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Imugene (AU:IMU)
ASX:IMU
Hydroxyurea, Cf33-Cd19 It Monotherapy, Cf33-Cd19 Iv Monotherapy, Cf33-Cd19 It Combination, Cf33-Cd19 Iv Combination, Blinatumomab
Solid Tumor, Adult
Phase I
Recruiting
A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)
Sep 14, 2023
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Pembrolizumab, Cf33-Hnis, Modified Folfox
Advanced Solid Tumor, Solid Tumor, Metastatic Cancer, Solid Tumor, Adult, Bile Duct Cancer, Cholangiocarcinoma, Solid Carcinoma
Phase I
Recruiting
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
Mar 22, 2022
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Pembrolizumab, Imu-131, Ramucirumab Plus Paclitaxel
Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stomach Cancer, Cancer Of Stomach, Stomach Adenocarcinoma
Phase II
Terminated
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
Mar 08, 2022
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Atezolizumab, Standard Of Care Chemotherapy, Imu-201 (Administered As Pd1-Vaxx) - Regimen 1, Imu-201 (Administered As Pd1-Vaxx) - Regimen 2, Imu-201 (Administered As Pd1-Vaxx) - Regimen 3
Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer Stage Iv, Non Small Cell Lung Cancer Stage Iiib, Squamous Non-Small-Cell Lung Cancer, Large Cell Carcinoma Lung, Adenocarcinoma Lung
Phase I
Active Not Recruiting
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults with Non-Small Cell Lung Cancer
May 10, 2020
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Bendamustine, Cyclophosphamide, Fludarabine, Azer-Cel, Il-2
Non-Hodgkin Lymphoma, B-Cell Acute Lymphoblastic Leukemia
Phase I
Recruiting
Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients With r/r NHL and r/r B-cell ALL
Aug 20, 2018
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Imu-131, Cisplatin And Either Fluorouracil (5-Fu) Or Capecitabine Or Oxaliplatin And Capecitabine.
Adenocarcinoma, Gastrointestinal Neoplasms
Phase I/II
Completed
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
Jun 01, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Imugene (IMU) have in its pipeline
IMU is currently developing the following drugs: Hydroxyurea, Cf33-Cd19 It Monotherapy, Cf33-Cd19 Iv Monotherapy, Cf33-Cd19 It Combination, Cf33-Cd19 Iv Combination, Blinatumomab, Pembrolizumab, Cf33-Hnis, Modified Folfox, Pembrolizumab, Imu-131, Ramucirumab Plus Paclitaxel. These drug candidates are in various stages of clinical development as the company works toward FDA approval.