On June 3, 2021 Geneos Therapeutics, a clinical stage company focused on the development of tumor neoantigen targeted personalized immunotherapies for cancer, reported that positive preliminary results of its ongoing first-in-human trial (Press release, Geneos Therapeutics, JUN 3, 2021, View Source [SID1234583490]). GT-30 is a phase I/II trial of personalized vaccine, GNOS-PV02, in combination with plasmid pIL-12 and pembrolizumab in patients in second line advanced hepatocellular carcinoma (HCC).

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As of May 13, 2021, 12 patients had initiated treatment in the GT-30 trial and received at least 1 dose of their combination therapy. The treatment was generally safe and well tolerated with no treatment related serious adverse events noted on the trial. Ten patients had reached at least the first on-treatment imaging timepoint of 9 weeks to enable evaluation of objective response by RECIST 1.1. The best overall response by the data cut-off date consisted of 3 patients achieving a partial clinical response (PR); 4 patients demonstrated stable disease (SD); and 3 patients had progressive disease (PD); representing an overall response rate (ORR) of 3/10 (30%) and a disease control rate of 7/10 (70%). The observed ORR of anti-PD1 alone monotherapy is 14%-17% in the 2nd line advanced HCC setting. Immune analysis of the pre-treatment and on-treatment patient samples demonstrated the induction and expansion of T cell clones in the peripheral blood and infiltration of T cells in the tumor tissue following vaccination.

Dr. Mark Yarchoan, Assistant Professor of Oncology, Johns Hopkins University will discuss the clinical trial design and advantages of Geneos’ GT-EPIC platform in an oral poster presentation titled:

Abstract #: TPS2680
"Personalized DNA neoantigen vaccine in combination with plasmid IL-12 and pembrolizumab for the treatment of patients with advanced hepatocellular carcinoma." – Yarchoan et al

Geneos is also presenting data from its ongoing collaboration with Dr. Tanner Johanns and colleagues at Washington University School of Medicine to treat a patient with newly diagnosed anaplastic astrocytoma/GBM under a single patient compassionate use IND. The patient is undergoing monotherapy treatment with their personalized cancer vaccine (GNOS-PV) and pIL12 in an adjuvant setting following resection of their tumor. As of the ASCO (Free ASCO Whitepaper) 2021 conference date the patient remains recurrence free 36 months since primary surgery and 23 months since initiation of the GNOS-PV + pIL12 treatment. The interim data demonstrated that the treatment was generally well tolerated with no treatment related serious adverse events. The patient received a vaccine comprising of 30 tumor antigens including 27 cancer neoantigens and 3 shared antigens. On-treatment immune analysis showed the induction and persistence of neoantigen directed T cells in the patient’s blood to 28 of 30 (93%) encoded antigens following GNOS-PV + pIL12 treatment.

Abstract #: e14561
"Personalized DNA neoantigen vaccine in combination with plasmid IL-12 for the treatment of a patient with anaplastic astrocytoma." – Johanns et al

"We are encouraged by the interim data from our personalized cancer vaccine program showing tumor shrinkage in combination with anti-PD1. Our GT-EPIC platform’s ability to drive CD8 T cells leading to meaningful clinical responses in intractable tumors is exciting," said Dr. Niranjan Y. Sardesai, President and CEO of Geneos Therapeutics. "A distinguishing feature of our HCC trial is that all the patients receive their first dose of GNOS-PV02+pIL12 at the same time as they receive their first dose of PD1 thus enabling direct comparison to the historical responses achieved by PD1 alone. These early data represent the first objective responses reported in HCC patients with plasmid DNA encoded cancer vaccines."