This is a phase II single-center study to evaluate the safety and effectiveness of vibecotamab, a CD3-CD123 bispecific antibody, in patients with acute myeloid leukemia with persistent or recurrent measurable residual disease and in patients with myelodysplastic syndrome that has not responded to or relapsed after conventional therapy

Start Date06 May 2022

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT02730312 / CompletedPhase 1

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies

The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Start Date01 Aug 2016

Sponsor / Collaborator

Xencor, Inc.

[+1]

100 Clinical Results associated with Vibecotamab

100 Translational Medicine associated with Vibecotamab

100 Patents (Medical) associated with Vibecotamab

Literatures (Medical) associated with Vibecotamab

14 Nov 2023·Blood advances

Phase 1 study of vibecotamab identifies an optimized dose for treatment of relapsed/refractory acute myeloid leukemia

Article

Author: Foran, James ; Kanodia, Jitendra ; Short, Nicholas ; Yilmaz, Musa ; Kye, Steve ; Ainsworth, William Barrett ; Patel, Anand ; Bashey, Asad ; Clynes, Raphael ; Stock, Wendy ; Ravandi, Farhad ; Mims, Alice ; Garcha, Raman ; Ding, Ying ; Mawad, Raya ; Kantarjian, Hagop ; Li, Huajiang ; Odenike, Olatoyosi

Abstract:

Acute myeloid leukemia (AML), an aggressive malignancy with unmet medical need, lacks immunotherapeutic options. CD123, the cellular receptor for interleukin-3, expressed in AML is an attractive target for tumor-specific therapy. Vibecotamab (XmAb14045), a humanized bispecific antibody, monovalently binds both CD3 and CD123 to recruit cytotoxic T cells to kill CD123+ tumor cells. This phase 1 study’s primary objectives were safety and tolerability and identification of a maximum tolerated dose/recommended dose for use as monotherapy in patients with relapsed/refractory AML. Identification of a recommended phase 2 vibecotamab dose comprised 3 step-up doses (Week 1), which were noted to reduce cytokine response syndrome (CRS), followed by weekly dosing (1.7 μg/kg, Cohort -1D). In 16 of 120 patients, at least 1 treatment-emergent adverse event was classified as a dose-limiting toxicity. CRS, the most common adverse event (59.2%), managed with premedication, were mostly ≤grade 2. A secondary objective was assessment of efficacy in patients with CD123-expressing leukemias. A total of 10 of 111 (9.0%) efficacy-evaluable patients with AML achieved an overall response of morphologic leukemia-free state or better with an overall objective response rate (ORR) of 9.0%. Response was only observed in patients receiving a target dose of 0.75 μg/kg or higher (n = 87) in which the efficacy-evaluable ORR was 11.5%. Response was associated with lower baseline blast counts in blood and bone marrow (<25%) suggesting potential benefit. This trial was registered at www.clinicaltrials.gov as #NCT02730312.

30 Apr 2023·Blood research

Plasmacytoid dendritic cell neoplasms.

Review

Author: Kim, Youjin ; Lee, Yoo Jin ; Park, Sang Hyuk ; Jo, Jae-Cheol

Plasmacytoid dendritic cells (pDCs) are type I interferon-producing cells that modulate immune responses. There are two types of pDC neoplasms: 1) mature pDC proliferation (MPDCP) associated with myeloid neoplasm and 2) blastic pDC neoplasm (BPDCN). MPDCP is a clonal expansion of mature pDCs that is predominantly associated with chronic myelomonocytic leukemia. In contrast, BPDCN is a clinically aggressive myeloid malignancy involving the skin, bone marrow, lymphatic organs, and central nervous system. There are various types of skin lesions, ranging from solitary brown or violaceous to disseminated cutaneous lesions, which often spread throughout the body. The expression of CD4, CD56, CD123, and pDC markers (TCL-1, TCF4, CD303, and CD304, etc.) are typical immunophenotype of BPDCN. Historically, BPDCN treatment has been based on acute leukemia regimens and allogeneic hematopoietic cell transplantation in selected patients. Recent advances in molecular biology and genetics have led to the development of targeted agents, such as tagraxofusp (a recombinant fusion protein targeting CD123), anti-CD123 CAR-T cells, XmAb14045, and IMGN632. Lastly, this review provides a comprehensive overview of pDC neoplasms.

