First human imaging data validate the potential
of MT1-MMP as a novel target in the treatment of cancer and
demonstrate positive properties of Bicycle Radionuclide Conjugates
(BRC®) for radiopharmaceutical use
Additional preclinical data demonstrate
biodistribution of BRCs can be optimized to maintain high tumor
uptake while significantly reducing kidney levels
Company strategy focuses on pursuing novel
targets using a range of isotopes to develop radiopharmaceuticals
with first-in-class potential
Bicycle Therapeutics to host conference call
and webcast today at 8 a.m. ET
Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical
company pioneering a new and differentiated class of therapeutics
based on its proprietary bicyclic peptide (Bicycle®) technology,
today announced the presentation of the first human imaging data
validating the potential of MT1-MMP as a novel target in the
treatment of cancer and demonstrating the positive properties of
Bicycle Radionuclide Conjugates (BRC®) for radiopharmaceutical use,
as well as preclinical data demonstrating optimized BRC
radioisotope delivery at the European Association of Nuclear
Medicine (EANM) 2024 Congress in Hamburg, Germany.
“Since our founding, our goal at Bicycle Therapeutics has been
to leverage the power of our platform in areas where we can have
the most impact for patients. Over the years, we have built a
robust pipeline of oncology therapies that includes targeted drug
conjugates, immuno-oncology agents and now, radiopharmaceuticals,”
said CEO Kevin Lee, Ph.D. “The exciting data presented at EANM
underscore the potential of our Bicycle Radionuclide Conjugates to
deliver a range of isotopes to novel cancer targets. Through our
strategy of pursuing novel targets with first-in-class potential
and selecting the isotope that best aligns with the target biology
and indication, we have an opportunity to potentially broaden the
use of radiopharmaceuticals to diagnose and treat cancer.”
In line with Bicycle Therapeutics’ radiopharmaceuticals
strategy, the company selected tumor antigen EphA2 as its second
BRC target and signed a letter of intent with leading isotope
technology company Eckert & Ziegler to put in place an
agreement to supply a range of radioisotopes and develop and
manufacture BRC molecules. Bicycle Therapeutics, through its
internal pipeline of wholly owned molecules and strategic
collaborations with industry and academic leaders in the field,
aims to be at the forefront of the development of next-generation
radiopharmaceutical therapies. Bicycle® molecules have ideal
properties for radioisotope delivery due to their low molecular
weight, high selectivity and affinity for their intended target and
rapid systemic clearance.
“The data presented at EANM demonstrate how our Bicycle®
platform is a powerful tool for de novo identification of
high-quality binders to important cancer targets. We believe the
ability to optimize the biodistribution properties of our
molecules, significantly reducing kidney retention while retaining
rapid, selective uptake in tumors, position Bicycle Radionuclide
Conjugates as a potentially best-in-class approach for targeted
radionuclide therapy,” said Michael Skynner, Ph.D., chief
technology officer of Bicycle Therapeutics. “MT1-MMP is the first
target for radiopharmaceutical development that we are pursuing
given its expression in many solid tumors such as non-small cell
lung cancer, esophageal and triple negative breast cancer.”
EANM 2024 Congress Data Highlights
During an oral presentation, the German Cancer Consortium (DKTK)
presented first human imaging data for a BRC targeting MT1-MMP.
They focused on a case study in a 65-year-old male diagnosed with
advanced pulmonary adenocarcinoma, the most common type of
non-small cell lung cancer, in the lung and lymph nodes confirmed
by endobronchial ultrasound (EBUS) biopsy. The patient received
fluorine-18-labelled FDG-PET/CT imaging, and two weeks later
received MT1-MMP PET/CT imaging up to one hour post injection of
the gallium-68-labelled BRC tracer.
Both scans revealed multiple lymph node metastases and bone
metastases in the sternum. MT1-MMP imaging demonstrated tracer
uptake in the primary tumor in the lung and lymph node and bone
metastases, consistent with FDG imaging. Additionally, the MT1-MMP
BRC tracer showed renal excretion, with all other organs showing
only negligible tracer uptake. Clear imaging contrast was also
observed at early time points.
