Biotechnology company specializing in cell therapies for hematologic malignancies and solid tumors; founded in Nanjing, China in 2014 and now headquartered in Somerset, New Jersey. GenScript Biotech holds roughly 48% of the equity as its largest shareholder, below a controlling majority. Listed on NASDAQ (LEGN).
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2014
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- Ying Huang, former Legend Biotech CEO who led Carvykti to become a nearly $2 billion blockbuster, has been appointed CEO of K2 Therapeutics. - K2 Therapeutics, formed by MPM BioImpact in 2024, simultaneously announced $50 million in seed financing to in-license first-in-class and best-in-class therapeutic candidates. - The startup has already secured eight preclinical-to-clinical programs, including an anti-5T4 antibody-drug conjugate from Adcoris and a CD3×CDH6 T-cell engager from Antengene. - K2 will operate a hub-and-spoke model, with Huang tasked to expand the portfolio through disciplined asset acquisition and focused development execution.
- Ever Supreme BioTechnology's allogeneic solid tumor CAR-T therapy CAR001 has advanced from Phase I to Phase IIa, with the first patient enrolled and a target to complete the trial in 2027. - Phase I data showed a recurrent glioblastoma patient achieving complete response with remission maintained through one year, and a colorectal cancer patient achieving partial response with 72.8% tumor shrinkage. - None of the 15 Phase I patients experienced Grade 2 or higher CRS, ICANS, or GvHD, underscoring a favorable safety profile for the off-the-shelf γδ T cell platform. - Management plans to apply to the Taiwan FDA for a five-year provisional drug approval in 2028 and expects substantive licensing negotiations within 1-2 years after Phase IIa data.
- Researchers identified the absolute number of CD27-negative, CD39-negative CAR T cells as a biomarker of therapeutic response in patients receiving low CAR T cell doses. - In the phase I/II HD-CAR-1 trial, 28 patients with relapsed or refractory B-cell malignancies received third-generation CD19-directed CAR T cells across a wide dose range. - Low-dose responders showed enrichment of non-exhausted effector and effector memory-like CAR T cells, while non-responders had naive or dysfunctional CD39-positive populations. - The biomarker was validated in an independent cohort of 42 patients treated with four commercial CD19- or BCMA-directed CAR T products.
- MaxCyte has entered a multi-platform technology license agreement with Genentech, a Roche Group member, to support cell therapy programs from discovery through cGMP manufacturing. - The non-exclusive license provides Genentech access to MaxCyte's ExPERT GTx platform and flow electroporation technology for ex vivo cell engineering without viral vectors. - The agreement spans multiple internal Genentech programs rather than a single therapeutic candidate, though specific programs and financial terms were not disclosed. - This partnership expands Genentech's cell therapy manufacturing capabilities as Roche continues building its presence in the field, following its late-2024 acquisition of Poseida Therapeutics.
- CAR-T therapy Carvykti, originating from China's Legend Biotech, has produced durable long-term remissions in heavily pretreated multiple myeloma patients, with 33% remaining disease-free at five years. - The therapy uses llama-derived nanobodies targeting BCMA, offering superior efficacy over traditional antibody-fragment CAR-T approaches, with 100% response rates in early trials versus 80% for competitors. - China's streamlined clinical trial ecosystem enabled Legend to move from first patient dosing in 2016 to stunning data presentation by 2017, outpacing American counterparts. - The Carvykti story signals a broader shift in global drug discovery, with roughly half of all major drug licensing deals in 2026 involving Chinese-originated therapies.
- Legend Biotech, an associate company of GenScript, reported positive phase one safety data for a potential first-in-class cell therapy treating relapsed or refractory B-cell non-Hodgkin lymphoma. - The trial enrolled 12 patients who experienced no toxicities, no serious adverse events, and no deaths during the early-stage safety evaluation. - The promising results will be presented as a late-breaking oral presentation at the European Hematology Association 2026 Congress in Stockholm. - China now accounts for approximately one-third of the global early-stage drug pipeline, reflecting the country's growing prominence in pharmaceutical innovation.
- The FDA issued draft guidance to streamline regulatory submissions for gene therapies using genome editing in human somatic cells, leveraging platform knowledge and publicly available data. - Legend Biotech presented first-in-human data at ASCO 2026 showing its DLL3-targeted CAR-T therapy LB2102 demonstrated manageable safety and encouraging clinical activity in heavily pretreated solid tumor patients. - Laverock Therapeutics secured approximately $2.8 million in grants to advance its AI-powered gene-control platform for T-cell and macrophage programs across oncology and non-oncology indications. - New CARTITUDE analyses confirmed sustained clinical benefits of CARVYKTI in multiple myeloma, with 30-month overall survival rates exceeding 85% across cytogenetic risk populations.
- Bristol Myers Squibb's subsidiary 2seventy bio has filed a patent infringement lawsuit against Johnson & Johnson and Legend Biotech at the Unified Patent Court, targeting their CAR-T cell therapy Carvykti. - The dispute centers on European patent EP 3 689 383, which protects a chimeric antigen receptor targeting B-cell maturation antigens, with both companies' therapies treating multiple myeloma. - This marks the first pharmaceutical case for the Brussels local division of the UPC and represents the growing trend of biotech patent disputes at the European court. - Parallel revocation proceedings have been initiated in the UK, while the patent remains under opposition at the European Patent Office, indicating a multi-jurisdictional battle over this critical cancer therapy technology.
- Legend Biotech officially opened a new 31,000-square-foot research and development facility in Philadelphia to support its expanding pipeline of next-generation cell therapies. - The facility will focus on CAR-T research and development for potential oncology and immunology indications, employing approximately 55 full-time team members. - The expansion strengthens Legend's U.S. presence, which now includes over 1,400 employees, and complements existing R&D operations in New Jersey. - Legend Biotech is the largest standalone cell therapy company with CARVYKTI, administered to over 9,000 multiple myeloma patients at 132 treatment centers across 44 states.
- Legend Biotech will present nine abstracts on CARVYKTI (ciltacabtagene autoleucel) at the 67th ASH Annual Meeting, including two oral presentations demonstrating long-term progression-free survival benefits and improved immune fitness with earlier treatment use. - The company will deliver first-in-human Phase 1 data for Lucar-G39D, an investigational anti-CD20/CD19 dual-CAR allogeneic gamma delta T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. - CARVYKTI is now commercially available in 14 countries and has treated more than 9,000 patients as the first and only BCMA-targeted CAR-T therapy approved for multiple myeloma patients with at least one prior line of therapy.
