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Nemucore Medical Innovations Announces Licensing Agreement With Pfenex Inc. Enabling Manufacture of Anti-Cancer Therapeutic NMI-8000, the Biologically Active Form of Mullerian Inhibitory Substance (MIS)

WORCESTER, Mass., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Nemucore Medical Innovations, Inc., a privately held, clinical-stage biopharmaceutical company dedicated to the development of therapies targeting multi-drug resistant cancers with a special emphasis on highly lethal women’s cancers, today announced an agreement with Pfenex Inc. (NYSE:PFNX) for a non-exclusive license to a production strain derived from Pfenex’s protein production platform, Pfēnex Expression Technology®, to develop and produce NMI-8000. NMI-8000 is the biologically active form of Müllerian Inhibitory Substance (MIS), which targets MIS type II receptor-positive cancers often associated with the female reproductive system. Financial terms were not disclosed.

The agreement follows a recent National Cancer Institute SBIR-funded program whereby Nemucore and Pfenex successfully developed a series of novel expression vectors and production strains for NMI-8000. The Pfenex platform is based on automated, high-throughput parallel screening of large libraries of novel, genetically engineered Pseudomonas fluorescens bacterial expression strains and expression vectors.

Timothy P. Coleman, Ph.D., Chairman, Chief Executive Officer and President of Nemucore commented, “NMI-8000 represents a completely novel therapeutic class of agents capable of treating female reproductive cancers by preferentially eliminating MIS type II receptor cells often associated with the chemo-resistant cancer stem cell fraction of the tumor. Although the therapeutic potential of MIS has long been recognized by the oncology community, until now, no one has been able to produce this biologic in enough quantity to initiate clinical trial development. We have now solved this challenge through the successful development of a production strain with Pfenex that can produce NMI-8000 at commercially relevant levels and are excited to advance NMI-8000 into clinical development.”

NMI-8000 is a member of the human TGF-β superfamily of proteins. The naturally occurring biological activity of this active MIS fragment is associated with regression of female reproductive tissue (Müllerian duct tissue) during normal male embryonic sexual differentiation. As many female reproductive cancers are associated with Müllerian duct-derived tissue, those cancers expressing Müllerian-associated receptors are prime candidates for NMI-8000 treatment. Preclinical studies have demonstrated that MIS biological activity induces regression or apoptosis of gynecological tumors with low systemic toxicity. In addition, MIS has been shown to specifically target ovarian cancer stem cells that respond poorly to current chemotherapeutics. Historically, because of its role as a cell cycle regulator, MIS has been extremely difficult to produce beyond low single-digit milligram per liter levels in mammalian production platforms, and has seen equally limited success using other non-mammalian production platforms.

About Nemucore Medical Innovations, Inc.

Nemucore Medical Innovations, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to the development of therapies targeting multi-drug resistant cancers with a special emphasis on highly lethal women’s cancers. Nemucore's most advanced candidate NMI-900, a potential "best-in-class" therapeutic for the treatment of ovarian cancer, is expected to begin a Phase 2b clinical trial in mid-2016. Two additional candidates are anticipated to enter clinical trial development later in 2016, targeting a variety of difficult-to-treat oncology indications, including breast, non-small cell lung cancer (NSCLC), myelodysplastic syndrome (MDS) and other cancers. For more information, please visit our website at www.Nemucore.com.

Contacts: Tim Coleman (investors) Nemucore Medical Innovations (508) 762-1017 BCC Partners (media) Karen L. Bergman (650) 575-1509 kbergman@bccpartners.com Jen LaVin (207) 360-0473 jlavin@bccpartners.com

Source:Nemucore Medical Innovations, Inc.