Professor YuChun Gu, Founder, Chief Scientist, and CEOAt the forefront of cell therapy is the groundbreaking induced pluripotent stem cell (iPSC) technology. iPSCs, derived from reprogrammed adult somatic cells like blood or skin cells, hold great potential due to their patient-specific nature, ease of accessibility, and absence of ethical quandaries. These attributes render iPSCs an attractive choice for cell-based therapeutic applications.
A notable leader in this domain is Allife Medicine, a trailblazer in China's burgeoning cellular therapeutics sector. The firm was founded through a collaborative effort of Chinese and UK scientists, with an emphasis on iPSC technology. It aims to develop cost-effective and universally adaptable cell and gene therapies. It has secured clinical approvals for iPSC-derived cellular drugs and chimeric antigen receptor natural killer (CAR-NK) cell therapy drugs. The firm is a pioneer in the domestic market, demonstrating its commitment to advancing regenerative medicine.
The regulatory environment in China is increasingly favorable for cellular therapies, with the worldwide market expected to reach an astounding growth. Allife Medicine is strategically positioned at the vanguard of this expansion, particularly in cellular therapy, gene therapy and tumor immunology.
“Our pioneering efforts in achieving industrial-scale production and clinical application of iPSCs underscore our strategic focus. We are proud to be the first in the country to achieve industrial-scale production and clinical translation of iPSC,” states Professor YuChun Gu, founder, Chief Scientist and CEO of Allife Medicine.
Allife Medicine has garnered widespread recognition and numerous accolades in the cell and gene therapy (CGT) sectors, both domestically and internationally. The company's innovative natural killer (NK) cell injection for ovarian cancer received clinical approval before the end of 2021. In May 2023, its endothelial progenitor cell injection for acute ischemic stroke commenced clinical trials at Tian Tan Hospital, Beijing. These developments, which have been approved by China's National Medical Products Administration (NMPA) represent significant strides in addressing previously unmet requirements in the country's medical landscape. By the end of 2023, Allife Medicine secured clinical approvals for ALF202, an endothelial progenitor cell for Peripheral Limb Ischemia.
Our Pioneering Efforts in Achieving Industrial-Scale Production and Clinical Application of iPSCs Underscore Our Strategic Focus
Allife Medicine stands at the forefront of iPSC innovation in therapeutics. It is distinguished by its unique development methodology that maximizes iPSC potential for both research and therapeutic applications.
An intricate process underscores the critical role it plays in the advancement of associated technologies.The process begins with collecting blood from healthy donors, from which somatic cells are isolated. These cells are then amplified in vitro and reprogrammed using plasmid transfection to create iPSC clones. iPSCs are expanded to form dedicated cell banks, allowing scalability and accessibility. These iPSCs are subsequently differentiated into various cell types that are tailored to specific therapeutic needs. The differentiated cells are cryopreserved. When needed, cells from the bank can be thawed and used.This streamlined process enables Allife Medicine to provide a consistent supply of iPSC-derived cells for research and therapeutic applications.
The iPSCs developed by Allife Medicine share the differentiation potential of embryonic stem cells that can transform into any human cell type or tissue. Their remarkable in vitro growth capabilities make them ideal for gene editing applications. The robust amplification capacity minimizes variability between batches and ensures quality control, enhancing their commercial and ethical viability.
The use of iPSC-derived cells in clinical applications has increased since Japan's inaugural clinical approval of iPSC-derived retinal pigment epithelial cells for the treatment of age-related macular degeneration in 2013. A significant breakthrough occurred in July 2020 when the United States granted the first investigational new drug (IND) for iPSC-derived CAR-T therapy. In April 2022, Allife Medicine secured approval from China's Drug Evaluation Center for their iPSC-derived endothelial progenitor cell (EPC) therapy for acute ischemic stroke. This was the first approval of its kind in China.
The company is constantly exploring groundbreaking pathways with an extensive pipeline in cellular therapy. This includes initiatives like islet transplantation for type I and type II diabetes, EPC therapy for acute ischemic stroke and Peripheral Limb Ischemia – already in clinical trials–and retinal pigment epithelium therapy for dry macular degeneration. Allife Medicine is also working on blood transfusion solutions. In tumor immunology, Allife Medicine focuses on four major pipelines, including CAR-NK therapy for ovarian cancer and TAPB-EIC therapy for prostate cancer. In gene therapy, six pipelines are under development for interventions for ailments like diabetic retinopathy and amyotrophic lateral sclerosis, with a focus on cell-delivered gene therapies for ophthalmic and rare diseases. The firm’s pipelines is bolstered by strategic partnerships with leading Chinese medical institutions, like Tian Tan Hospital, Beijing Cancer Hospital and Tongren Hospital.
Transforming Stroke Treatment with ALF201
Allife Medicine is developing ALF201, a product containing EPCs that are produced from iPSCs, as a novel treatment for acute ischemic stroke. In 2022, ALF201 received clinical default approval from the regulatory authorities of China and is currently in Phase-I clinical trials.
Endothelial progenitor cell therapy operates through key mechanisms, including the restoration of blood supply, prevention of neuronal damage, promotion of neurogenesis, and regulation of inflammation. These integral actions collectively contribute to the therapeutic efficacy of the treatment in addressing various aspects of acute ischemic stroke. EPCs can be cultivated under specific compositions and precise culture conditions, with a rapid differentiation cycle of only six days and an exceptional differentiation efficiency exceeding 99 percent. That efficiency paves the way for large-scale, standardized EPC production, opening doors to various clinical applications.
