Allogene Therapeutics

CAR-T Cell Therapy Funding Surges to $141.2 Billion as Industry Expands Globally

12 days ago

• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals. • More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017. • Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

15 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

16 days ago

• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

Caribou Biosciences Restructures, Abandons Autoimmune Program to Focus on Cancer Cell Therapies

a month ago

• Caribou Biosciences is cutting 32% of its workforce and discontinuing its experimental lupus treatment to concentrate resources on two promising off-the-shelf CAR-T therapies for cancer. • The CRISPR gene editing company is delaying planned clinical trial readouts until the second half of 2023 to gather more robust data on its CB-010 and CB-011 therapies for lymphoma and multiple myeloma. • The restructuring will extend Caribou's financial runway from mid-2026 to late 2027, as the company makes an all-or-nothing bet on proving its cell therapies can match the efficacy of personalized CAR-T treatments.

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.

Beam Therapeutics Reports Breakthrough in Alpha-1 Antitrypsin Deficiency Treatment with BEAM-302 Base Editing Therapy

3 months ago

• Beam Therapeutics' BEAM-302 demonstrated the first-ever clinical genetic correction of the disease-causing PiZ mutation in Alpha-1 Antitrypsin Deficiency patients, with a single dose producing durable increases in functional AAT protein. • The highest dose level (60mg) achieved mean total AAT of 12.4μM, exceeding the protective therapeutic threshold of 11μM, while reducing harmful mutant Z-AAT by up to 78% in circulation. • BEAM-302 showed a favorable safety profile with no serious adverse events across all dose levels, supporting continued dose escalation with updated data expected in the second half of 2025.

CAR T-cell Therapy Pipeline Surges with 180+ Companies Advancing Novel Cancer Treatments

3 months ago

• The CAR T-cell therapy pipeline has experienced significant growth, with over 180 companies actively developing more than 200 innovative cell therapy candidates across various stages of clinical development. • Recent breakthroughs include Hemogenyx's first human administration of HG-CT-1 for acute myeloid leukemia and NICE's approval of lisocabtagene maraleucel for large B-cell lymphoma treatment. • Strategic industry developments are accelerating progress, with companies like CARsgen Therapeutics forming alliances to advance allogeneic CAR-T products and multiple firms reporting successful trial milestones.

Allogene and Foresight Diagnostics Forge $37.3M Partnership for Lymphoma Diagnostic Development

3 months ago

• Allogene Therapeutics invests $37.3M in an expanded collaboration with Foresight Diagnostics to develop a minimal residual disease (MRD) assay for large B-cell lymphoma treatment. • The partnership aims to develop Foresight's MRD assay as a companion diagnostic for cemacabtagene ansegedleucel (cema-cel) across multiple international markets including EU, UK, Canada, and Australia. • The diagnostic will be utilized in the ALPHA3 pivotal trial to identify MRD-positive patients in remission, potentially improving cure rates for first-line LBCL treatment.

Cema-cel Shows Promising 2-Year Durability Data in Large B-Cell Lymphoma Treatment

3 months ago

• Allogene Therapeutics' cema-cel demonstrates sustained efficacy with 23.1-month median response duration in relapsed/refractory large B-cell lymphoma patients from ALPHA trials. • The allogeneic CAR T-cell therapy achieves remarkable complete response rates in first-line consolidation treatment for patients with low disease burden. • Long-term follow-up data reinforces cema-cel's safety profile and therapeutic potential as an off-the-shelf treatment option for lymphoma patients.

Allogene's CAR T-Cell Therapy Shows Promising Results in Large B-Cell Lymphoma Trials

3 months ago

• Phase 1 ALPHA and ALPHA2 trials demonstrate cemacabtagene ansegedleucel achieves 67% overall response rate and 58% complete response rate in relapsed/refractory LBCL patients using the selected Phase 2 regimen. • The therapy shows a manageable safety profile with no graft-versus-host disease or high-grade cytokine release syndrome, comparable to approved autologous CAR T-cell treatments. • Treatment initiation time of two days represents significant improvement over traditional autologous CAR T-cell therapies, which typically require over one month wait time.

Allogene's ALLO-329 Receives FDA IND Clearance for Autoimmune Disease Trial

4 months ago

• The FDA has cleared Allogene Therapeutics' IND application for ALLO-329, a dual-targeting allogeneic CAR T-cell therapy, to treat autoimmune diseases. • The Phase 1 RESOLUTION trial, planned for mid-2025, will assess ALLO-329's safety and efficacy in systemic lupus erythematosus, idiopathic inflammatory myopathies, and systemic sclerosis. • ALLO-329 targets both CD19+ B cells and CD70+ activated T cells and incorporates Allogene's Dagger® technology to potentially reduce or eliminate lymphodepletion. • The trial will evaluate two lymphodepletion arms, one using cyclophosphamide and another eliminating lymphodepletion, to demonstrate the Dagger® effect.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

4 months ago

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

FDA Accepts Abeona Therapeutics' BLA Resubmission for Prademagene Zamikeracel in RDEB Treatment

6 months ago

• The FDA has accepted Abeona Therapeutics' resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB). • Pz-cel, an autologous cell-based gene therapy, aims to address the unmet needs of RDEB patients by providing collagen VII expression at wound sites. • The BLA is supported by data from the Phase 3 VIITAL study and a Phase 1/2a study with up to 8 years of follow-up, showcasing clinical efficacy and safety. • The FDA has set a PDUFA target action date of April 29, 2025, with potential for Abeona to receive a Priority Review Voucher upon approval.

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.