This week: Astraveus SAS (Paris, France) announced plans to evaluate its novel platform for CAR-T manufacturing, while a new global contract development and manufacturing organization (CDMO) launched to address development and manufacturing challenges in the cell and gene industry. Plus, Aspen Neuroscience (CA, USA) is set to present encouraging 6-month data from its ongoing Parkinson’s disease trial of ANPD001 at the International Society of Cell and Gene Therapy (ISCT) 2025 annual meeting in New Orleans (LA, USA).

The news highlights:

• Partnership to deliver more accessible and affordable therapies
• Launch of a new cell development organization
• Encouraging Phase I/IIa data for Parkinson’s disease cell therapy

Partnership to deliver more accessible and affordable therapies

The Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen; Leiden, Netherlands) and Astraveus have collaborated to assess the Lakhesys Benchtop Cell Factory™ platform for use in CAR-T therapy manufacturing.

Developed by Astraveus, the novel platform is designed to reduce costs while increasing CAR-T manufacturing efficiency against current industry standards. In January 2025, Astraveus demonstrated the technology’s ability when it yielded the world’s first end-to-end production of CAR-T cells using a microfluidic benchtop system.

“Astraveus’ novel approach to the manufacturing of CAR-T cells represents a breakthrough technology with the ability to transform the industry by enabling the faster and cheaper development of these cutting-edge treatments,” explained NecstGen’s CEO, Paul Bilars.

Read more

Launch of a new cell development organization

At ISCT (7–10 May, 2025), Minaris Advanced Therapies™ (PA, USA), a CDMO and contract testing partner, officially launched with the mission to “solve the development and manufacturing challenges preventing these promising therapies from successful worldwide commercialization,” according to the company’s Chairman, Iain Baird.

Formed by two CDMOs, Minaris Regenerative Medicine (Tokyo, Japan), the US and UK operations of WuXi Advanced Therapies (PA, US), and the investment firm Altaris (NY, USA), Minaris Advanced Therapies is “built for speed, scale and science”.

“Minaris Advanced Therapies is designed to help the industry treat more patients by providing the experience, global footprint and platforms to accelerate timelines and enable commercialization,” explained Eytan Abraham, Chief Commercial and Technology Officer, Minaris Advanced Therapies.

The new company, with over 1,400 employees, features:

• Specialized experts across process development, manufacturing and regulatory compliance
• Modern facilities in Allendale, New Jersey, Philadelphia (all US), Munich (Germany) and Yokohama (Japan), all with state-of-the-art cleanrooms for commercial use
• Innovative platforms, enabling production of cell therapies, as well as scalable AAV and lentiviral vectors

“Many of the technologies needed to reduce [the] cost of goods sold and improve turnaround time already exist,” continued Abraham, “We will drive their adoption and implementation at scale.”

Read more

Encouraging Phase I/IIa data for Parkinson’s disease cell therapy

Aspen Neuroscience has reported Phase I/IIa data from its ongoing study, ASPIRO, assessing ANPD001. ANPD001 is an autologous dopaminergic neuronal precursor cell (DANPC)-based therapy for patients with moderate to advanced Parkinson’s disease, developed to replace damaged or lost dopaminergic neurons.

“In this first-of-its-kind study, we are seeing clinician-reported and patient-reported improvements as well as a strong safety and tolerability profile at 6 months. Importantly, ANPD001 has the unique advantage of not requiring immunosuppression,” commented Edward Wirth III, Chief Medical Officer of Aspen Neuroscience.

The 6-month data included three patients who received the therapy through a single surgical procedure. The data showed:

• An average of 45% improvement according to physician-reported scores
• An average of 72% improvement according to patient-reported scores
• No hemorrhages or serious complications during or after the surgical procedure
• No graft-induced dyskinesia — involuntary movement disorders — often seen in patients with Parkinson’s disease
• Reports of incision pain and tongue swelling, the latter related to being laid face down during surgery

The data was published in the Parkinsonism and Related Disorders Journal and will be presented at the 30th World Congress on Parkinson’s Disease and Related Disorders (7–10 May, 2025; NY, USA) and at ISCT 2025.

Read more

FDA-approved cell and gene therapies

This overview examines the cell and gene therapies that are currently FDA-approved, offering new possibilities for patients worldwide.