Tagged News
Hanmi Pharmaceutical Partners with MSD to Test Novel Bispecific Antibody BH3120 in Combination with KEYTRUDA
• Hanmi Pharmaceutical has entered a Clinical Trial Collaboration and Supply Agreement with MSD to evaluate its novel immunotherapy BH3120 in combination with KEYTRUDA for patients with progressive or metastatic solid tumors.
• BH3120 utilizes Hanmi's proprietary Pentambody platform, targeting both PD-L1 and 4-1BB simultaneously to enhance anti-tumor immune responses specifically in tumor tissues while minimizing systemic immune activation.
• The Phase 1 trial, led by Dr. Kim Dong-wan of Seoul National University Hospital, aims to overcome limitations of existing 4-1BB targeting therapies by leveraging BH3120's demonstrated ability to decouple immune activity between tumor microenvironment and normal tissue.
Biovica Signs Master Service Agreement to Support Next-Generation CDK4/6 Inhibitor Development for Breast Cancer
• Biovica International has secured a master service agreement with a biopharmaceutical company to provide TKa testing services for evaluating cell proliferation in drug development studies, with an initial work order valued at 1.2 MSEK.
• The agreement enables Biovica to contribute to the development of first-in-class next-generation CDK4/6 inhibitor therapeutics for breast cancer, potentially leading to a Companion Diagnostic product.
• This partnership adds to Biovica's existing portfolio of 13 master service agreements with pharmaceutical and biotech companies, highlighting growing industry demand for their blood-based cancer monitoring technology.
Promontory Therapeutics Completes Enrollment in Phase 2 Trial of PT-112 for Late-Stage Metastatic Prostate Cancer
• Promontory Therapeutics has completed enrollment of 109 patients in its Phase 2 trial of PT-112 for metastatic castration-resistant prostate cancer (mCRPC) across 32 clinical sites in the US and France.
• PT-112, the first small-molecule conjugate of pyrophosphate in clinical oncology development, works by inhibiting ribosomal biogenesis to induce immunogenic cell death in "immune-cold" prostate cancer.
• The study targets heavily pre-treated patients who have received at least three prior therapies, with topline safety and efficacy results expected in late 2024 following planned FDA meetings.
Related Clinical Trials:
Promontory Therapeutics Inc.
Posted 7/1/2014
India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost
• India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
• Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
• Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.
Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment
• Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
• Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
• Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.
Related Clinical Trials:
University of Washington
Posted 3/23/2022
Genmab
Posted 11/3/2020
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021
Hoffmann-La Roche
Posted 10/27/2021
Weill Medical College of Cornell University
Posted 11/1/2023
The Lymphoma Academic Research Organisation
Posted 9/5/2023
NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022
Reid Merryman, MD
Posted 7/18/2023
Clarity's 64Cu-SAR-bisPSMA Shows Promise in Detecting Prostate Cancer Recurrence in COBRA Trial
• Initial results from Clarity Pharmaceuticals' Phase 1/2 COBRA trial demonstrate that 64Cu-SAR-bisPSMA safely and effectively detects prostate cancer lesions in patients with biochemical recurrence who had negative standard-of-care imaging.
• The novel radiopharmaceutical identified lesions in up to 80% of patients on next-day imaging, with the number of detected lesions almost doubling compared to same-day imaging, highlighting a unique benefit of copper-64's longer half-life.
• Clinicians reported they would change treatment plans for approximately 50% of patients based on 64Cu-SAR-bisPSMA scan results, with two-thirds of these patients subsequently receiving focal or systemic therapy.
Related Clinical Trials:
Clarity Pharmaceuticals Ltd
Posted 12/21/2023
Clarity Pharmaceuticals Ltd
Posted 7/13/2021
Clarity Pharmaceuticals Ltd
Posted 4/11/2022
Merck and Daiichi Sankyo Form $22 Billion Alliance for Three Novel Antibody-Drug Conjugates
• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion.
• The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors.
• Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.
Related Clinical Trials:
Daiichi Sankyo
Posted 3/9/2022
Daiichi Sankyo
Posted 2/2/2021
Daiichi Sankyo
Posted 12/22/2020
Novel Targets and Strategic Sequencing: The Evolving Landscape of T-Cell Redirection Therapies in Multiple Myeloma
• CAR T-cell therapies and bispecific antibodies targeting BCMA and GPRC5D are transforming multiple myeloma treatment, with ciltacabtagene autoleucel showing unprecedented efficacy with a median PFS of 34.9 months in heavily pretreated patients.
• Disease progression rate is a critical factor in therapy selection, with rapidly progressing patients better suited for "off-the-shelf" bispecific antibodies, while patients with indolent disease may benefit more from CAR T-cell therapies despite longer manufacturing times.
• Strategic sequencing of therapies is crucial, as prior BCMA-directed bispecific antibody treatment significantly reduces the efficacy of subsequent BCMA-targeted CAR T-cell therapy, highlighting the importance of preserving T-cell fitness and considering antigen loss.
Related Clinical Trials:
Janssen Research & Development, LLC
Posted 9/17/2020
Janssen Research & Development, LLC
Posted 6/12/2020
Celgene
Posted 12/18/2017
Celgene
Posted 4/16/2019
Janssen Research & Development, LLC
Posted 11/7/2019
Janssen Research & Development, LLC
Posted 6/29/2018
Pfizer
Posted 2/2/2021
Janssen Research & Development, LLC
Posted 2/1/2021
Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure
• Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
• In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
• Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.
Related Clinical Trials:
Carrick Therapeutics Limited
Posted 11/14/2017
Revumenib Shows Promise in Phase 1 Trial for KMT2A-Rearranged and NPM1-Mutated Acute Leukemia
• Revumenib, a first-in-class menin inhibitor, demonstrated a 30% complete remission rate in heavily pretreated patients with KMT2A-rearranged or NPM1-mutated acute leukemia, with 78% achieving undetectable measurable residual disease.
• The oral therapy works by disrupting the menin-KMT2A interaction, downregulating key leukemogenic genes and promoting differentiation of leukemic cells, addressing a critical unmet need for these poor-prognosis genetic subtypes.
• While QT interval prolongation was the most common treatment-related adverse event (53%), the phase 1 trial established recommended phase 2 dosing with manageable safety profile, supporting further development of this targeted therapy.