BIO Asia-Taiwan’s CGT Vax Discovery Symposium—Collaborations, Innovations and Emerging Tech in Taiwan’s Vaccine Industry

Celltech Innovation Venture Studio Co., Ltd. (“CellTech Accelerator“), an Asian cell and gene therapy technology accelerator, has partnered with Minaris Regenerative Medicine Co., Ltd. (“Minaris”), a global contract development and manufacturing organization (CDMO) for cell and gene therapies (CGT). This strategic partnership aims to foster the growth and development in the field of regenerative medicine within the cell and gene therapy sector.

Announced at CellTech’s inaugural CGT-Vax symposium, the partnership with Minaris followed two relevant presentations by renowned experts in the field of CGT. Dr. Miguel Forte, President of the International Society of Cell and Gene Therapy (ISCT), discussed the global development of CGT products. Additionally, Dr. Hiroto Bando, CEO of Minaris, outlined Minaris’ contributions to business opportunities and challenges in gene cell therapy as a global CDMO. Finally, the event wrapped up with a spotlight on 12 emerging companies, each unveiling their innovative technologies.

Taiwan’s CellTech Accelerator and Japan’s Minaris Regenerative Medicine Announce Partnership

BIO Asia-Taiwan 2024, held in Taiwan—a hub for ICT and expanding biotech and medtech sectors—engaged the international biomedical community. The convention featured seminars, panel discussions, and satellite symposia with over 100 renowned speakers, plus valuable networking with leading companies and solution providers.

 This year, CellTech Accelerator launched its first CGT-Vax Discovery Symposium, highlighting Taiwan’s progress in vaccine and gene therapy. The symposium at the Nangang Exhibition Hall featured Michelle Ho, who noted Taiwan’s vaccine industry is emerging from its infancy. CellTech announced a strategic partnership with Minaris, reflecting their commitment to innovation in the CGT field.

 CellTech Accelerator’s leadership stressed the initiative’s importance. They aimed to build an ecosystem to support startups in overcoming challenges. With their extensive biotech experience, they recognized the need for funds, talent, and network cooperation. CellTech CEO James Tsai stated, “We are delegated to supporting these advancements. We are investing in innovative solutions and most importantly we are driving the purpose of partnerships. We are making a significant strive forward for greater healthcare.”

This partnership between Minaris and CellTech underscores their commitment to advancing cell therapy technologies. It positions Taiwan and Japan as leaders in the CGT sector, fostering innovation and a robust entrepreneurial ecosystem. Consequently, this collaboration aims to drive future industry success.

CellTech CEO, James Tsai (left) and Minaris Regenerative Medicine CEO, Hiroto Bando (right) announce partnership agreement at the CGT-Vax Discovery Symposium. Photo: BIO Asia Taiwan.

Insights from ISCT President, Miguel Forte, on Global Gene Therapy Trends

Further, the symposium explored CGT development and regulatory challenges faced by CDMOs in advanced technology stages. Dr. Miguel Forte, ISCT’s president, addressed key manufacturing aspects of cell and gene therapies, emphasizing opportunities in Taiwan and Japan. He noted a shift from traditional pharmaceutical approaches to a direct consumer model, focusing on personalized and targeted therapies. For example, Novartis’s KYMRIAH, a CD19-directed autologous T-cell therapy for young patients with refractory or relapsed B-cell precursor acute lymphoblastic leukemia (ALL), exemplifies this approach. Forte stressed the need for significant investment and support to foster development in the CGT field, highlighting substantial opportunities in Europe and Asia.

Next, Forte discussed ISCT’s global regulatory approach, which aligns diverse regulatory environments and provides effective coverage across regions. He highlighted rapid regulatory approvals in Asia, driven by high educational standards and a fast pace. Additionally, the rising emphasis on immuno-oncology and the expansion of clinical trials bridging Europe and the USA reflect a broader trend toward innovative and targeted treatments. Forte noted the field’s shift towards engineering cells to perform specific functions using advanced gene editing and processing technologies, emphasizing the need to adapt practices to meet new challenges and opportunities.

Looking ahead, Forte pointed out that Taiwan’s favorable regulatory environment enhances the likelihood of therapy approvals, supporting new innovations. He called for collaborative efforts to advance scientific knowledge and improve efficiency, mentioning ongoing reforms in European health technology legislation. Forte compared gene therapies to transplants, emphasizing their transformative potential and the importance of risk-sharing strategies to manage healthcare costs. As the field matures, advancements in cell editing and engineering, including epigenetic modifications and large-scale gene therapy, will drive further innovation. These developments promise new breakthroughs and underscore the necessity of continued investment and cooperation.

Hiroto Bando on Minaris’ Global Impact as a CDMO in the CGT Industry

Following, Hiroto Bando, CEO of Minaris Regenerative Medicine, outlined the opportunities and challenges in the CGT field, emphasizing the company’s latest product approval and the associated regulatory hurdles. Specifically, he noted that regulatory barriers impede the overseas expansion of regenerative medical products. During the European Medicines Agency (EMA) review of Advanced Therapy Medicinal Products (ATMPs), the review often involves numerous comments on Chemistry, Manufacturing, and Controls (CMC), addressing aspects such as chemical composition and quality control. These stringent requirements can cause significant delays for companies trying to enter international markets. Therefore, navigating these regulations remains a major challenge. He called for collaboration to address these challenges and highlighted Taiwan as a promising area for expansion, noting its potential in navigating current regulatory trends.

Minaris operates globally with facilities in Germany, the USA, and Japan, showcasing expertise in allogeneic and autologous settings, as well as native and genetically modified cells. The company’s high-quality products, including iPSC types, reflect its capabilities as a CDMO. Bando highlighted that “Minaris” combines “mirai” (future) and “miracles,” symbolizing the company’s mission to push medical boundaries. With over 25 years in the industry, Minaris has a strong US presence on both coasts, plus robust operations near Munich and Yokohama.

He emphasized the importance of choosing the right CDMO for specific needs. Minaris is committed to effective and safe new modalities. Bando expressed confidence in their ability to support the Taiwan market and beyond. Moreover, their Mountain View, California site offers convenient access for Asian countries. Ultimately, Bando encouraged potential collaborators to utilize Minaris’s resources to tackle challenges and advance in the US market.

Dr. Hiroto Bando, CEO of Minaris (left) and Dr. Miguel Forte, ISCT President, presented on the the international development of CGT products, examining regulatory challenges and CDMO related directions.

Startup Showcase Featured Innovative Biotech Companies

The event concluded with a startup showcase featuring 12 emerging companies and their novel technologies. Specifically, Pilatus Biosciences focuses on metabolic checkpoints for cancer immunotherapy. Pulxion Medical Technology offers PulStroke, a rapid screening solution for stroke risk assessment. TOKIWA-Bio develops stealth RNA vector (SRV) for improved cell programming. MediDiamond is pioneering immune cell therapy to reduce culture time and enhance activation. Auspex utilizes AI to personalize cancer treatment, particularly for lung cancer. Taiwan Universe BioMedicine Inc. innovates cost-effective vaccines using reverse genetics. BioPhenoMA specializes in detecting ultra-trace proteins with their patented technology, TN-cyclon™. TFBS Bioscience, Inc. provides comprehensive testing and manufacturing services for cell and gene therapy. HISHIH BioPharma is advancing SLIT therapy for allergies, aiming to shorten treatment duration. Advagene Biopharma is developing AD 17002 to induce IFN-1 with minimal adverse events. Maria von Biotech uses skin-derived stem cells to address hearing loss.

Author

Bernice Lottering