Heidelberg Pharma collaborates and holds license agreements with a number of leading academic and clinical institutions as well as pharmaceutical companies in Europe and North America. License agreements are an important part of the Company’s commercialization strategy.
Heidelberg Pharma is focused on the development and marketing of its proprietary ATAC technology. Heidelberg Pharma Research, the subsidiary responsible for operations, works on developing longer-term and extensive research collaborations, signing more extensive license agreements and securing additional MTA partners (Material Transfer Agreement) for evaluation projects.
In this model, Heidelberg Pharma will contribute the toxin linker technology to the cooperative partnership as a contribution in kind, while other biotechnology companies will contribute their traditional antibodies or innovative antibody formats such as antibody fragments. Together, novel ATACs will be developed up to the preclinical stage, in which their efficacy and tolerability can be meaningfully assessed. Through the consolidation of the relevant skills and resources at the project level, the internal contribution to the value chain is expected to be increased. A decision will later be taken with the partner in question as to whether joint clinical development is possible or whether direct licensing or sale of the product to third parties is preferable. Such collaborations relating to the ATAC technology were agreed with MabVax, Nordic Nanovector and Takeda.
Heidelberg Pharma’s existing clinical R&D projects will only be developed in cooperation with licensing partners. The out-licensing of MESUPRON® and REDECTANE® would generate upfront and milestone payments plus royalties on net sales in the event of successful development and regulatory approval. This also applies to a potential partnership for RENCAREX®.
A collaboration was agreed with US-based MabVax, San Diego, in February 2015. MabVax’s technology is based on the protective immune response from patients who have been immunized against targeted cancers with MabVax’s proprietary vaccines. From these patients, antibodies are isolated that target the tumor in question. MabVax’s HuMab-5B1 antibodies are thus fully human and target a specific surface antigen. The ATAC, consisting of HuMABb-5B1 and Heidelberg Pharma’s toxin Amanitin is currently in preclinical development in metastatic pancreatic cancer.
At the end of October 2016, Heidelberg Pharma has entered into a research collaboration with Nordic Nanovector ASA, Oslo, Norway, a biotech company focusing on the development and commercialization of novel targeted therapeutics in hematology and oncology. Under this arrangement, new ADCs will be developed to treat leukemias. Leukemias are orphan diseases with a significant unmet medical need.
An exclusive multi-target research agreement was signed in June 2017 with Takeda Pharmaceutical Company Limited for the joint development of antibody drug conjugates (ADCs) that use Amanitin as the payload. Under the terms of the exclusive research agreement, Heidelberg Pharma will produce Antibody Targeted Amanitin Conjugates (ATACs) using antibodies from Takeda’s proprietary portfolio for up to three undisclosed targets. Takeda has an option for an exclusive license for global development and commercialization rights to each of the product candidates resulting from the research collaboration. If it exercises the option, Takeda would be responsible for further preclinical and clinical development, as well as potential commercialization, of any product candidate it licenses.
Development and Commercialization of Other Products
The antibody RENCAREX® was investigated in a pivotal Phase III trial in the adjuvant treatment of non-metastatic renal cell carcinoma (RCC). In October 2012, Heidelberg Pharma announced that RENCAREX® did not meet its primary endpoint and showed no improvement in median DFS in the Phase III registration trial. The trial therefore was terminated.
Heidelberg Pharma has partnered RENCAREX® for co-development and commercialization in certain countries of South Europe (Spain, Italy, Portugal, Greece, and Andorra) with the Spanish pharmaceutical company Laboratorios del Dr. Esteve, Barcelona, Spain (see Press Release).
REDECTANE® (INN: 124I-Girentuximab) is a radiolabeled form of the monoclonal antibody Girentuximab, which binds to the Carbonic Anhydrase-9 (CAIX) antigen, expressed on the surface of cancer cells of the clear-cell phenotype. It has been shown that REDECTANE® with positron emission tomography (PET) and computer tomography (CT) is clearly superior to the use of diagnostic CT alone in diagnosing clear cell renal cell carcinomas.
Heidelberg Pharma has entered into a worldwide license agreement for the development and commercialization of REDECTANE® with the Australian company Telix Pharmaceuticals Limited in January 2017. (see Press Release)
MESUPRON® belongs to the uPA program of Heidelberg Pharma. According to Heidelberg Pharma, the uPA program is a promising new non-cytotoxic approach in cancer therapy to specifically block tumor metastasis and primary tumor growth in solid cancers. The drug candidate MESUPRON® is being developed for anti-metastatic treatment in a wide variety of solid tumor types. Heidelberg Pharma holds the worldwide commercialization rights of its uPA program, including the following development candidates:
- Oral uPA and serine protease inhibitor MESUPRON® (in phase II studies in patients with pancreatic or breast cancer)
- Several other compounds targeting components of the uPA system (Research)
At the end of June 2014, Heidelberg Pharma has entered into a second licensing and development partnership with the Israeli company RedHill Biopharma Ltd. covering all regions with the exception of Greater China. (see Press Release)