CLL

Prelude Highlights Continued Strength of Discovery Engine at 2024 AACR Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024

WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.

Key Points: 
  • Highly selective oral SMARCA2 degrader, PRT7732, shows robust anti-tumor activity in vivo as monotherapy and in combination with chemotherapy, at well-tolerated doses
    Next Generation CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of breast cancer, CRC and NSCLC
    WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.
  • “These presentations demonstrate our core competencies in medicinal chemistry and cancer biology to optimize and deliver compounds to the clinic with the potential to succeed as differentiated first- and/or best-in-class new therapies,” said Andrew Combs, Ph.D., Chief Chemistry Officer at Prelude Therapeutics.
  • Peggy Scherle, Ph.D., Chief Scientific Officer at Prelude, stated, “Advancement of our second highly selective SMARCA2 degrader strengthens Prelude’s leadership position in the emerging use of SMARCA2 protein degradation as a potential treatment option for underserved patients with cancer.
  • With both a first-in-class IV SMARCA2 degrader, PRT3789, in Phase 1 clinical development and now our oral SMARCA2 degrader, PRT7732, expected to enter the clinic later this year, we believe these distinct modalities may offer new therapies for patients with SMARCA4 mutations.”
    Details on the poster presentations are as follows:
    Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732
    PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays
    Title: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Antitumor Activity in Combination with BTK and BCL2 Inhibition in Various Lymphoid Malignancies
    PRT2527 is efficacious as monotherapy in preclinical models of DLBCL, CLL and MCL, and combines with both BTK and BCL2 inhibition to improve depth and duration of responses
    Title: The Brain Penetrant CDK4/6 Inhibitor, PRT3645, is Highly Effective in Combination with Other Targeted Therapies in Preclinical Models of Breast Cancer, CRC and NSCLC
    Next generation CDK4/6 inhibitor, PRT3645, demonstrates preclinical synergy with SERDs, as well as MEK1/2 and CDK2 inhibition

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

Retrieved on: 
Tuesday, April 9, 2024

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024

Retrieved on: 
Thursday, April 4, 2024

ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.

Key Points: 
  • ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.
  • The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study.
  • GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
  • “We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.

Olink® Insight Unveils Open-access Map of the Human Proteome, Aiding Biomarker Discovery and Understanding of Disease

Retrieved on: 
Tuesday, April 2, 2024

In April 2023, the UK Biobank Pharma Proteomics Project (UKB-PPP) released data produced from over 50,000 samples analyzed using the Olink® Explore platform.

Key Points: 
  • In April 2023, the UK Biobank Pharma Proteomics Project (UKB-PPP) released data produced from over 50,000 samples analyzed using the Olink® Explore platform.
  • The UKB-PPP is the largest population-scale proteomics study to date, yielding an unprecedented view into the biology of diseased and healthy individuals over a 10-year period.
  • By combining protein measurements with longitudinal healthcare data for each of the individuals, Olink derived the estimated effects of ~3,000 proteins on the future risk of disease.
  • Olink Insight is a free, web-based platform that puts the results of advanced computational data analysis into the hands of non-data scientists.

Bio-Path Holdings Provides 2024 Clinical and Operational Update

Retrieved on: 
Tuesday, April 2, 2024

HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.

Key Points: 
  • HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.
  • Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients.
  • Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing.
  • In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial.

Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, April 1, 2024

In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.

Key Points: 
  • In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.
  • Cash position of $177.2 million at the end of the fourth quarter of 2023.
  • REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported fourth quarter and full year 2023 financial results and corporate highlights.
  • “2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes.

Allterum Therapeutics receives $12 million product development grant from CPRIT to advance anti-CD127 therapeutic antibody into clinic

Retrieved on: 
Monday, April 8, 2024

HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127. CD127 is a receptor that is expressed in major subsets of multiple cancers including hematological cancers (ALL, AML, CLL, and lymphoma) and solid tumors (lung, breast, colorectal, H&N, esophageal cancers).

Key Points: 
  • Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
  • HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127.
  • An addition to the $12M Product Development Award, Allterum received a $2.9M CPRIT seed award in 2020, which supported early-stage development work for the 4A10 antibody and laid the foundation for the current grant.
  • "We are pleased to provide Allterum with this TTC product development award to advance their promising anti-cancer drug into clinic," said Dr. Kenneth Smith, CPRIT's Chief Product Development Officer.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

Retrieved on: 
Tuesday, March 26, 2024

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

U.S. FDA Approves Bristol Myers Squibb’s Breyanzi® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Retrieved on: 
Friday, March 15, 2024

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
  • “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success.
  • After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses.