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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) announced promising Phase I results for BT5528, targeting EphA2 in patients with advanced solid tumors. The study showed anti-tumor activity, particularly in ovarian and urothelial cancers, with an overall response rate of 22% for ovarian patients and 67% for urothelial patients. The safety profile appears favorable, with low incidence of serious side effects. Enrollment in the expansion cohorts at a recommended dose of 6.5mg/m2 every other week continues. A conference call will be held today at 8:30 a.m. ET.
Bicycle Therapeutics plc (NASDAQ: BCYC) announced management's participation in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 10:00 a.m. ET. The event will be accessible via a live webcast on Bicycle's website, with an archived replay available for 90 days afterwards. Bicycle Therapeutics specializes in developing innovative therapeutics utilizing its proprietary bicyclic peptide technology, focusing on drug candidates for underserved diseases.
Bicycle Therapeutics (NASDAQ: BCYC) reported continued clinical progress, including dosing the first patient in the Phase I/II study of BT5528. The expansion of collaboration with Genentech triggered a $10 million payment expected in Q3 2022. As of June 30, 2022, the company had cash and equivalents of $372.8 million, providing financial runway into 2025. R&D expenses rose to $19.9 million from $11.7 million year-over-year, while G&A expenses increased to $11.8 million. Net loss for the quarter was $26.8 million, or $(0.90) per share, compared to a loss of $17.9 million a year earlier.
Bicycle Therapeutics plc (NASDAQ: BCYC) announced the publication of an article in Bioconjugate Chemistry regarding the use of tris-Gold complexes to enhance the chemical diversity of its proprietary Bicycle peptides. The research showcases a method for constructing constrained Bicycle peptides, which may be beneficial for future targets. CEO Kevin Lee highlighted this publication as a sign of the company's robust research capabilities. Bicycle continues clinical trials for several candidates, including BT5528 and BT8009, targeting important tumor antigens.
Circle Pharma has appointed Paul Park as its Chief Business Officer to advance its lead program, an orally bioavailable Cyclin A inhibitor, towards clinical trials. Park brings extensive experience from previous roles at Ionis Pharmaceuticals and Amgen, where he led significant business transactions. The company aims to leverage its macrocycle platform to expand its pipeline, focusing on oncology therapeutics targeting cyclin proteins, which play a critical role in cancer cell regulation. Circle’s approach addresses unmet clinical needs in serious diseases.
Bicycle Therapeutics (NASDAQ: BCYC) reported the publication of preclinical data on BT7480, a novel tumor-targeted immune cell agonist, in the Journal of Medicinal Chemistry. BT7480 targets Nectin-4 and activates CD137, demonstrating unique properties such as small size and potent immune activation. This molecule is currently in Phase I development with ongoing dose escalation. Bicycle aims to advance its pipeline with BT7480 as a potential clinical candidate, leveraging its proprietary Bicycle technology to enhance anti-tumor immunity.
Bicycle Therapeutics (NASDAQ: BCYC) announced that Genentech, part of the Roche Group, has exercised its second expansion option under a 2020 collaboration agreement, initiating a new program to develop Bicycle®-based immuno-oncology therapies. This move entails a $10 million payment to Bicycle, marking significant progress in their strategic partnership. The collaboration focuses on discovering and pre-clinically developing novel therapeutics targeting multiple cancer types. Both companies are optimistic about the potential of Bicycle technology in advancing cancer treatment.
Bicycle Therapeutics (NASDAQ: BCYC) announced the dosing of the first patient in the Phase I/II trial of BT5528, a second-generation Bicycle Toxin Conjugate designed to target EphA2. Following a successful Phase I dose escalation, the expansion phase aims to evaluate BT5528's clinical activity in various cancer types, administering a recommended Phase II dose of 6.5 mg/m2 biweekly. Initial data, including safety and anti-tumor activity, is anticipated to be released next quarter. The trial includes up to 56 patients in the initial cohorts.
Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology firm focused on a unique class of therapeutics, will participate in a fireside chat at the Jefferies Healthcare Conference in New York City on June 8, 2022, at 8:00 a.m. ET. Investors can access a live webcast on their official site, with an archived replay available for 90 days post-event. Bicycle is pioneering the development of 'Bicycles,' synthetic short peptides that offer high affinity and selectivity for targeted diseases. Current clinical trials include BT5528 and BT8009, targeting EphA2 and Nectin-4.
Bicycle Therapeutics (NASDAQ: BCYC) announced the presentation of a Trials in Progress poster for its Phase I/II clinical trial of BT7480 at the 2022 ASCO Annual Meeting in Chicago, IL, scheduled for June 5, 2022. BT7480 is a novel Bicycle TICA™ targeting Nectin-4 while agonizing CD137 in patients with advanced malignancies. The study aims to evaluate the therapeutic potential of BT7480 in addressing unmet medical needs in oncology. Additional details about the study will be available on their website following the presentation.
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