in total symptom scores at 24 weeks.
In the second-line or later arm, where CPI-0610 is being evaluated as a monotherapy, 30% of evaluable patients who were not transfusion-dependent at baseline achieved more than 35% reduction in spleen volume at 24 weeks.
CPI-0610, when evaluated with Jakafi in second-line setting, resulting in 29% of non-transfusion dependent patients achieving more than 35% reduction in spleen volume at 24 weeks.
IGM Biosciences Inc IGMS: The biopharma presented Phase 1 dose-escalation study of IgM-based bispecific antibody IGM-2323 in patients with relapsed/refractory NHL, showing as of the data cut-off date of Oct. 30, of the 14 patients treated in the 0.5, 2.5, 10, 30 and 50/100 mg dose cohorts, nine showed evidence of tumor size reduction and two patients showed partial responses
Subsequent to the data cutoff, the two patients with follicular lymphoma treated at the 50/100 mg titration dose converted to complete responses.
Fate Therapeutics Inc FATE: The company presented a single patient case study from the Phase 1 study of FT596, which showed the heavily pre-treated patient with diffuse large B-cell lymphoma administered with a second single dose saw a deepening response as evidenced by further decrease in both tumor size and metabolic activity.
No dose-limiting toxicities were observed.
The company also released positive interim data from the Phase 1 study of FT516 in combination with Roche Holdings AG's Basel ADR Common Stock RHHBY Rituxan for B-cell lymphoma.
Losers:
Aptose Biosciences Inc APTO: The biopharma provided an update on CG-806, which is being evaluated in a Phase 1a/b study for refractory/relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. The company said the dose escalation study continues, showing progressive accrual of leading indicators of pharmacologic and clinical activity.
The company also shed light on the AML trial.
The negative reaction to Aptose's update may have to do with the fact that no official responses have been observed yet, HC Wainwright analyst Joseph Pantginis said in a Monday note.
Mustang Bio Inc MBIO: Mustang announced interim Phase 1/2 data for MB-106 in patients with relapsed/refractory B-cell NHL, showing extremely favorable safety profile and clinical activity.
An overall response rate of 89% and complete response rate of 44% were observed in the nine patients treated with the modified process. In patients with follicular lymphoma, the overall response rate and complete response rate were 85% and 57% from both the original and modified manufacturing processes.
The Price Action: At last check:
- Syros Pharma shares were advancing 22.07% to $9.47.
- Gamida Cell shares were rallying 48.68% to $10.36.
- Constellation Pharm was jumping 33.39% to $30.20.
- IGM Biosciences shares were rising 14.34% to $71.53.
- Fate shares were surging up 40.11% to $85.17.
- Aptose was slumping 19.61% to $4.92.
- Mustang Bio shares were sliding 17.97% to $3.15.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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