Lion TCR's Liocyx-M004 receives FDA clearance for phase 2 trial in HBV-related liver cancer
- Lion TCR's Liocyx-M004, an mRNA-encoded TCR-T cell therapy, received FDA clearance for a global Phase 2 trial.
- The trial will assess Liocyx-M004 as a monotherapy and in combination with lenvatinib for HBV-related hepatocellular carcinoma.
- Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to receive FDA IND approval and Fast Track designation.
- The trial aims to improve response rates and survival outcomes for patients with HBV-related liver cancer.
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Bicara Therapeutics enrolls first patients in pivotal trial for head and neck cancer
- Bicara Therapeutics has initiated the FORTIFI-HN01 trial, enrolling the first patients in a pivotal Phase 2/3 study.
- The trial evaluates ficerafusp alfa combined with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
- This global, randomized, double-blinded, placebo-controlled trial aims to enroll approximately 650 patients.
- Primary endpoints include overall response rate and overall survival, with potential for accelerated and full approval filings.
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Moleculin receives first country approval in Europe for MIRACLE Phase 3 AML trial
- Moleculin Biotech has received its first regulatory approval in Europe to begin recruiting for the MIRACLE Phase 3 trial for relapsed or refractory acute myeloid leukemia (AML).
- The trial will evaluate Annamycin in combination with Cytarabine (AnnAraC) and will be conducted globally, including sites in the US, Europe, and the Middle East.
- The trial features an adaptive design with early unblinding of preliminary efficacy and safety data expected in the second half of 2025.
- Annamycin has Fast Track Status and Orphan Drug Designation from the FDA and EMA for AML treatment.
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Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma
- The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, targeting relapsed/refractory multiple myeloma.
- The decision is expected by July 10, 2025, following the resolution of third-party manufacturing issues.
- The BLA is supported by data from the pivotal LINKER-MM1 trial, which investigates linvoseltamab in relapsed/refractory multiple myeloma.
- Linvoseltamab is also under review by the European Medicines Agency for the same indication.
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Ellipses in-licenses first-in-class novel immuno-oncology agent
- Ellipses Pharma has in-licensed global rights to 'GENA-104', a first-in-class immuno-oncology monoclonal antibody targeting CNTN4.
- GENA-104 was discovered by Genome & Company and will be developed by Ellipses under the identifier EP0089.
- A Phase 1 IND for EP0089 was approved by the South Korean Ministry of Food and Drug Safety in January 2024.
- Ellipses plans to initiate a Phase 1 clinical trial in South Korea in 2025, with potential expansion to the US and Europe.
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New breast cancer therapy approved in Thailand
- NERLYNX (neratinib) approved by Thailand FDA for early-stage and advanced HER2+ breast cancer.
- In early-stage, it reduces recurrence risk by up to 42% for HR+ patients starting within 12 months post-trastuzumab.
- In advanced cases, combined with capecitabine, it extends progression-free survival by 2.2 months over lapatinib plus capecitabine.
- Specialised Therapeutics to expand in Thailand, hiring new field force to support NERLYNX launch.
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IN8bio reports updated positive results from phase 1 trial of INB-100 in leukemia patients
- 100% of acute myeloid leukemia (AML) patients in the trial remain in complete remission with a median follow-up of 20.1 months.
- INB-100 shows improved survival outcomes with 90.9% progression-free survival (PFS) and 100% overall survival (OS) at one year.
- The therapy is well-tolerated with no significant side effects like cytokine release syndrome or neurotoxicity.
- Next steps include expanding the trial network and working towards a potential registrational trial.
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BostonGene collaborates with BeiGene to advance biomarker discovery in mantle cell lymphoma
- BostonGene and BeiGene are collaborating to identify tumor-based biomarkers in Mantle Cell Lymphoma (MCL).
- The initiative aims to understand molecular drivers of therapeutic response and resistance in MCL.
- BostonGene will use its AI platform to generate comprehensive genomic, transcriptomic, and immunological profiles.
- The study seeks to identify predictive and prognostic biomarker signatures to guide future treatment strategies.
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Kairos Pharma adds Huntsman Cancer Institute for Phase 2 ENV105 clinical trial
- Kairos Pharma has included Huntsman Cancer Institute in its Phase 2 trial for ENV105 targeting castrate-resistant prostate cancer.
- The trial involves patients receiving either apalutamide or a combination of apalutamide and ENV105.
- Supported by a grant from the National Cancer Institute, the trial aims to identify blood markers for patient selection.
- ENV105 is an antibody targeting CD105, a protein linked to drug resistance in cancer treatments.
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Bolt Biotherapeutics updates on cancer immunotherapy co-development with Toray Industries
- Bolt Biotherapeutics and Toray Industries are co-developing an ISAC targeting Caprin-1, a novel cancer target.
- Toray supplies antibodies like TRK-950, while Bolt provides linker-payloads from its Boltbody ISAC platform.
- TRK-950, targeting Caprin-1, is in Phase 2 development for gastric cancer, validating Caprin-1 as a promising target.
- The collaboration aims to commercialize the ISAC product candidate for multiple solid tumor types.
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Caris Life Sciences publishes landmark study demonstrating the superiority of Caris Assure
- Caris Life Sciences published a study in Clinical Cancer Research using Caris Assure to identify clonal hematopoiesis (CH) variants in 16,812 advanced cancer patients.
- The study found CH variants in 42.3% of patients, with significant prevalence in genes like CHEK2, BRCA2, and BRCA1.
- CH variants can lead to false positives in liquid biopsies, affecting treatment decisions, especially for PARP inhibitor therapies.
- The study emphasizes the importance of distinguishing CH from tumor-derived mutations to improve diagnostic accuracy and guide appropriate cancer therapy.
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Bayer unveils latest data from prostate cancer portfolio at 2025 ASCO GU Cancers Symposium
- Bayer will present new data from its prostate cancer portfolio at the ASCO GU Cancers Symposium in San Francisco, February 13-15, 2025.
- Key presentations include subgroup analyses from the Phase III ARANOTE and ARASENS trials, focusing on NUBEQA (darolutamide) in combination with ADT and docetaxel for mHSPC.
- The Phase II ARAMON trial results will be shared, investigating NUBEQA monotherapy in CSPC after biochemical recurrence.
- Investigator-initiated research on XOFIGO (radium-223 dichloride) will be presented, focusing on its use without ADT and retreatment in mCRPC patients.
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SpringWorks Therapeutics announces FDA approval of GOMEKLI for NF1-PN
- GOMEKLI (mirdametinib) approved by FDA for adults and children with NF1-PN.
- Approval based on Phase 2b ReNeu trial showing robust ORR and durable tumor volume reduction.
- SpringWorks received a rare pediatric disease priority review voucher from the FDA.
- Marketing Authorization Application under review by the European Medicines Agency.
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U.S. FDA approves Pfizer's ADCETRIS combination regimen for relapsed/refractory diffuse large B-cell lymphoma
- The U.S. FDA approved ADCETRIS in combination with lenalidomide and rituximab for adults with relapsed/refractory large B-cell lymphoma (LBCL).
- Approval is based on the Phase 3 ECHELON-3 study, showing significant improvement in overall survival for patients receiving the ADCETRIS combination.
- The study included patients who had previously received CAR-T therapy, with benefits observed regardless of CD30 expression.
- Next steps include potential regulatory actions in other geographies.
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Opna Bio receives orphan drug designation for OPN-6602 for multiple myeloma
- The FDA granted orphan drug designation to Opna Bio's OPN-6602 for treating multiple myeloma.
- OPN-6602 is an oral inhibitor targeting EP300/CBP, currently in a Phase 1 trial for relapsed or refractory multiple myeloma.
- The designation offers benefits like tax credits, FDA fee waivers, and seven years of market exclusivity upon approval.
- Opna Bio plans further development of OPN-6602 in combination with other standard-of-care agents.
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