Delving into the Latest Updates on iNeo-Vac-P01 with Synapse

Overview

Basic Info

Drug Type

Personalized antigen vaccine, Synthetic peptide vaccine, Therapeutic vaccine

Synonyms

Neoantigen peptides vaccine, iNeo Vac P01, 肿瘤新生抗原多肽治疗性疫苗

+ [3]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Bile Duct NeoplasmsEsophageal CarcinomaHepatocellular Carcinoma+ [5]

Inactive Indication

Advanced Malignant Solid NeoplasmLocally Advanced Malignant Neoplasm

Originator Organization

Hangzhou New Anjin Biotechnology Co., Ltd

Active Organization

Hangzhou New Anjin Biotechnology Co., Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价注射用P01在实体瘤根治手术后高危复发风险患者术后辅助治疗中的安全性和耐受性。次要目的：评价注射用P01在实体瘤根治手术后高危复发风险患者辅助治疗中的免疫原性和初步有效性。探索性目的：探索注射用P01在实体瘤根治手术后高危复发风险患者体内的药效动力学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of P01 for injection in the postoperative adjuvant treatment of patients at high risk of recurrence after radical surgery for solid tumors. Secondary objective: To evaluate the immunogenicity and preliminary efficacy of P01 for injection in the adjuvant treatment of patients at high risk of recurrence after radical surgery for solid tumors. Exploratory objective: To explore the pharmacodynamic characteristics of P01 for injection in patients at high risk of recurrence after radical surgery for solid tumors.

Start Date23 Jan 2024

Sponsor / Collaborator

Hangzhou New Anjin Biotechnology Co., Ltd

ChiCTR2300067818

/ RecruitingNot ApplicableIIT

A single-center, single-arm, open clinical trial of personalized neoantigen peptides vaccine sequential combined with TACE/HAIC, targeted therapy and immunotherapy in the treatment of advanced primary liver cancer

Start Date28 Jan 2023

Sponsor / Collaborator-

NCT04810910

/ RecruitingPhase 1IIT

Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Start Date30 Mar 2021

Sponsor / Collaborator

Zhejiang Provincial Peoples Hospital

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100 Clinical Results associated with iNeo-Vac-P01

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100 Translational Medicine associated with iNeo-Vac-P01

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100 Patents (Medical) associated with iNeo-Vac-P01

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6

Literatures (Medical) associated with iNeo-Vac-P01

01 Jan 2023·Frontiers in pharmacology

Insights into the mechanisms governing P01 scorpion toxin effect against U87 glioblastoma cells oncogenesis.

Article

Author: Souid, Soumaya ; Srairi-Abid, Najet ; Belghazi, Maya ; Marrakchi, Naziha ; Chantome, Aurelie ; Vandier, Christophe ; Essafi-Benkhadir, Khadija ; Jebali, Jed ; Mejdoub, Hafedh ; Aissaoui-Zid, Dorra ; Ayedi, Emna ; Mlayah-Bellalouna, Saoussen

The emerging concept of small conductance Ca²⁺-activated potassium channels (SK_Ca) as pharmacological target for cancer treatment has significantly increased in recent years. In this study, we isolated the P01 toxin from Androctonus australis (Aa) scorpion venom and investigated its effect on biological properties of glioblastoma U87, breast MDA-MB231 and colon adenocarcinoma LS174 cancer cell lines. Our results showed that P01 was active only on U87 glioblastoma cells. It inhibited their proliferation, adhesion and migration with IC₅₀ values in the micromolar range. We have also shown that P01 reduced the amplitude of the currents recorded in HEK293 cells expressing SK2 channels with an IC₅₀ value of 3 pM, while it had no effect on those expressing SK3 channels. The investigation of the SK_Ca channels expression pattern showed that SK2 transcripts were expressed differently in the three cancer cell lines. Particularly, we highlighted the presence of SK2 isoforms in U87 cells, which could explain and rely on the specific activity of P01 on this cell line. These experimental data highlighted the usefulness of scorpion peptides to decipher the role of SK_Ca channels in the tumorigenesis process, and develop potential therapeutic molecules targeting glioblastoma with high selectivity.

01 Sep 2020·Clinical Cancer ResearchQ1 · MEDICINE

A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors

Q1 · MEDICINE

Article

Author: Fang, Yong ; Chen, Rongchang ; Shou, Jiawei ; Han, Ning ; Li, Hongsen ; Chen, Shuqing ; Wang, Huina ; Chen, Lin ; Zhang, Shanshan ; Wang, Huimin ; Pan, Hongming ; Ye, Shengli ; Liu, Liang ; Mo, Fan ; Luo, Kai ; Zhou, Zhan

