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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
September 14, 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 September 14, 2024, Bicycle Therapeutics plc issued a press
release announcing updated clinical results for zelenectide pevedotin (formerly BT8009) in mUC, BT5528 in advanced solid tumors, and
BT7480 in advanced solid tumors. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K
and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits |
(d) 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: September 19, 2024 | |
BICYCLE THERAPEUTICS
PLC |
| | |
|
|
| | |
By: |
/s/ Alethia Young |
| | |
Name: |
Alethia Young |
| | |
Title: |
Chief Financial Officer |
Exhibit 99.1
Bicycle Therapeutics Presents Updated Clinical
Results Across Oncology Pipeline at ESMO Congress 2024
Updated monotherapy data for Nectin-4 targeting
zelenectide pevedotin in metastatic urothelial cancer (mUC) showed a promising 45% overall response rate (ORR), 11.1 months median duration
of response and a generally well-tolerated safety profile
EphA2-targeting BT5528 demonstrated an emerging
differentiated safety profile and antitumor activity in patients with advanced solid tumors, including a 45% ORR in mUC 6.5 mg/m2
every two weeks dose expansion cohort
Relatively low frequency and severity of treatment-related
peripheral neuropathy following monotherapy with Bicycle Toxin Conjugates® zelenectide pevedotin and BT5528, with patients
often able to continue therapy without modification
BT7480 demonstrated a favorable safety profile
and preliminary antitumor activity in advanced Nectin-4-associated solid tumors
BARCELONA, September 14, 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 updated Phase 1/2 clinical results for Bicycle Toxin Conjugate (BTC®)
zelenectide pevedotin (formerly BT8009) in metastatic urothelial cancer (mUC); BTC molecule BT5528 in advanced solid tumors, such as
mUC and ovarian; and Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) BT7480 in advanced solid
tumors. The company also shared an analysis of peripheral neuropathy, a key adverse event of interest associated with monomethyl auristatin
E (MMAE)-based drug conjugates, in patients treated with BTC molecules. These data will be presented during a poster session at the European
Society for Medical Oncology (ESMO) Congress 2024 in Barcelona today.
“We are pleased that the data presented at ESMO continue to support
the promising response and differentiated safety profiles of our Bicycle molecules. Importantly, our lead investigational therapy zelenectide
pevedotin continues to demonstrate an overall response rate that is in line with other drug conjugates used to treat metastatic urothelial
cancer, but with a marked improvement in tolerability. Overall, we believe the data continue to demonstrate the potential of our Bicycle
technology platform to create differentiated medicines designed to help patients not only to live longer but also to live well,”
said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. “These clinical data are just the first set of updates that we have guided to
delivering this year. In the coming months, we look forward to sharing initial imaging data from our growing radiopharmaceutical pipeline
and additional data for zelenectide pevedotin in bladder, breast and lung cancer.”
ESMO 2024 Data Highlights
Zelenectide pevedotin is a BTC® molecule targeting
Nectin-4, a well-validated tumor antigen, designed to overcome the significant toxicity associated with other drug conjugate approaches.
Updated results from the ongoing Phase 1/2 Duravelo-1 trial evaluating 5 mg/m2 weekly of zelenectide pevedotin monotherapy
in 45 mUC patients who had not previously been treated with enfortumab vedotin showed:
| · | Among 38 efficacy-evaluable patients, a 45% overall response rate (ORR), including 1 confirmed complete response and 16 partial responses
(13 confirmed). Stable disease was maintained in 9 patients, and 12 patients experienced progressive disease. |
| · | A median duration of response of 11.1 months among the 14 patients with confirmed responses. |
| · | An emerging differentiated safety profile, particularly around adverse events of interest such as peripheral neuropathy, skin reactions
and eye disorders. Notably, there were no Grade ≥3 treatment-related adverse events (TRAEs) of peripheral neuropathy (any kind), skin
reactions or eye disorders, and patients with pre-existing peripheral neuropathy were unlikely to develop worsening peripheral neuropathy
during treatment with zelenectide pevedotin. |
The global Phase 2/3 Duravelo-2 registrational trial of zelenectide
pevedotin in patients with mUC is currently enrolling. Additional data updates for zelenectide pevedotin in combination with pembrolizumab
in first line mUC and monotherapy in late line triple-negative breast cancer and non-small cell lung cancer (NSCLC) are planned for later
this year.
