2024/11/28
Mycenax and Apexcella collaborate to Advance Commercialization of Allogeneic Natural Killer Cell Therapies to Benefiting More Patients

Photo caption: On November 28, 2024, Pei-Jiun Chen (left), CEO and President of Mycenax, and Jen-Chine Wu (right), Apexcella's Interim CEO and CTO, signed a Memorandum of Understanding (MOU) to jointly promote the large-scale production of allogeneic natural killer (NK) cell therapy, benefiting more patients.

 

Taipei, Taiwan, Nov 28, 2024 — Mycenax Biotech Inc. (TWO:4726) today signed a Memorandum of Understanding (MOU) with Apexcella Biomedical Inc. to jointly develop the automated manufacturing process and foster commercialization of allogeneic natural killer (NK) cell therapies. This collaboration aims to enhance the efficiency of allogeneic NK cell scalable process, realize economic scale of production, reduce cost of goods (COGs), and provide safer, more affordable treatment options to meet the growing market demand.

 

Apexcella, established in 2022, is founded on the research of Professor John Yu (游正博), from Chang Gung Memorial Hospital, Linkou and Academician Alice Lin-Tsing Yu (陳鈴津) from Academia Sinica. The company focuses on developing of allogeneic NK cell therapies using the proprietary ApexNK® cell expansion technology platform, as well as further innovative CAR-NK cell therapies utilizing viral transduction technology.

 

Apexcella's Interim CEO and CTO, Jen-Chine Wu, stated that the company possesses the proprietary ApexNK® expansion technology platform, which can amplify NK cells from healthy donor blood by over a million fold without the need for complicated cell separation steps or co-culture with artificial feeder cells. To effectively address industrial pain points, the technology platform adopts modular design: Module One can directly culture blood mononuclear cells into a NK cell-enriched intermediate called "ANiK™" , which can be stably cryopreserved; Module Two can expand thawed ANiK™ cells into ApexNK® cells with high NK purity and potent anti-tumor activity within 2 weeks of culture in a closed system. The stable large-scale commercial production will significantly reduce manufacturing costs and provide an affordable option for patients.

 

Jui-lien Huang, Chairperson of Apexcella, emphasized the clinical benefits of NK cells, including a low risk of graft-versus-host disease (GvHD), neurotoxicity, and cytokine storms, making them a very safe allogeneic cell therapy. Apexcella aims to deliver effective, GMP-compliant allogeneic ApexNK® cell therapies. In addition to initiating Phase I clinical trials for hematological malignancies and solid tumors in 2025, Apexcella  also continues preclinical development of innovative CAR-ApexNK therapies.

 

As a CDMO partner, Mycenax will fully support the development of the allogeneic ApexNK® cell mass production process, utilizing high-throughput automated bioreactor system and comprehensive supports for 3D manufacturing technology to develop the most cost-effective allogeneic cell production techniques compliance with PIC/S GMP.

 

Pei-Jiun Chen, CEO and President of Mycenax, stated, "Mycenax will fully support cell therapy developers in accelerating the commercialization of allogeneic cell therapies, providing patients with efficient and low-side-effect treatment options." Mycenax is committed to offering one-stop development and manufacturing services for biopharmaceutical companies, enhancing production efficiency and reducing costs to lay the groundwork for the promotion of cell therapies.

 

About Apexcella

Apexcella Biomedical Inc. possesses proprietary ApexNK® cell expansion and viral transduction technology platforms, as well as in-process ANiK™ cryopreservation technology, to meet commercial-scale production requirements. This platform is globally competitive to develop next-generation and innovative NK cell-targeting immunotherapies, such as combination antibodies or NK cell engagers, or CAR-NK therapies. Apexcella aims to provide effective, timely, low-side-effect and affordable allogeneic cell therapies to meet unmet medical needs.

Company website: http://www.apexcella.com

 

About Mycenax

Mycenax takes the CDMO brand positioning of "big D and medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.06 billion NTD.

Stock code: Mycenax Biotech (4726).

