Delving into the Latest Updates on M108 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Target

CLDN18.2

Action

inhibitors

Mechanism

CLDN18.2 inhibitors(Claudin 18.2 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

CLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinomaGastrointestinal Neoplasms+ [4]

Inactive Indication-

Originator Organization

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Active Organization

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Inactive Organization-

License Organization

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Gracell Biotechnologies (Shanghai) Co., Ltd.

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (China)

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A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

Gastric/GEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health. However, standard chemotherapy has limited efficacy in advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities. The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin (CAPOX) versus placebo plus CAPOX as first-line treatment measured by progression free survival (PFS). This study will also evaluate safety, tolerability, pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody, as well as its effects on quality of life.

Start Date25 Dec 2023

Sponsor / Collaborator

FutureGen Biopharmaceutical (Beijing) Co., Ltd

CTR20210508

/ RecruitingPhase 1

M108单抗注射液在中国晚期不可切除实体瘤患者中的安全性、耐受性和药代动力学研究：一项多中心、开放、单药及联药剂量递增和单药及联药扩展的I期临床试验

[Translation] Safety, tolerability and pharmacokinetics of M108 monoclonal antibody injection in Chinese patients with advanced unresectable solid tumors: a multicenter, open-label, single-agent and combination-dose escalation and single-agent and combination-drug expansion phase I clinical trial

评价不同给药方案下M108单抗注射液在中国晚期不可切除的实体瘤患者中的安全性、耐受性，以及药代动力学特征以及抗肿瘤效果

[Translation]

To evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor effects of M108 monoclonal antibody injection at different dosing regimens in Chinese patients with advanced unresectable solid tumors

Start Date01 Jul 2021

Sponsor / Collaborator

FutureGen Biopharmaceutical (Beijing) Co., Ltd

NCT04894825

/ RecruitingPhase 1

A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.

Start Date11 Jun 2021

Sponsor / Collaborator

FutureGen Biopharmaceutical (Beijing) Co., Ltd

100 Clinical Results associated with M108

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100 Translational Medicine associated with M108

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100 Patents (Medical) associated with M108

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4

Literatures (Medical) associated with M108

01 Sep 2005·Journal of Veterinary Diagnostic InvestigationQ4 · AGRICULTURAL & FORESTRY SCIENCE

Evaluation of a New Antibody-Based Enzyme-Linked Immunosorbent Assay for the Detection of Bovine Leukemia Virus Infection in Dairy Cattle

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Buist, Willem ; de Jong, Mart C. M. ; Tarabla, Héctor D. ; Frankena, Klaas ; Engel, Bas ; Monti, Gustavo E.

The objective of this study was to validate a new blocking enzyme-linked immunosorbent assay (ELISA) (designated M108 for milk and S108 for serum samples) for detecting bovine leukemia virus (BLV) infection in dairy cattle. Milk, serum, and ethylenediaminetetraacetic acid–blood samples were collected from 524 adult Holstein cows originating from 6 dairy herds in Central Argentina. The M108 and S108 were compared with agar gel immunodiffusion (AGID), polymerase chain reaction and a commercial ELISA. Because there is currently no reference test capable of serving as a gold standard, the test sensitivity (SE) and specificity (SP) were evaluated by the use of a latent class model. Statistical inference was performed by classical maximum likelihood and by Bayesian techniques. The maximum-likelihood analysis was performed assuming conditional independence of tests, whereas the Bayesian approach allowed for conditional dependence. No clear conclusion could be drawn about conditional dependence of tests. Results with maximum likelihood (under conditional independence) and posterior Bayes (under conditional dependence) were practically the same. Conservative estimates of SE and SP (with 95% confidence intervals) for M108 were 98.6 (96.7; 99.6) and 96.7 (92.9; 98.8) and for S108 99.5 (98.2; 99.9) and 95.4 (90.9; 98.1), respectively. The ELISA 108 using either milk or serum to detect BLV-infected animals had comparable SE and SP with the official AGID and a commercial ELISA test, which are currently the most widely accepted tests for the serological diagnosis of BLV infection. Therefore, ELISA 108 can be used as an alternative test in monitoring and control programs.

01 Dec 1996·Biochemical and Biophysical Research CommunicationsQ3 · BIOLOGY

Analysis of Nuclear Localization of Laminin Binding Protein Precursor p40 (LBP/p40)

Q3 · BIOLOGY

Article

Author: Manabu Sato ; Yoshinao Kaneda ; Yasufumi Kaneda ; Yoshinaga Saeki ; Akihiro Iwamatsu ; Katsunari Kinoshita ; Kiyoji Tanaka

We isolated a monoclonal antibody M108, which recognized 40 kDa protein (p40) in the cytoplasm, the perinuclear region in interphase and the perichromosomal region during mitosis. As reported previously, it was revealed from the immunofluorescent observation and the biochemical analyses that the nuclear p40 was associated both with the nuclear envelope and the chromatin DNA in interphase nuclei. In this report, we isolated the p40 from cytoplasmic particles, and identified it by extensive microsequencing as LBP/p40, which was considered to be a precursor of laminin binding protein p67 (LBP/p67). Epitope-tagged LBP/p40 was expressed in cultured cells, and the protein was localized in the nucleus as well as in the cytoplasm. Further analysis showed that the nuclear LBP/p40 was tightly associated with the nuclear structures.

