LEGN Legend Biotech Corporation

44.3
-0.53  -1%
Previous Close 44.83
Open 44.57
52 Week Low 23.41
52 Week High 49.49
Market Cap $6,407,200,214
Shares 144,632,059
Float 144,632,059
Enterprise Value $5,764,354,498
Volume 192,489
Av. Daily Volume 448,628
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Upcoming Catalysts

Drug Stage Catalyst Date
Ciltacabtagene autoleucel (cilta-cel) (LCAR-B38M/JNJ-4528)
Multiple myeloma
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
LB1901
T-Cell Lymphoma
Phase 1
Phase 1
Phase 1 trial to be initiated in 2021.
LB1904
Pancreatic Cancer
Phase 1
Phase 1
Phase 1 trial ongoing.
LB1904
Gastric cancer
Phase 1
Phase 1
Phase 1 trial ongoing.
LB1910
Acute myeloid leukemia (AML)
Phase 1
Phase 1
Phase 1 trial ongoing.
LB1909
Relapsed and refractory B-cell lymphoma
Phase 1
Phase 1
Phase 1 trial ongoing.

Latest News

  1. NOVATO, Calif., June 30, 2021 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced the appointment of Corsee Sanders, Ph.D., to the Board of Directors, effective June 29, 2021. Dr. Sanders, an experienced veteran of the biopharma industry, will serve as an independent director.

    "Dr. Sanders' established experience in global clinical development and especially with new technologies will be instrumental as we further advance our ongoing clinical trials and continue to expand our rare disease pipeline of novel therapeutics for patients who have no other treatment options…

    NOVATO, Calif., June 30, 2021 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced the appointment of Corsee Sanders, Ph.D., to the Board of Directors, effective June 29, 2021. Dr. Sanders, an experienced veteran of the biopharma industry, will serve as an independent director.

    "Dr. Sanders' established experience in global clinical development and especially with new technologies will be instrumental as we further advance our ongoing clinical trials and continue to expand our rare disease pipeline of novel therapeutics for patients who have no other treatment options," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.

    Dr. Sanders most recently served as strategic advisor to the Chief Medical Officer (CMO) of Celgene, following Celgene's acquisition of Juno where she was an Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb (BMS), which acquired Celgene. In those roles, she ensured the effective integration of Juno's Chimeric Antigen Receptor T (CAR-T) Cell Development Organization into the Celgene and BMS organizations. Prior to that, Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including serving as Senior Vice President, Global Head of Clinical Operations and Industry Collaboration, for six years.

    "The ability to quickly develop effective medicines is critically important in rare diseases, where patients have few or no treatment options," said Dr. Sanders. "I am thrilled to join the Ultragenyx Board and support the executive team as it works diligently to make a significant impact on these patient populations."

    Currently, Dr. Sanders serves as a member of the Board of Directors of several biotechnology companies including Beigene Ltd. (NASDAQ:BGNE), Molecular Templates Inc. (NASDAQ:MTEM), Legend Biotech Corporation (NASDAQ:LEGN), and AltruBio (formerly AbGenomics) Inc. She is a member of the Board of Trustees and Chair of the Research Ethics Committee for the Fred Hutchinson Cancer Research Center, a non-profit cancer research organization in Seattle. Dr. Sanders graduated magna cum laude from the University of the Philippines where she earned a B.S. and M.S. in statistics. She also earned an M.A. and Ph.D. in statistics from the Wharton Doctoral Program at the University of Pennsylvania.

    About Ultragenyx Pharmaceutical Inc.

    Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease.

    The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx's strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

    For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.

    Contact Ultragenyx Pharmaceutical Inc.

    Investors & Media

    Joshua Higa

    415-475-6370



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  2. New Cell Therapy Facility in Belgium Establishes Manufacturing Presence in the European Union

    New facility builds upon Legend Biotech's collaboration with Janssen to advance the manufacturing of investigational CAR-T therapy ciltacabtagene autoleucel (cilta-cel), being developed for the treatment of multiple myeloma

    Legend Biotech Corporation ((Legend Biotech, NASDAQ:LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced the establishment of a state-of-the-art manufacturing facility in Belgium, as part of a joint investment with Janssen Pharmaceutica NV (Janssen), to expand global manufacturing capacity of innovative cellular therapies…

    New Cell Therapy Facility in Belgium Establishes Manufacturing Presence in the European Union

    New facility builds upon Legend Biotech's collaboration with Janssen to advance the manufacturing of investigational CAR-T therapy ciltacabtagene autoleucel (cilta-cel), being developed for the treatment of multiple myeloma

    Legend Biotech Corporation ((Legend Biotech, NASDAQ:LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced the establishment of a state-of-the-art manufacturing facility in Belgium, as part of a joint investment with Janssen Pharmaceutica NV (Janssen), to expand global manufacturing capacity of innovative cellular therapies.

    Legend has a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel, an investigational CAR-T therapy currently under review by several health authorities around the world including the United States and Europe for the treatment of patients with relapsed and refractory multiple myeloma.

    "The new location in Belgium is an ideal choice for Legend to launch our European manufacturing presence allowing us to tap into the area's vast talent pool and leverage the strong Belgian life sciences ecosystem," said Liz Gosen, Senior Vice President, Global Technical Operations. "We are excited to expand our existing robust manufacturing network to support the production and delivery of cilta-cel for patients across the globe."

    This facility adds to Legend's existing manufacturing facilities and presence in Nanjing, China and in Raritan and Somerset, N.J., U.S. The facility is anticipated to be operational by 2023.

    About Legend Biotech

    Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 900 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

    We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

    About Ciltacabtagene autoleucel (cilta-cel)

    Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy that is being studied in a comprehensive clinical development program for the treatment of patients with multiple myeloma. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. Applications seeking approval of cilta-cel for the treatment of patients with relapsed/refractory multiple myeloma are currently under regulatory review by several health authorities around the world including the United States and Europe.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the development of Legend Biotech's manufacturing infrastructure, including construction of new facilities. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" 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 indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the "Risk Factors" section of the Annual Report filed with the Securities and Exchange Commission on April 2, 2021. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

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  3. Longer-term results from the Phase 1b/2 CARTITUDE-1 study demonstrated 98 percent overall response rate, 80 percent stringent complete response rate and 66 percent progression free survival rate at 18 months with no new safety signals

    First results from the CARTITUDE-2 study of cilta-cel in earlier treatment lines will be premiered

    Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that new and updated results for ciltacabtagene autoleucel (cilta-cel), an investigational BCMA-directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma (RRMM…

    Longer-term results from the Phase 1b/2 CARTITUDE-1 study demonstrated 98 percent overall response rate, 80 percent stringent complete response rate and 66 percent progression free survival rate at 18 months with no new safety signals

    First results from the CARTITUDE-2 study of cilta-cel in earlier treatment lines will be premiered

    Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that new and updated results for ciltacabtagene autoleucel (cilta-cel), an investigational BCMA-directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma (RRMM), will be featured at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and at the European Hematology Association (EHA) Virtual Congress.

    At a median follow-up of 18 months, updated results from the Phase 1b/2 CARTITUDE-1 study including 97 heavily pretreated patients with RRMM demonstrated an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlighting a deepening response over time (from 67 percent reported at ASH 2020).1,2 The 18-month progression-free survival (PFS) rate was 66 percent (95 percent confidence interval [CI], 54.9-75.0) and overall survival rate (OS) rate was 81 percent (95 percent CI, 71.4-87.6). Patients had received a median of six prior lines of therapy (range, 3-18); 88 percent were triple-refractory and 42 percent were penta-refractory. Response rates were comparable (range, 95-100 percent) across prespecified subgroups, including number of prior lines of treatment, extramedullary plasmacytomas and cytogenetic risk.1

    These data will be featured in an oral presentation at the 2021 ASCO Annual Meeting on Tuesday, June 8th (Abstract #8005) and as a poster presentation at the 2021 EHA Virtual Congress on Friday, June 11th (Abstract #EP964). The CARTITUDE-1 study supported the Biologics License Application for cilta-cel by Legend Biotech's collaborator, Janssen, which has been accepted for priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2021.

    "What is remarkable about this study is that these patients, who had previously received multiple treatment regimens, have responded to cilta-cel without their disease progressing," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "These compelling results, paired with the manageable safety profile and sustained efficacy, demonstrate the potential of cilta-cel for patients with relapsed and refractory multiple myeloma."

