SAN DIEGO, Jan. 14, 2021 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced an agreement with Lentigen Technology, Inc. (“Lentigen”), a wholly-owned subsidiary of Miltenyi Biotec B.V. & Co. KG, to manufacture lentiviral vectors for Oncternal’s investigational ROR1-targeting CAR-T cell therapy program.
Lentigen is a leader in translating gene therapy products into the clinic, including design, construction and production of lentiviral vectors, from research through GMP manufacturing.
As part of the agreement, Lentigen will reserve capacity in 2021 to manufacture, test and release GMP lentivirus to support and accelerate the development of Oncternal’s CAR-T cell therapy program.
“Lentiviral vectors are an essential component in the CAR-T cell manufacturing process. Lentigen has successfully developed a large-scale, chemically-defined, serum-free lentiviral vector manufacturing process that ensures high quality and conformity with regulatory requirements,” said Boro Dropulic, Ph.D., M.B.A., General Manager and Chief Science Officer of Lentigen Technology, Inc. “We are excited to support Oncternal by manufacturing lentiviral vectors for its ROR1-targeting CAR-T program and help bring these novel cell therapies to patients with cancer.”
“Oncternal is working on rapidly advancing its ROR1-targeting CAR-T cell immunotherapy program, and we are pleased to work with Lentigen that is widely recognized as a global leader in producing GMP lentiviral vectors for the biopharma industry,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “ROR1 has emerged as an important target for cancer therapy, and we believe that our ROR1-targeting CAR-T program holds significant promise for patients with both hematologic cancers and solid tumors. Our goal is to achieve first-in-human dosing of the ROR1-targeting CAR-T therapy in the second half of 2021.”
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in an investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. In addition, Oncternal has a program utilizing the cirmtuzumab antibody backbone to develop a CAR-T therapy that targets 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 Oncternal’s current beliefs and expectations. Forward looking statements include statements regarding Oncternal’s beliefs, goals, intentions and expectations including, without limitation, the timing and ability of Lentigen to manufacture lentiviral vectors; Oncternal’s belief that ROR1-targeting CAR-T therapies hold significant promise for patients with hematologic cancers and solid tumors; the timing of any human dosing of its ROR1-targeting CAR-T therapy; and other statements regarding Oncternal’s development plans. Forward looking statements are subject to risks and uncertainties inherent in Oncternal’s business, which include, but are not limited to: the parties must negotiate and execute a master services agreement and related agreements prior to Lentigen initiating manufacturing of the lentiviral vectors; Oncternal’s dependence on Lentigen to manufacture the lentiviral vectors; the COVID-19 pandemic may disrupt Oncternal’s or Lentigen’s business operations; uncertainties associated with the preclinical and clinical development of the CAR-T cell therapy program; 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.
Corey Davis, Ph.D.
Source: Oncternal Therapeutics, Inc.