Company website: http://www.mycenax.com

 

Press Contact:

Liru Yeh

Email: liru.yeh@mycenax.com

 

 

Photo caption: On November 28, 2024, Pei-Jiun Chen (left), CEO and President of Mycenax, and Jen-Chine Wu (right), Apexcella's Interim CEO and CTO, signed a Memorandum of Understanding (MOU) to jointly promote the large-scale production of allogeneic natural killer (NK) cell therapy, benefiting more patients.

 

Taipei, Taiwan, Nov 28, 2024 — Mycenax Biotech Inc. (TWO:4726) today signed a Memorandum of Understanding (MOU) with Apexcella Biomedical Inc. to jointly develop the automated manufacturing process and foster commercialization of allogeneic natural killer (NK) cell therapies. This collaboration aims to enhance the efficiency of allogeneic NK cell scalable process, realize economic scale of production, reduce cost of goods (COGs), and provide safer, more affordable treatment options to meet the growing market demand.

 

Apexcella, established in 2022, is founded on the research of Professor John Yu (游正博), from Chang Gung Memorial Hospital, Linkou and Academician Alice Lin-Tsing Yu (陳鈴津) from Academia Sinica. The company focuses on developing of allogeneic NK cell therapies using the proprietary ApexNK® cell expansion technology platform, as well as further innovative CAR-NK cell therapies utilizing viral transduction technology.

 

Apexcella's Interim CEO and CTO, Jen-Chine Wu, stated that the company possesses the proprietary ApexNK® expansion technology platform, which can amplify NK cells from healthy donor blood by over a million fold without the need for complicated cell separation steps or co-culture with artificial feeder cells. To effectively address industrial pain points, the technology platform adopts modular design: Module One can directly culture blood mononuclear cells into a NK cell-enriched intermediate called "ANiK™" , which can be stably cryopreserved; Module Two can expand thawed ANiK™ cells into ApexNK® cells with high NK purity and potent anti-tumor activity within 2 weeks of culture in a closed system. The stable large-scale commercial production will significantly reduce manufacturing costs and provide an affordable option for patients.

 

Jui-lien Huang, Chairperson of Apexcella, emphasized the clinical benefits of NK cells, including a low risk of graft-versus-host disease (GvHD), neurotoxicity, and cytokine storms, making them a very safe allogeneic cell therapy. Apexcella aims to deliver effective, GMP-compliant allogeneic ApexNK® cell therapies. In addition to initiating Phase I clinical trials for hematological malignancies and solid tumors in 2025, Apexcella  also continues preclinical development of innovative CAR-ApexNK therapies.

 

As a CDMO partner, Mycenax will fully support the development of the allogeneic ApexNK® cell mass production process, utilizing high-throughput automated bioreactor system and comprehensive supports for 3D manufacturing technology to develop the most cost-effective allogeneic cell production techniques compliance with PIC/S GMP.

 

Pei-Jiun Chen, CEO and President of Mycenax, stated, "Mycenax will fully support cell therapy developers in accelerating the commercialization of allogeneic cell therapies, providing patients with efficient and low-side-effect treatment options." Mycenax is committed to offering one-stop development and manufacturing services for biopharmaceutical companies, enhancing production efficiency and reducing costs to lay the groundwork for the promotion of cell therapies.

 

About Apexcella

Apexcella Biomedical Inc. possesses proprietary ApexNK® cell expansion and viral transduction technology platforms, as well as in-process ANiK™ cryopreservation technology, to meet commercial-scale production requirements. This platform is globally competitive to develop next-generation and innovative NK cell-targeting immunotherapies, such as combination antibodies or NK cell engagers, or CAR-NK therapies. Apexcella aims to provide effective, timely, low-side-effect and affordable allogeneic cell therapies to meet unmet medical needs.

Company website: http://www.apexcella.com

 

About Mycenax

Mycenax takes the CDMO brand positioning of "big D and medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.06 billion NTD.

Stock code: Mycenax Biotech (4726).

Company website: http://www.mycenax.com

 

Press Contact:

Liru Yeh

Email: liru.yeh@mycenax.com

 

 

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