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We Will Persistently Drive the Development of iPSC Cell Therapies, Working Towards the Timely Commercialization of iPSC-Based Medications
In animal models, endothelial progenitor cells are administered through intravenous transplantation into a MACO experimental model with brain infarction. The results of these studies are encouraging. Administering diverse EPC doses at intervals of 24, 48, and 72 hours post-ischemic stroke is a crucial part of the therapeutic strategy. The high-dose acute therapy group exhibits a substantial decrease in the ischemic area and improvement in neurofunctional damage. EPCs can also completely restore vascular endothelium integrity and prevent intimal hyperplasia in a rat carotid artery balloon injury model.
ALF201 has shown considerable promise in the clinical trial phase. Administered intravenously to patients with acute ischemic stroke, it not only improves clinical outcomes; it extends the window for therapy. This is particularly relevant given that about 70 percent of acute ischemic stroke patients are ineligible for standard intravenous thrombolytic therapy. Traditional thrombolytic therapy is constrained by a limited time and a notable risk of bleeding complications. ALF201 emerges as a potentially transformative alternative in stroke care, offering new hope to a substantial patient demographic that is currently underserved by existing treatments.
From Innovation to Collaboration: Charting Growth in 2024
Allife Medicine uses a tripartite business model, establishing itself as a formidable force in the biotechnology sector. This structured model encompasses three core segments—supply and licensing of cell lines, independent research and development (R&D), and collaborative development combined with Contract Development and Manufacturing Organization (CDMO) services.
Renowned as a leading cell line supplier, Allife Medicine excels in providing iPSC-derived NK cell lines. Its clientele, comprising CAR-T cell therapy companies, significantly benefit from its strategic contributions that convert T-cell to NK-cell therapies. Allife Medicine is spearheading advancements in cellular therapy, independent research and commercialization.
"In addition to serving as a cell line supplier, our future commercialization approach involves advancing drug research, obtaining necessary approvals, and offering sales rights to major pharmaceutical entities post-approval," explains Gu.
The company's proficiency extends to its collaborative development and CDMO services, where it has established pivotal partnerships with antibody-drug corporations. These collaborations aim to develop products that improve the efficacy of combined antibody therapies, demonstrating Allife's commitment to innovation and cooperative research.
During the validation stage, 2019 and 2021, Allife Medical focused on preclinical research on peripheral blood-derived CAR-NK cells and iPSC-derived EPCs. This period culminated in the successful completion of an investigator-initiated trial, which resulted in the licensing of technology and the development of a profitable joint venture, generating substantial revenue.
The clinical translation phase, from 2022 to 2023, was a pivotal era in its growth trajectory. By the end of 2023, four products had reached the preclinical stage, with three acquiring IND approvals. A significant round of funding that resulted in several hundred million Yuan further cemented its stature in the industry.
As part of its short-term objectives for 2024, Allife Medicine intends to achieve critical milestones. These include completing Phase-II clinical trials for acute ischemic stroke and filing IND applications for two additional projects. The company also plans to relocate and inaugurate its new headquarters, laboratories and manufacturing facility in Beijing. Another round of financing is envisioned, which aligns with its strategy for continued growth and industry leadership.
Expert Team: Catalyst for Industry Success
Allife Medicine's remarkable success is attributable to its distinguished team. Its 190 employees include 140 dedicated R&D professionals, 42 of whom are PhD holders. Its R&D team comprises professionals from renowned institutions like Tsinghua University, Peking University, Cambridge University, and the Chinese Academy of Sciences.
This accomplished team has contributed significantly to the field, publishing over 80 papers and securing 104 patents. Their expertise extends to patents related to downstream differentiation of iPSCs and a comprehensive patent portfolio for CAR-NK technology.
Professor Gu leads this team, bringing a wealth of knowledge and experience to the organization. Holding a PhD from the University of Birmingham, he extended his expertise through post-doctoral research at Imperial College London and contributed as a fellow at the University of Cambridge. He is also the Honorary Consultant in GSK Cambridge Clinic Research Site. His commitment to healthcare developments is further evidenced in his roles as the honorary Director of Obstetrics and Gynecology at the University of Birmingham Hospital. He currently contributes to academic growth as a professor at the Institute of Molecular Medicine, Peking University.
Professor Tan, who has a PhD from the Chinese Academy of Sciences, a postdoctoral fellow at the University of Oxford and has conducted research at the University of Cambridge, as Senior Research Associate, is assisting him in bringing the company’s mission to life. He reviews experimental reports, addresses technical intricacies during experiments, and offers technical guidance to the team. His expertise enhances the technical foundation that is vital for the success of the firm’s endeavors.
Professor Ning, who has a Ph.D. from Aston University and a postdoctoral fellow at the University of Cambridge, is one of the pioneers in second-generation gene sequencing and a senior scientist at the Sanger Institute. He serves as Allife Medicine’s Chief Genetic Analysis Scientist and guides the team on genetic research directions.
Under the leadership of such revered experts, Allife Medicine has made remarkable strides in the clinical translation of its research. Its scientists push the boundaries of possibility in the medical field on a daily basis. Guided by a belief in making innovative medicines accessible to the public, Allife Medicine remains resolute in driving the development of iPSC cell therapies.
As Gu states, “Our commitment extends beyond scientific advancement. We will persistently drive the development of iPSC cell therapies, working towards the timely commercialization of iPSC-based medications.”
