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Article source: Medical Rubik's Cube Info
Author: Shi Bei
Recently, the official website of CDE showed that the clinical trial application of Lepu Bio/CG Oncology's CG0070 injection has been approved by the National Medical Products Administration (NMPA), and a phase I clinical study for the treatment of non-muscular invasive bladder cancer will be carried out in China
.
Source: CDE official website
CG0070 oncolytic virus anti-tumor drug was introduced by Lepu Biotech from CG Oncology, Inc.
of the United States, and obtained its product development, manufacturing and commercialization rights in Mainland China, Hong Kong and Macau
.
Medicine Rubik's Cube NextPharma
Oncolytic viruses can selectively replicate in tumor cells to lyse tumor cells, while avoiding affecting the growth of normal cells as much as possible.
With the development of tumor immunotherapy, oncolytic viruses have a role in malignant tumors and other diseases.
The therapeutic potential is getting more and more attention
.
Since the US FDA approved Amgen’s T-VEC oncolytic virus anti-tumor drugs in 2015, a number of oncolytic virus anti-tumor drugs worldwide have entered the clinical research phase
CG0070 is an oncolytic virus and anti-tumor drug.
It is a genetically modified adenovirus type 5 (Ad5).
It is modified to contain the cancer selective promoter E2F-1 and immune cell stimulating factor GM-CSF genes, selectively Replicate and lyse tumor cells in tumor cells deficient in Rb regulation
.
The rupture of cancer cells will release tumor-derived antigens and GM-CSF expressed along with the virus, thereby stimulating the systemic anti-tumor immune response
Mechanism of action of CG0070 (Source: CG Oncology official website)
On November 13, CG Oncology announced the preliminary clinical results of the Phase II CORE1 study of CG0070 combined with Keytruda in the treatment of non-muscle invasive bladder cancer (NMIBC) that did not respond to BCG (BCG)
.
As of the data cutoff date of November 8, 2021, 9 patients with evaluable efficacy have achieved 100% complete remission (CR) in the first 3 months
.
The CR rate of patients who reached the 6-month evaluable efficacy standard was 100% (n=6), and the CR rate of patients who reached the 9-month evaluable efficacy standard was also 100% (n=3)
In terms of safety, treatment-related adverse events (AE) are limited to transient grade 1-2 local genitourinary system symptoms and immune-related adverse events, including frequent urination, bladder spasm, fatigue, chills, autoimmune thyroiditis, bleeding, and dysuria And flu-like symptoms
.
No treatment-related grade 3 or higher AEs or serious adverse events (SAE) were observed
CG0070 is currently undergoing a phase III clinical study in the United States in combination with Keytruda for the treatment of non-muscle invasive bladder cancer that does not respond to BCG (BCG)
