Pharma, Startups

Cold Genesys gets $13.6M Series A for oncolytic virus to treat bladder cancer; recycles assets from defunct biotech

Cold Genesys, a sort of latter-day spinoff of the once-promising cancer vaccine maker Cell Genesys, […]

Cold Genesys, a sort of latter-day spinoff of the once-promising cancer vaccine maker Cell Genesys, has an engineered oncolytic virus that shows promise in treating a dangerous form of bladder cancer. The Newport Beach, California company just received $13.6 million from Hong Kong-based investment fund Ally Bridge Group.

It has rejiggered an adenovirus that typically causes the common cold, and plans to use the capital to advance its ongoing Phase II/III trial which evaluates the company’s lead compound, CG0070, in patients with high-risk carcinoma in situ non-muscle invasive bladder cancer. It began enrolling patients at 10 major cancer centers this past March.

At present, the disease has limited treatment options – typically bladder removal surgery and chemotherapy – so Cold Genesys’ therapy could offer a wildly different option for the difficult cancer, said Arthur Kuan, a managing partner of Ally Group who was just brought on by Cold Genesys as its vice president of research and clinical project management.

Ally Group VC firm, which has conducted the majority of its deals in the immuno-oncology space, has a strategy to identify biotech opportunities in the U.S. that it can bring to China, Kuan said.

Cold Genesys is kind of the next incarnation of Cell Genesys, which pursued aggressive Phase II and III clinical trials using this treatment method in prostate and pancreatic cancer. It failed in 2007, prompting a $38 million merger in 2009 with the now-defunct BioSante, a company that focused more on a female sexual dysfunction drug. Cold Genesys’ CG0070 asset was part of Cell Genesys’ pipeline; when Cold Genesys was formed in 2010, it acquired the compound from BioSante, Kuan said.

“The whole oncology asset of Cell Genesys was neglected after the merge, so that’s how the CEO of Cold Genesys was able to pick it up,” Kuan said.

Until the spanking-new cash infusion from Ally Group, Cell Genesys has been “bootstrapping it,” Kuan said, with funding from CEO Alex Yeung’s friends and family. But in the process, he activated an IND and obtained an SPA from the Food and Drug administration, and is sort of picking up where Cell Genesys left off in clinical trials. Only now, the focus is this dangerous bladder cancer.

Once the virus enters the cells – and it will enter both healthy and cancerous bladder cells – it will only begin to replicate in tumors cells that are undergoing rapid cell division, Kuan said.

“Tumor cells become a factory to produce these viruses – so after a point, they’ll no longer have the capability to hold anymore of the virus, so oncolysis will happen and the tumor cells will burst,” Kuan said.

The virus also carries a gene for a cytokine that will attract immune cells, particularly dendritic cells, which trigger the body’s own immune response when expunged from the tumor cell.

Kuan said Cold Genesys is building on the success of Amgen’s T-VEC, a repurposed herpes vaccine which last year was able to show that oncolytic viruses can actually make melanoma tumors more immunogenic. Amgen acquired the T-VEC compound three years ago when it bought BioVex for a whopping $1 billion.

There’s a great deal of promise in immunotherapy biologics as far as bladder cancer is concerned, according to a February report from Citi that’s summarized here. Given the poor efficacy of surgery and chemotherapy, Kuan said, the field’s ripe for a new way to attack this cancer.

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