News/Press Releases

2020

Oragenics Inc. and Aragen Bioscience Enter Agreement to Accelerate Development of TerraCoV2, a SARS-CoV-2 (COVID 19) Vaccine Candidate

TAMPA, FL & MORGAN HILL, CA, May 19, 2020 –Oragenics, Inc. (NYSE American: OGEN), (the “Company” or “Oragenics”), today announced, that through its wholly-owned subsidiary, Noachis Terra, it has entered into an agreement with Aragen Bioscience, a leading contract research organization focused on accelerating pre-clinical biologics product development, to advance TerraCov2 the Company’s SARS CoV-2 vaccine candidate. Under the terms of the agreement, Aragen will provide cell line development services to Oragenics to aid in the development of Oragenics’ TerraCoV2, which could provide specific immunity from the novel coronavirus (“SARS-CoV-2”), the root cause of coronavirus disease 2019 (“COVID-19”).

“Developing a variety of vaccine alternatives is critical to bringing the SARS-Cov-2 pandemic under control. Utilizing the technology created at NIH with Aragen’s pre-clinical development capabilities will help us accelerate the development of the TerraCov2 vaccine candidate. We believe the relationship between the companies will result in advancement of the vaccine candidate into the clinic as rapidly as possible,” said Alan Joslyn, Ph.D., President and CEO of Oragenics.

“We’re delighted to initiate this project with Oragenics. Our hope is that the combined efforts of Oragenics and Aragen can accelerate TerraCoV2 development and provide a vital response to COVID-19 and the devastating pandemic it has caused,” said Axel Schleyer, CEO of Aragen.

About Oragenics, Inc.

Oragenics, Inc. is focused on the creation of the TerraCoV2 immunization product candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious disease and oral mucositis. Through Noachis Terra, a wholly-owned subsidiary of Oragenics, the Company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from the novel coronavirus, SARS-CoV-2, which causes COVID-19. The TerraCoV2 immunization leverages coronavirus spike protein research conducted by the National Institute of Health, which issued a worldwide, nonexclusive intellectual property license to Noachis Terra. In addition, Oragenics also has two exclusive worldwide channel collaborations, one with Precigen, Inc.’s subsidiaries relating to the treatment of oral mucositis and the other with ILH Holdings, Inc., relating to the development of novel antibiotics.

For more information about Oragenics, please visit www.oragenics.com.

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products.

Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process Development through Commercial Manufacturing

Full Service “Sequence-to-Manufacturing” Offering Designed to Drive Efficiencies and Reduce Overall Timelines for Delivering Early-Stage CGMP Bulk Drug Substances 

TUSTIN, CA, and MORGAN HILL, CA, May 6, 2020 — Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, and Aragen Bioscience, a leading contract research organization (CRO) focused on accelerating pre-clinical biologics product development, today announced a co-marketing agreement that will provide clients an integrated “sequence-to-manufacturing” service.  Under terms of the non-exclusive agreement, the companies will offer customers Aragen’s cell line development expertise integrated with Avid’s upstream and downstream process development and analytical services to drive efficiencies and reduce overall timelines for delivering CGMP bulk drug substances.

“With pharmaceutical and biotechnology companies focused on delivering their innovative medicines to patients as quickly as possible, this alliance aims to speed the entire CGMP manufacturing process by having a single, integrated team oversee a single, integrated project timeline with significant built-in process efficiencies,” said Timothy Compton, chief commercial officer of Avid. “We view this collaboration with Aragen as a significant win for current and future clients of both companies and we are excited to contribute our deep CDMO expertise to the partnership, particularly our more than 15 years of commercial product manufacturing  experience.”

“I am excited about this partnership that will enable us to accelerate drug development timelines and deliver new biologic therapeutics to patients faster by integrating two best-in-class offerings to our customers,” said Axel Schleyer, CEO of Aragen. “Our services in discovery, cell line development, which includes our innovative RapTr™ platform, protein production and preclinical testing are a great match with Avid’s clinical and commercial manufacturing capabilities. We look forward to this collaboration that advances novel ideas into breakthrough medicines.”

About Avid Bioservices, Inc.

Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products.

