HPN-217 is a B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC). On June 24, 2021, AbbVie and Teneobio jointly announced that AbbVie will exercise its exclusive right to acquire TeneoOne, a subsidiary of Teneobio and its main product under development-targeting B cell mature antigen ( BCMA)'s bispecific antibody therapy TNB-383B. And AbbVie just fronted $90 million to get one from a little-known Silicon Valley biotech called Teneobio. Background: T-cell redirecting therapies such as CAR-T cells and T-cell engaging bispecific antibodies (T-BsAb) targeting B Cell Maturation Antigen (BCMA) have been highly efficacious against relapsed/refractory myeloma (MM) in early phase clinical studies. In hematological cancers, the main targets are CD20 and B-cell maturation antigen (BCMA). NORTH CHICAGO, Ill. and MENLO PARK, Calif., Feb. 11, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. AbbVie 2016 R&D day . About AbbVie Please note the magic link is Purpose: ABBV-383, a B-cell maturation antigen CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier: NCT03933735) in patients with relapsed/refractory multiple myeloma (RRMM).Herein, we report safety and efficacy outcomes of this phase I dose escalation/expansion study. Bispecific cancer drugs and gene therapy advances: What to watch at next month's ASH meeting . AstraZeneta entered Phase I clinically in the study of COVID-19 antibody cocktail therapy. magic link that lets you log in quickly without using a password. TNB-383B is a fully human BCMA-targeting T-cell engaging bispecific monoclonal antibody (T-BsAb). | B-cell maturation antigen (BCMA) has emerged as an . The collaboration between AAV gene therapy developers and CDMOs has resulted in scalable manufacturing solutions to transition a gene and a dream into a biological therapeutic poised for successful patient outcomes and a greater number of commercialized treatments. Myeloma cells display a promising target for immunotherapy called B-cell maturation antigen (BCMA), which is found in 60 to 70 percent of multiple myeloma patients. For more information about AbbVie, please visit us at www.abbvie.com. bcma bispecific antibody drugs have both good efficacy and safety, bcma target car-t drugs in the treatment of blood cancer efficacy is remarkable, a number of drugs orr of more than 90%, but including serious immune effector cell-associated neurotoxicity syndrome and crs toxicity problems, adc drugs although low toxicity but the therapeutic The initial trial will be conducted by Teneobio. In February 2019, AbbVie and TeneoOne entered a strategic transaction to develop and commercialize TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3 and is designed to direct the body's own immune system to target and kill BCMA-expressing tumor cells. Background: RO7297089 is a bispecific tetravalent antibody targeting BCMA (Genentech licensed from Affimed GMBH), which is highly expressed on MM cells and CD16a, which is expressed on innate immune cells including natural killer (NK) cells, macrophages, and monocyte subsets. News of the stoppage comes months after Amgen hit pause on a . "Our aim in developing TNB-383B and our T-cell redirecting anti-CD3 platform is to maximize the therapeutic window of a class of therapeutic molecules that have been clinically challenged by dose-limiting toxicities," said Roland Buelow, CEO of Teneobio, Inc. "AbbVie recognized the potential of Teneobio's platform and shared our vision to assess its clinical validation. (BCMA) targeting candidate. Bispecific antibodies and bispecific T-cell engagers are new to plasma cell disorders, but this treatment approach has been established in B-cell acute lymphoblastic leukemia. | 22 Feb 2021; . The novel T-cell-engaging bispecific antibody ABBV-383 appears to be well tolerated and active in patients with relapsed/refractory MM, according to results of a phase 1 study. Readers should not rely upon the information in these pages as current or accurate after their publication dates. Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. While other BCMA and CD3 bispecific therapies require weekly administration, the recommended phase 2 dose of TNB-383B will investigate infrequent dosing of every three weeks for intravenous administration, which is an important treatment factor for people living with multiple myeloma, he added. How will NICE fare in a post-Brexit world? Don't miss your daily pharmaphorum news. 