Biopharmaceutical company Navrogen, specialized in developing therapies for cancer and immune-related disorders, and Levena Biopharma, have agreed to collaborate in developing an antibody-drug conjugate or ADC designed to targeting humoral immuno-suppressed cancers.

The analyses of humoral immune responses against tumor antigens over the last decade have resulted in the discovery of diagnostic and prognostic markers that, ultimately, may lead to the exploration of new targets for immunotherapy.

In late 2019 Navrogen signed a Cooperative Research and Development Agreement with researchers at the U.S. National Cancer Institute (NCI). This agreement focuses on advancing antibody-based experimental medicines to targets associated with tumor-mediated immuno-suppression. The collaborative research is led by Ira Pastan, M.D, the co-chief of NCI Center for Cancer Research’s Laboratory of Molecular Biology.  The team of researchers has developed compounds that can uniquely target molecules on inflammatory cells and unlock their immuno-suppressed state within the tumor microenvironment. Under the terms of the agreement, Navrogen is responsible for validating and advancing the preclinical development of these compounds towards clinical trials.

As part of advancing the company’s pipeline of first-in-class, Navrogen has formed partnerships with top-tiered vendors who have proven track records in supporting the development of biological-based therapies to support clinical trials and commercialization. To enable the production of increasingly complex and hard-to-express biological drugs the company also signed a licensing agreement with Lonza for us of GS Xceed Expression System. In addition, the company employs GS piggyBac™ – a unique and versatile cell line engineering technology.

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Lonza’s GS piggyBac is capable of inserting large DNA cargos into transcriptionally active and genetically stable areas of the genome associated with highly expressed genes. As such, the system demonstrating higher yields and enhanced performance is supports the expression of challenging proteins

“Navrogen’s use of our GS PiggyBac system aligns the economics of bringing these first-in-class therapeutics to patients with current market needs”, commented Sarah Holland, D. Phil. Oxon; MBA, Global Head of Licensing at Lonza Pharma & Biotech.

Collaboration with Levana
Antibody-drug conjugates developed under this collaboration combine Levena’s linker and cytotoxic payload chemistry expertise along with Navrogen’s cancer-targeting antibodies discovered using its proprietary Humoral Immuno Oncology (HIO) platform technologies.

Navrogen’s antibodies are able to specifically target and combat HIO-suppressed cancers that produce factors that dampen antibody-mediated immune-effector activity as well as decrease ADC internalization and subsequent release of their cytotoxic payloads which is required for killing. This collaboration will also include the use of Levena’s process development and cGMP capabilities.

“Our collaboration with the exceptional scientists at Levena has enabled us to create a number of ADCs to specifically treat HIO-suppressed cancers,” stated Luigi Grasso, Ph.D., Chief Scientific Officer at Navrogen.

“The expansion of this collaboration will enable us to proceed with their advancement towards clinical trials,” Grasso added.

“We have employed several of our technologies with the Navrogen team over the past year to identify HIO-refractory ADC formats. And we look forward to continuing supporting their development plans that can benefit from our expertise and technologies,” Tong Zhu, Ph.D., Executive Director, Chemistry at Levena concluded.

Levena has developed site-specific conjugation technology (K-LOCK and C-LOCK) and novel proprietary linker toxin. The company currently operates a research and manufacturing facilities in Suzhou, Nanjing and San Diego with capabilities from ADC discovery research, process/analytical development to GMP production of linker-toxin and ADC conjugate.

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