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Lonza Will Manufacture Asher Bio's Cis-targeted IL-2 Fusion Protein

Asher Biotherapeutics, which is developing targeted immunotherapies for cancer, autoimmune, and infectious diseases, and Lonza, a CDMO, signed a manufacturing agreement for AB359, a cis-targeted IL-2 fusion protein, which selectively activates the IL-2 pathway

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Asher Biotherapeutics, which is developing targeted immunotherapies for cancer, autoimmune, and infectious diseases, and Lonza, a CDMO, signed a manufacturing agreement for AB359, a cis-targeted IL-2 fusion protein, which selectively activates the IL-2 pathway in CD8+ T cells. Unlike conventional immunotherapies that act on multiple cell types, cis-targeted immunotherapies engage two receptors on the same immune cell: an immunomodulatory receptor and a specific target that directs the therapy to the desired immune cell type. The result, according to an Asher official, is reduced side effects and optimized activity through a new level of selectivity. AB359 is intended to broaden Asher Bio’s application of cis-targeted immunotherapies to chronic infectious diseases. Lonza will provide drug substance manufacturing for AB359 for preclinical and clinical testing. Work on this program began in March 2022 at Lonza’s Slough (U.K.) site. Bi- and multi-specific molecules are a growing part of Lonza’s portfolio. Julie Trulson, PhD, head of CMC, Asher Bio, said, “Lonza’s determination in implementing steady improvements, and offering its customers a more integrated experience, will be essential as we advance our cis-targeted immunotherapies closer to patients.” “This collaboration marks our commitment and flexibility in tailoring our offering to the specific needs of emerging biotechs,” added Jeetendra Vaghjiani, PhD, executive director, clinical development, and strategic marketing, Lonza. Our teams have built the capabilities and experience, including more complex protein formats, to help take Asher Bio’s AB359 from development into the clinic.”

Presentations at AACR

Asher Bio plans to present new data for multiple research programs across its portfolio of cis-targeted immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting, being held in New Orleans, beginning today and ending next Wednesday, April 13. The presentations are intended to provide additional data supporting the potential of AB248, Asher Bio’s CD8-targeted IL-2 immunotherapy, and to demonstrate the cis-targeting platform’s ability to rapidly generate highly selective molecules that target multiple immunomodulators to a diverse set of immune cell types. Asher Bio expects to file an investigational new drug application for AB248, its CD8-targeted IL-2 immunotherapy, in the third quarter of 2022 and for AB821, its CD8-targeted IL-21 immunotherapy, in the second half of 2023.

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01How does interleukin-2 (IL-2)-diphtheria toxin fusion protein work?

Interleukin-2 (IL-2)-diphtheria toxin fusion protein is a biological product used for the treatment of cutaneous T-cell lymphoma (CTCL) in adults. IL-2-diphtheria toxin fusion protein is a kind of treatment that is designed to kill cancer cells in cutaneous T-cell lymphoma by carrying and releasing the diphtheria toxin inside the tumor cells. Cutaneous T-cell lymphomas are a group of rare cancers that start in the T-lymphocytes, also known as T-cells, an integral part of the immune system. CTCL affects the skin, but it is not a skin cancer. It is a type of lymphoma in which T-cells within the skin become cancerous, cause inflammations and rashes, and damage the skin. The skin contains a large number of T-cells which help fight infections. CTCL occurs when these T-cells turn abnormal and grow out of control. Initially it only affects the skin, but can spread to other organs such as lymph nodes, liver and spleen, in advanced stages. CTCL is classified as a type of non-Hodgkin lymphoma (NHL). Interleukin-2 is a protein produced by activated T-cells, and is a growth factor that promotes the growth of T-cells. The activated T-cells in the skin in cutaneous T-cell lymphomas produce this protein which aids the cancerous growth of T-cells. Interleukin-2 (IL-2)-diphtheria toxin fusion protein binds to IL-2 receptors on the tumor cells and kills them. Interleukin-2 (IL-2)-diphtheria toxin fusion protein is produced using DNA recombinant technology and contains human IL-2 and diphtheria toxin fragments. The IL-2 helps the drug bind to T-cells that express IL-2 receptors, and once the molecule enters the cell, the diphtheria toxin separates and inhibits protein synthesis, which leads to cell death. Currently, the only approved interleukin-2 (IL-2)-diphtheria toxin fusion protein therapy is denileukin diftitiox. It was originally approved by the FDA to treat CTCL, under the brand name of Ontak in 1999. Ontak was withdrawn in 2014, and the treatment has now been approved in August 2024 under the brand name of Lymphir.

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Peptide Therapy Guide Editorial Team

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