Bicycle Therapeutics and Cancer Research UK to Collaborate on Development of New Bicycle® Immuno-oncology Candidate, BT7401

Cancer Research UK to fund exploratory development of BT7401 through a Phase IIa clinical study

LONDON & CAMBRIDGE, UK & BOSTON, MA, USA I January 07, 2020 IBicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research, in which Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase IIa clinical study.

“The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle. “This new collaboration marks yet another initiative designed to help us bring a potentially important Bicycle-based therapy to patients more efficiently. We are excited to extend our relationship with Cancer Research UK by collaborating with them on BT7401. Cancer Research UK is a partner of choice, with a broad network of collaborators and extensive expertise in cancer treatment. Through our collaboration, we believe we will be able to characterize the biologic and therapeutic profile of BT7401, which we’re pleased to add to our growing portfolio of novel immuno-oncology assets.”

Dr. Nigel Blackburn, Cancer Research UK's director of drug development, said: "We’re delighted to be partnering again with Bicycle, building on our continuing relationship. Based on the preclinical data, we believe that BT7401 could offer improved anti-tumor activity with fewer side effects compared with antibody-based approaches, which so far have been limited by toxicity.”

Dr. Blackburn continued: “Looking to the future, we believe BT7401 has the potential to open up new treatment options for the large numbers of patients who stop responding to checkpoint inhibitors, and we look forward to working with Bicycle in this new endeavor.”

BT7401 is a chemically synthesized, multivalent small molecule agonist of CD137, comprised of Bicycles connected by stable linkers through a central hinge. Though prior programs using antibodies to agonize CD137 have demonstrated robust and durable anti-tumor effects, they have been limited by severe hepatotoxicity observed in clinical trials. Preliminary toxicology studies suggest BT7401 may circumvent this limitation. In addition, BT7401 has shown significant pharmacologic activity in preclinical models. These findings indicate that BT7401 may offer an improved therapeutic index compared to that of antibody-based approaches.

Under the terms of the Clinical Development Partnerships agreement, Cancer Research UK’s Centre for Drug Development will fund and sponsor development of BT7401 from current preclinical studies through the completion of a Phase IIa trial. Bicycle retains the right to advance the BT7401 program further, at which point an undisclosed payment split between cash and equity, success-based milestones and royalty payments would be made to Cancer Research UK.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle’s lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK visit www.cancerresearchuk.org.

SOURCE: Bicycle Therapeutics

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