Clinical Trial News
Cretostimogene Shows Promise in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
- Phase 3 trial of cretostimogene grenadenorepvec shows a 75.7% complete response rate in patients with high-risk BCG-unresponsive NMIBC.
- The 3- and 6-month landmark complete response rates were 68.2% and 63.6%, respectively, indicating sustained efficacy over time.
- The oncolytic immunotherapy was generally well-tolerated, with mostly low-grade genitourinary adverse events and no treatment discontinuations.
- CG Oncology plans to discuss advancing cretostimogene grenadenorepvec with the FDA as a potential new therapy for bladder cancer.
Highlighted Clinical Trials:
CG Oncology, Inc.
Posted 10/27/2020
Loyal's LOY-001 Receives FDA's Nod for Potential Lifespan Extension in Large Dogs
- Loyal's LOY-001 has received FDA agreement on its potential effectiveness in extending lifespan of large dog breeds, marking a significant milestone.
- The drug targets insulin growth factor-1 (IGF-1), a hormone linked to accelerated aging in larger dogs, aiming to improve their quality of life.
- LOY-001 is designed as a vet-administered injection given every 3-6 months, with potential market availability as early as 2026 after further trials.
- Clinical trials are ongoing, and Loyal is also developing alternative formulations, including daily pills, to cater to different dog sizes and owner preferences.
Acelyrin's Izokibep Clinical Trial Faces Dosing Error, Top-Line Psoriatic Arthritis Data Expected Q1 2024
- Acelyrin's psoriatic arthritis trial (PsA) experienced a dosing sequence error due to incorrect programming by Clinical Research Organization Fortrea, affecting some patients in specific dosing arms.
- The error, involving the 160mg Q2W and 80mg Q4W dosing arms, resulted in patients receiving placebo and active treatment in a random order, though no patient received more active ingredient than allowed.
- Acelyrin is addressing the error and conducting a review of ongoing izokibep trials, including an independent audit, with top-line data from the PsA trial expected in the first quarter of 2024.
- This update follows Acelyrin's previous announcement that izokibep failed to meet the primary endpoint in a Phase 2b/3 study for moderate to severe hidradenitis suppurativa.
CRISPR/Cas9 Technology Revolutionizes CAR-T Cell Therapy: Enhancing Efficacy and Overcoming Treatment Barriers
- CRISPR/Cas9 gene editing technology is being integrated with CAR-T cell therapy to address key limitations including immune checkpoint inhibition, T cell exhaustion, and manufacturing challenges.
- The technology enables precise knockout of immune checkpoint genes like PD-1 and CTLA-4, significantly enhancing CAR-T cell persistence and anti-tumor activity in preclinical studies.
- CRISPR/Cas9 facilitates development of universal "off-the-shelf" CAR-T cells by eliminating TCR and HLA genes, potentially reducing manufacturing costs and treatment timelines from weeks to days.
- Despite promising clinical trial results showing safety and feasibility, researchers continue addressing potential safety concerns including off-target effects and chromosomal instability.
GSK's Blenrep Shows Superiority in Phase III Multiple Myeloma Trial
- GSK's Blenrep demonstrated significant improvement in progression-free survival (PFS) as a second-line treatment for relapsed or refractory multiple myeloma.
- The DREAMM-7 trial compared Blenrep plus BorDex to daratumumab plus BorDex, involving 494 patients with disease progression after prior therapy.
- An independent review recommended early unblinding due to promising interim outcomes, including a positive overall survival (OS) trend.
- GSK plans to present detailed findings and communicate with health authorities regarding potential further regulatory action for Blenrep.
RPT193 Shows Clinical Improvement in Atopic Dermatitis Patients
- RPT193, an oral CCR4 antagonist, demonstrated greater improvements in clinical efficacy endpoints compared to placebo in adults with moderate to severe atopic dermatitis.
- The Phase 1 study highlighted that RPT193 was well-tolerated, with most treatment-emergent adverse events being mild to moderate across all cohorts.
- Patients receiving RPT193 400 mg QD showed numerically greater improvements in EASI, BSA, vIGA, and SCORAD scores compared to the placebo group over 28 days.
- Post-hoc analysis revealed statistically significant differences in efficacy endpoints at day 43, suggesting sustained efficacy beyond the treatment period.
Highlighted Clinical Trials:
RAPT Therapeutics, Inc.
Posted 8/12/2019
Imvax's Personalized Immunotherapy Shows Promise in Glioblastoma Treatment
- Imvax is developing Goldspire™, a personalized immunotherapy platform, to treat glioblastoma (GBM) by leveraging the complete antigenic profile of a patient's tumor.
- The Goldspire™ platform facilitates rapid processing of GBM tumor tissue, allowing for implantation shortly after tumor resection surgery, complementing standard-of-care therapies.
- A Phase 2b trial of Imvax's IGV-001 is underway, assessing its safety and effectiveness in newly diagnosed GBM patients, building on positive results from a Phase 1b trial.
- Imvax partners with the Glioblastoma Research Organization, demonstrating commitment to advancing brain cancer research and supporting GBM patients and their families.
Highlighted Clinical Trials:
Roswell Park Cancer Institute
Posted 5/4/2015
City of Hope Medical Center
Posted 5/1/2010
Oslo University Hospital
Posted 4/26/2018
Northwestern University
Posted 11/1/2016
Dana-Farber Cancer Institute
Posted 2/9/2015
Celldex Therapeutics
Posted 11/1/2011
University of Pennsylvania
Posted 11/18/2014
David Peereboom
Posted 5/21/2018
National Cancer Institute (NCI)
Posted 9/1/2020
Amgen
Posted 4/18/2018
DNAtrix, Inc.
Posted 10/6/2016
Baylor College of Medicine
Posted 10/1/2010
National Cancer Institute (NCI)
Posted 9/21/2017
Vaximm GmbH
Posted 11/21/2018
Duke University
Posted 12/1/2026
Clinica Universidad de Navarra, Universidad de Navarra
Posted 9/1/2013
University of Pennsylvania
Posted 3/11/2019
City of Hope Medical Center
Posted 5/18/2015
Celldex Therapeutics
Posted 8/1/2007
University of Virginia
Posted 3/1/2018
Clinica Universidad de Navarra, Universidad de Navarra
Posted 6/1/2015
DxVx Advances Licensing Deal for OVM-200 Cancer Vaccine in Asian Markets
- DxVx, a South Korean biotech company, is finalizing a licensing agreement with Oxford Vacmedix to develop and commercialize OVM-200 cancer vaccine in South Korea and China.
- OVM-200 targets survivin protein and has completed Phase 1a trials showing strong safety profile and immune response in advanced cancer patients.
- The deal includes upfront payments, development milestones, and royalties, with DxVx planning accelerated approval by 2027 for early patient access.
AstraZeneca Secures KRAS G12D Inhibitor in $419M Deal with Usynova
- AstraZeneca has licensed UA022, a novel KRAS G12D inhibitor, from Chinese biotech Usynova for $24 million upfront, with potential milestone payments reaching $395 million.
- The preclinical compound targets KRAS G12D mutations, which account for 26% of all KRAS mutations and are commonly found in pancreatic and colorectal cancers, addressing a significant unmet medical need.
- This strategic move positions AstraZeneca among select companies developing KRAS G12D inhibitors, including Mirati, Revolution Medicines, and Roche/Chugai, expanding the frontier of precision oncology.
Phase IIb Trial Evaluates Efficacy and Safety of Anyu Peibo Capsules for Major Depressive Disorder
A 6-week, phase IIb, randomized, double-blind, placebo-controlled study conducted across nine research sites in China evaluated the efficacy and safety of Anyu Peibo capsules in treating Major Depressive Disorder (MDD). The study involved 86 patients, comparing Anyu Peibo capsules (0.8 g twice daily) against a placebo. While the primary outcome did not show a significant difference between the two groups, secondary outcomes indicated potential benefits of Anyu Peibo capsules, including improvements in HAMD-17 and HAMA scores. The treatment was found to be safe and well-tolerated, with a lower incidence of adverse events compared to other antidepressants.
Highlighted Clinical Trials:
Shanghai Mental Health Center
Posted 6/30/2017
Shanghai Mental Health Center
Posted 1/23/2020