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FDA Clears IND for IKS014 HER2-Targeted ADC, Enabling US Clinical Trial Expansion

Oncology
  • The FDA has approved Iksuda Therapeutics' IND application for IKS014, a HER2-targeted antibody drug conjugate, allowing expansion of ongoing Phase 1 clinical trials to include US sites alongside existing locations in Australia, New Zealand, and Singapore.
  • Preliminary clinical data from the dose-escalation study demonstrates promising activity across multiple solid tumor types including breast, ovarian, gallbladder, and esophageal cancers, with notable efficacy in patients who relapsed after prior Enhertu treatment.
  • The Phase 1 trial is nearing completion of its dose-escalation phase and will proceed to expansion cohorts targeting HER2-positive breast cancer patients refractory to Enhertu, HER2-low breast cancer patients, and HER2-positive gastric cancer patients.
  • IKS014 utilizes a tumor-selective payload release mechanism with monomethyl auristatin F (MMAF) and showed impressive preclinical activity in both high- and low-HER2 expressing tumors with a favorable therapeutic index.

IKS014 in Advanced Solid Tumors That Express HER2

NCT05872295RecruitingPhase 1
Iksuda Therapeutics Ltd.
Posted 9/14/2023

Partial-Breast Radiation Proves Non-Inferior to Whole-Breast Treatment in 10-Year Follow-Up of UK IMPORT LOW Trial

Oncology
  • The UK IMPORT LOW trial's 10-year follow-up confirms that partial-breast and reduced-dose radiotherapy maintain similar efficacy to whole-breast radiotherapy in low-risk early breast cancer patients.
  • Ipsilateral breast tumor recurrence rates remained low across all treatment groups, with 2.8% for whole-breast, 1.9% for reduced-dose, and 3.0% for partial-breast radiation at 10 years.
  • Adverse effects were minimal across all groups, with breast shrinkage occurring in less than 10% of patients and supporting partial-breast radiotherapy as standard of care.
  • The findings provide long-term evidence for de-escalated radiation approaches in carefully selected patients with low-risk early-stage breast cancer.

Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

NCT00814567Unknown StatusNot Applicable
Institute of Cancer Research, United Kingdom
Posted 5/3/2007

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

Monoclonal AntibodyTargeted TherapyOncology
  • Amgen's Phase 3 FORTITUDE-101 trial met its primary endpoint, demonstrating that bemarituzumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with FGFR2b-positive gastric cancer.
  • The study enrolled 547 patients across 300 sites in 37 countries, targeting those with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who were non-HER2 positive.
  • Bemarituzumab represents the first positive Phase 3 results for an FGFR2b-targeted monoclonal antibody in gastric cancer, addressing a critical unmet need in a disease that causes over 650,000 deaths globally each year.
  • While the treatment showed efficacy, ocular adverse events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience.

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT05052801Active, Not RecruitingPhase 3
Amgen
Posted 3/7/2022

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

NCT05111626Active, Not RecruitingPhase 3
Amgen
Posted 3/14/2022

Laverock Therapeutics Raises £20M in Expanded Seed Funding, Reports Positive Data for Cancer Cell Therapy Programs

Gene EditingOncology
  • Laverock Therapeutics has expanded its seed funding round to more than £20 million, with the latest £6.5 million extension led by Calculus Capital and including participation from Eli Lilly and Company.
  • The company reported positive functional data for both its primary T-cell program LKV201 and macrophage program LKV301, demonstrating enhanced tumor control in hematological and solid tumor cancer models.
  • Laverock's programmable gene control platform uses recoded miRNAs to deliver tunable gene silencing, potentially transforming the efficacy, precision and safety of advanced cell therapies.
  • The funding will support lead product selection and optimization of preclinical programs while enabling partnerships to integrate Laverock's platform technologies into other therapeutic pipelines.

