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Takeda opens another manufacturing unit to expand its cell therapy product portfolio.

Takeda recently opened its 24,000 square-foot cell therapy manufacturing facility in Boston. The facility is expected to produce material through to Phase IIb trials. 

Back in 2019 alone, Takeda expanded its footprint in the cell therapy space by signing deals and establishing an internal translational cell therapy engine. 

The company has many oncology cell therapies in development, including the non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) allogeneic candidate TAK-007, which is currently in a Phase I/II study. Takeda also has several Phase I CAR-T programs, through separate partnerships with Memorial Sloan Kettering Cancer Center, Noile-Immune Biotech and others. 

(Source: BioProcess International, 2020)

Neogene Therapeutics becomes the second company to acquire a large number of investments in Europe. 

Neogene Therapeutics has become the second T-cell therapy developer to raise a large amount of Series A round in Europe this year. The Series A round was co-led by the VC firms EcoR1 Capital, Syncona, and Jeito Capital.

Neogene Therapeutics will use part of the acquired $109 million funds to advance its T-cell therapy immuno-oncology candidate into phase I clinical trials by 2022. The company will also use part of the funds to expand its offices in Europe and the United States. 

The company was founded in 2018 to develop T-cell therapies for a wide range of solid tumors. Neogene’s T-cell therapies generally resemble CAR T-cell therapies, in that the company takes immune T cells from a cancer patient and genetically engineers them to kill cancer cells before returning them to the patient. 

(Source: Labiotech Europe, 2020)

Gensight Biologics seeks approval for its Lumevoq treatment for patients with vision loss caused by Leber Hereditary Optic Neuropathy.  

Gensight Biologics recently submitted a marketing authorization application for its lead gene therapy Lumevoq to the European Medicines Agency (EMA). They hope to obtain approval for Lumevoq to treat patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON), caused by a mutation in the ND4 mitochondrial gene.

The company applied after seeing the results from the Phase I/IIa study and two Phase III efficacy studies, as well as long-term studies of the treatment. 

In the CLIN06 study, after two years post-treatment, patients experienced an average gain of +18.8 letters equivalent relative to the low point of their visual acuity in their Lumevoq treated eyes, compared to +17.3 letters equivalent in their treated eyes.

Three years after the one-time injection, the bilateral benefit was maintained with Lumevoq-treated eyes recording a mean improvement against patients’ equivalent relative to the low point of their visual acuity of +20.5 letters.

(Source: Pharma Times, 2020)