- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Oncolytic hsv-1(vc2) gm-csf regulates the proinflammatory profile suggestive of an immunomodulatory effect in PDAC cells (Section 11) - Mar 5, 2024 - Abstract #AACR2024AACR_4724;
Although 5-fluorouracil or gemcitabine-based chemotherapy is considered as standard of care, harnessing immunological pathways may potentially convert PDAC to a "hot" tumor, thereby providing survival advantage to patients...The FDA approval of T-VEC for the treatment of stage IIIB/IV melanoma validates the preceding argument...Based on the evidence presented here, it is speculated that VC2GM-CSF-induced proinflammatory profile in KPC and Mia PaCa-2 cells converts to an immunomodulatory one characterized by the regulation of FasL and PD-L1. The effect of VC2GM-CSF in a PDAC organoid model to understand the interplay between the tumor and the stromal cells in response to the virus is currently underway.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, IO biomarker, Gene therapy: HIV-Encoded Gene Therapy as Anti-cancer Therapeutics: A Narrative Review. (Pubmed Central) - Mar 4, 2024
Abstract is embargoed at this time. The FDA has cleared T-VEC, an HSV-based oncolytic virus, for use in biological cancer treatment after its successful completion of human clinical trials...HIV-encoded proteins are also hypothesized to promote mitochondrial homeostasis causing bystander-induced apoptosis.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
neoBCC (Amphith) - Feb 28, 2024 - Abstract #EADO2024EADO_204;
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Provenge (sipuleucel-T) / Bausch Health
Review, Journal: Advances and prospects of mRNA vaccines in cancer immunotherapy. (Pubmed Central) - Jan 4, 2024
We expect a rapid development of mRNA vaccines for cancer immunotherapy in the near future. This review provides a brief overview of the current status of mRNA vaccines, highlights the action mechanism of cancer mRNA vaccines, their recent advances in clinical trials, and prospects for their clinical applications.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Oncolytic virus: Commentary on oncolytic viruses: past, present, and future. (Pubmed Central) - Dec 27, 2023
Whither oncolytic viruses? From the peak of their popularity in the early 2000s, when the ONYX-015 adenovirus had just entered the clinic, and then again in 2015 when the Food and Drug Administration-approved talimogene laherparepvec (also known as OncoVEX), which briefly revived interest, oncolytic viruses (OVs) have mostly fallen out of favor despite the many pharmaceutical companies with OVs in development.This commentary enumerates and addresses the core conceptions, perceptions, and misconceptions that characterize the current 'trough of disillusionment' in which the field of anticancer virotherapy finds itself and suggests reasons for optimism.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, IO biomarker, Surgery: Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (clinicaltrials.gov) - Dec 6, 2023
P2, N=40, Active, not recruiting,
From the peak of their popularity in the early 2000s, when the ONYX-015 adenovirus had just entered the clinic, and then again in 2015 when the Food and Drug Administration-approved talimogene laherparepvec (also known as OncoVEX), which briefly revived interest, oncolytic viruses (OVs) have mostly fallen out of favor despite the many pharmaceutical companies with OVs in development.This commentary enumerates and addresses the core conceptions, perceptions, and misconceptions that characterize the current 'trough of disillusionment' in which the field of anticancer virotherapy finds itself and suggests reasons for optimism. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Vyjuvek (beremagene geperpavec) / Krystal Biotech
Preclinical, Journal, Gene therapy: Attenuated Replication-Competent Herpes Simplex Virus Expressing an ECM-Modifying Transgene Hyaluronan Synthase 2 of Naked Mole Rat in Oncolytic Gene Therapy. (Pubmed Central) - Nov 25, 2023
Another HSV-based drug, beremagene geperpavec (B-VEC), received approval in 2023 to treat the rare genetic disease dystrophic epidermolysis bullosa, and was also the first clinically approved HSV vector carrying an extracellular matrix (ECM)-modifying transgene...The viral replication, transgene expression and cytotoxic effect of the novel vector was studied in glioma cells. Our results show that an attenuated, replication-competent HSV vector expressing a foreign ECM-modifying transgene, namely HAS2, provides an effective tool to study and combat cancer in humans.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Tumor mutational burden, IO biomarker, Metastases: S1607: Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov) - Nov 8, 2023
P2, N=42, Active, not recruiting,
Our results show that an attenuated, replication-competent HSV vector expressing a foreign ECM-modifying transgene, namely HAS2, provides an effective tool to study and combat cancer in humans. Trial completion date: Jun 2023 --> Nov 2024
- |||||||||| Review, Journal, Gene therapy: Current State of Human Gene Therapy: Approved Products and Vectors. (Pubmed Central) - Oct 28, 2023
In this comprehensive exploration, we delve into a rich assortment of 16 drugs, from siRNA, miRNA, and CRISPR/Cas9 to DNA aptamers and TRAIL/APO2L, as well as 46 carriers, from AAV, AdV, LNPs, and exosomes to naked mRNA, sonoporation, and magnetofection. The article also discusses the advantages and disadvantages of each product and vector type, as well as the current challenges faced in the practical use of gene therapy and its future potential.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Oncolytic viral therapy: a review and promising future directions. (Pubmed Central) - Oct 25, 2023
Moreover, a major component of oncolytic viral therapy has been herpes simplex virus, with talimogene laherparepvec being the only FDA-approved oncolytic viral therapy for the treatment of melanomas...Intrathecal continuous delivery of OVs is a promising prospect, potentially by adapting the novel continuous irrigation and drainage IRRAflow catheter. Further exploration and testing of the IRRAflow catheter should be undertaken.
