Full Press Release Details
Bicycle Therapeutics Announces Pipeline
CAMBRIDGE, England & BOSTON, April 7, 2020 -Bicycle
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 progress
updates across its wholly-owned and partnered programs in oncology and non-oncology indications.
"We and our partners have recently achieved important
progress in the advancement of our pipeline that we believe could catalyze the next stage of growth for Bicycle," said Kevin
Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Cancer Research UK has identified a recommended dose, which
is within the therapeutic range predicted by preclinical models, for the Phase IIa study of BT1718, which we expect to commence
this year. Our next-generation Bicycle Toxin Conjugates (BTCs), BT5528 and BT8009, are quickly progressing through respective stages
of development. In addition, we believe our recently announced early discovery collaboration with Genentech will allow us to make
considerable investments in expanding our portfolio of immuno-oncology assets, including our wholly-owned programs nearing late
preclinical development. Beyond oncology, we continue to make progress on our partnered programs and to execute on our strategy
of leveraging our collaborators' expertise in specific therapeutic areas to advance the development of Bicycle-based
medicines across a broad range of serious diseases."
Dr. Lee continued: "While we expect that the evolving
COVID-19 pandemic may impact the pace of clinical development, at this time, we believe the strong progress we've achieved
across our pipeline to date will enable us to reach our anticipated 2020 milestones as planned."
BT1718, a potential first-in-class BTC targeting key tumor
Though not a key objective of the Phase I portion
of the Phase I/IIa study, preliminary signs of anti-tumor activity were observed during the dose escalation. As reported at the
European Society of Medical Oncology (ESMO) 2019 Annual Congress, 13 of 24 evaluable patients (54%) had stable disease at the eight-week
timepoint, including a patient who experienced a 45% reduction in a target lesion, with findings generally remaining consistent
as the trial progressed. Today, Bicycle announced that, in addition, one patient with small cell lung cancer experienced a partial
response, with a 68% reduction in a target lesion.
The Company anticipates that Cancer Research UK will
initiate the Phase IIa portion of the Phase I/IIa study of BT1718 in 2020, although timing may be dependent on the ongoing COVID-19
pandemic. These expansion cohorts will include patients determined to be MT1-MMP-positive based on a prespecified tumor membrane
H-score. Initially, patients will be enrolled into two expansion cohorts, one in squamous non-small cell lung cancer (NSCLC) and
the other in an all-comers "basket" cohort. Depending on results from these first two cohorts, additional cohorts may
BT5528, a BTC targeting EphA2, a potentially high-value
target for which antibody-based approaches have been unsuccessful
The Phase I/II multi-center, open-label trial is evaluating
BT5528 administered once-weekly as a single agent and in a lagging cohort in combination with nivolumab. The Phase I portion is
a dose escalation study primarily designed to assess the safety and tolerability of BT5528 and to determine an RP2D. Bicycle expects
the first patient in the combination arm will be dosed in 2020, subject to potential timing and other impacts of the ongoing COVID-19
BT8009, a Nectin-4 targeting BTC with a potentially differentiated
profile to marketed antibody-drug conjugate (ADC)
Novel, fully synthetic Bicycle systemic immune
cell agonists and tumor-targeted immune cell agonists (TICAs )
Partnered programs beyond oncology
Oxurion is preparing to initiate a Phase II trial
evaluating multiple doses of THR-149 in DME patients who respond sub-optimally to anti-VEGF therapy.
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.
Forward-Looking Statements
This press release may contain forward-looking statements
made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be
identified by words such as "aims," "anticipates," "believes," "could,"
"estimates," "expects," "forecasts," "goal," "intends,"
"may," "plans," "possible," "potential," "seeks,"
"will" and variations of these words or similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding Bicycle's collaborations with multiple third parties; the
discovery, development and potential commercialization of potential product candidates using Bicycle's technology and
under collaboration agreements with third-parties; anticipated advancement of preclinical development efforts and initiation
and progression of clinical trials; the therapeutic potential for Bicycles in various disease applications; the
potential impacts of the ongoing COVID-19 pandemic on site initiation, patient enrollment and treatment; and the potential to
receive milestone payments and royalties under Bicycle's collaboration agreements. Bicycle may not actually achieve the
plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on
these forward-looking statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent
in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle's
product candidates; availability and timing of results from preclinical studies and clinical trials; whether initial or
interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials;
the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising
from the testing or use of Bicycle's product candidates; risks related to Bicycle's ability to maintain existing
collaborations and realize the benefits thereof; expectations for regulatory approvals to conduct trials or to market
products; risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to
Bicycle's and its collaboration partners' abilities to meet other anticipated deadlines and milestones, presented
by the ongoing COVID-19 pandemic; and other important factors, any of which could cause our actual results to differ from
those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk
Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 10, 2020,
as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking
statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise,
except as otherwise required by law.
Investor and Media Contact:
Bicycle Therapeutics