ESTEVE Acquires Caprelsa Rights from Sanofi to Expand Rare Cancer Treatment Portfolio

Rare DiseaseOncology
  • ESTEVE has entered into an agreement with Sanofi to acquire Caprelsa® (vandetanib) rights in more than 50 countries for treating aggressive and symptomatic medullary thyroid cancer in adults and children above 5 years of age.
  • Caprelsa is a protein tyrosine kinase inhibitor that reduces blood supply to cancer cells and slows tumor growth, offering treatment options beyond surgery for this rare neuroendocrine tumor.
  • This acquisition represents another strategic step in ESTEVE's transformation into a highly specialized pharmaceutical company focused on rare diseases, following recent acquisitions in endocrinology and pediatric oncology.
  • The transaction is subject to customary regulatory clearances and strengthens ESTEVE's portfolio of treatments addressing significant unmet medical needs in specialized therapeutic areas.

Karnataka Government Seeks DCGI Investigation Into HCG Clinical Trial Ethics Violations

Oncology
  • Karnataka's Health and Family Welfare Department has formally requested the Drug Controller General of India to investigate alleged ethical violations in clinical trials at HealthCare Global Enterprises Ltd (HCG) in Bengaluru.
  • The investigation follows serious concerns raised by retired High Court Justice P Krishna Bhat, former Ethics Committee Chairperson at HCG, regarding conflicts of interest and patient safety violations.
  • Eli Lilly and Company terminated HCG's participation in two clinical studies in 2023 due to 15 protocol violations involving nine patients, including two deaths deemed unrelated to the violations.
  • The allegations include the Ethics Committee Director simultaneously serving as Principal Investigator for multiple trials, creating inherent conflicts of interest that compromise independent oversight and patient safety.

XOMA Royalty Corporation to Acquire Turnstone Biologics for $0.34 Per Share Plus Contingent Value Rights

Oncology
  • XOMA Royalty Corporation announced a definitive merger agreement to acquire Turnstone Biologics for $0.34 in cash per share plus contingent value rights.
  • The Turnstone Board of Directors unanimously approved the acquisition, with stockholders holding 25.2% of shares signing support agreements.
  • The tender offer will commence by July 11, 2025, with the merger transaction expected to close in August 2025.
  • Turnstone Biologics has been focused on developing selected tumor-infiltrating lymphocyte therapy for solid tumor treatment.

Urine DNA Test Predicts Bladder Cancer Recurrence After Immunotherapy Treatment

Oncology
  • A multi-institutional study published in Science Direct demonstrates that urine-based tumor DNA (utDNA) testing can predict which bladder cancer patients face higher recurrence risk after immunotherapy treatment.
  • Researchers analyzed utDNA from 89 patients in the SWOG S1605 trial using the UroAmp test, finding that positive utDNA results correlated with poorer treatment response and increased cancer recurrence rates.
  • The study offers potential for personalized bladder cancer care by enabling earlier identification of treatment response, potentially reducing unnecessary surgeries and improving patient outcomes.
  • This approach could help tailor therapy decisions sooner for the approximately 83,000 Americans diagnosed with bladder cancer annually, particularly those with high-risk disease unresponsive to BCG treatment.

FDA Grants Breakthrough Therapy Designation for Daraxonrasib in KRAS-Mutated Pancreatic Cancer

Targeted TherapyPrecision MedicineOncology
  • FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) in patients with KRAS G12 mutations.
  • The designation represents a significant regulatory milestone for targeting KRAS mutations in pancreatic cancer, one of the most challenging malignancies to treat.
  • Daraxonrasib's multi-selective RAS(ON) inhibition mechanism offers a novel therapeutic approach for patients with limited treatment options in the metastatic setting.

Regeneron Navigates EYLEA Decline with Pipeline Diversification and Regulatory Wins

Drug ApprovalOncology
  • Regeneron reported challenging Q1 2025 results with total revenues declining 4% to $3.029 billion, primarily driven by EYLEA franchise headwinds from biosimilar competition and pricing pressures.
  • The company's diversification strategy shows promise with Dupixent global sales rising 19% to $3.67 billion and EU approval of Lynozyfic for multiple myeloma, demonstrating pipeline strength beyond ophthalmology.
  • Strategic moves including a $7 billion infrastructure investment, inaugural dividend of $0.88 per share, and $1.05 billion share buyback program signal management confidence in long-term growth prospects.
  • Key regulatory catalysts ahead include FDA decisions on EYLEA HD expanded indications with August 2025 target date and potential approvals for odronextamab in follicular lymphoma.

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