Acute leukemia

Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update

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tisdag, maj 14, 2024
Acute leukemia, Patient, Pharmacokinetics, CML, Investigational New Drug, Trastuzumab, Food, MBC, HER2, Colorectal cancer, Therapy, BCR, MBA, MD, Cancer, PIPE, CRC, MMR, Research, Central nervous system, G&A, Tucatinib, Food and Drug Administration, Brain, Pharmaceutical industry

BOULDER, Colo., May 14, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the first quarter ended March 31, 2024, and provided a business update, including highlights of pipeline progress.

Key Points: 
  • “The first quarter of 2024 was a pivotal quarter for Enliven.
  • Research and development (R&D) expenses: R&D expenses were $20.0 million for the first quarter of 2024, compared to $11.9 million for the first quarter of 2023.
  • General and administrative (G&A) expenses: G&A expenses for the first quarter of 2024 were $6.0 million, compared to $4.5 million for the first quarter of 2023.
  • Net Loss: Enliven reported a net loss of $22.7 million for the first quarter of 2024, compared to a net loss of $14.7 million for the first quarter of 2023.

Indapta Therapeutics to Highlight its g-NK Cell Platform for the Treatment of Cancer and Autoimmune Disease in a Plenary Session at New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference

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torsdag, maj 23, 2024
Research, Genetics, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Patient, ADCC, Acute leukemia, Epstein–Barr virus, Food, Cytokine, NK, Clinical trial, Therapy, IND, Disease, Autoimmune disease, Conference, MD, Multiple sclerosis, Cancer, Multiple myeloma, Cytomegalovirus, CMV, Cell, NKG2C, Vaccine

In his talk, Dr. Frohlich will summarize the differentiated mechanisms of target cell killing for Indapta’s lead clinical program, IDP-023, a g-NK cell therapy product.

Key Points: 
  • In his talk, Dr. Frohlich will summarize the differentiated mechanisms of target cell killing for Indapta’s lead clinical program, IDP-023, a g-NK cell therapy product.
  • These mechanisms include highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.
  • Indapta is currently applying g-NK cells to hematologic cancers in an ongoing Phase 1 trial enrolling patients with non-Hodgkin’s lymphoma, multiple myeloma and acute myelogenous leukemia.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability.

Xspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib

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torsdag, maj 23, 2024
Oncology, Health, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, Proton, Acute leukemia, Patient, TKI, PPI, Prescription, CML, Karolinska Institute, Proton-pump inhibitor, Cmax, Enzyme inhibitor, Teaching hospital, Effect, Absorption, Tablet, Chronic myelogenous leukemia, Omeprazole, Combination therapy, Cancer, ASCO, Uppsala University, Society, NT, Dasatinib, Annual general meeting, Pharmaceutical industry

Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider.

Key Points: 
  • Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider.
  • Further, the presentation provides new information on the bioavailability of crystalline dasatinib when comedicated with a PPI, demonstrating a substantially higher than previously reported impact of PPIs on the bioavailability of crystalline dasatinib, with Cmax and AUC24 being reduced by 96% and 88% respectively.
  • “Consistent absorption and bioavailability of dasatinib are critical for adequate disease control and patient outcomes, this is however often overlooked in clinical practice as our data demonstrates,” said Per Andersson, CEO of Xspray.
  • Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability.

Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting

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torsdag, maj 23, 2024
Research, Infectious Diseases, Genetics, Clinical Trials, Stem Cells, Biotechnology, Health, Science, Oncology, Acute leukemia, Patient, Bone marrow, MAC, Risk, AML, Annual general meeting, Face, Tacrolimus, Death, ASCO, Mortality, Society, Busulfan, Graft-versus-host disease, Thiotepa, BFT, Acute myeloid leukemia, Pharmaceutical industry

Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31–June 4.

