Guangzhou Bio-gene Technology Co., Ltd.

GUANGZHOU, China, May 02, 2024 (GLOBE NEWSWIRE) -- Guangzhou Bio-gene Technologies, a biotechnology company engaged in the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors, today announced that the first patient was treated with BG1805, an investigational autologous CAR-T cell therapy targeting CLL-1, a member of the C-type lectin-like receptor family. BG1805 is being evaluated in a Phase 1 clinical study for the treatment of relapsed/refractory acute myeloid leukemia (AML), a severe disease affecting adults and children. “CLL-1 is an important drug target for the treatment of AML patients. We are very excited about the preclinical pro BG1805 and early clinical data from Investigator Initiated Trials (IIT).” said Dr. Min Luo, CTO, Guangzhou Bio-gene Technologies. “BG1805 is the first cell therapies in our pipeline that has advanced into formal clinical development, marking a major milestone for the company.” The ongoing Phase 1 trial of BG1805 is a multicenter, open-label study with relapsed/refractory AML. The primary objectives of the Phase 1 trial are the assessment of safety, tolerability, and identification of the recommended Phase 2 dose and lymphodepletion regimen. Key safety endpoints for the trial include treatment-emergent and treatment-related adverse events, and key efficacy endpoints include proportion of patients with complete or partial responses, proportion eligible for hematopoietic stem cell transplant, and proportion achieving minimal residual disease negative status. Multiple sites for the Phase 1 clinical trial of BG1805 are now open for enrollment. For more information, visit clinicaltrials.gov (NCT06118788). Guangzhou Bio-gene Technologies is developing several additional innovative autologous CAR-T cell therapies directed at important blood malignancy and solid tumor targets, including CD7, GPRC5D, B7H3, Claudin18.2, CDH17 as well as allogenic CAR-γδT therapies targeting CD19 and CLL-1/CD33. About BG1805 BG1805 is an investigational autologous CAR-T cell therapy targeting CLL-1, currently in a Phase 1 clinical study. BG1805 has previously been studied in Investigator Initiated Studies (IIT) and has demonstrated significant efficacy in both adults and children. About Guangzhou Bio-gene Technologies Guangzhou Bio-gene Technologies, a biotechnology company in Guangzhou, China, is dedicated the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors. A leader in CAR-T cell therapies, the company has advanced one autologous CAR-T candidate into Phase 1 clinical trials, six autologous CAR-T candidates into IIT studies and two allogenic CAR-T candidates into IIT studies. For more information, please visit . Contact Guangzhou Bio-gene Technologies, Ltd.: Bert E. Thomas IV +1.410.627.1734 bthomas@gzbiogene.com

The emerging pipeline of CAR-T in NHL includes late-stage, mid-stage, and early-stage drugs in different lines of therapies and different indications, mainly including B- cell Lymphoma such as DLBCL, FL, MCL, MZL, CLL/SLL, and others, with one of them being developed for a T-cell Lymphoma, PTCL. LAS VEGAS, April 15, 2024 /PRNewswire/ -- DelveInsight's CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Insights report includes a comprehensive understanding of current treatment practices, CAR T-Cell Therapy for NHL emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan]. Key Takeaways from the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report According to DelveInsight's analysis, the market size for CAR T-Cell therapy for NHL reached USD 1,200 million in 2023 across the US. DelveInsight's analysis reveals that the total incident cases of selected indications for CAR-T in NHL in the 7MM comprised ~155,200 in 2023. Leading CAR T-Cell therapy for NHL companies such as Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, and others are developing novel CAR T-Cell therapies for NHL drugs that can be available in the CAR T-Cell therapy for NHL market in the coming years. Other promising CAR T-Cell therapies for NHL in the pipeline include Cemacabtagene Ansegedleucel, Rapcabtagene Autoleucel, Zamtocabtagene Autoleucel, MB-106, CTX110, BBT369, Azercabtagene Zapreleucel , and others. BREYANZI is poised to dominate the CAR-T market in NHL in the forthcoming years, with potential approvals anticipated across two indications: CLL/SLL, follicular lymphoma and MCL. Notably, it has already secured approval for DLBCL in 3L+, 2L+ TE, and NTE. Novartis is progressing with its additional CD-19 CAR-T therapy, Rapcabtagene autoleucel, with expectations of a significantly reduced turnaround time for availability compared to KYMRIAH. Companies are leveraging the strength of dual and triple targeting in CAR-T therapies. Miltenyi Biomedicine, ImmPACT Bio, 2seventy bio, and Novartis are developing CD19/20 Bispecific CAR-T, CD79a/CD20 Bispecific CAR-T, and CD2xCD3xCD19 CAR-T, enhancing treatment efficacy by targeting multiple antigens simultaneously. Discover which therapies are expected to grab the major CAR T-Cell therapy for NHL market share @ CAR T-Cell Therapy for NHL Market Report CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Overview CAR-T cell therapy represents a groundbreaking advancement in cancer immunotherapy, especially for specific types of NHL that have shown resistance to traditional therapies. Through the manipulation of genetically modified T cells, this state-of-the-art treatment boosts the immune system's capacity to locate and eliminate cancerous cells. Essentially, CAR-T cell therapy modifies a patient's T cells genetically to carry chimeric antigen receptors (CARs) on their surface. These engineered CARs are tailored to identify and attach to particular proteins found on cancer cells' surfaces, thereby directing the immune system to effectively combat the malignancy. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Epidemiology Segmentation In 2023, DLBCL had the highest number of cases among all selected indications for CAR-T therapy, followed by Follicular lymphoma. The total incident cases of MZL in the 7MM were around 13,800 in 2023 and are projected to increase during the forecasted period. The CAR T-Cell therapy for NHL market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of Selected Indications for CAR-T in NHL (Mantle cell lymphoma, DLBCL, Follicular lymphoma, Marginal Zone Lymphoma, Primary mediastinal large B-cell lymphoma, Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma) and Total Indication-wise Eligible Cases of CAR-T in NHL. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Treatment Market The treatment landscape for NHL is complex, influenced by factors such as the type of NHL, the stage of the disease, the patient's overall health, and their preferences. CAR-T cell therapy has emerged as a promising option within this landscape, especially for aggressive B-cell NHLs that have not responded to standard treatments. Previously, such cases posed significant challenges, often resulting in poor outlooks despite attempts with salvage chemotherapy and autologous stem cell transplants. However, the introduction of CAR-T cell therapy has drastically changed this scenario, showing impressive response rates and the potential for long-lasting remissions even in patients with advanced disease after multiple prior treatments. The approval of various CAR-T therapies for NHL by the FDA highlights the importance of this advancement. YESCARTA, KYMRIAH, BREYANZI, and TECARTUS have all proven effective across different types of NHL, including DLBCL, follicular lymphoma, and mantle cell lymphoma. Ongoing research aims to improve CAR-T cell therapy for NHL further, seeking to increase effectiveness, decrease side effects, and expand the range of target antigens beyond CD19. Additionally, studies are looking into the combined use of CAR-T cell therapy with other treatments like checkpoint inhibitors or targeted therapies, with the ultimate goal of optimizing treatment outcomes for NHL patients. To know more about CAR T-Cell therapy for Non-Hodgkin's Lymphoma treatment guidelines, visit @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Management Emerging CAR T-Cell Therapies for NHL and Key Companies Cemacabtagene Ansegedleucel: Allogene Therapeutics Rapcabtagene Autoleucel: Novartis Zamtocabtagene Autoleucel: Miltenyi Biomedicine MB-106: Mustang Bio CTX110: CRISPR Therapeutics BBT369: 2seventy Bio Azercabtagene Zapreleucel: Imugene Learn more about the FDA-approved CAR T-Cell therapy for NHL @ Drugs for CAR T-Cell Therapy for NHL Treatment CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics The dynamics of the CAR T-Cell therapy for the NHL market are expected to change in the coming years. The market for CAR T-cell therapy in NHL is characterized by a surge in research and development activities, as pharmaceutical companies race to bring new therapies to the market. With several CAR T-cell therapies receiving FDA approval, competition among manufacturers is intense, driving innovation and investment in the field. As a result, we witness a dynamic landscape with ongoing clinical trials, collaborations, and strategic partnerships aiming to expand the reach and efficacy of CAR T-cell therapies for NHL. Moreover, the market dynamics of CAR T-cell therapy for NHL are influenced by patient accessibility and reimbursement challenges. Despite the remarkable efficacy of these therapies, their high cost poses a significant barrier to widespread adoption. Healthcare systems and insurers grapple with the economic implications of CAR T-cell therapy, leading to negotiations on pricing and reimbursement models. Efforts are underway to make these life-saving treatments more accessible to patients, including discussions on value-based pricing and outcome-based reimbursement. As the field continues to evolve, the CAR T-cell therapy for NHL market dynamics will be shaped by a delicate balance between the clinical benefits of CAR T-cell therapy and the economic considerations surrounding its widespread implementation in the treatment of Non-Hodgkin's lymphoma. Scope of the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report Therapeutic Assessment: CAR T-Cell Therapy for Non-Hodgkin's Lymphoma current marketed and emerging therapies CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics: Key Market Forecast Assumptions of Emerging CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Access and Reimbursement Discover more about CAR T-Cell