An Open-Label, Two-Part, Dose-Exploration and Multiple Expansion, Phase 2 Study of ONCOS-102 in Combination With Novel Immune-Targeted Anti-Cancer Agents in Patients With Unresectable or Metastatic Cutaneous Melanoma Resistant to Anti-PD-(L)1 Treatment

A Phase 2 study investigating the efficacy and safety of ONCOS-102 alone or in combination with balstilimab (a programmed death receptor-1 [PD-1] inhibitor).

Start Date01 Jan 2024

Sponsor / Collaborator

Targovax Oy

[+1]

NCT02963831

/ CompletedPhase 1/2IIT

A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1 (PD-L1) antibody, durvalumab, in adult subjects with peritoneal disease who have failed prior standard chemotherapy and have histologically confirmed epithelial ovarian cancer or metastatic colorectal cancer.

Start Date07 Sep 2017

Sponsor / Collaborator

Ludwig Institute for Cancer Research Ltd.

[+3]

NCT03003676

/ CompletedPhase 1

A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After PD1 Blockade

This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary objective of the study is to determine the safety of sequential treatment with ONCOS-102 followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: Part I: up to 12 patients will receive sequential treatment with ONCOS-102 followed by pembrolizumab. Part II: up to 12 patients will receive an initial treatment phase with ONCOS-102 followed by a treatment phase with ONCOS-102 in combination with pembrolizumab.

Start Date01 Dec 2016

Sponsor / Collaborator

Targovax Oy

100 Clinical Results associated with ONCOS-102

100 Translational Medicine associated with ONCOS-102

100 Patents (Medical) associated with ONCOS-102

Literatures (Medical) associated with ONCOS-102

01 Sep 2023·Journal for immunotherapy of cancer

ONCOS-102 plus pemetrexed and platinum chemotherapy in malignant pleural mesothelioma: a randomized phase 2 study investigating clinical outcomes and the tumor microenvironment

Article

Author: Martinez-Marti, Alex ; Ponce, Santiago ; Paz-Ares, Luis ; Navarro, Alejandro ; Vetrhus, Sylvia ; Ricordel, Charles ; Viteri, Santiago ; Isambert, Nicolas ; Jaderberg, Magnus ; Hansen, Thomas Birkballe ; Levitsky, Victor ; Cedrés, Susana ; Herrera-Juarez, Mercedes ; Serres, Xavier ; Lederlin, Mathieu ; Zugazagoitia, Jon

Background:

ONCOS-102, an oncolytic adenovirus expressing granulocyte-macrophage colony-stimulating factor, can alter the tumor microenvironment to an immunostimulatory state. Combining ONCOS-102 with standard-of-care chemotherapy for malignant pleural mesothelioma (MPM) may improve treatment outcomes.

Methods:

In this open-label, randomized study, patients with unresectable MPM received intratumoral ONCOS-102 (3×1011virus particles on days 1, 4, 8, 36, 78, and 120) and pemetrexed plus cisplatin/carboplatin (from day 22), or pemetrexed plus cisplatin/carboplatin alone. The primary endpoint was safety. Overall survival (OS), progression-free survival, objective response rate, and tumor immunologic activation (baseline and day 36 biopsies) were also assessed.

Results:

In total, 31 patients (safety lead-in: n=6, randomized: n=25) were enrolled. Anemia (15.0% and 27.3%) and neutropenia (40.0% and 45.5%) were the most frequent grade ≥3 adverse events (AEs) in the ONCOS-102 (n=20) and chemotherapy-alone (n=11) cohorts. No patients discontinued ONCOS-102 due to AEs. No statistically significant difference in efficacy endpoints was observed. There was a numerical improvement in OS (30-month OS rate 34.1% vs 0; median OS 20.3 vs 13.5 months) with ONCOS-102 versus chemotherapy alone in chemotherapy-naïve patients (n=17). By day 36, ONCOS-102 was associated with increased T-cell infiltration and immune-related gene expression that was not observed in the control cohort. Substantial immune activation in the tumor microenvironment was associated with survival at month 18 in the ONCOS-102 cohort.