Coronavirus (COVID-19) Update – Aragen Open for Business

April 2, 2020, MORGAN HILL, California — On March 31st, California officially extended the “Shelter in Place” order through early May for all non-essential businesses. However, Aragen does not fall under the definition and requirements for closure outlined, and we remain fully functional to support you and your business in any way we can.

At Aragen, the health of our employees, families and business partners is our absolute priority and we have implemented a full catalog of precautionary measures aimed to ensure the health and safety of everyone involved.

Please don’t hesitate to reach out if you are looking for support, seeking a US-based CRO to step into a current project, or are just running low on capacity during these times. Aragen’s labs are open in California and ready to work with you on any projects involving cell line development, protein production, protein analytics, antibody discovery, in vivo efficacy testing and cell based assays.

About Aragen

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products.

Aragen Bioscience, Inc. and University of Technology, Sydney Enter Into MoU to Support and Accelerate Biologics R&D in Australia

March 3, 2020, MORGAN HILL, Calif. & HYDERABAD, India — Aragen Bioscience, Inc, a fully owned subsidiary of GVK BIO and a leading large molecule CRO, and University of Technology Sydney (UTS), the top-ranked young university in Australia, are pleased to announce a collaboration to accelerate biologics R&D in Australia.

This partnership between UTS and Aragen unites the capabilities, experience, and expertise of two leading organizations to assist the Australian biopharma and biotech industries advance their ideas into medicines.

“Under this collaboration, customers can leverage Aragen’s proprietary, cutting edge, royalty-free CHO DG-44 expression system for therapeutic antibody production. Downstream clinical development and manufacturing requirements can be met through UTS’s Biologics Innovation Facility (BIF), providing the Australian Biopharmaceutical Industry with a seamless solution from Concept through Clinic,” said Dr. Axel Schleyer, CEO, Aragen Bioscience.

“We are delighted to partner with one of the top Australian institutions – UTS, which has the infrastructure and knowhow to support large molecule clinical development,” said Manni Kantipudi, Chairman, Aragen, & Chief Executive Officer, GVK BIO. “The Aragen team is recognized globally for its antibody research, having discovered three Novel Biological Entities (NBEs) that are now commercial. Through this collaboration with UTS, we expect to support the local industry by bringing together knowhow, experience, and world class infrastructure that marries speed, innovation, and costs.”

UTS Faculty of Science Business Development Manager, Dr Andrew Groth, said: “UTS welcomes the strategic partnership with Aragen to provide comprehensive but affordable cell line and expression technology solutions to Australian research communities and start-ups, to tackle the critical bottleneck during pre- and early-clinical stages of biologics development.”

About Aragen

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products. www.aragenbio.com

About UTS and UTS Biologics Innovation Facility

UTS is the top-ranked young university in Australia. With a vision to be a leading public university of technology recognized for their global impact. UTS is committed to practical innovation and research that benefits industry and society. The UTS Biologics Innovation Facility (BIF) is an unmatched Good Manufacturing Practice (GMP) training, research and scale-up manufacture bioprocessing facility designed to drive opportunities using state of the art equipment and best practice processing techniques. UTS BIF delivers the world’s best practice training in bioprocessing through licensing the curriculum from the National Institute for Bioprocessing Research and Training (NIBRT) based in Ireland. UTS BIF collaborates with GE Healthcare Life Sciences in facility design and equipment based on pilot-scale single-use technology. https://www.uts.edu.au/

Contacts

GVK BIO | Sarat Patanaik | sarat.patanaik@gvkbio.com

Source: GVK BIO

Aragen Bioscience announces the appointment of Steven Lang, PhD, MBA as Vice President, Biologics

The addition of Dr. Lang is part of a multiyear investment in Aragen’s team, facilities and technologies.

February 25, 2020 Morgan Hill, California — (PRWeb)Aragen Bioscience is pleased to announce the appointment of Dr. Steven Lang as Vice President, Biologics. Aragen, a wholly-owned subsidiary of GVK BIO, is a leading Contract Research Organization focused on accelerating biologics product development with an integrated offering that includes antibody discovery and humanization, stable cell line development, recombinant protein production and purification, and differentiated diseases models.

