HETANG Ventures Invests in Rekind Medicine to Advance iPSC-Based Cell Therapies for Neurodegenerative Diseases

According to the latest report from BCC Research, the global iPSC therapy market size is projected to reach $5.2 billion by 2028, with the Asia-Pacific region leading at a compound annual growth rate (CAGR) of 10.4%. Behind the expanding market scale lies the immense therapeutic potential demonstrated by iPSC-based cell drugs.

Taking iRegene's self-developed NouvNeu001 as an example, as a therapeutic drug for Parkinson's disease, an irreversible condition, NouvNeu001 achieves high-purity neuronal subtype differentiation through compound modulation. It forms connections with the body's original neurons and enhances cellular secretion functions, further strengthening the improvement of the original lesion by the transplanted cells to achieve comprehensive therapeutic effects. This truly "reverses" the progression of Parkinson’s disease and has the potential to revolutionize current clinical treatment methods.

As early as August 2023, NouvNeu001 was approved by the National Medical Products Administration (NMPA) to carry out combined Phase I-II clinical research, becoming the world's first chemically induced, off-the-shelf cell therapy to enter the clinical stage in the Parkinson's disease field.

In November 2024, the Phase I clinical trial of NouvNeu001 for mid-to-late stage Parkinson's disease has completed the enrollment of all subjects. Clinical results show that the subjects have good safety and generally exhibit significant improvements in motor function and quality of life. Especially in the low-dose group, the longest follow-up time for subjects has exceeded 60 weeks, and the behavioral improvement effects in patients are still stably ongoing.

"Some patients who were in an extremely severe condition and required family care for mobility at the time of enrollment could move independently after four weeks of treatment, and their walking ability became very stable after six months of treatment, greatly improving their quality of life." Dr. Wei Jun, founder and CEO of iRegene, pointed out that this might indicate the high feasibility of universal cell transplantation for treating Parkinson's disease, and the transplanted cells can function effectively in the patient’s body over the long term.

Guo Kai, Managing Director of Hetang Ventures, pointed out that the current drug strategy of transplanting dopamine precursor cells for the treatment of Parkinson's disease already has a clear biological mechanism and has recently been supported by preliminary clinical efficacy data. It is expected to become the first therapy capable of significantly delaying disease progression. The core product of iRegene, NouvNeu001, is the world’s first clinical-stage iPSC-derived dopamine precursor cell therapy. It demonstrates significant advantages in terms of clinical progress, clinical efficacy, and production costs.

It is reported that the Phase II clinical trial of NouvNeu001 will soon be officially launched in the near future. Overseas, in June 2024, the U.S. Food and Drug Administration (FDA) also formally approved the IND application for NouvNeu001, officially achieving "dual filing and dual approval" of IND in both China and the United States. The related Phase I clinical trial in the U.S. is also planned to commence in the first half of this year. The overall clinical progress in both China and the U.S. is significantly ahead of global competitors.

Similarly, in the field of Parkinson's disease, as the onset of such diseases becomes increasingly younger, iRegene has launched its self-developed product NouvNeu003 for early-onset Parkinson’s, achieving full lifecycle and full treatment cycle coverage for both elderly and early-onset Parkinson’s patient populations.

As early as December 2023, NouvNeu003 had received NMPA approval to officially enter Phase I clinical trials, adding another "first" for iRegene — the world's first iPSC-derived off-the-shelf cell therapy product to enter the registered clinical stage for early-onset Parkinson's disease.

Currently, NouvNeu003 has also completed the enrollment of all subjects in Phase I clinical trials, maintaining the same pace as the clinical progress of NouvNeu001. The clinical trial has also shown that subjects tolerated NouvNeu003 well and has preliminarily revealed specific cellular treatment patterns for early-onset Parkinson's disease, laying the foundation for subsequent confirmatory clinical studies.

Moreover, in other potential fields of iPSC-based cellular drugs, iRegene's breakthrough ophthalmic product NouvSight001 was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. This product targets the treatment of "retinitis pigmentosa-related indications" and represents the first off-the-shelf, iPSC-derived ophthalmic cell therapy developed by iRegene.

Overall, iRegene has become the leading enterprise in the international pluripotent stem cell field with the most regulatory approvals, the fastest pipeline progress, and the largest number of treated patients. Its unique "chemical induction" cell function remodeling platform has further demonstrated its distinct advantages in the clinical stage.

Dr. Wei Jun stated that iRegene has always adhered to the principle of "starting from the needs of patients and addressing real clinical demands," using "original innovation" to develop entirely new therapies that can truly reverse disease progression for patients. "This round of financing will further solidify the foundation for iRegene to accelerate clinical progress, and the team will undoubtedly continue its efforts to bring new therapies to a wide range of patients. Additionally, the completion of this financing will also provide support for iRegene to further expand into the international market."

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The content of this article is reproduced fromCell and Gene Therapy FieldOfficial Account

About Hetang Ventures

Hetang VenturesReorganized and established in 2014 under the strategic backdrop of promoting the transformation of scientific and technological achievements at Tsinghua University, Hotang Ventures is a professional investment management institution primarily focused on early-stage investments in science and technology innovation enterprises. Hotang Ventures concentrates on key fields such as life sciences, medical devices, information technology, and modern manufacturing. It has long been dedicated to investing in innovative enterprises with core hard technologies, while also specializing in incubating investments based on scientific and technological achievements from universities and top-tier hospital clinical experts. Currently managing nearly 4 billion yuan in funds, Hotang Ventures has invested in over 90 projects, supporting scientists and entrepreneurs with significant research discoveries and technological innovations in realizing "commercial transformation from 0 to 1." At the same time, it consistently adheres to selecting high-barrier “first-of-its-kind technologies” for early-stage investment. With outstanding performance, Hotang Ventures has received honors such as being ranked in the "Top 50 Early-Stage Investment Institutions in China" by The Financing and the "Top 50 Best Early-Stage Venture Capital Institutions in China" by CVSource.