IGV-001 / Imvax - LARVOL DELTA

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov) - P2 | N=93 | Active, not recruiting | Sponsor: Imvax | Trial primary completion date: Jan 2025 ➔ Sep 2025

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IGV-001 cellular immunotherapy for newly diagnosed glioblastoma: overcoming the logistic challenge. (PubMed, Front Oncol) - P2 | "Patients subsequently proceeded to standard-of-care treatment with concomitant radiation-temozolomide, followed by 6 cycles of adjuvant temozolomide. Our description of the IGV-001 protocol workflow may serve as a "blueprint" for future implementation of this type of cellular immunotherapy at other centers. We further discuss some of the lessons we have learned during the trial."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Imvax Announces Completion of $29 Million Financing and Confirms Timing for Topline Results of Phase 2b Trial of IGV-001 in Newly Diagnosed Glioblastoma (Businesswire) - "Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced the closing of a $29 million financing round from existing investors. Over the past 21 months, the Company has raised $86 million to support the completion of its randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM)....Financing funds operations into 2026; Company on track to report topline results from Phase 2b trial of IGV-001 in mid-2025."

Financing • P2b data • Glioblastoma

IGV-001: A biologic-device combination product elicits potent anti-GBM responses as a monotherapy and in combination with check point inhibition (SNO 2024) - P1, P2 | "Preventative treatment with mIGV-001 limited tumor progression and extended OS in mice orthotopically (i.e., intracranially) challenged with GL261-luc2 cells. The therapeutic benefit of mIGV-001 was enhanced with anti-PD-1 treatment and the combination therapy was superior to either monotherapy."

Combination therapy • Monotherapy • Glioblastoma • Oncology

Long-term survivors from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma (SNO 2024) - P2 | "Immune correlates of IGV-001 suggest an association between peripheral T cell clonal expansion and PFS/OS outcomes. A Phase 2b randomized, multicenter, double-blind, placebo-controlled study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and results are expected to be available in 2025."

Clinical • IO biomarker • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ISS Session - Development of IGV-001 for the treatment of newly diagnosed glioblastoma (SNO 2024) - "Learning ObjectivesBy the end of the session, participants will be able to describe:• Imvax's proprietary platform, Goldspire™, and the development of IGV-001• The clinical development of IGV-001 for the treatment of newly diagnosed glioblastomaImvax is a clinical-stage biotechnology company headquartered in Philadelphia with a unique platform technology, Goldspire™, focused on delivering personalized, whole tumor-derived immunotherapies across a range of solid tumors. IGV-001, Imvax's most advanced program, is currently being evaluated in a Phase 2b clinical trial in newly diagnosed glioblastoma patients."

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

Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (ndGBM) (SNO 2024) - P2 | "A review of blinded safety data did not show any emerging risk and supports no change to the benefit-risk profile of IGV-001 versus placebo. Updated data will be presented."

Clinical • IO biomarker • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

GoldspireTM: a biologic-device combination platform engineered to induce anti-tumor responses against solid tumors via immunogenic cell death (ICD) (SITC 2024) - P1, P2 | "The lead product, IGV-001, was evaluated in newly diagnosed GBM (ndGBM) patients in a phase 1b study...Ethics Approval Biospecimens were acquired from commercial sources. In vivo studies were conducted by 3rd party contract research organizations."

Immunogenic cell death • IO biomarker • Brain Cancer • CNS Tumor • Colorectal Cancer • Genito-urinary Cancer • Glioblastoma • Kidney Cancer • Liver Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Imvax to Present Safety Data on Lead Program, IGV-001, at 2024 SNO Annual Meeting (Businesswire) - "Separately, the Company will also host a symposium focused on the development of IGV-001 for the treatment of newly diagnosed glioblastoma. Imvax will present blinded safety data from the Company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). The Phase 2b study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and top-line results are expected to be presented in mid-2025. Imvax will also present follow-on data from its Phase 1b study of IGV-001 in patients with ndGBM, as well as preclinical data of IGV-001 in combination with checkpoint inhibitors."

P1 data • P2b data • Glioblastoma

Broad applicability of the Goldspire™ platform for the treatment of solid tumors. (PubMed, Clin Immunol) - P1, P2 | "Lead product IGV-001 was evaluated in newly diagnosed glioblastoma (ndGBM) patients in Phase 1a and 1b trials (NCT02507583)...The benefit of this immunotherapy was enhanced with anti-PD-1; combination treatment was superior to either monotherapy in orthotopic GBM and melanoma models. Lastly, Goldspire elicited immune T cell activation and memory phenotypes against patient-derived endometrial tumor-derived products in co-cultures with matching immune cells."

Journal • Brain Cancer • CNS Tumor • Colorectal Cancer • Endometrial Cancer • Glioblastoma • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

CS03: Development of IGV-001 for the treatment of newly diagnosed glioblastoma (EANO 2024) - "Sponsored By Imvax"

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

Phase 2b study of IGV-001 in newly diagnosed glioblastoma (EANO 2024) - "Sponsored By Imvax"

P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Early development of IGV-001 in glioblastoma: Treatment Landscape (EANO 2024) - "Sponsored By Imvax"

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

Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (EANO 2024) - P2 | "Standard of care (SOC) for suspected GBM begins with maximal safe resection followed by adjuvant radiotherapy and temozolomide, and maintenance temozolomide. To date, the review of blinded safety data did not show any emerging risk and supports that there is no change to the benefit-risk profile of treatment with IGV-001 versus placebo. The data will be updated before presentation."

