CG Oncology CEO Arthur Kuan talked about the biotech company’s experimental bladder cancer treatment in Phase 3 development and collaboration with Merck, among the company’s milestones, in response to emailed questions.
Why did you join CG Oncology?
Ally Bridge Group, a healthcare investment fund where I was a founding member, led CG Oncology’s (formerly Cold Genesys) Series A financing round. Operationally, I joined the company in 2015, and I was appointed CEO after the company’s founder and former CEO retired in 2016.
Addressing areas of significant unmet medical need in cancer has always been close to my heart, especially having had first-hand experience with my loved ones suffering from this devastating disease. CG Oncology is developing a proprietary, cutting-edge drug, having demonstrated both efficacy and safety in humans. The potential was clear and that gave me the conviction to join the company, and help bring this important therapy to patients.
Since becoming CEO, I led our team to successfully close our $22 million Series C and $47 million Series D financing rounds. Lead investors included ORI Healthcare Fund and Kissei Pharmaceutical, with participation from Lepu Medical, Camford Capital and Perseverance Capital Management. CG Oncology has raised a total of $83 million in financing since inception.
What need are you seeking to address in healthcare?
CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer.
Our lead asset, CG0070, is currently in Phase 3 clinical studies as monotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). In a clinical collaboration with Merck, we have also launched a Phase 2 clinical trial for CG0070 in combination with KEYTRUDA® (pembrolizumab) for BCG-unresponsive NMIBC. In this indication, there has not been a new FDA-approved drug in more than 20-plus years, until 2020 when pembrolizumab was approved as a monotherapy.
Most patients who have failed BCG intravesical therapy, the current standard of care, usually have no other choice but to proceed to cystectomy — a full surgical removal of the bladder, which is associated with major morbidity, mortality and a decrease in quality of life. Long-term and tedious medical care will continue for the rest of the patient’s life. CG0070 could serve to provide a therapeutic alternative for this patient population, that has limited options.
In addition, CG0070 is currently in Phase 1/2 clinical studies in combination with Bristol Myer’s OPDIVO® (nivolumab) for muscle invasive bladder cancer (MIBC). There are over 80,000 new cases of bladder cancer in the US annually, and approximately 160,000 cases in the EU. Bladder cancer is the 6th most common cancer after breast, lung, prostate, colorectal and melanoma. Our pipeline spans all 3 areas in bladder cancer – NMIBC, MIBC, as well as metastatic conditions.
CG0070 is also in development for important cancer indications outside of bladder including lung 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 both preferentially kill cancer cells and also generate anti-tumor immune responses. In other words, this pharmacological class deploys a two-pronged attack against cancer through both direct and also indirect killing. CG0070 is one of the only oncolytic viruses in Phase 3 development in the US, and at the forefront of this field.
CG0070 is based on a genetically modified common cold adenovirus backbone that contains a cancer-specific promoter and a GM-CSF transgene. CG0070 is designed to work in two important and complementary ways. First, it replicates inside tumor cells, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, which can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells.
The scientific rationale and clinical profile of CG0070 make it an ideal agent to be developed for a variety of solid tumor types, including those outside the bladder, and to be used alone or in combination with immune checkpoint inhibitors, such as pembrolizumab and nivolumab. Through this dual mechanism, these combination therapies have the potential to not only increase attack on cancer but also fight to deter its spread and recurrence in the future.
Is this your first healthcare startup? What’s your background in healthcare?
Prior to joining CG Oncology, I was a founding member of Ally Bridge Group, a global healthcare-focused investment fund that currently manages over USD$2B in assets. I was fortunate to be involved in many aspects of a startup fund at the time, including fundraising, and built a strong network in the US and China through our investments in those regions. The ability to make cross-border deals proved to be useful when leading CG Oncology, where we currently have a diverse investor base as well as several key strategic partners in Asia
I was also a member of Themes Investment Partners, a healthcare and environmental Private Equity fund based in Hong Kong. I began my career in an operational role at Dinova Capital, a Shanghai-based, medical technology incubator fund, evaluating medical device investment opportunities, where I played a central role in coordinating cross-border technology transfer and regulatory submissions for portfolio companies. I received my Masters in Biotechnology from Johns Hopkins and my B.A. in Biology from the University of Pennsylvania.?
What are some of your upcoming milestones?
In 2021, we will be announcing new strategic partnerships for combination studies, as well as interim results from our Phase 2 combination study with Merck’s KEYTRUDA® (pembrolizumab) in patients with BCG-unresponsive NMIBC cancer.
Who is your patient demographic?
Patients with bladder and other difficult-to-treat cancers with limited therapeutic options, including lung and colorectal cancer.
Who are your competitors?
Our competitors are companies developing other bladder cancer compounds and/or other oncolytic virus companies. In our lead indication, BCG-unresponsive NMIBC, CG0070 could be next to market. In the pharmacological class, oncolytic immunotherapy, CG0070 could also be the next to market.
Do you have clinical validation for your product?
CG0070, as a monotherapy, has been administered in over 100 patients to date for NMIBC, having demonstrated positive efficacy and safety.
At what stage of development is your lead product?
As a monotherapy, CG0070 is in an ongoing global Phase 3 trial (BOND3) for the treatment of BCG-unresponsive NMIBC. In the same indication, through a clinical collaboration with Merck, CG0070 is in a Phase 2 trial in combination with pembrolizumab. In addition, an investigator-initiated Phase 1/2 study (CORE2) is currently ongoing with CG0070 in combination with nivolumab as a neoadjuvant immunotherapy for MIBC in cisplatin-ineligible patients.
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