Emerging clinical pharmacokinetic and safety
profiles of Bicycle Toxin Conjugates® demonstrate differentiation
compared to antibody drug conjugates
Trial-in-progress poster outlines
registrational Phase 2/3 Duravelo-2 trial of BT8009, a Nectin-4
targeted Bicycle Toxin Conjugate, in patients with locally advanced
or metastatic urothelial cancer
Zelenectide pevedotin selected as International
Nonproprietary Name for BT8009
FDA Fast Track Designation Granted to BT5528
for the treatment of patients with metastatic urothelial cancer
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 that emerging Phase 1/2 clinical pharmacokinetic
(PK) and safety data for Bicycle Toxin Conjugates® (BTC® molecules)
BT8009 and BT5528 demonstrating differentiated safety and
tolerability profiles will be presented at the 2024 American
Society for Clinical Oncology (ASCO) Annual Meeting, taking place
May 31-June 4 in Chicago. The company also announced zelenectide
pevedotin as the International Nonproprietary Name (INN) for
BT8009, and U.S. Food and Drug Administration (FDA) Fast Track
Designation granted to BT5528 for the treatment of adult patients
with previously treated, locally advanced or metastatic urothelial
cancer (mUC).
“As we advance the development of our investigational therapies,
we are pleased to see the underlying characteristics of Bicycle®
molecules developed using our platform technology — small size for
rapid tissue penetration, tunable pharmacokinetics and high target
selectivity — are leading to emerging differentiated clinical
profiles that we believe have the potential to provide enhanced
benefits and quality of life for cancer patients who have advanced
disease,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. “At
ASCO, we look forward to presenting preliminary clinical
pharmacokinetic and safety data for our Bicycle Toxin Conjugates
zelenectide pevedotin, formerly BT8009, and BT5528 that show
substantial differences in their pharmacokinetic profiles compared
to antibody drug conjugates. Additionally, we continue to advance
enrollment and site activation for our Phase 2/3 Duravelo-2
registrational trial of zelenectide pevedotin in mUC and prepare
for multiple clinical and program updates in the second half of
2024. These include updates from the Phase 1/2 clinical trials of
zelenectide pevedotin and BT5528, for which the newly awarded FDA
Fast Track Designation demonstrates the continued need for targeted
therapies for patients living with advanced bladder cancer.”
PK and Safety Data from BTC® Molecules Title:
Breaking from the paradigm of antibody-drug conjugates: Evaluation
of clinical pharmacokinetics and safety of Bicycle Toxin Conjugates
(BTCs) Poster Session Title: Developmental Therapeutics –
Molecularly Targeted Agents and Tumor Biology Date and Time:
Saturday, June 1, at 9 a.m. CT Abstract Number: 3088
Speaker/Lead Author: Justin Bader, Pharm.D., MBA, Bicycle
Therapeutics
Bicycle Therapeutics researchers and collaborators sought to
compare PK behavior for BTC molecules to MMAE-containing antibody
drug conjugate (ADC) enfortumab vedotin (EV). To do this, the
researchers developed PK models and simulated PK exposures over a
28-day cycle for zelenectide pevedotin (5 mg/m2 once weekly) and
BT5528 (5 mg/m2 once weekly) and compared them to published PK
parameters for EV (1.25 mg/kg on Days 1, 8 and 15 of a 28-day
cycle). Results showed:
- BTC molecule half-life is substantially shorter than that of EV
(<1 hour vs 3.6 days), resulting in extensive elimination of the
BTC molecule within hours of dose administration rather than weeks.
MMAE half-life is also shorter following BTC molecule
administration relative to EV (1.9 days vs 2.6 days), potentially
due to a slower rate of MMAE release from the ADC.
- Relative to EV, BTC molecules achieved similar unconjugated
MMAE PK exposure over a 28-day cycle while maximum serum
concentration (Cmax) was elevated for unconjugated MMAE,
potentially driving rapid penetration into tumor tissue.
- Relative to EV, conjugated MMAE PK exposure from BTC molecules
was substantially lower, potentially limiting toxicities.
Zelenectide pevedotin and BT5528 continued to show promising
emerging safety and tolerability profiles, with data to be
presented from all patients dosed at Cycle 1 Day 1 with zelenectide
pevedotin 5 mg/m2 once weekly monotherapy (data as of March 22,
2024) and with BT5528 6.5 mg/m2 every two weeks monotherapy (data
as of March 14, 2024). The findings:
- Zelenectide pevedotin-related adverse events (AEs) occurred in
84% of patients, of which 31% were Grade ≥3.
- BT5528-related AEs occurred in 91% of patients, of which 22%
were Grade ≥3.
- In contrast to ADCs, treatment-related AEs of interest such as
peripheral neuropathy, skin reactions, ocular disorders and
hyperglycemia occurred at relatively low frequency and severity
with both BTC molecules.
Trial-in-Progress: Registrational Phase 2/3 Duravelo-2
Study Title: A phase 2/3 study of Bicycle Toxin
Conjugate BT8009 targeting Nectin-4 in patients with locally
advanced or metastatic urothelial cancer (la/mUC): Duravelo-2
Poster Session Title: Genitourinary Cancer – Kidney and
Bladder Date and Time: Sunday, June 2, at 9 a.m. CT
Abstract Number: TPS4619 Speaker/Lead Author: Yohann
Loriot, M.D., Ph.D., Institut de Cancérologie Gustave Roussy,
Université Paris-Saclay
The posters will be made available in the Publications section
of bicycletherapeutics.com following the presentations.
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,
previously 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®
Radio 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
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
anticipated progress across its R&D pipeline and the
advancement of its product candidates, including zelenectide
pevedotin, BT5528 and BT7480; the anticipated progression of
Bicycle’s clinical trials and the availability of and timing of
announcement of data from clinical trials and program updates for
clinical candidates; the development of potential
radiopharmaceutical or other product candidates using Bicycle’s
technology through various partnerships; the therapeutic potential
for Bicycles in oncology and other applications; and Bicycle’s
participation in the ASCO annual meeting. 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
clinical trials and clinical development of Bicycle’s product
candidates; the risk that Bicycle may not realize the intended
benefits of its technology or partnerships; availability and timing
of results from clinical trials; whether the outcomes of
preclinical studies will be predictive of clinical trial results;
the risk that trials may have unsatisfactory outcomes; potential
adverse effects arising from the testing or use of Bicycle’s
product candidates; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240523534475/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Deborah Elson Argot Partners media@bicycletx.com
212-600-1902
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