CG Oncology In response to an e-mail question, CEO Arthur Kuan talked about the biotech company’s experimental bladder cancer treatment in the third phase of development and its cooperation with Merck, which is one of the company’s milestones.
Why did you join CG Oncology?
I am one of the founding members of Ally Bridge Group, a healthcare investment fund, and led the Series A financing of CG Oncology (formerly Cold Genesys). In terms of operations, I joined the company in 2015. After the company’s founder and former CEO retired in 2016, I was appointed as CEO.
Addressing areas where there is a major unmet medical need for cancer has always been my voice, especially having first-hand experience with someone I love suffering from this devastating disease. CG Oncology is developing a proprietary cutting-edge drug that has proven effectiveness and safety in humans. The potential is obvious, which convinces me to join the company and help bring this important therapy to patients.
Arthur Kwan, CG Oncology
Since becoming the CEO, I led our team to successfully complete the $22 million Series C financing and the $47 million Series D financing. Major investors include ORI Healthcare Fund and Kissei Pharmaceutical, with participation from Lepu Medical, Camford Capital and Perseverance Capital Management. Since its establishment, CG Oncology has raised a total of US$83 million in funding.
What needs are you seeking to solve in the healthcare sector?
CG Oncology is a clinical-stage biotechnology company focused on developing the next development of oncolytic immunotherapy for patients with advanced cancer.
Our main asset, CG0070, is currently undergoing Phase 3 clinical research as a monotherapy for BCG (BCG) non-responsive non-muscle invasive bladder cancer (NMIBC). In the clinical cooperation with Merck, we also initiated a phase 2 clinical trial of the combination of CG0070 and KEYTRUDA ® (pembrolizumab) in the treatment of BCG-unresponsive NMIBC. In this indication, there has been no new FDA approved drug for more than 20 years until pembrolizumab is approved as a monotherapy in 2020.
Most patients who fail BCG intravesical treatment (the current standard of care) usually have no choice but to undergo cystectomy-complete surgical removal of the bladder, which is related to severe morbidity, mortality, and quality of life. Long-term and tedious medical care will last for the rest of the patient’s life. CG0070 can provide a treatment option for this patient population with limited options.
In addition, CG0070 is currently being used in conjunction with Bristol-Myers Squibb’s OPDIVO® (nivolumab) in a phase 1/2 clinical study of muscular invasive bladder cancer (MIBC). In the United States, there are more than 80,000 new cases of bladder cancer each year, and there are approximately 160,000 cases in the European Union. Bladder cancer is the sixthday The most common cancers after breast cancer, lung cancer, prostate cancer, colorectal cancer and melanoma. Our pipeline spans all 3 areas of bladder cancer-NMIBC, MIBC, and metastatic disease.
CG0070 is also being developed for important cancer indications other than the bladder, including lung cancer and colorectal cancer.
What does your product do? How does it work?
Oncolytic immunotherapy is a form of cancer treatment that uses genetically modified viruses to preferentially kill cancer cells and produce an anti-tumor immune response. In other words, this pharmacological category provides a two-pronged attack on cancer through direct and indirect killing. CG0070 is one of the only oncolytic viruses in the third phase of development in the United States and is at the forefront of this field.
CG0070 is based on a genetically modified common cold adenovirus backbone, which contains a cancer-specific promoter and a GM-CSF transgene. CG0070 is designed to work in two important and complementary ways. First, it replicates in tumor cells, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, as well as GM-CSF, which can stimulate a systemic anti-tumor immune response involving the body’s own white blood cells.
The scientific principles and clinical features of CG0070 make it an ideal drug for the development of various solid tumor types (including solid tumors outside the bladder). It can be used alone or in combination with immune checkpoint inhibitors (such as pembrolizumab and nivolumab) . Through this dual mechanism, these combination therapies may not only increase the attack on cancer, but may also prevent its spread and recurrence in the future.
Is this your first healthcare startup? What is your background in healthcare?
Before joining CG Oncology, I was a founding member of Ally Bridge Group, an investment fund focused on global healthcare and currently manages more than $2 billion in assets. At that time, I was fortunate to be involved in many aspects of venture funds, including fundraising, and through our investments in these regions, I established a strong network in the United States and China.Facts have proved that the ability to conduct cross-border transactions is very useful when leading CG Oncology. We currently have a diversified investor base and several major strategic partners in Asia
I am also a member of Themes Investment Partners, a healthcare and environmental private equity fund based in Hong Kong. My career started at Dinova Capital, a Shanghai-based medical technology incubation fund responsible for evaluating medical device investment opportunities, where I played a central role in coordinating the cross-border technology transfer and regulatory submission of portfolio companies. I received a master’s degree in biotechnology from Johns Hopkins University and a bachelor’s degree in biology from the University of Pennsylvania. ?
What are your upcoming milestones?
In 2021, we will announce a new joint research strategic partnership and the mid-term results of our Phase 2 joint research with Merck KEYTRUDA® (Pembrolizumab) In NMIBC cancer patients who do not respond to BCG.
Who is your patient population?
Bladder cancer and other difficult-to-treat cancer patients with limited treatment options, including lung cancer and colorectal cancer.
Who are your competitors?
Our competitors are companies that develop other bladder cancer compounds and/or other oncolytic virus companies. Among our leading indications, NMIBC, which is slow to respond to BCG, CG0070 may follow the market closely. In pharmacological oncolytic immunotherapy, CG0070 may also be the next to market.
Is your product clinically validated?
As a monotherapy, CG0070 has been used in more than 100 NMIBC patients so far and has shown positive efficacy and safety.
At what stage of development is your leading product?
As a monotherapy, CG0070 is undergoing a global phase 3 trial (BOND3) for the treatment of NMIBC that does not respond to BCG. In the same indication, through clinical cooperation with Merck, CG0070 and pembrolizumab jointly conducted a phase 2 trial. In addition, a phase 1/2 study (CORE2) initiated by the investigator is currently underway to combine CG0070 with nivolumab as a neoadjuvant immunotherapy for MIBC patients who are not eligible for cisplatin.
picture: Magic Mine, Getty Images
