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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934
December 13, 2024
Date of Report (Date of earliest event reported)
Bicycle
Therapeutics plc
(Exact name of registrant as specified in its
charter)
| England
and Wales |
|
001-38916 |
|
Not
applicable |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Blocks
A & B, Portway Building,
Granta
Park Great Abington, Cambridge
United Kingdom |
CB21
6GS |
| (Address of principal
executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: +44
1223 261503
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| | |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title
of each class |
Trading
Symbol (s) |
Name
of each exchange on which registered |
| Ordinary
shares, nominal value £0.01 per share |
n/a |
The
Nasdaq
Stock Market LLC* |
| American
Depositary Shares, each representing one ordinary share, nominal value £0.01 per share |
BCYC |
The
Nasdaq
Stock Market LLC |
* Not
for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On December 12, 2024, Bicycle Therapeutics
plc (the “Company”) issued a press release announcing data updates across the zelenectide pevedotin program and its development
strategy leveraging NECTIN4 gene amplification. A copy of the press release is attached as Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated into this Item 8.01 by reference.
On December 13, 2024, the Company hosted a
conference call and webcast to review the data updates for zelenectide pevedotin. The webcast and a copy of the presentation used in the
conference call can be accessed by visiting the “Presentation + Events” section at investors.bicycletherapeutics.com.
| Item 9.01 | Financial Statements and Exhibits |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Date: December 13, 2024 |
BICYCLE THERAPEUTICS PLC |
| |
|
| |
By: |
/s/ Alethia Young |
| |
Name: |
Alethia Young |
| |
Title: |
Chief Financial Officer |
Exhibit 99.1
Bicycle Therapeutics Announces Data Updates
Across Zelenectide Pevedotin Program and Development Strategy Leveraging NECTIN4 Gene Amplification
Topline combination data for zelenectide pevedotin
plus pembrolizumab in first-line metastatic urothelial cancer demonstrated a 60% overall response rate, in line with existing therapies
Dose selection and topline data from Phase 2/3
Duravelo-2 trial planned for 2H 2025
Heavily pretreated breast cancer and non-small
cell lung cancer patients with NECTIN4 gene amplification and/or polysomy demonstrated an enhanced response to zelenectide pevedotin
Company to advance development strategy leveraging
NECTIN4 gene amplification, with Phase 1/2 trials in breast cancer, lung cancer and multi-tumor planned for 2025
Bicycle Therapeutics to host conference call
and webcast with management and oncology experts on Friday, Dec. 13, at 8 a.m. ET
CAMBRIDGE, England & BOSTON, Dec. 12, 2024 – 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 data showing the enhanced anti-tumor activity of zelenectide pevedotin
monotherapy in breast cancer patients with NECTIN4 gene amplification at the 2024 San Antonio Breast Conference Symposium (SABCS)
in San Antonio, Texas. The company also announced topline combination data for zelenectide pevedotin plus pembrolizumab in previously
untreated (first-line) cisplatin-ineligible patients with metastatic urothelial cancer (mUC), provided an enrollment and timeline update
for the company’s Phase 2/3 Duravelo-2 trial and shared topline monotherapy data for zelenectide pevedotin in non-small cell lung
cancer (NSCLC) patients with NECTIN4 gene amplification. Bicycle Therapeutics will host a conference call and webcast tomorrow,
Dec. 13, at 8 a.m. ET to review the data updates for zelenectide pevedotin and discuss its development strategy leveraging NECTIN4
gene amplification. Management will be joined by oncology experts Sherene Loi, M.D., Ph.D., from the Peter MacCallum Cancer Centre
in Melbourne, Australia, and Niklas Klümper, M.D., from the University Hospital Bonn in Germany.
“The totality of the data shared today builds on the breadth
of previously reported data for zelenectide pevedotin that we believe, when combined with our ambitious development strategy leveraging
NECTIN4 gene amplification, position Bicycle as a leader in addressing Nectin-4 associated cancers,” said Bicycle Therapeutics
CEO Kevin Lee, Ph.D. “We are encouraged by the topline zelenectide pevedotin data in combination with pembrolizumab in first-line
mUC patients, which demonstrate zelenectide pevedotin’s response data are in line with other drug conjugates used to treat mUC while
its safety and tolerability profile continues to be differentiated. Additionally, we are very pleased with our progress in enrolling our
Duravelo-2 registrational trial for zelenectide pevedotin in mUC and look forward to providing dose selection and topline data in the
second half of next year.”
