Heidelberg Pharma collaborates and holds license agreements with several leading academic and clinical institutions as well as pharmaceutical companies worldwide. License agreements are an important part of the Company’s commercialization strategy.
The Company uses the ATAC technology to produce candidates for its own development portfolio. Heidelberg Pharma develops these up to early clinical development phases with the aim of demonstrating their applicability and efficacy in patients.
Heidelberg Pharma also licenses its technology platform to other pharmaceutical companies for the development of their own ATACs. The partner provides specific antibodies that are coupled with Amanitin and takes over the entire preclinical and clinical development of these ATACs.
Development partners for the ATAC technology include Magenta, Takeda and Chiome, for example.
Heidelberg Pharma works with production partners to supply its license partners with Amanitin linker material in GMP quality for their development projects as needed.
Since March 2018, an exclusive multi-target research agreement has been in place 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 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.
For the CD117 and CD45 targets, the options were exercised and ATAC development continued under exclusive licensing.
MGTA-117, the development candidate from the CD117 project is tested in clinical trials since March 2022. MGTA-117 is to be the first clinical ATAC candidate to be used for targeted preparation, or conditioning, of patients for stem cell transplants or gene therapy. MGTA-117 is currently tested in a dose escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MGTA-117 as a single dose in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome with excess blasts (MDS-EB).
Magenta is also working on the preclinical validation of the second product candidate, a CD45-ATAC, in various transplant and autoimmune diseases models. Successful development of these approaches could open doors for innovative applications beyond oncology for diseases of the immune system.
An exclusive multi-target research agreement has been in place with Takeda Pharmaceutical Company Limited since June 2017 for the co-development of ADCs that use Amanitin as payload. Under the terms of the exclusive research agreement, Heidelberg Pharma produced several ATACs using antibodies from Takeda’s proprietary portfolio. In September 2022 Takeda was granted an exclusive license to commercially develop an Antibody Targeted Amanitin Conjugate directed to a previously selected target molecule. Takeda is responsible for further preclinical and clinical development, as well as potential commercialization, of the licensed product candidate.
In July 2022, Heidelberg Pharma and Chiome Bioscience Inc. entered into an exclusive, target-specific research and option agreement under which one of Chiome’s monoclonal antibodies against one specific target will be combined with Heidelberg Pharma’s proprietary ATAC® platform. Chiome will have access to Heidelberg Pharma’s Amanitin toxin-linker platform technology and has an option for an exclusive, target-specific license for global development and commercialization rights to the product candidate resulting from the research collaboration.
TLX250-CDx (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 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.
upamostat is an inhibitor of the uPA system and, in the Company's view, represents a promising new, non-cytotoxic approach for the specific inhibition of metastasis and primary tumor growth in solid tumors. upamostat was developed by Heidelberg Pharma to Phase II.
Heidelberg Pharma has entered into a licensing and development partnership for upamostat in China with Link Health Group in March 2014.
We are looking for interesting partnerships to work together on the further development of the unique mode of action of the active ingredient Amanitin.
Please contact our Business Development team if you are interested in a collaboration or would like to learn more about our proprietary ATAC technology.
Your contact person
Dr. George Badescu