IGV-001 / Imvax - LARVOL DELTA

Future Clinical Development of IGV-001 (Businesswire) - "The Company met with the U.S. Food and Drug Administration (FDA) earlier this year to discuss the Phase 2b data and the regulatory pathway for IGV-001. Following this, the Company met with FDA in July to align on the key elements of a proposed randomized, open-label Phase 3 study of IGV-001 in approximately 375 uMGMT ndGBM patients in the United States. The planned primary endpoint of this study is overall survival (OS), and the study would include an interim analysis after a specified number of patient deaths. Imvax has incorporated the feedback from FDA into the proposed final protocol for the study, which it plans to submit to FDA in the coming months....'We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027'."

FDA event • Financing • New P3 trial • Glioblastoma

Imvax…announced that an abstract reporting results from the Company's randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM) has been accepted for poster and rapid oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO) (Businesswire) - "In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm (HR 0.60, P=0.0808). Additionally, patients in the IGV-001 arm experienced delayed deterioration of Karnofsky Performance Status (KPS) score, favorable quality-of-life measures, lower rates of severe toxicities, and reduced burden of serious adverse events as compared to the placebo arm."

P2b data • Glioblastoma

Initial efficacy and safety results of a randomized, double-blind, phase 2b study to evaluate IGV-001, an autologous cell immunotherapy, plus standard of care (SOC) versus placebo (PBO) plus SOC in adult patients with newly diagnosed glioblastoma (ndGBM) (SNO 2026) - No abstract available

Clinical • P2b data • Brain Cancer • Glioblastoma • Solid Tumor

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov) - P2 | N=99 | Active, not recruiting | Sponsor: Imvax | Trial primary completion date: Jun 2026 ➔ Jan 2027

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

Imvax...announced top line results from its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM) (Businesswire) - "In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33)....Company plans to discuss results and regulatory pathway of IGV-001 with U.S. FDA in the coming months."

FDA event • P2b data • Glioblastoma

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: Sep 2025 ➔ Apr 2026

Trial primary completion date • Brain Cancer • 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 | 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