Dr. Lee continued: “While early, the zelenectide pevedotin monotherapy
data in breast cancer and NSCLC patients with NECTIN4 gene amplification underscore its promising anti-tumor activity and solidify
our next steps for the therapy’s development. By leveraging NECTIN4 gene amplification, we expect to be able to identify
the patients who may most benefit from zelenectide pevedotin and accelerate development for solid tumor indications beyond bladder cancer.
Over the course of 2025, we plan to initiate Phase 1/2 trials evaluating zelenectide pevedotin in NECTIN4 gene-amplified breast
cancer, lung cancer and multiple other cancers.”
Topline Zelenectide Pevedotin Plus Pembrolizumab Combination Data
in First-line mUC Highlights
Zelenectide pevedotin is a Bicycle® Toxin Conjugate (BTC®)
targeting Nectin-4, a well-validated tumor antigen. Topline results from the ongoing Phase 1/2 Duravelo-1 trial evaluating zelenectide
pevedotin 5 mg/m2 weekly plus pembrolizumab 200 mg once every three weeks in 22 first-line cisplatin-ineligible patients with
mUC showed:
| · | 60% overall response rate (ORR) (12/20) among efficacy-evaluable patients.
Of the responses, 5 were confirmed and 7 were unconfirmed at the time of the data cut. Fifteen patients remained on treatment at the time
of the data cut. |
| · | Safety and tolerability profile was broadly consistent with late-line Duravelo-1
monotherapy and combination cohorts. |
| · | Adverse events of clinical interest such as peripheral neuropathy, skin reactions
and eye disorders were primarily low grade. There was one report of Grade 3 sensory peripheral neuropathy and one report of Grade 3 rash,
both of which were transient and reverted to Grade 1 upon dose interruption. |
More detailed data from this study will be presented at a future medical
meeting.
Bicycle Therapeutics is currently conducting the Phase 2/3 Duravelo-2
trial evaluating zelenectide pevedotin plus pembrolizumab versus chemotherapy in first-line mUC (Cohort 1), and zelenectide pevedotin
monotherapy and in combination with pembrolizumab in late-line mUC (Cohort 2). In each cohort, two doses of zelenectide pevedotin –
5 mg/m2 weekly and 6 mg/m2 two weeks on, one week off – are being initially assessed. Based on enrollment
progress, the company plans to report dose selection and topline data for both cohorts in the second half of 2025.
Zelenectide Pevedotin Monotherapy Data in Breast Cancer Patients
with NECTIN4 Gene Amplification Highlights (Presented at 2024 SABCS)
Gene amplification is a common mechanism by which cancer cells gain
function. Bicycle Therapeutics identified that the NECTIN4 gene sits on a commonly amplified chromosomal site in cancer, creating
more copies of the gene and often translating to more protein expression. Since zelenectide pevedotin binds to Nectin-4, it was hypothesized
that NECTIN4 gene amplification may predict response and could serve as a biomarker for therapy stratification.
The company conducted a post-hoc analysis of 38 heavily pretreated
breast cancer patients enrolled in Duravelo-1, of which 32 were confirmed to have triple-negative breast cancer (TNBC). The majority of
patients were treated with zelenectide pevedotin 5 mg/m2 weekly.
Of the 38 breast cancer patients enrolled, 35 patients were efficacy
evaluable. Additionally, 23 breast cancer patient samples were available for NECTIN4 testing, of which 8 demonstrated NECTIN4 gene
amplification or harbored NECTIN4 polysomy. Results showed:
| · | 62.5% ORR (5/8) among breast cancer patients with NECTIN4 gene amplification
or polysomy, compared to 14.3% ORR (5/35) among all efficacy-evaluable breast cancer patients. |
| · | Of the 5 partial responses, 4 were confirmed and 1 was unconfirmed. |
| · | No responses in non-amplified or non-polysomy patients. |
Of the 32 TNBC patients enrolled, 30 patients were efficacy evaluable.
Additionally, 19 TNBC patient samples were available for NECTIN4 testing, of which 7 demonstrated NECTIN4 gene amplification
or harbored a NECTIN4 polysomy. Results showed:
| · | 57.1% ORR (4/7) among TNBC patients with NECTIN4 gene amplification
or polysomy, compared to 13.3% ORR (4/30) among all efficacy-evaluable TNBC patients. |
| · | Of the 4 partial responses, 3 were confirmed and 1 was unconfirmed. |
| · | All 3 TNBC patients with NECTIN4 gene amplification who responded
to zelenectide pevedotin had prior treatment with sacituzumab govitecan. |
| · | No responses in non-amplified or non-polysomy patients. |
In this study of heavily pretreated breast cancer patients, zelenectide
pevedotin was generally well tolerated, and its safety and tolerability profile was consistent with data from other Duravelo-1 cohorts.
