Targovax ASA: Three posters presented at ESMO conference
(Thomson Reuters ONE) -
Oslo, Norway, 11 September 2017: Targovax ASA ("Targovax" or "the Company"; OSE:
TRVX), a clinical stage company focused on developing immuno-oncology therapies
to target solid tumors, today announces that three posters were presented during
the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, from
September 8-12.
Oystein Soug, Chief Executive Officer of Targovax, said, "The ESMO annual
conference is a place where clinicians and researchers from all over the world
gather to share important information with the goal of finding effective cancer
treatments. We are delighted that ESMO allowed us to participate with three
posters in this important forum."
"The data in the posters we presented highlight some of the important progress
we have made to date in the clinic with our two novel proprietary immunotherapy
technology platforms. The two posters summarizing the encouraging data from
early clinical studies with TG01, from the neo-antigen therapeutic cancer
vaccine platform, suggest it may have significant potential in the treatment of
RAS-mutated pancreatic cancer, which currently has a poor prognosis. The third
poster relates to an ongoing phase I/II study in mesothelioma, a rare and
difficult to treat cancer, with the lead drug candidate from our oncolytic virus
platform, ONCOS-102."
The complete poster abstracts can be found below.
An observational clinical study with RAS peptide vaccine TG01 evaluating immune
response, safety and overall survival in patients with non-resectable pancreatic
cancer
Background: The study evaluated the immune response, safety and survival of the
TG01/GM-CSF vaccine, an antigen-specific cancer immunotherapy consisting of 7
RAS peptides targeted to KRAS mutated pancreatic adenocarcinoma, in treatment
naive non-resectable pancreatic cancer patients. TG01/GM-CSF was recently
reported to elicit immune response and increased survival in resectable
pancreatic patients (ASCO 2017).
Methods: 25 treatment naive non-resectable pancreatic cancer patients were
immunised with TG01/GM-CSF at week 1, 2, 3, 4, 6, 10 (immunisation period)
followed, after a 3 months pause, by a booster period of four weekly
administrations. Patients were followed up for up to 12 months from 1st dose of
TG01/GM-CSF. Immune response was evaluated by Delayed Type Hypersensitivity
(DTH) skin reaction test, (S)AEs recorded throughout the study and survival data
calculated using Kaplan-Meier.
Results: 14/25 patients (56%) had a positive DTH by week 10. The TG01/GM-CSF
treatment was well tolerated with no reports of allergic or other adverse
hypersensitivity reactions. 13 patients experienced 19 SAEs; 5 were due to
disease progression, 13 were deaths due to disease progression, and one was
treatment related (hypoglycaemia). Median survival (MS) from first
administration of TG01/GM-CSF was for all treated patients (n=25) 4.5 months,
for DTH responders (n=14) 5.1 months and for DTH non-responders (n=11) 3.6
months. For the DTH responders the result compares favorably with untreated
patients (MS ~ 3.7 months)1. At 1 year, 4 patients of whom three DTH responders
were alive.
Conclusions: In patients treated with TG01/GM-CSF monotherapy, immune response
was recorded in 56% of the patients, results that correspond with data from a
Phase I/II trial with a similar RAS peptide vaccine in non-resectable pancreatic
patients2. Even though not statistically significant, the results indicate
increased survival for the immune responders. In the otherwise incurable
disease, the non-resectable pancreatic patients may therefore benefit from
immunisation with TG01/GM-CSF RAS peptide vaccine with few side effects.
TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant
adenocarcinoma of the pancreas
Background: The study evaluated the immune response, safety and clinical
efficacy of the TG01/GM-CSF vaccine, an antigen-specific cancer immunotherapy
consisting of 7 RAS peptides targeted to KRAS mutated pancreatic adenocarcinoma
(PAC). The efficacy of adjuvant chemotherapy in resected disease is limited with
1- and 2-year published overall survival (OS) rates ranging from 56-80% and
30-54% respectively. TG01 induces RAS mutant-specific T-cell responses which are
enhanced by co-administration of GM-CSF.
Methods: Patients were eligible after R0 or R1 PAC resection. As soon as
possible after surgery, TG01 (0.7 mg intradermal injection (id)) together with
GM-CSF (0.03 mg id) was given on days 1, 3, 5, 8, 15, 22 and 2-weekly thereafter
until the end of gemcitabine (starting within 12 weeks of surgery and given for
6 cycles). Thereafter TG01/GM-CSF was given 4-weekly up to 1 yr and 12-weekly up
to 2 yrs. Immune response was assessed using antigen-specific (TG01) Delayed-
Type Hypersensitivity and T-cell proliferation. OS and disease free survival
(DFS) was assessed from surgery; ~8 weeks before first TG01 injection.
Results: To date, 19 patients (68% R1) have been followed for 2 1/2 yrs. Median
CA19-9 was 15 (5, 240) U/ml at baseline. 8 SARs in 5 patients have occurred; 4
related to gemcitabine (anemia, pulmonary infection and 2 fever); 3 related to
TG01/GM-CSF (2 anaphylaxes and 1 hypersensitivity); and 1 possibly related to
all products (dyspnea). The allergic reactions only occurred after several
cycles of gemcitabine and resolved within 1-2 hrs. There were no treatment
related deaths. TG01 induce an immune response in 17/19 patients by week 11,
which demonstrate that TG01 vaccination activate TG01 specific T-cells. OS rate
at 2 yrs was 68.4 (95% CI 47.5, 89.3). OS rate at 2 1/2 yrs will be presented.
Median OS was 33.1 months (95% CI 16.8, 40.1). Median DFS was 13.9 months (95%
CI 5.4-21.0)
Conclusions: The regimen was generally well tolerated although some late,
manageable allergic reactions were seen. OS and DFS was encouraging in view of
published reports. TG01/GM-CSF generated early immune responses in 89% of
patients with R0/R1 resected pancreatic cancer. 13 patients have been recruited
in a modified dose cohort with 2 yrs data in 2Q 2018.
ONCOS-102 and pemetrexed/cisplatin in patients with unresectable malignant
pleural mesothelioma
Background: Mesothelioma is a rare cancer with poor prognosis and limited
treatment options, including surgery, radiotherapy and chemo (pemetrexed +
cisplatin/carboplatin). Adenoviruses are excellent immunotherapeutic agents with
a unique ability to prime and boost immune responses. ONCOS-102 is a
granulocyte-macrophage colony stimulating factor (GM-CSF) - expressing oncolytic
adenovirus (Ad5/3-D24-GMCSF). In a prior phase I study of 12 patients with
advanced solid tumors, 40% had stable disease (SD) at 3 months, 11/12 patients
had infiltration of CD8+ lymphocytes in lesions, and 10/12 had intralesional PD-
L1 expression increase. Lesional immune activation was seen in two patients with
mesothelioma.
Trial Design: A randomized Phase II study (n=24) with a non-randomized Phase Ib
safety lead-in cohort (n=6). The study will compare ONCOS-102 and chemo with
chemo alone (control arm). Eligible patients have histologically confirmed
unresectable disease and are not candidates for curative surgery. Patients can
be naïve to chemo, or have received and responded to chemo, but relapsed after
at least 6 months thus eligible for renewed chemo treatment. Patients must have
measurable disease with tumour accessible to intratumoural injections of ONCOS-
102 and biopsies. A Data Safety Monitoring Committee will review data when the
first 3 and all 6 patients have completed the Day 64 visit (i.e. after 2 cycles
of chemo and 4 injections of ONCOS-102). If safety is acceptable, phase II will
start with 10 patients in the control arm, and 14 patients in the experimental
arm.
Primary objective: Safety. Secondary objectives: 1) Tumour specific
immunological activation in peripheral blood and biopsies 2) Response Rate 3)
Progression Free Survival 4) Overall Survival and 5) Correlation between immune
activation and clinical outcome.
Treatment: Single cyclophosphamide dose followed by intratumoral injection of
ONCOS-102 at 3x1011viral particles (VPs) on days 1, 4, 8, 36, 78 and 120.
Pemetrexed (500mg/m2)/cisplatin(75mg/m2) is given on day 22 and every 3 weeks
for a maximum of 6 cycles. Imaging at baseline, Day 64 and 148. Tumor biopsies
from both injected and non-injected lesions at baseline and Day 36.
The abstract can be found on www.targovax.com.
In addition, the abstracts have also been published in the ESMO 2017 Congress
Abstract Book, a supplement to the official ESMO journal Annals of Oncology.
***
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli(at)targovax.com
Media and IR enquires:
Jan Petter Stiff - Crux Advisers (Norway)
Phone: +47 995 13 891
Email: stiff(at)crux.no
Julia Phillips/Simon Conway - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax(at)fticonsulting.com
About Targovax
Arming the patient's immune system to fight cancer
Targovax is a clinical stage company focused on developing and commercializing
novel immuno-oncology therapies to target, primarily, treatment-resistant solid
tumors. Immuno-oncology is currently one of the fastest growing therapeutic
fields in medicine.
The Company's development pipeline is based on two novel proprietary platforms:
The first platform, ONCOS, uses oncolytic viruses as potential multi-target,
neo-antigen therapeutic cancer vaccines. ONCOS exclusively uses an adenovirus
that has been engineered to be an immune activator that selectively targets
cancer cells. In phase I studies it has demonstrated immune activation at
lesional level which was associated with clinical benefit. In an ongoing phase I
trial in advanced melanoma we expect important proof of concept data for
checkpoint inhibitor refractory patients.
The second, TG, is a target specific, neo-antigen therapeutic cancer vaccine
platform that solely targets tumors that express mutated forms of the RAS
protein. Mutations to this protein are common in many cancers and are known to
drive aggressive disease progression and treatment resistance. There is a high
unmet medical need for therapies that are effective against tumors that express
these mutations. The TG platform's therapeutic potential stems from its ability
to enable a patient's immune system to identify and then destroy tumors bearing
any RAS mutations. In early 2017, key proof of concept data for the TG platform
from a clinical trial of TG01 in resected pancreatic cancer patients showed
encouraging overall survival and will give guidance for the future clinical
development of this platform.
Targovax's development pipeline has three novel therapeutic candidates in
clinical development covering six indications.
Both platforms are protected by an extensive portfolio of IP and know-how and
have the potential to yield multiple product candidates in a cost-effective
manner. Additionally, Targovax has other products in early stages of
development.
In July 2016, the Company listed its shares on Oslo Axess. In March 2017, the
shares moved to Oslo Børs, the main Oslo Stock Exchange.
About ESMO 2017 Congress
The European Society for Medical Oncology (ESMO) is the leading professional
organisation for medical oncology. The ESMO 2017 Congress, in partnership with
the European Association for Cancer Research (EACR), will bring cancer
researchers and clinicians together to enable collaboration and the exchange of
ideas, from the laboratory to the bedside and back. This exciting partnership
creates a unique cancer congress in Europe with huge scientific reach and the
true potential to improve the lives of cancer patients. The ESMO Congress is the
most influential annual meeting for oncology professionals in Europe.
For more information, visit: http://www.esmo.org/.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Targovax ASA via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 11.09.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 559351
Anzahl Zeichen: 14169
contact information:
Town:
Oslo
Kategorie:
Business News
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