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).


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.

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Thermostable viral envelope protein formulation

Maximizing protein expression