BT5528 is a BTC molecule targeting EphA2, a tumor antigen that
is widely expressed in many cancers and has historically been difficult to target using other drug conjugate approaches. Updated results
from the ongoing Phase 1/2 trial evaluating 6.5 mg/m2 every two weeks and 5 mg/m2 weekly of BT5528 monotherapy in
patients with advanced solid tumors showed:
| · | Among 113 efficacy-evaluable patients, a 12% ORR in patients with advanced solid tumors. |
| · | The highest anti-tumor activity in mUC, with a 34% ORR in all efficacy-evaluable patients enrolled in the dose escalation and expansion
cohorts. Among patients receiving 6.5 mg/m2 every two weeks, a 31% ORR was observed in the dose escalation and expansion cohort
and a 45% ORR was observed in the expansion cohort only. A lower but acceptable ORR of 27% was observed in patients receiving 5 mg/m2
weekly. |
| · | No objective responses in patients with ovarian cancer who received 5 mg/m2 weekly. However, 5 patients maintained stable
disease. |
| · | A suggested correlation between EphA2 expression and response. Among 14 patients with mUC who had available immunohistochemistry and
response data, a 43% ORR was observed in EphA2-positive patients compared to a 20% ORR in EphA2-negative patients. |
| · | A clearly differentiated emerging safety profile, with none of the hemorrhage events or hematological toxicities that have been associated
with other EphA2-targeting drug conjugates. |
The company has begun assessing BT5528 at 6.5 mg/m2 every
two weeks in combination with nivolumab. Results from this cohort are expected in 2025.
Low rates of treatment-related peripheral neuropathy (TRPN) following
monotherapy treatment with BTC molecules zelenectide pevedotin or BT5528. In 149 patients treated with zelenectide pevedotin and 74
patients treated with BT5528 from ongoing Phase 1/2 studies, results showed:
| · | TRPN in 28% of patients treated with zelenectide pevedotin and 19% of patients treated with BT5528, nearly all of which were low grade
(1-2). One Grade 3 event (neuralgia) was reported in a patient treated with zelenectide pevedotin following prior therapy with enfortumab
vedotin. No Grade 3-4 events were observed for BT5528. |
| · | Among zelenectide pevedotin-treated patients with peripheral neuropathy at baseline, 80% did not develop TRPN during treatment. |
| · | TRPN resulted in few dose modifications across the overall patient populations for zelenectide pevedotin and BT5528, and no drug withdrawals
were necessary for either BTC molecule. |
| · | TRPN had completely resolved in 14% (zelenectide pevedotin) and 21% (BT5528) of patients, and 26% and 21%, respectively, had some
resolution or improvement at time of reporting, though post-treatment follow-up was limited. Median time to resolution or improvement
of TRPN was 2.2 weeks for zelenectide pevedotin and 1.7 weeks for BT5528. |
The data support the hypothesis that the antibody-drug construct may
be a primary driver of peripheral neuropathy rather than MMAE toxicity as was previously believed.
BT7480 is a Nectin-4 targeted CD137 agonist designed to overcome
immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Initial data from the Phase 1/2 dose escalation
trial evaluating BT7480 in patients with advanced solid tumors showed:
| · | Among 39 patients assigned to receive one of 10 different doses (0.002-3.5 mg/kg weekly) of BT7480, an emerging differentiated safety
and tolerability profile with a low number of severe adverse events. Low rates of Grade ≥3 TRAEs (5%) and of treatment-related severe
adverse events (TRSAEs) (8%) were reported, with no such events among those receiving the highest dose of 3.5 mg/kg. |
| · | Best overall response of stable disease in 13 patients, 5 of whom had NSCLC. Stable disease was prolonged (>8 months) in 3 patients,
2 with NSCLC and 1 with anal cancer. There were 2 unconfirmed partial responses, both in patients with cervical cancer. |
| · | Preliminary biomarker analyses that support BT7480 dual targeting of CD137 and Nectin-4 as demonstrated by enhanced immune cell activation,
aligned with the proposed mechanism of action of BT7480. |
As the maximum tolerated dose for BT7480 has not yet been reached,
the company is continuing dose exploration in combination studies, starting with nivolumab.
The posters are available in the Publications section of the
Bicycle Therapeutics website.
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® 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 method and timing of announcement of data from clinical trials and program updates for clinical candidates; the
potential of the Bicycle technology platform to create differentiated medicines; the development of potential radiopharmaceutical or other
product candidates using Bicycle’s technology through various partnerships; 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 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; 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 August 6, 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 and media:
Stephanie Yao
SVP, Investor Relations and Corporate Communications
ir@bicycletx.com
857-523-8544
v3.24.3
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