Cytarabine

Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024

Retrieved on: 
Tuesday, April 9, 2024
Toxicity, Flow cytometry, Labs, Bone marrow, AML, Patient, Cytarabine, Acute myeloid leukemia, PLK1, AACR, BSA, De novo, Poster, Pharmaceutical industry

“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.

Key Points: 
  • “We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.
  • Our clinical program will incorporate the co-development of a companion diagnostic test,” said Thomas Bock, M.D., Chief Executive Officer of Notable.
  • Notable Labs provided an updated plan for the design of an open label Phase 2 study, including a dose optimization plan aimed at reducing toxicity while maintaining efficacy and an overview of study objectives and endpoints.
  • These preliminary metrics predict that 32-33% of de novo patients and 25% of R/R AML patients would be predicted to be responders if they were treated with volasertib.

Nkarta Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, March 21, 2024
Research, Conference, Cy, AML, Patient, SAN, Lymphoma, Cytopenia, Cytarabine, European Hematology Association, G&A, SLE, NHL, Clinical trial, Investment, Society, Safety, Depreciation, NK, Autoimmune disease, Pharmaceutical industry

Research and development (R&D) expenses were $96.8 million for the full year 2023 and $23.3 million for the fourth quarter of 2023.

Key Points: 
  • Research and development (R&D) expenses were $96.8 million for the full year 2023 and $23.3 million for the fourth quarter of 2023.
  • Non-cash stock-based compensation expense included in R&D expense was $8.0 million for the full year 2023 and $1.7 million for the fourth quarter of 2023.
  • General and administrative (G&A) expenses were $34.9 million for the full year 2023 and $7.9 million for the fourth quarter of 2023.
  • Net loss was $27.8 million, or $0.57 per basic and diluted share, for the fourth quarter of 2023.

Global Oncology Cancer Drugs Market Revenue Projected To Surpass $289 Billion By 2030

Retrieved on: 
Tuesday, January 9, 2024
Pancreatic cancer, Research, Biology, Prostate cancer, Cancer, Cytokine release syndrome, CRS, AML, Population Reference Bureau, Audit committee, AMGN, NK, Neoplasm, ADC, Acute myeloid leukemia, Paracetamol, PMR, NKG2D, NSCLC, Disease, Safety, Conditional sentence, Brain, Lung cancer, Breast, PALM, Cytarabine, Senior, Prevalence, Genetics, Nonsteroidal anti-inflammatory drug, Drug discovery, Graft-versus-host disease, Ruxolitinib, TSX, Therapy, Kidney cancer, Ageing, Patient, Stomach, Complete Response Letter, Fentanyl, Breast cancer, Novartis, Society, Eli Lilly, News, Food, Cancer pain, Johnson & Johnson, Morphine, FDA, Ovarian cancer, New Drug Application, ASH, ONC, Pharmaceutical industry

Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.

Key Points: 
  • Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.
  • The entire medical research fraternity has prioritized cancer research in order to find new ways of treatment and analysis.
  • According to Nova one advisor, the global Oncology Cancer Drugs market was valued at USD 147.2 billion in 2021 and it is expected to hit around USD 289.2 billion by 2030 with a CAGR of 8.4% during the forecast period 2022 to 2030.
  • The article continued: “Drugs such as morphine, fentanyl, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and others are used extensively in treating cancer pain in patients with lung cancer, bone cancer, and other types of cancer.

Nkarta Presents NKX101 Clinical Data at the 2023 American Society of Hematology Annual Meeting & Exposition

Retrieved on: 
Sunday, December 10, 2023
Cytokine release syndrome, Graft-versus-host disease, NKG2D, Cytarabine, MD, SAN, Society, Haematopoietic system, ASH, CRS, Patient, Acute myeloid leukemia, AML, NK

NKX101 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy donors and engineered to target NKG2D ligands.

