Batavia and ChromaTan receive NIIMBL grant to integrate column-free continuous chromatography into HIP-Vax® manufacturing platform for AAV 

Batavia and ChromaTan receive NIIMBL grant to integrate column-free continuous chromatography into HIP-Vax® manufacturing platform for AAV 

Woburn, MA, April 10, 2024 — Batavia Biosciences, a leading contract development and manufacturing organization, is excited to announce a new alliance with ChromaTan, Inc.  for the development and integration of BioRMB™ (formerly known as Continuous Countercurrent Tangential Chromatography or CCTC) technology into Batavia’s AAV HIP-Vax® manufacturing platform. This project further highlights Batavia’s commitment to improve AAV manufacturing, while reducing manufacturing costs and optimize the environmental footprint of biopharmaceuticals through process intensification.

Recombinant adeno-associated virus (rAAV) vectors are spearheading the development of next generation treatments to cure debilitating and life-threatening disorders. However, demand for rAAV is exceeding its production capacity, threatening to become a bottleneck in the treatment of large patient groups.

Continuous chromatography has been shown to greatly contribute to the intensification of manufacturing processes for monoclonal antibodies. Yet, similar applications for rAAV are still lacking. As a leading CDMO, Batavia Biosciences expects to increase its rAAV production capacity and to further reduce the associated cost of goods through integration of ChromaTan’s BioRMBTM – a novel column-free real moving bed continuous chromatography platform – into Batavia’s proprietary HIP-Vax® manufacturing platform.

“The promise of next generation platforms both upstream and downstream in the field of gene therapy is very powerful for multiple reasons such as improvements in manufacturability, process economics, improved recovery and product quality. This exciting partnership enabled by NIIMBL, will empower us to take that idea a step further – by directly integrating these hyper efficient next generation platforms we have the potential to transform rAAV manufacturing as we know it” says Oleg Shinkazh, Chief Technical officer at Chromatan.

Peter Abbink, Managing Director at Batavia Biosciences, Inc., adds: “At Batavia, we continuously seek innovative solutions to fuel our mission to enhance the accessibility and availability of critical life-changing treatments. We are privileged to have the backing of NIIMBL and are thrilled to embark on a productive partnership with ChromaTan on this endeavor.”

This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086).


New Test for Rapid and Low-cost Quality Control for Polio Vaccines

New Test for Rapid and Low-cost Quality Control for Polio Vaccines

Leiden, March 2024 – Batavia Biosciences, a contract development manufacturing organization, introduces a new low-cost, and fast tool, suitable for quality control of polio vaccines. This transformative advancement, described in the peer-review journal Vaccine, will provide substantial benefits in the final phases of the global poliovirus eradication efforts.    

To ensure the quality of the poliovirus vaccines and mitigate the risk of producing low immunogenicity batches owing to mutation accumulation in the poliovirus strain during production under laboratory conditions, rigorous monitoring is essential. Currently, this analysis is performed by next-generation sequencing (NGS). However, due to the high cost and time-consuming process, there is a need for a more suitable alternative for analyzing the genetic make-up of virus strains in polio vaccines.  

Lizet Opmeer, vaccine development scientist at Batavia Biosciences and author of the study: “Our mission is to drive innovations that improve vaccine production and ensure that vaccines are globally accessible. By introducing this groundbreaking and cost-saving tool, we aim to significantly contribute to the global effort of eradicating polio.”  

Batavia Biosciences developed a rapid alternative test that is low-cost, highly sensitive and can accurately detect mutations in poliovirus vaccines. Specifically, the new tool is a variant (allele)-specific locked nucleic acid-based reverse transcription quantitative real-time PCR (AS LNA qPCR) technology. This new tool offers comparable results to NGS but with a fraction of the cost and time, improving the quality control process of polio vaccines and potentially reducing production expenses.  

The analytic tool can be applied to measure and control the product quality during process development, scale-up, and release of the vaccine. Also, it is likely applicable to other vaccine strains, serotypes, and mutations. 

This advancing research, conducted in collaboration with Genomescan and with the financial support of the Bill & Melinda Gates Foundation, underscores Batavia Biosciences’ commitment to advancing healthcare technology. Through ongoing projects and initiatives, the organization strives to create lasting positive impacts on global health outcomes, ensuring the availability of safe and affordable biopharmaceuticals for all.

