We're proud to announce that we've funded a $50,000 grant to Katherine Onk and David Needham at DNKO LLC to fund the project: Effective Delivery of Doxorubicin to Invasive Margins in GBM: Establishing Optimal Warming Criteria for a Thermal Sensitive Liposome with Laser Interstitial Thermal Therapy (LITT) in a Porcine Brain Model. We only partially funded the project total amount of $322,000 and are saving up for the rest. 

MGMT promotor methylation status in glioblastoma is usually determined by molecular testing of tumor tissue samples, but testing methods and cutoff values vary across institutions. This study re-examined data from previous clinical trials of elderly glioblastoma patients using a strict definition of "unmethylated" (added safety margin below a main cutoff point to define "truly unmethylated" MGMT promotor) to determine the effectiveness of temozolomide (TMZ). Unsurprisingly, results showed that patients with truly unmethylated MGMT promotor status did not benefit from TMZ. This study concludes that validated, assay-specific methylation cutoffs should be applied in clinical trials and that better stratification of MGMT methylation status in clinical management will reduce toxicity without compromising outcomes for patients.

This study evaluated a new MRI technique called delta T1 (difference between pre- and post-contrast T1-weighted images) to measure extent of resection and residual tumor volume. The technique provides an objective way to routinely assess surgical outcomes for glioblastoma, and delta T1 residual tumor volume of greater or less than 5 cm3 could be a potential metric in predicting patient survival.

The CUSP9 protocol is an experimental treatment approach for recurrent glioblastoma that combines 9 repurposed drugs with low-dose continuous temozolomide (TMZ). While early studies showed the protocol can be safely administered under careful monitoring, researchers recently tested all subset combinations of the 9 drugs, in combination with TMZ, on two clonal cultures of glioma-initiating cells from patient samples. Results showed that several subset combinations produced equivalent effects to the full protocol. This study highlights the importance and feasibility of personalized treatment approaches based on functional testing. We are following research in this area closely!

SurVaxM is an off-the-shelf vaccine that stimulates an immune response against a tumor cell protein called survivin. The Phase 2b trial for newly diagnosed adult glioblastoma is ongoing (no longer recruiting), and there's also a Phase 1 trial currently recruiting for children with relapsed medulloblastoma, high grade glioma, ependymoma and newly diagnosed DIPG. SurVaxM received orphan drug status for treatment of adult GBM back in 2017, but the status has now been expanded in scope to include any malignant glioma in children or adults. This designation, given to drugs aimed at treating rare diseases, helps encourage drug development through incentives like tax credits and extended market exclusivity, but it does not speed up drug approval. We'd love to see an expanded access program offered for SurVaxM, but the cost would be significant. If any organizations or individuals are interested in partnering to help fund such a project, please let us know!

Bizaxofusp (also known as MDNA55) is an immunotoxin that targets and kills cancer cells expressing the interleukin-4 receptor (IL-4R), which is overexpressed in glioblastoma tumors. The latest evidence presented at ASCO 2024 showed that a single treatment of this drug with convection-enhanced delivery directly to the tumor site resulted in median overall survival of 13.5 months and a 12-month overall survival of 56.7% for patients with unresectable recurrent GBM. Additionally, patients who experienced tumor control (based on RANO 2.0 imaging criteria) following treatment had significantly improved median overall survival.  Based on these results, a Phase 3 trial is in the works.

We are honored to announce that Charity Navigator has awarded us the highest possible rating for the second consecutive year. Our commitment to transparency and accountability is reflected in our spotless 26-year history of passing internal audits conducted by our accountants. This year, we also underwent an extensive external audit to verify the integrity of our processes and the proper use of donations, which we passed with flying colors!

We have several impactful projects in the pipeline that can significantly advance our fight against this disease. However, we need your support now more than ever. Donations are crucial to accelerating our progress, and we also welcome volunteers to assist with our fundraising efforts.

We're very proud to announce this partnership with Head for the Cure and Cancer Commons. This alliance will help expand our impact by providing critical support to a broader network of brain tumor patients and caregivers. 

VBI-1901 is a vaccine that uses enveloped virus like particle (eVLP) technology to target two cytomegalovirus (CMV) antigens - gB and pp65. In the Phase 1/2a study for recurrent glioblastoma (n=16 patients), median overall survival was 12.9 months; patients who achieved a partial tumor response or stable disease (7/16) all reached a minimum survival of 12 months, and 1 patient survived at least 40 months. The Phase 2b trial is still in early stages, but 3/7 patients treated with the vaccine so far have achieved disease control (stable disease or partial response). We hope to see additional interim data reported by the end of this year.