Clinical • IO biomarker • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov) - P2 | N=93 | Active, not recruiting | Sponsor: Imvax | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Imvax Announces Completion of Enrollment in Phase 2b Clinical Trial of IGV-001 and Successful Financing (Businesswire) - "Imvax...announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM)....The primary endpoint of the Phase 2b trial is Progression Free Survival (PFS) and top-line data is expected by mid-2025. Separately, the Company today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IGV-001 for the treatment of ndGBM based on the Company’s existing Phase 1b data supporting its therapeutic potential in this underserved and life-threatening condition. Imvax also announced the closing of an approximately $35 million financing round, with half of the capital coming from new investors. Over the past 15 months, the Company has raised $57 million to support the completion of the Phase 2b trial."

Enrollment closed • Fast track • Financing • P2b data • Glioblastoma

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov) - P2 | N=93 | Recruiting | Sponsor: Imvax | Phase classification: P2b ➔ P2

Phase classification • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients. (PubMed, Future Oncol) - "Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety."

Clinical • Journal • Review • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Targeted immunotherapy for glioblastoma involving whole tumor-derived autologous cells in the upfront setting after craniotomy. (PubMed, J Neurooncol) - P2b | "We have since designed a rigorous double-blinded add-on placebo-controlled trial involving our implantable biologic drug device. We conclude that IGV-001 provides a novel immunotherapy platform for historically intransigent ndGBM in this ongoing phase 2b trial (NCT04485949)."

Journal • Review • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Imvax Presents New Data at 2023 SNO Annual Meeting Supporting its Lead Program, IGV-001, in Newly Diagnosed Glioblastoma (Businesswire) - P1b | N=33 | Antisense102 (NCT02507583) | "Imvax, Inc...today announced details of its two poster presentations at the 2023 Society for NeuroOncology (SNO) 28th Annual Meeting...'I’m pleased to report that the Phase 2b study is enrolling well, and we expect to complete enrollment in the first half of 2024.'...The first poster presentation....highlights a statistically significant correlation in Imvax’s Phase 1b study of IGV-001 between progression free survival (PFS) and overall survival (OS) in the intent-to-treat (ITT) study population, suggesting the use of median PFS as an end point in future ndGBM clinical trials. Additional data presented highlighted a significant decrease at various study points of the average neutrophil-to-lymphocyte (NLR) ratio. The NLR may be a potential biomarker for positive clinical outcomes, which will be further explored as part of Imvax’s ongoing Phase 2b study in ndGBM patients."

Enrollment status • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Imvax Presents New Data at 2023 SNO Annual Meeting Supporting its Lead Program, IGV-001, in Newly Diagnosed Glioblastoma (Businesswire) - "The second poster presentation...described the ongoing Phase 2b trial (NCT04485949) including study objectives, design, endpoints, locations, and key inclusion and exclusion criteria."

Clinical protocol • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

A randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy with antisense oligo IMV-001 targeting IGF-1R, vs placebo, in newly diagnosed glioblastoma patients (SNO 2023) - P2b | "Standard of care (SOC) for suspected GBM begins with maximal safe resection followed by adjuvant radiotherapy and temozolomide, and maintenance temozolomide. The primary outcome is PFS, defined as the time from randomization to first progression, as determined by blinded central radiology review, or death. Secondary outcomes include overall survival, defined as the time from randomization to death due to any cause, and safety."

Clinical • IO biomarker • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Additional results from a phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma. (SNO 2023) - P2b | "The neutrophil:lymphocyte (N:L) ratio emerged as a potential marker of good response that will be explored further in the ongoing Phase 2b study. Overall, these data support the ongoing Phase 2b randomized study designed to assess the efficacy and safety of IGV-001 in patients with ndGBM."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Independent Supported Session: Development of IGV-001 for the Treatment of Newly Diagnosed Glioblastoma (SNO 2023) - P2b | "The speakers will introduce the GoldspireTM platform, review the results of a Phase 1b clinical study of IGV-001 in ndGBM, and discuss the ongoing Phase 2b study of IGV-001 in ndGBM. Imvax’s portfolio also includes several other programs designed to stimulate a patient’s immune system against the entire antigen signature of their tumor.Boxed lunch will be provided and seating is limited."

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

Imvax to Present New Data on Lead Program, IGV-001, at 2023 SNO Annual Meeting (Businesswire) - "Imvax, Inc...announced two poster presentations at the 2023 Society for NeuroOncology (SNO) 28th Annual Meeting in Vancouver, British Columbia, Canada, from November 15-19, 2023. At the meeting, Imvax will present new data from its Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM), as well as information relating to the company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with ndGBM. On Friday, November 17, 2023, at 12:45 p.m. PT, Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will present an Independent Support Session focused on the development of IGV-001 for the treatment of ndGBM."

Clinical • P1 data • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor