Pharma Focus Asia

CStone and IMPACT Therapeutics' clinical collaboration progresses to IND filing acceptance for CS1001+IMP4297 combination therapy

Friday, February 08, 2019

CStone Pharmaceutical and IMPACT Therapeutics, Inc. ("IMPACT") today jointly announced that an Investigational New Drug (IND) filing has been accepted by the National Medical Products Administration (NMPA) for the combination of CStone's fully-human anti-PD-L1 monoclonal antibody (mAb) CS1001 with IMPACT's PARP inhibitor IMP4297 for multiple tumor types. CStone and IMPACT entered into a worldwide clinical collaboration for the two products in 2018, and the acceptance of the IND filing marks a major milestone in the global clinical collaboration.

Upon IND approval, CStone and IMPACT plan to initiate a joint clinical study that will assess the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of the anti-PD-L1 antibody CS1001 paired with PARP inhibitor IMP4297 as a combination therapy for patients with advanced solid tumors.

Both preclinical and clinical data suggest that the combination of a PD-L1 antibody with PARP inhibition has the potential to produce a synergistic anti-tumor effect. The pairing of CS1001 and IMP4297 is expected to prolong the survival of advanced cancer sufferers and potentially expand the scope of indications of each drug, leading to significant benefits to cancer patients as a result.

CStone's Chairman and CEO Dr. Frank Jiang commented: "Combination therapy is CStone's core R&D strategy. CS1001 is one of our backbone IO pipeline candidates, while IMP4297 has the potential to be the best-in-class. We are thrilled that IMPACT chose us as a strategic partner in 2018 and happy to see our collaboration moving forward. We look forward to achieving positive results in clinical studies and benefiting more Chinese patients."

IMPACT's CEO Dr. Bao Jun said: "We are delighted to be collaborating with one of China's leading biopharmaceutical companies. The successful filing of the IND for the combination of IMP4297 and CS1001 to begin Phase I studies demonstrates the close cooperation between both companies. We look forward to bringing improved treatment options for cancer patients through this partnership."

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