Avalon GloboCare and GE Healthcare Partner to Advance Cellular Therapies

Partnership handshake

Avalon GloboCare Corp. announced a strategic partnership with GE Healthcare on July 22. The deal is designed to accelerate Avalon’s standardization, automation and bio-production for CAR-T cells and other cellular therapies related to immunotherapy. This includes exosomes/extracellular vesicles (EV)-based regenerative therapeutics.

Avalon, based in Freehold, New Jersey, is an international biotech developer and healthcare service provider. In addition to its core platforms, Avalon Cell and Avalon Rehab, it provides strategic advisory and outsourcing services to clients in the healthcare market. Its U.S. subsidiary, GenExosome Technologies, focuses on liquid biopsies, precision medicine and regenerative medicine.

Its exosome technology is being designed for early detection of oral cancer, ovarian cancer, kidney cancer, skin regeneration and anti-fibrosis, as well as treatments for Alzheimer’s disease, arthritis, osteoporosis and others. Avalon Cell focuses on cell-based therapies related to in vitro diagnostics, regenerative medicine and cancer immunotherapy.

On July 15, Avalon provided updates on four of its clinical programs in cellular therapy. AVA-001, a CD19 CAR-T candidate, is in a first-in-human clinical trial in China for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin’s Lymphoma (NHL).

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AVA-101, a transposon-based, multi-targeted CAR-T candidate, is beginning preclinical development and validation and expects to enter the clinic in the first quarter of 2020. AVA-201 is a therapeutic candidate for oral cancer using engineered mesenchymal stem cells as a “bio-factory” to mass-produce miR-185, which suppresses cancer cell proliferation, invasion and migration cell cultures. The resulting miR-185 enriched exosomes, AVA-201, have been applied to oral leukoplakia lesions in animal models in a proof-of-concept study.

And finally, AVA-202 is a clinical-grade, exosome-based therapeutic candidate. The company recently finished its standardized bio-production work that it is co-developing with Weill Cornell Medicine. These exosomes have shown the ability to regenerate tissues, especially blood vessel formation and wound healing. The company plans to get AVA-202 into the clinic in the fourth quarter of this year for vascular diseases and wound healing, including treatment for diabetic foot ulcers.

The company is also commercializing its ACTEX-based product development for skin care, scar removal, and hair growth.

Under the new partnership with GE Healthcare, they will establish automated and standardized GMP cell production capabilities. Avalon will have access to GE Healthcare’s cell processing expertise and products by way of FlexFactory Cell Therapy Platform, FastTrak process development and training services. In addition, Avalon will have access to GE Healthcare’s SOP and validation protocol library.

Training for these procedures will be performed at both GE Healthcare and at Avalon’s Nanjing Epicon GMP facility in China, with the ability to use GE Healthcare’s bio-manufacturing resources.

In September 2018, Avalon entered a joint venture with Jiangsu Unicorn Biological Technology Co. called Epicon Biotech Co. It is located within the Nanjing BenQ Hospital, a Grade 3A medical center in Jiangsu Province, China. In June 2018, Avalon established a provincial network of translational cellular therapies and bio-banking programs in China with Jiangsu Unicorn.

The partnership with GE Healthcare provides access to Avalon’s clinical network in China and, according to Avalon, “empower Avalon to improve manufacturing throughput and efficiency, alleviate cost burden, and minimize variability in the automated and standardized bio-production process of clinical-grade cellular products (such as CAR-T, CAR-NK, and stem cell-derived exosomes/EV), therefore, accelerating the development of Avalon’s clinical and commercialization programs in cellular medicines.”

“Cellular medicines as a bio-industry sector has been growing and evolving at a rapid pace during recent years with vast potential to change the way various diseases are managed,” stated Angela Chen, GE Healthcare CGT Global Commercial Enterprise Solutions Leader. “GE Healthcare continues investing in technologies and services aimed at the thriving cellular medicine industry with a firm commitment of making these promising cellular therapeutic modalities accessible through successful industrialization.”

Chen went on to say, “We are pleased to work with Avalon GloboCare, a global leader in cell-based therapeutics and exosome technology, who share our mission and vision for advancing innovation and delivering automation, standardization and bio-production solutions for cellular medicines.”

This is yet another example of the industry’s focus on manufacturing for gene and cell therapies. In March, Thermo Fisher Scientific acquired gene and cell therapy manufacturer Brammer Bio for $1.7 billion in cash. Brammer Bio is a contract development and manufacturing organization (CDMO) focused on manufacturing viral vectors for gene and cell therapies.

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Also in March, bluebird bio announced it was opening a new gene therapy manufacturing facility in Durham, North Carolina. That factory will produce lentiviral vectors for its gene and cell therapies, including bb2121 and bb21217 for multiple myeloma and possibly LentiGlobin for transfusion-dependent beta-thalassemia (TDT) and sickle cell disease.

In May, Bayer announced plans to build a Cell Culture Technology Center in Berkeley, California, investing $150 million in the project. The center will develop biologics. The facility will be constructed on Bayer’s existing campus where its manufacturing currently makes its Factor III hemophilia A treatments. The new Cell Culture Technology Center is expected to open for clinical production in late 2021. The facility will be designed and built by Fluor. GE Healthcare was chosen to integrate its FlexFactory technology platform and supply all major unit operations, systems and ancillary equipment.

“Bayer’s Cell Center Technology Center will combine automation, digital capabilities and single-use bioprocessing technologies to streamline production to allow us to bring new medicines to patients faster,” stated Judy Chou, senior vice president and Global Head of Bayer Biotech and head of Bayer’s Berkeley site. “We’ve chosen to partner with Fluor and GE Healthcare on the Cell Culture Technology Center to leverage their expertise in designing flexible, scalable facilities for the future.”

According to a recent industry report, there are almost 300 gene therapies being developed to treat more than 100 diseases. As these therapies enter clinical trials and eventually the marketplace, the demand for specialized manufacturing capabilities and infrastructure are only likely to increase.

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