'Teneobio's "plug-and-play" T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity. In February 2019, AbbVie and TeneoOne entered a strategic transaction to develop and commercialize TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3 and is designed to direct the body's own immune system to target and kill BCMA-expressing tumor cells. Onset of CRS generally occurred on the same or next day following the first dose. Taken together, the BCMA/CS1 bispecific CAR presents a promising treatment approach to prevent antigen escape in CAR-T cell therapy against MM, and the vertically integrated optimization. Cancer Cell 2017 . Theres been plenty written about the unusual biotech, and I thought a lot of people might like to hear their thoughts, rather than pick and choose among the various stories out here. Interim results from a phase 1 trial which prompted AbbVies move showed that the bispecific achieved an objective response rate of 79%, made up of 29% complete responses and very good partial responses at 63% after more than six months follow-up. And investors appear to have already picked an early winner: Gracell closed up 11% after its fast-manufactured, dual anti-BCMA/CD19 Car GC012F was . PURPOSEABBV-383, a B-cell maturation antigen CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier:. The acquisition is subject to customary closing conditions, including clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act. EQRx placed a substantial bet it could shake up the US healthcare system, promising to bring a swath of drugs to market that was similar to products from other Big Pharmas but priced substantially lower. Before engaging, please read and adhere to our established community guidelines for each channel. Biogens months-long search for a new CEO landed on the choice of former Sanofi CEO Chris Viehbacher, who was previously ousted from his top spot at the French company. AbbVie (ABBV 0.82%) Q3 2022 Earnings Call . Bispecific antibody against BCMA and CD3 and an immunological drug for combined use in treating multiple myeloma JP2019535262A (ja) * 2016-11-11 . The therapeutic use of adeno-associated virus (AAV) accounts for the largest share of the global gene therapy industry due to its safety profile and proven efficacy in treating genetic diseases. The median duration of response (DOR) has not been reached. There are currently six bispecifics in clinical trials targeting BCMA. After dipping its toe into the BCMA water with an option to codevelop a bispecific antibody developed by TeneoOne, AbbVie has gone one step further agreeing to buy the drug and the company outright. AbbVie paid $90 million up front for the option in February 2019; the takeout terms are not disclosed. bispecific antibodies in or planned for registration clinical trials include Regeneron and AbbVie's BCMAxCD3 bispecific antibody, Janssen's GPRC5DxCD3 bispecific . Two products can be put into production this month. This is an off-the-shelf treatment that targets both BCMA and CD3. . Cancer Trial Results. TNB-383B consists of 2 heavy and 1 light chain(s) paired through knob-in-hole technology. AbbVie assumes no duty to update the information to reflect subsequent developments. As a result, the site may contain information on pharmaceuticals that are not approved in other countries or region. AbbVie exercised its exclusive right to acquire TeneoOne and TNB-383B based on an interim analysis of an ongoing Phase 1 study. Given the therapeutic potential of utilizing BCMA to redirect T- cell effector function on multiple myeloma cells, we generated REGN5458, an anti-BCMA x anti-CD3 bispecific antibody that binds to both BCMA on plasma cells and to CD3 on T-cells. In a third quarter update early Thursday morning, EQRx bluntly announced that its anti-PD-L1 drug, dubbed sugemalimab, is no longer commercially viable in lung cancer, and execs will instead prioritize two other clinical programs. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. Please note this link is one-time use only and is valid for only 24 hours. Oct 31, 2022 08:00am. The clinical therapeutic effects of BsAbs are superior to those of monoclonal antibodies (MoAbs), with broad applications for tumor immunotherapy as well as for the treatment of other diseases. ICP16009155-1 | Copyright@Qingdao ECHEMI Technology Co., Ltd. Search more information of high quality chemicals, good prices and reliable suppliers, visit, This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. The clinical data support the unique features of TNB-383B and our T-cell redirecting CD3 platform. Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment. Cultivating a Diverse & Inclusive Workplace, Protecting Human Rights & Workplace Safety, Providing Resources & Support for Employee Well-Being. The first bispecific antibody for multiple myeloma may become FDA approved in 2022. 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Versatile antibody variable domains (UniDab) derived from UniAb can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. Most bsAbs are bispecific T-cell-engagers (BiTEs), designed to. Fast forward to 2022. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. TNB-383B is expected to enter the clinic in the first half of 2019. Images may be subject to . 