ImmunityBio, a prominent biotechnology company, has made significant strides in cancer and immune-related therapies with its groundbreaking development of ANKTIVA® and CAR-NK (PD-L1 t-haNK). On February 27, 2025, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for these two promising treatments. This designation is pivotal for ImmunityBio, as it accelerates the development and approval process for ANKTIVA and CAR-NK in addressing lymphopenia caused by standard-of-care chemotherapy and radiotherapy, as well as in the treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. [Read more…]
New Frontiers in Gene-Editing and Stem Cell Innovation – Interview with Dr. Chen-Tsai of Applied StemCell
I had the honor of interviewing Dr. Ruby Yanru Chen-Tsai, Chief Scientific Officer and Co-founder of Applied StemCell Inc. (ASC), a fast growing biotechnology company in Milpitas, California. Specializing in gene-editing technologies and stem cell innovation, ASC offers an optimized series of tools for basic research study, drug discovery, bio-processing, bio-production and preclinical applications.
In this fascinating interview, we discuss Dr. Yanru Chen-Tsai’s impressive background, ASC’s unique product portfolio, its TARGATT™ gene editing technology, and the company’s future trajectory. [Read more…]
Cook MyoSite Announces Completion of Enrollment for the CELLEBRATE Study
Pittsburgh, Pa., February 12, 2025 — Cook MyoSite today announced the completion of enrollment of the CELLEBRATE Study, a Phase III clinical trial evaluating the efficacy and safety of iltamiocel compared to a placebo in the reduction of stress incontinence episode frequency in adult female participants with persistent or recurrent stress urinary incontinence (SUI) despite previous surgical treatment. This milestone builds upon the significance of iltamiocel receiving the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) which recognized the seriousness of this unmet need. [Read more…]
NecstGen Partners with Galapagos to Advance Decentralised CAR-T Cell Manufacturing in Europe
Leiden, Netherlands, 10th February 2025 – NecstGen, a leading Contract Development and Manufacturing Organization (CDMO) dedicated to Cell and Gene Therapies, is proud to announce a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in Europe and the U.S. to support decentralized manufacturing of Galapagos’ candidate cell therapy products. The partnership underscores both NecstGen’s and Galapagos’ commitment to advancing innovative therapies and bridging the gap between the translation of research, to large clinical trials, and bring products to patients. [Read more…]
Have We Reached the Age of Advanced Therapies?
In the past few years, there has been a spurt in clinical development of advanced therapies, including cell therapies, gene therapies and tissue engineering products. Several cell-based medicinal products have been approved in the U.S., Europe, China, Japan, South Korea, India, Canada, Australia and New Zealand. A number of start-up companies, hospitals, universities, and large biotech and pharma companies have started testing hundreds of cell-based product candidates in clinical studies.
With a visible acceleration in development, the advanced therapy field has evolved from a curiosity to a vibrant arena for competition. [Read more…]
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