01 Nov 1993·Journal of Cell ScienceQ2 · BIOLOGY

The analysis of 40 kDa nuclear protein, p40, in interphase cells and mitotic cells

Q2 · BIOLOGY

Article

Author: Kaneda, Yasufumi ; Kinoshita, Katsunari ; Kaneda, Yoshinao ; Sato, Manabu ; Tanaka, Kiyoji

ABSTRACTWe previously reported that the monoclonal antibody M108 recognized a 40 kDa protein both in the nucleus and the cytoplasm. This nuclear 40 kDa antigen was located in the nuclear envelope in interphase cells and in the perichromosomal region during mitosis. Now, we have analyzed this nuclear 40 kDa protein (p40) further, through morphological and biochemical approaches. At the beginning of mitosis, the perinuclear p40 detached from the nuclear envelope and moved to surround the condensing chromatin, while in the late stage of mitosis, the perichromosomal p40 moved back to the reassembled nuclear envelope. Most of the perichromo-somal p40 on the metaphase chromosome was solubilized only by DNase I treatment, not by either high salt or detergent treatment. On the other hand, the perinuclear p40 was not solubilized by DNase1 alone, or high salt detergent alone. Sequential treatments with DNase I and high salt detergent were required to extract p40 in interphase nuclei. These results suggest that p40 was associated both with the nuclear envelope and chro-matin DNA in interphase nuclei, while it bound only to chromatin DNA in mitosis.

100 Deals associated with M108

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	Phase 3	China	FutureGen Biopharmaceutical (Beijing) Co., Ltd	04 Dec 2023
CLDN18.2 positive stomach adenocarcinoma	Phase 3	China	FutureGen Biopharmaceutical (Beijing) Co., Ltd	04 Dec 2023
Gastrointestinal Neoplasms	Phase 2	-	FutureGen Biopharmaceutical (Beijing) Co., Ltd	-
Pancreatic Cancer	Phase 2	-	FutureGen Biopharmaceutical (Beijing) Co., Ltd	-
Advanced Malignant Solid Neoplasm	Phase 1	China	FutureGen Biopharmaceutical (Beijing) Co., Ltd	01 Jul 2021
Bile Duct Neoplasms	Phase 1	-	FutureGen Biopharmaceutical (Beijing) Co., Ltd	-
Pancreatic carcinoma non-resectable	IND Approval	China	FutureGen Biopharmaceutical (Beijing) Co., Ltd	19 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04894825 (ASCO_GI2025) Manual	Phase 1/2	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line \|	63	FG-M108 300 mg/m^2	(bsokweaphi) = the RP2D was determined to be FG-M108 at 300mg/m^2 plus CAPOX. aetchfbkdt (yhdebkyvzv )	Positive	23 Jan 2025
				FG-M108 600 mg/m^2
NCT04894825 (ASCO_GI2025) Manual	Phase 1/2	Pancreatic carcinoma non-resectable First line	50	FG-M108FG-M108 300mg/m^2 +gemcitabine+nab-paclitaxel	(slvflbmswl) = ampsihleqx dwcfwanzpm (bddnxtmzyv ) View more	Positive	23 Jan 2025
				FG-M108FG-M108 600mg/m^2 +gemcitabine+nab-paclitaxel	(slvflbmswl) = gmybzsynqz dwcfwanzpm (bddnxtmzyv ) View more
CTR20210508 (ESMO2024) Manual	Phase 1	CLDN18.2 positive Pancreatic Cancer First line	35	FG-M108 plus gemcitabine and nab-paclitaxel	(wnnbxpdqdz) = The most common were nausea (54.3%), emesis (51.4%) and hypoalbuminemia (42.9%). bvnmvbhigj (gcjxsgwuvb )	Positive	16 Sep 2024
NCT04894825 (ESMO2024) Manual	Phase 1/2	Gastroesophageal junction adenocarcinoma First line \|	52	FG-M108 plus CAPOX	(zzmvuhgcio) = idtwhcrags opdwfrnvwv (yxcceudlpe ) View more	Positive	16 Sep 2024
				FG-M108	(wnmnkdgslk) = ftecvrzciu znktrijfel (tharoubjji, 3.9 - 5.6)
NCT06177041 (ASCO2024) Manual	Phase 1/2	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line \|	52	FG-M108 plus CAPOX	(vrktlmbrhi) = lutctnrnss pjqibdgelo (pknrmdkjsp ) View more	Positive	24 May 2024
				FG-M108 plus CAPOX (low CLDN18.2 expressions (IHC 1+/2+/3+ ≥10% & 2+/3+ <40%))	(vrktlmbrhi) = bmduqliatb pjqibdgelo (pknrmdkjsp ) View more
NCT04894825 (FG-M108, ASCO2024)	Phase 1	CLDN18.2 positive Pancreatic Cancer First line CLDN18.2+	31	FG-M108 plus gemcitabine and nab-paclitaxel	(umeynqqhgn) = dwocsnwooy thujwldrll (cohsrftjjh )	Positive	24 May 2024

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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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