“It’s my pleasure to welcome Dr. Steven Lang to Aragen.” said Axel Schleyer, CEO, Aragen Bioscience. “The addition of Dr. Lang is part of Aragen’s ongoing investment in our team, facilities and technologies. This multiyear expansion in our capabilities has included adding over 15,000 square feet of laboratory space, introducing our proprietary RapTr™ Cell Line Development services and adding mass spectrometry to our analytical tool set. Dr. Lang’s technical expertise in discovery and development as well as his track record in creating innovative and dynamic teams will be invaluable in building on Aragen’s growth.”

Prior to joining Aragen, Dr. Lang was with Genentech’s Cell Culture department as a Director overseeing research material generation, cell line development, automation, and CHO process development covering activities from DNA to Phase 2 clinical supplies. In addition to his functional role, he led an initiative to modernize the CMC scientific data management processes. This work spawned numerous digitization efforts across the global Roche Technical Development network to drive efficiency, transparency and compliance. He also acted as a CMC leader for a project team delivering an innovative bispecific antibody into clinical trials.

Prior to Genentech, Dr. Lang was with Janssen Research and Development where he built the analytical discovery, stability screening and cell line development groups into important interfaces between discovery and development. He brought experience in biologics discovery, technology development, process optimization, project leadership, due diligence and strategic interactions. At Johnson & Johnson, he had roles spanning preclinical, early development, regulatory filings and late-stage/marketed product support as a functional and CMC project leader.

Dr. Lang received his PhD in Molecular Microbiology from State University of New York Stony Brook. He then undertook post-doctoral work at Stony Brook and Johnson & Johnson Pharmaceutical R&D. He received his MBA from Rider University.

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of In Vitro and In Vivo services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products.

Contact

sarat.patanaik@gvkbio.com

Serum Institute and Aragen Bioscience Announce Collaboration on Vaccine Development

January 8, 2020 HYDERABAD, India & SAN JOSE, Calif.–(BUSINESS WIRE)– Aragen Bioscience, Inc, a subsidiary unit of GVK BIO and one of the leading pre-clinical CRO specializing in monoclonal antibody and other large-molecule product development and Serum Institute of India Pvt. Ltd. (Serum), the world’s largest vaccine manufacturer, are pleased to announce a collaboration for the development of multiple stable cell lines to support Serum’s HIV program. This partnership between Serum and Aragen unites two organizations that are committed to ‘Accelerating Life Sciences R&D’ with the goal of developing affordable monoclonal antibodies that improve the quality of human life.

Aragen will leverage its expertise with their RapTrplatform utilizing proprietary vectors and CHO DG44 host cells to develop the cell lines. Combined with the analytics platform, Aragen is set to provide Serum with high expressing cell lines enabling Serum to quickly move their program forward into Manufacturing. With a proven track record of more than 50 years in developing affordable medicines, Serum will focus its efforts on advancing these novel molecules into impactful vaccines or therapies that treat and prevent diseases world-wide.

“We are delighted to partner with the global leader in Vaccines,” said Manni Kantipudi, Chairman, Aragen, & Chief Executive Officer, GVK BIO. “The Aragen team is recognized globally for its ability to clone and express challenging proteins. Through this collaboration with Serum, we expect to build on this expertise to develop and deliver affordable biologicals.”

“SIIPL is very pleased to join hands with Aragen. SIIPL is already in collaboration with IAVI and Scripps Research for discovery of novel monoclonal antibodies against HIV. With our manufacturing capabilities and this collaboration with Aragen to develop stable cell lines, SIIPL will be able to provide cost effective monoclonal antibodies against HIV for the developing and developed world,” stated Mr. Adar Poonawalla, CEO, SIIPL.

About GVK BIO

GVK BIO, a leading Contract Research & Development Organization servicing the global Life-sciences industry, is headquartered in Hyderabad, India with operations in five sites including Aragen Bioscience, Inc. in California, USA. Established in 2001, GVK BIO has over 19 years of experience across the Research and Development value chain with a focus on speed and quality while ensuring safety and compliance. GVK BIO’s team of over 2500 highly qualified scientists, backed by a no-conflict business model, well-defined and scalable processes, modern facilities, and a strong customer-centric partnering approach, focus on bringing its customers’ products to market.www.gvkbio.com

About Serum

Serum Institute of India Pvt. Ltd. was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics. Serum is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

Serum is ranked as India’s No. 1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.