In an e-poster, Bicycle Therapeutics presented preclinical data
demonstrating the suitability of Bicycle molecules to deliver
indium to tumors in vivo due to their favorable properties,
including specific tumor uptake, rapid tumor penetration and rapid
renal elimination. Additionally, imaging showed how the
biodistribution profile of BRCs can be optimized to maintain high
tumor uptake and retention while significantly reducing kidney
uptake and retention. These data build on the body of preclinical
data the company has published in this area demonstrating the use
of Bicycle molecules to effectively deliver various radioisotopes,
such as lutetium and lead, to tumors.
Altogether, the data presented at EANM validate the potential of
MT1-MMP as a novel target in the treatment of cancer, demonstrate
the translatability of BRC preclinical data and highlight the
potential of Bicycle molecules for targeted radionuclide
therapy.
The e-poster, “Bicycle Radionuclide Conjugates for radioisotope
delivery to solid tumors,” is available in the Publications section
of the Bicycle Therapeutics website.
Conference Call Details Bicycle Therapeutics will host a
conference call and webcast today, Oct. 23, at 8 a.m. ET to review
the first human imaging data and outline the company’s
radiopharmaceuticals strategy. To access the call, please dial
833-816-1408 (U.S.) or +1-412-317-0501 (international) and ask to
join the Bicycle Therapeutics call. A live webcast and replay of
the conference call will be accessible in the Investor section of
the Company’s website at www.bicycletherapeutics.com.
About Bicycle Therapeutics Bicycle Therapeutics is a
clinical-stage pharmaceutical company developing a novel class of
medicines, referred to as Bicycle® molecules, for diseases that are
underserved by existing therapeutics. Bicycle molecules 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 Bicycle molecules attractive candidates for
drug development. The company is evaluating zelenectide pevedotin
(formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting
Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule
targeting EphA2, a historically undruggable target; and BT7480, a
Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®)
targeting Nectin-4 and agonizing CD137, in company-sponsored
clinical trials. Additionally, the company is developing Bicycle
Radionuclide Conjugates (BRC®) for radiopharmaceutical use and,
through various partnerships, is exploring the use of Bicycle®
technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with
many key functions and members of its leadership team located in
Cambridge, Mass. For more information, visit
www.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 validation of
MT1-MMP as a target for the treatment of cancer, the suitability of
BRCs for radiopharmaceutical use and the potential of this
approach; Bicycle’s plans for an agreement with Eckert &
Ziegler to develop, manufacture and supply a range of
radioisotopes; Bicycle’s anticipated progress across its internal
and partnered pipelines in radiopharmaceuticals, the
translatability of Bicycle’s BRC preclinical data and the ability
of the Bicycle platform to identify binders for cancer targets;
Bicycle’s development across its R&D pipeline and the
advancement of its product candidates, including zelenectide
pevedotin, BT5528 and BT7480; and the therapeutic potential for
Bicycles in oncology and other applications. 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
research and development and in the initiation, progress and
completion of preclinical studies and clinical trials and the
identification and development of Bicycle’s potential and current
product candidates; the risk that Bicycle may not realize the
intended benefits of its platform, technology or partnerships;
timing of results from preclinical studies and clinical trials;
whether the outcomes of preclinical studies will be predictive of
clinical trial results; the risk that preclinical studies and
clinical trials may have unsatisfactory outcomes; potential adverse
effects arising from the testing or use of Bicycle’s product
candidates; the risk that Bicycle’s management have not focused the
company’s activities on the clinical programs and research areas
with the highest potential to maximize value creation; and other
important factors, any of which could cause Bicycle’s actual
results to differ from those contained in the forward-looking
statements, are described in greater detail in the section entitled
“Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on May 2, 2024,
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 because of any new information, future
events, changed circumstances or otherwise, except as otherwise
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20241023085848/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications stephanie.yao@bicycletx.com
857-523-8544
Matthew DeYoung Argot Partners ir@bicycletx.com 212-600-1902
Media: Jim O’Connell Weber Shandwick media@bicycletx.com
312-988-2343
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