Investigational immunotherapy


Clinical outcomes and immune responses in a Phase 1/2 study of personalized, neoantigen-directed immunotherapy in patients with advanced MSS-CRC, GEA and NSCLC

D.V. Catenacci, et al.


Neoantigen-directed prime/boost immunotherapy in combination with CPI is well-tolerated and generates strong and persistent T-cells to multiple neoantigens. Increases in T-cells correlate with a novel pattern of response and clinical benefit characterized by a transient spike then decline in ctDNA, tumor markers, and tumor size, notably in pts with MSS-CRC.



Safety, efficacy, immunogenicity of arenavirus-based vectors HB-201 and HB-202 in patients with HPV16+ cancers

M.R. Posner, et al.


Arenavirus-based vectors HB-201 and HB-201/HB-202 appeared well tolerated and showed preliminary anti-tumour activity as single agents in this heavily pretreated population of patients with HPV16+ cancers. Induction of circulating E7E6-specific activated CD8+ T-cells was observed.



A phase I clinical trial on intratumoral injection of autologous CD1c (BDCA-1)+/CD141 (BDCA-3)+ myeloid dendritic cells (myDC) in combination with talimogene laherparepvec (T-VEC) in patients with advanced pretreated melanoma

J.K. Schwarze, et al.


IT co-injection of CD1c (BDCA-1)+ +/- CD141 (BDCA-3)+ myDC plus T-VEC is feasible, tolerable, and resulted in encouraging early signs of durable antitumor activity in pts with ICI-refractory melanoma.



Naxitamab for the Treatment of Refractory/Relapsed High-Risk Neuroblastoma (HR NB): Updated Efficacy and Safety Data from the International, Multicenter Phase II Trial 201

J. Mora, et al.


Naxitamab provided a clinically meaningful response in patients with R/R HR NB with bone and/or BM disease only, with a manageable safety profile in the outpatient setting addressing a significant unmet medical need.



Entinostat, nivolumab and ipilimumab in advanced HER2-negative breast cancer (ETCTN-9844)

E.T. Roussos Torres, et al.


The combination of entinostat, nivolumab and ipilimumab at the RP2D was associated with expected (ir) AEs in advanced HER2-negative breast cancer. An ORR of 30% suggests this combination should be evaluated further. Correlative analyses from serial biospecimens pre- and post-therapy to evaluate the immune response and landscape will be presented.



GTB-3550 TriKE™ safely activates and delivers IL-15 to NK cells, but not T cells, in immune suppressed patients with advanced myeloid malignancies, a novel paradigm exportable to solid tumors expressing Her2 or B7H3

J.S. Miller, et al.


GTB-3550 TriKE given as a monotherapy safely induced a sustained functional expansion of endogenous NK cells with anti- tumor activity in advanced AML and MDS patients treated with at least 25 mcg/kg/day. Second generation solid tumor TriKE therapeutics against HER2 and B7H3 will be tested clinically next year.