MVR-C5252 / ImmVira Pharma - LARVOL DELTA

A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: ImmVira Pharma Co. Ltd

New P1/2 trial • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor

Intratumoral IL-12/anti-PD-1 Oncolytic HSV1 (MVR-C5252) is safe and immunoactive in recurrent high-grade glioma: preliminary phase 1 results from a multicenter multistage clinical trial (EANO 2025) - "Preliminary data show that MVR-C5252 is safe, feasible, and active in recurrent HGG. Early CSF-based analyses reveal induction of Th1 and cytotoxic CD8⁺ T cell responses and remodeling of the CNS immune milieu. Stages 2-3 will define the optimal regimen for Phase 2 evaluation."

Clinical • IO biomarker • P1 data • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CD4 • CD8 • GZMB • IFNG • IL10 • IL12A • IL12RB1 • PRF1

ImmVira Presented Clinical Results of Oncolytic Product MVR-C5252 Targeting Malignant Glioma via Convection-Enhanced Delivery at 2025 AACR Annual Meeting (PRNewswire) - P1 | N=51 | PuMP (NCT06126744) | "The Phase I trial, for which the clinical study results were released, was conducted in collaboration with Duke University....In Stage 1A of the study, three patients received 5×10⁶ PFU and completed the dose-limiting toxicity ('DLT') period. Serial cytokine analysis of cerebrospinal fluid ('CSF') showed dynamic immune responses and intended biologic activity, with measurable changes in cytokine concentrations post-infusion. In addition, no serious adverse events ('SAEs'), DLTs, or Grade 3–5 adverse events ('AEs') occurred. The only reported Grade 1–2 AEs included fatigue, flu-like symptoms, and cognitive disturbance, indicating a favorable safety profile of MVR-C5252 delivered via CED."

P1 data • Malignant Glioma

A phase 1 study of intratumoral HSV1 co-expressing IL-12 and PD1 blocking antibody (MVR-C5252) in recurrent high-grade glioma (AACR 2025) - P1 | "Preliminary findings indicate MVR-C5252 delivered via CED is safe and well-tolerated in recurrent HGG, with early immune activation suggesting intended biologic activity. Ongoing dose escalation and immune analyses aim to define the therapeutic potential of MVR-C5252.Clinical Trial Identifier: NCT06126744."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • IL12A

PuMP: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Enhanced therapeutic efficacy for glioblastoma immunotherapy with an oncolytic herpes simplex virus armed with anti-PD-1 antibody and IL-12. (PubMed, Mol Ther Oncol) - "Moreover, syngeneic mouse models showed that the murine surrogate of C5252 has superior anti-tumor activity compared to the unarmed backbone virus, with enhanced immune activation. Taken together, our findings support C5252 as a promising therapeutic option for glioblastoma treatment, positioning it as a highly promising candidate for clinical translation."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Herpes Simplex • Oncology • Solid Tumor • CASP3 • CASP7 • CNTFR • IL12A

Advanced glioblastoma immunotherapy: Attenuated herpes oncolytic virus armed with anti-PD-1 antibody and IL-12 (AACR 2024) - "With the unique combination of safety, potent anti-tumor activity, and immune-stimulatory properties, MVR-C5252 makes it a big potential candidate to address the pressing need for effective treatment strategies of GBM."

IO biomarker • Metastases • Oncolytic virus • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • CASP3 • IL12A

PuMP: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: Duke University | Initiation date: Feb 2024 ➔ May 2024

Trial initiation date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

PuMP: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: Duke University

New P1 trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

ImmVira's oncolytic product MVR-C5252 targeting malignant glioma obtained NMPA's approval for Clinical Trial in China (PRNewswire) - "ImmVira announced that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ('NMPA') for Phase I clinical trial in China on March 29, 2023....The Company is also planning to jointly carry out clinical research on MVR-C5252 with Duke University in the U.S., and for the first time to use Convection Enhanced Delivery ('CED') as the administration method."

Licensing / partnership • New P1 trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Oncolytic herpes simplex virus delivery of dual CAR targets of CD19 and BCMA as well as immunomodulators to enhance therapeutic efficacy in solid tumors combined with CAR T cell therapy. (PubMed, Front Oncol) - "Efficacy studies demonstrated that combination with T7011 and CAR-T or CAR-T cells showed significant synergistic anti-tumor responses in several solid tumor models. These studies indicated that the new generation of oHSV T7011 can be a promising combinational therapy with CD19 or BCMA-specific CAR T cells for the treatment of a broad range of solid tumors."

CAR T-Cell Therapy • IO biomarker • Journal • Hematological Disorders • Hematological Malignancies • Herpes Simplex • Immune Modulation • Infectious Disease • Inflammation • Oncology • Solid Tumor • CD19 • IL12A

ImmVira announced its signing of Series C+ financing and negotiation with further investors for the round (PRNewswire) - "ImmVira announced its successful signing of Series-C+ financing transaction documents with the first batch of investors recently....ImmVira has made numerous progress and breakthroughs since the closing of Series C financing. For pipeline research and development, MVR-T3011 IT (intratumoral injection) program is accelerating Phase II clinical study in the U.S. and China...in HNC, sarcoma, and along with other indications; MVR-T3011 IV (intravenous injection) program has achieved preliminary robust safety results and validated clinical biological activities in Phase I clinical study in U.S. and China; MVR-C5252 (targeting Glioma) program has successfully obtained IND clearance and ODD from FDA, and will initiate clinical trial shortly; MVR-T7 series (combo with CAR-T/ADC/BiTE) program has completed in-house pilot-scale manufacturing, and is currently under negotiation with multiple partners for IND application of combination treatment."

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Head and Neck Cancer • Oncology • Sarcoma

"#ImmViras Brand New #oHSV Product #MVRC5252 Targeting #MalignantGlioma Obtained #FDAs #OrphanDrug Designation https://t.co/mRzPEfdSBS" (@1stOncology)

Orphan drug • Brain Cancer • Glioma • Oncology • Solid Tumor

ImmVira's Brand New oHSV Product MVR-C5252 Targeting Malignant Glioma Obtained FDA's Orphan Drug Designation (PRNewswire) - "On August 1, 2022, U.S. time, ImmVira's brand new oncolytic herpes simplex virus ('oHSV') product MVR-C5252 targeting Malignant Glioma has obtained Orphan Drug Designation ('ODD') from U.S. Food and Drug Administration...The ODD status will further accelerate the clinical development and registration of MVR-C5252 in the United States, and will also allow MVR-C5252 to enjoy exclusive marketing and development rights and other benefits, such as protocol assistance from FDA..."

Orphan drug • Oncology

A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1; N=51; Not yet recruiting; Sponsor: ImmVira Pharma Co. Ltd

Clinical • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MRI

ImmVira's MVR-C5252 Targeting Brain Tumor Obtained US FDA's Approval for Clinical Trial (PRNewswire) - "ImmVira announces MVR-C5252 targeting Glioblastoma has received the U.S. FDA clearance to proceed with clinical trial on August 6, 2021...The IND clearance of MVR-C5252 in the United States highlights ImmVira's strong and sustainable research and development capability in designing and synthesizing viral vector with functional specificity, and marks another important step for ImmVira's pipeline expansion."

IND • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor