Rexahn Pharmaceuticals Inc., of Rockville, Md., reported final data from the dose-escalation segment (stage 1) of a phase Ib/IIa trial showing that in metastatic renal cell carcinoma patients that have previously received multiple therapies, Archexin treatment produced both stable disease (which persisted for up to 383 days) and a reduction in tumor burden. Read More
Genticel SA, of Toulouse, France, reported 12-month data from its phase II study of immunotherapeutic candidate GTL001, which is designed to clear human papillomavirus (HPV) 16 and/or 18 infection, showing clear statistical separation (p=0.018) in the predefined subgroup of patients with normal cytology, which comprises about 75 percent in GTL001's target population. Read More
Abbvie Inc., of North Chicago, and the University of Chicago said they entered a five-year collaboration agreement designed to improve the pace of discovery and advance medical research in oncology at both organizations. Read More
Peptimimesis SAS, of Strasbourg, France, has received €500,000 (US$600,000) as the first tranche of a €1.2 million investment from Cap Innov'Est, a regionally based seed fund. Read More
The Government Accountability Office (GAO) released a report on high-containment laboratories, in response to concerns raised over safety lapses in federal laboratories in 2014 and 2015, finding that most of the eight departments and 15 agencies reviewed had policies that were not comprehensive. Specifically, policies at five departments and nine agencies were not comprehensive because they did not contain all six elements that the GAO identified as key for managing biological agents in high-containment laboratories. Those elements are incident reporting, roles and responsibilities, training, inventory control, inspections and requiring adherence to or referencing leading laboratory safety guidance. Three of the eight departments and five of the 15 agencies did not have policies. In addition, as of December 2015, two departments and five agencies did not have up-to-date policies. Read More
NEW DELHI – The U.S. FDA has rapped yet another Indian pharma company with a warning letter that drew attention to "significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals." Read More
Positive data with Oncosec Medical Inc.'s Immunopulse interleukin-12 (IL-12) electroporation therapy against melanoma "set pulses racing," in the words of H.C. Wainwright analyst Mark Breidenbach, as investors cheered evidence that the approach could boost CD8+ tumor-infiltrating lymphocytes (TILs) and thereby set patients up to benefit more from anti-PD-1/PD-L1 therapy, the emerging standard of care in the deadly skin cancer. Read More
LONDON – Gut microbiome specialist Enterome Bioscience SA has raised €14.5 million (US$16.5 million) in a series C financing that will fund phase I and phase II development of the lead program in inflammatory bowel diseases (IBD), which is based on small molecules in-licensed earlier this week from Vertex Pharmaceuticals Inc. Read More
Pharma's growing recognition of the strategic importance of the microbiome in drug discovery as well as its alignment with the company's approach to development paved a path for Second Genome Inc. to close a $42.6 million series B round co-led by Pfizer Venture Investments and Roche Venture Fund, Peter DiLaura, Second Genome's president and CEO, told BioWorld Today. Read More
