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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, April 30, 2025 /PRNewswire/ -- 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), a notoriously aggressive blood cancer. In a investigator-initiated trial (IIT) led by the Hematology Department at Tongji Hospital, a heavily pretreated relapsed/refractory (R/R) patient with advanced DLBCL achieved complete remission (CR) after 1 month of the in vivo CAR-T treatment, with durable response sustained over three months. Notably, the treatment eliminated the need for lymphodepletion, a standard yet toxic preconditioning step in traditional CAR-T protocols. Clinical Breakthrough: Redefining Safety, Efficacy, and Speed Key trial findings: 1. Rapid and Deep Response: A relapsed DLBCL male patient achieved complete hematological remission (CR) within 28 days following a single dose of Genocury's CD19 in vivo CAR-T without lymphodepletion. Flow cytometric analysis revealed significant CAR-T cell expansion kenetics, with sustained therapeutic efficacy confirmed through 90-day follow-up monitoring. 2. Unprecedented Safety Profile : Unlike conventional CAR-T, which carries a ~50% risk of cytokine release syndrome (CRS) and neurotoxicity, this novel therapeutic approach demonstrated complete absence of: Cytokine release syndrome (CRS) Immune effector cell-associated neurotoxicity syndrome (ICANS) Lymphodepletion-related complications - typically associated with increased infection risk- further underscores the therapy's safety profile. Reimagining CAR-T: In Vivo Engineering Breakthroughs Genocury's in vivo CAR-T platform overcomes two critical roadblocks in current CAR-T therapy: Eliminates Ex Vivo Manipulation: Traditional CAR-T requires 3-4 week vein-to-vein timeline by harvesting, modifying, and expanding a patient's T cells outside the body, and $400K price tag stem from this time-consuming process. Genocury's proprietary in vivo CAR-T vector delivers CAR payload directly into circulating T cells in vivo, enabling functional CAR-T generation. Lymphodepletion-Free Protocol: Current protocols require the harsh preconditioning chemotherapy for immune reset - a leading cause of hospitalization. Genocury's lymphodepletion-free approach reduces treatment-related complications and logistical burdens, as well as enabling significant CAR-T cell expansion. Statement from Prof. Jia Wei , M.D., Ph.D. PI (principal investigator), Tongji Hospital Cancer Center (Wuhan) "In this groundbreaking case, we observed the patient treated with Genocury's CD19 in vivo CAR-T achieved complete remission through 90-day follow-up - achieved without any lymphodepletion, which fundamentally challenges current cellular therapy dogma" said Dr. Jia Wei, "This therapy combines the benefits of autologous CAR-T with the accessibility of universal therapies, potentially ending the era of unaffordable cancer treatments. This could democratize access to CAR-T globally, we are very excited to advance this paradigm-shifting approach." About Genocury Biotech Shenzhen Genocury Biotech Co., Ltd. is a clinical-stage biotechnology pioneer redefining in vivo cell engineering through its proprietary Vivoexpress™ platform. This modular delivery system enables targeted delivery of genetic payloads with organ-specific tropism. The company dedicated to deliver next-generation immunotherapies for oncology and autoimmune disorders by developing universal cell and gene therapies for patients worldwide. About Tongji Hospital Hematology Department Since its establishment in 1959, the Hematology Department of Tongji Hospital is one of China's earliest and most prestigious hematology centers. Recognized for clinical excellence and innovative research, it evolved into a premier academic medical center well known as a national key discipline (2007) and national clinical key specialty (2011), and serves as the largest cell immunotherapy center in Hubei Province. With 74 medical professionals, including 22 full professors and 50 PhD practitioners, the department collectively manage over 10.000 annual patient cases. Specializing in complex hematologic malignancies ranging from leukemia, lymphoma, and myeloma to multiple other hematologic malignancies, Tongji Hospital Hematology Department solidifies its position as a leading clinical and research institution in Asia. Media Contact: [email protected] SOURCE Genocury Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Novel CAR design selectively targets malignant cells for patients with relapsed/refractory CD5-positive hematological diseases HOUSTON, April 22, 2025 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating MB-105, a first-in-class CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma. “This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.” The Phase 2 trial is a multi-center, single-arm, two-stage, open-label study designed to evaluate the safety and efficacy of MB-105 in patients with relapsed or refractory CD5-positive T-cell lymphoma. It will enroll approximately 46 patients across both stages. The trial will be conducted at leading cancer centers across the United States, with the first patient dosed at The University of Texas MD Anderson Cancer Center. The trial is led by Swaminathan P. Iyer, M.D., Professor in the Department of Lymphoma/Myeloma at MD Anderson. The Phase 2 trial builds on promising Phase 1 results in T-cell lymphoma, where MB-105 demonstrated both a favorable safety profile and durable remissions in heavily pretreated patients with relapsed/refractory T-cell lymphoma. CD5 CAR-T cells were successfully manufactured for 93% of attempted production runs. Importantly, the therapy showed a manageable safety profile with no grade 3 or higher cytokine release syndrome or neurologic events observed. The unique CAR design enabled selective targeting of malignant cells while preserving normal T-cell function. Additional information on the Phase 2 trial, which is currently enrolling patients, can be found on www.clinicaltrials.gov, NCT identifier NCT06534060. This milestone follows the company's successful Series A financing in October 2024, which was led by Mission BioCapital and 4BIO Capital, with participation from KdT Ventures, Alexandria Venture Investments, Volnay Therapeutics, Modi Ventures, and Mansueto Investments. Existing investors TMC Venture Fund, Cancer Focus Fund, Small Ventures, and Portal Innovations also participated in the round. Following the financing, the company has rapidly achieved significant clinical and regulatory milestones, including receiving FDA orphan drug designation for MB-105 in January 2025, which provides various development incentives and seven years of market exclusivity following potential FDA approval. About MB-105MB-105 is an orphan-drug designated, first-in-class autologous CD5-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL). The therapy employs a proprietary CAR design that enables selective targeting of malignant cells while preserving normal T-cell function. The Phase 2 clinical trial of MB-105 (NCT06534060) is currently enrolling for patients with relapsed / refractory T cell lymphoma. About March BiosciencesHouston-based March Biosciences, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. Its lead asset, MB-105, is a CD5-targeted CAR-T cell therapy currently in Phase 2 clinical development for patients with relapsed / refractory T-cell lymphoma. The company has raised over $52 million to date, inclusive of venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program. Learn more at www.march.bio. Forward-Looking StatementsThis press release contains forward-looking statements that involve risks and uncertainties. Any statement describing March Biosciences’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the clinical development of MB-105, the progress of clinical trials for pipeline candidates, regulatory approvals, market demand for new therapies, competitive dynamics in the biotechnology sector, and macroeconomic conditions. Contacts: Corporate:Sarah HeinChief Executive Officersarah@march.bio Media:Jon YuICR HealthcareMarchBioPR@icrhealthcare.com

Designations Follow Recent Investigational New Drug (IND) Application Clearance for the RESOLUTION Basket Study of ALLO-329 in Rheumatology Dual CD19/CD70 CAR T Specifically Designed to Enhance Therapeutic Benefit, Expanding Treatment Potential Across a Range of Autoimmune Indications Leverages Proprietary Dagger® Technology to Reduce or Eliminate Lymphodepletion, Potentially Expanding Access to a Broader Patient Population Phase 1 RESOLUTION Trial Initiation Planned for Mid-2025 with Initial Proof-of-Concept by Year-End 2025 April 07, 2025 -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc). "Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape," said Zachary Roberts, M.D., Ph.D., EVP of Research and Development and Chief Medical Officer of Allogene. "Leveraging our extensive expertise, we've developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction or elimination of lymphodepletion – a key barrier in this patient population." The Company expects to initiate the Phase 1 RESOLUTION basket trial in mid-2025. The trial is designed to evaluate the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely. Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications. Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. The content above comes from the network. if any infringement, please contact us to modify.