() specializes in developing cell-based technologies but is also involved in the management of stem-cell banks and clinical laboratories and the fight against coronavirus (COVID-19).
Via its two platforms, Avalon Cell and Avalon Rehab, thecompany develops proprietary diagnostic and therapeutic products leveraging regenerative medicine and exosome technology. It markets proprietary exosome isolation systems and related products to hospitals.
In laymans terms, exosomes are akin to powerful messengers (tiny, membrane-bound vesicles) released by cells into biofluids like plasma/serum, urine, and saliva.
Avalon says exosomes, which carry cellular proteins and genetic material, can help fight the progression of certain cancers and act as biomarkers to detect tumors through liquid biopsy tests.
The Freehold, New Jersey-based company has also developed proprietary cancer immunotherapy called CAR-T, short for chimeric antigen receptor therapy. CAR-T involves genetically modifying T-cells, specifically manufactured for each individual patient, to activate the bodys immune system to recognize and destroy cancer cells.
Avalons lead CAR-T therapy is AVA-001, which is designed to treat relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma.And the company has developed a number ofskincare and wound-healing products that use clinical-grade tissue-specific exosomes as additives.
In March 2021, Avalon announced that it will work with the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center to advance the firms RNA based candidates andrelapsed/refractory B-cell lymphoblastic leukemia and non-Hodgkin lymphoma treatment, AVA-001, whichtargets tumor antigens on cancer cells.Avalon CEO David Jin has described the collaboration as a milestone in the clinical development and production of AVA-011 and other RNA-based FLASH-CAR candidates ahead of the start of the firms first-in-human clinical trials.
Avalon and the UPMC Cancer Center will co-develop and deploy Avalons new Point-of-Care (POC) Modular Autonomous Processing System (PMAPsys) onsite. This is a proprietary lab platform intended to provide POCprocess development, optimization, validation and manufacturing of clinical-grade products for cell and gene therapies at Good Manufacturing Practice (GMP) facilities.
Earlier in March, Avalon also reported that it is expanding its co-development research program with the Massachusetts Institute of Technology (MIT), involving the use of CRISPR-based genome editing and QTY protein design technology to potentially treat and prevent cancer metastasis the spreading of cancer cells from the initial tumor site to surrounding tissues and organs. Their workhas already generated a prototype device to soak up the excess chemokines and cytokines produced in the body that lead to the potentially fatal cytokine storm, which can occur in patients with COVID-19, and in cancer patients being treated with CAR T-cell therapy.
Avalon also had a busy spell in the final quarter of 2020. In October, the company forged a strategic collaboration for the global distribution of COVID-19 point-of-care antibody rapid test devices. It noted that the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved by the US Food and Drug Administration (FDA).
The FDA has issued an emergency use authorization (EUA) for the test device as well as for the Assure/EcoStep COVID-19 IgG/IgM Rapid Test Device. Under the agreement, Adial has granted Avalon non-exclusive, sub-distribution rights worldwide for both tests. As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals,or other locations where there is a healthcare professional.
In the December 2020 issue of NatureBiopharma Dealmakers, Avalons Jin, highlighted the bio-developer's ongoing scientific and clinical developments including a first-in-human trial of a mucosal, intranasal vaccine against SARS-CoV-2 that is planned for early 2021.
In September, Avalon had announced the launch of its new allogeneic mesenchymal stromal cell (MSC) therapeutic platform as a potential therapy for COVID-19. The company said it believes that its MSC platform could offer a unique approach to treat the potentially fatal acute respiratory distress syndrome, multi-system inflammatory syndrome and cytokine storm-related to severe cases of COVID-19.
In addition to being a potential therapy for COVID-19, the company said the platform would also be developed to treat bone marrow transplant-related complications of acute graft versus host disease (aGVHD).
In the December Nature Biopharma Dealmakers issue, Dr Jin also described the companys innovative, MSCtherapy candidate, CB-MSC-1, which possess unique anti-inflammatory and immunomodulatory activities, as well as AVA-001, Avalons third-generation CAR T cell therapy that has shown robust activity in patients in a Phase 1 trial.
At the start of October, Avalon said it had expanded the Phase 1 clinical trial of AVA-001, to include enrollment of patients with relapsed/refractory non-Hodgkin lymphoma. AVA-001 is a chimeric antigen receptor (CAR) T-cell (a type of white blood cell) therapy and allogeneic mesenchymal stromal cell (MSC, or connective tissue) therapy, which is designed to improve the bodys capacity to kill cancer cells. Earlier in the year,Avalon had successfully completed a first-in-human trial of the drug, and found that nine out of 10 patients with relapsed/refractory B-cell acute lymphoblastic leukemia achieved complete remission within one month.
Avalon also has a partnership with the Institute for Synthetic Bioarchitectures at the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria. The collaboration melds BOKUs S-layer nanotechnology with Avalons expertise in biomanufacturing, cell therapy engineering, and clinical development. Avalon will leverage the pioneering work of Professor Uwe B. Sleytr, who is a top expert on applied surface layer (S-layer) technology, and Professor Emeritus in the Department of Nanobiotechnology at BOKU.
Professor Sleytr is also a member of Avalons Scientific and Clinical Advisory Board.Avalon and BOKU are establishing a research facility, the Christian Doppler Laboratory, on the BOKU campus.In connection with the new facility, Avalon and BOKU have signed a pact to jointly apply for a matching research grant from the Christian Doppler Laboratory Foundation.
In thestatement announcing thecollaboration with the UPMCHillman Cancer Center,Avalon CEO Dr David Jin said: "We are excited about our partnership on thenew point-of-care Modular Autonomous Processing Systemwith UPMC, which we believe will help accelerate the path to bringing our own and third-party cell therapies to market.We are working diligently to fast-track development and commercialization of our cellular immune-oncology therapeutic products, while providing the highest quality and safety standards for our patients."
Contact the author Uttara Choudhury at firstname.lastname@example.org
Follow her on Twitter: @UttaraProactive
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