01 Mar 2023·Clinical and translational science

First‐in‐human study of JNJ‐63709178, a CD123/CD3 targeting antibody, in relapsed/refractory acute myeloid leukemia

Article

Author: Tucker, Trevor ; Perez‐Simon, Jose Antonio ; Boyiadzis, Michael ; Salamero, Olga ; Grunwald, Michael R. ; Daskalakis, Nikki ; Xu, Xiaoying ; Alonso‐Dominguez, Juan Manuel ; Desai, Pinkal ; Yang, Jay ; Pemmaraju, Naveen ; Donnellan, William ; Goldberg, Jenna D. ; Li, Xiang ; Ferrante, Lucille ; Guttke, Christina

Abstract:

This study aimed to identify a recommended phase II dose and evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary clinical activity of JNJ‐63709178, a CD123/CD3 dual‐targeting antibody, in patients with relapsed or refractory acute myeloid leukemia. Intravenous (i.v.) and subcutaneous (s.c.) administration of JNJ‐63709178 were evaluated. The i.v. infusions were administered once every 2 weeks (cohorts 1–5 [n = 17]) or twice weekly (cohorts 6–11 [n = 36]). A twice‐weekly s.c. dosing regimen with step‐up dosing was also studied (s.c. cohorts 1–2 [n = 9]). Treatment‐emergent adverse events (TEAEs) greater than or equal to grade 3 were observed in 11 (65%) patients in cohorts 1–5 and 33 (92%) patients in cohorts 6–11. At the highest i.v. dose (4.8 μg/kg), 5 (71%) patients discontinued treatment due to TEAEs. For s.c. administration (n = 9), eight (89%) patients experienced TEAEs greater than or equal to grade 3 and injection site reactions (≤ grade 3) emerged in all patients. At 4.8 μg/kg (i.v. and s.c.), the mean maximum serum concentrations were 30.3 and 3.59 ng/ml, respectively. Increases in multiple cytokines were observed following i.v. and s.c. administrations, and step‐up dosing strategies did not mitigate cytokine production or improve the safety profile and led to limited duration of treatment. Minimal clinical activity was observed across all cohorts. The i.v. and s.c. dosing of JNJ‐63709178 was associated with suboptimal drug exposure, unfavorable safety profiles, limited clinical activity, and inability to identify a recommended phase II dose.

News (Medical) associated with Vibecotamab

28 Sep 2022

·www.prnewswire.com

Bispecific Antibodies for Cancer Market Size to Grow by USD 396.56 million, Emerging Bispecific Antibody Generation Platforms to be Key Trend - Technavio

