|Over a week ago|
Fly Intel: Pre-market Movers » 09:0507/1607/16/20
ACIU, LCI, DELL, PAG, ABT, BAC, TWTR, TCDA, DIS, APTO, VMW
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Aptose Biosciences 10.5M share Spot Secondary priced at $5.25 » 06:2207/1607/16/20
The deal range was…
The deal range was $5.25-$5.50. Piper Sandler acted as sole book running manager for the offering.
Fly Intel: After-Hours Movers » 19:0507/1507/15/20
AA, PIXY, HIG, NBRV, RTIX, DELL, VMW, SPCE, MNK, DKNG, SNBR, TCDA, APTO, CYTK, BCEL, TWTR, FEYE
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Aptose Biosciences announces offering of common shares, no amount given » 16:0307/1507/15/20
Aptose Biosciences announced that it has commenced an underwritten public offering of its common shares. Aptose intends to use the net proceeds of the offering to (i) accelerate and expand clinical trials for CG-806; (ii) accelerate and expand clinical trials for APTO-253; (iii) acquire and fund (including through partnerships and in-licensing) additional clinical assets; and (iv) for working capital and general corporate purposes. Piper Sandler is acting as the sole active book-running manager for the offering.
|Over a month ago|
Aptose receives FDA allowance of IND for Phase 1a/b study of CG-806 » 07:0406/2906/29/20
Aptose Biosciences announced that the U.S. Food and Drug Administration completed its review of the company's Investigational New Drug application and has granted IND allowance for the initiation of a Phase 1a/b clinical study of CG-806, the company's highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia. CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia and non-Hodgkin's lymphomas, who have failed or are intolerant to current therapies. Aptose intends to initiate the Phase 1 a/b study in the second half of 2020 in AML patients who have relapsed, are resistant or refractory to current treatment.
Aptose Biosciences' EHA update 'incrementally positive,' says Piper Sandler » 13:2506/1206/12/20
Following an update made…
Following an update made in conjunction with the the Congress of the European Hematology Association, or EHA, meeting, Piper Sandler analyst Tyler Van Buren said the Phase I dose escalation trial for 806 "continues to progress well." An "added surprise" reported by Aptose Biosciences was that lymphocytosis was observed early in a DL4 CLL/SLL patient, which "continues to suggest that 806 is reaching therapeutically-active levels in patients," according to Van Buren. The analyst, who said he continues to "like the setup into ASH," reiterates an Overweight rating on Aptose shares following what he called an "incrementally positive" update.
JonesTrading optimistic about potential of Aptose Biosciences' CG-806 » 11:0006/1206/12/20
JonesTrading analyst Matthew Cross keeps a Buy rating and $12 price target on Aptose Biosciences amid the company's key update on the Phase 1 dose-escalation study of CG-806 in patients with r/r B-cell malignancies at the EHA virtual conference. While the analyst noted that this is still preliminary at this stage, he said he is "increasingly optimistic" about the potential of CG-806.
Aptose Biosciences presents early Phase 1a/b CG-806 clinical findings » 07:0306/1206/12/20
Aptose Biosciences announced that new clinical data on CG-806, its oral, first-in-class FLT3/BTK cluster selective kinase inhibitor, was presented in a poster presentation today at the 25th Congress of the European Hematology Association, EHA25 Virtual Congress. Early Clinical Findings from a Phase 1 a/b Dose Escalation Trial to Evaluate the Safety and Tolerability of CG-806 in Patients with Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas reviewed CG-806 data for eight patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma or non-Hodgkin's lymphoma in the first in-human Phase 1 a/b, open-label, single arm, multicenter dose-escalation clinical study. The poster is available on the posters and presentations section of the Aptose website here. For more information on the ongoing study, please visit www.clinicaltrials.gov here. CG-806 was well-tolerated in patients treated at 150mg, 300mg and 450mg BID over multiple cycles, with no drug-related dose-limiting toxicities or serious adverse events. CG-806 treatment led to lymphocytosis in two CLL patients and delivered complete inhibition of phospho-BTK and multiple oncogenic survival pathways in all patients receiving greater than or equal to 300mg BID. Plasma from CG-806 treated patients completely inhibited phospho-FLT3 in a plasma inhibitory activity assay, and patients receiving greater than or equal to 300mg BID achieved steady state PK levels known to be effective in murine tumor models. Separately, Aptose announced it has submitted an IND for a parallel Phase 1 a/b clinical study of CG-806 in patients with relapsed or refractory FLT3-mutant or FLT3-wildtype acute myeloid leukemia.