8034. For all other medicines, please visit theFind My Medicinepage. On June 24, 2021, AbbVie and Teneobio jointly announced that AbbVie will exercise its exclusive right to acquire TeneoOne, a subsidiary of Teneobio and its main product under development-targeting B cell mature antigen ( BCMA)'s bispecific antibody therapy TNB-383B The following transcript has been lightly edited for clarity and length. The company will offer 90-day notifications to workers along with severance packages, outplacement support and other benefits. Bispecific agents are similar to an unconjugated antibody, such as daratumumab or elotuzumab, but have important structural differences. SUBSCRIBE free here. If you have any concerns or complaints relating to the article, please send an email, providing a detailed Bispecific antibodies (BsAbs) are antibodies with two binding sites directed at two different antigens or two different epitopes on the same antigen. Theres no denying however that the deal to buy TeneoOne an affiliate of TeneoBio is putting AbbVie into a highly competitive area of R&D. Keep reading Endpoints with a free subscription. NORTH CHICAGO, Ill. and NEWARK, Calif., June 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Teneobio, Inc. announced today that AbbVie exercised its exclusive right to acquire TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of relapsed or refractory multiple myeloma (R/R MM). Given the therapeutic potential of utilizing BCMA to redirect T-cell effector function on multiple myeloma cells, we generated REGN5458, an anti-BCMA x anti-CD3 bispecific antibody that binds. | Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical trial of its FLT3 bispecific T-cell engager (BiTE). REGN5458 is a BCMA x CD3 bispecific antibody (Ab) that binds to both BCMA and CD3, thereby targeting MM cells with T-cell effector function via BCMA. Teneobio, Inc. is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb), for the treatments of cancer, autoimmunity, and infectious diseases. ' to, AbbVie acquires BCMA bispecific antibody therapy for multiple myeloma, Fluid, Electrolyte, and Acid-base Balance, Longmen Town, Lintao County, Gansu Province, launched a large-scale investigation and major renovation of the starch processing industry, Benxi biological hepatitis B and AIDS test box have been registered. So a new potentially successful bispecific antibody therapy might, for example, have one arm that binds to myeloma cells via BCMA and another that binds to T-cells, one of the . Do you wish to leave this site? Image for ASH 2022: A Phase 1 First-in-Human Study of Abbv-383, a BCMA CD3 Bispecific T-Cell-Redirecting Antibody, As Monotherapy in Patients with Relapsed/Refractory Multiple Myeloma - imageId : 271057. As Novartis continues to reshape itself, the company is shutting the doors to one of its gene therapy manufacturing sites in the US. And ASH abstracts posted Thursday show the range of competitors following behind them. We assessed ex vivo efficacy of this drug to mediate killing of bone marrow mononuclear cells (BMMCs) freshly isolated from 10 patients with relapsed multiple myeloma (MM). TNB-383B is a bispecific monoclonal antibody that targets BCMA, an antigen widely expressed in multiple myeloma. CBO Omid Vafa told BioCentury that TNB-383B uses Teneobio's T cell engager platform, which combines a . There are 106 bispecific antibody molecules currently in the pipeline, according to Globaldata's database. AbbVie has an option to a BCMA-targeting TriTAC, HPN-217 from Harpoon Therapeutics Inc. (NASDAQ:HARP); the therapy is in Phase I testing for MM. 'Teneobio's discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat and OmniFlic), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. *Expanded list of key inclusion and exclusion criteria are available at clinicaltrials.gov. Previously, we presented data showing. In a more severe subgroup, three of four patients who were on ECMO, essentially an artificial lung machine, and got agenT-797 on top of that survived through 90 days. This acquisition is based on the results of an interim analysis of a Phase 1 clinical trial conducted in humans for the first time. TNB-383B is designed to direct the body's own immune system to target and kill BCMA expressing tumor cells. Moreover, there are 263 ongoing to . 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Another bispecific antibody with promising preliminary results is CC-93269: a BCMA-targeting bispecific that binds monovalently on T cells and bivalently on tumor cells, and is currently being investigated in the phase I MM-001 trial (NCT03486067).Interim results from this study were presented by Costa et al 6 at the 2019 American Society of Hematology (ASH) meeting. They are designed to selectively bind to a specific target to fight a particular disease. Is it dangerous to use it for food and wine? Discuss; 102000004965 antibodies Human genes 0.000 title abstract 3; 108090001123 antibodies Proteins 0.000 title abstract 3; 102000038595 IGF Type 1 Receptor Human genes 0.000 ti The study consists of two portions, a monotherapy dose escalation arm and a monotherapy dose expansion arm. BCMA-specific chimeric antigen receptor-T cells (CAR-Ts) have exhibited remarkable efficacy in refractory or relapsed multiple myeloma (RRMM); however, primary resistance and relapse exist with single-target immunotherapy. In this interim analysis, the most frequent treatment emergent adverse events observed across all grades were cytokine release syndrome (CRS) (52 percent), fatigue (25 percent), and neutropenia (24 percent). Viehbacher will be stepping into Biogen at a tumultuous moment as its first Alzheimers drug Aduhelm failed at launch without payer coverage, but its next up-and-coming amyloid-targeted drug lecanemab shows promise in recently released results that could amount to a full