Unigene Laboratories Inc., Peptelligence(TM) Drug Delivery Platform and Certain Assets comprises Peptelligence™ drug delivery, recombinant manufacturing platforms, and company’s Biotechnologies Strategic Business Unit. Peptelligence offers intellectual property covering drug delivery and manufacturing technologies, peptide research and development, and proprietary know-how.
Enteris BioPharma, Inc. Initiates Clinical Program for Tobrate™ in Uncomplicated Urinary Tract Infection
Jul 13 16
Enteris BioPharma, Inc. announced the initiation of its clinical program for Tobrate™, an oral tablet formulation of tobramycin, for the treatment of uncomplicated urinary tract infections (uUTIs). Tobrate™ utilizes the company's proprietary Peptelligence™ platform, a novel formulation technology that enables oral delivery of molecules that are typically injected, including peptides and BCS class II, III, and IV small molecules. As detailed in the Investigational New Drug (IND) application, which was accepted by the U.S. Food and Drug Administration (FDA) in April, Tobrate™ will initially be evaluated in a randomized, double-blind, single ascending dose/multiple ascending dose (SAD/MAD) Phase 1 pharmacokinetic (PK) study in 24 healthy volunteers. Data from the Phase 1 study is expected in the first quarter of 2017. Enteris announced that it has partnered with RRD International, LLC (RRD) for the development of Tobrate™. Working closely with Enteris, under a product development structure, RRD will provide strategic, regulatory and clinical development support to advance Tobrate™ in the clinic through the end of Phase 2 meeting with FDA. As part of this elationship, RRD will share risk by taking an equity stake in Enteris. Additionally, Enteris BioPharma's oral peptide delivery technology is the subject of several active external development programs, the most advanced of which include Tarsa Therapeutics' TBRIA, an oral calcitonin for patients with postmenopausal osteoporosis and an oral formulation of Cara Therapeutics' CR845, a potent peripheral kappa opioid receptor agonist which demonstrated positive safety, tolerability, PK and efficacy data in a recently completed Phase 2a clinical trial in chronic pain patients with osteoarthritis of the knee or hip.
Enteris BioPharma, Inc. Announces Management Appointments
Jan 19 16
Enteris BioPharma, Inc. announced the appointment of Joel Tune as Chief Executive Officer and the promotion of Paul Shields, Ph.D., to Chief Operating Officer. Mr. Tune and Dr. Shields, along with Brian Zietsman, President and CFO, will be responsible for leading Enteris BioPharma as the company pursues strategic alternatives to capitalize on multiple growth opportunities involving its proprietary oral delivery technology, highly-differentiated product pipeline, and cGMP compliant recombinant peptide and protein manufacturing facility. Mr. Tune most recently, has been advising early stage and small pharmaceutical, biotech, contract services and medical device companies on a variety of matters including strategy, operations and business development. Prior to his promotion to Chief Operating Officer, Dr. Shields served as Enteris BioPharma's Vice President of Operations since the company's founding in July 2013. Dr. Shields previously served as the Vice President, Manufacturing Operations for Unigene Laboratories from 2005 to 2013.