21 January 2019
BerGenBio announces start of phase I trial evaluating ADCT-601, a novel anti-AXL ADC, in patients with advanced solid tumours
- ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed to ADC Therapeutics for antibody drug conjugate (ADC) development
- Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75 cancer patients
- ADCT-601 is BerGenBio’s third clinical candidate targeting AXL
Bergen, Norway, January 21 2019 – BerGenBio ASA (OSE:BGBIO), announces that the first patient has been dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting antibody drug conjugate (ADC), in patients with advanced solid tumours.
ADCT-601 is composed of a humanised monoclonal antibody against human AXL (BGB601) discovered by BerGenBio, conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. BGB601 was out-licensed for ADC development to ADC Therapeutics SA (ADCT). In preclinical studies, ADCT-601 has demonstrated potent and specific anti-tumour activity in multiple in vivo models and was stable and well tolerated, as reported by ADCT at the American Association of Cancer Research (AACR) annual congress in 2018.
The open-label, multi-centre, single arm phase I trial will enrol approximately 75 patients with selected tumour types and will be managed and sponsored by license partner ADC Therapeutics. For more information see https://clinicaltrials.gov (accessing trial identifier NCT03700294).
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We congratulate ADC Therapeutics on reaching this important milestone. We are pleased to now see three of our AXL-targeting modalities in clinical development with the potential to address large patient populations. Our focus remains on completing our ongoing oncology phase II programme with bemcentinib, a first-in-class highly selective oral AXL inhibitor, and start randomised, potentially pivotal trials later this year. In the meantime, we look forward to providing updates on the development of BGB149, a therapeutic AXL antibody, and ADCT-601, an anti-AXL ADC, as they progress through phase I testing.”
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About ADCT-601
BerGenBio out-licensed two novel and proprietary anti-AXL monoclonal antibodies invented by the Company to ADC Therapeutics SA (ADCT) for the development of an antibody drug conjugate (ADC).
ADCT-601 is composed of BGB601, a humanised monoclonal antibody that binds to human AXL, conjugated using GlycoConnect™ technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalised into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is currently undergoing Phase I clinical testing (NCT03700294).
Under the license, a series of development, regulatory and sales-based milestones are due to BerGenBio from ADCT upon the achievement of certain specified events. The first milestone payment is triggered during the phase I clinical study.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II oncology clinical development programme focussed on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601) are undergoing phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). www.bergenbio.com
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mark Swallow/David Dible, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
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This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
