Cytarabine

Nurix Therapeutics Presents Data from Studies of Its Targeted Protein Degraders in B Cell Malignancies and Initiates Expansion of NX-2127 Phase 1b Trial in Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma Indications

Retrieved on: 
Wednesday, June 14, 2023

SAN FRANCISCO, June 14, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced the presentation of clinical and preclinical data from its targeted protein degradation programs, NX-5948 and NX-2127, which are being evaluated in ongoing Phase 1 clinical trials in patients with relapsed/refractory B cell malignancies. These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.

Key Points: 
  • These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.
  • Limitations of current covalent and non-covalent BTK inhibitors include the susceptibility to mutational escape as a basis for resistance.
  • Nurix’s BTK degraders have the potential to address these limitations of BTK inhibitors and provide a new therapeutic option for patients.
  • Nurix is announcing plans to initiate two new Phase 1b dose expansion cohorts in the ongoing Phase 1a/1b clinical trial of NX-2127 in patients with relapsed or refractory B-cell malignancies.

Notable Labs Presents Data Demonstrating PPMP’s Potential to Identify Novel Drug Combinations in JMML at the 2023 EHA Hybrid Congress

Retrieved on: 
Friday, June 9, 2023

FOSTER CITY, Calif., June 09, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Inc. (“Notable”), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today presented data from an ex vivo study demonstrating the potential for its Predictive Precision Medicine Platform (PPMP) to identify more active investigational pre-hematopoietic stem cell therapy (pre-HCST) regimens for the treatment of juvenile myelomonocytic leukemia (JMML) at the European Hematology Association (EHA) Hybrid Congress being held in Frankfurt, Germany on June 8 – 15, 2023.

Key Points: 
  • Of 130 drug combinations, 27 were shown to be more active in killing leukemic cells ex vivo than compounds represented in these combinations on their own.
  • These results highlight PPMP as a potential tool for identifying superior drug combinations for patients with high medical needs, including with JMML.
  • Abstract title: Tretinoin and calcitriol enhance treatment regimens for juvenile myelomonocytic leukemia in ex vivo drug sensitivity assays.
  • Additional meeting information can be found on the 2023 EHA Congress website, https://ehaweb.org/congress/eha2023-hybrid-congress/eha2023/ .

Foghorn Therapeutics Announces FDA Has Lifted Clinical Hold on Phase 1 Study of FHD-286 in Relapsed and/or Refractory AML/MDS Patients

Retrieved on: 
Monday, June 5, 2023

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.“With a focus on patient safety, we have worked with the FDA to resolve the clinical hold on FHD-286 in AML and MDS,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Clinical data suggest FHD-286 is a potent, broad-based differentiation therapeutic, and we believe it has significant combination potential as a treatment in AML. We anticipate commencing a Phase 1 combination study focusing on first-line relapsed and/or refractory AML patients in the third quarter of 2023.”

Key Points: 
  • Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.
  • Foghorn has amended the protocol and plans to commence a Phase 1 study of FHD-286 in combination with decitabine or low-dose cytarabine (LDAC) in relapsed and/or refractory AML patients.
  • Foghorn plans to commence the Phase 1 combination study of FHD-286 in relapsed and/or refractory AML patients in the third quarter of 2023.
  • The study will enroll relapsed and/or refractory AML patients and the protocol allows for first-line relapsed and/or refractory AML patients.

Notable Labs to Present Predictive Precision Medicine Platform (PPMP) Data in Juvenile Myelomonocytic Leukemia (JMML) at European Hematology Association (EHA) Hybrid Congress June 8 – 15, 2023

Retrieved on: 
Wednesday, May 17, 2023

FOSTER CITY, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Inc. (“Notable”), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced an abstract has been accepted for poster presentation at the European Hematology Association (EHA) Hybrid Congress to be held in Frankfurt, Germany on June 8 – 15, 2023.

Key Points: 
  • FOSTER CITY, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Inc. (“Notable”), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced an abstract has been accepted for poster presentation at the European Hematology Association (EHA) Hybrid Congress to be held in Frankfurt, Germany on June 8 – 15, 2023.
  • The abstract highlights results of a research study demonstrating the utility of Notable’s PPMP for identifying potentially more effective pre-hematopoietic stem cell therapy drug combinations, as compared to regimens currently used in JMML.
  • The study showed that the addition of tretinoin to fludarabine + cytarabine or to 5-azacitidine, or calcitriol to 5-azacitidine, to patients’ samples further reduced the ex vivo blast counts compared to treatment with only fludarabine + cytarabine, or 5-azacitidine, respectively.