NEW YORK, Sept. 28, 2022 /PRNewswire/ -- In the bispecific antibodies for cancer market, emerging bispecific antibody generation platforms will be a key trend during the forecast period. For instance, Xencor is developing XmAb20717, XmAb22841, XmAb23104, XmAb24306, and XmAb14045, which are currently in the early phase of development, using the XmAb antibody engineering platform. In addition, Aptevo Therapeutics has developed APVO436 using its ADAPTIR platform for treating patients with acute myeloid leukemia. Therefore, such platforms will drive market growth during the forecast period. Continue Reading Technavio has announced its latest market research report titled Global Bispecific Antibodies for Cancer Market 2022-2026 The bispecific antibodies for cancer market size is expected to grow by USD 396.56 million from 2021 to 2026. In addition, the growth momentum of the market will accelerate at a CAGR of 9.06% during the forecast period, according to Technavio. Our comprehensive report summary includes the market size and forecast along with research methodology. The FREE sample report is available in PDF format The increasing prevalence of cancer is driving the growth of the bispecific antibodies for cancer market growth. However, factors such as the high cost of drugs may challenge the market growth during the forecast period. Bispecific Antibodies For Cancer Market: Type Landscape By type, the market has been segmented into CD19 or CD3 and CD30 or CD16A. The CD19 or CD3 segment will be the largest contributor to market growth during the forecast period. Bispecific antibodies have several advantages when compared to monoclonal antibodies. They can redirect specific immune cells to the site of the tumor cells to boost tumor killing. In addition, they can potentially increase the binding specificity by interacting with two different cell-surface antigens instead of one. They are also able to block two different pathways that exert unique pathogenesis simultaneously. Such advantages will drive the growth of the segment during the forecast period. Bispecific Antibodies For Cancer Market: Geographic Landscape Based on geography, the market has been segmented into North America, Europe, Asia, and Rest of World (ROW). North America is expected to have significant growth during the forecast period. About 39% of the market's overall growth is expected to originate from this region. The US is the key country for the bispecific antibodies for the cancer market in North America. The growth of this region is attributed to factors such as the availability of reimbursement schemes. Moreover, this region is expected to grow at a faster rate than other regions. Find out about the contribution of each region of the market. Buy Now to gain access to country-specific information Companies Covered ABL Bio Inc. AFFIMED N.V. Akeso Inc. Amgen Inc. Aptevo Therapeutics Inc. Astellas Pharma Inc. Chugai Pharmaceutical Co. Ltd. Eli Lilly and Co. EPIMAB BIOTHERAPEUTICS INC. F. Hoffmann La Roche Ltd. F-STAR THERAPEUTICS INC. Glenmark Pharmaceuticals Ltd. Johnson and Johnson Inc. Mereo BioPharma Group Plc Merus N.V. Pfizer Inc. Regeneron Pharmaceuticals Inc. TG Therapeutics Inc. Xencor Inc. Y mAbs Therapeutics Inc. For learning about strategic initiatives used by vendors, as well as key news and the latest developments, View our FREE PDF Sample Report Now What our reports offer Market share assessments for regional-level and country-level segments Strategic recommendations for the new entrants Covers market data for 2021, 2022, until 2026 Market trends (opportunities, drivers, threats, challenges, investment opportunities, and recommendations) Strategic recommendations in key business segments as per the market approximations Competitive landscaping highlighting the common trends Company profiling with detailed strategies, recent developments, and financials Supply chain trends that map the latest technological advances Related Reports Non-melanoma Skin Cancer Market by Type and Geography - Forecast and Analysis 2022-2026: The non-melanoma skin cancer market share is expected to increase by USD 180.97 million from 2021 to 2026. Colorectal Cancer Therapeutics Market by Type and Geography - Forecast and Analysis 2022-2026: The colorectal cancer therapeutics market share is expected to increase by USD 2.45 bn from 2021 to 2026. Browse Health Care Market Reports Table of Contents 1 Executive Summary 1.1 Market overview Exhibit 01: Executive Summary – Chart on Market Overview Exhibit 02: Executive Summary – Data Table on Market Overview Exhibit 03: Executive Summary – Chart