Aptose Biosciences reports Q1 EPS (15c), consensus (15c) » 16:0405/0505/05/20
Total cash and cash…
Total cash and cash equivalents and investments as of March 31, were $90M. Based on current operations, the company expects that cash on hand and available capital provide the company with sufficient resources to fund all planned company operations including research and development into 2022."I'm pleased to report that Aptose has made significant progress thus far in 2020. Despite external turmoil caused by the COVID-19 pandemic, we've continued to advance our two clinical programs, CG-806 and APTO-253, and continued dose escalation," said William G. Rice, chairman, president and CEO. "Both drug candidates continue to demonstrate favorable safety profiles to date, and have generated proof of pharmacologic activity and early indications of clinical activity. CG-806 has, thus far, materialized as resilient to the COVID-19 disruptions because of its profile as a safe, orally administered agent directed at critically ill patients with hematologic malignancies and because of the sites chosen for our clinical studies. We look forward to reporting our progress on both clinical fronts at major hematology conferences throughout the remainder of the year."
|Over a quarter ago|
Aptose Biosciences presents preliminary data on CG-806 » 09:0704/2704/27/20
Aptose Biosciences presented the early clinical data on CG-806, the company's oral, first-in-class FLT3/BTK cluster selective kinase inhibitor, at the AACR Virtual Annual Meeting I, in lieu of the live oral presentation originally planned. Rafael Bejar M.D., Ph.D., Aptose's Chief Medical Officer, presented a video summary of Abstract # 9967 - Early clinical findings from a phase 1a/b dose escalation trial to evaluate the safety and tolerability of CG-806 in patients with relapsed or refractory CLL/SLL or non-Hodgkin's lymphomas. The first-in-human tests of CG-806 are being carried out in a Phase 1a/b clinical study. The target population in the study includes patients with significant unmet needs including patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic leukemia or non-Hodgkin lymphoma (NHL) who have failed or been intolerant to two lines of established therapy. CG-806 is administered as oral capsules dosed twice daily in 28-day cycles. The study design includes an accelerated titration followed by a 3+3 dose escalation to establish the recommended Phase 2 dose for planned expansion cohorts and future studies. The first patient, treated with 150 mg BID of CG-806, was heavily pretreated, carried a TP53 mutation, and had severe thrombocytopenia prior to study entry. This patient currently is in the eleventh cycle of therapy without having experienced a dose-limiting toxicity and has been dose escalated to the 450 mg BID dose level. The second patient, treated at the 300 mg BID dose level, had significant marrow involvement with neutropenia and thrombocytopenia at study entry, and developed a brisk lymphocytosis, but did not experience a DLT through four cycles of therapy including no worsening of their thrombocytopenia or neutropenia. The study has now completed three dose levels without observing any drug-related severe adverse events and has not reached a dose-limiting toxicity. Three patients completed the safety evaluation period at the third dose level, 450 mg BID, and as a result, the fourth dose level was opened. The first patient, previously dosed at 150 mg BID was dose escalated to dose level 3 at 450 mg BID. Enrollment is open and dosing is ongoing at the 600 mg BID dose level with no drug-related SAEs or DLTs encountered to date. Key findings to date: No drug-related SAEs or DLTs have been observed in patients to date. CG-806 demonstrates favorable steady state pharmacokinetics evidenced by stable trough plasma concentrations reached by Day 8 in the first two patients treated at dose levels 1 and 2. CG-806 has shown on-target pharmacologic activity demonstrated by plasma inhibitory assays with reporter cells exposed to patient plasma for 6 hours. Phospho-BTK is markedly reduced after exposure to plasma from the patient treated at dose level 1 and completely abrogated with plasma form the patient treated at dose level 2. Similar results are seen for the phosphorylation of PDGFR-alpha, a target of CG-806, for SYK, which lies in the same signaling pathway as BTK and for ERK. Lymphocytosis was noted at dose level 2 - pharmacologic BTK inhibition in CLL promotes exfiltration.