Delving into the Latest Updates on GEN-1044 with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms

Target

5T4 x CD3

Action

modulators, stimulants

Mechanism

5T4 modulators(Trophoblast glycoprotein modulators), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)

Therapeutic Areas

Neoplasms

Active Indication

Neoplasms

Inactive Indication

Bladder CancerEsophageal CarcinomaMetastatic Solid Tumor+ [5]

Originator Organization

Genmab A/S

Active Organization

Genmab A/S

Inactive Organization

Genmab, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Author: Janmaat, Maarten L ; Rademaker, Rik ; Satijn, David ; Burm, Saskia M ; Gielen, Ellis ; Verzijl, Dennis ; Kemper, Kristel ; van den Brink, Edward N ; Sasser, A Kate ; Koopman, Louise A ; de Poot, Stefanie AH ; Plantinga, Theo S ; Houtkamp, Mischa ; Boross, Peter ; Engelberts, Patrick J ; Breij, Esther CW

CD3 bispecific antibodies (bsAbs) show great promise as anticancer therapeutics. Here, we show in-depth mechanistic studies of a CD3 bsAb in solid cancer, using DuoBody-CD3x5T4. Cross-linking T cells with tumor cells expressing the oncofetal antigen 5T4 was required to induce cytotoxicity. Naive and memory CD4+and CD8+T cells were equally effective at mediating cytotoxicity, and DuoBody-CD3x5T4 induced partial differentiation of naive T-cell subsets into memory-like cells. Tumor cell kill was associated with T-cell activation, proliferation, and production of cytokines, granzyme B, and perforin. Genetic knockout ofFASorIFNGR1in 5T4+tumor cells abrogated tumor cell kill. In the presence of 5T4+tumor cells, bystander kill of 5T4−but not of 5T4−IFNGR1−tumor cells was observed. In humanized xenograft models, DuoBody-CD3x5T4 antitumor activity was associated with intratumoral and peripheral blood T-cell activation. Lastly, in dissociated patient-derived tumor samples, DuoBody-CD3x5T4 activated tumor-infiltrating lymphocytes and induced tumor-cell cytotoxicity, even when most tumor-infiltrating lymphocytes expressed PD-1. These data provide an in-depth view on the mechanism of action of a CD3 bsAb in preclinical models of solid cancer.

100 Deals associated with GEN-1044

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	-	Genmab A/S	-
Bladder Cancer	Preclinical	Denmark	Genmab A/S	15 Jul 2020
Bladder Cancer	Preclinical	United States	Genmab A/S	15 Jul 2020
Bladder Cancer	Preclinical	Spain	Genmab A/S	15 Jul 2020
Bladder Cancer	Preclinical	Israel	Genmab A/S	15 Jul 2020
Non-Small Cell Lung Cancer	Preclinical	Spain	Genmab A/S	15 Jul 2020
Non-Small Cell Lung Cancer	Preclinical	United States	Genmab A/S	15 Jul 2020
Non-Small Cell Lung Cancer	Preclinical	Israel	Genmab A/S	15 Jul 2020
Non-Small Cell Lung Cancer	Preclinical	Denmark	Genmab A/S	15 Jul 2020
Squamous Cell Carcinoma of Head and Neck	Preclinical	Spain	Genmab, Inc.	15 Jul 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04424641 (first-in-human clinical trial, CTgov)	Phase 1/2	Metastatic Solid Tumor \| Esophageal Carcinoma \| Squamous Cell Carcinoma of Head and Neck \| Triple Negative Breast Cancer \| Non-Small Cell Lung Cancer \| Bladder Cancer \| Prostatic Cancer \| Uterine Neoplasms	48	GEN1044 (GEN1044 Doses 0.3/3/3 mg)	pvkpntudol(pbnmjzywxz) = eatmknkjyr gwbqucnfia (fuwgxuxlfm, kvxwknhngz - nwjyybhlwn) View more	-	01 Feb 2023
				GEN1044 (GEN1044 Doses 1/3/10 mg)	pvkpntudol(pbnmjzywxz) = icohxnhqrw gwbqucnfia (fuwgxuxlfm, qkynhpgrsq - sevmjahkyb) View more

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Approval

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Biosimilar

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