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companies to watch - 2013 Roundup of the Centyrex venture by transitioning the technology into the Janssen R&D; BCE and expanding the use of the Centyrin platform." That means Centyrex will essentially feed the pipeline with newer, early-stage products, handing them off to the BCE at the clinical development stage. The BCE has also assumed responsibility for Centyrin products already in development, as well as taking in a handful of Centyrex employees. COMING IN 2014 • "We look forward to further studying and progressing our work in oncology. We also look forward to applying the Centyrin technology to targeted therapies that have increased safety and efficacy." April — StemCells "Things are now starting to get really interesting," says CEO Martin McGlynn about the company's new-year status. He cites early clinical data from trials of its proprietary purified human neural stem cells (HuCNS-SC) in spinal cord injury, dry AMD (age-related macular degeneration), Pelizaeus-Merzbacher disease (PMD), and Batten disease. "Confirming the extraordinary results seen in the various animal models used to justify the initiation of the clinical trials now underway or already completed." Phase 2 trials will get underway in 2014, with interim efficacy results planned for mid-2015. StemCells also recruited some industry veterans, such as Eliseo Salinas, M.D., as EVP R&D; and Greg Schiffman, former CFO of Dendreon. Earlier in the year, the company built and commissioned its own state-of-the-art cGMP cell-processing facility in Sunnyvale, CA. It raised money in several ways, receiving the first tranche ($3.8 million) out of a $19.3 million California Institute for Regenerative Medicine funding of an IND (investigational new drug) for restoration of lost memory in Alzheimer's disease, a $10 million loan from Silicon Valley Bank, and $25.3 million in equity-based financings. DEVELOPMENTS TO DATE • August: Promising two-year data from patients with Pelizaeus-Merzbacher disease (PMD) treated with HuCNSSC cells began showing gains in neurological function and more pronounced myelination compared to year one. • June – October: Phase 1/2 clinical trial for chronic spinal cord injury was expanded to the U.S. and Canada. Eight of the 12 patients in the current study already have been transplanted in Switzerland. • September: The FDA approved the expansion of the number of clinical sites from two to five in the company's Phase 1/2 dry AMD trial and a five-fold increase in the cell dose. Seven of the 16 patients in the study already have been transplanted. COMING IN 2014 • determine next steps for the advancement of the PMD program • complete dosing in Phase 1/2 chronic spinal cord injury and dry AMD trials • initiate controlled Phase 2 chronic spinal cord injury and dry AMD trials • report data from the current Phase 1/2 spinal cord injury and dry AMD trials May — Immune Pharmaceuticals Survival by merger. In the spring when we covered this Israeli developer of in-licensed cancer and inflammation drugs, the company was in the early stages of a merger with troubled EpiCept, primarily with the aim of buying an entry into the U.S. public capital markets. Since then, its focus has been divided between completing the merger — actually structured as a reverse merger — and pushing along its pipeline products: chemo-related pain drug AmiKet and chemokine blocker bertilimumab. Reading between the lines of its roundup responses, it seems the company has made progress on both fronts, as CEO Daniel Teper expresses in this summary of the company's status: "Immune has the ability to finance through public markets and execute its clinical milestones in 2014 to 2015." DEVELOPMENTS TO DATE • August: closed merger with EpiCept with Immune historical shareholders owning approximately 85 percent of the combined company on a fully diluted basis • November: listed on OTCQX (New York) and NASDAQ OMX First North Premier (Stockholm) • During 2013: identified and planned Phase 2 clinical trials for bertilimumab in an orphan indication (Bullous pemphigoid), which will add to the already launched Phase 2 trial in ulcerative colitis COMING IN 2014 • up-listing to NASDAQ (New York) • full two-year financing through secondary public offering • partnering of Phase 3-ready AmiKet with fast-track designation for chemotherapy-induced neuropathic pain • Phase 2 data for bertilimumab in Bullous pemphigoid, an orphan autoimmune skin disease June — Cempra A blockbuster in its pipeline? That was the central question in Cempra's CtW in mid-2013. Proof is everything, especially for a company that claims it has created both a new class of antibiotics, the "fluoroketolides," and a new way of delivering them, "loading dose formulation," exemplified by its lead drug candidate, oral solithromycin. Cempra's founder, President, and CEO Prabhavathi Fernandes says, "We have reached significant milestones in the second half of 2013, propelling our company to its next stage of development." On the heels of its June CtW, the company raised $54 million in a public offering of common stock and secured up to $58 million from a BARDA (Biomedical Advanced Research and Development Authority, HHS) drug development contract to develop solithromycin for pediatric use and biodefense. February 2014 LifeScienceLeader.com 33