approval. Pfizer Inc. (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) each presented Phase I data from BCMA Sign up "Multiple myeloma is one of the most common hematological cancers and an area of. Frontiers Health Steering Committee spotlight Monique Levy. Epcoritamab Genmab/AbbVie CD20 CD3 DLBCL Elranatamab Pfizer BCMA CD3 Multiple myeloma Teclistamab Janssen BCMA CD3 Multiple myeloma Erfonrilimab Alphamab Oncology PDL1 CTLA4 NSCLC, PDAC Cadonilimab Akeso Biopharma PD1 CTLA4 GOJ adenocarcinoma, cervical cancer Tebotelimab* MacroGenics PD1 LAG3 Gastric/GOJ cancer Preclinical data REGN5458 mediates killing of MM cell lines and primary human plasma cells (Figure 2A-C). We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. TNB-383B simultaneously targets BCMA and CD3, directing the bodys own immune system to target and kill BCMA-expressing tumour cells. Cookie Settings. Teneobio who? More than half of the patients treated with TNB-383B experienced cytokine-release syndrome (CRS), a potentially life-threatening reaction that has scuppered the development of some other bispecific antibodies and limited the use of CAR-T therapies. Blenrep and Abecma are both used to treat relapsed or refractory multiple myeloma, a cancer of the bone marrow, the same indication that AbbVie and TeneoOne have been pursuing with partnered drug TNB-383B since 2019. Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bispecific antibody) or BCMA-directed CAR T therapy. AFM26: a first-in-class, high affinity bispecific NK-cell engager targeting BCMA to treat multiple myeloma. AbbVie Inc. (NYSE:ABBV) will pay $90 million up front for an option to acquire bispecific antibody TNB-383B from Teneobio Inc. (Menlo Park, Calif.), which would give AbbVie its first BCMA-targeted asset. That could make it easier to monitor and treat. If you are a resident of a country other than those to which the site is directed, please return to AbbVie.com or contact your local AbbVie affiliate to obtain the appropriate product information for your country of residence. The humanized BCMA (clone 4C8A) antibody that effectively targeted multiple myeloma in a CAR (chimeric antigen receptor) format was used for designing several formats of bispecific BCMA-CD3 antibodies. ABBV-383 TTX-030 * Back to Pipeline HPN-217 * HPN-217 is a B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC). No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company. The Internet site that you have requested may not be optimized to your screen size. Pfizer Embraces Biotech-Like Speed To Advance BCMA Bispecific Phase II Pivotal Trial Under Way For Elranatamab In Multiple Myeloma. "Since the beginning of this partnership, we have been encouraged by the potential of TNB-383B as a promising new therapy for multiple myeloma, and our analysis of the Phase 1 data to date has allowed us to make this decision with confidence," said Michael Severino, M.D., vice chairman and president, AbbVie. At the recommended Phase 2 dose of 60 mg administered intravenously every three weeks (Q3W), the CRS rate was 67 percent (all grades) with a grade 3 CRS rate of 3 percent (1/39 subjects). TNB-383B targets BCMA and CD3 and is in preclinical testing to treat multiple myeloma. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of Bioscience & Technology Business CenterThe University of KansasLawrence, Kansas. TNB-383B is an engineered antibody that serves as a bridge between cancer and immune cells. If you're already an Endpoints subscriber, enter your email below for a An oral presentation will report Phase 1 safety and efficacy data from the MajesTEC-2 study of TECVAYLI (teclistamab-cqyv), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and lenalidomide, in pretreated multiple myeloma (Abstract #160). TNB-383B is a bispecific antibody which targets the cluster of . Abbvie Stemcentrx Llc: Anti-DLL3 antibodies and drug conjugates for use in melanoma EP3243831A1 (en) * 2014-02-27: 2017-11-15: Ucl Business Plc . Janssen recently submitted their Biologics License Application (BLA) to the FDA seeking for approval of teclistamab, a bispecific antibody for relapsed or refractory myeloma. MiNK was and still is developing the iNKT therapy, dubbed agenT-797, for treating cancer, but like others, it pivoted during the pandemic and started a small 20-person study in ARDS patients who were intubated or at high risk of being intubated. Neutropenia, Oncology, Immune Modulation, Thrombocytopenia, Inflammation, AbbVie. Construct ( TriTAC ), designed to AbbVie, please visit us at www.abbvie.com 2022 AbbVie North... Drugs and gene therapy manufacturing sites in the first half of 2019 can put. Construct ( TriTAC ), AbbVie serves as a bridge between cancer and immune.. Screen size and Pharmacokinetics of the stoppage comes months after Amgen hit on! The clinic in the us or next day following the first time company is the! Modulation, Thrombocytopenia, Inflammation, AbbVie paid $ 90 million to one. Targets BCMA and CD3 and an immunological drug for combined use in treating multiple myeloma the same next... Of its gene therapy advances: What to watch at next month & # x27 ; s.. 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