Drugs / ONCOS-102
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03003676 | Dec 2016 → Jul 2020 | — | Targovax Oy | Completed | No outcome recorded |
| Phase 1 | NCT01598129 | Apr 2012 → Oct 2013 | cancer | Targovax Oy | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03514836 | May 2018 → Jan 2021 | castration-resistant prostate carcinoma | SOTIO a.s. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02963831 | Sep 2017 → Jun 2022 | appendix cancer, ovarian carcinoma | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT02879669 | Jun 2016 → May 2020 | — | Targovax Oy | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05561491 | Jan 2024 → Jun 2027 | cutaneous melanoma | Targovax Oy | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2023-09-04 | Targovax Oy | Results ONCOS-102 mesothelioma study published in Journal for ImmunoTherapy of Cancer circio.com ↗
In first line patients, the OS rate at 30 months was 34.1% for ONCOS-102-treated patients, which is a clear improvement over the first-line SoC-only control group where the OS rate was 0%. |
| 2022-10-20 | Targovax Oy | Results The ONCOS-102 phase 1b melanoma study is published in the prestigious scientific journal Clinical Cancer Research – with updated publication info circio.com ↗
As expected, ONCOS-102 generated strong and durable immune activation in the treated patients, which translated into a promising objective response rate (ORR) of 35%. |
| 2022-10-20 | Targovax Oy | Results The ONCOS-102 phase 1b melanoma study is published in the prestigious scientific journal Clinical Cancer Research circio.com ↗
As expected, ONCOS-102 generated strong and durable immune activation in the treated patients, which translated into a promising objective response rate (ORR) of 35%. |
| 2022-09-27 | Targovax Oy | Regulatory Targovax’ studie i føflekkreft har blitt godkjent for oppstart av amerikanske FDA circio.com ↗
Targovax annonserer i dag at FDA har akseptert og gitt formelt klarsignal for å igangsette fase 2 kombinasjonsstudien med ONCOS-102 i føflekkreft. |
| 2022-09-27 | Targovax Oy | Regulatory Targovax receives approval to proceed with the ONCOS-102 phase 2 melanoma study from the US FDA circio.com ↗
Targovax ASA (OSE: TRVX), a clinical-stage immuno- oncology company developing immune activators to target solid tumors, today announces that the FDA has accepted the protocol and given the formal go-ahead to proceed with the planned ONCOS-102 phase 2 trial in melanoma. |
| 2022-05-27 | Targovax Oy | Results Targovax announces publication of the two abstracts accepted for poster presentation at ASCO 2022 circio.com ↗
The first poster summarizes the complete efficacy and immunological study data for the Targovax-sponsored mesothelioma trial, showing strong 30-month survival rate of 34.3% in the ONCOS-102-treated group vs. 18.2% in the control group |
| 2022-03-09 | Targovax Oy | Results Targovax ASA: Poster presentation at the AACR Annual Meeting circio.com ↗
The abstracts show ONCOS-102 drives pro-inflammatory modulation of the tumor micro-environment in PD-1 refractory melanoma tumors. |
| 2021-12-20 | Targovax Oy | Results Targovax ASA: ONCOS-102 achieves 25.0 months median overall survival in first line mesothelioma circio.com ↗
At the 30-month follow-up, mOS was 25.0 months for the subgroup of randomized, first-line ONCOS-102-treated patients (n=8). |
| 2021-09-16 | Targovax Oy | Results Targovax ASA: Poster at European Society for Medical Oncology (ESMO) circio.com ↗
The poster concludes that co-administration of ONCOS-102 and pembrolizumab is safe and feasible for patients with melanomas progressing on PD-1 blockade. |
| 2021-06-22 | Targovax Oy | Regulatory Targovax receives Fast Track designation for ONCOS-102 in melanoma circio.com ↗
today announces that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA. |
| 2021-06-10 | Targovax Oy | Results Targovax’s ONCOS-102 mesothelioma 24-month data shows class-leading median overall survival circio.com ↗
At the 24-month follow-up, it was determined that the final mOS will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (n=8). |
| 2021-02-23 | Targovax Oy | Results Continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up circio.com ↗
At the 21-month follow-up, half of the patients in the first-line ONCOS-102-treated group of the randomized part of the trial were still alive, and mOS was not yet reached. |
| 2021-02-15 | Targovax Oy | Regulatory Targovax receives Fast-Track designation for ONCOS-102 circio.com ↗
The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. |
| 2020-12-01 | Targovax Oy | Results Targovax announces impressive objective responses as well as effects on non-injected lesions in ONCOS-102 trial in anti-PD1 refractory melanoma patients circio.com ↗
For the trial overall, tumor responses were observed in 7 out of 20 evaluable patients treated with the ONCOS-102 and pembrolizumab combination, translating into an ORR of 35% by RECIST 1.1 criteria. |
| 2020-11-24 | Targovax Oy | Results Targovax demonstrates encouraging survival data for ONCOS-102 in mesothelioma circio.com ↗
At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. |
| 2020-10-13 | Targovax Oy | Results Targovax announces that the ONCOS-102 and durvalumab trial successfully completes part 1 in colorectal cancer circio.com ↗
The pre-defined disease control efficacy threshold in part 1 in the colorectal cancer cohort has been met |
| 2020-06-22 | Targovax Oy | Results Targovax’s ONCOS-102 mesothelioma 12-month data powerfully demonstrate broad immune activation linked to clinical benefit circio.com ↗
The median Progression Free Survival (mPFS) for ONCOS-102 treated first line patients remains at 8.9 months, which is identical to the previously reported early data. |
| 2020-05-14 | Targovax Oy | Results Targovax announces that the ONCOS-102 and durvalumab abstract is selected for a Poster Discussion Session at ASCO circio.com ↗
No dose-limiting toxicities were observed, and the combination had an acceptable safety profile. |
| 2020-05-04 | Targovax Oy | Results Targovax releases update for mesothelioma trial combining ONCOS-102 and chemotherapy circio.com ↗
The median Progression Free Survival (mPFS) remains in line with previously published data and compares favorably with historical control. |
| 2020-01-21 | Targovax Oy | Results Targovax announces encouraging data in mesothelioma study combining ONCOS-102 and standard of care chemotherapy circio.com ↗
Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the first set of clinical results from the randomized phase I/II trial of ONCOS-102 in combination with standard of care chemotherapy in malignant pleural mesothelioma (MPM). |
| 2019-11-11 | Targovax Oy | Results Presentation of ONCOS-102 melanoma data at SITC Annual Meeting circio.com ↗
Dr. Shoushtari, MD, Medical Oncologist, Memorial Sloan Kettering, presented results from part 1 of Targovax’s phase I trial in anti-PD1 refractory melanoma combining ONCOS-102 with Keytruda. |
| 2019-07-08 | Targovax Oy | Results Targovax announces encouraging results from part 1 of the ONCOS-102 and Keytruda combination trial in anti-PD1 refractory melanoma circio.com ↗
The efficacy is also very encouraging, with three of nine patients demonstrating a clinical response (33% ORR); one patient had a complete response (CR) and two patients had partial responses (PR) according to RECIST1.1 and irRECIST assessment criteria. |
| 2019-06-03 | Targovax Oy | Results Targovax announces publication of in vivo abscopal effect of ONCOS-102 and Keytruda combination circio.com ↗
By Day 40, tumors on the non-injected side of the animals had shrunk by an average of 70%. |
| 2018-09-27 | Targovax Oy | Results Targovax announces interim results from Phase I trial of ONCOS-102 in checkpoint inhibitor refractory melanoma circio.com ↗
Results show that one of the six patients had a complete response to the treatment. |
| 2018-09-12 | Targovax Oy | Results Targovax announces publication of new oncolytic virus data in the Journal of Medical Virology and Cancer Gene Therapy circio.com ↗
This result provides an important in vivo mechanistic proof that ONCOS-102 can generate a directed T-cell response towards a well-known TAA. |
| 2018-05-02 | Targovax Oy | Results Targovax announces early signal of efficacy in ONCOS-102 trial in mesothelioma circio.com ↗
Three out of the six patients (50%) responded, with one patient showing a partial response and two patients showing stable disease, according to the Response Evaluation Criteria In Solid Tumors guidelines, RECIST 1.1. |
| 2018-02-07 | Targovax Oy | Results Targovax announces completion of safety lead-in and preliminary immune activation data in ONCOS-102 trial in mesothelioma circio.com ↗
Systemic release of several pro-inflammatory cytokines was observed (3/3 patients analyzed), demonstrating that the treatment triggers an innate immune response. |
| 2018-01-04 | Targovax Oy | Results Targovax announces that ONCOS-102 generates immune activation in checkpoint inhibitor refractory melanoma patients circio.com ↗
These data indicate that ONCOS-102 may induce both an innate and adaptive immune activation in CPI refractory patients. |
| 2017-12-11 | Targovax Oy | Results Targovax announces that first combination trials with ONCOS-102 have passed their initial, planned, independent safety reviews circio.com ↗