Conclusions:

ONCOS-102 plus pemetrexed and cisplatin/carboplatin was well tolerated by patients with MPM. In injected tumors, ONCOS-102 promoted a proinflammatory environment, including T-cell infiltration, which showed association with survival at month 18.

04 Jan 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti–PD-1–Resistant Advanced Melanoma

Communications

Author: Shoushtari, Alexander N. ; Olszanski, Anthony J. ; Hornyak, Thomas J. ; Hansen, Thomas B. ; Nyakas, Marta ; Levitsky, Victor ; Jäderberg, Magnus ; Wolchok, Jedd D. ; Kuryk, Lukasz

Abstract:

Purpose::

Intratumoral oncolytic virotherapy may overcome anti–PD(L)-1 resistance by triggering pro-inflammatory remodeling of the tumor microenvironment. This pilot study investigated ONCOS-102 (oncolytic adenovirus expressing GM-CSF) plus anti–programmed cell death protein 1 (PD)-1 therapy in anti–PD-1–resistant melanoma.

Patients and Methods::

Patients with advanced melanoma progressing after prior PD-1 blockade received intratumoral ONCOS-102 either as priming with 3 doses (3 × 1011 viral particles) during Week 1 [Part 1 (sequential treatment)] or as 4-dose priming and 8 booster doses every 3 weeks [Part 2 (combination treatment)]. From Week 3, all patients received pembrolizumab every 3 weeks (≤8 doses). The primary endpoint was safety. Objective response rate (ORR), progression-free survival, and immunologic activation in repeat biopsies were also investigated.

Results::

In 21 patients (Part 1, n = 9; Part 2, n = 12) ONCOS-102 plus pembrolizumab was well tolerated: most adverse events (AE) were mild/moderate in severity. Pyrexia (43%), chills (43%), and nausea (28%) were the most common ONCOS-102–related AEs. There were no dose-limiting toxicities. ORR was 35% [response evaluation in solid tumors (RECIST) 1.1, irRECIST]. Reduction in size of ≥1 non-injected lesions observed in 53% patients indicated a systemic effect. In injected tumors, persistent immune-related gene expression and T-cell infiltration were associated with clinical benefit. Viral persistence and efficacy in injected and non-injected lesions without additional toxicity supported Part 2 dosing regimen in future studies.

Conclusions::

ONCOS-102 plus pembrolizumab was well tolerated and led to objective responses in patients with anti–PD-1–resistant advanced melanoma. ONCOS-102 promoted T-cell infiltration, particularly cytotoxic CD8+ T cells, which persisted at Week 9, driving clinical benefit. Further investigation of ONCOS-102 plus PD-1 blockade is warranted.See related commentary by Levi and Boland, p. 3

04 Jan 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

ONCOS-102: A Step Forward or Sideways?

Communications

Author: Levi, Shoshana T. ; Boland, Genevieve M.

Summary:

Treatment of anti–PD-1 refractory melanoma remains a challenge. Intratumoral injection of ONCOS-102, a chimeric oncolytic adenovirus expressing GMCSF, into anti–PD-1–resistant melanoma with administration of pembrolizumab was safe and effective. Response to therapy was associated with increased lymphocyte infiltration and expression of cytotoxicity and costimulatory genes.See related article by Shoushtari et al., p. 100