More about AS LNA qPCR test  

AS LNA qPCR, which stands for variant-specific locked nucleic acid-based reverse transcription quantitative real-time PCR technology, is a powerful method that can be used to identify different versions of genes, DNA sequences, or single nucleotide polymorphisms (SNPs). This technique involves converting RNA into DNA and subsequently amplifying and quantifying the DNA in real-time using Quantitative Real-Time Polymerase Chain Reaction (qPCR). The detection of SNP variants is achieved by utilizing fluorescent dye-labeled probes containing Locked Nucleic Acid (LNA), a stable form of modified nucleic acids, which specifically targets and detects specific SNPs.  

It’s like a super-accurate genetic detective tool that can help to find different gene versions. In this case this test specifically detects mutations that can accumulate in poliovirus strains during vaccine production. 

About the study 

“High throughput AS LNA qPCR method for the detection of a specific mutation in poliovirus vaccine strains” by Lizet Opmeer, et al. https://doi.org/10.1016/j.vaccine.2024.01.103, as published in Vaccine, by Elsevier

 DOI: 10.1016/j.vaccine.2024.01.103 
 

About Vaccine 

Vaccine is the pre-eminent journal in the field of vaccinology. It is the official journal of The Japanese Society for Vaccinology and is published by Elsevier. 

https://www.sciencedirect.com/journal/vaccine

Copies of this paper are available to credentialed journalists upon request, please contact the Elsevier Newsroom at newsroom@elsevier.com. 

Batavia and Candel collaborate to develop therapeutics against glioma brain tumors 

Batavia and Candel collaborate to develop therapeutics against glioma brain tumors 

Woburn, MA, March 21, 2024 — Today, Batavia Biosciences, a leading Contract Development and Manufacturing Organization, announces a new partnership with Candel Therapeutics, Inc. (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer. The collaboration aims to accelerate the development and production of CAN-3110, an oncolytic viral immunotherapy for glioma brain tumors, based on a replication attenuated Herpes Simplex Virus (HSV). 

Batavia Biosciences will use its HIP-Vax® technology to develop a highly intensified, scalable and robust manufacturing process for Candel Therapeutics. This work will enable the production of CAN-3110 for toxicity studies and establish a Good Manufacturing Practice (GMP)-compatible process for the upcoming clinical trials.

“We are very pleased that Candel Therapeutics decided to contract Batavia Biosciences based on our proven track record with developing highly intensified processes resulting in low cost of goods. We are honored to collaborate with Candel Therapeutics, a biopharmaceutical company with extensive scientific expertise in working to develop solutions for patients with brain tumors”, says Peter Abbink, PhD, Managing Director at Batavia Biosciences, Inc., located in Woburn, MA.

CAN-3110 recently received FDA Fast-Track Designation to speed up the development for this promising immunotherapy candidate to improve overall survival in patients with recurrent high-grade glioma (HGG). In October 2023, Candel Therapeutics and academic collaborators at Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in Nature1. Recurrent HGG is one of the most aggressive malignancies for which there is currently no cure available, representing a significant and urgent unmet medical need. This collaboration aims to advance and accelerate the development of treatments for this devastating disease.

“Candel is excited to be partnering with Batavia, an organization we consider to be best in class with respect to HSV bioprocessing as well as our chosen manufacturing platform. We’re confident this relationship will ensure CAN-3110 is produced in a manner that ensures safe and effective medicine is available to every patient in need of this potentially life-changing therapy” says David Maheu, Vice President, Viral Vector Process & Analytical Development at Candel Therapeutics.

1Reference:  Ling Al et al. Nature 2023;623:157-166


About Candel Therapeutics 

Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, related to Candel including, without limitation, express or implied statements regarding the timing and advancement of Candel’s development programs, including CAN-3110; expectations regarding the therapeutic benefit of Candel’s programs, including the potential for Candel’s programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties identified in Candel’s SEC filings, including Candel’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. Candel cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Candel disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Candel’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Batavia Biosciences Joins iAds – Intelligent Design of Adenovirus Vectors Program 

Batavia Biosciences Joins iAds – Intelligent Design of Adenovirus Vectors Program 

Leiden, March 7, 2024 – Batavia Biosciences, a leading contract development and manufacturing organization, is excited to announce its active engagement in the iAds – Intelligent design of Adenovirus vectors program. The iAds consortium brings together 6 partners from 5 European countries and aims to apply a disruptive approach for viral vector design. This strategic involvement underscores Batavia Biosciences’ commitment to advancing state-of-the-art research and fostering collaborations that drive innovation within the viral vector field. 

Gene therapy is emerging as a promising therapeutic approach to address many areas of currently unmet medical need, such as neurodevelopmental, or neurodegenerative disorders and cardiovascular diseases. A frequently used vector in these development programs is the adenoviral vector. In the iAds program, new adenoviral vectors will be developed with improved targeting of the cardiovascular or central nervous systems to overcome limitations imposed by the patient’s immune system and from off-target effects.

The iAds consortium brings Batavia Biosciences together with IGMM, Janssen Vaccines, CNB-CSIC, Umeå University and the University of Edinburgh and combines their expertise in structural biology, receptor biology, clinical gene transfer, immunology, vaccines and GMP manufacturing to establish a disruptive approach to viral vector design.

Batavia Biosciences has a long-standing track record in the development and manufacturing of viral vectors such as the adenovectors and is an integral player in the cell and gene therapy field. Its extensive experience in bioprocess development and industrial scale manufacturing will be leveraged to develop a manufacturing process for this new generation of adenovirus vectors and produce research batches for pre-clinical testing. This way Batavia aims to accelerate and streamline the development trajectory from early-stage discovery into the clinic.

Wilfried Bakker, Director Science & Innovation at Batavia Biosciences, adds: “This collaboration highlights our commitment to advancing scientific knowledge and reinforces our position as a center of excellence in the viral vector field.”

About iAds 

iAds, a European Innovation Council (EIC) Pathfinder project, aims to maximize the potential of adenovirus vector for vaccines and gene transfer. This project is made possible in part by a contribution from the European Innovation Council under the grant agreement No 101098647.

For more information, please visit www.intelligentadenoviruses.eu

Batavia Biosciences Joins NXTGEN Hightech Program, to Advance Cell and Gene Therapy 

Batavia Biosciences Joins NXTGEN Hightech Program, to Advance Cell and Gene Therapy 

Leiden, January 9, 2024 – Batavia Biosciences, a contract development and manufacturing organization, is excited to announce its active participation in the NXTGEN Hightech Biomedical program. The NXTGEN Hightech program brings together many partners across several domains to deliver structural and sustainable economic growth in The Netherlands and contribute to solutions for societal challenges in health care, energy transition, safety and food. By joining the NXTGEN Hightech program, Batavia Biosciences is committed to advancing the cell and gene therapy field. 

The NXTGEN Hightech is a National Growth Fund program that aims to strengthen The Netherlands’ position as global leader in high-tech innovation. NXTGEN Hightech is a major investment in the future of the national economy and brings together over 330 partners across disciplines. It is a bold and ambitious program that has the potential to make a real difference in the world.

Wilfried Bakker, Director Science & Innovation at Batavia Biosciences, adds: “At the core of the program is Batavia Biosciences’ key focus on the development of environmentally friendly, reproducible, sustainable and cost-effective manufacturing technologies for new therapies in high demand.”

Addressing the critical aspect of cell culturing in the development of cell and gene therapies, this biomedical program emphasizes the need for new equipment and materials to improve process control. Batavia Biosciences is actively involved in this project with the goal of facilitating the adoption of sensor technology by pharmaceutical and biotech companies, which is critical for guaranteeing reproducible and lower-cost manufacturing for new therapies. This includes advancements and demonstration of sensors in a production setting, playing a crucial role for the evaluation of the innovative technologies.

Batavia Biosciences has a strong track record of offering state-of-the-art development and manufacturing solutions for viral vectors and is an integral player in the cell and gene therapy field. Its extensive experience in bioprocessing makes Batavia Biosciences a valuable partner in demonstrating new sensor technologies in a production environment.

Menzo Havenga, CEO Batavia Biosciences, concludes: “Beyond collaboration, the company is dedicated to being a driving force in the NXTGEN consortium, actively shaping the future of production and process technologies for life-changing therapies.”

About NXTGEN Hightech 

This project is made possible in part by a contribution from the National Growth Fund program NXTGEN Hightech. This program will invest as much as € 1 billion until 2030 with over 330 partners, in more than 60 projects and in six essential domains. In doing so, NXTGEN Hightech will make a significant contribution to the structural and sustainable economic growth in the Netherlands and offer solutions for the major societal challenges in the areas of energy transition, health, safety and food.  

For more information, please visit www.nxtgenhightech.nl 

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Maximizing protein expression