Acute myeloid leukemia

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

Retrieved on: 
Monday, March 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Azacitidine, VTX, Phase, Wake Forest University, Patient, Trial of the century, Survivor, Acute myeloid leukemia, Cancer, AML, Pharmaceutical industry

Accordingly, we can start the Phase I/II combo-study very soon.

Key Points: 
  • Accordingly, we can start the Phase I/II combo-study very soon.
  • The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML.
  • This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML.
  • Please take notice of our own innovative approach for miserable cancer patients and contact with us.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Antengene Presents Four Preclinical Posters at AACR 2024

Retrieved on: 
Saturday, April 6, 2024
PRMT5, AML, CDX, Risk, Weight loss, LILRB4, MTAP, Acute myeloid leukemia, CRS, Cancer, IND, AACR, PDX, Antibody, DDI, TCE, Immunohistochemistry, San Diego Convention Center, Cytokine release syndrome, Vaccine

SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.

Key Points: 
  • SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.
  • Study results showed that ATG-042 has the potential to elegantly target tumor cells while sparing healthy cells, with an attractive developability profile.
  • 12:00 AM - 3:30 AM, April 10, 2024 (Beijing Time)
    This preclinical study was designed to test the in vitro/in vivo efficacy, and preclinical pharmacokinetic (PK) properties of ATG-042.
  • This poster presents the discovery and validation of a novel, highly sensitive immunohistochemistry (IHC) antibody that selectively identifies CLDN18.2.

Sutro Biopharma Reports Full Year 2023 Financial Results, Business Highlights and Select Anticipated Milestones

Retrieved on: 
Monday, March 25, 2024
CBFA2T3, Endometrial cancer, NSCLC, ASH, AML, International, Part, Patient, SAN, STRO, Acute myeloid leukemia, Cancer, Spacecraft, Lung cancer, RAM, PROC, Investment, Phenotype, Society, ADC, Hematology, Nursing

SOUTH SAN FRANCISCO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today reported its financial results for the full year 2023, its recent business highlights, and a preview of select anticipated milestones.

Key Points: 
  • “The year 2023 was pivotal for Sutro, with the initiation of REFRαME-O1, our registration-directed study of luvelta for platinum-resistant ovarian cancer (PROC) patients, further validating our next-generation ADC capabilities.
  • The registration-directed trial, REFRαME-O1, for treatment of PROC is enrolling, with an anticipated ~140 sites in ~20 countries to be opened by the end of 2024.
  • Upon exercising the option, Vaxcyte paid Sutro $50 million and is obligated to pay Sutro an additional $25 million within six months.
  • Upon the occurrence of certain regulatory milestones, Vaxcyte would be obligated to pay Sutro up to an additional $60 million.

Kineta Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, Combination, CPI, AML, Caregiver, Bone marrow, Insurance, Patient, Merck, Acute myeloid leukemia, Cancer, Public expenditure, Pembrolizumab, Lung cancer, Trial of the century, Cytokine release syndrome, AACR, Chemokine, Clinical trial, Annual report, Safety, Workforce, Infrared spectroscopy correlation table, NK, VISTA, Pharmaceutical industry

SEATTLE, March 21, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives, announced today financial results for the full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash.
  • We truly appreciate the efforts of the healthcare professionals, the patients and their caregivers, and the Kineta employees involved in this trial.
  • Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
  • Cash position: As of December 31, 2023, cash was $5.8 million, compared to $13.1 million as of December 31, 2022.

Senti Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Reviews Recent Highlights

Retrieved on: 
Thursday, March 21, 2024
HCC, Research, AML, Logic, Partnership, Spark Therapeutics, SAN, Patient, Gene, SNTI, Acute myeloid leukemia, Doctor of Philosophy, IND, Investment, Investigational New Drug, Therapy, Hepatocellular carcinoma, FDA, Food, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • SENTI-202 for AML: In December 2023, Senti Bio announced the IND application for SENTI-202 was cleared by the U.S. Food and Drug Administration (“FDA”).
  • Cash, Cash Equivalents and Short-term Investments: As of December 31, 2023, Senti Bio held cash, cash equivalents and short-term investments of $35.9 million.
  • G&A Expenses: General and administrative expenses were $9.3 million for the fourth quarter of 2023, compared to $9.8 million for the same period in 2022.
  • Net Loss: Net loss was $18.7 million, or $0.42 per basic and diluted share, for the quarter ended December 31, 2023.

LAVA Provides Business Updates and Reports Fourth Quarter and Year-End Financial Results

Retrieved on: 
Wednesday, March 20, 2024
Research, LAVA, AML, Risk, Patient, Acute myeloid leukemia, CRS, Syndrome, Cancer, Completeness, Pembrolizumab, IND, DLT, Investment, Bone marrow, Infrared spectroscopy correlation table, Premedication, CD123, MDS, Cytokine release syndrome

LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conferenceDesigned to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive prostate cancer cells

Key Points: 
  • LAVA-1207 has enrolled dose level 9 in our Phase 1/2a trial of patients with metastatic castration-resistant prostate cancer (mCRPC).
  • We continue to be encouraged by the favorable safety profile and preliminary signs of anti-tumor activity.
  • We plan to provide new data for LAVA-1207 at an upcoming medical conference in the second half of 2024,” said Stephen Hurly, President and Chief Executive Officer of LAVA.
  • “These advances represent important steps for our proprietary Gammabody® T-cell engagers as we evaluate their potential to treat cancer.

Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

Retrieved on: 
Monday, March 18, 2024
Principal, Nasdaq First North, Survival, ASH, AML, Associate, Webcast, Patient, Acute myeloid leukemia, Doctor of Philosophy, MD, Quality of life, Myelodysplastic syndrome, Faron Pharmaceuticals, HMA, Myelocyte, Society, Helsinki University Central Hospital, Azacitidine, MDS, MCR, FDA, AIM, SAE, Pharmaceutical industry

TURKU, Finland and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

Key Points: 
  • Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.
  • 4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.
  • Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.
  • After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots.