CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), CD79B inhibitors(B-cell antigen receptor complex-associated protein beta chain inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication

B-Cell LymphomaChronic Lymphocytic LeukemiaDiffuse Large B-Cell Lymphoma+ [4]

Inactive Indication-

Originator Organization

Janssen Research & Development LLC

Active Organization

Janssen Research & Development LLC

Johnson & Johnson (China) Investment Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Clinical Trials associated with JNJ-80948543

NCT06660563

/ Active, not recruitingPhase 1

A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies

The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).

Start Date22 Oct 2024

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06139406

/ Active, not recruitingPhase 1

A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)

The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].

Start Date06 Dec 2023

Sponsor / Collaborator

Janssen Research & Development LLC

NCT05424822

/ Active, not recruitingPhase 1

A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

Start Date18 Aug 2022

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with JNJ-80948543

100 Translational Medicine associated with JNJ-80948543

100 Patents (Medical) associated with JNJ-80948543

Literatures (Medical) associated with JNJ-80948543

HAEMATOLOGICA

Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma

Article

Author: DeYoung, Phillip M ; Han, Chao ; Feldkamp, Michael D ; Lowenstein, Cassandra ; Hojnacki, Taylor ; Bekkers, Mariette ; Janssen, Lut ; Fontan, Lorena ; Nemani, Neeharika ; Philippar, Ulrike ; Chen, Jun ; Medeiros, Nicole ; Wu, Sam ; Lasorsa, Elena ; Vloemans, Nele ; Wu, Bingyuan ; Suls, Toon ; Perova, Tatiana ; Srinivasan, Srimathi ; Cornelissen, Ivo ; Sukumaran, Siddharth ; Habte, Habtom ; Holland, Cam ; Daskalakis, Nikki ; Krayer, John ; Attar, Ricardo ; McRee, Autumn J ; Kuchnio, Anna ; Yang, Danlin ; Amorim, Ricardo ; Singh, Sanjaya ; Elsayed, Yusri

Despite advances in targeted therapies, relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) remains incurable in the majority of patients. Thus, there is a critical need to expand the treatment options for R/R B-NHL to improve patient outcomes. In this study, we characterized JNJ-80948543, a novel trispecific T-cell engager (TCE), designed to target CD79b+ and/or CD20+ lymphoma cells and bind to CD3 T cells with low affinity. By engaging two tumor-antigens, JNJ-80948543 may enhance tumor binding through avidity effects, potentially improving eradication of heterogeneous cell populations and reducing the risk of antigen escape. Preclinical data confirmed potent T-cell–mediated cytotoxicity against CD79b+ and/or CD20+ cells, with increased potency upon dual antigen engagement, consistent with an avidity effect. To mitigate cytokine release syndrome and T-cell exhaustion commonly associated with TCEs, JNJ-80948543 was designed with a low-affinity CD3 arm. In vitro, JNJ-80948543 achieved effective cytotoxicity with lower cytokine release compared to a matched high-affinity CD3 trispecific, JNJ-80948556. Despite reduced cytokine secretion by JNJ-80948543, both antibodies demonstrated comparable antitumor activity in xenograft mouse model. Collectively, the selectivity, potent cytotoxicity, tumor growth inhibition, and favorable cytokine profile of JNJ-80948543 supports its clinical development. Phase 1 clinical trials are ongoing to evaluate JNJ-80948543 as a monotherapy (NCT05424822) and in combination with a co-stimulatory bispecific antibody (NCT06139406) in patients with R/R B-NHL.