News (Medical) associated with ONCOS-102

18 Jan 2023

·www.prnewswire.com

Significant Positive Shift in the Malignant Pleural Mesothelioma Market with 5.7% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the malignant pleural mesothelioma market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like AstraZeneca (Imfinzi), Hoffmann-La Roche (Tecentriq (Atezolizumab) Plus Avastin (Bevacizumab), Sellas Life Sciences Group (GALINPEPIMUT-S), PharmaMar (Lurbinectedin, and Trabectedin), and several others are investigating their candidates for malignant pleural mesothelioma treatment. LAS VEGAS, Jan. 18, 2023 /PRNewswire/ -- DelveInsight's Malignant Pleural Mesothelioma Market Insights report includes a comprehensive understanding of current treatment practices, malignant pleural mesothelioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Malignant Pleural Mesothelioma Market Report As per DelveInsight analysis, the malignant pleural mesothelioma market size in the 7MM was approximately USD 280 million in 2021. According to the assessment done by DelveInsight, the estimated total malignant pleural mesothelioma incident cases in the 7MM were approximately 10.8K in 2021. Globally, leading malignant pleural mesothelioma companies such as Amphera BV, Polaris Pharmaceuticals, Sellas Life Sciences Group, Momotaro-Gene, PharmaMar, AstraZeneca, Targovax, TCR2 Therapeutics, Hoffmann-La Roche, Novartis, MolMed, Ys Therapeutics, Merck Sharp & Dohme Corp., Kissei Pharmaceutical Co., Ltd., NovoCure Ltd, AGC Biologics S.p.A, Aduro Biotech, Inc, Bristol-Myers Squibb, Novotech (Australia) Pty Limited, Kyorin Pharmaceuticals, ACADIA Pharmaceuticals, and others are developing novel malignant pleural mesothelioma drugs that can be available in the malignant pleural mesothelioma market in the coming years. The promising malignant pleural mesothelioma therapies in the pipeline include MesoPher, Pegargiminase, Galinpepimut-S (Vaccine), MTG201 + nivolumab, ZEPZELCA (lurbinectedin), IMFINZI, ONCOS-102, TC-210, TECENTRIQ Plus AVASTIN , and others. In December 2022, efficacy and safety data from the phase II/III DENIM trial in Mesothelioma were released by Amphera. In September 2022, Pegargiminase received Fast track status from the US FDA for Mesothelioma. In June 2022, Momotaro-Gene announced that it completed the enrolment in its phase II trial for Mesothelioma (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in the USA (Intratumoural). In 2015, the US FDA granted Orphan Drug Designation for MTG-201 for the treatment of malignant mesothelioma. Discover which therapies are expected to grab the major malignant pleural mesothelioma market share @ Malignant Pleural Mesothelioma Market Report Malignant Pleural Mesothelioma Overview Mesothelioma is a rare, aggressive form of malignant tumor that develops in the lining of the lungs, abdomen, or heart after inhaling asbestos fibers. Pleural mesothelioma is a cancer of the pleura, which is the mesothelium that surrounds the lungs. It is the most common type of mesothelioma, accounting for most diagnosed cases. Because men are more likely to be exposed to asbestos, they are more likely to develop mesothelioma. Asbestos exposure is the leading cause of pleural mesothelioma. Asbestos is a mineral group that occurs naturally as bundles of tiny fibers. These fibers can be found in soil and rocks all over the world. Malignant pleural mesothelioma symptoms include chest pain, bloody coughing, difficulty swallowing, dry cough, fluid in the lungs, dyspnea, fever, weight loss, and fatigue. Pleural mesothelioma is frequently diagnosed through a series of tests, including one or more imaging scans, such as an X-ray or CT scan, performed first to identify tumors or metastasis (spreading of disease). Malignant Pleural Mesothelioma Epidemiology Segmentation DelveInsight estimates that there were approximately 10.8K incident cases of malignant pleural mesothelioma in the 7MM in 2021. In the EU5 countries, the highest number of incident cases of MPM was found in the United Kingdom in 2021, followed by Germany and Italy, respectively. The malignant pleural mesothelioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of Mesothelioma Total Incident Cases of MPM Total Type-specific Cases of MPM Total Incident Cases of MPM Segmented by Age and Gender Total Incident Cases of MPM by Stages Total Treated Cases of MPM Download the report to understand which factors are driving malignant pleural mesothelioma epidemiology trends @ Malignant Pleural Mesothelioma Epidemiological Insights Malignant Pleural Mesothelioma Treatment Market The malignant pleural mesothelioma treatment aims to prolong life, manage symptoms, alleviate pain, and kill cancer cells. When treating malignant pleural mesothelioma, doctors will use a combination of different treatment options to remove as much of cancer as possible. Malignant pleural mesothelioma treatment options currently include chemotherapy, radiation, and surgery. Multimodal therapy refers to the use of multiple approaches by specialists. MPM patients who are diagnosed early benefit the most from surgery. Currently, two main procedures for MPM management are used: pleurectomy and decortication (P/D) and extrapleural pneumonectomy (EPP). Chemotherapy is the most commonly used malignant pleural mesothelioma treatment. Patients with unresectable cancer are frequently treated with palliative systemic chemotherapy. Alimta (pemetrexed) and cisplatin are the most effective combination of mesothelioma drugs. The first drug regimen, nivolumab and ipilimumab, were approved by the US FDA in 2020 for the treatment of adult patients with unresectable malignant pleural mesothelioma. The EMA also approved nivolumab in combination with ipilimumab for the first-line treatment of adult patients with inoperable malignant pleural mesothelioma. Later, in August 2021, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the combination. To know more about malignant pleural mesothelioma treatment guidelines, visit @ Malignant Pleural Mesothelioma Management Malignant Pleural Mesothelioma Pipeline Therapies and Key Companies MesoPher: Amphera BV Pegargiminase: Polaris Pharmaceuticals Galinpepimut-S (Vaccine): Sellas Life Sciences Group MTG201 + nivolumab: Momotaro-Gene ZEPZELCA (lurbinectedin): PharmaMar IMFINZI: AstraZeneca ONCOS-102: Targovax TC-210: TCR2 Therapeutics TECENTRIQ Plus AVASTIN: Hoffmann-La Roche Learn more about the FDA-approved malignant pleural mesothelioma drugs @ Drugs for Malignant Pleural Mesothelioma Treatment Malignant Pleural Mesothelioma Market Dynamics The dynamics of the malignant pleural mesothelioma market are anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading pharma companies. In addition, the malignant pleural mesothelioma clinical pipeline is robust, with several therapies in development across a wide range of drug classes/technologies, including monoclonal antibodies, gene therapy, vaccines, and small molecules. Moreover, advances have been made in recent years, such as a better understanding of molecular pathogenesis and the immunological tumor microenvironment. Furthermore, clinical studies investigating systemic therapies for MPM continue to grow. These trials are primarily concerned with immunotherapy, either alone or in combination with other immunotherapies and non-immunotherapies. Thus, significant progress has been made in terms of therapies, pathophysiology, and diagnosis, all of which are expected to contribute to the upcoming malignant pleural mesothelioma market. Furthermore, the frontline setting is still relatively untapped (only a few approved therapies) and can provide lucrative opportunities for several companies to explore the malignant pleural mesothelioma market. However, early detection of MPM is difficult due to the lack of specific symptoms and long latency period (i.e., 20 to 50 years), making current screening approaches ineffective in diagnosing patients at early disease stages, with the majority of patients diagnosed in later or advanced stages. Moreover, the current gold standard of treatment, Alimta, is set to lose malignant pleural mesothelioma market exclusivity in the United States this year, which will significantly impact the sales value of Alimta as well as other emerging drugs in combination with pemetrexed. Thus, these factors will likely to impede the growth of the malignant pleural mesothelioma market. Scope of the Malignant Pleural Mesothelioma Market Report Therapeutic Assessment: Malignant Pleural Mesothelioma current marketed and emerging therapies Malignant Pleural Mesothelioma Market Dynamics: Malignant Pleural Mesothelioma market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Malignant Pleural Mesothelioma Market Access and Reimbursement Discover more about malignant pleural mesothelioma drugs in development @ Malignant Pleural Mesothelioma Clinical Trials Table of Contents Related Reports Malignant Pleural Mesothelioma Epidemiology Forecast Malignant Pleural Mesothelioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted malignant pleural mesothelioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Malignant Pleural Mesothelioma Pipeline Malignant Pleural Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant pleural mesothelioma companies, including TCR2 Therapeutics, Hoffmann-La Roche, Novartis, MolMed, Ys Therapeutics, Merck Sharp & Dohme Corp., Kissei Pharmaceutical Co., Ltd., among others. Mesothelioma Market Mesothelioma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key mesothelioma companies, including Amphera, AstraZeneca, Hutchmed, Momotaro-Gene Inc., Sanofi, among others. Mesothelioma Pipeline Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key mesothelioma companies, including Amphera, AstraZeneca, Hutchmed, Momotaro-Gene Inc., Sanofi, among others. Malignant Mesothelioma Market Malignant Mesothelioma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key malignant mesothelioma companies, including Epizyme, Ys Therapeutics, Novartis, Bayer, RS Oncology, among others. Malignant Mesothelioma Pipeline Malignant Mesothelioma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant mesothelioma companies, including Epizyme, Ys Therapeutics, Novartis, Bayer, RS Oncology, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Fast TrackImmunotherapyOrphan DrugDrug ApprovalPhase 2