- |||||||||| Journal, PD(L)-1 Biomarker, IO biomarker: Systemic Therapy for Melanoma: ASCO Guideline Update. (Pubmed Central) - Oct 22, 2023
Talimogene laherparepvec is no longer recommended as an option for patients with BRAF wild-type disease who have progressed on anti-PD-1 therapy. Ipilimumab- and ipilimumab-containing regimens are no longer recommended for patients with BRAF-mutated disease after progression on other therapies.This full update incorporates the new recommendations for uveal melanoma published in the 2022 Rapid Recommendation Update.Additional information is available at www.asco.org/melanoma-guidelines.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus: Biosafety and biohazard considerations of HSV-1-based oncolytic viral immunotherapy. (Pubmed Central) - Oct 5, 2023
With comprehensive information and educational programs, our hope is that updated biosafety guidance on OV immunotherapies will reduce logistical hurdles to ensure that patients have access to these innovative and potentially life-saving medicines across treatment settings. This work reviews a comprehensive collection of data in conjunction with the opinions of the authors based on their clinical experience to provide the suggested framework and key considerations for implementing biosafety protocols for OV immunotherapies, namely T-VEC, the only approved agent to date.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date: NIVEC: Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease (clinicaltrials.gov) - Oct 4, 2023
P2, N=24, Active, not recruiting,
This work reviews a comprehensive collection of data in conjunction with the opinions of the authors based on their clinical experience to provide the suggested framework and key considerations for implementing biosafety protocols for OV immunotherapies, namely T-VEC, the only approved agent to date. Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Apr 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Journal, Metastases: Synergistic Effect of TVEC and Radiotherapy in the Treatment of Advanced Melanoma. (Pubmed Central) - Oct 3, 2023
However, we did not find a significant difference in locoregional recurrence or OS. Given some promise with the combined approach and potential immune enhancement from RT, larger trials are needed to better understand the potential positive signal from our study.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Biomarker, Enrollment change, Trial suspension: Neoadjuvant T-VEC in High Risk Early Melanoma (clinicaltrials.gov) - Sep 15, 2023
P2, N=6, Suspended,
Suspended --> Active, not recruiting N=62 --> 6 | Recruiting --> Suspended
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Preclinical, Journal, Oncolytic virus: Multiple Administration Routes, Including Intramuscular Injection, of Oncolytic Tanapoxvirus Variants Significantly Regress Human Melanoma Xenografts in BALB/c Nude Mice Reconstituted with Splenocytes from Normal BALB/c Donors. (Pubmed Central) - Aug 30, 2023
The Food and Drug Administration in the United States has approved one oncolytic herpes simplex virus expressing granulocyte-macrophage colony-stimulating factor (Talimogene Laherparepvec) for the treatment of metastatic melanoma, and others could soon follow for this and other cancers...The results demonstrated that TPV/?66R/mIL-2 treatment IV or IM had significantly greater rates of tumor regression than RC-treated mice but failed to exert this effect when both routes were used simultaneously. Data obtained through these experiments support the continued development of Tanapoxvirus for the treatment of human melanoma and using immune reconstitution to create intact adaptive immunity in a xenograft context, which can allow other tropism-limited OVs to be studied against human cancers.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Oncolytic virus: A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer. (Pubmed Central) - Aug 29, 2023
P1
This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities. Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, canerpaturev (TBI-1401) / Takara
Review, Journal, IO biomarker: New Treatment Horizons in Uveal and Cutaneous Melanoma. (Pubmed Central) - Aug 26, 2023
Furthermore, combining oncolytic viruses with immunotherapies, such as CAR-T cell therapy, holds great potential. Understanding the intrinsic molecular features of melanoma and their role in shaping novel therapeutic approaches provides insights into targeted interventions and paves the way for more effective treatments for CM and UM.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Synergistic Effect of TVEC and Radiotherapy in the Treatment of Advanced Melanoma (Hall B2; In Person Only; Screen: 26) - Aug 22, 2023 - Abstract #ASTRO2023ASTRO_1357;
