CELL AND GENE THERAPY
Bicycle Therapeutics | September 08, 2022
Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide technology, today announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients with advanced solid tumors.
“The therapeutic profile from the dose escalation portion of the Phase I/II trial of BT5528 in patients with late-line disease suggests both differentiated safety and promising activity, most notably in ovarian and urothelial cancers. Significant safety concerns seen with antibody drug conjugate approaches have limited the ability to effectively address EphA2, a target which correlates with tumor progression and is overexpressed in many cancers. Based on BT5528’s promising and differentiated safety profile, we hope to demonstrate the true therapeutic potential of this target, this program and our broader Bicycle Toxin Conjugate platform.”
Dominic Smethurst, Chief Medical Officer of Bicycle Therapeutics
“Smaller size, tumor penetration, pharmacokinetic and other qualities distinguish BT5528 and other members of our BTC platform from traditional toxin delivery systems and may confer significant advantages,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “Clinical data emerging from our BT5528 study continues to elucidate these potential advantages, and supports the continued, rapid advancement of our Bicycle-targeted therapeutics platform, all with the ultimate goal of creating unique, impactful medicines that transform the lives of patients. Enrollment continues on schedule in the expansion portion of this trial, and we anticipate providing further updates next year.”
BT5528, a BTC targeting EphA2, a target for which prior antibody-based approaches have been unsuccessful, has demonstrated anti-tumor activity and differentiated tolerability. Bicycle has established an RP2D dose and is enrolling ongoing expansion cohorts.
Bicycle advancing BT5528 in ongoing expansion cohorts. In June 2022, Bicycle announced the dosing of the first patient in the part B dose expansion portion of the Phase I/II trial. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on results from these cohorts. Dose expansion is taking place in urothelial (n=14) and ovarian (n=14) cancers as well as in a basket cohort of other solid tumors (n=28), including non-small cell lung, triple-negative breast, head and neck, and esophageal cancers.
Conference Call Details
Bicycle Therapeutics will host a conference call and webcast today, September 7, 2022, at 8:30 a.m. ET to review the BT5528 trial data. To access the call, please dial at least 10 minutes prior to the start time and ask to be joined to the Bicycle Therapeutics call. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website,
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, Massachusetts.
Synaffix | September 07, 2022
Synaffix B.V. and Emergence Therapeutics AG announce that the Companies have entered into a licensing agreement of up to $360 million, providing Emergence access on a target-specific basis to Synaffix's proprietary antibody drug conjugate technologies comprising GlycoConnect™, HydraSpace™ and SYNtecan E™ linker-payload.
Under the terms of the agreement, Synaffix will be eligible to receive up to $360 million in upfront and milestone payments plus royalties on commercial sales. The first program will commence at signature, with the option to expand the collaboration to additional targets. The agreement is the result of positive proof of concept data following a successful initial discovery research collaboration between the companies.
Emergence will be responsible for the research, development, manufacturing and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies.
Jack Elands, Chief Executive Officer of Emergence Therapeutics, commented: "This transaction demonstrates our commitment to the development of our pipeline of first-in-class and/or best-in-class ADCs. Beyond our lead program ETx-22, a next generation Nectin-4 ADC, we are actively advancing further programs to develop treatments for high unmet-need cancers. We are impressed with the Synaffix technology and are pleased to select it as a key component to accelerate our pipeline of ADCs."
"This marks an important milestone for Synaffix as this is the 10th ADC developer who has licensed our innovative ADC technology to develop proprietary ADCs for their own pipeline. By consolidating all essential technologies within Synaffix, we have repeatedly enabled the development of best-in-class and first-in-class ADCs under a single technology license agreement. We are thrilled that Emergence has selected Synaffix as its long-term ADC technology partner and look forward to working closely with Emergence as they build out their portfolio of ADC candidates."
Peter van de Sande, Chief Executive Officer of Synaffix
About Synaffix B.V.
Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform. In addition to GlycoConnect™ and HydraSpace™ technology, the toxSYN™ linker-payload platform rounds out a fully complementary technology platform that enables any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix.
The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Granted patents covering Synaffix' technology provide end-to-end protection of the manufacturing technology as well as the resulting products through at least 2035. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen, Innovent Biologics, ProfoundBio, Kyowa Kirin, Genmab and Macrogenics.
