Ajinomoto Bio-Pharma Services Announces Manufacturing Partnership with CytoDyn for Drug Product Used in COVID-19 Clinical Trials

Ajinomoto Bio-Pharma Services | May 05, 2020

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce it has entered into a manufacturing services agreement with CytoDyn Inc., a late stage biotechnology company, for the supply of the investigational new drug, leronlimab (PRO 140), which is currently being used in clinical trial protocols for Mild-to-Moderately Ill and Severely Ill COVID-19 patients. Aji Bio-Pharma provides high quality drug product aseptic fill finish services for CytoDyn. Leronlimab, a novel CCR5 antagonist with the potential for multiple therapeutic indications, has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by the U.S. Federal Drug Administration (FDA) as part of Phase 1, Phase 2 and Phase 2b/3 clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clinical trials for Phase 2 and Phase 2b/3. "We are very excited to support CytoDyn's efforts to utilize this promising antibody therapeutic in the fight against COVID-19," said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services.

Spotlight

The objective of this chapter is to give an overview and analysis of the current trends and developments in biotechnology in aquaculture research and management. The technological developments along with structural changes in the aquaculture sector may affect access and intellectual property rights (IPR) regimes.

Spotlight

The objective of this chapter is to give an overview and analysis of the current trends and developments in biotechnology in aquaculture research and management. The technological developments along with structural changes in the aquaculture sector may affect access and intellectual property rights (IPR) regimes.

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RESEARCH, INDUSTRY OUTLOOK

BigHat Biosciences Announces Research Collaboration with Merck

BigHat Biosciences, Inc. | November 30, 2022

BigHat Biosciences, Inc., a biotechnology company with a machine learning-guided antibody discovery and development platform, announced a collaboration with Merck, known as MSD outside of the United States and Canada, to apply the company’s technology to design candidates for up to three drug discovery programs. BigHat’s design platform, Milliner, integrates a high-speed characterization with ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach could help reduce the difficulty of optimizing antibodies and other therapeutic proteins. Under the collaboration, BigHat and Merck will collaborate to optimize up to three proteins by leveraging BigHat’s platform to synthesize, express, purify, and characterize molecules. Mark DePristo, co-founder and CEO of BigHat, continued, "We are thrilled to be collaborating with Merck's world-class drug development teams to design safer, more effective antibodies for these important therapeutic programs.” The teams have initiated work on the first program and are looking forward to using the power of the complementary skills sets within each research team to generate high-quality lead antibodies. “We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients,” said Elizabeth Schwarzbach, BigHat’s Chief Business Officer. "This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline." “This agreement with BigHat expands Merck’s strategy of applying AI/ML across our drug discovery capabilities. We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates.” Juan Alvarez, vice president of Biologics Discovery, Merck Research Laboratories About BigHat Biosciences, Inc. BigHat Biosciences is designing safer, more effective antibody therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. They apply these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. BigHat’s broad pipeline of wholly-owned and partnered therapeutic programs span many disparate indications with high unmet need, such as cancer, inflammation, and infectious disease. BigHat has raised over $100M from top investors, including Section 32, a16z, and 8VC.

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INDUSTRIAL IMPACT

Alloy Therapeutics Raises $42 Million Series D Financing to Accelerate Discovery Technology Development Across Biologic Modalities

Alloy Therapeutics, Inc. | October 04, 2022

Alloy Therapeutics, a biotechnology ecosystem company, has closed $42 million in Series D financing led by its existing investors 8VC and Mubadala Capital and joined by return investors Thiel Capital, Presight Capital, Founders Fund, and other unnamed family offices and sovereign wealth funds. Alloy will use proceeds from the Series D financing to further support the drug discovery community with new pre-competitive drug discovery technologies in new biologic modalities and new partnership models designed to fuel innovation. Since Alloy’s Series C fundraise in March 2021, Alloy has expanded from its foundational antibody discovery technologies and discovery services into T-cell receptors with the launch of its Keyway TCR Discovery division, and genetic medicines through its collaboration with Dr. Sudhir Agrawal, the inventor of gapmer technology. Alloy has further expanded with three new research sites, in Basel, CH; Athens, GA; and San Francisco, CA. “After three years of hard work and planning, we were proud to formally launch Keyway TCR Discovery in January 2022. We envision a future in 20 years where engineered TCRs and TCR mimics are as successful a modality as monoclonal antibodies are today. Keyway believes this is possible by providing unrestricted access to enabling technologies and discovery services without pharma having to spend billions of dollars to acquire companies for proprietary technologies and people.” Dongxing Zha, CEO of Keyway and Alloy’s CTO for TCR Modalities In response to growing engagement from partners, Alloy will further leverage its Series D funds to continue to invest in expanded offerings across all six of its modalities. These will support the drug discovery community in the pursuit of multi-modal therapeutics while reducing or eliminating stacked downstream payments. Through its affiliated venture studio, 82VS, Alloy supports scientist-entrepreneurs with seamless access to its cutting-edge technologies and discovery services. 82VS companies are often the first customers of Alloy’s innovations, having full access to the Alloy suite of technologies and discovery services to advance the best drug candidates and invent new applications that can benefit the broader Alloy ecosystem and, ultimately, patients and their caregivers. To best serve the vast discovery needs of pharmaceutical companies, Alloy is pioneering an Innovation Subscription offering that gives its collaborators access to all current and future Alloy technology platforms for one flat, annual fee with no milestones or royalties. Partners benefit from Alloy as an ever-growing source of pre-competitive, foundational discovery technology. Alloy also supports complementary CROs, CDMOs and other discovery and development service providers as a critical part of the collaborative ecosystem to empower pharma in its mission to cure disease. In this subscription model, Alloy provides a new home for promising pre-competitive technologies and academic breakthroughs that have traditionally been underfunded or unavailable to all. “Our Innovation Subscription model is available now as an exciting next step in furthering our collaborative mission and unlocking the potential for sharing foundational, pre-competitive drug discovery technologies with the global drug discovery community,” said Alloy Therapeutics Chief Executive Officer and Founder Errik Anderson. “Including this financing, Alloy will have invested hundreds of millions of dollars in innovation that the largest pharma companies can access through a flat, annual subscription with no additional milestones or royalties. Emerging biotech and academics can access our tech through collaboration and more traditional and creative structures. Combined with the reinvestment of 100% of our revenue, including our subscription revenue, back into innovation and access to innovation, Alloy is a new for-profit business model that plays for the collective long game in a non-zero-sum way. The value of a subscription goes up every year, while the fees stay flat or even will decrease with scale. We price this so a single avoided royalty will pay for the entire platform access over a 20-plus-year period. We are grateful for our longstanding investors for supporting this vision of arming the drug discovery industry with the tools they need to discover and develop the best medicines for patients more quickly.” Alloy launched in 2017 to democratize foundational, pre-competitive technologies and capabilities for the discovery of therapeutic biologics and has since grown with over 130 partners across academia, biotech, and large biopharma. Its first platform was the ATX-Gx™, a suite of transgenic mouse strains for human antibody discovery that was originally in-licensed from a major pharma company and made broadly available to the drug discovery ecosystem by Alloy, with open access to newly introduced strains. Through its DeepImmune™ Antibody Discovery services, Alloy helps partners find the best therapeutic antibody candidates against targets of interest, by deploying a bespoke blend of its proprietary in vivo, in vitro, and in silico technologies and workflows. In 2022, Alloy launched Keyway™ TCR Discovery as its second fully integrated technology and services offering for the discovery of therapeutic engineered TCRs and TCR mimics. “Alloy has successfully expanded its flagship discovery offering in antibodies to multiple promising modalities to better serve the global drug discovery community,” said Alaa Halawa, Head of Mubadala Capital’s US Ventures business, which first backed Alloy as an investor in its Series C financing. “We are proud to partner with the company as it executes on its promise of enabling scientists through the development of transformative drug discovery technologies. We look forward to seeing how the partnership with large pharma partners and other venture firms will leverage Alloy’s platform to enable their therapeutic discovery teams and emerging startups to advance the best medicines.” About Alloy Therapeutics aAlloy Therapeutics is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners across academia, biotech, and the largest biopharma, Alloy democratizes access to pre-competitive tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics across six modalities, including antibodies, TCRs, genetic medicines, peptides, cell therapies, and drug delivery. Partners may access all current and future technologies for a flat annual fee through Alloy’s Innovation Subscriptions offering. As a reflection of Alloy’s relentless commitment to the scientific community, Alloy reinvests 100% of its revenue in innovation and access to innovation. About Alloy’s Antibody Discovery Offering Alloy’s first foundational platform, the ATX-Gx™ mice, is a suite of proprietary transgenic mice strains for human therapeutic antibody discovery, which can be accessed in your lab or through DeepImmune™ Antibody Discovery. This service integrates Alloy’s full complement of proprietary in vivo, in vitro, and in silico discovery and optimization technologies into one comprehensive service offering for fully human monoclonal and bispecific antibody discovery. The technologies and protocols can be replicated in a partner’s organization through a platform transfer and as part of an Alloy Innovation Subscription. Alloy is a leader in bispecific antibody discovery and engineering services, utilizing its proprietary ATX-CLC common light chain platform integrating novel transgenic mice and phage display. About Keyway™ TCR Discovery In 2022, Alloy launched Keyway™ TCR Discovery, Alloy's second fully integrated platform and service offering. Led by a team of TCR therapeutic pioneers and experts and leveraging the full resources of the Alloy ecosystem, Keyway provides comprehensive proprietary technology and capabilities for end-to-end discovery of TCR mimics and engineered TCRs, which includes production and quality control of MHC/peptide complexes, biophysical characterization, specificity testing, reformatting, and engineering, affinity maturation, and in vivo and in vitro preclinical testing. Partners may access Keyway's technology and capabilities through a standard or bespoke one-stop-shop discovery campaign, platform transfer, or Innovation Subscription.

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INDUSTRIAL IMPACT

Emergence Therapeutics Licenses Synaffix ADC Technology Platform in $360M Deal

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: www.emergencetx.com 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.

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