Innovation & Business Idea
ADCendo aims to develop novel cures for several cancer types and has produced convincing data on the efficacy of its lead compound ADCE-001. This is a precision drug directed at a novel target receptor, uPARAP, which is highly upregulated in e.g soft tissue sarcoma (STS), GBM, and subsets of breast cancer. ADCE-001 is an antibody-drug-conjugate (ADC) consisting of a potent cytotoxic payload linked to ADCendo’s proprietary, species cross-reactive, antibody targeting the surface protein uPARAP. ADCendo will continue its own development program within an orphan drug designation or establish partnerships for late stage development and commercialization.
Customers / Target Market
STS is an orphan cancer indication with approximately 34,000 new cases in US and Europe each year. About one-third of all new cases are diagnosed at the latest stage of progression, where 5-year survival is as low as 16%. Analysis of STS patient material has revealed that more than 80% of these cases have an elevated expression level of uPARAP. ADCendo has estimated its potential peak sales of ADCE-001 for STS to a minimum of $600 M and up to more than $1.5 B.
The treatment of STS relies on surgery, radiation and ineffective chemotherapy, none of which are considered competing products to ADCE-001, which is developed for patients with inoperable/metastatic disease. For these patients no effective treatment is currently available.
Intellectual Property Status
Under a license agreement, ADCendo holds exclusive rights to the development of the invention. The IP covers ADCs comprising the anti-uPARAP antibodies combined with payloads. An FTO analysis revealed no IPR challenging ADCendo’s planned product.
Development Status & Future Steps
ADCendo has created a panel of uPARAP-targeting ADCs, which shows curative effects in a mouse model of disease after single treatment. During 2019, ADCendo will perform the final characterization of its proprietary antibodies. A cytotoxin will be selected, and a non-human-primate tolerability study will be conducted. While these things are ongoing, large scale GMP production of ADCE-001 will be initiated.
ADCendo may either partner with pharma companies for co-development or take the compound all the way through a phase IIb trial prior to out licensing.
ADCendo was spun out of Copenhagen University Hospital by scientists together with a former CEO from Santaris.
Henrik Stage - +25 years of executive experience in biotech and finance. Served as CFO and CEO of Santaris Pharma A/S.
Niels Behrendt - Head of the Cancer Invasion Section at The Finsen Laboratory.
Lars H. Engelholm - PI at The Finsen Laboratory. Expertise in antibody technologies and molecular biology.
Christoffer F. Nielsen - Expertise in ADC strategies and payload technology.
Andreas Hald - Experience from commercial drug development in several larger companies.
The need for finance is divided into four investment rounds.
1 - €1.3 M year: 2019/2020 - Tolerability studies in non human primates and initiation of large scale production.
2 - €3.75 M year: 2021 - Production of a non-GMP batch and performing IND-enabling tox studies.
3 - €6.3 M year: 2022 - GMP-production and phase I/IIa.
4 - €6.17 M year: 2022/2023 - phase IIb trial and application for conditional approval.
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