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Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment

Precision MedicineDrug ApprovalOncologyTargeted Therapy
  • Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer.
  • The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
  • Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.

Finnish Researchers Develop Gene Signature Test to Predict Cancer Immunotherapy Response

Precision MedicineOncology
  • University of Turku scientists have identified a five-gene signature that predicts which cancer patients will respond to bexmarilimab immunotherapy, potentially improving treatment outcomes through personalized selection.
  • The study revealed bexmarilimab works best in "immunologically silent" tumor environments by activating macrophages against cancer cells, while also triggering B cell responses in adjacent healthy tissue.
  • This Finnish-developed immunotherapy has shown promising results across multiple solid tumor types, with researchers now working toward clinical validation of the gene signature for patient profiling.

Biostate AI Secures $12M Series A to Revolutionize RNA Sequencing and Molecular Diagnostics

AIPrecision MedicineOncology
  • Biostate AI has raised $12 million in Series A funding led by Accel to develop affordable RNA sequencing technology and AI-powered diagnostic models.
  • The company's proprietary BIRT and PERD technologies reduce RNAseq costs by nearly an order of magnitude, enabling researchers to run 2-3 times more samples within existing budgets.
  • Founded by former professors David Zhang and Ashwin Gopinath, Biostate AI aims to build "foundation models" for molecular medicine by analyzing billions of RNA expressions to predict disease evolution and drug responses.

Sanofi and Regeneron Announce AIM4 Trial to Advance Personalized Asthma Treatment

Monoclonal AntibodyPrecision Medicine
  • Sanofi and Regeneron revealed plans at ATS 2025 to launch the innovative AIM4 clinical trial, focusing on personalized treatment approaches for asthma patients.
  • The trial represents a significant advancement in precision medicine for respiratory care, aiming to match patients with optimal therapies based on their specific asthma phenotypes.
  • This initiative builds on the companies' existing respiratory portfolio and reflects the growing industry trend toward tailored therapeutic strategies for chronic respiratory conditions.

ACT Technology Shows Promising Results in Enhancing Chemotherapy for Colorectal Liver Metastases

OncologyPrecision Medicine
  • EXACT Therapeutics' Phase 1 ACTIVATE trial demonstrates that Acoustic Cluster Therapy (ACT) significantly enhances chemotherapy effectiveness, with ACT-treated tumors showing 29% reduction in diameter compared to 7% with chemotherapy alone.
  • The innovative treatment demonstrated a clear dose-response relationship, with higher doses (40 μl/kg) of PS101 producing greater tumor shrinkage than lower doses (20 μl/kg), while maintaining an excellent safety profile.
  • These positive results support advancement to the Phase 2 ENACT trial targeting pancreatic cancer, potentially offering new hope for patients with difficult-to-treat solid tumors.

PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin

NCT04021277TerminatedPhase 1
EXACT Therapeutics AS
Posted 9/17/2019

Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

NCT06850623RecruitingPhase 2
EXACT Therapeutics AS
Posted 6/19/2025

Enibarcimab Shows Promising Results in Biomarker-Guided Septic Shock Treatment

Monoclonal AntibodyPrecision Medicine
  • Journal of Critical Care has published positive results from AdrenoMed's Phase II AdrenOSS-2 trial, showing enibarcimab improved organ function and reduced 28-day mortality in septic shock patients.
  • The precision medicine approach used two biomarkers (bio-ADM and DPP3) to identify patients most likely to benefit from treatment, with mortality rates of 18% in the enibarcimab group versus 26% in placebo.
  • Based on these promising findings, AdrenoMed is advancing to a confirmatory Phase IIb/III BOOST trial, potentially addressing a critical unmet need in septic shock treatment where mortality rates remain at 30-50%.

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

NCT03085758CompletedPhase 2
Adrenomed AG
Posted 12/12/2017

Adrecizumab-LPS Study

NCT03083171CompletedPhase 1
Adrenomed AG
Posted 1/4/2017

Adrecizumab Phase 1 Trial

NCT02991508CompletedPhase 1
Radboud University Medical Center
Posted 5/23/2016

FDA Approves First Blood Test for Alzheimer's Diagnosis, Boosting Roche and BioArctic Shares

FDA ApprovalNeurologyPrecision Medicine
• The U.S. Food and Drug Administration has approved the first blood test for diagnosing Alzheimer's disease, potentially revolutionizing patient identification and treatment pathways.
• The diagnostic breakthrough is expected to drive market activity for pharmaceutical companies Roche and BioArctic, whose shares showed positive movement following the regulatory announcement.
• This blood test could significantly streamline the Alzheimer's diagnostic process, making it more accessible and efficient compared to traditional methods that rely on expensive brain scans and invasive procedures.

FDA Questions Pfizer's Approach to Expand Talzenna's Indication in Prostate Cancer

OncologyPrecision MedicineTargeted Therapy
  • The FDA has raised concerns about Pfizer's strategy to expand Talzenna's indication to all castration-resistant prostate cancer patients, questioning the reliance on an "incompletely defined" subgroup without HRR gene mutations.
  • Pfizer is seeking to broaden Talzenna's current first-line indication from only HRR-mutated castration-resistant prostate cancer to an all-comers population, representing a significant potential market expansion.
  • The regulatory scrutiny highlights ongoing challenges in precision medicine approaches and biomarker-based treatment strategies in oncology drug development.

FDA Advisory Committee Rejects Pfizer's Talzenna Expansion for Broader Prostate Cancer Population

OncologyPrecision MedicineTargeted Therapy
  • Pfizer's application to expand Talzenna's indication to all castration-resistant prostate cancer (CRPC) patients was rejected by FDA's advisory committee due to insufficient data in biomarker-negative patients.
  • The company sought to broaden Talzenna's current approval beyond patients with HRR gene mutations, but FDA questioned the reliance on an "incompletely defined" subgroup analysis.
  • FDA oncology chief Richard Pazdur emphasized that chance effects could not be ruled out due to the lack of a formal efficacy analysis in patients without HRR mutations.

Gustave Roussy Launches UMBRELLA Trial: Using Blood-Based Tumor DNA to Revolutionize Cancer Follow-Up Care

OncologyPrecision MedicineAI
  • Gustave Roussy has initiated UMBRELLA, a groundbreaking phase III trial that personalizes post-treatment cancer monitoring based on minimal residual disease (MRD) detected through blood-based circulating tumor DNA analysis.
  • The trial will evaluate two strategies: pre-emptive immunotherapy (tislelizumab) for MRD-positive patients and reduced follow-up schedules for MRD-negative patients with non-metastatic lung, colorectal, pancreatic, and soft tissue sarcomas.
  • UMBRELLA represents the first French multi-cancer trial using MRD status for therapeutic stratification, aiming to enroll over 700 patients across 10-11 centers in a collaborative effort involving Veracyte, IntegraGen, and BeiGene.

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

NCT06332274RecruitingPhase 3
Gustave Roussy, Cancer Campus, Grand Paris
Posted 4/16/2025
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