CG Oncology is a biotech company focused on developing innovative treatments for bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). Their two main clinical programs involve cretostimogene grenadenorepvec (CG0070), an oncolytic immunotherapy. CG Oncology filed confidentially on October 27, 2023. The company filed publicly this week with the SEC to raise up to $100 million in an initial public offering.
Here’s a summary of their key clinical results:
Promising Monotherapy Results:
- BOND-003 Phase 3 Trial: Interim data from this trial for high-risk BCG-unresponsive NMIBC showed a 75.7% complete response rate at any time for patients treated with CG0070 monotherapy. This is highly encouraging, as Bacillus Calmette Guerin (BCG) is currently the standard first-line treatment for NMIBC, but some patients fail to respond and have limited options.
- First Phase 3 Monotherapy Data: Presented at SUO 2023, this data confirmed the promising results from BOND-003, with a focus on durable complete response rates and disease-free survival.
Combination Therapy Shows Positive Early Signs:
- CORE-001 Phase 2 Trial: Early data from this trial combining CG0070 with pembrolizumab (an immunotherapy drug) showed an 85% complete response rate at the initial 3-month timepoint in BCG-unresponsive NMIBC patients. This suggests potential for further efficacy improvements.
According to Science Magazine, “Preliminary results from a small phase 3 study presented at a conference last week suggest these unconventional cancer treatments, known as oncolytic viruses, might work after all. The data showed that an oncolytic virus developed by Irvine, California–based CG Oncology eliminated tumors in 64% of 66 patients with bladder cancer that didn’t respond to mainline treatment. The follow-up period was only 6 months, and much more research is necessary. But even a positive phase 3 result is enough to “shake the world of oncolytic viruses,” says surgical oncologist Omeed Moaven of the Louisiana State University Medical Center.”
Fast Track and Breakthrough Therapy Designations:
The FDA granted both designations to CG0070 for high-risk BCG-unresponsive NMIBC, highlighting the drug’s potential and potentially accelerating its path to approval.
Investors
Early Investors (Seed Rounds):
- Ally Bridge Group: A global healthcare-focused investment platform co-founded by CG Oncology’s CEO, Arthur Kuan.
- Themes Investment Partners: A Private Equity fund where Arthur Kuan previously focused on healthcare and biotech investments.
- Dinova Capital: A MedTech incubator fund involved in cross-border technology transfer and new company formation.
Series A and B Rounds:
- RA Capital Management: A leading healthcare investment firm specializing in life sciences ventures.
- Malin Corporation: A healthcare investment company focused on early-stage life sciences businesses.
- Longitude Capital: A global healthcare investment firm with expertise in oncology and rare diseases.
- Acorn Bioventures: A venture capital firm investing in early-stage life sciences companies in Europe and Asia.
Later Rounds (C onwards):
- ORI Capital: A healthcare-focused venture capital firm based in China.
- Decheng Capital: A venture capital firm focusing on healthcare investments in China.
- BVF Partners: A global healthcare investment firm focused on late-stage life sciences companies.
- Avidity Partners: A venture capital firm investing in innovative life sciences companies.
- Foresite Capital: A healthcare-dedicated venture capital firm.
- TCGX: A life sciences-focused venture capital firm.
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