on Global Market Characteristics Exhibit 04: Executive Summary – Chart on Market by Geography Exhibit 05: Executive Summary – Chart on Market Segmentation by Type Exhibit 06: Executive Summary – Chart on Incremental Growth Exhibit 07: Executive Summary – Data Table on Incremental Growth Exhibit 08: Executive Summary – Chart on Vendor Market Positioning 2 Market Landscape 2.1 Market ecosystem Exhibit 09: Parent market Exhibit 10: Market Characteristics 3 Market Sizing 3.1 Market definition Exhibit 11: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 12: Market segments 3.3 Market size 2021 3.4 Market outlook: Forecast for 2021-2026 Exhibit 13: Chart on Global - Market size and forecast 2021-2026 ($ million) Exhibit 14: Data Table on Global - Market size and forecast 2021-2026 ($ million) Exhibit 15: Chart on Global Market: Year-over-year growth 2021-2026 (%) Exhibit 16: Data Table on Global Market: Year-over-year growth 2021-2026 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 17: Five forces analysis - Comparison between 2021 and 2026 4.2 Bargaining power of buyers Exhibit 18: Bargaining power of buyers – Impact of key factors in 2021 and 2026 4.3 Bargaining power of suppliers Exhibit 19: Bargaining power of suppliers – Impact of key factors in 2021 and 2026 4.4 Threat of new entrants Exhibit 20: Threat of new entrants – Impact of key factors in 2021 and 2026 4.5 Threat of substitutes Exhibit 21: Threat of substitutes – Impact of key factors in 2021 and 2026 4.6 Threat of rivalry Exhibit 22: Threat of rivalry – Impact of key factors in 2021 and 2026 4.7 Market condition Exhibit 23: Chart on Market condition - Five forces 2021 and 2026 5 Market Segmentation by Type 5.1 Market segments Exhibit 24: Chart on Type - Market share 2021-2026 (%) Exhibit 25: Data Table on Type - Market share 2021-2026 (%) 5.2 Comparison by Type Exhibit 26: Chart on Comparison by Type Exhibit 27: Data Table on Comparison by Type 5.3 CD19 or CD3 - Market size and forecast 2021-2026 Exhibit 28: Chart on CD19 or CD3 - Market size and forecast 2021-2026 ($ million) Exhibit 29: Data Table on CD19 or CD3 - Market size and forecast 2021-2026 ($ million) Exhibit 30: Chart on CD19 or CD3 - Year-over-year growth 2021-2026 (%) Exhibit 31: Data Table on CD19 or CD3 - Year-over-year growth 2021-2026 (%) 5.4 CD30 or CD16A - Market size and forecast 2021-2026 Exhibit 32: Chart on CD30 or CD16A - Market size and forecast 2021-2026 ($ million) Exhibit 33: Data Table on CD30 or CD16A - Market size and forecast 2021-2026 ($ million) Exhibit 34: Chart on CD30 or CD16A - Year-over-year growth 2021-2026 (%) Exhibit 35: Data Table on CD30 or CD16A - Year-over-year growth 2021-2026 (%) 5.5 Market opportunity by Type Exhibit 36: Market opportunity by Type ($ million) 6 Customer Landscape 6.1 Customer landscape overview Exhibit 37: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 38: Chart on Market share by geography 2021-2026 (%) Exhibit 39: Data Table on Market share by geography 2021-2026 (%) 7.2 Geographic comparison Exhibit 40: Chart on Geographic comparison Exhibit 41: Data Table on Geographic comparison 7.3 North America - Market size and forecast 2021-2026 Exhibit 42: Chart on North America - Market size and forecast 2021-2026 ($ million) Exhibit 43: Data Table on North America - Market size and forecast 2021-2026 ($ million) Exhibit 44: Chart on North America - Year-over-year growth 2021-2026 (%) Exhibit 45: Data Table on North America - Year-over-year growth 2021-2026 (%) 7.4 Europe - Market size and forecast 2021-2026 Exhibit 46: Chart on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 47: Data Table on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 48: Chart on Europe - Year-over-year growth 2021-2026 (%) Exhibit 49: Data Table on Europe - Year-over-year growth 2021-2026 (%) 7.5 Asia - Market size and forecast 2021-2026 Exhibit 50: Chart on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 51: Data Table on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 52: Chart on Asia - Year-over-year growth 2021-2026 (%) Exhibit 53: Data Table on Asia - Year-over-year growth 2021-2026 (%) 7.6 Rest of World (ROW) - Market size and forecast 2021-2026 Exhibit 54: Chart on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 55: Data Table on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 56: Chart on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) Exhibit 57: Data Table on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) 7.7 US - Market size and forecast 2021-2026 Exhibit 58: Chart on US - Market size and forecast 2021-2026 ($ million) Exhibit 