Delving into the Latest Updates on Atigotatug with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-fucosyl-GM1, Fucosyl-GM1 antibody

+ [1]

Target

Fuc-GM1

Action

inhibitors

Mechanism

Fuc-GM1 inhibitors(Ganglioside fucosyl GM1 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Solid tumorExtensive stage Small Cell Lung CancerSmall Cell Lung Cancer

Inactive Indication

Congenital hypoplasia of lung

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

Sino-American Shanghai Squibb Pharmaceuticals Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 936772904H

Source: *****

Sequence Code 97142L

Source: *****

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

Start Date17 Mar 2021

Sponsor / Collaborator

Bristol Myers Squibb Co.

JPRN-JapicCTI-163424

/ Unknown statusPhase 1

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Start Date01 Jan 2017

Sponsor / Collaborator

Bristol-Myers Squibb KK

NCT02949895

/ CompletedPhase 1

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Start Date29 Nov 2016

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Atigotatug

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100 Translational Medicine associated with Atigotatug

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100 Patents (Medical) associated with Atigotatug

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4

Literatures (Medical) associated with Atigotatug

01 Nov 2022·JTO Clinical and Research Reports

BMS-986012, an Anti–Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study

Article

Author: Markman, Ben ; Urbanska, Katarzyna ; Tannenbaum-Dvir, Sarah ; Rudin, Charles M ; He, Chunsheng ; DiPiero, Andrew ; Andelkovic, Vladimir ; Basciano, Paul ; Clarke, Stephen ; Juergens, Rosalyn A ; van Herpen, Carla ; Lin, Hongxia ; Sanghavi, Kinjal ; Leighl, Natasha B ; Surmont, Veerle ; Kim, Dong-Wan ; Kollia, Georgia ; Liu, Yu ; Sibille, Anne ; Ready, Neal ; Sanatani, Michael ; Rivera, Mirelis Acosta ; Snow, Stephanie ; Chu, Quincy ; Lathers, Deanne

IntroductionFucosyl-GM1 is a monosialoganglioside with limited expression in healthy tissues and high expression on SCLC cells. BMS-986012 is a nonfucosylated, first-in-class, fully human immunoglobulin G1 monoclonal antibody that binds to fucosyl-GM1.MethodsCA001-030 is a phase 1/2, first-in-human study of BMS-986012 as monotherapy or in combination with nivolumab for adults with relapsed or refractory SCLC. Safety is the primary end point. Additional end points include objective response rate, duration of response, progression-free survival, pharmacokinetics, and overall survival.ResultsPatients (BMS-986012 monotherapy, n = 77; BMS-986012 + nivolumab, n = 29) were predominantly of male sex (58%), 63 years old (mean), current or past tobacco users (97%), and treated previously with first-line systemic therapy (99%). The most common treatment-related adverse event was pruritus (n = 95 [90%]). Grade 4 treatment-related adverse events were reported in 2% (n = 2) of patients. The objective response rate (95% confidence interval [CI]) was higher with BMS-986012 plus nivolumab (38% [20.7%-57.7%]) than with monotherapy (4% [0.8%-11.0%]). Median (95% CI) duration of response with BMS-986012 plus nivolumab was 26.4 (4.4-not reached) months. Progression-free survival (95% CI) at 24 weeks with monotherapy and BMS-986012 plus nivolumab was 12.2% (6.0%-20.7%) and 39.3% (21.7%-56.5%), respectively. The pharmacokinetics profile of monotherapy and BMS-986012 plus nivolumab suggested dose proportionality across the tested dose range. Median overall survival (95% CI) with monotherapy and BMS-986012 plus nivolumab was 5.4 (4.0-7.3) and 18.7 (8.2-37.3) months, respectively.ConclusionsBMS-986012 in combination with nivolumab represents a well-tolerated, potential new therapy for relapsed or refractory SCLC. BMS-986012 is currently being explored in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in extensive-stage SCLC (NCT04702880).

15 Oct 2018·Clinical Cancer ResearchQ1 · MEDICINE

A Novel, Fully Human Anti–fucosyl-GM1 Antibody Demonstrates Potent In Vitro and In Vivo Antitumor Activity in Preclinical Models of Small Cell Lung Cancer

Q1 · MEDICINE

Article

Author: Park, Kwon-Sik ; Wang, Xi-Tao ; Chen, Bing ; Menezes, Daniel ; Rangan, Vangipuram S. ; Pan, Chin ; Sun, Huadong ; Oyasu, Miho ; Cardarelli, Pina M. ; Sage, Julien ; Cristea, Sandra ; LeBlanc, Heidi ; Ponath, Paul ; Deshpande, Shrikant ; Strachan, Debbie

