Kolltan Pharmaceuticals Begins Phase 1b Cancer Study Evaluating KTN3379 in Combination with Multiple Targeted Therapies at Sarah Cannon Research Institute

Four-arm Clinical Trial Initiated and Enrolling Patients

NEW HAVEN, Conn.--()--Kolltan Pharmaceuticals today announced the initiation of the Phase 1b portion of its KTN3379 clinical trial program in combination with targeted therapies. Kolltan is a privately held biopharmaceutical company focused on the discovery and development of novel antibody-based drugs targeting receptor tyrosine kinases (RTKs). The Phase 1b is evaluating KTN3379 in specific cancer populations and in combination with cetuximab, erlotinib, vemurafenib and trastuzumab, all currently approved cancer drugs. These combinatorial agents were chosen based on preclinical studies. The first patient was treated at the Sarah Cannon Research Institute in Nashville, TN, where the study is being conducted by principal investigator, Dr. Todd M. Bauer. The study will also be conducted at Sarah Cannon Research Institute’s Denver site with Dr. Gerald S. Falchook serving as principal investigator.

KTN3379 is a human monoclonal antibody designed to block the activity of ErbB3, an RTK that belongs to the epidermal growth factor receptor, or EGFR, family. ErbB3 is believed to be an important receptor regulating cancer cell growth and survival. ErbB3 is expressed in many cancers including head and neck, breast, colorectal, lung, gastric, ovarian and melanoma. While there are several successful currently marketed products targeting two members of the EGFR family, there are none that directly target ErbB3.

"The initiation of the Phase 1b portion of our KTN3379 clinical program is critical for the evaluation of patients with several tumor types using selected combinations of targeted therapies," said Jerry McMahon, Ph.D., President and Chief Executive Officer of Kolltan Pharmaceuticals. “We plan to use the data from this portion of our trial to select combinations and indications to move into larger Phase 2 trials next year. We are delighted to have Sarah Cannon partner with us in conducting this study.”

The data from the recently completed dose escalation portion of the Phase 1 clinical trial have been selected for an oral presentation at the upcoming 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, November 18-21, 2014. The oral presentation will describe results from the dose escalation portion of the Phase 1 clinical trial program that focused on pharmacokinetics, biomarkers and safety and will discuss the preclinical data to support the expansion into Phase 1b combination studies. The preclinical data supporting this clinical trial is planned to be presented at upcoming medical conferences.

About Kolltan Pharmaceuticals

Kolltan, a privately held clinical-stage company, is focused on the discovery and development of novel antibody-based drugs targeting receptor tyrosine kinases for the treatment of cancer and other diseases with significant unmet need. Kolltan’s founders and members of its management team have deep expertise and a proven track record in drug discovery, development and commercialization of innovative therapeutics, including drugs targeting kinases. Located adjacent to the Yale Medical School in New Haven, Connecticut, Kolltan is working in close collaboration with the laboratory of Kolltan Co-Founder, Dr. Joseph Schlessinger, as well as the Yale medical and scientific community, to bring important medicines to cancer patients and other patients with serious diseases. In addition to KTN3379, the company has two preclinical programs targeting the KIT RTK for inflammatory diseases and oncology, as well as a discovery pipeline consisting of product candidates directed at a range of RTK targets.

Forward-Looking Statements

Any statements in this news release about future expectations, plans and prospects for Kolltan constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of a variety of important factors. Kolltan anticipates that subsequent events and developments may cause its views to change. However, while Kolltan may elect to update these forward-looking statements in the future, Kolltan specifically disclaims any obligation to do so.

Contacts

Media Inquiries
Burns McClellan
Justin Jackson, 212-213-0006
jjackson@burnsmc.com
or
Investor Inquiries
Kolltan Pharmaceuticals, Inc.
203-907-0951

Contacts

Media Inquiries
Burns McClellan
Justin Jackson, 212-213-0006
jjackson@burnsmc.com
or
Investor Inquiries
Kolltan Pharmaceuticals, Inc.
203-907-0951