On Apr 7, 2015 Panther Biotechnology, Inc. ( OTC PINK : PBYA ), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders reported that it has entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk’s pharmaceutical technology assets (Press release, Panther Biotechnology, APR 7, 2015, View Source [SID1234517414]). The transaction will provide Panther Biotechnology with a proprietary, multinationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications.
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The lead development program is a ligand-drug conjugate, TRF-DOX, a combination of transferrin glycoproteins with Doxorubicin for targeted delivery to tumors with the reduction of serious side effects. Clinical results demonstrate significant improvement over Doxorubicin. In a randomized, double blind, controlled study of patients with advanced FIGO stage IV ovarian cancer, the addition of either TRF-DOX or Doxorubicin to conventional chemotherapy was compared. Treatment with TRF-DOX resulted in a statistically significant increase in survival over Doxorubicin in patients with drug resistant ovarian cancer. In a non-blinded study in patients with acute leukemia, TRF-DOX was dosed at 10% of the usual dose and demonstrated an 87% decline in cancer cells circulating in the blood and no extension of the disease to bone marrow in 100% of the patients. TRF-DOX also exhibited a complete response of both the primary tumor and metastatic lesions in a patient with angiosarcoma after having failed three months of standard chemotherapy. Panther plans to submit applications for a phase 2 study in ovarian cancer and a phase 1a / 1b study in lung cancer.
TRF-DOX leverages the targeting ability of the plasma protein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a dose reduction of ten to one hundred-fold kills all cancer cells in multiple indications. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.
Under the terms of the agreement, in exchange for substantially all the assets of Faulk Pharmaceuticals, Panther will issue shares of the common stock of Panther Biotechnology, Inc. in addition to a tiered royalty payment agreement based on the achievement of specified revenue milestones for any commercialized products based on the acquired technology. As part of the agreement, Panther will also gain access to a strong research and development network and a portfolio of domestic and international patents. The transaction is expected to close by the end of May.
"We are very excited to be acquiring Faulk Pharmaceutical’s technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer," stated Evan Levine, Chief Executive Officer of Panther Biotechnology. "This acquisition is a continuation of our strategy to build out a robust pipeline with novel pharmaceutical technologies that improve the efficacy and tolerability of validated therapies."
"Panther’s expanded pipeline now includes both early and later stage drugs that address multi-billion dollar market opportunities for cancer and autoimmune diseases. The oncology assets under exploration include molecules targeting certain cancer stem cells," said Dr. Jayesh Mehta who is a Director of Panther and Professor of Medicine at the Northwestern University Feinberg School of Medicine, and heads the Hematopoietic Stem Cell Transplant Program of Northwestern Memorial Hospital.
"Our decision to join Panther has been driven both by our conviction in their ability to leverage our technology platform and also by the high value we see in the TRF-DOX program," stated Dr. W. Page Faulk, founder of Faulk Pharmaceuticals. "We look forward to taking an active role in advancing TRF-DOX into new clinical trials, in addition to furthering the development of the pipeline of drug candidates we created. We are very pleased to become part of a company that shares our commitment to improving the lives of patients suffering from cancer and other diseases with high unmet medical needs."