Synaffix | July 01, 2022
Synaffix B.V. a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates with best-in-class therapeutic index, today announces that Kyowa Kirin Co., Ltd.a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, has expanded the license agreement with Synaffix by adding a third ADC target to its research evaluation and development efforts under this deal. In addition it exercised its option to take exclusive development and commercialization rights for an undisclosed ADC target under the terms of this agreement.
This follows a successful initial research collaboration between the companies whereby Kyowa Kirin has demonstrated a highly competitive preclinical therapeutic index for its lead program under this collaboration, prepared from a Kyowa Kirin antibody using Synaffix's ADC technology.
The technology licensed from Synaffix include GlycoConnect™, HydraSpace™, and multiple toxSYN™ linker-payloads, which allow for the drug-to-antibody ratio to be tailored to 1, 2 or 4 to optimize the therapeutic index of the ADC.
Under the terms of the amended license agreement, Synaffix will receive an immediate payment of $5 million and is eligible to receive total potential payments for the first ADC program alone of up to $171m plus royalties on commercial sales.
"We are thrilled with the successful ADC data, expansion of this license agreement and to see a leading global pharmaceutical company like Kyowa Kirin deploying Synaffix ADC technology in order to fulfill its mission of improving the lives of patients with cancer worldwide."
Floris van Delft, Ph.D., Chief Scientific 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 2039. 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 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.
The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position.
ColubrisMX | July 01, 2022
ColubrisMX, Inc., developer of the world's first flexible endoluminal robotic system which enables scar-free and less invasive surgical procedures, announced that the Company has rebranded to ENDOQUEST Robotics™. The Company also announced the simultaneous launch of its new website, www.endoquestrobotics.com.
"Since being founded, our company has made rapid progress in the development of technologies that represent historic advances in endoluminal surgery, with the potential to bring millions of patients access to procedures that are less invasive and scar-free. This rebranding as ENDOQUEST Robotics reinforces our commitment to being the leader in innovation in flexible robotic technology for a wide range of needs in endoscopic surgeries in the years ahead."
Kurt Azarbarzin, Chief Executive Officer of ENDOQUEST Robotics
ENDOQUEST's advanced robotic platform enables therapeutic endoscopists and surgeons to perform endoluminal surgeries through the body's existing lumens, eliminating the need for incisions that lead to visible scarring. ENDOQUEST's Endoluminal Surgical System combines the flexibility of conventional endoscopy with the advantages of traditional surgical techniques that can improve control and precision. The Company's proprietary endoscope is a flexible and steerable overtube that functions as a robotic delivery system able to deliver two surgical instruments and a flexible videoscope to a surgical target. With the enhanced capabilities of the ENDOQUEST ELS System, advanced endoscopists and surgeons can access locations in the digestive tract through a body's natural orifice using traditional surgical techniques not previously possible.
"Following completion of our successful $76 million Series C financing, we remain very encouraged by the growing levels of investor, gastroenterologist and surgeon interest in our ELS System technology and are working aggressively to advance this development program to an Investigational Device Exemption filing with the U.S. Food and Drug Administration," Azarbarzin added. "We look forward to providing an update on our progress on July 1, 2022 at the Society of Robotic and Digital Surgery's Annual Meeting at the Disney World Yacht and Beach Club Resort in Lake Buena Vista, Florida."
About ENDOQUEST Robotics
ENDOQUEST Robotics has developed the ENDOQUEST Endoluminal Surgical System, the world's first endoluminal robotic surgical system that makes it possible for therapeutic endoscopists and surgeons to perform upper and lower gastrointestinal surgery less-invasively through a trans-oral or trans-anal approach. ENDOQUEST's robotic platform combines the flexibility of endoscopy that is able to navigate the curvature of patients' anatomy with instrumentation that allows the physician to use a conventional two-handed surgical technique. The ENDOQUEST ELS System has further potential applications in a range of minimally invasive surgeries including appendectomy and cholecystectomy that can be performed with no external incisions.
Replica Analytics | June 30, 2022
Critical Path Institute and Replica Analytics, an Aetion company, announced a new partnership that involves leveraging synthetic data to further catalyze the generation of actionable solutions to accelerate drug development for rare diseases.
Replica Analytics will help generate synthetic datasets across rare and orphan indications in which patient-level datasets are often quite small, which heightens considerations regarding data privacy and accessibility.
Together with real data, these synthetic data will help maximize the utility of C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform which provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted to accelerate drug development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data. Once added to RDCA-DAP, the synthetic data will also represent valuable real-world, electronic health record (EHR) based data available on the platform, opening doors to modeling and research based on longitudinal focused analyses.
"Our collaboration with Replica Analytics is important because synthetic data can add value to real-world data while observing data privacy considerations, which will help accelerate overall rare disease drug development. The goal of RDCA-DAP is to provide a centralized and standardized infrastructure to support and accelerate rare disease characterization and therapy development, this collaboration is in line with our efforts."
RDCA-DAP Scientific Director Alexandre Betourne, Pharm.D., Ph.D
Synthetic data generation is a privacy enhancing technology that has been gaining rapid adoption, particularly in the life sciences sector. SDG uses AI to create machine learning models that learn the statistical patterns and properties of real datasets to generate data that retain the same characteristics as the original dataset, but with no one-to-one mapping back to an identifiable person. SDG can help amplify small datasets, simulate virtual patients to augment patients in existing datasets, and optimize the design of small sample clinical trials.
"We are certainly seeing a growing opportunity to partner with organizations like C-Path for generating datasets that are fit-for-purpose," says Khaled El Emam, Ph.D., SVP and GM of Replica Analytics. "Synthetic data, which preserves the integrity and utility of source data, as well as being privacy-protective, can be a very valuable tool to enable this collaboration."
In May 2022, C-Path hosted a webinar in which the Replica Analytics team introduced SDG and discussed the role the technology can play in researching and treating rare diseases. The event was recorded and can be viewed on C-Path's YouTube channel.
Critical Path Institute is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations.
Critical Path Institute is supported by the Food and Drug Administration of the U.S. Department of Health and Human Services and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government sources, totaling $11,196,634. The contents are those by the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
About Replica Analytics, an Aetion company
Replica Analytics is the premier science-based SDG technology provider to the healthcare industry. The company a pioneer in the development of unique technologies for generating privacy-protective synthetic data that maintain the statistical properties of real-world data. The company was acquired in late 2021 by Aetion, the leading regulatory-grade real-world evidence technology provider. Replica Synthesis software provides a full suite of synthetic data generation and evaluation capabilities that can solve multiple grand challenges facing the life sciences industry, and health research in general.
Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation.