Bicycle Therapeutics Announces Major Development Across Many Therapeutic Packages Outside of Oncology

CAMBRIDGE, England & BOSTON–(Business WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology enterprise groundbreaking a new

CAMBRIDGE, England & BOSTON–(Business WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology enterprise groundbreaking a new and differentiated class of therapeutics based mostly on its proprietary bicyclic peptide (Bicycle®) technological innovation, currently announced development updates for its Bicycle-based partnered programs outside of oncology.

Above the very last 5 many years, Bicycle’s system has been to use our novel technological know-how to discover and establish a pipeline of modern property in oncology while on top of that using non-dilutive funding and collaborations to take a look at the therapeutic potential of Bicycles in condition parts outdoors of oncology. Today, for the initially time, we are giving an overview on our development in demonstrating the wide utility of this system to develop molecules with the probable to address some of the most serious health conditions and address foreseeable future healthcare worries,” reported Kevin Lee, Ph.D., Main Government Officer of Bicycle Therapeutics. “It’s amazingly exciting to see how the Corporation has worked innovatively and really collaboratively with lots of diverse institutions to deal with these issues and, at the similar time, generated significant revenues to offset the costs of building and progressing our internal oncology pipeline. I would like to thank all of our collaborators for their enthusiasm in this endeavor and appear forward to continuing our work to advance these significant molecules.”

Bicycle has reached the 1st milestone in its collaboration with Dementia Discovery Fund (DDF) and the University of Oxford’s ARUK Oxford Drug Discovery Institute (ODDI)

  • The Company identified and optimized nM affinity Bicycles to TREM2, a genetically validated target for the remedy of dementia, and nM affinity Bicycles to transferrin receptor 1 (TfR1), a molecular shuttle. In 2019, Bicycle proven a collaboration with DDF, later expanded to incorporate ODDI, to use Bicycle technological know-how for the discovery and improvement of probable novel therapeutics for the treatment method of dementia. The a few events are collaborating to identify and characterize Bicycles that bind to and activate TREM2, a genetically validated dementia focus on. As element of the collaboration, Bicycle is also using its technology to establish binders to TfR1, a blood mind barrier transporter, that could perhaps allow supply of Bicycles, or any other molecular payload, into the central anxious process (CNS), or other organ devices, expressing TfR1. Under the terms of the collaboration with DDF, Bicycle retains all legal rights to the TfR1 molecules outdoors of the license granted for use with targets outlined in just the DDF collaboration.

Bicycle developments platform in several anti-infective locations, such as antimicrobials and antivirals

  • Innovate UK’s Biomedical Catalyst (BMC) awarded the Corporation funding to advance a Bicycle inhibitor for a key cell wall biosynthesis focus on in Enterobacterales, Penicillin Binding Protein 3 (PBP3). Bicycle is working with its proprietary platform to try to handle the significant healthcare challenge of antimicrobial resistance and has recognized a number of opportunity Bicycle PBP3 inhibitors. Through grants awarded by the British isles federal government and in collaboration with investigators at the College of Warwick, Bicycle intends to progress these PBP3 inhibitors, likely representing the very first novel course of antibiotics recognized in decades, to prospect and preliminary toxicology testing.
  • Innovate Uk, less than a particular program targeting essential systems to fast respond to the challenge of COVID-19 (UKRI Ideas to Deal with COVID-19 – Innovate United kingdom Write-up 25), offered funding to guidance Bicycle’s efforts to discover new healthcare answers to the SARS-CoV-2 pandemic. Bicycle has identified a lot of discrete families of Bicycles which bind to at least 10 unique epitopes on the SARS-CoV-2 spike protein, binders to the Nucleocapsid protein and the viral attachment site on the host ACE2 human receptor. By means of Bicycle’s partnership with scientists at the MRC Laboratory of Molecular Biology, Bicycles discovered by these screens have demonstrated nanomolar activity in inhibiting SARS-CoV-2 an infection of human lung cells. These monomeric Bicycles have been conjugated with each other to make a varied selection of bi-paratopic and multi-valent tiny molecules (less than 10kD), some of which are lively in the picomolar vary in viral entry assays and could be resistant to the present-day SARS-CoV-2 variants of concern. Bicycle continues to progress these novel compounds in pre-scientific evaluation. Bicycle has also formed partnerships with diagnostic gurus to assess its novel SARS-CoV-2 binding Bicycles in Lateral Flow Assessments and other diagnostic screening formats.

Bicycle has made sizeable progress through partnerships with biopharmaceutical therapeutic space leaders in indications exterior of oncology

  • The Business has correctly uncovered and superior targets exterior of oncology through the ongoing collaboration with AstraZeneca, a world biopharmaceutical firm, to discover novel agents for the remedy of respiratory and cardiometabolic diseases. Two belongings have been transitioned to AstraZeneca for more enhancement and are currently becoming progressed in their discovery pipeline. Two more belongings reached transition criteria and were transitioned to AstraZeneca but were returned to Bicycle by AstraZeneca.
  • Bicycle has also discovered targets in its collaboration with Bioverativ (acquired by Sanofi in 2018) for the treatment of unusual hematological illnesses. The Bioverativ collaboration correctly determined nM multi-valent inhibitors to P-Selectin, which inhibited human neutrophil binding and rolling, with prospective apps in sickle mobile ailment and other inflammatory illnesses. The Bioverativ collaboration also determined the initial small molecule Component VIII mimetic for the probable remedy of Hemophilia A. This mimetic is comprised of a multivalent Bicycle binding to both of those Aspect IX and Element X, leading to the generation of activated Variable X (FXa), which effectively activated thrombin in plasma from Hemophilia A clients ex vivo. In 2019, Sanofi elected not to go after even more growth, and the collaboration agreement was terminated. These “lead stage” belongings have now been returned to Bicycle.

Kevin Lee commented, “With four Bicycle molecules now in medical trials for both equally oncology and non-oncology indications, the engineering has proven initial proof of clinical tolerability and suitability for pharmaceutical progress, and I seem ahead to observing how Bicycles may convey essential new remedy opportunities to inadequately served people in added therapeutic spots.”

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a medical-phase biopharmaceutical company establishing a novel class of medications, referred to as Bicycles, for health conditions that are underserved by current therapeutics. Bicycles are totally synthetic short peptides constrained with small molecule scaffolds to sort two loops that stabilize their structural geometry. This constraint facilitates goal binding with large affinity and selectivity, generating Bicycles beautiful candidates for drug advancement. Bicycle’s guide product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is becoming investigated in an ongoing Stage I/IIa clinical demo in collaboration with the Centre for Drug Growth of Cancer Investigate United kingdom. Bicycle is also evaluating BT5528, a next-era BTC targeting EphA2, in a business-sponsored Period I/II trial. BT8009 is a BTC focusing on Nectin-4, a properly-validated tumor antigen, and is also currently currently being evaluated in a Organization-sponsored Stage I/II demo. Bicycle is headquartered in Cambridge, Uk with quite a few vital features and members of its leadership workforce found in Lexington, MA. For additional info, pay a visit to bicycletherapeutics.com.

Forward-Hunting Statements

This push release could comprise forward-wanting statements designed pursuant to the safe and sound harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may possibly be identified by text this kind of as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variants of these phrases or related expressions that are supposed to identify forward-on the lookout statements, though not all ahead-hunting statements incorporate these terms. Ahead-looking statements in this press release incorporate, but are not minimal to, statements regarding expected advancement of preclinical growth efforts and initiation of clinical trials the availability of knowledge from preclinical research and medical trials Bicycle’s capacity to crank out shareholder benefit the therapeutic potential of Bicycle’s and its collaborators’ pre-medical targets and solution candidates Bicycle’s and its’ collaborators’ potential to achieve planned milestones and the availability of long run funding. Bicycle may perhaps not basically reach the plans, intentions or anticipations disclosed in these ahead-hunting statements, and you really should not put undue reliance on these ahead-searching statements. Genuine benefits or functions could vary materially from the plans, intentions and expectations disclosed in these ahead-hunting statements as a outcome of a variety of elements, which include: threats to Bicycle’s and its collaboration partners’ qualities to meet expected deadlines and milestones introduced by the ongoing COVID-19 pandemic uncertainties inherent in the initiation and completion of preclinical scientific tests and clinical trials and medical growth of Bicycle’s item candidates by Bicycle or its collaboration partners the hazard that Bicycle or its collaboration partners might not recognize the intended positive aspects of Bicycle’s technology availability and timing of results from preclinical scientific tests and medical trials regardless of whether the results of preclinical scientific tests will be predictive of medical trial final results regardless of whether initial or interim outcomes from a clinical trial will be predictive of the closing final results of the trial or the final results of potential trials the hazard that research and trials might be delayed and might not have satisfactory results probable adverse consequences arising from the testing or use of Bicycle’s product candidates pitfalls connected to Bicycle’s skill to retain present collaborations and recognize the advantages thereof anticipations for regulatory approvals to perform trials or to sector solutions and other important components, any of which could induce our precise outcomes to differ from individuals contained in the forward-seeking statements, are described in bigger depth in the segment entitled “Risk Factors” in our Yearly Report on Form 10-K submitted with the Securities and Trade Commission (SEC) on March 11, 2021, as effectively as in other filings Bicycle may well make with the SEC in the upcoming. Any forward-wanting statements contained in this push launch discuss only as of the date hereof, and Bicycle expressly disclaims any obligation to update any ahead-wanting statements contained herein, whether as a final result of any new information, future activities, adjusted instances or in any other case, besides as otherwise needed by legislation.