Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team

Bicycle Therapeutics | January 06, 2022

Bicycle Therapeutics plc, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide  technology,  announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480.

Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year. We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics.”

 Kevin Lee, Ph.D., Chief Executive Officer

Bicycle Toxin Conjugates® (BTCs) BT8009 and BT5528
In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC™ targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors  version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported.

Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year.

The Phase I/II trial of BT5528, Bicycle’s second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week.

Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™) BT7480
Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021.

Management Team Updates
Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the company’s Chief Operating Officer has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycle’s proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the company’s Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom.

“We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycle’s success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives.” Dr. Lee added, “I am similarly enthusiastic about Alistair’s appointment as COO and believe his operational experience and track record of successfully identifying, recruiting, and retaining key talent at large, multinational companies will be instrumental in helping guide Bicycle through our next phase of growth.”

About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles 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 Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate  targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. 


Bioprocess engineering is the alteration or application of renewable materials to generate value-added products. It encompasses discovery, research, development and the manufacturing and commercialization of products. Products developed include: fuels, food, feed, pharmaceuticals, nutraceuticals and a multitude of value-added biomaterials found in and used by all industries.

Other News

Light Bio Partners with Ginkgo Bioworks to Optimize the Brightness of Glowing Plants through Bioluminescence Engineering

Light Bio | April 18, 2022

Light Bio, Inc., a company that is creating bioluminescent plants for home and garden, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced a collaboration to leverage Ginkgo's plant cell assays for bioluminescence engineering. Through the agreement, Ginkgo aims to help improve the luminescent output and efficiency of the enzymes within Light Bio's glowing ornamental plants. The scientists at Light Bio have discovered a new type of bioluminescence mechanism and are using synthetic biology to engineer plants to efficiently emit light. The original light emission pathway Light Bio uses in its glowing plants comes from bioluminescent mushrooms, and the company is now focused on expanding its engineering capabilities to support the creation of glowing plants. We are excited to collaborate with Ginkgo toward additional multifold output and efficiency improvements powered by Ginkgo's plant cell engineering capabilities across both individual enzyme and metabolic pathway improvements, Light Bio has already achieved strong light emission results on our glowing plant luminescence to date." Keith Wood, CEO, Light Bio. Nothing captures the wonder of biology quite like seeing glowing plants in person, Our platform enables developers to imagine with biology and to design all types of cells, from bacteria and yeast to mammalian and plant cells. We're so excited to bring this unique application onto our platform and to help Light Bio bring the magic of glowing plants to people." Jason Kelly, CEO, Ginkgo Bioworks. About Light Bio Light Bio creates novel biodesigns in living light. Through consumer-led applications of synthetic biology, Light Bio is opening new markets with products that have never existed before. Led by a team with deep experience in the development and commercialization of bioluminescence products, the company is sustained by its proprietary technologies backed by a strong patent portfolio. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.

Read More


ImmunoTek Bio Centers First to Launch VeinViewer® Technology for Plasma Donations

ImmunoTek Bio Centers | April 27, 2022

Donating plasma is now easier, thanks to a smart new tool allowing technicians to see the map of veins inside a plasma donor's arm. ImmunoTek Bio Centers proudly announces its two divisions – ImmunoTek Plasma and Freedom Plasma – are the first blood plasma collection centers to use this groundbreaking technology. The VeinViewer®, developed by Christie Medical Holdings, has had great success in hospitals and medical clinics, and recently in pilot programs with ImmunoTek. Using the VeinViewer® in a plasma donation setting provides phlebotomists with real-time images of the donor's veins before needle insertion. The VeinViewer® uses direct projection vein illumination to identify vein patterns and display them on a patient's skin. As part of plasma donation, a needle is inserted into the donor's arm to withdraw blood that is then separated into individual parts during a process called plasmapheresis. Being able to easily see where the donor's veins are located helps phlebotomists as they insert the needle to begin the process. Our technicians found that using the VeinViewer® provides a clear look at a donor's veins before the needle is inserted. The ability to see this image increases their accuracy, makes the donation process faster, and reduces the likelihood of reinserting the needle, We are proud to be the first plasma collection company to offer this next-level service for our donors." Blair McKinney, Chief Operating Officer of ImmunoTek Bio Centers. We are delighted ImmunoTek selected Christie's leading vascular visualization technology to aid in establishing a comfortable environment and efficient encounter for donors." Paul Damiani, Christie Medical Holdings, Inc President. ImmunoTek has created an unparalleled donation ambiance and we look forward to integrating the unmatched VeinViewer for an even better donor experience." Lisa Kaufman, Vice President at Christie. The United States provides 2/3 of the world's supply of plasma, which is used to make critical life-saving medicines and plasma-based therapies. Blood plasma is in great demand and the need for it increases 6-8 percent yearly. Increasing plasma donations helps meet the need for plasma around the world. ABOUT IMMUNOTEK BIO CENTERS, LLC ImmunoTek Bio Centers LLC is the fastest-growing independent plasma collection center operator in the United States and is a global leader in developing a reliable plasma supply chain for biotech companies. Since its inception in 2013, ImmunoTek has built and operated more than 50 plasma collection centers, most of which are or are in the process of becoming FDA-licensed and EU-certified, with nearly 40 additional centers in progress. ABOUT CHRISTIE MEDICAL HOLDINGS, INC. Christie Medical Holdings is a medical device manufacturer based in Lake Mary, FL, USA. Our market-leading, VeinViewer® Vision2 and Flex systems, are near-infrared, vascular imaging devices that allow clinicians to clearly see accessible vasculature as a real-time HD image, projected directly on the surface of the patient's skin. Since its invention, VeinViewer has transformed over the years into the current innovative models found in over 50 countries to accurately and safely illuminate veins up to 10 mm deep. It is the only vein finder of its kind that can positively impact the entire Pre-, During- and Post-access procedure through proven clinical and cost-saving results.

