CG Oncology CEO Arthur Kuan talked concerning the biotech firm’s experimental bladder most cancers therapy in Section 3 improvement and collaboration with Merck, among the many firm’s milestones, in response to emailed questions.
Why did you be a part of CG Oncology?
Ally Bridge Group, a healthcare funding fund the place I used to be a founding member, led CG Oncology’s (previously Chilly Genesys) Sequence A financing spherical. Operationally, I joined the corporate in 2015, and I used to be appointed CEO after the corporate’s founder and former CEO retired in 2016.
Addressing areas of great unmet medical want in most cancers has all the time been near my coronary heart, particularly having had first-hand expertise with my family members affected by this devastating illness. CG Oncology is growing a proprietary, cutting-edge drug, having demonstrated each efficacy and security in people. The potential was clear and that gave me the conviction to hitch the corporate, and assist deliver this necessary remedy to sufferers.
Since changing into CEO, I led our workforce to efficiently shut our $22 million Sequence C and $47 million Sequence D financing rounds. Lead buyers included ORI Healthcare Fund and Kissei Pharmaceutical, with participation from Lepu Medical, Camford Capital and Perseverance Capital Administration. CG Oncology has raised a complete of $83 million in financing since inception.
What want are you in search of to deal with in healthcare?
CG Oncology is a clinical-stage biotechnology firm targeted on growing the subsequent evolution of oncolytic immunotherapy for sufferers with superior most cancers.
Our lead asset, CG0070, is at the moment in Section 3 medical research as monotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder most cancers (NMIBC). In a medical collaboration with Merck, we’ve got additionally launched a Section 2 medical trial for CG0070 together with KEYTRUDA® (pembrolizumab) for BCG-unresponsive NMIBC. On this indication, there has not been a brand new FDA-approved drug in additional than 20-plus years, till 2020 when pembrolizumab was authorized as a monotherapy.
Most sufferers who’ve failed BCG intravesical remedy, the present commonplace of care, often haven’t any different selection however to proceed to cystectomy — a full surgical elimination of the bladder, which is related to main morbidity, mortality and a lower in high quality of life. Lengthy-term and tedious medical care will proceed for the remainder of the affected person’s life. CG0070 might serve to supply a therapeutic various for this affected person inhabitants, that has restricted choices.
As well as, CG0070 is at the moment in Section 1/2 medical research together with Bristol Myer’s OPDIVO® (nivolumab) for muscle invasive bladder most cancers (MIBC). There are over 80,000 new circumstances of bladder most cancers within the US yearly, and roughly 160,000 circumstances within the EU. Bladder most cancers is the 6th commonest most cancers after breast, lung, prostate, colorectal and melanoma. Our pipeline spans all 3 areas in bladder most cancers – NMIBC, MIBC, in addition to metastatic situations.
CG0070 can also be in improvement for necessary most cancers indications exterior of bladder together with lung and colorectal most cancers.
What does your product do? How does it work?
Oncolytic immunotherapy is a type of most cancers therapy that makes use of genetically modified viruses to each preferentially kill most cancers cells and likewise generate anti-tumor immune responses. In different phrases, this pharmacological class deploys a two-pronged assault towards most cancers by each direct and likewise oblique killing. CG0070 is among the solely oncolytic viruses in Section 3 improvement within the US, and on the forefront of this subject.
CG0070 relies on a genetically modified widespread chilly adenovirus spine that incorporates a cancer-specific promoter and a GM-CSF transgene. CG0070 is designed to work in two necessary and complementary methods. First, it replicates inside tumor cells, inflicting tumor cell lysis and immunogenic cell dying. Then, the rupture of the most cancers cells can launch tumor-derived antigens, together with GM-CSF, which may stimulate a systemic anti-tumor immune response that entails the physique’s personal white blood cells.
The scientific rationale and medical profile of CG0070 make it a perfect agent to be developed for quite a lot of strong tumor sorts, together with these exterior the bladder, and for use alone or together with immune checkpoint inhibitors, corresponding to pembrolizumab and nivolumab. By this twin mechanism, these mixture therapies have the potential to not solely enhance assault on most cancers but additionally battle to discourage its unfold and recurrence sooner or later.
Is that this your first healthcare startup? What’s your background in healthcare?
Previous to becoming a member of CG Oncology, I used to be a founding member of Ally Bridge Group, a world healthcare-focused funding fund that at the moment manages over USD$2B in property. I used to be lucky to be concerned in lots of features of a startup fund on the time, together with fundraising, and constructed a powerful community within the US and China by our investments in these areas. The flexibility to make cross-border offers proved to be helpful when main CG Oncology, the place we at the moment have a various investor base in addition to a number of key strategic companions in Asia
I used to be additionally a member of Themes Funding Companions, a healthcare and environmental Non-public Fairness fund primarily based in Hong Kong. I started my profession in an operational function at Dinova Capital, a Shanghai-based, medical know-how incubator fund, evaluating medical system funding alternatives, the place I performed a central function in coordinating cross-border know-how switch and regulatory submissions for portfolio firms. I acquired my Masters in Biotechnology from Johns Hopkins and my B.A. in Biology from the College of Pennsylvania.
What are a few of your upcoming milestones?
In 2021, we can be saying new strategic partnerships for mixture research, in addition to interim outcomes from our Section 2 mixture examine with Merck’s KEYTRUDA® (pembrolizumab) in sufferers with BCG-unresponsive NMIBC most cancers.
Who’s your affected person demographic?
Sufferers with bladder and different difficult-to-treat cancers with restricted therapeutic choices, together with lung and colorectal most cancers.
Who’re your opponents?
Our opponents are firms growing different bladder most cancers compounds and/or different oncolytic virus firms. In our lead indication, BCG-unresponsive NMIBC, CG0070 may very well be subsequent to market. Within the pharmacological class, oncolytic immunotherapy, CG0070 may be the subsequent to market.
Do you could have medical validation to your product?
CG0070, as a monotherapy, has been administered in over 100 sufferers up to now for NMIBC, having demonstrated optimistic efficacy and security.
At what stage of improvement is your lead product?
As a monotherapy, CG0070 is in an ongoing world Section 3 trial (BOND3) for the therapy of BCG-unresponsive NMIBC. In the identical indication, by a medical collaboration with Merck, CG0070 is in a Section 2 trial together with pembrolizumab. As well as, an investigator-initiated Section 1/2 examine (CORE2) is at the moment ongoing with CG0070 together with nivolumab as a neoadjuvant immunotherapy for MIBC in cisplatin-ineligible sufferers.
Image: magicmine, Getty Photos