Heidelberg Pharma collaborates and holds license agreements with a number of leading academic and clinical institutions as well as pharmaceutical companies worldwide. 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 Magenta 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®.
In March 2018, Heidelberg Pharma announced that it had signed an exclusive multi-target research agreement with Magenta Therapeutics. The collaboration will combine Magenta’s stem cell platform with proprietary antibodies for up to four exclusive targets with Heidelberg Pharma’s proprietary ATAC (Antibody Targeted Amanitin Conjugates) technology for the development of new ATACs. Magenta has an option for an exclusive license for global development and commercialization rights to each of the product candidates resulting from the research collaboration. Under the terms of the exclusive research agreement for multi-target molecules, Magenta will have access to Heidelberg Pharma’s Amanitin toxin-linker platform technology. Press Release
After exercising the option for the further development of the target molecule CD117 in October 2018, Magenta exercised the option for the target molecule CD45 in November 2019 and will continue the development of ATACs based on it under an exclusive licensing agreement.
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. Press Release
Development and Commercialization of Other Products
TLX250-CDx (INN: 124I-Girentuximab, formerly REDECTANE®) 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 TLX250-CDx 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 TLX250-CDx with the Australian company Telix Pharmaceuticals Limited in January 2017. Press Release
Upamostat (formerly 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 upamostat is being developed for anti-metastatic treatment in a wide variety of solid tumor types. Heidelberg Pharma developed upamostat until Phase II.
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. Press Release
- Janssen Biotech Inc., Malvern, USA/University of Leiden, Netherlands, 1999: Licensing of G250/Girentuximab antibody. Press Release