Cell therapy weekly: Affini-T secures US$175 million to accelerate innovative T cell therapy for solid tumor cancers

Written by Sarah Rehman

This week: Affini-T secures US$175 million to accelerate innovative T cell therapy for solid tumor cancers, ATMP clinical trials database report reveals the UK as a leader in advanced clinical research, Pluristem reveal positive results from its innovative hematology Phase I study and Fujifilm acquires Shenandoah Biotechnology to streamline therapies from preclinical to clinical phases.

The news highlights:


Affini-T secures US$175 million to accelerate innovative T cell therapy for solid tumor cancers

Affini-T Therapeutics (MA, USA), a start-up biotechnology company spun out of the Fred Hutchinson Cancer Research Center (WA, USA), has recently secured US$175 million in financing, co-led by Vida Ventures (MA, USA) and Leaps by Bayer (Berlin, Germany). With 57 employees across two labs in Seattle and Boston, the company has its efforts set on developing medicines for patients with solid tumor cancers. The funding will be funneled into operationalizing the company’s platform discovery engine and accelerating multiple programs into the clinic.

The platform aims to manipulate T cells to recognize cancer cells, much like CAR-T therapy. Affini-T differentiates itself through the ability to make these cells last longer in the patient’s body, with increased anti-tumor response through the addition of CD8 to cells.

“Our differentiated platform combines highly active TCRs with unique synthetic biology, allowing us to pioneer novel therapeutic approaches intended to eradicate solid tumors. With proven management, an unparalleled founding team of scientific innovators and leaders in immunology and cellular engineering, we look forward to bringing life-changing medicines to patients in need,” commented Jak Knowles, MD, co-founder, president and chief executive officer of Affini-T.

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ATMP clinical trials database report reveals the UK as a leader in advanced clinical research

The 2021 Advanced Therapy Medicinal Product (ATMP) clinical trials database and report, published by Cell and Gene Therapy Catapult (London, UK), has shown a continued growth in the number of ATMP clinical trials conducted across the UK. The report reveals that there was a total of 168 ATMP clinical trials last year, a 9% increase of trials from the previous year. Further, there was a 32% increase of translation into first-in-human trials, a promising sign for the success of these ATMPs.

These results consolidate the UK’s position as a leader in the field of advanced clinical research, representing 9% of all global ATMP trials. “The rising and sustained commercial investment in UK ATMP clinical trials showcases the incredible strength and dynamism of the UK ATMP industry, driven in part by the dedicated ATTC network. It is clear that the recognition of the UK’s world leading clinical space for ATMPs is continuing to grow internationally, attracting investment in trials. This is a testament to the ongoing support of the UK Government and the industry,” remarked Matthew Durdy, CEO of Cell and Gene Therapy Catapult.

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Pluristem reveal positive results from its innovative hematology Phase I study

Pluristem Therapeutics Inc. (Haifa, Israel), a regenerative medicine company developing novel cell therapies, has recently announced its positive results from its hematology Phase I study. The study aims to evaluate the safety and efficacy of intramuscular injections of PLX-R18 in patients with incomplete recovery following hematopoietic cell transplantation. Incomplete recovery or poor graft function is life-threatening, therefore there is significance in solving this unmet medical need.

The 12 months of post-treatment data reveal that PLX-R18 has a meaningful advantage over other existing treatments, reducing mortality from 29% to 18%. As a result, the treatment has been granted Orphan Drug Designation by the FDA.

“A quick and effective way to improve the hematological profile of sick patients—resulting in faster recovery and decreased transfusions—would be a game-changer for the field, and we will continue to explore its clinical applications. The FDA’s recognition of PLX-R18’s potential to treat ARS is also significant,” noted Yaky Yanay, chief executive officer of Pluristem. “This treatment potentially carries great significance for current events in Ukraine and Europe, providing hope for treatment in the case of a nuclear event. We are proud of this product line, which might hold the key to promoting wellbeing, improving the standard of care, and possibly saving lives,” they continued.

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Fujifilm acquires Shenandoah Biotechnology to streamline therapies from preclinical to clinical phases

FUJIFILM Irvine Scientific (CA, USA), a global life sciences and medical media provider, has announced that it will acquire Shenandoah Biotechnology Inc. (PA, USA), a manufacturer of cytokines and growth factors. The news comes after Shenandoah’s recent launch of CTG™, their own GMP-grade cytokines. Combining FUJIFILM’s experience in manufacturing ancillary materials for cell and gene therapy and Shenandoah’s high quality recombinant proteins, the two companies together have the ability to seamlessly transition therapies from preclinical to clinical phases.

“The acquisition of Shenandoah Biotechnology marks an important milestone for us to establish a leading position as a partner for pharmaceutical customers in the rapidly-growing market of advanced therapy. Fujifilm will, by maximizing our group synergy, continue to expand Life Sciences Business while contributing to the creation of new therapies that fulfill unmet medical needs,” stated Teiichi Goto, president and chief executive officer, representative director of FUJIFILM Corporation.

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