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· The second poster presents clinical data from the externally sponsored trial
exploring intra-peritoneal (IP) delivery in colorectal or ovarian cancer with
peritoneal metastasis, showing that ONCOS-102 generated immune responses and was
safe to administer IP in combination with a PD-L1 checkpoint inhibitor
Oslo, Norway, 27 May 2022 - Targovax ASA (OSE: TRVX), today announces
publication of the two ONCOS-102 abstracts accepted for presentation at the
American Society of Clinical Oncology (ASCO) Annual Meeting 3-7 June 2022. The
posters will present clinical results from the completed phase 1/2 trials in
malignant pleural mesothelioma and in heavily pre-treated, MS-stable colorectal
or ovarian cancer with peritoneal metastasis.
First poster title: Final survival outcomes and immune biomarker analysis of a
randomized, open-label, phase I/II study combining oncolytic adenovirus ONCOS
-102 with pemetrexed/cisplatin (P/C) in patients with unresectable malignant
pleural mesothelioma (MPM)
Session Title: Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other
Thoracic Cancers
Time: Monday 6 June 2022, 8:00-11:00 AM CDT, Abstract 8561
Presenter: Dr Santiago Ponce, Medical Oncology, Hospital 12 Octubre, Madrid,
Spain
The poster summarizes the overall findings from the completed, randomized phase
1/2 trial in 31 patients with MPM; 20 patients received intra-tumoral (IT) ONCOS
-102 in combination with standard of care (SoC) chemotherapy and 11 patients in
a control group received SoC chemotherapy only.
In the randomized part of the trial, the 30-month overall survival (OS) rate was
34.3% in the ONCOS-102 treated group (n=14) vs. 18.2% in the SoC-only control
group (n=11). In first-line patients, the ONCOS-102 group achieved a median
overall survival (mOS) of 25.0 months (n=8) vs. 13.5 months mOS in the SoC-only
control group (n=6). The ONCOS-102 first-line mOS compares favorably to SoC
historical control studies reporting mOS of 12-16 months1, as well as the
combination of nivolumab and ipilimumab which demonstrated mOS of 18.1 months in
a phase 3 trial that led to FDA approval2. Tumor biopsy immune cell analyses
revealed strong T-cell infiltration induced by ONCOS-102 in patients with
partial response (PR) or stable disease (SD), but not in progressors. These
observations were confirmed by RNAseq gene expression analysis. The breadth and
strength of immune response induced by ONCOS-102 correlated with both tumor
response and survival. Further clinical trials in MPM are clearly warranted to
validate these positive findings in a larger patient cohort.
Second poster title: Study to evaluate intraperitoneal (IP) ONCOS-102 with
systemic durvalumab in patients with peritoneal disease who have epithelial
ovarian (OC) or metastatic colorectal cancer (CRC): Phase 2 results
Session Title: Development Therapeutics, Immunotherapy
Time: Sunday 5 June 2022, 8:00-11:00 AM CDT, Abstract 2600
Presenter: Dr Dmitriy Zamarin, Memorial Sloan Kettering Cancer Center, New York,
USA
The poster reports clinical data from the ONCOS-102 phase 1/2 combination trial
with anti-PD-L1 checkpoint inhibitor durvalumab in heavily pre-treated, MS
-stable CRC (n=36) or OC (n=19) with peritoneal metastases. This is a patient
population with few treatment alternatives that only offer marginal efficacy and
where checkpoint inhibitor monotherapy does not have any meaningful activity.
The trial was managed by an external consortium with Ludwig Cancer Research as
sponsor, where Targovax was a collaboration partner.
This is the first time ONCOS-102 has been administered IP and in combination
with an anti-PD-L1 checkpoint inhibitor. IP delivery of ONCOS-102 was
demonstrated to be feasible and well-tolerated, both as monotherapy and in
combination with systemic durvalumab. Whereas the initial OC cohort did not meet
the efficacy criteria and was closed, the initial CRC cohort met the efficacy
criteria and was expanded. In the full CRC cohort (n=36) two patients remained
progression free at the end of the study (week 24), but the primary efficacy
endpoint of 4 patients remaining progression free at week 24 was not met.
Tumor biopsy immune cell analysis showed increased T-cell infiltration in
several patients, confirming that IP administered ONCOS-102 can induce immune
activation in heavily pre-treated, immunologically silent solid tumors. Of note,
the selected IP dose was the same as used for IT delivery of ONCOS-102 (3x1011
V.P.), although IP delivery is expected to result in lower tumor exposure to the
virus relative to IT. Hence, higher doses of IP delivered ONCOS-102 could
potentially enhance both the immunological response and clinical activity.
Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: “We are very pleased
to have two ONCOS-102 studies accepted for presentation at ASCO this year, which
is a very important forum to showcase and discuss our clinical data with
international experts in the field. In our exploratory clinical program we have
now demonstrated that ONCOS-102 can be delivered safely intra-tumorally and
intra-peritoneally in combination with PD-1 and PD-L1 checkpoint inhibitors, as
well as chemotherapy. Importantly, we have also seen robust immunological and
clinical activity in solid tumors of different origins. This gives us confidence
to bring ONCOS-102 forward into later stage development, with the first step
being a multi-cohort phase 2 trial in PD1-refractory melanoma where we will test
several I-O combinations, including the second-generation anti-CTLA4 checkpoint
inhibitor botensilimab.”
About ASCO
American Society of Clinical Oncology Annual Meeting, ASCO 2022 will be held in
McCormick Place, Chicago, Illinois, United States between 3-7 June 2022.
The 2022 ASCO Annual Meeting Program will offer presentations on the latest
research in cancer care. This year’s program will feature sessions complementing
the meeting’s theme: Advancing Equitable Cancer Care Through Innovation.
References
1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas
2020 SITC 2020 poster
2 Baas et al. The Lancet, 2021
For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@targovax.com
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
About Targovax
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing
immune activators to target hard-to-treat solid tumors. Targovax’s focus is to
activate the patient’s immune system to fight cancer, and thereby bring benefit
to cancer patients with few available treatment alternatives. Targovax is
assessing its product candidates in different cancer indications, including
melanoma, mesothelioma, multiple myeloma and colorectal cancer, and has
demonstrated a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, which has been engineered to selectively infect cancer
cells and activate the immune system to fight the cancer. On the back of very
encouraging clinical data in several indications, both as monotherapy and in
combinations, ONCOS-102 will progress into a phase 2 trial in multiple
combinations in melanoma patients resistant to PD1 checkpoint blockade.
Building on successful studies demonstrating clinical efficacy and providing
deep mechanistic insights, the ONCOS platform is being expanded into delivery of
circular RNA (circRNA). In addition, Targovax has a KRAS immunotherapy program,
with lead cancer vaccine candidate, TG01, due to enter the clinic in the second
half of 2022. This provides Targovax with a rich pipeline of innovative future
immunotherapy product candidates to follow ONCOS-102.
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