Cancer Research Horizons (CRH) is on the lookout for potentially transformative oncology drugs that could benefit from its expertise. CRH, which is the innovation arm of the charity Cancer Research UK (CRUK) operates as a clinical developer ‘with a twist’. It can offer the operational skills and network of scientific and clinical experts to advance assets for biopharma partners. It’s already working with Bicycle Therapeutics, Eli Lilly, Roche, and UCB.
That connection with the CRUK network provides CRH with a real differentiator. While university offices source intellectual property from their own labs, CRH works with the network of institutions that receive funding from CRUK, which is among the largest charitable funders of cancer research worldwide. CRH can draw on early-stage translational discovery and foster assets through to late-stage clinical development, all within a CRUK setting.
CRUK’s Centre for Drug Development (CDD) is the clinical center that sits within the CRUK research network. The CDD specializes in pioneering first-in-class therapies and facilitating first-in-human clinical trials. With a track record that includes six registered medicines and a development pipeline, the CDD is comparable to a medium-size biopharmaceutical company.
“We have terrific expertise within the CDD, and we can link up the operational capabilities of the CDD with the really interesting science and clinical expertise in the CRUK network at large to help companies progress their drugs to the benefit of everyone: for us, for them, and ultimately for patients,” said George Tzircotis, Associate Director of Business Development at CRH.
The biotech within CRUK
With 120 employees and 30 years’ experience partnering with industry and academia, the CDD has all the expertise needed to run a phase 1 clinical trial, including its own medical sciences, pharmacology, project management, data management, and clinical operations teams.
The CDD team identifies the best way to advance projects and find people in the CRUK network with scientific and clinical expertise aligned to the programs. Once the plan is in place, the CDD helps the partner to finish off the preclinical studies, prepares the regulatory paperwork, and performs all the work needed to generate data. The goal is to use the CDD’s network and operational capabilities to add value.
The CDD mostly applies its capabilities to programs sourced from industry. Drug developers that lack cancer expertise, have more assets than they can develop, or otherwise need external support can work with the CDD to advance candidates to clinical milestones.
The CDD puts programs through a stringent review process before bringing them into its portfolio. Once the CDD chooses to work on a drug, it enters into a contract with the industry partner that gives the CDD the right to prepare for and run a clinical trial with that drug. The CDD sponsors the clinical trial and has the final say on decisions about its conduct. At the end of the study, the CRH grants the industry partner a license to the data and receives milestone payments and royalties if the drug advances through the clinic and on to the market.
The Christie Hospital. This hospital, located in Manchester, UK, is among the 17 adult and 12 pediatric sites in the Centre for Drug Development (CDD)’s clinical trial network.
A track record of success
UCB recently partnered with the CDD on two candidates. The Belgian biopharma company approached the CDD and, after working through the review process, reached an agreement that gives the CDD a license to study the assets in the clinic. The CDD is now using its own capabilities and talking to experts in the CRUK network to design and run clinical trials.
The current CDD portfolio of 12 clinical trials also includes the DETERMINE (Determining Extended Therapeutic indications for Existing drugs in Rare Molecularly defined Indications using a National Evaluation) platform trial, a basket umbrella study that is formalizing the collection of data on the off-label use of licensed medicines. Potential patients are identified by other trials or the National Health Service (NHS) system as having a tumor with an actionable mutation that could be treated by one of the drugs in the DETERMINE portfolio. Roche has partnered on the project, providing access to seven medicines that the center is testing to collect data that could support label expansions.
CDD’s ability to foster first-in-class drug development is exemplified by the center spending years to assess whether immunoglobulin E (IgE) antibodies could be a viable class of medicines. Approved monoclonal antibodies are immunoglobulin G (IgG) type, but the CDD’s work has shown that an IgE candidate is well-tolerated and may have better anti-cancer effects. A biotech company, Epsilogen, raised £31 million to build on these proof-of-concept clinical studies. CRUK was also vital to the rise of Artios, a DNA damage-response biotech company with a therapeutic asset entering phase 2 that has raised £110 million in a Series C funding round. The charity’s drug discovery group, CRH’s Therapeutic Innovation, helped to build Artios around a portfolio of CRUK molecules.
“This is a model that we like, incubating companies within this drug discovery space, raising additional investment, and letting them progress their own pipelines. It’s something that we’re exploring repeating in the future,” Tzircotis explained.
As the innovation arm of CRUK, CRH is also actively looking for new clinical development partners for the CDD. Biopharma companies that partner with the CDD access the center’s rare set of capabilities, enabling them to benefit from a streamlined path into the clinic and the unique value the CRUK group brings to drug development programs.