HOLLISTON, Mass. – October 13, 2014 – Veristat, a full service Clinical Research Organization (CRO), announced today that Molecular Templates, a venture-backed biopharmaceutical company that develops next-generation immunotoxins for the treatment of cancer and other serious diseases, has entered into a Preferred Provider Agreement with Veristat.
“We are elated following the FDA’s approval of our IND application for MT-3724 and are eager to begin the next steps of our clinical journey with Veristat. Veristat will support the initiation of our Phase I program, which will assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of MT-3724 in patients with non-Hodgkin’s B-Cell Lymphoma who are resistant or refractory to all currently available therapies,” commented Jason Kim, President and CFO, Molecular Templates.
Under this agreement, Veristat will provide a broad spectrum of clinical support given their depth of experience in oncology and work with novel therapeutics. Services will include clinical monitoring, safety management, data management, data monitoring committee services, statistics and medical writing support for the company's lead compound, MT-3724. This compound is the first immunotoxin to target the B-cell specific CD20 surface antigen. MT-3724 will enter clinical trials for the treatment of patients with relapsed non-Hodgkin’s lymphoma in the fourth quarter of 2014.
David Valacer, Chief Medical Officer, Molecular Templates stated, “By partnering with a like-minded, scientifically focused company such as Veristat, we have found a core team of high caliber collaborators who can help us to accelerate the development of our new class of targeted biologic therapies. This agreement with Veristat is a great step forward for our company given Veristat’s therapeutic and regulatory understanding of both the fundamental elements of clinical research and the broader impact of our work.”
Barbara Balser VMD, Executive Vice President and Chief Scientific Officer of Veristat noted, “We are grateful to be chosen by Molecular Templates and look forward to a long and collaborative working relationship. Now that the FDA has cleared the path, the Veristat team can begin work on the Phase I study, an important milestone in the development of this compound. Our clinical team is focused on making a difference in the success of the program and we are honored to be able to contribute our expertise and support to the critical components of the clinical development of this important novel therapy.”
About Molecular Templates Molecular Templates is a venture-backed biopharmaceutical company focused on the discovery and development of a new class targeted biologic therapeutics with distinct advantages over existing Antibody Drug Conjugates (ADCs). This biologic platform technology is being used to develop multiple therapies across a wide range of cancers. The Company’s lead compound, MT-3724, an immunotoxin targeting CD20, will initiate a Phase I study for the treatment of non-Hodgkin’s Lymphoma this year. For more information, please visit moleculartemplates.com.
About Veristat Veristat, Inc. is an innovative, science-focused clinical research organization (CRO) in its 20th year of providing expertise in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark. For more information, please visit www.veristat.com.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Molecular Templates’ drug candidates. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. Any forward-looking statements contained in this press release speak only as of the date hereof, and each of Molecular Templates and Veristat expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.