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Recent popular reports by Yimike ★ The article elaborates: CAR-T production whole-process solution combing ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? MedClub News June 2, 2021 / eMedClub News/--May 27, 2021, enGene announced that its LEGEND study has completed its first patient administration.
enGene is a clinical-stage biotechnology company that develops non-viral gene therapies for local administration to mucosal tissues through its proprietary DDX platform.
The LEGEND study is the first human phase 1/2 clinical trial of EG-70 in non-muscular invasive bladder cancer (NMIBC) patients who do not respond to BCG (BCG).
EG-70 is a non-viral gene therapy based on enGene's proprietary DDX platform.
It encodes two RIG-I agonists to stimulate the innate immune system, and it also encodes IL-12 to stimulate the adaptive immune system.
After EG-70 is administered in the bladder, through this two-pronged approach to stimulate the immune system, it has produced significant tumor regression in preclinical models of bladder cancer, and can induce effective immune memory and the lowest toxicity indicators.
On November 2, 2020, the FDA approved the IND application for EG-70.
On December 3, 2020, according to enGene’s announcement, EG-70, as its company’s first clinical stage candidate product, was granted Fast Track status by the FDA, which means it is eligible for accelerated approval and rolling review, and can be more closely related to the FDA.
communication.Recommended reading: The new non-viral gene therapy has been granted fast track qualification by the FDA, and a phase 1/2 clinical trial for the treatment of bladder cancer will be launched.
Jason Hanson, CEO of enGene, said: “Starting the first time for EG-70 Clinical research is an important milestone for enGene, which verifies that our platform has the potential to develop new therapies with clinically significant results.
This is the first time that non-viral gene therapy that can directly activate innate immunity and acquired immunity has been used as Human anti-tumor agents are evaluated, and we all look forward to the results of this trial that will positively affect the lives of patients struggling with refractory cancers.
"The LEGEND study is an open-label, single-agent, multi-center, dose-escalation study The trial aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of intravesical administration of EG-70 in NMIBC patients who do not respond to BCG and recommend radical cystectomy.
The expected start time of the study is March 2021, and the preliminary end time is expected to be June 2024, subject to the last data collection in the main outcome measurement.
The entire study is expected to end in February 2026.
The study consists of two parts: Phase 1 is the dose escalation phase to determine its safety and the recommended dose (RP2D) for Phase 2; Phase 2 is the effectiveness study phase under RP2D to determine its efficacy.
In the first phase, the patient will receive a cycle of EG-70 to infuse a 50-ml volume of study drug into the bladder through a catheter, with a target retention time of 60 minutes.
A cycle is defined as two intravesical administrations one week apart, followed by another 10 weeks of administration (1 cycle lasts approximately 12 weeks).
By the second stage, patients will receive up to 4 cycles of EG-70, and the rest of the treatment dose and method will remain unchanged.
Outcome measurement in Phase 1 will include the nature, incidence, relevance and severity of all adverse events (AE) and serious adverse events (SAE) within 2 years; Outcome measurement in Phase 2 will include the nature of treatment emergency adverse events within 3 years In addition to the incidence, relevance and severity, the percentage of CR patients with cystoscopy at 48 weeks will also be included.
The complete remission rate will be measured by determining the number of patients with no recurrence of high-grade disease.
Dr.
Gary Steinberg, Professor and Director of the Goldstein Urology Bladder Cancer Center of the Perlmutter Cancer Center of New York University Langone Health Project, and the lead principal investigator of the EG-70 1/2 study, said: "BCG non-responding high-risk NMIBC patients except for radical cystectomy There are no treatment options outside of surgery, and this treatment has significant morbidity and changes in quality of life.
Based on our understanding of high-grade bladder cancer, BCG resistance/recurrence mechanism and EG-70 mechanism of action , I firmly believe that this new type of intravesical treatment has potential, almost no side effects, and can bring meaningful changes to patients.
"Reference: 1.
https:// first-in-human-dosing-of-eg-70-for-the-treatment-of-non-muscle-invasive-bladder-cancer-in-phase-1-2-clinical-trial Original news reports on cutting-edge technologies, industry trends, and industry insights of innovative drugs, with over 160,000 users of all-media high-end matrix users, of which over 50% are industrial users, approximately 30% are scientific research and clinical users, and over 5% are users of investment institutions .
