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Clinical Trial News

Epsilogen Completes Series B Expansion to Advance IgE Antibody Therapy for Ovarian Cancer

  • Epsilogen secured additional funding of £12.5m in Series B expansion, bringing the total to £43.25m, to support clinical development of its IgE antibody pipeline.
  • The lead candidate, MOv18 IgE, will be evaluated in a Phase Ib trial for platinum-resistant ovarian cancer, showing promise as a first-in-class cancer IgE antibody.
  • MOv18 IgE targets folate receptor alpha, which is overexpressed in various cancers, and has demonstrated safety and initial clinical activity in a Phase I trial.
  • Epsilogen is also advancing its IgE-based pipeline, including IgE bispecifics and IgE/IgG combination antibody molecules, to enhance functionality in oncology.

Tarlatamab Shows Promise in Treating Extensive-Stage Small Cell Lung Cancer

  • Tarlatamab-dlle demonstrates a manageable safety profile and promising survival outcomes in first-line maintenance extensive-stage small cell lung cancer (ES-SCLC).
  • In a phase 2 study, patients with ES-SCLC previously treated with platinum-based chemotherapy showed continued anticancer activity with a median overall survival of 15.2 months.
  • Tarlatamab, a bispecific T cell engager, binds to DLL3 on cancer cells and CD3 on T cells, activating T cells to eliminate cancer cells.
  • The FDA granted accelerated approval to tarlatamab-dlle for ES-SCLC that has progressed during or after platinum-based chemotherapy.

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395RecruitingPhase 1
Amgen
Posted 8/24/2022

Evaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Melanoma Phase 2 Trial

  • Evaxion Biotech reports a 69% Overall Response Rate (ORR) in its Phase 2 trial of EVX-01 combined with pembrolizumab for advanced melanoma.
  • The interim analysis showed that 11 out of 16 patients experienced objective clinical responses, with 15 patients exhibiting tumor reduction.
  • The complete one-year dataset will be presented at the ESMO Congress, followed by a webinar featuring key opinion leader Professor Georgina V. Long.
  • EVX-01, designed using Evaxion's AI-Immunology™ platform, is tailored to individual patient's tumor profiles, potentially enhancing treatment efficacy.

A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

NCT05309421RecruitingPhase 2
Evaxion Biotech A/S
Posted 8/30/2022

Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)

NCT03715985Unknown StatusPhase 1
Herlev Hospital
Posted 1/28/2019

ESMO 2024: AbbVie and Nuvalent Present Promising Data on Novel Cancer Therapies

• AbbVie presented data on mirvetuximab soravtansine for platinum-sensitive ovarian cancer, showing a 51.9% objective response rate in pre-treated patients. • Nuvalent's NVL-655 and zidesamtinib demonstrated durable responses in heavily pre-treated NSCLC patients, targeting ALK and ROS1, respectively. • AbbVie's telisotuzumab vedotin (Teliso-V) is under FDA review for accelerated approval in c-Met overexpressing non-small cell lung cancer. • Nuvalent plans to initiate a Phase 3 trial (ALKAZAR) of NVL-655 in TKI-naïve ALK-positive NSCLC patients in the first half of 2025.

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

NCT05456685Active, Not RecruitingPhase 2
AbbVie
Posted 9/28/2022

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

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

NCT05029882Active, Not RecruitingPhase 1
AbbVie
Posted 10/13/2021

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT04928846RecruitingPhase 3
AbbVie
Posted 3/25/2022

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

NCT06084481RecruitingPhase 1
AbbVie
Posted 11/9/2023

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626RecruitingPhase 1
Nuvalent Inc.
Posted 6/9/2022

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

2023-505110-14-00RecruitingPhase 2
AbbVie Deutschland GmbH & Co. KG

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

NCT05445778RecruitingPhase 3
AbbVie
Posted 12/27/2022

Sinopharm's Mpox Vaccine Candidate Cleared for Clinical Trials in China

  • Sinopharm's mpox vaccine candidate, developed by the Shanghai Institute of Biological Products, has been approved for clinical trials in China.
  • The vaccine is a replication-deficient vaccine based on the Modified Vaccinia Ankara (MVA) strain, similar to the Jynneos vaccine.
  • Preclinical studies suggest the vaccine can generate good immune protection against the mpox virus in non-human primate models.
  • China has reported over 2,500 mpox cases and currently has no approved mpox vaccines, making this a significant step.