It was reported in March 2024 that the METIS trial met its primary endpoint of time to intracranial progression for patients with brain metastases from non-small cell lung cancer (21.9 months in TTFields group vs 11.3 months in control group). Additional data from the METIS trial was presented at the 2024 ASCO Annual Meeting showing that patients treated with TTFields also had prolonged quality of life deterioration-free survival (not reached in TTFields group vs 7.7 months in control group). 

This is a great documentary about patient advocacy for ALS, and there are many parallels for patients living with high grade brain tumors. While the ACT for ALS bill was signed into law in 2021, patients and families living with ALS, high grade brain tumors, and other rapidly progressing terminal illnesses are still fighting for the Promising Pathway Act. The PPA is mentioned towards the end of the documentary. If you have Amazon Prime, this film is worth watching. 

The final webinar in our May series is tomorrow! Wednesday, May 29 (7pm EST) IMVAX Phase 2b Trial, Dr. Brad Zacharia.

The Promising Pathway Act 2.0 was officially introduced to Congress last week! If you haven't already, clink this link to contact your Congressional representatives in support of the bill! It takes 2 minutes.

We're proud to announce the following research grants:

1. $48,836 grant to Dr. Ekokobe Fonkem at Medical College of Wisconsin to fund the project: "Advancing Immunotherapy for Glioblastoma: Pre-Clinical Development of a Novel PI3K Inhibitor"

2. $35,000 grant to Dr. Monika Haack at Beth Israel Deaconess Medical Center to fund the project: "Computer modeling for tumor treating fields"

3. $10,053 to Dr. Samuel Singer at The Feinstein Institutes for Medical Research to fund the project: "Assessment of sST2 Staining in Tumor Tissue from Glioblastoma, IDH-Mutant High Grade Glioma and High Grade Meningioma"

Niraparib is a PARP inhibitor approved for ovarian cancer. It disrupts cancer cells' ability to repair DNA damage. In the Phase 0 part of this study, presumed newly-diagnosed glioblastoma patients were given the drug for 4 days prior to resection, and resected tumor tissue was then tested to measure drug accumulation. All Phase 0 patients (n=46) met the accumulation threshold. Of the 27 patients with MGMT-unmethylated tumors, 19 were enrolled in the Phase 2 part of the study, where they received niraparib during radiation followed by a maintenance phase of niraparib alone. Median overall survival was 20.3 months, which is significantly better than the historic median of only 12.3 months for unmethylated GBM. While this study was small, a larger Phase 3 study is being planned which will compare niraparib with temozolomide for newly diagnosed MGMT-unmethylated GBM (more here). 

Preclinical research has shown that endogenous hydrogen sulfide (H2S) can act as a tumor suppressor against glioblastoma. Directly giving patients H2S is risky, so researchers at the Cleveland Clinic are exploring whether the body's natural production of H2S can be increased by reducing thyroid hormone levels. In addition to continued preclinical work, Dr. Hine and Dr. Peereboom will run a small Phase 2 trial to evaluate the safety and efficacy of using oral methimazole (drug approved to treat hyperthyroidism) in patients with progressive GBM. They'll also look at other potential ways to enhance H2S signaling in patients, aside from using thyroid hormone inhibitors. 

This is very exciting! This partnership to develop renewable energy facilities will direct 90% of profits towards cancer research and services, focusing specifically on glioblastoma and diffuse midline glioma. We are honored to be a part of this project, and we will invite organizations and researchers worldwide to collaborate in applying these funds towards the most promising research when the funds start flowing in!

As noted above, we have a webinar on this trial on Wednesday. IMVAX expects to be able to share top-line results sometime in 2025, but we'll cover the latest status and updates during our webinar.

The Promising Pathway Act 2.0 will be introduced into Congress this Thursday. Before it gets introduced, we need to contact all of our legislators and ask them to cosponsor it. Use our form for details and a quick way to send emails to your senators and representatives! Then ask all of your friends to do the same!

Please do this even if you've already contacted your representatives on behalf of the original bill. We're closer than ever before, and garnering additional cosponsors will help push this bill across the finish line!

'Empowering Brain Tumor Patients' webinar this Thursday, May 23, 2024 (6pm EST) with Dr. Isabelle Germano, Dr. Kevin Elmore, and Dr. Stanislav Lazarev. This webinar is hosted by the Icahn School of Medicine at Mount Sinai, in collaboration with the National Brain Tumor Society and the Musella Foundation. The webinar can be accessed by visiting https://bit.ly/3UuvmRK.

Video recordings for all of our Brain Tumor Awareness Month Webinars are available here. Our final event for the series will be Wednesday, May 29, 2024 (7pm EST) IMVAX Phase 2b trial, Dr. Brad Zacharia.