31 May 2022

·www.globenewswire.com

Agenus Advances Portfolio with 6 Clinical Collaborations

LEXINGTON, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced that it has entered into 3 new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of clinical collaborations. These 6 collaborations span a range of Agenus’ clinical assets, including botensilimab (Fc-enhanced anti-CTLA-4), balstilimab (anti-PD-1), zalifrelimab (anti-CTLA-4), and QS-21 STIMULON™. Agenus is pursuing partnerships with companies developing agents with complementary mechanisms, paving the way for promising immunotherapy combinations to address immunosuppression in the tumor microenvironment. The combination studies are being sponsored and executed by our collaborators, with drug supply and scientific support provided by Agenus. This strategy, enabled by in-house integrated manufacturing and scientific capabilities, positions Agenus to achieve the insights and advances needed to drive development on accelerated timelines. “These new collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis are exciting next steps in our partnership strategy to broaden combinations and indications under evaluation with our immunomodulatory antibodies,” said Dr. Steven O’Day, Chief Medical Officer at Agenus. “We believe these combinations may unlock the power of immunotherapy more broadly, potentially offering new and promising benefit to patients with treatment-resistant solid tumors.” Agenus’ new and ongoing clinical collaborations are supporting and enabling: Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102 (oncolytic virus) in patients with PD-1 relapsed/refractory melanoma. ONCOS-102 is designed to induce immune activation and immunogenic cell death to improve response to immunotherapy.Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076 (CD205-targeting antibody-drug conjugate) in patients with solid tumors, including lung, gastric, and ovarian cancer. OBT076 is expected to deplete CD205+ cancer cells, and immuno-suppressive cells within the tumor microenvironment, leading to T cell activation and increased response to immunotherapy.Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide (hypoxia-reversal agent) in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer. Evofosfamide is anticipated to reduce tumor hypoxia and restore T cell infiltration and activity within the tumor microenvironment, increasing responsiveness to checkpoint therapy.Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01 (KRAS vaccine) in up to 3 cancer indications, including multiple myeloma. TG01 is designed to induce T cells that recognize and destroy mut-RAS cancer cells; QS-21 STIMULON is expected to improve immune cell recognition, activation, and TCR diversity of the immune response.Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer. CR6086 is expected to inhibit the immune suppressive role of prostaglandins in the tumor microenvironment, improving immunogenicity and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.Nelum is conducting a clinical trial combining zalifrelimab with NLM-001 (hedgehog inhibitor) and chemotherapy in patients with advanced pancreatic cancer. NLM-001 in combination with chemotherapy is anticipated to condition the tumor microenvironment to improve T cell infiltration, activation, and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021. About AgenusAgenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter. Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the use of therapeutic candidates botensilimab, balstilimab, zalifrelimab, and QS-21 STIMULON, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety profile of the therapeutic candidates, both alone and in combination with each other and/or other agents; future clinical and regulatory development plans and commercialization plans for botensilimab, balstilimab, zalifrelimab, and QS-21 STIMULON; and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website: www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contact Ethan Lovell, Chief External Affairs & Communications OfficerAgenus Inc.339-927-1763ethan.lovell@agenusbio.com