About Emergence Therapeutics AG
Emergence Therapeutics is a European biopharmaceutical company developing novel antibody drug conjugates (ADC) to treat high-need cancers. Its lead program combines a highly specific antibody with optimized linker and payload technology to target Nectin-4 – an important target for a broad range of cancers which has been clinically validated as an ADC target by enfortumab vedotin, now approved for the treatment of urothelial cancers by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Emergence Therapeutics is also actively developing a pipeline of further first- or best-in-class ADCs driven by therapeutic need. Emergence is supported by a network of world-leading experts in immuno-oncology and a leading international investor syndicate. Emergence Therapeutics AG is based in Duisburg, Germany with a subsidiary in Marseille, France. For more information, please visit:
About The Synaffix ADC Platform Technology
Synaffix' proprietary ADC technology platform consists of GlycoConnect™, HydraSpace™ and toxSYN™ technologies. Both GlycoConnect™ and HydraSpace™ are clinical-stage technologies that enable best-in-class ADCs with significantly enhanced efficacy and tolerability.
GlycoConnect™ is a conjugation technology that exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. HydraSpace™ is a compact and highly polar spacer technology that is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN™ is a linker-payload platform that spans key, validated MOAs for ADC product development, including SYNtecan E™ and SYNeamicin G™, among other linker-payloads.
Naveris, Inc. | September 20, 2022
Naveris, Inc., a commercial-stage life sciences company dedicated to improving patient care through earlier detection of viral-driven cancers, today announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society.
Naveris’ blood tests for earlier cancer detection use proprietary patented DNA fragmentomics technology to distinguish between viral DNA arising from cancers versus infection. Proceeds from this financing will be used to advance commercialization of NavDx, Naveris’ flagship blood test for the early detection of cancers caused by the human papillomavirus (HPV), and to generate the clinical data needed to expand into other cancer types and indications.
“We are delighted to have the continued support of Gurnet Point Capital and TechU Ventures, and to welcome Alice Pomponio and the rest of the BrightEdge team, who collectively bring a deep understanding of both the oncology space and commercial-stage businesses. We founded Naveris on the belief that advances in molecular diagnostics will play a vital role in improving cancer outcomes. This new investment underscores NavDx’s commercial success and potential, and our experienced team’s ability to transform this vision into a reality for patients and oncologists.”
Piyush B. Gupta, Ph.D., Naveris founder and Chief Executive Officer
"Since our initial investment in 2020, we have been impressed by the Naveris team's vision and their ability to commercially execute on a differentiated strategy in the rapidly developing field of blood-based cancer detection,” said Travis Wilson, Partner at Gurnet Point Capital. “We are pleased to be providing additional capital to ensure that their transformative technology for early cancer detection will benefit as many patients as possible."
“We could not be more excited to back Piyush and his team as Naveris works to increase access to diagnose, detect, and monitor viral cancers” said Alice Pomponio, BrightEdge Managing Director. “We understand the burden of HPV related cancers on patients. And we seek to build on the years of research and advocacy of the American Cancer Society to support the next generation of mission aligned companies reducing patient burden.”
Along with Naveris' commercial activities, more than 25 medical institutions have partnered with the company to conduct clinical studies and trials utilizing its technology. The company has also partnered with biotechnology companies developing immunotherapies for HPV-related cancers.
About Naveris, Inc.
Founded in 2017, Naveris is a privately held biotechnology company with facilities in Massachusetts and North Carolina. The company’s mission is to improve outcomes for the millions of people at risk of developing viral cancers through novel molecular diagnostics that enable earlier cancer detection. Naveris’ clinical laboratory is certified for high complexity testing under CLIA, and is accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center.
About Gurnet Point Capital
Gurnet Point Capital is a leading healthcare fund that invests in de-risked life sciences companies. Gurnet Point primarily focuses on businesses that have high growth potential in the late product development and commercialization stages of their evolution. These companies become partners not just because of their capacity to generate economic value, but also because of their potential to deliver social impact. Gurnet Point’s team of highly experienced industry executives work closely with its portfolio companies, with an active approach driving operational transformation and outsized returns.