Spectrum Pharma (NASDAQ: SPPI) announced it has entered into a licensing agreement with Hanmi Pharmaceuticals for poziotinib, a drug being investigated for the treatment of cancer.
Poziotinib (HM781-36B) is a novel, oral, quinazoline-based pan-HER inhibitor that irreversibly blocks signaling through the HER family of tyrosine-kinase receptors including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), as well as HER receptor mutations; this, in turn, leads to inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of HER family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently, poziotinib is being investigated by Hanmi in EGFR-mutant NSCLC (Phase 2, sponsored by National OncoVenture), gastric cancer (Phase 2), head & neck cancer (Phase 2) and HER2 positive breast cancer (Phase 2, sponsored by National OncoVenture). National OncoVenture is a funding initiative by the Korean government\'s National Cancer Center.
“We continue to make progress on achieving our goal of becoming leaders in Oncology, and we believe that this late clinical stage drug acquisition continues to build and further strengthen our oncology portfolio,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “Poziotinib has shown promising early clinical activity with 60% (6/10) of patients with breast cancer having responses in Phase 1 clinical trials. These patients were heavily pre-treated, had previously received and failed multiple lines of treatment, and had been previously treated with the HER2-directed therapies, trastuzumab and lapatinib. In addition, tumor responses were also seen in patients with gastric cancer, colorectal cancer, and lung cancer. We are pleased to continue to work closely with Hanmi Pharmaceuticals and further our ongoing collaboration as we work together to bring more treatment options to cancer patients.”
“Despite the availability of a number of HER2-directed therapies, most patients with metastatic breast cancer relapse and die because of progressive disease,” said Dr. Francisco Esteva, Professor of Medicine, Director, Breast Medical Oncology Associate, Director of Clinical Investigation, Laura and Isaac Perlmutter Cancer Center New York University Langone Medical Center. “Therefore, there is a critical need for new treatments to improve the outcome for these patients. The fact that breast cancer patients previously treated with trastuzumab and lapatinib have shown responses to poziotinib is very exciting. If these early data are confirmed in additional clinical trials, poziotinib could become a very important treatment option for patients with breast cancer.”
Under the terms of the agreement, Spectrum received exclusive license to develop, manufacture and commercialize worldwide excluding Korea and China. Hanmi shall remain responsible for the cost of the ongoing Phase 2 studies through completion.

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