News (Medical) associated with JNJ-80948543

22 Nov 2024

·www.businesswire.com

B-cell Lymphoma Pipeline Insight 2024, with Comprehensive Insights for 295+ Companies and 300+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "B-cell Lymphoma - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This "B-cell Lymphoma- Pipeline Insight, 2024" report provides comprehensive insights about 295+ companies and 300+ pipeline drugs in B-cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence B-cell Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve B-cell Lymphoma. B-cell Lymphoma Emerging Drugs Chapters This segment of the B-cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. B-cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different B-cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in B-cell Lymphoma There are approx. 295+ key companies which are developing the therapies for B-cell Lymphoma. The companies which have their B-cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma. The report covers 300+ products under different phases of clinical development like: Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration B-cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. B-cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses B-cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging B-cell Lymphoma drugs. B-cell Lymphoma Report Insights B-cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs B-cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing B-cell Lymphoma drugs? How many B-cell Lymphoma drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of B-cell Lymphoma? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the B-cell Lymphoma 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 B-cell Lymphoma and their status? What are the key designations that have been granted to the emerging drugs? Key Players Lisocabtagene maraleucel Hoffmann-La Roche Nektar Therapeutics Miltenyi Biomedicine AVM Biotechnology Lin BioScience Incyte Corporation ADC Therapeutics Genor Biopharma Beijing InnoCare Pharma Tech Co., Ltd. CARGO Therapeutics Chia Tai Tianqing Pharmaceutical Group Co., Ltd. SystImmune LIBO PHARMA Abclon BeiGene Cellectis Iovance Biotherapeutics, Inc. Guangzhou Excelmab Y-mAbs Therapeutics TG Therapeutics Sutro Biopharma AbbVie Aleta Biotherapeutics Janssen Research & Development Lantern Pharma Beijing Immunochina Medical Science and Technology Bantam Pharmaceutical Lin Bioscience SFA Therapeutics neoX Biotech March Biosciences HUTCHMED Key Products Bristol Myers Squibb Glofitamab NKTR-255 Zamtocabtagene autoleucel MB-CART20.1 AVM0703 LBS-007 Parsaclisib Loncastuximab tesirine GB-241 ICP-248 CRG-022 TQB3702 GNC-038 NM-IL-12 AT101 BGB-16673 UCART20x22 IOV-2001 EX103 CD38-SADA TG-1801 STRO-001 ABBV-319 ALETA-001 JNJ-80948543 LP-284 INS19 CAR-T Cells BTM 3566 LBS-007 SFA-001 NXD07 MB-105 HMPL A067 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/qxd94m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2ASCOCell TherapyPhase 1

18 Oct 2022

·www.fiercebiotech.com

J&J, flush with blood cancer assets, cuts one from the pipeline

Johnson & Johnson's R&D spending is up in 2022 compared to 2021. Johnson & Johnson has not shied away from its blood cancer ambitions, with six phase 1 assets bubbling at the base of the company’s oncology pipeline. But not all the early contenders have made it this far. The company has cut JNJ-6665—a dihydroorotate dehydrogenase inhibitor—according to an updated pipeline (PDF) revised for the company’s third-quarter report on Tuesday. A spokesperson for J&J told Fierce Biotech the asset had been axed "as part of a strategic portfolio decision." JNJ-6665 had been in the middle of a phase 1 trial for patients with acute myeloid leukemia and myelodysplastic syndrome. The dose escalation study was testing JNJ-6665 as both a monotherapy and in combination with either Onureg or Venclexta, with the aim of recruiting 157 patients. The company began recruiting in November 2020 and wrapped up in August, with trial sites spanning the U.S., France, Spain, Korea and the U.K. Preclinical research of the drug found that when combined with azacitidine in animals, there was evidence of a “lack of antagonism in the anti-leukemic activity.” The drug’s axing comes as other blood cancer assets were added to J&J's pipeline over the third quarter, including from a multi-project collaboration with Nouscom. One of those projects, VAC85135, is a cancer vaccine candidate indicated for certain blood cancers. In May, VAC85135 received a green light from the FDA to launch into clinical trials and recruitment is ongoing. J&J also added JNJ-8543 to the roster, another phase 1 blood cancer asset. The early stage shifting comes as the company’s R&D spend continues to outpace 2021. In the third quarter of this year, the Big Pharma spent nearly $3.6 billion on research and development compared to $3.42 billion for the same period a year ago. Through the first nine months of the year, the R&D spend reflected as a percent of sales was 15.1% in 2022 compared to 14.5% in 2021.

Vaccine

100 Deals associated with JNJ-80948543

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Lymphoma	Phase 1	United States	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	Japan	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	Australia	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	Denmark	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	France	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	Israel	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
B-Cell Lymphoma	Phase 1	Poland	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
Chronic Lymphocytic Leukemia	Phase 1	United States	Janssen Research & Development LLC	18 Aug 2022
Chronic Lymphocytic Leukemia	Phase 1	United States	Johnson & Johnson (China) Investment Ltd.	18 Aug 2022
Chronic Lymphocytic Leukemia	Phase 1	China	Janssen Research & Development LLC	18 Aug 2022

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