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
enGene is a clinical-stage biotechnology company that develops non-viral gene therapies for local administration to mucosal tissues through its proprietary DDX platform.
The LEGEND study is the first human phase 1/2 clinical trial of EG-70 in non-muscular invasive bladder cancer (NMIBC) patients who do not respond to BCG (BCG).
EG-70 is a non-viral gene therapy based on enGene's proprietary DDX platform.
It encodes two RIG-I agonists to stimulate the innate immune system, and it also encodes IL-12 to stimulate the adaptive immune system.
After EG-70 is administered in the bladder, through this two-pronged approach to stimulate the immune system, it has produced significant tumor regression in preclinical models of bladder cancer, and can induce effective immune memory and the lowest toxicity indicators.
On November 2, 2020, the FDA approved the IND application for EG-70.
On December 3, 2020, according to enGene’s announcement, EG-70, as its company’s first clinical stage candidate product, was granted Fast Track status by the FDA, which means it is eligible for accelerated approval and rolling review, and can be more closely related to the FDA.
communication.Recommended reading: The new non-viral gene therapy has been granted fast track qualification by the FDA, and a phase 1/2 clinical trial for the treatment of bladder cancer will be launched.
Jason Hanson, CEO of enGene, said: “Starting the first time for EG-70 Clinical research is an important milestone for enGene, which verifies that our platform has the potential to develop new therapies with clinically significant results.
This is the first time that non-viral gene therapy that can directly activate innate immunity and acquired immunity has been used as Human anti-tumor agents are evaluated, and we all look forward to the results of this trial that will positively affect the lives of patients struggling with refractory cancers.
"The LEGEND study is an open-label, single-agent, multi-center, dose-escalation study The trial aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of intravesical administration of EG-70 in NMIBC patients who do not respond to BCG and recommend radical cystectomy.
The expected start time of the study is March 2021, and the preliminary end time is expected to be June 2024, subject to the last data collection in the main outcome measurement.
The entire study is expected to end in February 2026.
The study consists of two parts: Phase 1 is the dose escalation phase to determine its safety and the recommended dose (RP2D) for Phase 2; Phase 2 is the effectiveness study phase under RP2D to determine its efficacy.
In the first phase, the patient will receive a cycle of EG-70 to infuse a 50-ml volume of study drug into the bladder through a catheter, with a target retention time of 60 minutes.
A cycle is defined as two intravesical administrations one week apart, followed by another 10 weeks of administration (1 cycle lasts approximately 12 weeks).
By the second stage, patients will receive up to 4 cycles of EG-70, and the rest of the treatment dose and method will remain unchanged.
Outcome measurement in Phase 1 will include the nature, incidence, relevance and severity of all adverse events (AE) and serious adverse events (SAE) within 2 years; Outcome measurement in Phase 2 will include the nature of treatment emergency adverse events within 3 years In addition to the incidence, relevance and severity, the percentage of CR patients with cystoscopy at 48 weeks will also be included.
The complete remission rate will be measured by determining the number of patients with no recurrence of high-grade disease.
Dr.
Gary Steinberg, Professor and Director of the Goldstein Urology Bladder Cancer Center of the Perlmutter Cancer Center of New York University Langone Health Project, and the lead principal investigator of the EG-70 1/2 study, said: "BCG non-responding high-risk NMIBC patients except for radical cystectomy There are no treatment options outside of surgery, and this treatment has significant morbidity and changes in quality of life.
Based on our understanding of high-grade bladder cancer, BCG resistance/recurrence mechanism and EG-70 mechanism of action , I firmly believe that this new type of intravesical treatment has potential, almost no side effects, and can bring meaningful changes to patients.
"Reference: 1.
https:// first-in-human-dosing-of-eg-70-for-the-treatment-of-non-muscle-invasive-bladder-cancer-in-phase-1-2-clinical-trial Original news reports on cutting-edge technologies, industry trends, and industry insights of innovative drugs, with over 160,000 users of all-media high-end matrix users, of which over 50% are industrial users, approximately 30% are scientific research and clinical users, and over 5% are users of investment institutions .
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
