Glioblastoma Multiforme Highlights - ASCO 2021

Catch the highlights from Day 3 ASCO21 specifically curated by DelveInsight’s SMEs that are bound to impact the Glioblastoma Multiforme Market. 

Abstract 2532: Genenta’s Temferon evaluated in patients with newly diagnosed GBM (TEM-GBM Study)

This year at ASCO 2021, Genenta presented data for its key asset, Temferon, a lentivirus based hematopoietic stem progenitor cell immuno-gene therapy, to treat patients with glioblastoma multiforme (TEM-GBM Study). The asset is delivered via engineered tumour-infiltrating monocytes (Tie2 expressing monocytes – TEMs). Temferon turns TEMs into a “Trojan Horse” to release IFN-α inside tumors, which acts against the cancer growth, thereby rebuilding the immune system.

Temferon was delivered in up to 21 newly diagnosed patients with glioblastoma & unmethylated MGMT

promoter. In all, 15 patients were enrolled in part A (dose escalation) of the study. The study showed that seven patients had progressive disease as this was highly obvious with this tumour type. Serious adverse events (SAEs) included infections, venous thromboembolism, brain abscess, poor performance status and others. This study demonstrated that Temferon was well tolerated by patients, with no dose-limiting toxicities identified to date.

Abstract 2047: VBI Vaccines present data on GM-CSF and AS01B adjuvants in a phase I/IIa trial of a therapeutic CMV vaccine (VBI-1901) against recurrent glioblastoma (GBM)

As new advances are going on in glioblastoma, VBI Vaccines also presented data from its phase I/II study evaluating CMV vaccine (VBI-1901) against recurrent glioblastoma (GBM) at ASCO 2021. As per the company, VBI-1901 is a novel cancer vaccine; an immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65.

Although much research is going on in the field, patients still have very limited treatment options

and have a high mortality rate as this tumour progresses very rapidly. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy.

The study enrolled 10 patients in arm 1 (VBI-1901 10µg GM-CSF) and 10 patients in arm 2 ((VBI-1901

10µg AS01B). The early results from the study achieved a disease control rate of 40% (including 2 partial responses (PR) and 2 stable diseases (SD)) in arm A and 50% in arm B (including 5 SD). 6-month and 12-month OS rates in arm 1 were 80% and 60%, while in arm 2 were 89%

and not reached.

The results concluded that VBI-1901 was well tolerated with better overall survival rates as compared

to historical values and justified further clinical evaluation in a randomized, controlled trial expected to begin later in 2021, as per the company.

INSIGHTS: Although many companies are investigating their therapies in GBM, many fail in late-stage clinical trials due to a lack of their ability to cross the blood-brain barrier, which poses a major challenge not just only to immunotherapies but also to vaccines. Another company, Candel Therapeutics, also presented data at this medical conference on first-in-human CAN-3110 (icp-34.5 expressing hsv-1 oncolytic virus) in patients with recurrent high-grade glioma, which demonstrated a tolerable safety profile and encouraging preliminary overall survival. All these data suggest that despite continuous failures, researchers still pin their hopes to bring advancements in brain tumours.

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