SAN DIEGO–(BUSINESS WIRE)–Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical needs, today announced the appointment of Gunnar Kaufmann, Ph.D., as Chief Scientific Officer and Igor Bilinsky, Ph.D., as Chief Business Officer.
“Dr. Kaufmann brings to Oncternal significant expertise in advancing preclinical programs from concept to the clinic and successfully initiating and executing collaborations with corporate partners, and Dr. Bilinsky has extensive experience in business strategy, corporate development and strategic partnering,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe that the addition of these two industry veterans to our executive team will be key in helping us achieve our ambitious goals of advancing our three oncology drug programs.”
Dr. Kaufmann, who has extensive experience in discovery and preclinical development of both biotherapeutics and small molecule drug product candidates, will focus on progressing Oncternal’s preclinical product development programs and exploring opportunities to expand the Company’s product development pipeline. Prior to joining Oncternal, Dr. Kaufmann served as Senior Vice President, Immunotherapy, Head of Research and Global Partnerships at Sorrento Therapeutics, Inc. Dr. Kaufmann was previously a faculty member at The Scripps Research Institute and still serves as Adjunct Assistant Professor in the Departments of Chemistry and Immunology and Microbial Science. Dr. Kaufmann holds a B.S. in human biology from Phillips University Marburg, an M.S. in human biology from Ernst-Moritz-Arndt University Greifswald, and a Ph.D. from The Scripps Research Institute’s Biology Program.
Dr. Bilinsky, who has more than 20 years of experience as a senior executive and consultant to the biotechnology industry, will be responsible for strategic planning and advancing corporate and business development initiatives at Oncternal. Dr. Bilinsky formerly served as Chief Operating Officer of AmpliPhi Biosciences Corporation, a biotechnology company developing targeted therapies for patients with life-threatening bacterial infections. Previously, Dr. Bilinsky was General Manager, Immuno-Oncology, and Senior Vice President, Special Operations and Research Operations, at Ignyta, Inc., a biotechnology company focused on precision medicine in oncology that was acquired by Roche. Prior to joining Ignyta, Dr. Bilinsky was Senior Vice President, Corporate Development at Vical Inc., Vice President, Business Development and Special Operations at Halozyme Therapeutics, Inc., and Chief Executive Officer of Androclus Therapeutics, Inc. Dr. Bilinsky was previously a principal in the healthcare practice of the Boston Consulting Group, Inc., where he advised companies in the biotechnology and pharmaceutical industries on business strategy, operational performance, and mergers and acquisitions. Dr. Bilinsky received his B.S. in physics from the Moscow Institute of Physics and Technology and his Ph.D. in physics from the Massachusetts Institute of Technology.
Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine. In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine. CIRM has also provided funding to support development programs for cirmtuzumab and a CAR-T product candidate that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.
In August 2019, Oncternal announced it has opened for enrollment its randomized Phase 2 study of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib in patients with CLL. The decision to open the Phase 2 portion of the Company’s ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was triggered by favorable outcomes from the Part 1 dose-finding and Part 2 dose-confirming cohorts of the clinical trial, including an observed interim objective response rate (ORR) of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part 2. The Company continues to see a well-tolerated safety profile consistent with that seen with ibrutinib treatment alone.
In June 2019, Oncternal presented interim data from its ongoing Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting – the largest oncology conference of the year. Results from the first 12 patients with CLL treated in the Part 1 dose-finding portion of the Phase 1 study showed an observed interim ORR of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone.
Oncternal also disclosed at the June 2019 ASCO meeting that six patients with mantle cell lymphoma (MCL) had been treated in a separate cohort of the CIRLL study. One patient with MCL who had relapsed following an allogeneic stem cell transplant experienced a confirmed complete response (CR) after 3 months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This CR appears to be durable, and has been confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib treatment.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing a diverse pipeline of product candidates for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation and progression. The pipeline includes its lead clinical program, cirmtuzumab, a monoclonal antibody designed to inhibit the ROR1 receptor that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL and MCL, and TK216, a small-molecule compound that is designed to inhibit E26 transformation specific (ETS) family oncoproteins, which is being evaluated in a Phase 1 clinical trial alone and in combination with vincristine as a treatment for Ewing sarcoma, a rare pediatric cancer. In addition, Oncternal has a CAR-T program targeting ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. More information is available at www.oncternal.com.
Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding Oncternal’s expectations regarding its ability to advance its three oncology drug programs. The inclusion of forward-looking statements should not be regarded as a representation by Oncternal that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Oncternal’s business, including, without limitation: uncertainties inherent in the clinical development process and in obtaining regulatory approval of cirmtuzumab, TK216 and Oncternal’s other product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; Oncternal’s dependence on the success of its product development programs; the risk that interim results of a clinical trial do not necessarily predict future or final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing Oncternal’s product candidates; the Company’s reliance on third parties for the manufacture of its product candidates and the risk that sufficient quantities of such product candidates may not be available to perform clinical studies or at an acceptable cost, which could delay, prevent or impair Oncternal’s development efforts; Oncternal’s limited operating history and the fact that it has incurred significant losses, and expects to continue to incur significant losses for the foreseeable future; risks related to the inability of Oncternal to obtain sufficient additional capital to continue to advance the development of its product candidates; and other risks described in Oncternal’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.