AbstractPurpose: The ganglioside fucosyl-GM1 (FucGM1) is a tumor-associated antigen expressed in a large percentage of human small cell lung cancer (SCLC) tumors, but absent in most normal adult tissues, making it a promising target in immuno-oncology. This study was undertaken to evaluate the preclinical efficacy of BMS-986012, a novel, nonfucosylated, fully human IgG1 antibody that binds specifically to FucGM1.Experimental Design: The antitumor activity of BMS-986012 was evaluated in in vitro assays using SCLC cells and in mouse xenograft and syngeneic tumor models, with and without chemotherapeutic agents and checkpoint inhibitors.Results: BMS-986012 showed a high binding affinity for FcγRIIIa (CD16), which resulted in enhanced antibody-dependent cellular cytotoxicity (ADCC) against FucGM1-expressing tumor cell lines. BMS-986012–mediated tumor cell killing was also observed in complement-dependent cytotoxicity (CDC) and antibody-dependent cellular phagocytosis (ADCP) assays. In several mouse SCLC models, BMS-986012 demonstrated efficacy and was well tolerated. In the DMS79 xenograft model, tumor regression was achieved with BMS-986012 doses of 0.3 mg/kg and greater; antitumor activity was enhanced when BMS-986012 was combined with standard-of-care cisplatin or etoposide. In a syngeneic model, tumors derived from a genetically engineered model of SCLC were treated with BMS-986012 or anti-FucGM1 with a mouse IgG2a Fc and their responses evaluated; when BMS-986012 was combined with anti–PD-1 or anti-CD137 antibody, therapeutic responses significantly improved.Conclusions: Single-agent BMS-986012 demonstrated robust antitumor activity, with the addition of chemotherapeutic or immunomodulatory agents further inhibiting SCLC growth in the same models. These preclinical data supported evaluation of BMS-986012 in a phase I clinical trial of patients with relapsed, refractory SCLC. Clin Cancer Res; 24(20); 5178–89. ©2018 AACR.

01 Oct 2013·BioanalysisQ4 · MEDICINE

Systematic Investigation of Orthogonal SPE Sample Preparation for The LC–MS/MS Bioanalysis of A Monoclonal Antibody After Pellet Digestion

Q4 · MEDICINE

Article

Author: Aubry, Anne-Françoise ; Yuan, Long ; Arnold, Mark E ; Ji, Qin C

Background: Increasing assay sensitivity is critical for promoting the application of LC–MS/MS quantitative bioanalysis of therapeutic proteins. A sample processing method that can selectively remove the abundant background peptides in the serum tryptic digests and retain the target peptides can greatly improve the assay sensitivity. Results: Mixed-mode strong-cation exchange SPE was systematically investigated as an orthogonal sample separation technique to reversed-phase UHPLC for the analysis of a test monoclonal antibody, BMS-986012, in monkey serum after pellet digestion. Strong cation exchange SPE efficiently removed most of the background peptides and reduced the matrix effect and background level in the monitored mass transition channels. As a result, improved sensitivity was observed for the surrogate peptides VVSV and SLIY. Conclusion: This orthogonal approach provides a simple and easy-to-develop sample preparation method that can selectively remove most background peptides and extract the target peptides, therefore, improving the LC–MS/MS assay sensitivity.

100 Deals associated with Atigotatug

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14831

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 2	Australia	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Japan	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	United States	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Netherlands	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Greece	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Canada	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Poland	Bristol Myers Squibb Co.	17 Mar 2021
Extensive stage Small Cell Lung Cancer	Phase 2	Romania	Bristol Myers Squibb Co.	17 Mar 2021
Small Cell Lung Cancer	Phase 2	Puerto Rico	Bristol Myers Squibb Co.	14 Nov 2014
Small Cell Lung Cancer	Phase 2	South Korea	Bristol Myers Squibb Co.	14 Nov 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04702880 (ESMO2024)	Phase 2	Extensive stage Small Cell Lung Cancer First line fuc-GM1	132	BMS-986012 + CE/NIVO	(xmrutdadud) = ehlxbhknka vpbsuifqki (qjmecjkvfa, 5.0 - 7.9) View more	Positive	13 Sep 2024
				CE/NIVO	(xmrutdadud) = vqrjhvjqje vpbsuifqki (qjmecjkvfa, 4.8 - 6.6) View more
NCT04702880 (Pubmed) Manual	Phase 1/2	Small Cell Lung Cancer	106	Nivolumab+BMS 986012	(gutykxqsav) = utnuxicpau opiryajbxt (frgbkgagcu, 21.7 - 56.5) View more	Positive	27 Aug 2022
				BMS 986012	(gutykxqsav) = skajdixouf opiryajbxt (frgbkgagcu, 6.0 - 20.7) View more
NCT02247349 (WCLC2021 \| WCLC2021) Manual	Phase 1/2	Small Cell Lung Cancer	29	BMS-986012+nivolumab	(lqarplvcyt) = pruritus 93%;fatigue 28%;dry skin 28% ;hypothyroidism 17% gycnqlrhpo (cxnvccizpz ) View more	Positive	28 Jan 2021

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

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Atigotatug

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation