NEW HAVEN, Conn.--(BUSINESS WIRE)--Kolltan Pharmaceuticals, Inc., a privately held clinical-stage company focused on the discovery and development of novel antibody-based drugs targeting receptor tyrosine kinases, today announced key oral and poster presentations related to its lead development programs at upcoming conferences. An abstract on the Company’s anti-KIT monoclonal antibody drug candidate, KTN0158, has been chosen for oral presentation at the 30th Annual Society for Immunotherapy of Cancer (SITC) Conference, being held November 4- 8 in National Harbor, Maryland. Kolltan will also be presenting preclinical data on KTN0158 and KTN3379, its anti-ErbB3 monoclonal antibody drug candidate, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held November 5- 9 in Boston, Massachusetts.
SITC Conference
Kolltan will be presenting data from a preclinical study evaluating the targeting of KIT on innate immune cells that enhances the antitumor activity of checkpoint inhibitors in vivo. KTN0158 is a proprietary, humanized anti-KIT IgG1 monoclonal antibody drug candidate being developed as a potential antibody-based therapy for cancer and mast cell-related diseases. The Company plans to file an investigational new drug application (IND) for KTN0158 with the FDA in the fourth quarter of 2015.
Targeting KIT on Innate Immune Cells enhances the Antitumor Activity of Checkpoint Inhibitors in vivo (Abstract ID 112276)
Authors: Richard Gedrich, Scott Seibel, and Theresa LaVallee, Translational Medicine, Kolltan Pharmaceuticals, Inc., New Haven, CT; Joseph Paul Eder, Yale Cancer Center, New Haven, CT
Session Title: Innate Immunity
Presentation Time: 5.00pm to 5:15pm EST
Session Date/ Time: Saturday, November 7, 2015, 4:05 pm to 5:30 pm EST
Location: Gaylord National Hotel & Convention Center
AACR-NCI-EORTC International Conference
Kolltan also will present data on KTN0158 from a preclinical study evaluating KTN0158 in dogs with spontaneous mast cell tumors.
KTN0158, a humanized anti-KIT monoclonal antibody, demonstrates antitumor activity in dogs with mast cell tumors (Abstract # C167)
Authors: Cheryl London, Sarah Rippy, Heather Gardner, Gerald Post, Neal Janson, Linda Crew, Theresa LaVallee, and Richard Gedrich, The Ohio State University, Columbus, OH, The Veterinary Cancer Center, Norwalk CT, and Kolltan Pharmaceuticals, Inc., New Haven, CT
Speaker: Cheryl London, DVM, PhD, Diplomate ACVIM (Oncology), Professor, The Thekla R. and Donald B. Shackelford Professorship in Canine Medicine, The Ohio State University
Session ID: Poster Session C
Session Title: Therapeutic Agents: Biological
Session Date/ Time: Sunday, November 8, 2015, 12:30pm to 3:30pm EST
Location: Exhibit Hall C-D, Hynes Convention Center
An additional poster at EORTC will feature preclinical data for Kolltan’s anti-ErbB3 (HER3) monoclonal antibody drug candidate, KTN3379. The Company will be presenting preclinical data that supports potential Phase 2 studies in BRAF mutant cancers and other tumor settings.
KTN3379 overcomes ErbB3-mediated resistance of BRaf/MEK inhibition in BRaf-mutated melanoma (Abstract # A154)
Authors: Gwenda F. Ligon, Jay S. Lillquist, Edward J. Natoli, Jr., Jennifer A. Pendleton, Ada Y. Vail, Andrew R. Proffitt, Christine Y Lubeski, J. Paul Eder, Carolyn F. Sidor, Ronald A. Peck, Theresa M. LaVallee, and Diego Alvarado, Kolltan Pharmaceuticals, Inc., New Haven, CT; Yale Cancer Center, New Haven, CT
Speaker: Diego Alvarado, PhD, Director, Research, Kolltan Pharmaceuticals
Session ID: Poster Session A
Session Title: Therapeutic Agents: Biological
Session Date/ Time: Friday, November 6, 2015, 12:15pm to 3:15pm EST
Location: Exhibit Hall C-D, Hynes Convention Center
About KTN3379
KTN3379 is a human monoclonal antibody designed to block the activity of ErbB3 (HER3), a receptor tyrosine kinase (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, lung, gastric, and melanoma. While there are several successful currently marketed products targeting two members of the EGFR family, there are none that directly target ErbB3. In cancer, ErbB3 activation can be driven by its ligand, neuregulin (NRG), or in its absence, through overexpression of its co-receptor ErbB2 (HER2).
Kolltan is conducting multiple clinical trials evaluating KTN3379 in the treatment of solid tumors. These trials include an ongoing Phase 1b multi-center, open-label, dose escalation clinical trial of KTN3379 in patients with solid tumors, with expansion cohorts testing KTN3379 in combination with cetuximab, erlotinib, vemurafenib, or trastuzumab. In addition, the Company is conducting a Phase 1b study in thyroid cancer, evaluating the treatment of patients with radioactive iodine refractory BRAF mutated cancers with a combination of KTN3379 and vemurafenib. A third clinical study is evaluating tissue responses to KTN3379 in newly diagnosed patients with head and neck cancers who are treated with KTN3379 prior to their surgical resection.
About KTN0158
KTN0158 is a proprietary, humanized monoclonal antibody designed using structure-based approaches to block the activation of KIT, an RTK that is expressed on many cancers and mast cells. Kolltan applied novel insights about the x-ray crystallographic structure of the KIT receptor to identify a unique way to inhibit the function of KIT through binding to the domain that is near the cell membrane and blocking dimerization. This targeting of KIT proximal to the membrane is a novel approach compared to targeting the ligand and led to Kolltan’s discovery of KTN0158.
There are currently no KIT-targeting antibodies on the market for any disease indication. In oncology, KIT is expressed in tumors such as GIST, melanoma, AML, SCLC, and others. No KIT-targeting drugs are approved for non-GIST tumor types and treatment of GIST tumors with approved multi-targeted small-molecule tyrosine kinase inhibitors (TKIs) does not always lead to long-term clinical benefit due to resistance, including secondary mutations that overcome small-molecule drug approaches.
As a monoclonal antibody, the Company believes KTN0158 is particularly suited to block KIT dimerization and inhibit activation and signaling of the receptor and therefore lead to potent inhibition of both wild-type and mutant KIT forms. Kolltan is planning to file an IND with the FDA for KTN0158 in 2015 followed by the initiation of clinical trials in oncology in 2016. A second IND filing for KTN0158 is anticipated in 2016 for neurofibromatosis 1 (NF1). KIT and mast cells have been associated with the etiology of NF1, an orphan disease afflicting approximately 100,000 individuals in the U.S.
About Kolltan Pharmaceuticals
Kolltan, a privately held clinical-stage company, is focused on the discovery and development of novel, antibody-based drugs targeting RTKs 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 RTKs. Kolltan is working in close collaboration with the laboratory of Kolltan Co-Founder, Dr. Joseph Schlessinger, as well as the Yale University medical and scientific community. The Company has a broad and novel portfolio of therapeutic biologics targeting multiple RTKs that are advancing in clinical and preclinical development and are expected to generate multiple near-term milestones. Kolltan’s most advanced product candidates include KTN3379, a human monoclonal antibody designed to block the activity of ErbB3 which is in Phase 1b clinical trials in solid tumors, and KTN0158, a humanized monoclonal antibody designed to block the activation of KIT, which is being developed as a potential therapy for cancer and mast cell-related diseases and is anticipated to enter clinical trials in early 2016.
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.
