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7 May, 2021 - 10:39 By Tony Quested

Bicycle Therapeutics closing in on prolific pay dirt

Cambridge UK biotech business Bicycle Therapeutics plc is freewheeling towards broad-based commercialisation of its technology. While Q1 losses have widened because of the push for sales, the cash position has been considerably strengthened and the portfolio is rich in promise.

The company is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology.

Chief executive Kevin Lee said: We’ve had a great start to 2021 as we advance multiple Bicycle Toxin Conjugates® (BTCs) in the clinic, prepare for BT7480, our lead tumour-targeted immune cell agonist, to enter the clinic later this year and continue to expand the use of our platform outside of oncology, while also significantly strengthening our balance sheet.

“We plan to build on this momentum during the year and our presentation of preclinical data at the American Association for Cancer Research (AACR) in April serves to highlight the potential therapeutic benefits that Bicycles may offer toward improving the treatment paradigms for people living with cancer and other serious diseases.”

At AACT, Bicycle presented new preclinical data describing the discovery of BT7480, a novel Nectin-4/CD137 Bicycle tumour-targeted immune cell agonistTM (Bicycle TICA) during a ‘New Drugs on the Horizon’ session. 

The company expects BT7480 to enter the clinic in the second half of 2021. Additionally, it presented five posters and one presentation highlighting preclinical data across multiple programs in Bicycle’s oncology pipeline.

Bicycle has also detailed progress updates for its Bicycle programs outside of oncology and achieved the first milestone in the collaboration with Dementia Discovery Fund (DDF) and the University of Oxford’s Alzheimer’s Research UK Oxford Drug Discovery Institute.

The company identified and optimised nM affinity Bicycles to transferrin receptor 1 (TfR1), a molecular shuttle. The three parties are collaborating to identify and characterise Bicycles that bind to and activate TREM2, a genetically validated dementia target.

The company has advanced the platform in multiple anti-infective areas, including antimicrobials and antivirals: Innovate UK’s Biomedical Catalyst awarded the company funding to advance a Bicycle inhibitor for a key cell wall biosynthesis target in Enterobacterales, Penicillin Binding Protein 3 (PBP3). 

Bicycle, working with investigators at the University of Warwick, intends to progress these PbP3 inhibitors – potentially the first novel class of antibiotics identified in decades – to candidate and initial toxicology testing. 

Additionally, under a specific Innovate UK program targeting key technologies to rapidly respond to the challenge of the COVID-19 pandemic, Bicycle received funding to support its efforts to discover new healthcare solutions to SARS-CoV-2.

Since January 2021, Bicycle has completed the sale of $75 million through its at-the-market offering program. Gross proceeds during the first quarter of 2021 totalled $60.6m, with an additional $14.4m in gross proceeds recognised in April 2. 

Also during the second quarter of 2021, the company received $2m from Genentech for achieving specified criteria under the collaboration research plan. Cash as of March 31 does not include the April 2021 ATM proceeds or Genentech proceeds. 

In addition, in March, the company drew an additional $15m available under its debt facility with Hercules Capital, Inc. and amended the loan and security agreement to extend the interest-only payment period until the second half of 2023, with the potential to further extend it into 2024, contingent on the satisfaction of performance milestones.

Cash was $195.9m as of March 31 compared to $136m at the end of December.

Research and development expenses were $9.7m for the three months ended March 31 compared to $7.8m for the same quarter in 2020.

Net loss was $16.2m compared to $11.3 million in the first quarter of 2020.

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