Porton Advanced and Ascist Biotech Partner to Advance IND Submission in China for Adult Pancreatic Progenitor Cell Therapy for Diabetes

Key Points

• Porton Advanced and Ascist Biotech are partnering to advance an IND submission in China for an autologous adult pancreatic progenitor cell therapy targeting diabetes.
• In an investigator-initiated trial, the first subject remained insulin-free for nine months after transplantation, and all three treated patients showed fasting C-peptide levels returning to the normal range.
• Porton Advanced will provide process development, GMP manufacturing, and IND submission support for the cell therapy.

Porton Advanced, a CDMO specializing in cell and gene therapy, and Ascist Biotech announced a strategic partnership to advance the IND submission in China for an adult pancreatic progenitor cell therapy targeting diabetes. Under the agreement, Porton Advanced will provide process development, GMP manufacturing, and IND submission support for the cell therapy product.

According to the International Diabetes Federation, approximately 537 million adults worldwide are living with diabetes, with over 90% having type 2 diabetes. As the disease progresses, many patients eventually require insulin therapy, facing risks of hypoglycemia and cardiovascular complications.

Ascist Biotech focuses on the research and clinical translation of autologous adult stem cell therapies. The investigator-initiated trial of “autologous transplantation of islets derived from adult pancreatic progenitor cells for the treatment of diabetes” has reported encouraging preliminary results: the world’s first subject completely discontinued insulin within weeks after transplantation and has remained insulin-free for nine months post-surgery, achieving excellent glycemic control (TIR >95%) with continuous improvement in islet function. All three patients infused to date have shown fasting C-peptide levels returning to the normal range.

The therapeutic approach utilizes adult pancreatic progenitor cells as the cell source. Autologous (sourced from the patient) cells are obtained through minimally invasive endoscopic procedures, expanded and differentiated in vitro into insulin-secreting islet cells, and then re-infused into the patient. Because the cells are autologous, patients do not require immunosuppressive therapy. The manufacturing cycle is approximately two months, substantially shorter than current pluripotent stem cell-based technologies. The companies reported that preclinical animal studies and preliminary clinical results have identified no tumorigenic risk associated with the transplanted cell clusters.

CDMO Capabilities

Porton Advanced has established CDMO capabilities covering mainstream cell therapy modalities, including CAR-T, TCR-T, UCAR-T, NK, CAR-NK, MSC, TIL, and iPSC, providing process development, GMP manufacturing, and IND submission support. The company has supported 27 innovative therapies in obtaining clinical trial approvals globally, with over 30 Single Patient IND projects and 14 Phase I/II or commercial-stage process change projects ongoing.

The company has established a full lifecycle quality management system compliant with NMPA, FDA, and EMA standards and has been granted a Drug Manufacturing License (Class C), qualifying it to undertake commercial contract manufacturing of cell and gene therapy products.

Andrew Chen, CEO of Porton Advanced, said: “We are delighted to enter into this strategic partnership with Ascist Biotech. The encouraging exploratory clinical breakthrough in adult pancreatic progenitor cell therapy for diabetes is truly exciting, and accelerating the IND submission for this therapy is our shared goal. With our established cell therapy CDMO platform and full-lifecycle quality system, Porton Advanced is well positioned to help advance this innovative therapy and bring better medicines to diabetes patients sooner.”

Lijian Song, CEO of Ascist Biotech, said: “Porton Advanced has extensive project experience in the cell therapy CDMO field. This collaboration will strongly advance the clinical translation of our adult pancreatic progenitor cell program. We look forward to working together to bring an immunosuppression-free, more accessible autologous cell therapy to diabetes patients worldwide.”

About Ascist Biotech

Hangzhou Ascist Biotech Co., Ltd. focuses on the R&D and clinical translation of autologous adult stem cell therapies, addressing major health challenges in organ repair, chronic diseases, and immune system disorders. Leveraging its proprietary technology platform, AS-H-Clone, the company has established capabilities for the efficient isolation, purification, and expansion of healthy autologous adult stem cells from multiple organs.

About Porton Advanced

Porton Advanced Solutions is a subsidiary of Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. Its services span from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, investigator-initiated clinical trial services, and IND applications to clinical trials, NDAs, and commercialization. The company has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors, cell therapy CMC services, bacterial vector and nucleic acid therapies.

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