Clinical Trial News
Glofitamab-GemOx Shows Survival Benefit in Phase 3 STARGLO Trial for R/R DLBCL, But FDA Advisory Committee Questions US Applicability
• The phase 3 STARGLO trial demonstrated that glofitamab combined with gemcitabine and oxaliplatin nearly doubled median overall survival to 25.5 months compared with 12.9 months for rituximab-GemOx in transplant-ineligible R/R DLBCL patients.
• Despite showing a 41% reduction in death risk and 63% reduction in disease progression, the FDA's Oncologic Drugs Advisory Committee voted 8-to-1 against the applicability of the trial data to US patients, citing regional outcome differences.
• Glofitamab, a CD20xCD3 bispecific antibody, is currently approved in over 30 countries and has accelerated approval in the US, with an FDA decision on full approval expected by July 20, 2025.
Highlighted Clinical Trials:
Hoffmann-La Roche
Posted 2/23/2021
Hoffmann-La Roche
Posted 2/21/2017
FDA Approves Hyalex Orthopaedics' IDE Supplement for Pivotal Trial of Freestyle Knee Implant
• The FDA has approved Hyalex Orthopaedics' supplemental IDE application, allowing expansion of their Early Feasibility Study into a pivotal clinical trial for the Freestyle Knee Implant.
• The novel implant technology targets patients with cartilage damage and early osteoarthritis of the femoral condyle, addressing an estimated $2 billion market in the US with limited current treatment options.
• Early clinical evaluations have shown promising results in mimicking natural joint mechanics and helping patients return to active lifestyles, according to principal investigator Dr. Sabrina Strickland.
Highlighted Clinical Trials:
Hyalex Orthopaedics, Inc.
Posted 4/4/2024
Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment
• 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.
CellProthera Partners with CELLforCURE by SEQENS for Phase 3 Manufacturing of Heart Attack Cell Therapy
• CellProthera has selected CELLforCURE by SEQENS as its CDMO partner for Phase 3 manufacturing of ProtheraCytes, an autologous expanded CD34+ stem cell therapy for severe heart attack patients.
• The partnership will begin with technology transfer in 2025, with clinical batch production expected to start in 2026 following favorable FDA feedback on the Phase 3 trial design.
• ProtheraCytes aims to improve heart failure event-free survival following severe heart attacks and has shown promising results in Phase 1/2b studies as it advances toward market authorization.
Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals
• 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.
Tourmaline Bio's Heart Disease Antibody Shows Promise in Phase 2, But Shares Fall Amid Competition Concerns
• Tourmaline Bio's antibody drug pacibekitug demonstrated significant reduction in cardiovascular risk biomarkers compared to placebo in Phase 2 trials, but shares fell 18% as investors question its competitive edge against Novo Nordisk's offering.
• Schrödinger announced CFO Geoffrey Porges will leave the company amid near-record low share prices, coinciding with plans to lay off 7% of staff as part of cost-cutting measures.
• CRISPR Therapeutics is expanding its technological capabilities through a $95 million deal with Sirius Therapeutics to develop SRSD107, a novel siRNA blood thinner designed to minimize bleeding risk.
Finnish Researchers Develop Gene Signature Test to Predict Cancer Immunotherapy Response
• 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.
USC Spine Center Joins Pivotal CLARITY Trial to Evaluate Nociscan for Chronic Low Back Pain
• Keck Medical Center of USC has joined the CLARITY trial to evaluate Aclarion's Nociscan technology, which uses MR Spectroscopy and AI to identify sources of chronic low back pain.
• The randomized, multi-center CLARITY trial will enroll 300 patients across prestigious institutions including Johns Hopkins Medicine, Northwestern Medicine, and Texas Back Institute.
• Nociscan is the first evidence-supported platform to noninvasively distinguish between painful and nonpainful discs in the lumbar spine, potentially transforming diagnosis and treatment for 266 million people worldwide with degenerative spine disease.
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