The philanthropic philosophy of Serum continues with its work on newer vaccines and biologicals.

Learn more about Serum Institute of India a https://www.seruminstitute.com/

2019

GVK BIO announces the appointment of Axel Schleyer, Ph.D. as Chief Executive Officer, Aragen Bioscience, Inc.

May 08, 2019, Hyderabad, India/California, US: GVK BIO is pleased to announce the appointment of  Dr. Axel Schleyer as Chief Executive Officer, Aragen Bioscience Inc.  Aragen, a wholly-owned subsidiary of GVK BIO, is a leading Contract Research Organization focused on accelerating biologicals product development with an integrated offering that includes antibody discovery and humanization, stable cell line development, recombinant protein production and purification, and differentiated diseases models.

“I am delighted to welcome Dr. Axel Schleyer as the Chief Executive Officer, Aragen Bioscience. Axel brings a wealth of business, technology, regulatory and strategic acumen, and has an impressive record of consistently delivering high performance with a customer focus, said Manni Kantipudi, Chairman, Aragen Bioscience, Director & CEO, GVK BIO. “We are confident that under his leadership, Aragen will expand its offering, and build on its growth over the past few years”.

“I am excited to lead Aragen Bioscience and look forward to assisting our customers in developing solutions that impact human health. With large molecules contributing to approximately 40% of the global portfolio, interest in Biologics research continues to grow rapidly” added Dr. Axel Schleyer. “With its strong scientific leadership, ‘customer first’ culture, state-of-the-art infrastructure, and an ideal location in the Bay area, Aragen is well positioned to benefit from market trends.

A seasoned Pharmaceutical and Biotechnology professional, Dr. Schleyer has over two decades of industry experience, building and leading high-performance teams, spearheading global business initiatives, and formulating business strategies resulting in successful outcomes. Prior to joining Aragen, Dr. Schleyer served as Senior Vice President, AGC Biologics and has held roles of increasing responsibilities at Lonza, Siegfried, Baxter Healthcare and Boehringer Ingelheim.

Dr. Schleyer has completed his postdoctoral studies at The Scripps Research Institute, La Jolla, CA and at Carlsberg Institute, Copenhagen, Denmark. He completed his Ph.D. in Chemistry from the University of Hamburg, and holds a Master of Business Administration degree from California State University, San Marcos.

About GVK BIO

GVK BIO, a leading Contract Research & Development Organization servicing the global Biopharma industry; is headquartered in Hyderabad, India with operations in five sites including California, USA. Established in 2001, GVK BIO has over 18 years of experience across the Research and Development value chain with a focus on speed and quality while ensuring safety and compliance. GVK BIO’s team of over 2100 highly qualified scientists, backed by a no-conflict business model, well-defined and scalable processes, modern facilities, and a strong customer-centric partnering approach, focus on bringing its customers’ products to market. www.gvkbio.com

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of    In Vitro and In Vivo services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products. www.aragenbio.com

Contact

sarat.patanaik@gvkbio.com

2018

Aragen Bioscience Expands RapTr Cell Line Development Services

San Francisco, CA  March 19, 2018 – Aragen Bioscience, Inc, a leading pre-clinical CRO specializing in monoclonal antibody and other large-molecule product development, announced today that their RapTr™ Cell Line Development Services have been expanded to include CHO-GS cell lines. The company is introducing their new services at the Bioprocess International West Conference in San Francisco this week.

RapTr™ services combine proven host cell lines and vector combinations with an innovative clone selection process. This results in a highly flexible and customizable platform that rapidly delivers high titers, allowing researchers to characterize and evaluate product quality at all stages of development — from early-stage discovery to manufacturing. Both RapTr cell lines are regulatory-friendly and royalty-free.

