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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.

Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals

CAR-TOncology
  • New research from Swiss institutions demonstrates that age-related immune decline significantly reduces the effectiveness of CAR-T cell cancer therapy by impairing mitochondrial function and metabolism.
  • Scientists identified decreased levels of nicotinamide adenine dinucleotide (NAD) as the key factor behind reduced antitumor activity in CAR-T cells from older individuals.
  • Researchers successfully rejuvenated aged CAR-T cells by restoring NAD levels in preclinical models, suggesting potential strategies to improve immunotherapy outcomes in older cancer patients.

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.

Lymphodepletion Enhances MAR-T Cell Therapy Efficacy in Lymphoma Patients, Marker Therapeutics Reports

OncologyCAR-T
  • Marker Therapeutics' Phase 1 APOLLO study shows lymphodepletion significantly improves expansion and persistence of MT-601 MAR-T cells in lymphoma patients, potentially enhancing anti-tumor activity.
  • Early clinical data reveals promising efficacy with 78% objective response rate and 44.4% complete response rate in patients who relapsed after or are not candidates for anti-CD19 CAR-T therapy.
  • The non-genetically modified MAR-T cell approach targets six different tumor antigens, demonstrating excellent safety with no dose-limiting toxicities while potentially offering manufacturing advantages over current engineered T cell therapies.

Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

NCT05798897RecruitingPhase 1
Marker Therapeutics, Inc.
Posted 1/2/2023

Novel BAFF-R CAR-T Therapy Achieves Complete Response in Heavily Pretreated Follicular Lymphoma Patient

CAR-TOncology
  • PeproMene Bio's first-in-class BAFF-R targeted CAR-T cell therapy (PMB-CT01) has achieved complete remission in a heavily pretreated follicular lymphoma patient who had failed seven prior therapies including CD19 CAR-T.
  • All seven patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with PMB-CT01 have achieved complete responses lasting from 1 to 29+ months, with minimal toxicity reported.
  • PMB-CT01 targets the BAFF receptor, which is crucial for B-cell survival, potentially making it harder for tumor cells to escape therapy through antigen loss compared to CD19-targeted approaches.

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL

NCT04690595RecruitingPhase 1
PeproMene Bio, Inc.
Posted 5/18/2021

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

NCT05370430RecruitingPhase 1
PeproMene Bio, Inc.
Posted 6/13/2022

KaliVir Advances Novel Oncolytic Immunotherapy VET3-TGI in Phase 1/1b Trial for Advanced Solid Tumors

Oncology
  • KaliVir Immunotherapeutics has successfully completed the first cohort of its STEALTH-001 Phase 1/1b trial evaluating VET3-TGI in patients with advanced solid tumors.
  • The Data Safety Committee has reviewed safety data and cleared dosing for the next intratumoral and intravenous cohorts, allowing the trial to progress to higher dose levels.
  • VET3-TGI is a novel oncolytic immunotherapy designed to selectively kill tumor cells while delivering an immuno-stimulatory payload of interleukin-12 and a TGFbeta inhibitor.

A Study of VET3-TGI in Patients With Solid Tumors

NCT06444815RecruitingPhase 1
KaliVir Immunotherapeutics
Posted 9/16/2024

PharmaEssentia's Ropeginterferon Shows Promising Results in Phase 3 Trial for Essential Thrombocythemia

OncologyRare Disease
  • PharmaEssentia will present positive Phase 3 SURPASS-ET trial results showing ropeginterferon alfa-2b-njft achieved significantly higher durable clinical response rates compared to anagrelide (42.9% vs. 6.0%; p=0.0001) in essential thrombocythemia patients.
  • The trial demonstrated not only effective blood count control but also a measurable reduction in JAK2 mutation allele burden over 12 months, addressing an underlying disease mechanism that current treatments fail to target.
  • Ropeginterferon alfa-2b-njft (marketed as BESREMi® for polycythemia vera) could potentially offer a new second-line treatment option for essential thrombocythemia, a rare blood disorder characterized by excessive platelet production.

Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis

NCT05731245RecruitingPhase 2
National Taiwan University Hospital
Posted 2/8/2023

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

NCT04285086Active, Not RecruitingPhase 3
PharmaEssentia
Posted 8/25/2020

Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025

OncologyMonoclonal Antibody
  • Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma treatment.
  • The company will present research on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma, addressing significant unmet medical needs.
  • Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma will be featured in an oral presentation.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

NCT03713593CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 12/31/2018

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

NCT04008797RecruitingPhase 1
Eisai Inc.
Posted 7/11/2019

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

NCT04662710Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/30/2020

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.

FDA Greenlights Promontory Therapeutics' Phase 3 Trial Design for PT-112 in Metastatic Prostate Cancer

OncologyOrphan Drug
  • Promontory Therapeutics has successfully completed an End of Phase 2 meeting with the FDA, reaching agreement on key aspects of a registrational Phase 3 trial for PT-112 in metastatic castration-resistant prostate cancer.
  • The FDA approved the proposed dosing regimen, patient population, study comparator, and endpoints, with an interim analysis provision that could allow for drug approval before study completion.
  • Preliminary clinical outcomes from the Phase 2 trial of PT-112 will be presented at the upcoming ASCO 2025 Annual Meeting on June 2nd, following recent presentation of immune response biomarker data at AACR 2025.

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

NCT02266745Active, Not RecruitingPhase 2
Promontory Therapeutics Inc.
Posted 7/1/2014

PT-112 in Subjects With Thymoma and Thymic Carcinoma

NCT05104736RecruitingPhase 2
National Cancer Institute (NCI)
Posted 4/6/2022

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