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Avacta's pre|CISION Technology Makes Toxic Chemotherapy Safer and More Effective

Targeted TherapyOncology
  • Avacta has developed a novel "masked" chemotherapy approach called pre|CISION that dramatically improves safety profiles of toxic cancer drugs while maintaining therapeutic efficacy.
  • The technology works by rendering chemotherapy inactive in normal tissues and only activating the drug when it reaches the tumor microenvironment, significantly reducing systemic toxicity.
  • Clinical applications of pre|CISION technology could potentially transform cancer treatment by allowing higher dosing of potent chemotherapeutics and expanding treatment options for patients who cannot tolerate conventional chemotherapy.

China Approves Xuanyuening (Bireociclib): First Dual-Indication CDK Inhibitor for Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • China's NMPA has approved Xuanzhu Biopharm's Bireociclib (Xuanyuening®), a novel multi-target CDK inhibitor for HR+/HER2- advanced breast cancer with dual indications.
  • The drug can be used in combination with fulvestrant after endocrine therapy failure and is the only CDK4/6 inhibitor approved in China as monotherapy for heavily pretreated patients.
  • Clinical trials showed impressive efficacy with median PFS of 17.5 months in combination therapy and 11 months as monotherapy, addressing specific needs of Chinese breast cancer patients.

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

NCT04539496Unknown StatusPhase 1
Sihuan Pharmaceutical Holdings Group Ltd.
Posted 5/22/2018

A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

NCT05077449Active, Not RecruitingPhase 3
Xuanzhu Biopharmaceutical Co., Ltd.
Posted 11/16/2021

Narmafotinib Combination Shows Superior Response in Pancreatic Cancer ACCENT Trial

Targeted TherapyOncology
  • Amplia Therapeutics' Phase 1b/2a ACCENT trial has recorded 15 confirmed partial responses in pancreatic cancer patients receiving narmafotinib combined with standard chemotherapy.
  • The trial results demonstrate that adding narmafotinib, a highly selective FAK inhibitor, to gemcitabine and Abraxane chemotherapy is superior to chemotherapy alone in advanced pancreatic cancer.
  • With 21 of 55 enrolled patients still on study, researchers anticipate additional partial responses may be observed before final data readout expected in mid-Q3 2025.

ACCENT: AMP945 in Combination with Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer

NCT05355298Active, Not RecruitingPhase 1
Amplia Therapeutics Limited
Posted 5/31/2022

Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression

OncologyTargeted TherapyDrug Approval
  • The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
  • All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
  • The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

NCT02099058Active, Not RecruitingPhase 1
AbbVie
Posted 1/15/2014

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial

OncologyTargeted Therapy
  • A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses.
  • At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment.
  • The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.

Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma

NCT03770416CompletedPhase 2
M.D. Anderson Cancer Center
Posted 2/15/2019

Exosomes Emerge as Dual-Purpose Tools in Cancer: From Drug Resistance Mechanisms to Therapeutic Delivery Systems

Targeted Therapy
  • Exosomes, nano-sized vesicles secreted by cells, play crucial roles in gastrointestinal cancer drug resistance by transferring oncogenic molecules between cancer cells and their microenvironment, with over 4.8 million GI cancer cases worldwide highlighting the urgent need for resistance-overcoming strategies.
  • Tumor-derived exosomes (TDEs) demonstrate significant therapeutic potential as drug delivery vehicles, offering superior biocompatibility and targeting ability compared to synthetic nanoparticles, while also serving as promising biomarkers for cancer diagnosis through liquid biopsy approaches.
  • Advanced microfluidic technologies are revolutionizing exosome isolation and detection methods, enabling more precise characterization of exosomal contents for both diagnostic applications and therapeutic targeting in cancer treatment.

Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

NCT05334849Completed
Lin Chen
Posted 11/1/2018

Pancreatic Cancer Detection Consortium

NCT06388967Recruiting
City of Hope Medical Center
Posted 3/15/2023

Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue

NCT01294072RecruitingNot Applicable
University of Louisville
Posted 1/1/2011

A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From EIther Primary Gastric Cancer or Colorectal Cancer (CRC)

NCT05375604TerminatedPhase 1
Codiak BioSciences
Posted 6/28/2022

Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

NCT02393703Recruiting
Memorial Sloan Kettering Cancer Center
Posted 3/1/2015

SiVEC's BactPac Platform: Engineered Bacteria Redefining Targeted Drug Delivery for Cancer and Beyond

OncologyTargeted Therapy
  • SiVEC Biotechnologies has developed BactPac, an innovative platform using engineered non-pathogenic bacteria to both produce and deliver therapeutic biologics with precise cellular targeting capabilities.
  • The company's lead asset, SVC-KRAb, delivers circular mRNA to produce nanobodies targeting mutant RAS proteins, reducing tumor volume by over 80% in preclinical studies with clinical trials expected in Q3 2026.
  • BactPac offers significant advantages over conventional delivery systems, including targeted delivery to difficult-to-reach tissues, immune evasion enabling repeat dosing, and simplified manufacturing through bacterial fermentation processes.

BRAF p.V600E Mutation Shows Limited Prognostic Value in Papillary Thyroid Cancer Risk Stratification

Targeted Therapy
  • A new study of 301 papillary thyroid carcinoma patients found that BRAF p.V600E mutation, present in 78.7% of cases, does not significantly predict disease recurrence when other clinical factors are considered.
  • Multivariate analysis identified large-volume lymph node metastasis and male gender as the only significant predictors of recurrence, while BRAF p.V600E showed no association with increased recurrence risk.
  • Despite limited prognostic utility, BRAF p.V600E testing remains clinically important for identifying patients who may benefit from targeted BRAF inhibitor therapies in aggressive or radioactive iodine-refractory cases.

Taiwan's Formosa Pharmaceuticals Signs Exclusive Licensing Deal with Almac Discovery for ADC Development

Monoclonal AntibodyTargeted TherapyOncology
  • Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Northern Ireland's Almac Discovery to develop novel antibody-drug conjugates for cancer treatment.
  • The partnership combines Formosa's antibody expertise with Almac's proprietary drug-linker technology, aiming to address unmet needs in oncology with more targeted therapeutic approaches.
  • This collaboration represents a significant expansion of Taiwan's growing presence in the global biopharmaceutical sector, particularly in the rapidly evolving ADC market.

NICE Opens Consultations for Two Targeted Therapies in Advanced Non-Small-Cell Lung Cancer

Targeted TherapyPrecision Medicine
  • NICE has initiated public consultations for adagrasib targeting KRAS G12C mutations and encorafenib with binimetinib for BRAF V600E mutations in advanced non-small-cell lung cancer.
  • The consultation for adagrasib closes on June 2, 2025, while the encorafenib-binimetinib combination consultation extends until June 24, 2025.
  • Both draft guidance documents are available for public comment through NICE's online consultation platform, with final recommendations potentially changing based on stakeholder feedback.
  • These consultations represent critical steps toward expanding targeted treatment options for patients with specific genetic mutations in advanced NSCLC.

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