PLYMOUTH MEETING, Pa.,
June 3, 2021 /PRNewswire/
-- Geneos Therapeutics, a clinical stage company focused on
the development of tumor neoantigen targeted personalized
immunotherapies for cancer, announced today positive preliminary
results of its ongoing first-in-human trial. 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).
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
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."
About Geneos Therapeutics
At Geneos Therapeutics, we believe that personalized therapies
are the future of cancer treatment. Our passion is to develop
personalized therapies to unleash the most powerful force against
cancer – the patients' own immune system. Our approach using our
GT-EPIC™ platform is to target unique neoantigens (abnormal
mutations produced by cancer cells) from individual patient tumors
to develop novel and personalized treatments for cancer.
About GT-30 trial:
The GT-30 trial (NCT04251117) is a single-arm phase I/II
clinical trial to assess the safety, immunogenicity, and
preliminary efficacy of GNOS-PV02 in combination with cytokine
IL-12 (pIL12; INO-9012) and pembrolizumab in patients with advanced
HCC. Twenty-four patients are anticipated to be enrolled. After
progression or intolerance with first-line therapy, patients can
commence trial therapy with concurrent personalized vaccine and
pembrolizumab. Patients are recruited upon diagnosis or during
first-line treatment with tyrosine kinase inhibitors (TKI). Tumors
are biopsied for exome and transcriptome sequencing. The tumor
specific vaccine is designed, optimized and manufactured during
first-line therapy. Each vaccine encodes up to 40 neoantigens,
which includes all detected neoantigens for the majority of HCC
patients. GNOS-PV02 + pIL12 are administered Q3w for the first 4
doses and Q9w thereafter until disease progression. Pembrolizumab
is delivered Q3w until disease progression. Immunogenicity of each
of the vaccine epitopes is determined by ex vivo ELISpot and
flow cytometry. Clinical activity is assessed by RECIST1.1 at
baseline and every 9 weeks. Serial biopsies are obtained at 9 weeks
and upon disease progression to evaluate changes in the exome,
transcriptome and changes to the tumor microenvironment.
About GT-EPIC™ Platform:
Geneos Therapeutics' GT-EPIC™ Neoantigen-Targeting Platform is
based on clinically-validated DNA medicines technology exclusively
licensed from Inovio Pharmaceuticals, Inc. (NASDAQ: INO) for use in
developing personalized, neoantigen-targeting immunotherapies. The
GT-EPIC™ platform allows Geneos to develop exquisitely personalized
DNA-based therapies tailored to each patient's unique tumor
mutations. The platform is developed to deliver the following key
advantages: ability to drive potent and broad T cell immune
responses, capability to target an unprecedented number of
neoantigens in a single formulation, and a rapid manufacturing
turnaround time. Geneos believes that these are three key
differentiators that will drive the company, and the oncology
space, into the next generation of neoantigen targeted
immunotherapies.
This press release contains certain forward-looking
statements relating to our business, including our plans regarding
the development of tumor neoantigen targeted personalized
immunotherapies for cancer, our expectations regarding our research
and development programs, including the planned expansion and
conduct of clinical trials and the availability and timing of data
from those trials, and the use of our capital resources. Actual
events or results may differ from the expectations set forth
herein. There can be no assurance that any product candidate in
Geneos' pipeline will be successfully developed, manufactured or
commercialized, that final results of clinical trials will be
supportive of regulatory approvals required to market licensed
products, or that any of the forward-looking information provided
herein will be proven accurate. Forward-looking statements speak
only as of the date of this release, and Geneos undertakes no
obligation to update or revise these statements, except as may be
required by law.
View original
content:http://www.prnewswire.com/news-releases/geneos-therapeutics-announces-clinical-updates-on-personalized-cancer-vaccine-program-301305022.html
SOURCE Geneos Therapeutics, Inc.