CytoDyn Advances Leronlimab Pipeline Across Oncology, Inflammation, and HIV

• CytoDyn's leronlimab sees renewed progress with the FDA lifting its clinical hold in March 2024, enabling the advancement of clinical trials. • A Phase II study of leronlimab in relapsed/refractory microsatellite stable colorectal cancer is set to begin screening patients in early 2025. • Leronlimab is under investigation for HIV-related chronic inflammation, with trials designed to clarify its mechanism of action on biomarkers. • Preclinical studies of leronlimab are underway for MASH and glioblastoma, with potential synergies being explored with existing treatments.

PDS Biotech Presents Promising VERSATILE-002 Data for HPV16-Positive Head and Neck Cancer

  • PDS Biotech will present updated data from the VERSATILE-002 trial at the ESMO Congress 2024 in Barcelona, Spain.
  • The trial evaluates Versamune® HPV (PDS0101) in combination with KEYTRUDA® (pembrolizumab) as a first-line treatment.
  • The treatment targets patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
  • The poster presentation will include survival data and be available on PDS Biotech's website after the event.

Cereno Scientific's CS1 Receives Orphan Drug Designation in EU for Pulmonary Arterial Hypertension

  • Cereno Scientific's CS1 has been granted Orphan Medicinal Product Designation (OMPD) in the EU for Pulmonary Arterial Hypertension (PAH).
  • CS1, a histone deacetylase (HDAC) inhibitor, is currently in a Phase II trial evaluating its safety and efficacy in PAH patients.
  • The OMPD provides Cereno Scientific with market exclusivity and other benefits for CS1 in the EU, potentially aiding its development and commercialization.
  • Cereno's pipeline includes CS014, in Phase I for thrombosis prevention, and CS585, a preclinical IP receptor agonist for cardiovascular diseases.

FDA Approves Illumina's TruSight Oncology Comprehensive Assay as Pan-Tumor Companion Diagnostic

  • The FDA has approved Illumina's TruSight Oncology (TSO) Comprehensive Assay as a pan-tumor companion diagnostic, enhancing precision medicine.
  • TSO Comprehensive is the first FDA-approved kit for identifying NTRK-positive solid tumor patients eligible for larotrectinib and RET fusion-positive NSCLC patients for selpercatinib.
  • The assay profiles over 500 biomarkers using next-generation sequencing, facilitating personalized therapy recommendations and clinical trial enrollment.
  • Illumina is partnering with pharmaceutical companies to expand TSO Comprehensive's companion diagnostic claims, with future claims pending regulatory approvals.

Deucrictibant Shows Sustained Benefits in Hereditary Angioedema Treatment

  • Data from open-label extensions of Phase 2 trials demonstrate deucrictibant's sustained efficacy in preventing and treating swelling attacks associated with hereditary angioedema (HAE).
  • Results showed a 93% reduction in HAE attack rates after one year in the extension period, with a median monthly attack rate of zero.
  • Pharvaris is advancing deucrictibant with Phase 3 trials for both on-demand (RAPIDe-3) and prophylactic (CHAPTER-3) treatment of HAE, and exploring its potential in acquired angioedema.
  • The median time to onset of symptom relief was 1.1 hours, with nearly all (98.5%) of attacks starting to ease within 12 hours.

Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

NCT06343779RecruitingPhase 3
Pharvaris Netherlands B.V.
Posted 2/26/2024

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

NCT04618211CompletedPhase 2
Pharvaris Netherlands B.V.
Posted 2/3/2021

Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

NCT05047185CompletedPhase 2
Pharvaris Netherlands B.V.
Posted 4/19/2022

Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

NCT05396105Enrolling by InvitationPhase 2
Pharvaris Netherlands B.V.
Posted 12/28/2022

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