Clinical Trial News
More Impact AG Secures US Patent for Needle-Free Speedinject Technology
• More Impact AG has been granted a US patent for Speedinject, an innovative needle-free injection technology developed by its subsidiary The Key Unternehmensberatung GmbH.
• The electromagnetically driven system offers a precise, painless, and environmentally friendly alternative for drug administration, particularly targeting diabetes and weight loss treatments.
• With the US pharmaceutical market valued at $634 billion and projected to reach $884 billion in five years, Speedinject is positioned to launch in both EU and US markets by late 2025.
Lymphodepletion Enhances MAR-T Cell Therapy Efficacy in Lymphoma Patients, Marker Therapeutics Reports
• 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.
Highlighted Clinical Trials:
Marker Therapeutics, Inc.
Posted 1/2/2023
Novel BAFF-R CAR-T Therapy Achieves Complete Response in Heavily Pretreated Follicular Lymphoma Patient
• 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.
Highlighted Clinical Trials:
PeproMene Bio, Inc.
Posted 6/13/2022
PeproMene Bio, Inc.
Posted 5/18/2021
KaliVir Advances Novel Oncolytic Immunotherapy VET3-TGI in Phase 1/1b Trial for Advanced Solid Tumors
• 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.
Highlighted Clinical Trials:
KaliVir Immunotherapeutics
Posted 9/16/2024
PharmaEssentia's Ropeginterferon Shows Promising Results in Phase 3 Trial for Essential Thrombocythemia
• 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.
Highlighted Clinical Trials:
PharmaEssentia
Posted 8/25/2020
Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025
• 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.
Highlighted Clinical Trials:
Eisai Inc.
Posted 7/11/2019
Merck Sharp & Dohme LLC
Posted 12/30/2020
Actimed Therapeutics Launches Program to Combat Muscle Loss in GLP-1 Treated Obesity Patients
• Actimed Therapeutics has initiated a two-part development program investigating S-pindolol benzoate for preserving muscle mass in patients on GLP-1 receptor agonist therapy for obesity.
• The PROACT clinical trial will assess S-pindolol benzoate's ability to counter the unwanted lean body mass reduction often seen with GLP-1 receptor agonist treatments, with first patient enrollment expected by mid-2025.
• Preclinical studies exploring the drug's mechanisms and efficacy in obesity models have been completed, with results expected in the coming months.
CHOP Researchers Develop Breakthrough AAV Vectors for Brain Gene Therapy at Lower Doses
• Researchers at Children's Hospital of Philadelphia have engineered new adeno-associated viral (AAV) vectors that can target brain cells at significantly lower doses than current therapies, potentially improving safety and reducing costs.
• Two novel capsids were identified: AAV-Ep+ for Batten disease treatment and AAV-DB-3 for Huntington's disease, both showing robust efficacy in preclinical models and human neurons derived from stem cells.
• The breakthrough could transform treatment for neurodegenerative disorders by enabling one-time precision therapies that require lower doses while maintaining therapeutic efficacy, with potential applications for other inherited disorders.
Experimental Medication Shows Promise in Treating Cocaine Addiction
• A novel experimental medication targeting brain reward pathways has demonstrated efficacy in helping people with cocaine addiction reduce their drug use, addressing a significant unmet medical need.
• Current addiction treatment options exist for alcoholism and opioid use disorder, but no FDA-approved medications are available for stimulant addictions like cocaine, which contribute to approximately half of all overdose deaths in the US.
• In a separate small trial, an experimental vaccine designed to prevent cocaine from reaching the brain showed promising results, with vaccinated participants 17% more likely to test negative for cocaine compared to those receiving placebo.
Philikos Initiates Phase 1/2 Trial of T-Guard for Diffuse Cutaneous Systemic Sclerosis
• Philikos has enrolled the first patient in a Phase 1/2 trial evaluating T-Guard for diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disorder with limited treatment options.
• The open-label study will assess safety and preliminary efficacy in 12 early-stage dcSSc patients whose disease remains refractory despite prior immunosuppressive therapy.
• T-Guard, administered as four infusions over one week, aims to provide a safer alternative to hematopoietic stem cell transplantation by selectively depleting disease-associated T cells and NK cells.