However, we did not find a significant difference in locoregional recurrence or OS. Given some promise with the combined approach and potential immune enhancement from RT, larger trials are needed to better understand the potential positive signal from our study.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial termination, Tumor mutational burden: Glaspy BMS CA209-9ET Breast: Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted (clinicaltrials.gov) - Aug 15, 2023
P1, N=6, Terminated,
Given some promise with the combined approach and potential immune enhancement from RT, larger trials are needed to better understand the potential positive signal from our study. Trial completion date: Jul 2024 --> May 2023 | Active, not recruiting --> Terminated; enrollment
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, PD(L)-1 Biomarker, IO biomarker, Surgery: Clinical updates in neoadjuvant immunotherapy for melanoma before surgery. (Pubmed Central) - Aug 14, 2023
Localized intralesional therapies such as Talimogene laherparepvec (T-VEC) and Tavokinogene Telseplasmid (TAVO) electro-gene-transfer combined with anti-PD1 have demonstrated favorable pathologic responses and increased immune activation...Current evidence supports neoadjuvant therapy as a standard of care for locoregionally advanced melanoma. Ongoing research will define the optimal regimens and the biomarkers of therapeutic predictive and prognostic value.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion, Trial completion date, Trial primary completion date: Study of TVEC in Patients With Cutaneous Squamous Cell Cancer (clinicaltrials.gov) - Jul 27, 2023
P2, N=11, Completed,
No abstract available Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Jul 2023 | Trial primary completion date: Mar 2026 --> Jul 2023
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, tasadenoturev (DNX-2401) / DNAtrix
Review, Journal, Oncolytic virus: Oncolytic virotherapy evolved into the fourth generation as tumor immunotherapy. (Pubmed Central) - Jul 25, 2023
Further investigation in a prospective trial is warranted. OVs, which are advancing into clinical trials, are being envisioned as the frontier clinical anti-tumor agents coming soon.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Enrollment closed, IO biomarker: NCI#10057: Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers (clinicaltrials.gov) - Jul 20, 2023
P2, N=68, Active, not recruiting,
OVs, which are advancing into clinical trials, are being envisioned as the frontier clinical anti-tumor agents coming soon. Recruiting --> Active, not recruiting
- |||||||||| Review, Journal, Gene therapy: Clinical applications of gene therapy for rare diseases: A review. (Pubmed Central) - Jul 17, 2023
An initial comparison of the effectiveness of AAV and oligonucleotide therapies in SMA is possible with Zolgensma, an AAV serotype 9 vector, and Spinraza. Through these examples of marketed gene therapies and gene cell therapies, we will discuss the expanding applications of such novel technologies to previously intractable rare diseases.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic virus, Tumor cell: Development and application of oncolytic viruses as the nemesis of tumor cells. (Pubmed Central) - Jul 13, 2023
In recent years, oncolytic virus therapy has shown increasingly promising application prospects and has become a major research focus in the field of cancer treatment. This article reviews the development, classification, and research progress of oncolytic viruses, as well as their mechanisms of action, therapeutic methods, and routes of administration.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Intratumoral Immunotherapy: Is It Ready for Prime Time? (Pubmed Central) - Jul 10, 2023
Studies mainly focused on multi-metastatic patients, with some positive trials such as T-VEC in melanoma, but evidence of clinical benefit is still lacking...The clinical benefit might be improved in patients with a low tumor burden. Future clinical trials should focus on adequate timing of treatment delivery during the course of the disease, particularly in the neoadjuvant setting.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change, Trial completion date, Metastases: TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - Jun 22, 2023
P1/2, N=8, Active, not recruiting,
No abstract available Recruiting --> Active, not recruiting | N=46 --> 8 | Trial completion date: Jun 2024 --> Nov 2024
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