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.
TFF Pharmaceuticals, Inc. | July 16, 2022
TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced a significant expansion of its R&D operations through the lease of a new research and development facility located in Austin, Texas.
The new facility of over 3,500 square feet significantly increases TFF’s total lab space, adding a dedicated lab for downstream processing of products created via Thin Film Freezing, which will complement the company’s existing formulation development capabilities. As TFF expands its in-house and partnered research, including applications in biologics, the additional laboratory space will also provide significantly more real estate to accommodate larger equipment to facilitate scale-up and manufacturing, as well as to produce supplies for preclinical studies.
The new space will be supervised by Donald Owens, Ph.D., Director of Product Development at TFF, and supported by John Koleng, Ph.D., R.Ph., Vice President of Product Development and Manufacturing. The company also plans to expand the product development team in Austin, which will be based at the new facility, to support the growing number of partnered projects. The lease arrangement used to finance the facility is also a major advantage, providing TFF with a highly flexible and capital efficient approach in expanding its R&D operations while preserving capital resources.
“The opening of our new Austin R&D facility represents an important evolution of TFF’s operations, reflecting growing demand for our Thin Film Freezing technology and product development services. The Austin facility will enable us to increase testing capacity so that we can run a larger number of feasibility studies, including a focus on biologics where demand has continued to grow. Additionally, as many of our partnered programs move to clinical evaluation, the ability to scale-up manufacturing in parallel becomes mission critical. We expect the new Austin facility will allow us to meet the current growing demand for Thin Film Freezing-based products.”
The addition of this facility also cements Austin as a central hub of TFF’s research operations. The company maintains a close relationship and research collaborations with academic institutions, including the University of Texas at Austin, where TFF has extensive early-stage formulation capabilities.
“As our internal programs advance and our network of partnerships expands, establishing this additional research space in Austin is a natural next step,” added Glenn Mattes, CEO of TFF Pharmaceuticals. “I’m confident that Don and John will spearhead a successful expansion and scale-up of TFF’s capabilities to meet growing demand. We will also continue to work closely with our partners, including Dr. Robert O. Williams, Special Advisor to TFF and Co-Inventor of the Thin Film Freezing technology, who continues to advance new research demonstrating the broad applications and advantages of our technology from his home base at UT Austin.”
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The Thin Film Freezing process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert any drug, including vaccines, small and large molecules and biologics, into an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, and continues to expand its pipeline by collaborating with a broad array of pharmaceutical companies, academic institutions and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally.
Vivera Pharmaceuticals, Inc. | May 26, 2022
Vivera is pleased to announce the allowance of its third U.S. patent for ZICOH™, the Company's high-tech, electronic dose-controlled portfolio of drug delivery devices. The patent allowance from the U.S. Patent and Trademark Office secures ZICOH's rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules, and tablets.
ZICOH is an electronic dose-controlled delivery device and technology designed to enable real-time communication through the drug supply chain, from drug manufacturers, distributors, and wholesalers to pharmacists, providers, physicians, caregivers, and patients. The device can be programmed to dispense the medication dosage type, amount, and frequency according to the health care provider's orders to ensure compliance with dispensed prescriptions while also implementing controls to help prevent medication misuse and abuse. Later versions of the device will also implement user authentication features, such as fingerprint authorization and facial recognition, to help prevent prescription drugs from being diverted.
Medication reminders are another core feature of ZICOH. These reminders can be programmed into the device by the pharmacist per the physician's orders to alert the patient when it's time to take their medication. This feature can be particularly beneficial for patients who forget to take medications on time or for patients and caregivers who manage multiple medications.
"ZICOH is a major innovation in the medical device and technology sectors. This device is going to make it easier than ever for patients to comply with their medication regimens, regardless of how complex they are."
Mehdi Hatamian, Ph.D., Chief Scientific Advisor for Vivera
This third patent differs from the device's two previously issued patents in that it specifically pertains to the dispensing of tablets, capsules, and pills. The device has already secured its patent rights as a secure, smart liquid and inhaler delivery device with automated dose delivery, measurement, and management.
"We are proud of the progress we have made on the development of ZICOH's multiplatform uses and technology," said Paul Edalat, CEO and Chairman of Vivera. "The way that Tesla revolutionized the automotive industry, and the way Apple created a category for smart devices, is what Vivera is doing to the prescription dispensing industry. ZICOH will forever change the way that medications are prescribed and dispensed, and Vivera is reaching the milestones to get there in a fraction of the time projected."
Vivera is looking forward to bringing ZICOH to market. The Company has already initiated the device's design and is looking forward to having a working prototype by late summer 2022.
About Vivera Pharmaceuticals
Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH™, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.