
Strategy
Heidelberg Pharma firmly believes that it is developing targeted and highly effective therapies for the treatment of cancer by leveraging its ADC technology based on the toxin Amanitin, which could be of great medical benefit for patients. The strategy’s core elements are the development of the pipeline projects until clinical proof of concept, the initiation of further research and option agreements and their extension to include long-term license agreements.
The proprietary ATAC candidate pamlectabart tismanitin (HDP-101) is being tested for the first time in patients with multiple myeloma.
Our strategic partner Huadong is planning to launch a trial in China with the dose established for the Phase IIa part of clinical trials. Before they can carry out this planned trial, a ‘bridging study’ must be conducted with a small cohort of patients to demonstrate the comparability of the substance in the Chinese population.
At Heidelberg Pharma, we are working hard to continually review partnership opportunities for pipeline projects that we are not actively developing at present (HDP-102, HDP-103, HDP-104 and HDP-201) due to our focus on HDP-101.
In order to further expand the therapeutic potential beyond the Antibody Targeted Amanitin Conjugates available at Heidelberg Pharma, additional research and option agreements are to be signed with pharmaceutical partners. The collaboration with existing partners is expected to be continued and expanded as planned, ideally culminating in one or more therapeutic candidates.
The current and future ADC partnerships could expand the range of applications for the technology to additional oncological applications as well as including possible applications outside oncology and underpin validation of the technology. Furthermore, the conclusion of further partnership agreements whereby the granting of exclusive license rights for the testing, development and marketing of each individual ADC could generate increasingly significant and growing revenues as projects mature, in the form of customary upfront payments, co-funding of development, milestone payments and royalties.
Biotechnology remains a growth market with a high unmet medical need in oncology. Heidelberg Pharma is focusing on developing an Amanitin-based drug conjugate for treating cancer. The Executive Management Board is confident that ATAC technology in general and the candidate pamlectabart tismanitin in particular could be a promising new therapeutic option for seriously ill patients and could cover the unmet need. The refinement of the candidate is expected to drive the Company’s growth, underpinned by strategic collaboration with its pharmaceutical partners.
Both Heidelberg Pharma’s own development activities and the ATAC partner programs have the potential to evolve into innovative therapies. The focus is on the further clinical development of the ATAC candidates, which should produce better marketing opportunities for this technology and/or ATAC candidates, and therefore enhance Heidelberg Pharma’s revenue potential. Additional positive safety and efficacy data and progress on projects by our partners should significantly reduce the risks to which the Company is exposed.