Despite it being only two months since our last review of the CAR-T world, the scientific and commercial developments have continued unabated. As previously we have selected some highlights below:
In March 2018, Orgenesis, a contract development and manufacturing service provider for advanced cell therapies was listed on the NASDAQ. Orgenesis has established partnerships with companies such as Servier, CRISPR Therapeutics, Adaptimmune Therapeutics and Athersys and is enjoying rapidly growing revenues. In April 2018, Cell and Gene Therapy Catapult, a centre of excellence seeking to make the UK a leading nation in cell and gene therapy, opened their manufacturing centre in Stevenage. The centre aims to support the transition from early stage research to viable therapies by offering companies a flexible site for the development of large scale manufacturing and opportunities for collaboration. As highlighted in our article last month, these are further examples of the developing CAR-T side industries in manufacturing and other ancillary activities.
Also in April 2018, Allogene Therapeutics, a new biotech company co-founded and led by former executives of Kite Pharma, launched with Series A financing of $300 million from an investment consortium including Pfizer, Gilead and the University of California amongst others. Allogene will focus exclusively (as the name suggests) on allogenic (i.e. off the shelf) CAR-T therapies. In April 2018, Pfizer transferred to Allogene its rights in CAR-T clinical candidate UCART19, together with 16 pre-clinical CAR-T assets. UCART19, is exemplary of the commercial moves that abound in the CAR-T space; originally developed by Cellectis, then by Servier, and then developed further in collaboration with Pfizer. Cellectis itself, also in April 2018, took advantage of favourable market conditions to raise an additional $164 million in a follow-on offering on the NASDAQ.
On the scientific front, Celyad’s CAR-T therapy, CYAD-01, which contains autologous T cells transduced with a CAR based on the NKG2D receptor, reported on 3 May 2018 the successful treatment of single patients in its LINK and SHRINK trials and with no toxicity observed to date – the LINK trial is also without the need for initial chemotherapy treatment. LINK and SHRINK are Phase I trials in colorectal cancer patients with unresectable liver metastases. The same therapy is also under investigation in acute myeloid leukemia (THINK trial) in which positive results have already been reported. Celyad currently has a dual listing on the Euronext and NASDAQ and an existing relationship with Ono Pharmaceuticals in relation to this therapy. Celyad has also granted a non-exclusive licence to Novartis for Celyad’s US patent relating to the production of allogenic CAR-T cells. The licence covers two targets currently under development by Novartis, under which Novartis makes an upfront payment, further target-based milestone payments and single-digit royalties if the therapy for either target makes it to market.