Low rates of Grade ≥3 treatment-related adverse events (TRAEs) (34.2%) and Grade ≥3 treatment-related serious adverse events (TRSAEs)
(10.5%) occurred. The most common TRAEs were fever (pyrexia), nausea and diarrhea. TRAEs of clinical interest, including peripheral neuropathy
(any kind) and skin reactions, were low grade.
“Although the sample size was limited, this post-hoc analysis
highlights the encouraging anti-tumor activity of zelenectide pevedotin in breast cancer patients with NECTIN4 gene amplification,
particularly among those with TNBC who urgently need new treatment options,” said Professor Sherene Loi, M.D., Ph.D., consultant
medical oncologist in the Breast Unit and group leader at the Peter MacCallum Cancer Centre in Melbourne, Australia. “As innovative
and genomically targeted therapies for breast cancer continue to emerge, these findings position zelenectide pevedotin as a promising
potential new therapy and NECTIN4 gene amplification as a novel target for breast cancer drug development.”
The poster presentation, “Enhanced anti-tumor activity of zelenectide
pevedotin in triple-negative breast cancer (TNBC) patients with NECTIN4 gene amplification” is available in the Publications
section of the Bicycle Therapeutics website.
Topline Zelenectide Pevedotin Monotherapy Data in NSCLC Patients
with NECTIN4 Gene Amplification Highlights
The company conducted a post-hoc analysis of 40 pretreated patients
with NSCLC enrolled in Duravelo-1. The majority of patients received zelenectide pevedotin 5 mg/m2 weekly.
Of the 40 patients enrolled, 34 patients were efficacy evaluable. Additionally,
19 patient samples were available for NECTIN4 testing, of which 6 demonstrated NECTIN4 gene amplification. Five out of 6
patients with NECTIN4 gene amplification were efficacy evaluable. Results showed:
| · | 40.0% ORR (2/5) among patients with NECTIN4 gene amplification, compared
to 8.8% ORR (3/34) among all efficacy-evaluable patients. |
| · | Of the 3 partial responses, 2 were confirmed and 1 was unconfirmed. |
| · | Out of 19 patients tested for NECTIN4 gene amplification, none of
the non-amplified patients responded. |
The safety and tolerability profile of zelenectide pevedotin was broadly
consistent with data from other Duravelo-1 monotherapy cohorts.
More detailed data from this study will be presented at a future medical
meeting.
Overview of Development Strategy Leveraging NECTIN4 Gene
Amplification
Bicycle Therapeutics plans to advance development of zelenectide pevedotin
in broader indications outside of mUC utilizing a NECTIN4 gene amplification strategy to target patients who have the potential
for significantly deeper responses.
Over the course of 2025, Bicycle Therapeutics plans to initiate several
additional Phase 1/2 trials to assess zelenectide pevedotin in NECTIN4 gene-amplified breast cancer, lung cancer and multiple other
cancers. Through this strategy, the company believes it has the opportunity to become the leader in addressing Nectin-4 associated cancers
and potentially transform the treatment landscape for thousands of patients in the United States.
Conference Call Details
Bicycle Therapeutics will host a conference call and webcast on
Friday, Dec. 13, at 8 a.m. ET to review the data updates for zelenectide pevedotin. The company’s management team
will be joined by Sherene Loi, M.D., Ph.D., Peter MacCallum Cancer Centre, and Niklas Klümper, M.D., University Hospital Bonn.
To access the call, please dial +1-833-816-1408 (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 Bicycle’s development of zelenectide pevedotin, BT5528 and BT7480 as well as potential
radiopharmaceutical product candidates; the company’s plans to utilize a NECTIN4 gene amplification strategy in the clinical
development of zelenectide pevedotin; expectations with respect to Bicycle’s ability to identify the patients who may most benefit
from zelenectide pevedotin, to advance or accelerate development of this product candidate for broader indications, including solid tumor
cancers beyond bladder cancer, and to become a leader in addressing Nectin-4 associated cancers; the planned initiation of clinical trials
of zelenectide pevedotin in breast cancer, lung cancer, and other cancers; the timing and manner of announcement of data and program updates
from clinical trials for zelenectide pevedotin, including reporting of dose selection and topline data from the Duravelo-2 trial; and
the use of Bicycle’s technology through various partnerships to develop potential therapies in diseases beyond oncology. 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, partnerships or NECTIN4 gene amplification strategy;
timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future
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 October 31, 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.
###
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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Bicycle Therapeutics (NASDAQ:BCYC)
過去 株価チャート
から 12 2024 まで 1 2025
Bicycle Therapeutics (NASDAQ:BCYC)
過去 株価チャート
から 1 2024 まで 1 2025
