Imvax Charges Ahead with Phase IIb Glioblastoma Trial

By Mark Terry
March 30, 2023

Philadelphia-based Imvax recently announced it had dosed the first patient in its Phase IIb trial of IGV-001 in patients with newly diagnosed glioblastoma. Company CEO John Furey took time to speak with BioBuzz about the study and the company as a whole.

IGV-001 is the company’s lead program, an autologous biologic-device combination product. It comes out of the company’s Goldspire™ technology program.

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Furey said, “We basically take a patient’s tumor cells and we utilize insulin-like growth factor type 1 receptor (IGF-1R) antisense and incubate the tumor overnight and radiate the cells as well. Essentially, we think that the combination of approaches and use of a microchamber induces immunogenic cell death.”

The antigens are generated from the immunogenic cell death and contained in the microchambers. In treating glioblastoma, a brain tumor, the microchambers are implanted for 48 hours on either side of the abdomen. Then they are removed.

“The antigens that have been generated from that person’s own tumor signature basically migrate to the lymphatic system and generate T-cells. In glioblastoma, one of the major limitations for treatment is the blood-brain barrier is closed in most cases. But as this procedure takes place within two to three days after the craniotomy where we get the starting tumor material, the blood-brain barrier is still open,” Furey said.

This allows the T-cells to penetrate the brain and into the tumor site cavity and attack the remaining residual tumor that’s left after the surgical procedure.

“It’s a unique approach. It uses vaccine-like approaches in generating a T-cell response, but it’s not your classical cancer vaccine per se,” Furey said.

The Phase IIb trial is expected to enroll up to 93 participants at about 25 sites in the U.S. In March 2023, they expect to activate five to seven sites. Although it will depend on how the study progresses, Furey thinks they will have data by mid-2025, when they expect to see progression-free survival (PFS) signals emerge. The primary endpoint of the study is PFS. Key secondary endpoints include overall survival (OS) and safety.

Furey notes that there hasn’t been an advance in the care for glioblastoma patients for almost two decades. “We expect there to be a significant interest in this study and we already had significant interest before we actually launched it. We are hopeful that we will have everybody recruited by the end of this calendar year.”

He also points out that glioblastoma is a rare cancer, with only about 13,000 patients in the U.S. As a result, the FDA has granted the therapy Orphan Drug designation.

Imvax was founded in 2016, spun out of technology licensed from Thomas Jefferson University. The research was developed by Imvax’s co-founder and Chief Medical Officer, David W. Andrews, M.D. Andrews still serves at Thomas Jefferson University Hospital as Professor and Vice Chair of Clinical Service, Department of Neurological Surgery, and Chief of the Division of Neuro-oncology.

Furey said that Andrews had conducted a Phase Ib study earlier on newly diagnosed glioblastoma patients. “The company did a Series A round in 2017 and a B round in July 2019. I joined in September 2019 and we did a C round for $112 million in July 2020. We had some wonderful interim Phase Ib data Andrews had presented at AACR (American Association for Cancer Research). Over the last three-and-a-half years, using the proceeds from the A and B round, what we’ve done is developed a fully integrated biotech company.”

In addition to IGV-001, the company’s pipeline includes IEC-001 for endometrial cancer, IHC-001 for hepatocellular carcinoma, IUC-001 for urothelial cancer and IOC-001 for ovarian cancer.

The company is currently preparing an Investigational New Drug (IND) application for a Phase Ib trial for IEC-001 in endometrial cancer.

“We have our own manufacturing, our own research and our own clinical development capabilities,” Furey said. “When David spun out the company, initially it was very much focused on glioblastoma, but there were some hints about other tumors. And we have been doing primary science work, preclinical work, and have line-of-sight to additional indications in the gynecological space.”

Phase I trials of IGV-001 demonstrated the therapy-device combination was safe and well tolerated. The Phase Ib trial also showed several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and several biomarker changes that indicated the presence of an immune response.

The Phase Ib trial was performed at Jefferson, said Furey, with 33 patients. “It was both a dose-ranging study and a safety study on post hoc analysis. A typical patient can experience probable median survival of between 15 and 16 months with traditional glioblastoma treatment. What we actually saw with our patients in the highest dose was median survival of 38 months and an equivalent tripling of PFS, which was very comparable to the OS. And the quality of life for those patients was pretty good as well.”

Given the current investing environment, Furey says everybody has “been really keenly looking at their platform, at their clinical programs and making thoughtful decisions about where to play their bets.”

Imvax has very good preclinical data in other cancers, with expectations of filing for an endometrial cancer study. Furey said, “I think our emphasis in the next 12 to 18 months in terms of funding and support will be for the Phase IIb trial in glioblastoma. And we want to prosecute that and then we’ll see where we are, probably in early 2024, what the funding and investment environment looks like in order to launch other studies. I think if we have a good PFS readout in 2025, we will have a lot more room to maneuver in terms of what we would do related to further studies and advancing the company.”