Key Points: 
  • Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31–June 4.
  • The presentation will highlight outcomes of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML).
  • AML is an aggressive form of blood cancer and the most common acute leukemia in adults.
  • “These data continue to advance our mission of expanding potentially life-saving treatment to patients and their providers who face limited viable options today.”
    Details of the Orca Bio presentation follow:

Fate Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

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torsdag, maj 9, 2024
FDA, Investment, Risk, Destiny, IND, Autoimmune disease, Enrollment, Death, Hospital, GAAP, NK, GEJ, Multiple myeloma, CRS, HER2, Pharmacokinetics, Graft-versus-host disease, Food, Lupus, Data, ADR, BCL, Histology, Therapy, BCMA, Autoimmunity, Safety, Trastuzumab, Research, TRAC, Incidence, IPSC, Chronic lymphocytic leukemia, Acute leukemia, Investigational New Drug, Cancer, Cell, Cmax, Patient, Gene, Society, B-cell lymphoma, BCM, Cytokine release syndrome, Immune system, SLE, Vaccine

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • The patient was discharged after a three-day hospital stay without any notable adverse events.
  • The Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m.
  • ET to review financial and operating results for the quarter and full year ended March 31, 2024.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

IN8bio Reports First Quarter 2024 Financial Results and Recent Corporate Highlights

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torsdag, maj 9, 2024
CD33, Cancer, Gene expression, Cell, Cranial cavity, Myelodysplastic syndrome, DRI, EHA, Survival, Temozolomide, Research and development, Canadian Aviation Regulations, GBM, AML, Leukemia, IND, ASCO, CD123, Patient, Gene, CML, Society, Acute myeloid leukemia, AACR, Annual general meeting, MDS, Acute leukemia, Pharmaceutical industry

NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results for the first quarter ended March 31, 2024 and recent corporate highlights.

Key Points: 
  • (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results for the first quarter ended March 31, 2024 and recent corporate highlights.
  • “We continued to make significant progress advancing our gamma-delta T cell programs in the first quarter of 2024,” said William Ho, CEO and co-founder of IN8bio.
  • INB-100: Report updated interim results from the ongoing Phase 1 investigator-sponsored trial at the 2024 EHA Annual Meeting, held June 13-16 in Madrid, Spain.
  • INB-200: Report interim Phase 1 long-term follow up results in GBM at multiple medical meetings in 2024 including at the 2024 ASCO Annual Meeting.

TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities

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tisdag, april 16, 2024
Patient, Cancer, T-ALL, MRD, HLA, Collection, Trial of the century, HCT, AML, IND, Blood, Syndrome, Acute myeloid leukemia, Acute leukemia, Neoplasm, TCR, Therapy, MDS, ALL, Medical imaging

WALTHAM, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today provided an update on its solid tumor and heme malignancies clinical programs.

Key Points: 
  • “We continue to make meaningful progress across both our solid tumor and heme malignancies Phase 1 clinical programs.
  • This should allow for rapid enrollment into the treatment protocol over the course of the year,” said Gavin MacBeath, Ph.D., Chief Executive Officer.
  • Phase 1 solid tumor clinical study has been initiated; first three patients expected to be dosed in early May 2024.
  • Completion of Phase 1 enrollment and reporting of one-year clinical and translational data on initial patients is anticipated in the second half of 2024.

Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

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torsdag, april 11, 2024
Patient, BCR, Safety, MMR, TKI, CML, Caregiver, Second generation, Therapy, Acute leukemia, Pharmaceutical industry

BOULDER, Colo., April 11, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

Key Points: 
  • "Similar to our experience with previous successful Phase 1 trials in CML, ELVN-001 looks promising.
  • The preliminary data support that ELVN-001 is a potent and highly selective BCR::ABL1 inhibitor that has activity in heavily pre-treated patients, including post-asciminib patients."
  • “We are thrilled with ELVN-001’s initial Phase 1 data in heavily pre-treated patients with CML,” said Sam Kintz, Co-founder and Chief Executive Officer of Enliven.
  • The discussion will cover details of ELVN-001’s Phase 1 initial proof of concept data, the evolving treatment paradigm in CML, and how ELVN-001 could fit into the CML landscape.

Orphan designation: Ziftomenib Treatment of acute myeloid leukaemia, 12/01/2024 Positive

Retrieved on: 
torsdag, april 18, 2024
Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, D04, Acute leukemia, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of acute myeloid leukaemia on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive

Retrieved on: 
torsdag, april 18, 2024
Eurostat, Diagnosis, Civil service commission, Clinical research, Health, B cell, Growth, Cell, Bone marrow, Infection, AML, Disease, Patient, Committee, Knowledge, Regulation, CD70, Cancer, EMA, IRIS, Business park, Acute myeloid leukemia, European, COMP, European Commission, Blood, Azacitidine, Safety, Haematopoietic system, Marketing, Acute leukemia, Medicine, Pharmaceutical industry

Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive

Key Points: 


Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive