Heidelberg Pharma GmbH, a wholly owned subsidiary of Wilex AG based in Ladenburg, Germany, and Swiss drugmaker F. Hoffmann-La Roche Ltd, Basel, Switzerland, are extending their existing 2013 license agreement to apply Heidelberg’s antibody drug conjugate technology to the further development of Roche antibodies. As part of the ongoing agreement, Heidelberg also grants Roche exclusive rights to one additional tumor target previously reserved for in-house development.

The aim of the new agreement is to identify and develop novel Antibody Targeted Amanitin Conjugates (ATACs) based on Heidelberg’s patented technology to couple α-Amanitin to antibodies.

Death Cap mushroom
α-Amanitin is a bicyclic peptide naturally occurring in the green Death Cap mushroom. It potently inhibits the biosynthesis of RNA, a mechanism that is critical for the survival of cells. Accordingly, ATACs exhibit comparable activity against proliferating and resting tumour cells. This proliferation independent activity differentiates ATACs from other ADCs, which preferentially target proliferating tumour cells. As an additional advantage ATACs could offer a substantial capability to overcome the resistance mechanisms that might limit the efficacy of other antibody drug conjugates. The ATACs tested so far have shown strong anti-tumour activity in several preclinical tumour models.

Extended license agreement
Based on the license agreement, Heidelberg receives an upfront payment and further regular payments for granting access to its technology and providing research services to Roche, which has the opportunity to exercise options for licences to develop and market selected ATACs. Heidelberg will manufacture these substances for clinical research and receive undisclosed milestone payments and royalties for each development candidate selected.

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As part of the agreement Heidelberg could potentially receive up to EUR 52 million in upfront and milestone payments for successful clinical development and regulatory approval plus royalties for the exclusive rights to the additional undisclosed tumor target.

“This extension provides a number of interesting opportunities. We are pleased to extend our collaboration to include additional Roche targets and the in-house target that Wilex had previously reserved for later development. As with many of these early research collaborations, our operating costs are covered by upfront payments and fees; the full value will potentially come later in the development cycle. We work together on the same aim to ultimately benefit patients,” noted Jan Schmidt-Brand, PhD, Managing Director of Heidelberg Pharma GmbH and CEO/CFO of Wilex AG.

Published in: Wilex AG website

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