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- zelenectide pevedotin (BT8009) / Bicycle Therap
A phase 2/3 study of bicycle toxin conjugate zelenectide pevedotin (BT8009) targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC) (Duravelo-2). (Level 1, West Hall; Poster Bd #: J26) - Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_642;
P2/3
Clinical Trial Registration Number: NCT06225596 The abstract will be released to the public on February 10, 2025 at 2:00 PM PST
- Enhanced anti-tumor activity of zelenectide pevedotin in triple negative breast cancer (TNBC) patients (pts) with NECTIN4 gene amplification (amp) (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1761;
- || zelenectide pevedotin (BT8009) / Bicycle Therap
Trial completion date, Trial primary completion date, Metastases: Duravelo-1: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies (clinicaltrials.gov) - Sep 26, 2024
P1/2, N=329, Recruiting, Sponsor: BicycleTx Limited
Clinical Trial Registration Number: NCT06225596 The abstract will be released to the public on February 10, 2025 at 2:00 PM PST Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
- zelenectide pevedotin (BT8009) / Bicycle Therap, Padcev (enfortumab vedotin-ejfv) / Astellas, Pfizer
Effects of Nectin-4 targeted Bicycle Toxin Conjugate, zelenectide pevedotin (BT8009), and enfortumab vedotin on a human corneal tissue model (Exhibition Hall) - Sep 7, 2024 - Abstract #EORTCNCIAACR2024EORTC_NCI_AACR_413;
Unless they are part of the media programme, embargoed or not consented, all abstracts will be released on 9 October 2024. All other abstracts will be released on the day of presentation.
- zelenectide pevedotin (BT8009) / Bicycle Therap, BT5528 / Bicycle Therap
Breaking from the paradigm of antibody-drug conjugates: Evaluation of clinical pharmacokinetics and safety of bicycle toxin conjugates (BTCs). (Hall A; Poster Bd #: 233) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2061;
P1/2
Preliminary data show substantial differences between BTC and ADC PK, and a promising BTC safety profile, possibly resulting from the distinct PK and selectivity (and specificity) of Bicycle peptides. These data highlight the potential value of BTCs as a platform for developing therapies against advanced malignancies.
- zelenectide pevedotin (BT8009) / Bicycle Therap
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. (Hall A; Poster Bd #: 308a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1784;
P1/2, P2/3
Cohort 2 will include n?315 pts with ?1 prior systemic therapy, excluding enfortumab vedotin or other MMAE-based therapy...Cohort 1 will be randomized 1:1:1 to receive: 1) BT8009 5 mg/m 2 on days (D)1, 8, and 15 + pembro 200 mg on D1; 2) BT8009 6 mg/m 2 on D1 and 8 + pembro 200 mg on D1; or 3) chemotherapy (gemcitabine + cisplatin / carboplatin, followed by avelumab maintenance)...Efficacy endpoints will be assessed per RECIST v1.1. This study is actively recruiting.
- |||||||||| zelenectide pevedotin (BT8009) / Bicycle Therap
New P2/3 trial, Monotherapy, Metastases: Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (clinicaltrials.gov) - Jan 26, 2024
P2/3, N=956, Recruiting, Sponsor: BicycleTx Limited
- || zelenectide pevedotin (BT8009) / Bicycle Therap
Trial completion date, Trial primary completion date, Metastases: Duravelo-1: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies (clinicaltrials.gov) - Dec 31, 2023
P1/2, N=329, Recruiting, Sponsor: BicycleTx Limited
- Characterization of Nectin-4 protein expression in non-small cell lung cancer patients. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_341;
- BT8009 / Bicycle Therap
BT8009-100: A phase I/II study of novel bicyclic peptide and MMAE conjugate BT8009 in patients (pts) with advanced malignancies associated with nectin-4 expression, including urothelial cancer (UC). (On Demand | Level 1, West Hall; Poster Board No. K2) - Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_515;
P1/2
Evaluation of BT8009 as monotherapy at RP2D(s) and in combination with an immune checkpoint inhibitor will be explored during the expansion phase of this trial; cohorts will include pts with renal impairment to support further development in cis-ineligible pts, pts with previously untreated cis-ineligible metastatic UC, pts with refractory UC, and tumor-specific cohorts outside of bladder cancer. Clinical trial information: NCT04561362.
- ||||| BT8009 / Bicycle Therap
Clinical, Fast track designation, Metastases: @FDAOncology Fast Track Designation Granted to #BT8009, a new nectin-4 targeted bicycle Toxin Conjugate for Patients with Previously Treated Locally Advanced or Metastatic #UrothelialCarcinoma BladderCancer | Bicycle Therapeutics https://t.co/zEldP8no3Y (Twitter) - Jan 5, 2023
- ||| zelenectide pevedotin (BT8009) / Bicycle Therap
Enrollment change, Trial completion date, Trial primary completion date, Metastases: Duravelo-1: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies (clinicaltrials.gov) - Nov 21, 2022
P1/2, N=329, Recruiting, Sponsor: BicycleTx Limited
Clinical trial information: NCT04561362. N=172 --> 329 | Trial completion date: Jun 2023 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2025
- | BT8009 / Bicycle Therap
Journal: Discovery of BT8009: A Nectin-4 Targeting Bicycle Toxin Conjugate for the Treatment of Cancer. (Pubmed Central) - Nov 15, 2022
Multiparameter chemical optimization involving introduction of non-natural amino acids resulted in a lead Bicycle that demonstrated high affinity for Nectin-4, good stability in biological matrices, and a much-improved physicochemical profile. The optimized Bicycle was conjugated to the cytotoxin Monomethyl auristatin E via a cleavable linker to give the targeted drug conjugate BT8009, which demonstrates potent anticancer activity in in vivo rodent models.
