Bicycle Therapeutics Announces First Human Imaging Data from European Association of Nuclear Medicine 2024 Congress and Outlines Strategy for Leadership in Next-Generation Radiopharmaceuticals
Bicycle Therapeutics (NASDAQ: BCYC) presented the first human imaging data at EANM 2024 Congress, validating MT1-MMP as a novel cancer treatment target. The data came from a case study of a 65-year-old male with pulmonary adenocarcinoma, where the Bicycle Radionuclide Conjugates (BRC®) demonstrated positive imaging properties and specific tumor uptake. The company also presented preclinical data showing optimized biodistribution of BRCs with high tumor uptake and reduced kidney retention.
The company announced EphA2 as its second BRC target and plans to collaborate with Eckert & Ziegler for radioisotope supply and BRC development.
Bicycle Therapeutics (NASDAQ: BCYC) ha presentato i primi dati di imaging umano al Congresso EANM 2024, convalidando MT1-MMP come un nuovo bersaglio terapeutico per il cancro. I dati provenivano da uno studio di caso di un uomo di 65 anni con adenocarcinoma polmonare, in cui i Bicycle Radionuclide Conjugates (BRC®) hanno dimostrato proprietà di imaging positive e un'assimilazione specifica del tumore. L'azienda ha anche presentato dati preclinici che mostrano una biodistribuzione ottimizzata dei BRC con alta assimilazione tumorale e ridotto ritenzione renale.
L'azienda ha annunciato EphA2 come suo secondo bersaglio BRC e prevede di collaborare con Eckert & Ziegler per la fornitura di radioisotopi e lo sviluppo di BRC.
Bicycle Therapeutics (NASDAQ: BCYC) presentó los primeros datos de imagen humana en el Congreso EANM 2024, validando MT1-MMP como un nuevo objetivo de tratamiento para el cáncer. Los datos provienen de un estudio de caso de un hombre de 65 años con adenocarcinoma pulmonar, donde los Bicycle Radionuclide Conjugates (BRC®) mostraron propiedades de imagen positivas y una captación específica del tumor. La empresa también presentó datos preclínicos que muestran una biodistribución optimizada de los BRC con alta captación tumoral y reducción de la retención renal.
La compañía anunció EphA2 como su segundo objetivo BRC y planea colaborar con Eckert & Ziegler para el suministro de radioisótopos y el desarrollo de BRC.
바이시클 테라퓨틱스 (NASDAQ: BCYC)는 EANM 2024 총회에서 첫 번째 인간 이미징 데이터를 발표하며 MT1-MMP를 새로운 암 치료 목표로 검증했습니다. 데이터는 폐 선암을 앓고 있는 65세 남성의 사례 연구에서 나왔으며, Bicycle Radionuclide Conjugates (BRC®)는 긍정적인 이미징 특성과 특정 종양 흡수를 보여주었습니다. 이 회사는 또한 높은 종양 흡수와 감소된 신장 유지력을 가진 BRC의 최적화된 생체 분포를 보여주는 전임상 데이터를 발표했습니다.
회사는 EphA2를 두 번째 BRC 목표로 발표하고 Eckert & Ziegler와 협력하여 방사성 동위원소 공급 및 BRC 개발을 계획하고 있습니다.
Bicycle Therapeutics (NASDAQ: BCYC) a présenté les premières données d'imagerie humaine lors du Congrès EANM 2024, validant MT1-MMP comme nouvelle cible de traitement du cancer. Les données proviennent d'une étude de cas d'un homme de 65 ans atteint d'adénocarcinome pulmonaire, où les Bicycle Radionuclide Conjugates (BRC®) ont démontré des propriétés d'imagerie positives et une absorption spécifique des tumeurs. L'entreprise a également présenté des données précliniques montrant une biodistribution optimisée des BRC avec une forte absorption tumorale et une rétention rénale réduite.
L'entreprise a annoncé EphA2 comme sa deuxième cible BRC et prévoit de collaborer avec Eckert & Ziegler pour l'approvisionnement en radio-isotopes et le développement des BRC.
Bicycle Therapeutics (NASDAQ: BCYC) präsentierte die ersten menschlichen Imaging-Daten auf dem EANM 2024 Kongress und validierte MT1-MMP als neues Ziel für die Krebsbehandlung. Die Daten stammen aus einer Fallstudie eines 65-jährigen Mannes mit pulmonalem Adenokarzinom, bei der die Bicycle Radionuclide Conjugates (BRC®) positive Imaging-Eigenschaften und eine spezifische Tumoraufnahme zeigten. Das Unternehmen präsentierte auch präklinische Daten, die eine optimierte Biodistribution der BRC mit hoher Tumoraufnahme und reduzierter Nierenretention zeigen.
Das Unternehmen kündigte EphA2 als sein zweites BRC-Ziel an und plant eine Zusammenarbeit mit Eckert & Ziegler zur Lieferung von Radionukliden und zur Entwicklung von BRC.
- First human imaging data successfully validated MT1-MMP as a novel cancer treatment target
- BRC demonstrated specific tumor uptake with minimal uptake in other organs
- Preclinical data showed optimized biodistribution with high tumor retention
- Strategic partnership with Eckert & Ziegler for radioisotope supply
- None.
Insights
The first human imaging data for Bicycle's MT1-MMP targeted radiopharmaceutical demonstrates significant clinical potential. The gallium-68 labeled BRC tracer successfully identified both primary tumor and metastases in a lung cancer patient, matching FDG-PET/CT results while showing ideal biodistribution properties. The rapid renal clearance and minimal off-target uptake are particularly promising features that could translate to improved safety profiles.
The preclinical optimization data showing maintained tumor uptake with reduced kidney retention addresses a key challenge in radiopharmaceutical development. The platform's ability to deliver various isotopes (fluorine-18, gallium-68, lutetium, lead) provides flexibility in both diagnostic and therapeutic applications. This versatility, combined with novel target selection like MT1-MMP and EphA2, positions Bicycle to potentially expand radiopharmaceutical treatment options in multiple solid tumor types.
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
“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 (
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
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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Investors:
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Source: Bicycle Therapeutics plc
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