CollaborateAntibodyCell TherapyVaccineImmunotherapy

04 Nov 2021

·www.biospace.com

Targovax ASA: Third quarter 2021 results

OSLO, Norway, Nov. 4, 2021 /PRNewswire/ -- Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, today announces its third quarter 2021 results. Targovax's CEO will give an online presentation and update on the clinical program to investors, analysts and the press at 10:00 CET today (details below). THIRD QUARTER HIGHLIGHTS Received acceptance of two posters to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November Presented poster at European Society for Medical Oncology (ESMO) Received European Patent for ONCOS-102 in combination with chemotherapy Announced Dr Lone Ottesen's appointment as Chief Development Officer and Ola Melin as Head of Manufacturing POST-PERIOD HIGHLIGHTS In October, Dr. Erik Digman Wiklund was appointed as new Chief Executive Officer. Dr. Wiklund has a strong scientific background in cancer research, and intimate knowledge of the company and its technology having served as Chief Business Officer and Chief Financial Officer of Targovax since 2017. Former CEO Øystein Soug will remain with the company following the appointment of Dr. Wiklund. Mr. Soug will act as a special advisor and also serve as interim CFO providing important strategic and management continuum for the company. KEY FIGURES Erik Digman Wiklund, CEO commented: "Taking over the leadership of Targovax at a time when we have demonstrated a clear signal of efficacy accompanied by a deep biomarker data package for our lead candidate ONCOS-102, is a truly exciting opportunity. The insights we have gained allow us to select the optimal combination strategy for the next development step, as well as to design innovative and differentiated second generation ONCOS vectors to shape our platform for the future." Presentation We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation. Reporting material TRVX Q3 report.pdf TRVX Q3 presentation.pdf The quarterly report and presentation are also available at the website . 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 This information was brought to you by Cision The following files are available for download: View original content: SOURCE Targovax Company Codes: Bloomberg:TRVX@NO, ISIN:NO0010689326, RICS:TRVX.OL, Stockholm:TRVXO