“We’re excited to broaden our RapTr™ services to include the CHO-GS cell line. This expansion will give our clients much more flexibility with development decisions”, said Virginie Menard Rose, Ph.D., Director of Cell Line Development and Upstream Process Development. “Our royalty-free, fee-for-service approach also eliminates the requirement for negotiating a third-party cell licensing agreement.

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of In Vitro and In Vivo services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products.

2017

Aragen Bioscience Announces AAALAC Accreditation

MORGAN HILL, CA November 10, 2017  – Aragen Bioscience announced today full accreditation from the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care). “Animal research continues to play an important role in the development of novel and improved medicines to treat human diseases. We acknowledge that animal research is a subject of ethical concern for both our partners and the public; we take our responsibility to animal welfare very seriously,” commented Malavika Ghosh, Vice President, Preclinical Research. “We also recognize that laboratory animal research has proven to be an essential element in the development of therapeutics. As part of our commitment to the ethical and responsible treatment of animals in research, we have applied for and received full accreditation from AAALAC.” AAALAC accreditation is a voluntary, peer-reviewed assessment by a private nonprofit organization that promotes the humane treatment of animals in science. AAALAC accreditation is recognized worldwide as the “gold standard” for animal research programs.

“Our partners have come to rely on us for both the design and implementation of their preclinical studies “ Dr. Ghosh continued. “AAALAC accreditation helps demonstrate that we are engaged in responsible animal research and dedicated to good science.”

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly-owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of In Vitro and In Vivo services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products

RapTr Cell Line Development services introduced

SAN DIEGO, CA June 20, 2017 – Aragen Bioscience, Inc, a leading pre-clinical contract research organization specializing in the discovery and preclinical development of high-value biotech and pharmaceutical products, announced today at the BIO International Convention the introduction of RapTr™ services. RapTr™ Cell Line Development Services combine the proven CHO-DG44 host cell line and vector combination with an innovative clone selection process. The results are a highly flexible and customizable platform delivering high titers in a rapid timeframe from early stage Discovery through to the Clinic. RapTr also incorporates state-of-the-art analytical methods to characterize and evaluate product quality at all stages.  As RapTr is based on CHO-DG44, it is regulatory-friendly and royalty-free.

“Building on our decades of experience in cell line development and recent investments in expanding our biologics team and facilities, we’re excited to announce RapTr™. We believe that our suite protein expression and analytical services will give our clients tremendous flexibility in developing cell lines and generating high quality proteins using a single scalable platform regardless of their stage of development.” said Oren Beske, Ph.D., President of Aragen Bioscience.

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly-owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of In Vitro and In Vivo services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products

2016

July 11, 2016
MORGAN HILL, California – July 11, 2016: Aragen Bioscience, Inc. (Aragen), leading pre-clinical contract research organization specializing in the discovery and early development of high-value biologics and diagnostic products has appointed Oren Beske, Ph.D. as the President of Aragen Bioscience.

January 26, 2016
MORGAN HILL, California – January 28, 2016: Aragen Bioscience, Inc. (Aragen), leading contract research organization specializing in the study and early development of biologic and diagnostic products, has initiated construction on a new, state of the art research facility.

2015

September 8, 2015
Aragen Bioscience Announces Licensing Agreement for Protein Production Technology from ProteoNic Biotechnology


2014

January 2, 2014
GVK BIO and Aragen Bioscience Sign Definitive Agreement to Acquire Aragen Bioscience, Inc.


2013

May 2, 2013
Aragen Bioscience and Innovent Biologics Announce Collaboration for Biotherapeutic Product Development

September 12, 2013
Bullet Bio Provides Update On Recent Financing And Results From Proof-Of-Concept Study For Lead Product Candidate


2012

August 2, 2012
Aragen Bioscience, Inc. successfully completes antibody humanization project


2011

October 26, 2011
XOMA and Aragen Bioscience Announce Antibody Humanization Services AgreementXOMA and Aragen Bioscience Announce Antibody Humanization Services Agreement

June 1, 2011
Aragen Bioscience Announces Cooperative Research and Development Agreement with the U.S. Army

April 5, 2011
Aragen Bioscience Awarded Three PreClinical Development NIAID Subcontracts