Read More


Portal Innovations Expands Chicago Operations Triples Space in Fulton Labs

Portal Innovations | February 03, 2022

Portal Innovations continues its momentum in Chicago by launching the second phase of its operations with the opening of 35,000 square feet of premier wet and dry lab and office space at 400 North Aberdeen in Fulton Labs. The new facility will allow Portal, a life sciences venture development engine, to grow and scale its investment in early-stage biotech companies in Chicago. Portal has tapped Patrick Flavin to serve as President of its flagship Chicago operation. With over 20 years of experience building high-performing teams and collaborations with corporate partners in several public and private life sciences companies, Patrick brings his seasoned biotech-entrepreneurial experience to navigate Portal’s portfolio expansion. Patrick was the founding Executive Director at MATTER and currently serves as a Managing Director at Portal. “I am excited to partner with Patrick as we continue to build Portal into a premier platform of investment in transformative companies with the best innovators, entrepreneurs, academic institutions, and venture capitalists. Patrick’s experience and vision are crucial for Portal to reach the next level here in Chicago.” Portal Founder and CEO John Flavin Through its “Crafted Capital” model, Portal invests seed financial funding, offers access to fully equipped wet and dry lab space, and provides management expertise to leading scientific and entrepreneurial founders. Portal is building a valuable portfolio of life sciences companies at the seed to series A investment stage for long-term value creation. Portal has partnered with Trammell Crow Company, one of the largest commercial real estate developers in the United States, to catalyze the Chicago regional life sciences ecosystem at the Fulton Labs Campus and is currently investing in and supporting companies in its existing 11,000 square feet of wet and dry lab and office space at 1375 West Fulton Street. “I am thrilled to expand our operations in Fulton Labs during a very exciting time for breakthroughs in biotech,” said Patrick Flavin. “Portal’s expansion of lab and office space will accelerate our ability to invest in, house, and support the promising life sciences companies that are emerging from the region’s top tier research institutions.” About Portal Innovations Portal Innovations is a premier venture development engine that bridges scientific ideation in life sciences, medtech, and bioinformatics through commercial proof of concept by delivering crafted capital, including seed funding, specialized equipment, lab space, and management expertise to high-potential early-stage companies.

Read More


Slingshot Biosciences, Inc. Partners With Cambridge Bioscience to Distribute Synthetic Cells Throughout United Kingdom and Ireland

Slingshot | June 16, 2022

SLINGSHOT BIOSCIENCES, INC. the makers of synthetic cells that bring consistent precision and accurate control to replace inconsistent blood and tissue controls for use in flow cytometry and other biotech markets, today announced they have extended their distribution channel through a new agreement with Cambridge Bioscience, a UK-based specialist distributor of life science research tools. The agreement entitles Cambridge Bioscience to the right to distribute and resell Slingshot Bio’s products in the United Kingdom and Ireland. Through Cambridge Bioscience’s network of customers, Slingshot Bio will be able to establish its presence in the United Kingdom and Ireland market with the well-established presence and expertise of Cambridge Bioscience which has been selling into flow cytometry for many years. Cambridge Bioscience’s network will provide us with the market penetration needed to reach our full sales potential. Slingshot Biosciences has considered many distribution partners and we are confident that Cambridge Bioscience’s extensive knowledge in the field, prominent presence, and large customer base will help us leverage our position in the flow cytometry market.” Jeffrey Kim, CEO & Founder. About Slingshot Biosciences, Inc. Founded in 2012, Slingshot Biosciences is a fast-growing life sciences company with a platform technology and paradigm-shifting mission to make synthetic cells the gold standard for all cell-based applications—including diagnostics, and adoptive cell therapy development and instrument calibration.

Read More


Bioprocess engineering is the alteration or application of renewable materials to generate value-added products. It encompasses discovery, research, development and the manufacturing and commercialization of products. Products developed include: fuels, food, feed, pharmaceuticals, nutraceuticals and a multitude of value-added biomaterials found in and used by all industries.