CELLECTIS | MedPath

B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area. • Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025. • Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.

AstraZeneca Acquires EsoBiotec for Up to $1 Billion to Transform Cancer Cell Therapy

2 months ago

• AstraZeneca has agreed to acquire Belgium-based EsoBiotec for up to $1 billion, with an initial payment of $425 million and additional milestone-based payments of up to $575 million. • EsoBiotec's Engineered NanoBody Lentiviral (ENaBL) platform enables in vivo modification of immune cells, potentially reducing cell therapy delivery time from weeks to minutes through a simple injection. • The acquisition, expected to close in Q2 2025, aims to revolutionize cancer treatment by making cell therapies more accessible and efficient for patients while expanding AstraZeneca's oncology portfolio.

Celldex Advances Barzolvolimab Phase 3 Program in Chronic Urticaria with Strong Pipeline Progress

3 months ago

• Celldex Therapeutics reports significant progress in Phase 3 trials of barzolvolimab for chronic spontaneous urticaria (CSU), with active enrollment ongoing across 40 countries and 500 sites. • The company's Phase 2 CSU study demonstrated unprecedented efficacy with 71% of patients achieving complete response at Week 52, setting a new standard in disease treatment. • Celldex expands its portfolio by initiating Phase 2 trials in atopic dermatitis and launching CDX-622, their first bispecific antibody targeting inflammatory diseases.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

Allogene Therapeutics Advances AlloCAR T Pipeline in Oncology and Autoimmune Diseases

6 months ago

• Allogene's ALPHA3 trial for cema-cel in large B-cell lymphoma is actively enrolling, potentially integrating CAR T into first-line treatment. • ALLO-316 demonstrated a 50% overall response rate in heavily pretreated renal cell carcinoma patients, earning FDA's RMAT designation. • ALLO-329, a dual CD19/CD70 CAR T for autoimmune diseases, is set for IND filing in Q1 2025, aiming to reduce lymphodepletion. • The company maintains a strong financial position with $403.4 million in cash, projecting operations funding into the second half of 2026.

CRISPR Weekly Roundup: Advancements in Gene Editing and Clinical Trials

7 months ago

• Beam Therapeutics reported a patient death in their BEAM-101 sickle cell disease trial, likely due to the conditioning regimen. • AstraZeneca scientists engineered PsCas9 for therapeutic genome editing in mouse liver, showing promise for hypercholesterolemia treatment. • YolTech Therapeutics' novel LNP system delivers base editor mRNA to bone marrow cells, activating foetal haemoglobin production for blood disorder treatment.

Cellectis Bolsters Financial Position with AstraZeneca Collaboration, Advances CAR-T Pipeline

7 months ago

• Cellectis' cash reserves surged to $264 million, fueled by a strategic investment and collaboration revenue from AstraZeneca, extending the company's financial runway to 2027. • Three new R&D programs have been initiated with AstraZeneca, encompassing allogeneic CAR T therapies for hematological malignancies and solid tumors, plus an in vivo gene therapy. • The UCART123 program for relapsed/refractory acute myeloid leukemia is being deprioritized to concentrate resources on the more promising BALLI-01 and NATHALI-01 studies. • Phase I data for the BALLI-01 (UCART22) and NATHALI-01 (UCART20x22) studies are expected in 2025, with strong patient demand reported for the UCART20x22 program.

Gene Therapy Clinical Trial Pipeline Surges with Over 180 Companies Leading Innovation

7 months ago

• The gene therapy market is experiencing substantial growth, fueled by technological advancements, increased investments, and a deeper understanding of genetic diseases. • Key players are actively engaging in collaborations, mergers, and acquisitions to enhance their research and development capabilities and broaden their product portfolios. • Regulatory bodies like the FDA and EMA are expediting the approval process for gene therapies, acknowledging their potential in addressing unmet medical needs. • Ethical considerations and public perception surrounding gene editing, particularly germline modifications, remain critical factors influencing market dynamics and regulatory policies.

Off-The-Shelf Allogeneic CAR-T Therapies Show Promise for B-Cell Malignancies

a year ago

• Allogeneic "off-the-shelf" CAR-T cell therapies are emerging as alternatives to autologous CAR-T treatments, offering faster availability, reduced manufacturing complexity, and potentially lower costs for patients with B-cell malignancies. • Gene editing technologies including CRISPR/Cas9, TALEN, and novel approaches are being used to disrupt T-cell receptor genes and prevent graft-versus-host disease while maintaining anti-tumor efficacy in clinical trials. • Early clinical results show promising efficacy with manageable toxicity profiles, with several allogeneic CAR-T products targeting CD19, CD20, CD22, or multiple antigens demonstrating objective response rates of 40-85% in various B-cell malignancies.