AbstractPurpose:Because of their high tumor specificity and immunogenicity, neoantigens have been considered as ultimate targets for cancer immunotherapy. Neoantigen-based vaccines have demonstrated promising efficacy for several cancer types. To further investigate the antitumor potentials for other types of solid tumors, we designed a peptide-based neoantigen vaccine, iNeo-Vac-P01, and conducted a single-arm, open-labeled, investigator-initiated clinical trial (NCT03662815).Patients and Methods:Personalized neoantigen vaccines were designed and manufactured according to our bioinformatics analysis results from the whole-exome sequencing of tumor and peripheral blood cell DNAs. Patients were scheduled to be vaccinated subcutaneously with adjuvant on days 1, 4, 8, 15, and 22 (prime phase), and days 78 and 162 (boost phase). Additional immunizations were administrated every 2–3 months as per patient's potential benefit. The safety and efficacy were assessed through adverse events (AE), progression-free survival (PFS), overall survival (OS), and other parameters.Results:Of the 22 patients enrolled with advanced malignancies, 20 had no or mild AEs, while 2 had grade 3 or 4 acute allergic reactions only after their sixth boost vaccination. The disease control rate was 71.4%. The median PFS was 4.6 months, whereas the median OS was not reached (12-month OS = 55.1%). Around 80% of individual peptides or peptide pools elicited measurable specific immune response. In addition, our findings revealed several potential biomarkers for the prediction of better response.Conclusions:iNeo-Vac-P01 as monotherapy is feasible and safe for patients with advanced solid tumors. It could elicit T-cell–mediated immune response targeting tumor neoantigens, and might have promising antitumor efficacy.See related commentary by Filderman and Storkus, p. 4429

01 Mar 2010·Bioorganic & Medicinal ChemistryQ3 · MEDICINE

Novel thiophene derivatives as PTP1B inhibitors with selectivity and cellular activity

Q3 · MEDICINE

Article

Author: Xiaomin Luo ; Deju Ye ; Xu Zhang ; Xu Shen ; Hualiang Jiang ; Hong Liu ; Fei Wang ; Yu Zhang ; Mingfang Zheng

A series of novel thiophene derivatives was designed, synthesized and their activities as competitive inhibitors of protein tyrosine phosphatase (PTPs) 1B (PTP1B) inhibitors were evaluated. All the compounds showed inhibitory potencies, and 10 of these exhibited moderate inhibitory activities with IC(50) values less than 10 microM. The activity of the most potent compound P28 (IC(50)=2.1 microM) was 15 times higher than that of the hit compound P01. Further, four representative compounds (P19, P22, P28, and P31) demonstrated remarkably high selectivities against other PTPs (e.g., PTPalpha, LAR, CD45, and TCPTP); P19 exhibited greater than sixfold selectivity over highly homologous TCPTP. More importantly, these compounds are permeable to cell membranes. The treatment of CHO-K1 cells with P28 (10 microM) resulted in increased phosphorylation of AKT, which suggested extensive cellular activity of this compound. The novel chemical entities reported in this study could be used for overcoming the poor selectivity and low cellular activity of PTP1B inhibitors and might represent a starting point for development of therapeutic PTP inhibitors.

100 Deals associated with iNeo-Vac-P01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bile Duct Neoplasms	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Esophageal Carcinoma	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Hepatocellular Carcinoma	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Intestinal Neoplasms	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Melanoma	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Stomach Cancer	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	23 Jan 2024
Pancreatic Cancer	Phase 1	China	Hangzhou New Anjin Biotechnology Co., Ltd	24 Oct 2017
Colorectal Cancer	IND Approval	China	Hangzhou New Anjin Biotechnology Co., Ltd	07 Apr 2023
Advanced Malignant Solid Neoplasm	Preclinical	China	Hangzhou New Anjin Biotechnology Co., Ltd	07 Feb 2018
Locally Advanced Malignant Neoplasm	Preclinical	China	Hangzhou New Anjin Biotechnology Co., Ltd	07 Feb 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03662815 (ASCO2022) Manual	Phase 1	Neoplasms	28	GM-CSF+iNeo-Vac-P01 (had received RFA treatment within 6 months before scheduled for vaccination)	(qhmftydynm) = jiabxteavz lodxcxqaaa (jzbqnxvdtq ) View more	Positive	02 Jun 2022
NCT03662815 (ASCO2022) Manual	Phase 1	Neoplasms	28	GM-CSF+iNeo-Vac-P01 (had not received RFA treatment within 6 months before scheduled for vaccination)	(qhmftydynm) = kecrkpopbx lodxcxqaaa (jzbqnxvdtq ) View more	Positive	02 Jun 2022
NCT03645148 (Pubmed \| Front Immunol) Manual	Phase 1	Pancreatic Cancer	7	iNeo Vac P01	(duumseaqkg) = oqhqfhseaf botanhaddi (qtrzwmkfom ) View more	Positive	13 Aug 2021
NCT03662815 (Pubmed \| Clin Cancer Res) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	22	iNeo Vac P01	(pzxqijgvzx) = acizhiuhez ngeeodrdfj (jtzpzrpyps ) View more	Positive	01 Sep 2020