Welcome!

News Feed Item

Goodwin Biotechnology Announces a Collaboration with Aspyrian Therapeutics for cGMP Manufacturing of an Innovative Antibody Drug Conjugate

PLANTATION, Fla., March 24, 2014 /PRNewswire/ -- Goodwin Biotechnology, Inc.  announced an agreement with Aspyrian Therapeutics, Inc. for the technology transfer, process development, scale-up, and cGMP manufacturing of a novel Antibody Drug Conjugate (ADC) for use in Phase I clinical trials. 

Aspyrian Therapeutics has secured an exclusive license from the National Cancer Institute for a new ADC technology platform, Near-infrared Photoimmunotherapy (PIT), which permits highly efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor. Because the payload in this unique ADC is inert until it is both in the tumor and activated by near-infrared (NIR) light, it overcomes the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems.

"We are pleased to have been selected to partner with Aspyrian Therapeutics for this leading edge ADC project," said SooYoung Lee, PhD, Chief Operating Officer at Goodwin Biotechnology. "This important project is a testament to our experience and expertise in bioconjugation that has been developed and refined over more than a decade. This initiative has been led by Muctarr Sesay, PhD, Vice President of Process Development who is one of the pioneers in process development and cGMP manufacturing of many ADCs and biologic drug conjugates, which Goodwin has successfully manufactured for human clinical studies." 

"The technical expertise that Goodwin Biotechnology offers in the field of bioconjugation, coupled with the responsiveness and flexibility they exhibited during the selection process, made them the obvious choice," noted Miguel Garcia-Guzman, PhD, Chief Scientific Officer at Aspyrian Therapeutics. "Our mission is to leverage the potential of the PIT platform by developing a pipeline of proprietary and partnered ADC products, and this collaboration represents a critical milestone in this endeavor." 

Near-infrared Photoimmunotherapy (PIT) is based on three components:

  1. An antibody that binds to cell-surface antigens.
  2. The NIR IR700DX dye conjugated to the antibody via a stable linkage.
  3. NIR light dosimetry to activate the conjugate (cell killing occurs whether the conjugate is surface-bound or internalized).

Upon administration of non-ionizing NIR light, PIT induces rapid cell killing by localized disruption of cell membranes of only those cells targeted by the antibody conjugate. Importantly, unbound conjugates and free dye do not elicit any phototoxicity upon NIR irradiation. The combination of selective binding to surface antigens and organ-localized NIR activation permits highly efficacious disease-specific ablation, while sparing nearby healthy tissues and structures.

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a world-class CMO that offers a Single Source Solution™ through partnerships with clients for cell line development or exploratory proof of concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs) and other Biologic Drug Conjugates for early and late stage clinical trials. By working with Goodwin Biotechnology, our clients can enhance the value of their product candidates with clear development and manufacturing strategies as well as a road map to meet the highest quality product requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical approval pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 20 years of experience as an independent contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Additional information may be found at http://www.GoodwinBio.com.

About Aspyrian Therapeutics, Inc.
Aspyrian Therapeutics is a San Diego-based start-up biotechnology company. Together with its collaborators, Aspyrian aims to develop a novel class of ADCs that enable local control of tumors without damaging nearby healthy organs, tissues and structures.  Aspyrian plans to advance its first product into the clinic by the end of 2014 for the treatment of head and neck cancers, with the intent to obtain Phase I data, including safety and anticancer responses, by the end of 2015. Additional information may be found at http://www.aspyriantherapeutics.com/.

For more information on the process development and GMP manufacturing of biologics, please contact Goodwin Biotechnology: 
Robin McCallum, MSc
Business Development Manager
(954) 327-9656 
[email protected]    

SOURCE Goodwin Biotechnology, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...