What You Need to Know About CBT Pharmaceuticals

Based in Pleasanton, California, CBT Pharmaceuticals was spun out of Crown Bioscience with four development-stage assets in the oncology space.

Sanjeev Redkar, CBT’s President and Chief Executive Officer, told BioSpace, “These novel products were invented within the Crown umbrella by a really strong discovery team. We have two of those molecules in the clinic now and the clinical data has been presented at conferences.”

The company is focused not only on the possibility of oncology monotherapies, but has an emphasis on the possibility of its compounds being tested and eventually commercialized in combination therapies with partners.

Redkar noted that he and his management team have significant experience in bringing products to market. “We work together extremely well, and have experience in big and biotech start-ups.”

Company Leadership

Sanjeev Redkar – President and Chief Executive Officer. A co-founder of the company, Redkar was previously the Senior Vice President of Product Development at Astex Pharmaceuticals, an Otsuka Pharmaceuticals company.

Gavin Choy – Executive Vice President and Chief Operating Officer. Prior to joining CBT, Choy was the Senior Vice President of Clinical Sciences and Operations at Galena Biopharma. Before that, he was the Vice President of Clinical Services and Operations at Astex Pharmaceuticals, an Otsuka Pharmaceuticals company. He has also had leadership roles at SuperGen, Hana Biosciences, and Gilead Sciences.

Sarath Kanekal – Head, Regulatory Affairs and Quality. Kanekal previously held leadership positions at Novartis, GlaxoSmithKline, Astex, Absorption Systems and Revia.

Company Financing

CBT Pharmaceuticals received $5 million in seed funding from Crown Bioscience when it was spun out. On August 2016, it closed on a $9.7 million Series A financing led by Orbimed Asia.

Pipeline

The company has four pipeline products, two of which are currently in the clinic. CBT retains worldwide ex-China rights to three of the products, CBT-101, CBT-501 and CBT-502, and world-wide rights to CBT-102.

CBT-101 is an oral agent targeting the epithelial to mesenchymal transition pathway that is dysregulated in some tumors. It is a specific c-Met receptor inhibitor. It is being evaluated by CBT in a Phase 1 trial in the US and two Phase I trials in China by CBT's China partner, Beijing Pearl Biotechnology Co.

CBT-501 is a novel IgG4 humanized monoclonal antibody against PD-1. The drug is in two Phase I trials for solid tumors. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA) and the Phase I trial is active in China by Genor BioPharma, a Walvax company. 

CBT-502 is a novel IgG1 humanized monoclonal antibody against PDL-1. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA) and the Phase I trial will be initiated, sponsored by CBT's partner, Chia Tai TianQing (CTTQ). 

CBT-102 is an inhibitor of the MAP Kinase pathway, targeting CSF1R, b-RAF and c-RAF kinases in addition to inhibiting angiogenesis by affecting the VEGF and PDGF receptors. It has shown broad antitumor activity in preclinical models in liver cancer, breast cancer, colorectal cancer, and non-small cell lung cancer, and has a potential in combination with checkpoint inhibitors.

Redkar told BioSpace, "There are several combination trials ongoing and it's a crowded space, but the reason why the space is crowded is because of the excitement of combination therapies bringing a possible cure for cancer. Our plan is to develop one or more, with an aim of at least two combination sponsored trials in 2018, and we're talking to several partners for possibilities with other combinations."

Market Competition

As Redkar noted, the oncology space is crowded with a trend toward combination therapies, which to date, often involves a Big Pharma company’s immuno-oncology assets being tested in combination with other partnered assets. Redkar said, "You have Merck, Bristol-Myers Squibb and Genentech that have checkpoint inhibitors on the market. But the strategy for large companies that are in the market is to expand sales from say $5 billion to $10 billion. That’s a different approach than someone like CBT trying to get their first product approval."

Dollars and Deals

CBT currently has partnerships with three companies in China with three of its products, Genor BioPharma, Chia Tai TianQing, and Beijing Pearl Biotechnology. Redkar noted that those three are currently in place, but, he added, "We're working on a large number of partnerships. They aren’t disclosed yet, but they’re in different stages for co-development and combination trials globally, not just in Asia."

What to Look For

With four pipeline products, two already in the clinic, a three-to-five-year timeline may have products in the marketplace, if all goes well. CBT hopes to have at least two of its compounds in multiple combination trials in 2018, and already has plans to extend its current trials in China and Australia into other countries, particularly the U.S., once promising data starts coming in.

"Five years is a long time," Redkar told BioSpace, "but if we’re are able to establish two good, solid, proof-of-concept trials, potentially even approval in those and have commercial partnerships, I think that would have created value for patients."

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