Encouraging news for bladder cancer patients who are unresponsive to Bacillus Calmette-Guerin (BCG)! Cold Genesys Inc., a clinical-stage biopharmaceutical working to develop novel immunotherapies, announced March 18th the closing of a $22 million Series C preferred stock financing. The round included new investors, including the lead one, ORI Healthcare Fund L.P. (“ORI Fund”), and Perseverance Capital Management also participated.
The small executive team at Cold Genesys is led by CEO Arthur Kuan, a former private equity investor who earlier helped start prominent Chinese investment firm Ally Bridge Group. Along with its investors for the Series C, the executive team is focusing all its efforts on the development of CG0070. A modified adenovirus type 5, CG0070 works like a standard oncolytic virus: it is designed to infect cancer cells, killing them, then the immune system is signaled to attack any surviving cancer cells.
Back in 2010, when it was only starting to function, Cold Genesys acquired the drug, which had already gone through Phase I, from BioSante Pharmaceuticals, for $95,000 upfront and 20 percent of the stock. Nine years later, CG0070 has been tested in more than 100 bladder cancer patients in a Phase II trial as a monotherapy. The new drug is now lined up for combination trials with Merck’s Keytruda, and other checkpoint modulators.
Cold Genesys, Inc. announced the clinical collaboration with Merck (known as MSD outside the United States and Canada) last November. It was meant to evaluate the combination of Cold Genesys’ lead oncolytic immunotherapy candidate CG0070 with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in a Phase 2 clinical study.
The trial was supposed to evaluate the preliminary safety and efficacy of CG0070 plus KEYTRUDA in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Since this was a serious unmet medical need, the FDA having not approved any drug for this indication in the last 20 years, the importance of the trial’s outcome was even higher.
CG0070, an investigational oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells. It does so by using their defective retinoblastoma (Rb) pathway, which can be found in many cancers. Favorable safety results and encouraging efficacy in patients with NMIBC following BCG failure have been proven after CG0070 has gone through several clinical studies, including a completed Phase 2 study (BOND2).
“We are delighted to be collaborating with Merck on this innovative combination approach,” said Arthur Kuan, CEO of Cold Genesys. “CG0070, which has demonstrated clinical safety and efficacy in over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with KEYTRUDA, which also has demonstrated single agent activity in the indication.”
The new funds will help Cold Genesys push through its ongoing clinical programs and support the continued advancement of its lead oncolytic immunotherapy CG0070. Both Cold Genesys’ team and the new investors believe in the company’s future and the efficacy of the oncolytic therapies.
“Cold Genesys has reached an exciting stage in its development, and this financing demonstrates continued investor confidence in our leadership and future in the field of oncolytic immunotherapy,” said Arthur Kuan, CEO of Cold Genesys. “We have made significant progress within the last year, from new leadership appointments to our partnership with Merck to evaluate their anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in combination with CG0070 in a Phase 2 clinical study. Our robust pipeline based on our oncolytic immunotherapy platform, partnerships with leading institutions, and key advancements in our clinical program, demonstrate our commitment to rapidly advancing therapies that will change the lives of patients with bladder cancer and other solid tumors.”
“We are a strong believer in using the oncolytic immunotherapy approach in both monotherapy and combo therapy to combat cancer,” said Simone Song, Senior Partner of ORI Fund. “We are very fortunate to have the opportunity to work with an outstanding firm such as Cold Genesys which has completed the Phase 2 study for NMIBC. We have confidence that Cold Genesys will fulfill the unmet medical need for NMIBC, and we also hope that Cold Genesys can become a platform company to benefit patients with various types of solid tumors by applying its oncolytic immunotherapy expertise.”
Cold Genesys is a clinical-stage immuno-oncology company focused on the development of oncolytic immunotherapies to combat cancer. The company’s lead candidate CG0070 has completed an investigation in a Phase 2, single-arm, open-label, multicenter study (BOND2) for patients with NMIBC who failed BCG therapy and refused cystectomy. In addition, Cold Genesys is exploring the use of CG0070 in combination with immune checkpoint modulators in different solid tumors.
The ORI Fund is a $200 million venture capital fund focused on investing in innovative companies with disruptive technologies in the global healthcare industry. The fund is founded by Ms. Simone (Hong Fang) Song, former investment banker and head of China Healthcare at Goldman Sachs.