Nkarta Reports First Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, May 11, 2023

Cash and Cash Equivalents: As of March 31, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of $332.1 million.

Key Points: 
  • Cash and Cash Equivalents: As of March 31, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of $332.1 million.
  • Non-cash stock-based compensation expense included in R&D expense was $2.1 million for the first quarter of 2023.
  • Non-cash stock-based compensation expense included in G&A expense was $2.7 million for the first quarter of 2023.
  • Net Loss: Net loss was $30.8 million, or $0.63 per basic and diluted share, for the first quarter of 2023.

Jazz Pharmaceuticals to Showcase Rapidly Expanding Oncology Pipeline and Advances in Current Product Portfolio at ASCO 2023

Retrieved on: 
Thursday, April 27, 2023

DUBLIN, April 27, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with its partners, will present nine abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023. Presentations include clinical data from trials of zanidatamab, Zepzelca® (lurbinectedin) and Vyxeos® (daunorubicin and cytarabine).

Key Points: 
  • Presentations include clinical data from trials of zanidatamab, Zepzelca® (lurbinectedin) and Vyxeos® (daunorubicin and cytarabine).
  • "The breadth of oncology data being presented by Jazz and our partners reflects our relentless focus on raising the standard of care for some of the most difficult-to-treat cancers."
  • Pivotal data from the Phase 2b study of the bispecific antibody zanidatamab in previously treated HER2-amplified BTC was selected by ASCO as an oral presentation.
  • Other presentations at the annual meeting feature data from our oncology pipeline and current product portfolio, across a range of solid tumors and hematological malignancies, include:
    The full ASCO abstracts will be available on May 25, 2023, after 5 p.m.

Jazz Pharmaceuticals to Showcase Rapidly Expanding Oncology Pipeline and Advances in Current Product Portfolio at ASCO 2023

Retrieved on: 
Thursday, April 27, 2023

DUBLIN, April 27, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with its partners, will present nine abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023. Presentations include clinical data from trials of zanidatamab, Zepzelca® (lurbinectedin) and Vyxeos® (daunorubicin and cytarabine).

Key Points: 
  • Presentations include clinical data from trials of zanidatamab, Zepzelca® (lurbinectedin) and Vyxeos® (daunorubicin and cytarabine).
  • "The breadth of oncology data being presented by Jazz and our partners reflects our relentless focus on raising the standard of care for some of the most difficult-to-treat cancers."
  • Pivotal data from the Phase 2b study of the bispecific antibody zanidatamab in previously treated HER2-amplified BTC was selected by ASCO as an oral presentation.
  • Other presentations at the annual meeting feature data from our oncology pipeline and current product portfolio, across a range of solid tumors and hematological malignancies, include:
    The full ASCO abstracts will be available on May 25, 2023, after 5 p.m.

Marker Therapeutics Reports Fiscal Year 2022 Corporate and Financial Results

Retrieved on: 
Wednesday, March 22, 2023

HOUSTON, March 22, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported fiscal year 2022 financial results and provided updates for its clinical development programs.

Key Points: 
  • Cash Position and Guidance: At December 31, 2022, Marker had cash and cash equivalents of $11.8 million.
  • R&D Expenses: Research and development expenses were $26.1 million for the year ended December 31, 2022, compared to $27.8 million for the year ended December 31, 2021.
  • G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2022, compared to $12.9 million for the year ended December 31, 2021.
  • Net Loss: Marker reported a net loss of $29.9 million for the year ended December 31, 2022, compared to a net loss of $41.9 million for the year ended December 31, 2021.

Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

Retrieved on: 
Monday, February 13, 2023

HOUSTON, Feb. 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.

Key Points: 
  • The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin.
  • "We also are encouraged by the absence of cardiotoxicity with Annamycin to date," Mr. Klemp added.
  • 20 subjects were enrolled in the trial with the age range of 24-76 years with a median age of 64.5.
  • As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial.

Biosight Launches a Phase 1/2 Clinical Trial of Aspacytarabine in Combination with Venetoclax for First-Line AML Induction Therapy, Followed by Aspacytarabine Consolidation

Retrieved on: 
Tuesday, November 22, 2022

The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.

Key Points: 
  • The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.
  • We are therefore very excited to be launching this first combination therapy trial".
  • Results from a recently completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and impressive single-agent activity.
  • Additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML.