SHANGHAI, China — GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009). GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the...
Latest News
Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)...
COPENHAGEN, Denmark – Genmab A/S (Nasdaq: GMAB) today announced positive results of the Phase 3 EPCORE® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate...
New data showed that rinatabart sesutecan (Rina-S®) 100 mg/m2 led to a confirmed objective response rate (ORR) of 50.0 percent, including two complete responses (CR), and median duration of response (mDOR) was not reached after a median follow-up of 7.7 months Continued evaluation of single-agent Rina-S 100 mg/m2 in patients with advanced...
COPENHAGEN, Denmark – Genmab A/S (Nasdaq: GMAB) today announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination with other standard of care treatments in adult patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Results from two arms of the EPCORE® NHL-2 trial, evaluating first-line,...
COPENHAGEN, Denmark – Genmab A/S (Nasdaq: GMAB) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the safety and efficacy of investigational epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy administered in the outpatient setting in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one...
COPENHAGEN, Denmark – Genmab A/S (Nasdaq: GMAB) announced today its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R2) for the treatment...
Genocury launched the in vivo CD19 CAR-T therapy to reach the clinical stage, demonstrating exceptional safety, efficiency and durability. Results are attained without requiring lymphodepletion. SHENZHEN, China — Genocury Biotech today revealed groundbreaking clinical data from its noval in vivo CD19 CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL),...
Genomenon, Inc.®, an AI-driven genomics company, today announced a collaboration with Alexion, AstraZeneca Rare Disease that will make critical information needed for the diagnosis and treatment for a set of rare diseases more readily accessible. The goal of this collaboration is to empower genetic testing labs with the data they need to...
Tokyo, Japan – Researchers in the RIKEN Center for Brain Science (CBS) examined the genetics of autism spectrum disorder (ASD) by analyzing mutations in the genomes of individuals and their families. They discovered that a special kind of genetic mutation works differently from typical mutations in how it contributes to...