Five years after the first autologous CAR T cell therapy was approved, an off-the-shelf allogeneic CAR T program, ALLO-501A, is moving into a Phase 2 that Allogene Therapeutics expects to support regulatory approval in the US.
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Allogene’s ALLO-501A advances into potentially pivotal trial
CLINICAL AND REGULATORY
Allogene’s allogeneic CAR-T advances to potentially pivotal trial
ALPHA2 is a single-arm study testing the CD19-directed CAR T therapy in relapsed/refractory large B-cell lymphoma (LBCL) patients. The primary endpoint is ORR. In prior trials, ALLO-501A showed slightly lower overall ORR than autologous CAR T cells in LBCL.
Instil pauses its tumor infiltrating lymphocyte clinical trials
A voluntary pause of dosing in trials of tumor infiltrating lymphocyte therapies ITIL-168 and ITIL-306 from Instil Bio highlights the continued challenges of efficient personalized cell therapy manufacturing. The company said a decrease in the rate of successful manufacturing resulting in the inability to dose some patients led the company to pause enrollment in trials of both of its clinical candidates as it completes an analysis of its manufacturing processes. No unexpected safety issues were identified in the patients who did receive ITIL-168 in the Phase 2/3 DELTA-1 melanoma trial.
Atara’s allogeneic T cell therapy gets CHMP nod for ultra rare indication
In October’s review meeting, EMA’s CHMP recommended approval of Atara’s allogeneic T cell therapy Ebvallo to treat patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease who have received at least one prior therapy. An approval would be the first ever for allogeneic T cell therapy. The opinion was based on results from Phase 3 ALLELE study, in which Ebvallo showed a 50% objective response rate, a median time to response of 1.1 months and median overall survival of 18.4 months. The indication is an ultra-rare cancer with no approved treatments.
DEALS AND FINANCING
BMS gains CAR T safety switch through Autolus deal
Autolus Therapeutics entered into an agreement with BMS to incorporate Autolus’ proprietary RQR8 safety switch into an initial set of selected cell therapy programs on a target-by-target basis for the treatment of cancer, with an option for Bristol Myers Squibb to incorporate the RQR8 safety switch in additional cell therapy programs beyond the initial set of selected programs. Autolus’ proprietary RQR8 switch works by administration with the widely available and approved pharmaceutical antibody, rituximab. Once administered, rituximab binds to the engineered CD20 epitopes on the surface of the cell therapy and triggers selective cell death. Autolus will receive an upfront payment for access to the RQR8 safety switch for the initial set of cell therapy programs with the potential for near term option exercise fees and development milestone payments. In addition, Autolus would be entitled to receive royalties on net sales of all BMS cell therapy products that incorporate the RQR8 safety switch.
Kite teams up with Refuge on next-generation CAR T cells
Pioneering CAR T cell company Kite Pharma is moving one step further into next-generation cell designs through a partnership with Refuge Biotechnologies to access its synthetic biology platform. Kite, a Gilead subsidiary, now has exclusive rights to Refuge’s technology to create immune cell therapies for hematological malignancies, while Refuge retains rights for all solid tumor indications. With the technology, expression of immunostimulatory or immunosuppressive genes can be turned on or off in the presence of specific tumor antigens to drive increased antitumor immunity and decreased cell exhaustion.
GSK exits clinical oncology cell therapies with NY-ESO-1 drops
More programs fall from GSK’s struggling cancer pipeline as the pharma terminates at least three TCR cell therapy programs against NY-ESO-1 and ends its deal with Lyell. The moves take GSK out of the clinical oncology cell therapy arena completely, and serve another blow to cell therapy development for solid tumors. Lyell Immunopharma disclosed that GSK is terminating a 2019 collaboration to develop genetically and epigenetically modified T cell therapies for cancer. It’s also discontinuing development of a pair of preclinical and an early clinical TCR T cell therapies targeting NY-ESO-1 that incorporate Lyell’s reprogramming technology. GSK’s other TCR cell therapy partner Adaptimmune Therapeutics announced that pharma was returning rights to its most advanced NY-ESO-1 targeting cell therapy, letetresgene autoleucel (lete-cel), and a preclinical TCR candidate against PRAME. The companies first signed a collaboration and licensing deal in 2014, which Adaptimmune expects GSK to terminate following the program transfer.
