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Clinical Trial News

F2G Secures $100 Million to Advance Antifungal Olorofim After FDA Rejection

• F2G has raised $100 million to fund late-stage testing of olorofim, an antifungal drug intended to treat invasive aspergillosis, after initial FDA rejection. • The funding round was co-led by AMR Action Fund and ICG, with participation from eight other investors, signaling strong confidence in olorofim's potential. • Olorofim, an orotomide antifungal, targets a key enzyme in fungi and has received Breakthrough Therapy designation, with ongoing Phase 3 trials comparing it to AmBisome. • The investment will support completion of the Phase 3 trial, resubmission to the FDA, and preparations for the potential U.S. launch of olorofim.

Olorofim Aspergillus Infection Study

NCT05101187RecruitingPhase 3
F2G Biotech GmbH
Posted 3/31/2022

FDA Advisory Panel to Review IceCure's ProSense for Early-Stage Breast Cancer

  • The FDA's Medical Device Advisory Committee Panel will convene on November 7, 2024, to assess ProSense cryoablation for early-stage, low-risk breast cancer.
  • ProSense offers a minimally invasive alternative to lumpectomy for approximately 70,000 women diagnosed annually in the U.S.
  • The FDA's decision on marketing authorization for ProSense is anticipated by early 2025, following the Advisory Panel's recommendations.
  • Clinical data from the ICE3 study showed a 96.3% local recurrence-free rate at 5 years with ProSense and adjuvant endocrine therapy.

Alzheimer's Clinical Trials Face Critical Diversity Challenge: Experts Call for Inclusive Enrollment

• Clinical trials for Alzheimer's disease medications predominantly enroll white patients, with recent studies like TRAILBLAZER-ALZ 2 and CLARITY AD showing over 75% white participation despite the disease affecting all populations.
• Current screening criteria and eligibility cutoffs, developed primarily from non-Hispanic populations, may inadvertently exclude minority groups and patients with comorbidities like Down syndrome, limiting comprehensive efficacy data.
• Experts emphasize that successful diverse enrollment requires improved compensation for participants, better accessibility of trial centers, and research teams that reflect target communities.

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

NCT03887455Active, Not RecruitingPhase 3
Eisai Inc.
Posted 3/27/2019

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

NCT04468659Active, Not RecruitingPhase 3
Eisai Inc.
Posted 7/14/2020

Sernova's Cell Pouch Shows Long-Term Islet Survival in Type 1 Diabetes Trial

  • Sernova's Cell Pouch demonstrated long-term survival of insulin-producing islet cells after five years in a patient with type 1 diabetes, achieving sustained insulin independence.
  • Histological data confirmed healthy islet cells producing insulin, glucagon, and somatostatin throughout all chambers of the Cell Pouch, with robust vascularization and no detrimental fibrosis.
  • The Cell Pouch system offers a contained and retrievable cell therapy approach, representing a significant advancement in type 1 diabetes treatment, according to lead investigator Dr. Piotr Witkowski.
  • Sernova is progressing with further clinical trials and partnerships to develop a scalable, stem cell-derived islet replacement therapy, aiming for a functional cure for type 1 diabetes.

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

NCT03513939RecruitingPhase 1
Sernova Corp
Posted 2/7/2019

Sinopia Biosciences Awarded $2.2M SBIR Grant to Advance Oral Mucositis Program

  • Sinopia Biosciences received a $2.2M Phase II SBIR grant from the NIDCR to advance its oral mucositis program, focusing on lead discovery and optimization.
  • The grant will support the use of Sinopia's LEADS® platform, which leverages AI/ML to identify therapeutic targets and candidates for oral mucositis.
  • Sinopia's LEADS® platform analyzes multi-omics data from disease models, combined with high-throughput screening and predictive modeling.
  • Oral mucositis, a debilitating side effect of cancer therapy, affects up to 90% of head and neck cancer patients, potentially halting or modifying treatment.

GSK's mRNA Influenza Vaccine Shows Promise in Phase II Trial, Advancing to Phase III

  • GSK's mRNA seasonal influenza vaccine candidate met pre-defined success criteria in Phase II trials for both younger and older adults, demonstrating positive immune responses against influenza A and B strains.
  • The mRNA platform elicited strong overall antibody titers with an acceptable safety profile, supporting its potential as a next-generation influenza vaccine.
  • Based on the Phase II results, GSK plans to advance its mRNA influenza vaccine program into late-stage clinical development, aiming for a best-in-class vaccine.
  • The Phase II trial (NCT06431607) assessed the reactogenicity, safety, and immunogenicity of different dose levels of the vaccine in 500 healthy adults.

A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults

NCT06431607CompletedPhase 2
GlaxoSmithKline
Posted 5/23/2024

Bright Minds Biosciences Advances BMB-101 for Drug-Resistant Epilepsy in Phase 2 Trial

  • Bright Minds Biosciences is collaborating with Firefly Neuroscience to analyze EEG data from the Phase 2 BREAKTHROUGH study of BMB-101.
  • The BREAKTHROUGH study is evaluating BMB-101, a selective 5-HT2C receptor agonist, in adults with Absence Epilepsy and Developmental Epileptic Encephalopathy.
  • BMB-101 has shown promise as a best-in-class 5-HT2C agonist with potential applicability for drug-resistant epilepsy patients.
  • The Phase 2 trial is designed as a basket study, aiming to enroll 20 participants to address rare epilepsy disorders resistant to current treatments.

A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

NCT05667779CompletedPhase 1
QurAlis Corporation
Posted 12/22/2022

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

NCT06532396CompletedPhase 1
QurAlis Corporation
Posted 7/1/2024

Vironexis' VNX-101 Cleared for Phase 1/2 Trial in CD19+ Acute Lymphoblastic Leukemia

  • Vironexis Biotherapeutics received FDA clearance for its IND application for VNX-101, an AAV-based gene therapy, enabling a Phase 1/2 trial for CD19+ acute lymphoblastic leukemia.
  • VNX-101 uses the TransJoin platform to express a bispecific T-cell engager, targeting CD19 on tumor cells and CD3 on T-cells to facilitate cancer cell killing.
  • The Phase 1/2 trial is anticipated to begin in Q4 2024, marking the first clinical trial of an AAV-delivered cancer immunotherapy, with Fast Track and Rare Pediatric Disease designations.
  • Vironexis' TransJoin technology aims to improve safety, efficacy, and durability compared to CAR-T therapy and bispecific antibodies, while streamlining manufacturing and reducing treatment burden.

Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)

NCT06533579RecruitingPhase 1
Vironexis Biotherapeutics Inc.
Posted 5/30/2025

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

NCT04581473Active, Not RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020

A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

NCT04984356CompletedPhase 1
Wugen, Inc.
Posted 1/14/2022

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

NCT03277729Active, Not RecruitingPhase 1
Fred Hutchinson Cancer Center
Posted 12/5/2017

Summit Therapeutics Secures $235 Million to Advance Ivonescimab Clinical Trials

  • Summit Therapeutics has raised $235 million through a private stock sale to fund clinical trials for ivonescimab, an investigational cancer treatment.
  • The financing involved the sale of over 10 million shares at $22.70 each, matching the closing stock price on the announcement day.
  • Major internal figures and leading biotech investors participated, signaling strong confidence in the company's lead drug candidate.
  • The funds will support the clinical development of ivonescimab and other corporate initiatives, with shares subject to SEC registration for resale.

Florey Institute to Accelerate MND Drug Discovery with Novel iPSC Screening Platform

  • The Florey Institute receives $5 million to advance drug screening for Motor Neurone Disease (MND) using a novel iPSC-based platform.
  • The platform uses iPSCs from over 100 MND patients to screen potential treatments by assessing their ability to keep motor neurons alive.
  • Initial screenings accurately mirrored clinical trial outcomes, showing 95% of previously tested drugs were ineffective, validating the platform's accuracy.
  • This technology aims to improve the efficiency of MND drug trials by filtering out ineffective drugs early, potentially revolutionizing drug discovery for sporadic MND.

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