Heidelberg Pharma is pursuing a partnering strategy which paves the way to using antibodies which would not be accessible without the respective partner and to generate early cash returns. As part of this strategy, Heidelberg Pharma entered into a multi-target research and option agreement with Takeda in June 2017. Following a number of successful trial runs, in June 2017, Heidelberg Pharma signed an exclusive research agreement for up to three research targets with Takeda for the joint development of ATACs. Under the terms of the agreement, Takeda has the option to in-license up to three ATAC candidates, triggering milestone payments estimated at up to USD 113mn each and royalties on sales. Nordic Nanovector and MabVax also collaborate with Heidelberg Pharma contributing cancer-specific antibodies for different tumor types. All these early stage molecules are currently part of a comprehensive series of internal in vivo trials in rodents to explore their anti-tumor potential and pharmacokinetic properties. Those programs are run under a costs and benefits sharing agreement.
In parallel, Heidelberg Pharma is working on its proprietary portfolio and intends to start a Phase I/II by end of 2018 with HDP-101 in multiple myeloma and to evaluate efficacy by the ende of 2020. The company in-licensed the BCMA target from the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) in Berlin. BCMA is a surface protein that is highly expressed in multiple myeloma cells. Being the third most common hematologic cancer, it represents a EUR 9bn market with major unmet medical need where new, more effective therapies are needed.
The non-clinical development of HDP-101 has started in 2016. This includes cell line development for the production of non-GMP and GMP batches of antibody material for use in the manufacturing of HDP-101 clinical material. Celonic AG, Basel, Switzerland, a contract development and manufacturing organization (CDMO) for biopharmaceutical proteins, is taking care of these tasks externally. Further, the team will perform non-clinical studies at the same time, including tolerability studies in monkeys, in-line with high quality standards (GLP/GMP) to guarantee safety for subsequent human trials.
Heidelberg Pharma expects to take the following next steps in 2017 and 2018:
- Completion of technology transfer and upscaling GMP manufacturing of payload, linker and antibody
- Scientific Advice at regulatory authorities, namely Paul Ehrlich Institute and US-FDA
- GMP availability of complete ATAC molecule HDP-101
- Preparation including design of clinical trial
- Initiation of regulatory process for Phase I IND approval
Outside the field of ATAC technology, Heidelberg Pharma wants to exploit the clinical portfolio, formerly developed by WILEX AG and considered as non-core activities, through partnering activities. Those legacy products, REDECTANE® and MESUPRON®, have already been licensed to partners that are supposed to continue and complete the development and will be obliged to pay royalties to the Company once and if they are registered and marketed. The Phase II drug candidate MESUPRON® has been out-licensed to RedHill Biopharma Ltd., Israel, and Link Health Co., China, for further development and subsequent marketing. The PET/CT diagnostic Phase III drug candidate REDECTANE® has been licensed to Telix Pharmaceuticals for a pivotal study. Telix is an Australian company focused on bio-radiopharmaceuticals. The Phase IIItherapeutic antibody RENCAREX® is available for out-licensing and continued development for external partners.
In addition, Heidelberg Pharma has a small preclinical service business performing pharmacology studies for internal purposes and for other research companies. It enables the ATAC team access to in vivo tumor models in house.
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