On April 23, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, and CrystalGenomics, Inc., (KOSDAQ:083790), a Korea-based biopharmaceutical company with drug discovery, development and commercialization capabilities, reported a co-development agreement for an investigational combination therapy of CBT-501 and CG200745 across a variety of solid tumors with high unmet medical needs (Press release, CBT Pharmaceuticals, APR 23, 2018, View Source [SID1234525574]).

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Under the terms of the exclusive agreement, CBT and CrystalGenomics will be responsible for the co-development and global commercialization of the combination of CBT-501 and CG200745 in multiple tumor types. A Phase Ib/II study is expected to be initiated by the end of 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, Ph.D., President and Chief Executive Officer. "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."

"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" said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) and ligand (PD-L1) have been considered as major breakthroughs in the treatment of various cancers including melanoma, renal, lung, and bladder cancers. However, despite the robust efficacy observed in these cancers, the majority of patients either do not respond or eventually relapse due to resistance which may be innate or acquired. There has been recent reports suggesting immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501 for its immunomodulatory effects in addressing the patient population that do not respond to single agent immunotherapy.

About CBT-501

CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors, recurrent or refractory to standard of care therapies (NCT03053466, NCT03374007).

About CG200745

CG200745, is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer (NCT02737228) and Phase Ib for myelodysplastic syndrome (NCT02737462) in Korea. CG200745 has the potential to be a best-in-class compound based on preclinical and interim Phase Ib/II clinical data and is projected to have superior pharmacokinetic (PK) profile, pharmacodynamic (PD) response, efficacy, and safety, over other HDAC inhibitors. In its first-in-human study of the toxicity, PK and PD in patients with refractory solid malignancies, stable disease was observed in 57.1% of the subjects treated with CG200745 as monotherapy and excellent safety profile was observed as the maximum tolerated dose (MTD) was never reached (NCT01226407).