Cell therapy weekly: unveiling a new cell expansion system
This week: PHC Corporation of North America (IL, USA) announced it will unveil a prototype of its LiCellGrow cell expansion system at Advanced Therapies Week (20-23 January 2025; Dallas, Texas), Aurion Biotech (WA, USA) released topline data from a Phase I/II trial of its allogeneic cell therapy for corneal edema and Indapta Therapeutics (WA and TX, USA) secured US$22.5 million in funding to advance its allogeneic natural killer cell therapy for cancer and autoimmune diseases.
The news highlights:
- LiCellGrow cell expansion system to be unveiled at Advanced Therapies Week
- Positive topline results from corneal edema cell therapy trial
- $22.5 million secured to advance natural killer cell therapy
LiCellGrow cell expansion system to be unveiled at Advanced Therapies Week
PHC Corporation of North America will debut a prototype of its LiCellGrow cell expansion system at Advanced Therapies Week 2025. The LiCellGrow system, currently in development, aims to revolutionize cell and gene therapy manufacturing by providing real-time insights into metabolic changes in cells. This innovation allows for automatic adjustments to the culture environment, optimizing conditions to enhance cell quality and growth. By streamlining production, the system hopes to expand access to cell and gene therapies, particularly for conditions such as cancers and hematologic disorders.
Traditional methods of cell quality assessment rely on manual sampling, which can reduce efficiency and increase costs. LiCellGrow addresses these challenges with its proprietary In-Line monitoring technology, which continuously measures key cell metabolism indicators, glucose and lactate, without manual intervention. The system automatically adjusts the culture medium, ensuring a stable and optimal environment while minimizing contamination risks.
Positive topline results from corneal edema cell therapy trial
Aurion Biotech has announced the topline data from its Phase I/II CLARA trial of AURN001, an allogeneic cell therapy aimed at treating corneal edema secondary to corneal endothelial dysfunction. AURN001 combines human corneal endothelial cells with a rho kinase inhibitor and is administered as a one-time procedure to the eye.
The trial, involving 97 subjects across the US and Canada, assessed the safety, tolerability and efficacy of various AURN001 doses. The primary endpoint, improvement in visual acuity, showed a dose-dependent response, with the high-dose group exhibiting a statistically significant improvement in best-corrected visual acuity compared to the control group. Key secondary endpoints, including changes in best-corrected visual acuity and central corneal thickness, also favored the high-dose arm. Patient-reported quality of life improved, particularly in the high-dose group.
“We are thrilled with the topline results of the CLARA trial,” said Michael Goldstein, president and chief medical officer of Aurion Biotech. “We were especially pleased that in the high-dose AURN001 arm at six months, there was a statistically significant improvement in the primary endpoint. Based on these findings, combined with the generally favorable safety profile in the CLARA trial, we look forward to bringing the high dose of AURN001 forward into our proposed Phase III pivotal trials.”
$22.5 million secured to advance natural killer cell therapy
Indapta Therapeutics has secured US$22.5 million in funding to advance its allogeneic natural killer cell therapy for cancer and autoimmune diseases. Investors in this round include RA Capital Management (MA, USA), Leaps by Bayer (Leverkusen, Germany), Vertex Ventures HC (CA, USA), Pontifax (Herzeliya, Israel) and the Myeloma Investment Fund (CT, USA).
Indapta’s CEO, Mark Frohlich, said, “This funding will enable us to generate significant additional data in our ongoing trial of IDP-023 in cancer as well as initial data from our first trial in autoimmune disease.”
The company has finished enrolling patients in the safety run-in phase of its Phase I trial of IDP-023 for non-Hodgkin lymphoma and multiple myeloma and the trial is now enrolling additional cohorts to receive IDP-023 in combination with monoclonal antibodies targeting CD20 or CD38.
In August, the FDA cleared the Investigational New Drug application for IDP-023 combined with ocrelizumab in progressive multiple sclerosis.
