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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 the first patient has been dosed in a Phase I/II trial for BT7480, a novel tumor-targeted immune cell agonist targeting Nectin-4, which aims to enhance anti-tumor immunity. This marks Bicycle's first entry into immuno-oncology and its fourth product candidate in clinical development within four years. The trial will primarily assess the safety and tolerability of BT7480, which has shown encouraging preclinical results. Future trials may include combinations with nivolumab.
Bicycle Therapeutics (NASDAQ: BCYC) announced a publication in the Journal for ImmunoTherapy of Cancer featuring preclinical data on BT7480, a tumor-targeted immune cell agonist. This innovative therapy targets Nectin-4 and activates CD137 selectively in tumor environments, enhancing anti-tumor immunity with intermittent use. The findings reveal BT7480’s capability to rapidly alter the tumor immune microenvironment, leading to complete regressions in mouse models. Bicycle aims to commence a Phase I/II clinical trial by year's end, furthering its commitment to cancer treatment innovation.
bit.bio has appointed three new directors to its board, aiming to leverage their expertise to enhance its synthetic biology cell programming technology. Dr. Hermann Hauser becomes chair of the board, bringing extensive experience from founding Arm Ltd and Solexa. Sir Gregory Winter, a Nobel prize-winning scientist, joins to bolster therapeutic applications using human cells. Alan S. Roemer, an accomplished biotechnology entrepreneur, will support capital markets and operational growth strategies. Collectively, these leaders are expected to drive bit.bio's mission in transforming healthcare.
Bicycle Therapeutics (NASDAQ: BCYC) announced that Genentech has exercised an option to expand their collaboration by initiating a new program under their 2020 agreement. This expansion will allow both companies to develop novel Bicycle-based immuno-oncology therapies and triggers a $10 million payment to Bicycle. The ongoing collaboration focuses on discovering and pre-clinically developing innovative immunotherapies targeting multiple cancer types. CEO Kevin Lee expressed optimism about the partnership's potential to deliver new cancer treatments.
Bicycle Therapeutics plc (Nasdaq: BCYC) has successfully closed its public offering of 3,726,852 American Depositary Shares (ADSs) as of October 15, 2021. The offering generated $201.3 million in gross proceeds, with additional shares sold due to underwriters' options. Goldman Sachs, Morgan Stanley, and SVB Leerink served as book-running managers. The ADSs were offered under an effective shelf registration statement and available via a prospectus supplement. This offering positions Bicycle Therapeutics for future growth opportunities.
Bicycle Therapeutics plc (Nasdaq: BCYC) has priced a public offering of 3,240,741 American Depositary Shares (ADSs) at $54.00 each, aiming for gross proceeds of $175.0 million. The underwriters have a 30-day option to purchase an additional 486,111 ADSs. Proceeds will be utilized for advancing its product pipeline and for research and development. The offering is set to close on or around October 15, 2021, pending customary conditions. Goldman Sachs, Morgan Stanley, and SVB Leerink are managing the offering.
Bicycle Therapeutics plc (Nasdaq: BCYC) has launched an underwritten public offering of $125 million in American Depositary Shares (ADSs), with an option for underwriters to purchase an additional $18.75 million. The funds will support the advancement of Bicycle's product pipeline and general corporate purposes. The offering is subject to market conditions and may not be completed as planned. Major financial institutions managing the offering include Goldman Sachs, Morgan Stanley, and SVB Leerink.
Bicycle Therapeutics (NASDAQ: BCYC) reported promising interim results from its Phase I trials for BT5528 and BT8009 targeting advanced cancers. BT5528 showed 100% tumor reduction in urothelial patients and an 80% disease control rate in ovarian cancer patients. A recommended Phase II dose of 6.5-8.5mg/m² every other week was established. In the BT8009 trial, 36% of urothelial patients had partial responses. Both drugs were well tolerated with no dose-limiting toxicities noted. Expansion cohorts for BT5528 are expected to start in 2022.
Bicycle Therapeutics (NASDAQ: BCYC) has announced that interim Phase I results from its Phase I/II trial of BT5528, a second-generation Bicycle® Toxin Conjugate targeting EphA2, will be presented at the AACR-NCI-EORTC Virtual International Conference on October 7-10, 2021. The plenary oral presentation will be conducted by Dr. Meredith McKean from the Sarah Cannon Research Institute. The company will also host a conference call on October 7, 2021, at 3:00 p.m. ET to discuss these results and updates from the BT8009 program.
Bicycle Therapeutics plc (NASDAQ: BCYC) announced its participation in several investor conferences throughout September 2021. Key events include the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, a pre-recorded presentation at H.C. Wainwright's Global Investment Conference on September 13, the Morgan Stanley Global Healthcare Conference on September 14, and the Cantor Virtual Global Healthcare Conference on September 27. Live webcasts of these events will be available on Bicycle's website, with archived replays accessible for 30 days.
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