    Median time to first response was one month (range, 0.9–10.7 months) and responses deepened over time. Out of 61 minimal residual disease (MRD) evaluable patients, 92 percent achieved MRD negativity status at 10-5 at a median of one month (range, 0.8-7.7 months) post infusion.

    Cilta-cel data showed a safety profile consistent with what has been previously reported and no new safety signals were observed with longer-term follow-up. The most common hematologic adverse events (AEs) observed in the CARTITUDE-1 study were neutropenia (96 percent); anemia (81 percent); thrombocytopenia (79 percent); leukopenia (62 percent); and lymphopenia (53 percent). Cytokine release syndrome (CRS) of any grade was observed in 95 percent of patients, with a median duration of four days (range, 1-97), and median time to onset of seven days (range, 1-12). Of the 92 patients with CRS, 95 percent experienced Grade 1/2 events and CRS resolved in 91 patients (99 percent) within 14 days of onset. There was no new incidence of neurotoxicity; neurotoxicity of any grade was observed in 21 percent (n=20) of patients, with Grade 3 or higher neurotoxicity observed in 10 percent (n=10) of patients.

    "We are excited to share these latest results from the CARTITUDE-1 study which continue to show deep and sustained responses in patients who have been treated with cilta-cel," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "At Legend Biotech, we are continuing our efforts to build a robust pipeline of next-generation cell therapies with the potential to address unmet needs. We look forward to our continued collaborative efforts with Janssen as we to bring this personalized treatment to patients, pending regulatory approvals."

    New Data from CARTITUDE-2

    For the first time, data will also be reported from Cohort A of CARTITUDE-2 (NCT04133636), a Phase 2 study evaluating the safety and efficacy of cilta-cel in patients with multiple myeloma (MM) in earlier-line settings.3,4 Cohort A included 20 patients who had progressive MM after 1-3 prior lines of therapy and were refractory to lenalidomide, including 1 patient treated in an outpatient setting. Data showed early and deep responses with a manageable safety profile consistent with what has been observed in the CARTITUDE clinical development program. At a median follow-up of 5.8 months, ORR was 95 percent with 75 percent of patients achieving sCR or complete response. These initial results will be showcased in a poster discussion at ASCO 2021 (Abstract #8013) and as an oral presentation at the 2021 EHA Congress (Abstract #S190).

    Another poster (ASCO Abstract #8028, EHA Abstract #EP1003) will discuss the incidence, mitigation and management of neurologic AEs in patients in Cohort A from the CARTITUDE-2 study.5,6 The results show neurologic AEs were generally manageable in patients following treatment with cilta-cel. Neurotoxicities occurred in 20 percent (n=4) of patients, however, there were no movement and neurocognitive treatment-emergent AEs or Grade 3 neurotoxicity events observed in patients of Cohort A. Data from the CARTITUDE clinical development program, in which over 100 patients have been dosed, suggest that additional patient management strategies have been successfully implemented to prevent and reduce the incidence of neurotoxicity. Cilta-cel is being investigated in patients with MM in various clinical settings as part of CARTITUDE-2 and a Phase 3 study (CARTITUDE-4, NCT04181827) in earlier settings.

    About CARTITUDE-1

    CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1,2 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

    About CARTITUDE-2

    CARTITUDE-2 (NCT04133636) is an ongoing, multi-cohort, Phase 2 study evaluating the safety and efficacy of cilta-cel in with multiple myeloma. CARTITUDE-2 Cohort A includes patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. The primary objective was percentage of patients with negative minimal residual disease (MRD) status at 10-5.3,4

    About Multiple Myeloma

    Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.7 Although treatment may result in remission, unfortunately, patients will most likely relapse.8 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.9 Refractory multiple myeloma is when a patient's disease is non-responsive or progresses within 60 days of their last therapy.10,11 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections. 12 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.13

    About Cilta-cel

    Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was accepted by the U.S. FDA and a Marketing Authorisation Application has been accepted by the European Medicines Agency.

