gene therapy

Oxford Biomedica and Homology Medicines last week launched a U.S.-based adeno-associated virus (AAV) CDMO offering clients “innovative manufacturing expertise” in AAV and lentiviral-based cell and gene therapies, according to a joint press release. Under the deal, Oxford Biomedica will pay Massachusetts-based Homology $130 million upfront and pump $50 million more into the joint entity—dubbed Oxford Biomedica Solutions—in exchange for an 80% stake.

In other CDMO news, Fujifilm Diosynth…

The wave of CDMO capacity expansions continued into the new year with contract manufacturer ZhenGe Biotech raising $100 million in series C funding to build “multiple” 15,000-liter production lines, according to its press release last week.

Founded in 2017, the Shanghai-based company—which also has facilities in Maryland—claims expertise in monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins and vaccines. The new round brings its total financing to $225…

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Sanofi is backing out of a collaboration with Sangamo Therapeutics to develop a gene-edited sickle cell disease therapy, California-based Sangamo announced last week.

The news came weeks after Sangamo touted favorable proof-of-concept data on SAR445136 from a Phase 1/2 trial. In the press release, Sanofi’s R&D chief attributed the move to a strategic focus on “universal genomic medicine approaches.” But BioPharma Dive noted that Sangamo’s product is “far behind” a rival gene…

Bluebird Bio’s gene therapy for sickle cell disease led to complete resolution of severe vaso-occlusive events and reduced hemolysis in a Phase 1/2 study, the Massachusetts company announced Sunday.

Bluebird presented the data on lovo-cel (formerly LentiGlobin) at the 63rd American Society of Hematology Annual Meeting (ASH) and in the New England Journal of Medicine. The company noted that cases of acute myeloid leukemia in two people treated with the therapy were “unlikely related,”…

Reportedly flush with Covid-19 vaccine revenues, Pfizer will shell out approximately $6.7 billion in cash to buy San Diego-based Arena Pharmaceuticals, the companies announced Monday. The acquisition will boost Pfizer’s Inflammation and Immunology program, the press release said.

Pfizer will also invest $68.5 million to build a gene therapy manufacturing facility in North Carolina, the New York-headquartered company announced Wednesday.

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Ten pharma companies have joined a U.S. FDA and U.S. National Institutes of Health initiative to streamline the gene therapy development process for rare diseases.

Armed with $76 million from the NIH and private partners, the Bespoke Gene Therapy Consortium will pursue a standardized therapeutic development model based on the adeno-associated virus (AAV) vector. The initiative will support four to six clinical trials, each focused on a different rare disease, according to an FDA press…

Catalent is investing an additional $230 million to expand viral vector manufacturing capacity at its Maryland gene therapy campus, the company announced Tuesday. The U.S. CDMO already pumped $130 million into the plant last year for Covid-19 vaccine production.

CDMOs have been expanding globally to keep up with demand for their products.

Fujifilm announced Tuesday it is putting approximately $850 million in cash into its CDMO arm, Fujifilm Diosynth Biotechnologies, to boost biologics capacity in Britain and the United States—joining a multibillion-dollar CDMO investment spree among companies worldwide.

In the U.S., the investment will double cell culture production for recombinant vaccines. Across the Atlantic, the money will triple cell culture capacity (and will include cGMP capacity for continuous manufacturing),…

Boston-based Vertex Pharmaceuticals and Swiss biotech CRISPR Therapeutics announced a significant amendment on Tuesday to their collaboration on a potential sickle cell disease (SCD) cure.

Vertex will pay CRISPR $900 million upfront (plus up to $200 million in milestones) to expand its interest in CTX001, an investigational CRISPR/Cas9-based gene editing therapy that the companies say may provide a cure to both SCD and transfusion-dependent beta-thalassemia (TDT).

In other gene…

Novartis announced Wednesday a collaboration with the Gates Foundation to develop an accessible in vivo gene therapy for sickle cell disease (SCD) that could potentially be administered once, directly to a patient, without the need to modify the cells in a lab. The collaboration aims to provide affordable and practical gene therapy for low-resource settings, the press release said.

In other SCD news, Massachusetts-based Bluebird Bio announced Tuesday that it has temporarily suspended…