New Combo Treatment for Advanced Solid Tumors is Goal of Partnership

New Combo Treatment for Advanced Solid Tumors is Goal of Partnership

CBT Pharmaceuticals and CrystalGenomics announced they are developing a combination therapy — CBT-501 plus CG200745 — with the potential to treat people with various advanced solid cancers.

The companies plan to test the investigative treatment in a Phase 1b/2 trial expected to open this year.

“This partnership with CrystalGenomics enables CBT to leverage their clinical development expertise while further strengthening our immuno-oncology combination approach to deliver promising best-in-class treatments to patients with cancer,” Sanjeev Redkar, PhD, president and CEO of CBT Pharmaceuticals, said in a press release. “We believe the combination therapy of CBT-501 and CG200745 has the potential to be synergistic for patients across a range of cancers where alternative therapies are needed.”

CBT-501 (genolimzumab) is an immunotherapy that CBT Pharmaceuticals, based in the U.S. and China, is developing to treat solid tumors. A monoclonal antibody, it is called a programmed death-1 (PD-1) inhibitor because it targets a protein — PD-1 — present on the surface of immune cells, and which many cancer cells use as a type of “shield” to escape detection by the immune system.

Blocking PD-1 eliminates that shield, helping a person’s immune system target and destroy cancer cells.

This antibody has a safety profile found in preclinical studies to be comparable to approved anti-PD-1 antibodies like  Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab), CBT reports on its website.

CG200745, being developed by CrystalGenomics of South Korea, is a next-generation, pan-histone deacetylase (HDAC) inhibitor, a class of chemical compounds that work to block with specificity gene expression, or activity, in tumor cells.

“We are excited to work with the CBT team, who are uniquely qualified to accelerate development of our novel HDAC inhibitor in combination with CBT-501, a differentiated anti-PD1 antibody” Joong Myung Cho, PhD, chairman and CEO of CrystalGenomics, said in the release.

CBT-501 is in two Phase 1 clinical trials (NCT03053466 and NCT03374007) assessing its safety, tolerability, pharmacokinetic properties and most effective dose in patients with advanced solid tumors. The first study is taking place in Australia and runs through March; the second is being conducted in China and includes lymphoma patients. Both are recruiting patients and information is available by clicking on their respective identification numbers.

CG200745 is now in a Phase 1/2 clinical trial in patients with advanced pancreatic cancer  (NCT02737228) and in a Phase 1/2 study (NCT02737462) in people with myelodysplastic syndrome, a cancer of the blood-forming cells in bone marrow. Both studies are being conducted at a single site in Seoul, and recruiting patients.

In a Phase 1 safety and tolerability study (NCT01226407) in cancer patients whose solid tumors failed to respond to standard care, CG200745 was found to be both safe and well-tolerated, with signs of efficacy. Stable disease lasting at least six weeks was seen in 57.1 percent of enrolled patients, or 16 of 28 people, a study published in 2015 reported.