December 22, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SANTA CLARA, Calif. – CBT Pharmaceuticals, which was founded earlier this year, will head into 2017 with a goal of taking two oncology programs into the clinic, one of which, if successful, could emerge as a challenger to Bristol-Myers Squibb ’s Opdivo. At least, that’s the hope of CBT’s Chief Executive Officer Sanjeev Redkar.
“These programs are quite exciting,” Redkar said in an exclusive interview with BioSpace. He believes the company’s sophomore year will be a good one.
The two programs set to enter the clinic include CBT-101, an oral agent that targets the epithelial to mesenchymal transition (EMT) pathway, which is dysregulated in several tumors. It is a highly specific inhibitor of the c-Met receptor. The drug candidate is already in a Phase I trial in China and the company plans to initiate a Phase I trial here in the United States in early 2017. The Phase I trial will evaluate the safety, tolerability and preliminary efficacy in cancer patients with c-MET dysregulated malignancies, Redkar said.
The other Phase I candidate is CBT-501, a novel IgG4 humanized monoclonal antibody targeting the Programmable Death-1 (PD-1) membrane receptor on immune cells. The company plans on launching a Phase I trial in Australia next year and also hopes to start an additional trial in China with its partner, Genor BioPharma.
CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti PD-1 antibodies, Opdivo (nivolumab) and Merck ’s Keytruda (pembrolizumab), according to company data. Additionally, CBT-501 has a “superior profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity,” the company said.
Preclinical work has shown the experimental drugs to be “extremely durable over several years.”
“There’s just so much fantastic work going on and these could impact such a wide variety of tumors,” Redkar said. “There is an absolute need to bring these treatments to market.”
While Redkar did not disclose full plans for the company’s pipeline, he said CBT Pharma will explore “smaller tumor markets” to carve out a niche that larger companies may overlook.
CBT Pharma does plan to break into the Chinese market, which Redkar said is expected to grow to be a $160 billion market. He said CBT has local partners in China, which will be important when it comes to penetrating the Chinese market.“A lot of companies are trying to move into China, which is sparking a lot of innovation there in discovery and clinical development,” Redkar said.
Redkar said the company settled on the idea of running trials in multiple countries because CBT leadership believes drugs should be developed globally.
To support the planned trials and continued business growth, CBT was able to secure $9.75 million in Series A financing in August. Added to cash reserves, that gave the company an operating budget of $14.75 million. That funding should sustain the company through the end of 2017, Redkar said.
“We’re a relatively small company with limited resources. We operate very lean,” he said.
Redkar said the company’s two other clinical programs, CBT-102 and CBT-502, will depend on the success of the first two. He added that CBT Pharma is open to partnerships to help develop the drugs. CBT-102 is a kinase inhibitor that has shown to be effective against liver, breast, colorectal, and non-small cell lung cancer models.
CBT-502 is a novel IgG4 humanized monoclonal antibody against the Programmable Death Ligand-1 (PDL-1) membrane receptor on tumor cells. It is currently undergoing Investigational New Drug studies with hopes of moving into a clinical trial in China in partnership with Chia Tai TianQing, according to company information.
CBT Pharma currently has eight employees, three full time and five who work on a contract basis.
If 2017 is as promising as Redkar hopes, the company could see some surprising growth. Until then, though, Redkar said he is excited about what the future holds for CBT Pharma.
