Advancing clinical drug development
As the world's only charity-funded drug development facility, Cancer Research UK’s Centre for Drug Development is unique in its focus on ushering first-in-class and best-in-class therapeutics through early stage clinical development. In 2022/23, the Centre for Drug Development teams continued to de-risk these high-risk programmes and engage industry in creative ways to bring new clinical benefits to cancer patients.
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The DETERMINE trial: shifting the clinical trial paradigm to advance the treatment of rare cancers
Cancers that are diagnosed in fewer than 6 in 100,000 people each year are defined as rare, but together they make up 22% of all cancers diagnosed worldwide, more than any single type of cancer. As such, people with rare cancers make up a large cohort that is consistently underserved by treatment options.
DETERMINE* aims to address that. Open to adults, teenagers and children, the trial evaluates whether drugs targeting identifiable genetic alterations that are approved for use in some cancers, can be used to treat patients with other cancers, including rare cancer patients, who have the same genetic alteration.
“With technological advances in genetic testing we’ve learned that some rare tumours contain genetic abnormalities which may benefit from targeted treatment currently only available for more common cancer types.”
Matthew Krebs
Chief Investigator for the DETERMINE trial.
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The DETERMINE trial: shifting the clinical trial paradigm to advance the treatment of rare cancers
Cancers that are diagnosed in fewer than 6 in 100,000 people each year are defined as rare, but together they make up 22% of all cancers diagnosed worldwide, more than any single type of cancer. As such, people with rare cancers make up a large cohort that is consistently underserved by treatment options.
DETERMINE* aims to address that. Open to adults, teenagers and children, the trial evaluates whether drugs targeting identifiable genetic alterations that are approved for use in some cancers can be used to treat patients with other cancers, including rare cancers, who have the same genetic alteration.
“With technological advances in genetic testing we’ve learned that some rare tumours contain genetic abnormalities which may benefit from targeted treatment currently only available for more common cancer types.”
Matthew Krebs
Chief Investigator for the DETERMINE trial.
The Centre for Drug Development sponsors and manages the trial, with the University of Manchester as the lead centre. When the trial opened in November 2022, Roche provided seven of their targeted drugs for evaluation across five treatment arms. In December 2022, Novartis joined to provide access to their drug(s) as well. The Cancer Research Horizons business development team are in active conversation with multiple potential partners to add new treatment arms and appropriate technologies to DETERMINE. We hope more pharmaceutical and biotechnology companies will continue to contribute to this breakthrough trial.
Its unique design means that any treatment that appears to be working for patients on the trial will be submitted for review by the Cancer Drugs Fund (CDF). The intention is that the CDF team, working with NHS England Clinical Policy team, will then decide whether a period of data collection in the CDF is appropriate to assess if the drug could be used as a routine treatment option on the NHS for patients with this cancer type.
The team dosed their first patient in March 2023, with the first trial site opening at the Christie Hospital in Manchester. There are now trial sites in Oxford, Cambridge and Newcastle, with additional sites due to open across the adult and paediatric Experimental Cancer Medicine Centres network. In recognition of the quality of work behind the DETERMINE trial, it garnered two awards this year: the Centre for Drug Development won the Team Excellence in the Management of Clinical Data Award from the Association of Clinical Data Management, and the trial itself won the 2023 Bionow Healthcare Project of the Year Award for its innovative design and ability to help this large group of underserved people with rare cancers.
*DETERMINE: Determining Extended Therapeutic indications for Existing drugs in Rare Molecularly-defined Indications using a National Evaluation platform trial.
Spotlight
UCB and two antibody therapies
In March 2023 we began a multi-project collaboration with global pharmaceutical company UCB, uniting their renowned antibody discovery expertise with the clinical development capabilities of Cancer Research UK’s Centre for Drug Development.
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UCB and two antibody therapies
In March 2023 we began a multi-project collaboration with global pharmaceutical company UCB, uniting their renowned antibody discovery expertise with the clinical development capabilities of Cancer Research UK’s Centre for Drug Development.
In our first partnership pursuing more than one agent with one company, we will take two of UCB’s investigational antibody candidates, UCB6114 and UCB4594, through clinical trials. If successful, they have the potential to offer cancer patients access to new targeted treatment options.
UCB6114 is a potential first-in-class antibody targeting gremlin-1, a glycoprotein secreted by the tumour stroma. UCB4594 is an antibody targeting the immune checkpoint, human leukocyte antigen G (HLA-G).
While the Centre for Drug Development is leading the design and delivery of Phase 1/2 clinical trials, UCB will continue to manufacture both candidates, complete the ongoing UCB6114 clinical study (ONC001) and provide support. UCB will retain exclusive rights to further develop and commercialise both assets and will receive a licence to the results of the clinical trials from Cancer Research Horizons in return for success-based milestone and royalty payments.
Hummingbird Bioscience goes all in
In March 2023, Hummingbird Bioscience, a clinical-stage biotechnology company, exercised its option to license the clinical trial results of its HER3-targeting antibody, HMBD-001, from Cancer Research Horizons.
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Hummingbird Bioscience goes all in
In March 2023, Hummingbird Bioscience, a clinical-stage biotechnology company, exercised its option to license the clinical trial results of its HER3-targeting antibody, HMBD-001, from Cancer Research Horizons.
The Centre for Drug Development is sponsoring and managing the first-in-human Phase 1/2a clinical trial on HMBD-001, which aims to establish the recommended Phase 2 dose for patients with HER3-expressing solid tumours who are resistant to approved therapies. Based on the existing dose escalation data, Hummingbird Bioscience will initiate additional biomarker-stratified clinical trials with HMBD-001, which will run in parallel with the Centre for Drug Development’s trial.
“Our Cancer Research UK collaboration has been pivotal for the development of HMBD-001 and brings us one step closer to providing a precision therapy for patients with HER3-expressing cancers.”
Piers Ingram
Chief Executive Officer of Hummingbird Bioscience
Hummingbird’s decision to exercise its licensing option early in the clinical development process highlights its enthusiasm for the promising data emerging from the trial and is a testament to Centre for Drug Development’s quality of work.