Immunotherapy

100 Deals associated with ONCOS-102

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	-	Targovax Oy	01 Jan 2024
Prostatic Cancer	Phase 2	Czechia	Excoso as	24 May 2018
Appendiceal Neoplasms	Phase 2	United States	MedImmune LLC	07 Sep 2017
Appendiceal Neoplasms	Phase 2	United States	Circio Holding ASA	07 Sep 2017
Metastatic Colorectal Carcinoma	Phase 2	United States	Circio Holding ASA	07 Sep 2017
Metastatic Colorectal Carcinoma	Phase 2	United States	MedImmune LLC	07 Sep 2017
Ovarian Epithelial Carcinoma	Phase 2	United States	MedImmune LLC	07 Sep 2017
Ovarian Epithelial Carcinoma	Phase 2	United States	Circio Holding ASA	07 Sep 2017
Peritoneal Neoplasms	Phase 2	United States	Circio Holding ASA	07 Sep 2017
Peritoneal Neoplasms	Phase 2	United States	MedImmune LLC	07 Sep 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02879669 (ASCO2023) Manual	Phase 1/2	Unresectable Pleural Malignant Mesothelioma	31	ONCOS-102 + Pemetrexed or cisplatin	xjlcuhgsvv(pbxomonlmt) = isjchqdqcu nldvhncmvn (aqdwhfsecl ) View more	Positive	31 May 2023
				Pemetrexed or cisplatin	xjlcuhgsvv(pbxomonlmt) = rbowdylrhi nldvhncmvn (aqdwhfsecl ) View more
NCT02963831 (CTgov)	Phase 1/2	Ovarian Cancer \| Appendiceal Neoplasms \| Colorectal Cancer ... View more	67	ONCOS-102+cyclophosphamide+Durvalumab (Cohort A: ONCOS-102 Dose Escalation)	drrfpmzjrc = mxeeivknel jgrvgbylif (njxrkywtvw, eavnnftsfu - zfbqxnybjs) View more	-	22 Dec 2022
				ONCOS-102+cyclophosphamide+Durvalumab (Cohort 1: Epithelial Ovarian Cancer)	drrfpmzjrc = dfplgjusgt jgrvgbylif (njxrkywtvw, tqrratzsug - sdhjwjejfs) View more
NCT03003676 (615, SITC2022)	Phase 1/2	Refractory Melanoma GM-CSF-encoding oncolytic adenovirus \| pembrolizumab	21	ONCOS-102	fmgasgycdf(osojpayfbj) = 33% styrqmzrsc (zneqpidqje ) View more	Positive	07 Nov 2022
				Pembrolizumab
NCT02879669 (ASCO2022)	Phase 1/2	Unresectable Pleural Malignant Mesothelioma	25	ONCOS-102 + P/C	pzawjwiuye(vxnkwvthlb) = cejnmiahvz ocrfekywan (zunxjwkctt ) View more	-	02 Jun 2022
				P/C	pzawjwiuye(vxnkwvthlb) = vovjazbyrq ocrfekywan (zunxjwkctt ) View more
NCT02879669 (462, SITC2021)	Phase 1/2	Unresectable Pleural Malignant Mesothelioma First line immune markers	-	ONCOS-102 + pemetrexed/cisplatin	bbwmufennv(lstwvqlynt) = bixccygbnu xziavssbvz (umglsblvmo ) View more	Positive	10 Nov 2021
				pemetrexed/cisplatin	bbwmufennv(lstwvqlynt) = tuqqvnxvps xziavssbvz (umglsblvmo ) View more
NCT03003676 (ESMO 12021 \| ESMO 22021) Manual	Phase 1	Refractory Melanoma	21	pembrolizumab+ONCOS-102	soeyebwiip(nxlbubhkqd) = pyrexia (10%), chills (8%), nausea and hypertension (4%) nmhskmncxy (xtmwyjyhso ) View more	Positive	16 Sep 2021
				pembrolizumab+ONCOS-102
NCT03003676 (615 \| ONCOS-102, CTgov)	Phase 1	Unresectable Melanoma	21	ONCOS-102+Cyclophosphamide+Pembrolizumab (Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1)	ieqelwldqe = syxoubghpu krholuyexy (swuywhndwq, jitmatevsl - ybxaiqbqgx) View more	-	09 Aug 2021
				ONCOS-102+Cyclophosphamide+Pembrolizumab (Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2)	ieqelwldqe = kmslfajzme krholuyexy (swuywhndwq, xvaooovctl - khzybgitdg) View more
NCT02879669 (361, SITC2020)	Phase 1/2	Unresectable Pleural Malignant Mesothelioma PD-L1 \| M2 to M1 macrophages	-	ONCOS-102 + pemetrexed/cisplatin	upcrtrmsix(utxbvdfygs) = qgfehmeiqg zpfczsowru (tnwtmbbbll ) View more	Positive	10 Dec 2020
				pemetrexed/cisplatin	upcrtrmsix(utxbvdfygs) = vljlymwyfe zpfczsowru (tnwtmbbbll ) View more
NCT02879669 (PRNewswire) Manual	Phase 1/2	Mesothelioma	31	Standard of Care+ONCOS-102	fiyilrqywq(wpliqaipkg) = itjuzjssrl sdxtpxysdp (lxivkphsvz )	Positive	24 Nov 2020
				Standard of Care	fiyilrqywq(wpliqaipkg) = ofxvzkwkjw sdxtpxysdp (lxivkphsvz )
NCT02963831 (ASCO 12020 \| ASCO 22020) Manual	Phase 1/2	Ovarian Epithelial Carcinoma \| Metastatic Colorectal Carcinoma	17	durvalumab+cyclophosphamide+ONCOS-102	nwrkiqnhzm(efvqdxmfvy) = hypokalemia (n = 2); anemia, myocarditis, increased GGT, and influenza like illness (n = 1 each) ggiwixgobi (uejbtspnek ) View more	Positive	29 May 2020

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