    About Legend Biotech

    Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

    We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

    To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's clinical efforts, its partnership with Janssen, and the data relating to CARTITUDE-1 and CARTITUDE-2 studies. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" 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 indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the "Risk Factors" section of the Annual Report filed with the Securities and Exchange Commission on April 2, 2021. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    References

    1. Usmani, S. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1. Abstract #8005 [Oral]. To be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
    2. Usmani, S. Updated CARTITUDE-1 Results of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma. Abstract #EP964. To be presented at the 2021 European Hematology Association Meeting.
    3. Agha, M. CARTITUDE-2: Efficacy and Safety of the BCMA-Directed CAR-T Cell Therapy, Ciltacabtagene Autoleucel, in Patients With Progressive Multiple Myeloma After 1–3 Prior Lines of Therapy. Abstract #8013 [poster]. To be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
    4. Agha, M. Efficacy and Safety of the BCMA-Directed CAR-T Cell Therapy, Ciltacabtagene Autoleucel, in Patients With Progressive Multiple Myeloma After 1–3 Prior Lines of Therapy: Initial Results From CARTITUDE-2. Abstract #S190 [oral]. To be presented at the 2021 European Hematology Association Meeting.
    5. Einsele H. Incidence, mitigation, and management of neurologic adverse events in patients with multiple myeloma (MM) treated with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-2. Abstract #8028 [poster]. To be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
    6. Einsele H. Incidence, Mitigation, and Management of Neurologic Adverse Events in the Phase 2 Cartitude-2 Study of Ciltacabtagene Autoleucel in Patients With Multiple Myeloma. Abstract #EP1003 [Poster]. To be presented at the 2021 European Hematology Association Meeting.
    7. American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed November 2020.
    8. Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
    9. National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed May 2021.
    10. National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed May 2021.
    11. Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
    12. American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed May 2021.
    13. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

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  4. Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) submitted by Janssen Biotech, Inc. (Janssen) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy. The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 29, 2021.

    Priority review is usually granted to investigational therapies which, if approved, may offer significant…

    Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) submitted by Janssen Biotech, Inc. (Janssen) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy. The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 29, 2021.

    Priority review is usually granted to investigational therapies which, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. 1 Cilta-cel previously received Breakthrough Therapy Designation in December 2019, which is intended to expedite the development and review time for a potential new medicine. 2

    "Cilta-cel has shown great promise in the treatment of patients with heavily pretreated multiple myeloma according to study findings reported to date. Today's priority review designation marks another significant milestone for this cell therapy," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We look forward to our continued collaborative efforts with Janssen and in working with the FDA to bring this transformative therapy to patients who are in need of new treatment options."

    The regulatory submission for cilta-cel is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. Updated longer term follow up data will be featured at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8005) and European Hematology Association's (EHA) Virtual Congress (Abstract #EP964) next month.

    About CARTITUDE-1

    CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.3 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

    About Multiple Myeloma

    Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse.5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient's disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.10

    About Cilta-cel

    Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. Orphan Drug Designations were also granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel has been accepted by the U.S. FDA and a Marketing Authorisation Application has been accepted by the European Medicines Agency.

    About Legend Biotech

    Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 900 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

    We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

    To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the timing and outcome of regulatory reviews relating to cilta-cel, including the BLA accepted by the U.S. FDA and the MAA accepted by the EMA, and the potential for cilta-cel as a safe and effective treatment. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" 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 indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the "Risk Factors" section of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 2, 2021. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    References

    1. U.S. Food and Drug Administration. "Priority Review" Available at http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Accessed May 2021.
    2. U.S. Food and Drug Administration. "Frequently Asked Questions: Breakthrough Therapies" Available at https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies#:~:text=Fast%20Track%20Designation%3A%20Fast%20track,fill%20an%20unmet%20medical%20need. Accessed May 2021.
    3. ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Last accessed May 2021.
    4. American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed November 2020.
    5. Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
    6. National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed November 2020.
    7. National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed November 2020.
    8. Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
    9. American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed November 2020.
    10. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

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  5. Legend Biotech Corporation (NASDAQ:LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced it will present at the Jefferies Virtual Healthcare Conference on June 3, 2021 at 9:30 am ET. This webcast will be available to investors and other interested parties by accessing the Legend Biotech website at https://investors.legendbiotech.com

    About Legend Biotech

    Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with…

    Legend Biotech Corporation (NASDAQ:LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced it will present at the Jefferies Virtual Healthcare Conference on June 3, 2021 at 9:30 am ET. This webcast will be available to investors and other interested parties by accessing the Legend Biotech website at https://investors.legendbiotech.com

    About Legend Biotech

    Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

    We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

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