59: Data Table on US - Market size and forecast 2021-2026 ($ million) Exhibit 60: Chart on US - Year-over-year growth 2021-2026 (%) Exhibit 61: Data Table on US - Year-over-year growth 2021-2026 (%) 7.8 Ireland - Market size and forecast 2021-2026 Exhibit 62: Chart on Ireland - Market size and forecast 2021-2026 ($ million) Exhibit 63: Data Table on Ireland - Market size and forecast 2021-2026 ($ million) Exhibit 64: Chart on Ireland - Year-over-year growth 2021-2026 (%) Exhibit 65: Data Table on Ireland - Year-over-year growth 2021-2026 (%) 7.9 China - Market size and forecast 2021-2026 Exhibit 66: Chart on China - Market size and forecast 2021-2026 ($ million) Exhibit 67: Data Table on China - Market size and forecast 2021-2026 ($ million) Exhibit 68: Chart on China - Year-over-year growth 2021-2026 (%) Exhibit 69: Data Table on China - Year-over-year growth 2021-2026 (%) 7.10 Hungary - Market size and forecast 2021-2026 Exhibit 70: Chart on Hungary - Market size and forecast 2021-2026 ($ million) Exhibit 71: Data Table on Hungary - Market size and forecast 2021-2026 ($ million) Exhibit 72: Chart on Hungary - Year-over-year growth 2021-2026 (%) Exhibit 73: Data Table on Hungary - Year-over-year growth 2021-2026 (%) 7.11 India - Market size and forecast 2021-2026 Exhibit 74: Chart on India - Market size and forecast 2021-2026 ($ million) Exhibit 75: Data Table on India - Market size and forecast 2021-2026 ($ million) Exhibit 76: Chart on India - Year-over-year growth 2021-2026 (%) Exhibit 77: Data Table on India - Year-over-year growth 2021-2026 (%) 7.12 Market opportunity by geography Exhibit 78: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges 8.3 Impact of drivers and challenges Exhibit 79: Impact of drivers and challenges in 2021 and 2026 8.4 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 80: Overview on Criticality of inputs and Factors of differentiation 9.3 Landscape disruption Exhibit 81: Overview on factors of disruption 9.4 Industry risks Exhibit 82: Impact of key risks on business 10 Vendor Analysis 10.1 Vendors covered Exhibit 83: Vendors covered 10.2 Market positioning of vendors Exhibit 84: Matrix on vendor position and classification 10.3 ABL Bio Inc. Exhibit 85: ABL Bio Inc. - Overview Exhibit 86: ABL Bio Inc. - Product / Service Exhibit 87: ABL Bio Inc. - Key offerings 10.4 Amgen Inc. Exhibit 88: Amgen Inc. - Overview Exhibit 89: Amgen Inc. - Product / Service Exhibit 90: Amgen Inc. - Key offerings 10.5 Astellas Pharma Inc. Exhibit 91: Astellas Pharma Inc. - Overview Exhibit 92: Astellas Pharma Inc. - Product / Service Exhibit 93: Astellas Pharma Inc. - Key news Exhibit 94: Astellas Pharma Inc. - Key offerings 10.6 Eli Lilly and Co. Exhibit 95: Eli Lilly and Co. - Overview Exhibit 96: Eli Lilly and Co. - Business segments Exhibit 97: Eli Lilly and Co. - Key offerings Exhibit 98: Eli Lilly and Co. - Segment focus 10.7 F. Hoffmann La Roche Ltd. Exhibit 99: F. Hoffmann La Roche Ltd. - Overview Exhibit 100: F. Hoffmann La Roche Ltd. - Business segments Exhibit 101: F. Hoffmann La Roche Ltd. - Key news Exhibit 102: F. Hoffmann La Roche Ltd. - Key offerings Exhibit 103: F. Hoffmann La Roche Ltd. - Segment focus 10.8 Johnson and Johnson Inc. Exhibit 104: Johnson and Johnson Inc. - Overview Exhibit 105: Johnson and Johnson Inc. - Business segments Exhibit 106: Johnson and Johnson Inc. - Key news Exhibit 107: Johnson and Johnson Inc. - Key offerings Exhibit 108: Johnson and Johnson Inc. - Segment focus 10.9 Merus N.V. Exhibit 109: Merus N.V. - Overview Exhibit 110: Merus N.V. - Key offerings 10.10 Pfizer Inc. Exhibit 111: Pfizer Inc. - Overview Exhibit 112: Pfizer Inc. - Product / Service Exhibit 113: Pfizer Inc. - Key news Exhibit 114: Pfizer Inc. - Key offerings 10.11 Regeneron Pharmaceuticals Inc. Exhibit 115: Regeneron Pharmaceuticals Inc. - Overview Exhibit 116: Regeneron Pharmaceuticals Inc. - Product / Service Exhibit 117: Regeneron Pharmaceuticals Inc. - Key offerings 10.12 TG Therapeutics Inc. Exhibit 118: TG Therapeutics Inc. - Overview Exhibit 119: TG Therapeutics Inc. - Product / Service Exhibit 120: TG Therapeutics Inc. - Key offerings 11 Appendix 11.1 Scope of the report 11.2 Inclusions and exclusions checklist Exhibit 121: Inclusions checklist Exhibit 122: Exclusions checklist 11.3 Currency conversion rates for US$ Exhibit 123: Currency conversion rates for US$ 11.4 Research methodology Exhibit 124: Research methodology Exhibit 125: Validation techniques employed for market sizing Exhibit 126: Information sources 11.5 List of abbreviations Exhibit 127: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

CollaborateAntibody

09 Nov 2021

·endpts.com

UPDATED: Novartis washes its hands of another bispecific at the center of $2.5B Xencor deal

A centerpiece of Novartis’ $2.5 billion bispecifics deal with Xencor has been sidelined, the California biotech said in its third quarter earnings report Monday. Novartis terminated its ex-US rights to the program dubbed vibecotamab, a bispecific targeting CD123 and CD3 for acute myeloid leukemia. The move will take effect next February, Xencor said Monday. Xencor will drop development of the drug altogether as well, saying it has no future plans for in-house research. The Swiss biopharma previously handed back rights to the other Xencor drug involved in the partnership in January 2019. That program, a CD20 and CD3 bispecific called plamotamab, is now one of Xencor’s lead candidates, with updated Phase I data coming at ASH next month and a new partner signed in J&J’s Janssen. In Monday’s earnings call with analysts, Xencor CEO Bassil Dahiyat alluded to a tougher competitive landscape shrinking new opportunities in AML — following AbbVie and Roche’s 2019 approval of Venclexta — in response to a question about why Novartis backed out. He also noted CD123’s difficulty as a target, saying its “narrow therapeutic window” brings challenges in dosing frequency. “In spite of the very encouraging early complete remissions that we’ve had and continuing additional activity we’ve seen, all those pieces make the product profile and the competitive landscape tough, really frankly tough for us to want to pursue and our partner, Novartis, agree,” Dahiyat said. In an email to Endpoints News , a Xencor spokesperson said the deal remains ongoing, with the pair working on “a bispecific antibody and a non-bispecific antibody that incorporates another of our XmAb Fc domains.” Novartis and Xencor originally agreed to develop vibecotamab, previously known as XmAb14045, back in 2016 when the companies signed a deal giving Xencor $150 million upfront and promising another $2.4 billion in milestones. At the time, it had been the latest in a string of high-profile biopharmas to partner with Xencor, following Amgen, Merck and J&J, among others. But while vibecotamab was still a preclinical program in 2016, it soon ran into trouble in the clinic. The FDA slapped a hold on a Phase I study in February 2019 after two patients in the trial died, one from cytokine release syndrome and another from acute pulmonary edema following several doses. Regulators lifted the hold the following April, after Xencor amended study protocols to update how CRS is monitored and managed. It’s not clear if investigators ever determined whether the deaths were linked to the drug. Additional studies for vibecotamab had previously been scheduled for 2020, but Xencor said previously that plans had been affected by the Covid-19 pandemic. Now, though, those plans have been shelved. CD123 has given other drugmakers trouble in the past, as well as bispecifics with CD3. In 2016, the FDA put a full hold on a J&J program for the target combo, and Cellectis saw a patient death in 2017 for a CD123-targeting CAR-T candidate. Novartis, meanwhile, has its own in-house CD123 called JEZ567, being studied for AML. This article was updated to include comment from Xencor.

