Delving into the Latest Updates on Personalized Cancer Vaccine(Stemirna Therapeutics) with Synapse

Overview

Basic Info

Drug Type

Personalized antigen vaccine, Therapeutic vaccine, mRNA vaccine

Synonyms

Personalized Cancer Vaccine (PCV), Personalized mRNA tumour vaccine(Stemirna Therapeutics Co. Ltd.), mRNA-based personalized Cancer Vaccine

+ [6]

Target-

Action

stimulants

Mechanism

Gene transference, Immunostimulants

Therapeutic Areas

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

Adenocarcinoma of large intestineAdvanced Esophageal Squamous Cell CarcinomaAdvanced Lung Non-Small Cell Carcinoma+ [5]

Originator Organization

Stemirna Therapeutics Co., Ltd.Startup

Active Organization-

Inactive Organization

Stemirna Therapeutics Co., Ltd.Startup

Drug Highest PhaseSuspendedPhase 1

First Approval Date-

Regulation-

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This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.

Start Date20 Jul 2023

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.Startup

NCT05198752

/ Unknown statusPhase 1

A Phase 1 Clinical Study to Evaluate the Tolerability, Safety,Immunogenicity and Efficacy of the Neoantigen mRNA Personalised Cancer Vaccine SW1115C3 in Patients With Advanced Malignant Solid Tumours

This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.

Start Date18 Mar 2022

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.Startup

NCT03908671

/ RecruitingNot Applicable

Clinical Trial on the Safety and Efficacy of Neoantigen Antigen mRNA Tumor Vaccine in the Treatment of Advanced Esophageal Cancer and Non-small Cell Lung Cancer

A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung cancer

Start Date18 Oct 2019

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.Startup

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100 Clinical Results associated with Personalized Cancer Vaccine(Stemirna Therapeutics)

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100 Translational Medicine associated with Personalized Cancer Vaccine(Stemirna Therapeutics)

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100 Patents (Medical) associated with Personalized Cancer Vaccine(Stemirna Therapeutics)

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1

Literatures (Medical) associated with Personalized Cancer Vaccine(Stemirna Therapeutics)

American Journal of Cancer Research

Personalized mRNA vaccine combined with PD-1 inhibitor therapy in a patient with advanced esophageal squamous cell carcinoma

Article

Author: Wang, Yiran ; Wang, Wei ; Zhan, Xianbao ; Peng, Xiaobo ; Wu, Meihong ; Tang, Shuhui ; Zhang, Linli ; Zhang, Yingyi ; Wang, Bin ; Li, Jie ; Chen, Longpei ; Feng, Dan

Therapeutic cancer vaccines are valuable tools for educating the immune system to fight tumors precisely. Cancer cells are characterized with genetic instability and abundant somatic mutations, leading to the production of tumor specific antigens (TSA) called neoantigens. The main goal of neoantigen-based cancer vaccines is to activate the immune system and elicit effective tumor-specific T-cell responses. There have been no reports of advanced esophageal squamous cell carcinoma (ESCC) cases achieving partial remission after personalized mRNA (messenger RNA) vaccine treatment. As personalized neoantigen-based immunotherapies are emerging, here we report a 67-year-old male patient diagnosed with ESCC and multiple enlarged mediastinal lymph nodes, where mRNA vaccines were used for the first time. Tissue samples from the recurrence focus in the esophagus were subjected to whole transcriptome sequencing. The neoantigens were identified by bioinformatics analyses. The top 20 neoantigens were selected to compose the polyneoantigen vaccine, which were administered at 1 mg every 3 weeks for 4 cycles in combination with a PD-1 (programmed death-1) inhibitor. The patient was boosted with a single dose of the PD-1 inhibitor 8 weeks after the 4th cycle. In addition, immune responses were evaluated before and after the 4 cycles of vaccine therapy, and the lesions were evaluated by imaging examination. Our results revealed that neoantigen-based vaccines significantly activated the tumour-specific immune response. TCR (T cell receptor) V-J pairing analysis showed an increase in the abundance of oligoclonal TCRs, indicating improved homogeneity. No grade 3 or higher drug-related adverse events were observed, except for grade 4 thrombocytopenia caused by PD-1 inhibitor treatment. The patient achieved a partial response (PR), with a progression-free survival (PFS) time of 457 days, the OS (overall survival) time of 457 days, and DOR (duration of response) of 377 days. Our report suggests that combining the personalized mRNA vaccine therapy with PD-1 blockade therapy may be an effective treatment strategy for patient with advanced esophageal cancer. However, further clinical trials are necessary to confirm the efficacy and safety of personalized neoantigen-based immunotherapies in the treatment of advanced ESCC. This trial is registered with ClinicalTrials.gov, NCT03468244 on March 16, 2018, and is now complete.

100 Deals associated with Personalized Cancer Vaccine(Stemirna Therapeutics)

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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 1	Australia	Stemirna Therapeutics Co., Ltd.Startup	18 Mar 2022
Advanced Malignant Solid Neoplasm	Phase 1	Austria	Stemirna Therapeutics Co., Ltd.Startup	18 Mar 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	24 Oct 2021
Esophageal Carcinoma	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	18 Oct 2019
Non-Small Cell Lung Cancer	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	18 Oct 2019
Adenocarcinoma of large intestine	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	01 May 2018
Advanced Esophageal Squamous Cell Carcinoma	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	01 May 2018
Pancreatic adenocarcinoma	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	01 May 2018
stomach adenocarcinoma	Phase 1	China	Stemirna Therapeutics Co., Ltd.Startup	01 May 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03468244 (Pubmed \| Am J Cancer Res) Manual	Not Applicable	Advanced Esophageal Squamous Cell Carcinoma	1	Personalized mRNA vaccine	(nrultfqcbh) = No grade 3 or higher drug-related adverse events were observed, except for grade 4 thrombocytopenia caused by PD-1 inhibitor treatment. onswnenspu (palxsnumzg )	Positive	01 Jan 2024