Delving into the Latest Updates on PM-8001 with Synapse

Overview

Basic Info

Drug Type

Antibody fusion proteins

Synonyms

Target

PDL1 x TGF-β

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors), TGF-β inhibitors(Transforming growth factor beta inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesInfectious Diseases

Active Indication

Advanced Malignant Solid NeoplasmLung CancerHuman Papillomavirus Infection+ [1]

Inactive Indication-

Originator Organization

Biotheus, Inc.Startup

Active Organization

Biotheus, Inc.Startup

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 695499894

Sequence Code 20818993CDR1-H

Sequence Code 1038074879CDR2-H

Sequence Code 13222313

Sequence Code 187943linker

Sequence Code 1038074878

Sequence Code 1038074877

Sequence Code 695499843CDR3-H

The purpose of this research is to assess the safety, tolerability and effectiveness of PM1021 Monotherapy and PM1021 in Combination with PM8001 in Patients with Advanced Solid Tumours. In this study, up to 30 patients will be enrolled in Australia only.
Advanced solid cancers are associated with poor prognosis and pose a significant challenge for treatment strategies. Effective treatments for advanced metastatic malignancies that have failed available standard of care treatment represent a major unmet medical need.
Biotheus Inc. is developing PM1021, a monoclonal anti-T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibody (IgG1) and PM8001 (a PD-L1/TGF-beta bispecific Fc fusion protein) as treatment for advanced solid tumours.

Start Date30 Oct 2023

Sponsor / Collaborator

Biotheus, Inc.Startup

CTR20212814

/ RecruitingPhase 1

评价PM8001注射液联合化疗或靶向药物在肺癌中的安全性、耐受性、药代动力学及初步疗效的I期临床试验

[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of PM8001 injection combined with chemotherapy or targeted drugs in lung cancer

Ia期：评估PM8001联合化疗或靶向药物治疗方案的安全性和耐受性。 Ib期：评估各队列联合治疗方案的无进展生存期（PFS）。

[Translation]

Phase Ia: Evaluate the safety and tolerability of PM8001 combined with chemotherapy or targeted drug therapy. Phase Ib: Evaluate the progression-free survival (PFS) of the combined therapy in each cohort.

Start Date29 Dec 2021

Sponsor / Collaborator

Biotheus, Inc.Startup

ChiCTR2100052617

/ RecruitingPhase 1IIT

A phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM8001 plus chemotherapy/targeted drugs in patients with lung cancer

Start Date01 Dec 2021

Sponsor / Collaborator

Shanghai Chest Hospital

100 Clinical Results associated with PM-8001

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100 Translational Medicine associated with PM-8001

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100 Patents (Medical) associated with PM-8001

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1

Literatures (Medical) associated with PM-8001

01 Jan 2023·Frontiers in oncology

Case Report: Keratoacanthoma and type I diabetes secondary to treatment with PM8001, a bifunctional fusion protein targeting TGF-β and PD-L1.

Author: Xu, Hailing ; Qi, Rongbin ; Li, Yujing ; Lv, Dongqing ; Fu, Xinyu ; Yu, Yingying ; He, Susu

Immune-related adverse reactions primarily involve the skin and the endocrine, digestive, and respiratory systems. In the endocrine system, these adverse effects mainly include hypophysitis, thyroiditis, hypoadrenalism, and rarely, diabetes mellitus. The most common symptoms in the skin are pruritus, rash, and infrequently, eruptive keratoacanthoma. Here, we report a case of a 67-year-old woman who developed eruptive keratoacanthoma of the skin 6 weeks after beginning treatment with a bispecific antibody (PM8001), targeting both programmed cell death receptor 1 and transforming growth factor β, as well as type I diabetes mellitus-induced ketoacidosis after 13 weeks. The type I diabetes appeared to stabilize after insulin treatment, and the keratoacanthoma gradually resolved after drug discontinuation. This case report describes a case of the effects of PM8001 immunotherapy on the endocrine glands and skin, together with a review of the relevant literature, and summarizes the different clinical characteristics of rare immune-related adverse events resulting from PM8001 immunotherapy to provide a reference for their early detection, diagnosis, and treatment.

100 Deals associated with PM-8001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Biotheus, Inc.Startup	28 Jun 2020
Lung Cancer	Phase 1	China	Biotheus, Inc.Startup	29 Dec 2021
Human Papillomavirus Infection	IND Approval	China	Biotheus, Inc.Startup	08 Jul 2022
Non-Small Cell Lung Cancer	IND Approval	China	Biotheus, Inc.Startup	05 Mar 2022
Solid tumor	Preclinical	China	Biotheus, Inc.Startup	24 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2000033828 (ASCO2022)	Phase 1	Neoplasms	108	PM8001	(xnpfedxmhv) = ozplttconq wluqbnwkbd (ikuylbmvhf, 4.3% - 20.4%) View more	-	02 Jun 2022

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Clinical Trial

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Approval

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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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