Key Points: 
  • NKX101 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy donors and engineered to target NKG2D ligands.
  • As reported in June 2023, of those patients who received NKX101 after a disease-specific lymphodepletion (LD) regimen comprising fludarabine and cytarabine (Flu/Ara-C), four of six achieved CR/CRi.
  • In the follow up presented today, three of those four patients remained in CR/CRi at 4 months from treatment with NKX101.
  • Recent progress in therapy for r/r AML has been limited to targeted therapies, which only help a minority of patients.

Notable Labs Announces JCO Precision Oncology Publication Demonstrating PPMP Potential to Identify Novel Drug Combinations in JMML

Retrieved on: 
Thursday, November 9, 2023
EHA, CD38, Associate, UCSF Benioff Children's Hospital, European Hematology Association, Juvenile myelomonocytic leukemia, Transplant, Disease, Database, UCSF, Patient, ASCO, Hematopoietic stem cell transplantation, APL, AZA, Blood, Cytarabine, FLA, Cancer, Tretinoin, Acute promyelocytic leukemia, Trial of the century, Malignancy, Society, Physician, Cell, Bone marrow, Drug combination, Pharmaceutical industry, JMML

FOSTER CITY, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Inc. (“Notable”) (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced the publication of data from an ex vivo study demonstrating the potential for its Predictive Precision Medicine Platform (PPMP) to identify more effective pre-hematopoietic stem cell transplantation (pre-HSCT) regimens for the treatment of juvenile myelomonocytic leukemia (JMML) in the November 9th Issue of the American Society of Clinical Oncology (ASCO) Journal JCO Precision Oncology. Part of this data was recently presented at the European Hematology Association (EHA) Hybrid Congress held in Frankfurt, Germany on June 8 – 15, 2023. Details of that presentation can be found on the Company’s website at https://notablelabs.com/.

Key Points: 
  • JMML is a rare, aggressive pediatric malignancy for which curative treatment is restricted to hematopoietic stem cell transplantation.
  • Pre-HSCT therapies, i.e., therapies prior to transplantation, include moderately intensive chemotherapy (particularly fludarabine and cytarabine in combination (FLA)) and azacytidine (AZA) monotherapy.
  • Applying its proprietary PPMP technology to blood or bone marrow samples from JMML patients, Notable screened 130 drug combinations and discovered that 27 of these combinations (26 dual-, 1 triple-combination) were more effective ex vivo than the components of these combinations tested individually.
  • “This publication marks the culmination of a multi-year collaboration between UCSF and Notable Labs,” remarked Dr. Stieglitz.

Nkarta Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, November 9, 2023
Safety, Therapy, Workforce, Investment, Clinical trial, B-cell lymphoma, Rituximab, Depreciation, Patient, Research, FDA, Autoimmune disease, G&A, SLE, Hematology, Lupus Research Alliance, Lupus nephritis, Cytarabine, Cancer, R, Kinetics, AML, American Society of Hematology, Lupus, Society, NHL, Poster, LD, NK, Pharmaceutical industry, Cryptocurrency, Fine chemical, Vaccine, Rare-earth element, LN

In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory (r/r) AML.

Key Points: 
  • In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory (r/r) AML.
  • In October 2023, Nkarta announced the opening of a new cohort in its Phase 1 study of NKX019 in r/r NHL.
  • As of September 30, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of $278.4 million.
  • Net loss was $25.6 million, or $0.52 per basic and diluted share, for the third quarter of 2023.

GlycoMimetics Announces Independent Presentations on Uproleselan at American Society of Hematology Annual Meeting including New Clinical Data in Treated Secondary Acute Myeloid Leukemia

Retrieved on: 
Sunday, December 10, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acute myeloid leukemia, LDAC, Safety, National Cancer Institute, ASH, Leukemia, Cellular, IIT, Cytogenetics, HCT, Pedal, Patient, Inflammation, Male, Cytarabine, Biobank, University, Transplant, AML, MD Anderson Cancer Center, Cancer, Society, Myelodysplastic syndrome, Cladribine, Haematopoietic system, Venetoclax, Pharmaceutical industry, Glycomimetic

“These findings underscore the broad potential of uproleselan, if successfully developed in combination with existing therapies, to benefit people with heterogeneous forms of AML.

Key Points: 
  • “These findings underscore the broad potential of uproleselan, if successfully developed in combination with existing therapies, to benefit people with heterogeneous forms of AML.
  • Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
    This Phase 1b/2 clinical trial evaluated safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and LDAC in patients with ts-AML.
  • This rare, high-risk study population is defined by prior chemotherapy treatment of a previous hematologic disorder, such as myelodysplastic syndrome.
  • Study investigators concluded these data support this low-risk approach to marrow blast reduction and disease control in preparation for HCT.

GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023

Retrieved on: 
Friday, November 3, 2023
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, MD Anderson Cancer Center, Neurotransmission, NCI, Food, Cytarabine, Alliance for Clinical Trials in Oncology, Inflammation, Safety, European Medicines Agency, Sickle cell disease, Volunteering, ASH, Pharmacokinetics, Cancer, National Cancer Institute, PIP, NDA, Cladribine, Patient, Food and Drug Administration, AML, D, Pharmaceutical industry, Glycomimetic

GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the third quarter ended September 30, 2023.

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the third quarter ended September 30, 2023.
  • With the addition of the time-based analysis, the company expects topline results by the end of Q2 2024.
  • Third Quarter 2023 Financial Results:
    Cash position: As of September 30, 2023, GlycoMimetics had cash and cash equivalents of $49.4 million as compared to $47.9 million as of December 31, 2022.
  • A live webcast of the call will be available on the “ Investors ” tab on the GlycoMimetics website.

Nkarta Receives FDA Clearance of IND Application for NKX019 in Lupus Nephritis

Retrieved on: 
Tuesday, October 17, 2023
Investment, Food, Lupus nephritis, Division, Death, Cytarabine, NKG2D, Risk, Rituximab, IND, Safety, University, AML, Conference call, AID, Brattleboro Retreat, Autoimmune disease, Dialysis, FDA, B-cell lymphoma, Workforce, Department of Medicine – University of Pamplona, Lupus, ET, CAR, Immune system, Patient, End organ damage, Rheumatic Disease Clinics of North America, LN, Kidney disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAN, MRD, NK, University of Massachusetts Chan Medical School, Parikh, Conference, Investigational New Drug, SLE, NHL, Pharmaceutical industry, Vaccine, Cryptocurrency, Nursing, LD, Rheumatology, Medicine

(1)

Key Points: 
  • (1)
    The multi-center, open label, dose escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory LN.
  • “The clearance of Nkarta’s IND for NKX019 in lupus nephritis is an important achievement for Nkarta, and we feel NK cell therapy is ideally suited for the treatment of autoimmune disease,” said Paul J. Hastings, President and CEO of Nkarta.
  • Nkarta announced today the opening of a new cohort in its Phase 1 study of NKX019 in r/r NHL.
  • Nkarta management will discuss its program in autoimmune disease and other corporate updates on Tuesday, October 17, at 8:00 a.m.

Moleculin Doses First Subjects in Phase 2 Portion of Clinical Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

Retrieved on: 
Monday, October 2, 2023
US Foods, STS, AML, Doxorubicin, CRi, Lung, Anthracycline, FDA, Virus, Food, Safety, Pharmaceutical industry, Cytarabine

HOUSTON, Oct. 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and viruses, today announced the initial subjects have been treated in the Phase 2 portion of the Company's Phase 1B/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML (MB-106).

Key Points: 
  • Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "This milestone marks an important step in advancing the development of Annamycin for the treatment of AML.
  • Based on the positive preliminary results demonstrated in the Phase 1B portion of this trial, we continue to believe that Annamycin has the potential to be a meaningful treatment option for the treatment of AML.
  • As previously announced, Moleculin successfully and safely completed the Phase 1B portion of the trial at 230 mg/m2 of Annamycin in this combination study in August 2023.
  • For more information about the MB-106 Phase 1/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.