The safety reviews of ONCOS-102 in the first four patients in the melanoma trial and first three patients in the mesothelioma trial have been completed without any safety concerns. |
| 2016-10-21 | Targovax Oy | Results Targovax presents ONCOS-102 scientific rationale at the European Society of Gene and Cell Therapy circio.com ↗
Clinical data from a recently completed Phase I study show how ONCOS-102 was able to immune activate patients with treatment refractory malignant mesothelioma at a lesional level by performing both baseline and follow-up biopsies. |
| 2016-07-06 | Targovax Oy | Results Targovax presents encouraging preclinical data on ONCOS-102 circio.com ↗
The International Journal of Cancer publishes preclinical in vivo data in a mesothelioma xenograph model, demonstrating synergy of ONCOS-102 with pemetrexed and cisplatin, the current standard of care in malignant pleural mesothelioma. |
| 2016-06-09 | Targovax Oy | Regulatory Targovax receives regulatory approval in Spain to conduct a clinical trial with its oncolytic virus ONCOS-102 circio.com ↗
Targovax receives regulatory approval to conduct a study in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung. |
| 2016-02-02 | Targovax Oy | Regulatory Targovax submits a study of its adenovirus based immune therapy ONCOS-102 to the regulatory authorities in Spain circio.com ↗
Targovax has submitted a study protocol to the regulatory authorities in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos. |
| 2015-11-05 | Targovax Oy | Results Targovax ASA: Immunotherapy with ONCOS-102 show potential to activate immunologically silent tumors and reduce local immune suppression in advanced tumors circio.com ↗ |
| 2015-01-12 | Targovax Oy | Regulatory Targovax ASA: ONCOS-102 granted US lung cancer orphan drug designation circio.com ↗
Oncos Therapeutics Ltd., a company developing novel cancer immune therapies, announced today that the US Food and Drug Administration (FDA) has granted an orphan drug designation for its lead compound ONCOS-102 in the treatment of malignant mesothelioma. |
| 2014-12-17 | Targovax Oy | Results Targovax ASA: “ONCOS-102 sensitizes tumors to other immunotherapies” – Paper published in the latest issue of OncoImmunology circio.com ↗
The treatment resulted in prominent infiltration of CD8+ lymphocytes to tumor, marked induction of systemic antitumor CD8+ T-cells and induction of Th1-type polarization in the tumor. |
| 2014-11-25 | Targovax Oy | Regulatory Targovax ASA: Oncos Therapeutics receives a positive opinion on orphan drug designation for ONCOS-102 circio.com ↗
On 13 November 2014, the Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the application for orphan drug designation for Oncos Therapeutics’ lead compound ONCOS-102, a genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor. |
| 2014-11-20 | Targovax Oy | Results Targovax ASA: Oncos presented a poster at EORTC-NCI-AACR Meeting 2014 circio.com ↗
Oncos presented a poster at EORTC-NCI-AACR meeting entitled “Tumor-infiltrating lymphocytes (TILs) following intratumoral administration of ONCOS-102 are associated with prolonged overall survival in last line solid tumor patients” |
| 2014-11-10 | Targovax Oy | Results Targovax ASA: Oncos presented a poster at the SITC Annual Meeting 2014 circio.com ↗
Gene expression analysis of tumors demonstrates an induction of Th1 type immune response following intratumoral administration of ONCOS-102 in refractory solid tumor patients |
| 2014-06-02 | Targovax Oy | Regulatory Oncos Therapeutics granted US and EU Orphan Drug Designation for ONCOS-102 in ovarian cancer circio.com ↗
We are pleased to receive orphan drug designations for ONCOS-102 from the two leading regulatory agencies in the world. |
| 2014-05-08 | Targovax Oy | Results Targovax ASA: ONCOS – achievement in cancer immunotherapy – PRESS RELEASE circio.com ↗
The data were presented in two separate podium presentations on May 7th and 8th at the Annual Meeting of the Association for Cancer Immunotherapy (CIMT) in Mainz, Germany. |
| 2014-02-28 | Targovax Oy | Regulatory Targovax ASA: ATMP classification for ONCOS-102 by European Medicines Agency circio.com ↗
Advanced-therapy medicinal product (ATMP) classification was confirmed for Oncos’ lead product ONCOS-102 by the Committee for Advanced Therapies (CAT) of European Medicines Agency. |
All press releases naming this drug 70 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ONCOS-102 | “ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis” NCT03514836 ↗ |
| Known as | CGTG-102 | “ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers” NCT01598129 ↗ |
| Route | Intravenous | “for intratumoral and intravenous injection” NCT01598129 ↗ |