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Bicycle Therapeutics plc (symbol: BCYC) is a pioneering clinical-stage biotechnology company with a mission to transform the pharmaceutical industry through its innovative Bicycle® product platform. This revolutionary platform focuses on developing a new class of medicines known as Bicycles, which are synthetic short peptides constrained to form two loops. These loops stabilize their structural geometry, granting them superior targeting abilities and efficiency compared to existing drug conjugate modalities.
The core business of Bicycle Therapeutics centers around creating transformational new therapies to enhance treatment options in oncology and other serious diseases. The company’s leading product candidate, BT1718, is a Bicycle Toxin Conjugate (BTC) designed to maximize tumor penetration while minimizing adverse effects on healthy tissues. Bicycles combine the beneficial properties of multiple therapeutic entities in a single modality – showcasing the affinity and selective pharmacology typical of antibodies, the rapid distribution kinetics of small molecules, and the adjustable pharmacokinetic half-life of peptides.
Bicycle Therapeutics is committed to addressing high unmet medical needs, particularly in oncology. Their proprietary IP is grounded in the groundbreaking work of scientific founders, and the company has made significant strides with their unique approach. Recent achievements include successful clinical trials and strategic partnerships aimed at advancing their robust pipeline of product candidates.
This innovative approach ensures that Bicycles exhibit a favorable safety profile and improved tolerability, making them a promising alternative to traditional therapies. As the company continues to evolve, it remains dedicated to enhancing patient outcomes and pioneering new treatment paradigms in the biotech space.
Bicycle Therapeutics (NASDAQ: BCYC) reported fourth-quarter and full-year 2022 results, highlighting significant progress with advanced clinical trials for BT8009, BT5528, and BT7480. BT8009 received Fast Track Designation from the FDA, and Phase I results showed anti-tumor activity in treated patients. The company has a cash position of $339.2 million, expected to support operations into 2025. R&D expenses rose to $81.6 million in 2022, leading to a net loss of $112.7 million, or $(3.80) per share. Further updates on trials are anticipated by the end of 2023, positioning the company for future milestones.
Bicycle Therapeutics (NASDAQ: BCYC) announced promising results from the Phase I trial of BT8009, a novel BTC targeting Nectin-4, showing a 50% overall response rate and a 75% clinical benefit rate in urothelial cancer. A complete response was recorded at the 5 mg/m² dose. As of
Bicycle Therapeutics plc (NASDAQ:BCYC), a pioneering biotechnology firm, will participate in a fireside chat at the SVB Securities Global Biopharma Conference on February 15, 2023, at 9:20 a.m. ET. This event will be held virtually, and a live webcast will be accessible on their website, www.bicycletherapeutics.com. The archived version of the chat will be available for 90 days. Bicycle Therapeutics specializes in developing novel therapeutics, called Bicycles, which are designed for diseases lacking effective treatments. Their ongoing clinical trials include BT5528, BT8009, BT7480, and BT1718, targeting various significant tumor antigens.
The report titled "Non-Viral / Intracellular Drug Delivery Systems Market" by ResearchAndMarkets.com highlights the rising demand for efficient drug delivery systems in the biopharmaceutical industry. It notes that over 20% of the proteome resides within cell membranes, necessitating innovative delivery methods for therapeutic intervention. Key advancements include non-viral systems such as exosome-based techniques and cell-penetrating peptides. The report reveals that around 1,300 patents have been filed, indicating substantial innovation, with over 20,000 studies on oligonucleotide-based therapeutics underway. The market is expected to grow significantly in the near term.
Nerviano Medical Sciences announced the appointment of Terrence West as New Business, Virtual CEO, tasked with enhancing the value of its oncology drug asset NMS-173. With over 25 years in biopharma and expertise in drug development, West aims to strategically position NMS-173, a dual IDH1/IDH2 inhibitor, against current cancer therapies. The drug shows promise in overcoming resistance mechanisms and has demonstrated significant anti-tumor activity. This leadership move reflects Nerviano's intent to strengthen its presence in the Boston biotech market.
Bicycle Therapeutics plc (NASDAQ: BCYC) will present results from its Phase I/II trial of BT8009 at the 2023 ASCO GU Cancers Symposium, taking place in San Francisco from February 16-18, 2023. The conference call, scheduled for February 14 at 8:00 a.m. ET, will feature Dr. Capucine Baldini and Dr. Daniel Petrylak discussing the data on BT8009, a BTC targeting Nectin-4. The poster presentation, under the title 'BT8009-100,' will occur on February 17. Bicycle Therapeutics specializes in innovative therapies, focusing on advanced malignancies.
Bicycle Therapeutics (NASDAQ:BCYC) announced the FDA's grant of Fast Track Designation for its BT8009 monotherapy targeting urothelial cancer. This designation aims to expedite the development of therapies addressing serious unmet medical needs. CEO Kevin Lee highlighted the importance of this FTD for aligning with the FDA to meet patient needs. Fast Track programs can benefit from more frequent FDA interactions and may qualify for Accelerated Approval and Priority Review if criteria are met, indicating progress in BT8009’s development.
Bicycle Therapeutics (NASDAQ: BCYC) announced the presentation of preclinical data for BT7480 and BT7455 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, from November 8-12, 2022. Five posters will be presented, highlighting innovative findings related to tumor-targeted immune cell agonists. Notable topics include the efficacy of Bicycle NK-TICA and the evaluation of humanized animal models. This event underscores Bicycle's commitment to advancing their proprietary bicyclic peptide technology in cancer therapy.
Bicycle Therapeutics (NASDAQ:BCYC) has announced updates from the ongoing Phase I/II trial of its therapy BT8009, targeting cancers expressing Nectin-4. The Phase I dose escalation is complete, establishing recommended doses of 5mg/m² and 7.5mg/m² for the Phase II expansion, where the first patient has already been dosed. Encouraging responses were observed in patients with non-small cell lung cancer and urothelial cancer, including confirmed responses consistent with earlier findings. Results will be shared at a conference in 2023.
Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology firm specializing in innovative therapeutics, has announced its participation in several upcoming investor conferences in November and December 2022. Notable events include the Cowen’s 6th Annual IO Next Summit on November 11 and the Jefferies London Healthcare Conference on November 17, among others. Live webcasts of the fireside chats will be available on the company’s website, with archived versions accessible for 90 days. Bicycle Therapeutics focuses on developing novel peptide-based medicines for underserved diseases.
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