- | BT8009 / Bicycle Therap
Journal: BT8009; a Nectin-4 targeting Bicycle® Toxin Conjugate for treatment of solid tumors. (Pubmed Central) - Sep 20, 2022
These physical and PK characteristics differentiate BT8009 from ADCs and may provide benefit in terms of tumor penetration and reduced systemic exposure. BT8009 is currently in a Phase 1/2 multicenter clinical trial across the USA, Canada and Europe, enrolling patients with advanced solid tumors associated with Nectin-4 expression.
- |||| BT8009 / Bicycle Therap
P1 data: BT8009 a novel 🚲 bicycle toxin conjugate (BTC) targeting Nectin-4 tumor antigen with much lower MW compared to antibodies. Promising agent with notable activity in first-in-human trial including both CR and PR presented by @MeredithMcKean @SarahCannonDocs #AACR2022 @AACR (Twitter) - Apr 10, 2022
- ||||| BT8009 / Bicycle Therap
Clinical, P1/2 data: .@MeredithMcKean, takes the stage at #AACR22 to present, “BT8009-100 Phase I/II Study Of Novel Bi-Cyclic Peptide And MMAE Conjugate BT8009 In Patients With Advanced Malignancies Associated With Nectin-4 Expression” be sure to join her session today from 3-5 p.m. (Twitter) - Apr 10, 2022
- |||| BT8009 / Bicycle Therap
Biomarker, Clinical: Congratulations to @MeredithMcKean and Team! Oral Presentation of Ph I data: BT8009 - Nectin-4 targeting toxin conjugate - in ‘Biomarker Advances in Clinical Trials’ at #AACR22 https://t.co/zmUB1vf5h3 @SarahCannonDocs (Twitter) - Apr 10, 2022
- Opdivo (nivolumab) / Ono Pharma, BMS, Padcev (enfortumab vedotin) / Seagen, Astellas
BT8009-100 phase I/II study of novel bi-cyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies associated with nectin-4 expression (Great Hall BC, Convention Center) - Mar 9, 2022 - Abstract #AACR2022AACR_1714;
P1/2
BT8009 exhibits a promising preliminary tolerability profile and preliminary antitumor activity. The molecule will continue to be explored in the current dose-escalation/dose-expansion study of BT8009 monotherapy and in combination with nivolumab.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Association of combined phase I/II study of a novel bicyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies with Nectin-4 expression. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2725;
P1/2
Study BT8009-100 (NCT04561362) will evaluate safety and tolerability of weekly and every other week BT8009 administration, alone and in combination with q4w nivolumab...PK serial collections will be taken on D1 through D15 . Radiologic tumor assessments for response per RECIST will be taken every two months.
- BT8009 / Bicycle Therap
[VIRTUAL] A multi tumor survey of Nectin-4 expression to guide BT8009 indication selection () - Mar 13, 2021 - Abstract #AACR2021AACR_4441;
P1/2
Breast and bladder cancer had the greatest frequency of Nectin-4 positivity. Subtype analysis in breast cancer identified enrichment of Nectin-4 expression in hormone receptor negative and human epidermal growth factor receptor 2 positive tumors.
- BT8009 / Bicycle Therap
[VIRTUAL] Molecular-based enrichment strategy for Nectin-4 targeted Bicycle toxin conjugate BT8009 () - Mar 11, 2021 - Abstract #AACR2021AACR_338;
P1/2
We demonstrate the potential utility of using pre-existing patient NGS data with SDHC amplifications to increase the frequency of identifying patients with high Nectin-4 expressing tumors via IHC. The use of this strategy is ongoing at all current sites enrolling patients to BT8009-100.
- |||| zelenectide pevedotin (BT8009) / Bicycle Therap
New P1/2 trial, PD(L)-1 Biomarker, Metastases: Duravelo-1: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies (clinicaltrials.gov) - Sep 22, 2020
P1/2, N=146, Recruiting, Sponsor: Bicycle Tx Limited
- BT8009 / Bicycle Therap, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies (On-Demand) - Jul 21, 2020 - Abstract #ESMO2020ESMO_880;
Targeting Nectin-4 is an established effective therapeutic strategy in 3rd-line bladder cancer following the recent approval in the U.S. of enfortumab vedotin for bladder cancer patients after receiving chemotherapy and immune checkpoint therapy...Initial dose escalation cohorts utilize a single subject design, which converts to a 3+3 design for intermediate cohorts and ultimately to a Bayesian design to determine MTD/MAD and RP2D for BT8009 with and without nivolumab...Legal entity responsible for the study: Sarah Cannon Development Innovations. Funding: BicycleTx Ltd.
- BT8009 / Bicycle Therap
BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, shows target selectivity, and efficacy in preclinical large and small tumor models (Board 61: Level 2 - Hall D) - Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_493;
BT8009 shows excellent efficacy in xenograft models expressing Nectin-4 target and its pharmacokinetic profile enables it to provide a rapid attainment of high tumor exposure levels with reduced systemic exposure. IND-enabling studies are currently ongoing with BT8009.