Antibody

09 Nov 2021

·www.biospace.com

Novartis Walks Away from $2.6 Billion Xencor Collaboration

Taljat David/Shutterstock Shares of Xencor were down nearly 6% after the company announced Novartis terminated its rights to develop vibecotamab, a CD123 x CD3 blood cancer bispecific, which was part of a 2016 collaboration valued at $2.6 billion. Since the collaboration was first forged, Novartis has slowly stepped away from the partnership. In 2019, the Swiss pharma giant backed away from developing XmAb13676, a CD20 x CD3 bispecific antibody, following a strategic pipeline reprioritization. Now, Novartis is terminating rights to the vibecotamab program, effective February 2022. In 2019, shortly after Novartis dumped development rights to XmAb13676, the other asset was hit with a partial clinical hold by the U.S. Food and Drug Administration. The CD123 x CD3 blood cancer bispecific was assessed in a Phase I study for acute myeloid leukemia. Two patients in the trial died. CD123 is a tumor-associated antigen overexpressed on the surface of some tumor cells. The CD3 complex is a group of proteins on the surface of T-cells. Multiple companies have taken this approach against leukemia, but results have been less than encouraging. In 2016, Janssen and Genmab saw a hold placed on their CD123 x CD3 candidate for acute myeloid leukemia. Cellectis also caught a clinical hold on two Phase I trials of its CD123 asset, UCART123. Xencor announced Novartis’ decision in its third quarter financial report. The company stated that it would continue the ongoing study of vibecotamab, but it no longer intends further internal development of the drug once it is complete. There is still hope that something from the partnership with Novartis could be salvaged through the development of another asset. Earlier this year, the larger company selected a candidate to develop. The outcome for that study is still off in the future. Although the partnership with Novartis has taken a significant blow, Xencor could see fruit from a collaboration with Janssen. In October, the two companies entered into a partnership to advance the development of plamotamab and XmAb CD28 bispecific antibody combinations to treat patients with B-cell malignancies. Under terms of that deal, Janssen secured exclusive worldwide development and commercial rights to plamotamab, an investigational tumor-targeted XmAb bispecific antibody, currently in Phase I clinical development as a potential treatment for patients with CD20-expressing hematologic malignancies. Xencor is paying 20% of costs, including those for a subcutaneous formulation study that is expected to enter clinical studies in 2022. In the meantime, Xencor will continue, at its own expense, the combination study of plamotamab, tafasitamab and lenalidomide. Xencor is also partnered with Bristol Myers Squibb on the development of potential antibody treatment for COVID-19. The two companies will advance the development of Xencor’s Xtend Fc technology. Featured Jobs on BioSpace

AntibodyFinancial StatementCollaborate

100 Deals associated with Vibecotamab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	US	The University of Texas MD Anderson Cancer Center	06 May 2022
Myelodysplastic Syndromes	Phase 2	US	The University of Texas MD Anderson Cancer Center	06 May 2022
Blast Phase Chronic Granulocytic Leukemia	Phase 1	US	Xencor, Inc.	01 Aug 2016
Blastic Plasmacytoid Dendritic Cell Neoplasm	Phase 1	US	Xencor, Inc.	01 Aug 2016
CD123 Positive Hematologic Neoplasms	Phase 1	US	Xencor, Inc.	01 Aug 2016
Pre B-cell acute lymphoblastic leukemia	Phase 1	US	Xencor, Inc.	01 Aug 2016
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	Phase 1	US	Xencor, Inc.	01 Aug 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Phase 2	Acute Myeloid Leukemia \| Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	23	Vibecotamab	nieeavyuoq(pmbyvhgvfm) = vxwwrqyhui pflytfeatp (xblfctpmdk ) View more	-	09 Dec 2023

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