Toxic leukoencephalopathy

SELLAS Announces Positive Phase 1 Data with CDK9 Inhibitor GFH009 Monotherapy in Patients with Relapsed/Refractory Hematologic Malignancies

Retrieved on: 
Tuesday, December 13, 2022

NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies. Results include preliminary safety and efficacy data presented this week at the American Society of Hematology (ASH) Annual Meeting, along with updated data since the ASH abstract cutoff date of August 2, 2022.

Key Points: 
  • NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies.
  • Anti-cancer effects were also observed at multiple dose levels in both the r/r AML and r/r lymphoma treatment groups.
  • Neutrophil counts improved in most patients from both groups while on treatment, and drug-related severe neutropenias were observed in less than 10% of enrolled patients.
  • GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications.

Aptose Announces Updated Clinical Responses, Breadth of Activity, and Safety Across Four Dose Levels of Tuspetinib in Difficult-to-Treat Acute Myeloid Leukemia Populations

Retrieved on: 
Sunday, December 11, 2022

“The welcome blend of safety and breadth of activity seen with tuspetinib in AML patients makes this an ideal candidate for combination therapy,” remarked Dr. Daver.

Key Points: 
  • “The welcome blend of safety and breadth of activity seen with tuspetinib in AML patients makes this an ideal candidate for combination therapy,” remarked Dr. Daver.
  • Prior to Aptose licensing tuspetinib, Hanmi Pharmaceutical Company demonstrated complete remissions at the 80 mg dose level.
  • As of January 1, 2022, Aptose assumed control of clinical trial activities and has demonstrated additional complete remissions at the 120 mg, 160 mg, and now the 40 mg dose levels.
  • Vignettes of patient experiences highlight the potency and breadth of tuspetinib to deliver complete remissions among several mutationally-defined populations with a diversity of adverse mutations.

Aptose to Hold Clinical Update and Data Review of AML Drug Tuspetinib on Sunday, December 11th

Retrieved on: 
Wednesday, December 7, 2022

The webcast event will include a comprehensive review of current clinical data for Aptose’s lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose’s oral, dual lymphoid and myeloid kinase inhibitor.

Key Points: 
  • The webcast event will include a comprehensive review of current clinical data for Aptose’s lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose’s oral, dual lymphoid and myeloid kinase inhibitor.
  • The data review will highlight results from the recently completed Phase 1/2 dose escalation clinical trial of tuspetinib.
  • The slides will be available on Aptose’s website here and the webcast of the presentation will be archived shortly after the conclusion of the event.
  • Note that the poster presentations will include additional data not found in the previously published abstracts.

Humanetics Corporation Presents at the MedInvest Oncology Investor Conference

Retrieved on: 
Friday, December 16, 2022

Humanetics Corporation, a clinical-stage pharmaceutical company focused on novel products to improve outcomes for patients with cancer, presented at the MedInvest Oncology Investor Conference in New York City on December 15, 2022.

Key Points: 
  • Humanetics Corporation, a clinical-stage pharmaceutical company focused on novel products to improve outcomes for patients with cancer, presented at the MedInvest Oncology Investor Conference in New York City on December 15, 2022.
  • At the conference, Ronald Zenk, President and Chief Executive Officer at Humanetics, delivered a corporate overview and details on the companys lead drug candidate, BIO 300.
  • BIO 300 is a new class of drug focused on improving outcomes in cancer patients who receive first-line radiotherapy with or without concurrent chemotherapy.
  • These patients suffer from myriad unintended side effects, which can reduce the efficacy of treatment and/or result in serious toxicities.

Syros Presents Safety Lead-in Data from SELECT-AML-1 Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine and Announces Plans to Initiate Randomized Portion of Phase 2 Trial

Retrieved on: 
Saturday, December 10, 2022

As of October 13, 2022, eight newly diagnosed, unfit, RARA-positive patients had been enrolled in the trial, including six who were evaluable for response.

Key Points: 
  • As of October 13, 2022, eight newly diagnosed, unfit, RARA-positive patients had been enrolled in the trial, including six who were evaluable for response.
  • - Tamibarotene in combination with venetoclax and azacitidine administered at approved doses showed no evidence of increased toxicity relative to the doublet combination of venetoclax and azacitidine.
  • This includes rates of myelosuppression, which were comparable to reports with venetoclax and azacitidine in this population.
  • The randomized portion is expected to initiate in Q1 2023, with data expected in 2023 or 2024.

KSQ Therapeutics Announces First Patient Dosed in Combination Portion of the Ongoing Phase 1 Study of KSQ-4279, a First-In-Class USP1 Inhibitor, in Patients with Advanced Solid Tumors

Retrieved on: 
Wednesday, December 7, 2022

This stage of the clinical study will investigate KSQ-4279 across multiple indications, both in combination with a PARP inhibitor and in combination with chemotherapy.

Key Points: 
  • This stage of the clinical study will investigate KSQ-4279 across multiple indications, both in combination with a PARP inhibitor and in combination with chemotherapy.
  • "The initiation of the combination therapy portion of the study is a significant milestone for KSQ.
  • Study KSQ-4279-1101 is a Phase 1 clinical trial expected to enroll approximately 140 patients with advanced solid tumors.
  • KSQ-4279 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors.

Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

Retrieved on: 
Tuesday, December 13, 2022

The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

Key Points: 
  • The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.
  • "CFI-400945 had previously shown single agent complete remissions in refractory high risk AML.
  • Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.
  • The Company's internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor).

Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

Retrieved on: 
Tuesday, December 13, 2022

The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

Key Points: 
  • The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.
  • "CFI-400945 had previously shown single agent complete remissions in refractory high risk AML.
  • Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.
  • The Company's internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor).

Curis Announces Additional Encouraging Clinical Data from TakeAim Leukemia Study of emavusertib (CA-4948) in Monotherapy R/R AML and hrMDS

Retrieved on: 
Monday, December 12, 2022

LEXINGTON, Mass., Dec. 12, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib (CA-4948), a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. Patients in a targeted population are those with disease harboring U2AF1, SF3B1 (collectively "spliceosome") or FLT3 mutations. The company also announced positive initial data of emavusertib in combination with venetoclax in patients with AML or hrMDS that enrolled in the combination phase (Phase 1b) of the TakeAim Leukemia study prior to the partial clinical hold placed in April 2022.

Key Points: 
  • This represents 11 additional patients treated in targeted monotherapy populations and 13 additional patients in the non-targeted monotherapy population.
  • In addition to the monotherapy data, there are 4 patients with AML/hrMDS who have been treated with emavusertib in combination with venetoclax.
  • Previous data presented by Curis highlighted preliminary efficacy data of emavusertib in R/R AML/MDS patients whose disease is characterized by spliceosome or FLT3 mutation.
  • TakeAim Leukemia Study (NCT04278768) - This study is only enrolling in the monotherapy dose finding phase (phase 1a) of the study.

CellCentric presents early clinical data at ASH: inobrodib (CCS1477), first in class p300/CBP bromodomain inhibitor treating relapsed refractory multiple myeloma

Retrieved on: 
Monday, December 12, 2022

Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."

Key Points: 
  • Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."
  • Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational
    CellCentric has developed inobrodib from concept through to clinical trials.
  • It is an oral, first in class small molecule inhibitor drug that targets twin cancer gene regulators p300 and CBP.
  • The company actively pursued multiple drug discovery programmes before prioritising p300/CBP inhibition and inobrodib.