therapy for NHL drugs in development @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Clinical Trials Table of Contents Related Reports CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-Cell therapy for NHL companies, including Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, among others. CAR T-Cell Therapy Market CAR T-Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy companies, including CytoAgents, Genentech, Incyte Corporation, Caribou Biosciences, Chimeric Therapeutics, Allogene Therapeutics, Kyverna Therapeutics, iCell Gene Therapeutics, Synthekine, Janssen Research & Development, SecuraBio, ImmPACT Bio, A2 Biotherapeutics, Gracell Biopharmaceuticals, Wugen, Sana Biotechnology, Oncternal Therapeutics, Vor Biopharma, CARsgen Therapeutics, Autolus Limited, Arcellx, Kite, Novartis, Lyell Immunopharma, ImmPACT Bio, Tmunity Therapeutics, Poseida Therapeutics, Precigen, AffyImmune Therapeutics, 2seventy bio, Takeda, Cartesian Therapeutics, Cabaletta Bio, Legend Biotech, Miltenyi Biomedicine, Beam Therapeutics, among others. CAR T-Cell Therapy Competitive Landscape CAR T-cell Therapy Competitive Landscape – 2024 report provides comprehensive insights about the pipeline and current landscape, pipeline and marketed drug profiles, and the key CAR T-cell therapy companies, including Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy, Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, among others. CAR T-Cell Therapy for Multiple Myeloma Market CAR T-Cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Cartesian Therapeutics, Arcellx, Novartis, Bristol-Myers Squibb, CARsgen Therapeutics, Poseida Therapeutics, Juno Therapeutics, CRISPR Therapeutics, bluebird bio, Cellectis SA, Caribou Biosciences, Luminary Therapeutics, Celyad Oncology, Allogene Therapeutics, Gadeta, Nanjing IASO Biotherapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

DUBLIN--( BUSINESS WIRE )--The "CAR T - Cell Therapy - Competitive Landscape, 2022" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 193+ companies and 450+ drugs in CAR T - Cell Therapy Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Chimeric antigen receptors (CARs) are recombinant receptors for antigens which redirect the specificity and function of T lymphocytes and/or other immune cells in a single molecule. Cancer Immunotherapy utilizes and enhances the immune system's standard capacity and is considered one of the most promising approaches for treating various diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) are severe. CAR T-cells are the fusion proteins of a selected single-chain fragment variable from a specific monoclonal antibody and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains-most commonly, a single-chain variable fragment (scFv) derived from the variable domains of antibodies with the signalling domains of the TCR chain and additional costimulatory domains from receptors, such as CD28, OX40, and CD137. CAR T-cell therapy involves genetic modification of a patient's autologous T-cells to express a CAR, specific for a tumor antigen, followed by ex vivo cell expansion and re-infusion back to the patient. Report Highlights In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. In March 2022, JW Therapeutics announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. In May 2022, Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings In March 2021, The US Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for the treatment of multiple myeloma. In June 2021, based on ZUMA-3 study data, the US FDA has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL In April 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and/or refractory multiple myeloma Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing CAR T - Cell Therapy drugs? How many CAR T - Cell Therapy drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of CAR T - Cell Therapy? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the CAR T - Cell Therapy therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for CAR T - Cell Therapy and their status? What are the key designations that have been granted to the emerging and approved drugs? Key Players Alnylam Pharmaceuticals JW Therapeutics Gilead Sciences Janssen Pharmaceuticals Innovent Biologics Sorrento Therapeutics Cartesian Therapeutics CASI Pharmaceuticals/Juventas Cell Therapy Novartis Poseida Therapeutics Shanghai Unicar-Therapy Bio-medicine Technology Sinobioway Cell Therapy Co., Ltd. Tessa Therapeutics Wuhan Bio-Raid Biotechnology Miltenyi Biomedicine Bristol-Myers Squibb Autolus Limited Beijing Immunochina Medical Science and Technology Carsgen Therapeutics Cellular Biomedicine Group Chongqing Precision Biotech Eureka Therapeutics Formula Pharmaceuticals Guangzhou Bio-gene Technology Hebei Senlang Biotechnology Mustang Bio MolMed Aurora BioPharma Atara Biotherapeutics Autolus Bellicum Pharmaceuticals Kecellitics Biotech Company Ltd Yake Biotechnology Minerva Biotechnologies Allogene Therapeutics PersonGen BioTherapeutics (Suzhou) Precision BioSciences Pregene (ShenZhen) Biotechnology Company Shanghai GeneChem Shanghai Longyao Biotechnology Shenzhen BinDeBio For more information about this report visit https://www.researchandmarkets.com/r/mxr3h1