The primary endpoint of the study will be Objective Response Rate, and secondary endpoints include Duration of Response, Progression-Free Survival, Overall Survival and safety parameters.Part one of the study will enroll up to 20 patients in each of two dose cohorts: 500mg/m2 and 750mg/m2.These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32ND Annual Meeting of the Society for Immunotherapy of Cancer (SITC), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies.
When available, copies of the final prospectus relating to the offering may be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146, or email: [email protected]; J. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Evercore Group L. C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or email: [email protected] (Nasdaq: ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced data from preclinical studies with ADU-1604, the company’s humanized anti-CTLA-4 monoclonal antibody.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. Data from these in vitro and in vivo studies demonstrate the potency of ADU-1604 and its ability to inhibit tumor growth and enhance T cell-dependent antibody responses.
Furthermore, proof of mechanism was demonstrated by a clear signal in a plasma nitrogen endpoint. “These data support the hypothesis that SYNB1020 treatment may provide clinical benefit in patients with UCDs or liver disease, and will inform dose selection in our planned Phase 1b/2a study of SYNB1020 in patients, which we expect to begin in the first half of 2018.” “This first-in-human study represents a significant milestone for our new class of Synthetic Biotic medicines and demonstrates that they can operate from the gastrointestinal tract to metabolize systemic toxins,” said JC Gutiérrez-Ramos, Ph.
SYNB1020, is a novel, first-in-class, Synthetic Biotic medicine that is orally delivered and designed to treat elevated blood ammonia levels, or hyperammonemia, in genetic urea cycle disorders (UCD) or in chronic liver disease “The positive data from our Phase 1 study in healthy volunteers, demonstrates that SYNB1020 was well-tolerated and had a statistically significant dose-dependent effect on the level of a nitrogen endpoint, providing evidence to support its mechanism of action,” said Aoife Brennan, M. D., Synlogic’s president and chief executive officer.
“How can I get part-timers that come in and give me the available supply to satisfy the demand?