Earlier this month, we announced a $50,000 grant to DNKO LLC for preclinical research on a treatment using heat sensitive liposomes combined with LITT for targeted drug delivery. We now have a brief webinar available on the project, as well as a donation fund set up to help get this treatment into human trials.      

This trial was discussed during our May Brain Tumor Awareness Month Webinar series: see here. The treatment used to be called PVSRIPO, but it's now called Lerapolturev. The trial is now recruiting, with the aim of enrolling up to 80 patients with supratentorial recurrent glioblastoma who are eligible for maximal safe resection for their recurrence. 

This preclinical study used an interesting combination of immunotherapies (fc-enhanced anti-ctla-4 and anti-pd-1), chemotherapy (doxorubicin), and specialized drug delivery (pulsed ultrasound and microbubbles). It was highly effective in murine models, achieving a 90% cure rate as well as immunological memory. There is a Phase 2 clinical trial at Northwestern University testing this combination in newly diagnosed glioblastoma.

From our friends at Roon!
As many of you know, the Musella foundation has partnered with the Roon team to help create a wonderful online resource for those navigating glioblastoma. The app has top experts (you can see them all here https://www.roon.com/gbm/experts  from across the country answering all the questions that come up during the journey of GBM. The answers are provided via short form video and easy to consume. All the content is curated and contextualized into the journey of the disease. The newest features include AI to help you find the information you need most easily. On their home screen, you can ask the system any question you have, and it will respond with an answer sourced from the experts on Roon. From there, you can find and explore the videos.

We're proud to announce we can now accept cryptocurrency donations, including Bitcoin, USD Coin, and Ethereum!

Tumor Treating Fields demonstrated good tolerability across >25,000 users, and the safety profile was consistent across subgroups (age, sex, and diagnosis). The most common treatment-related adverse events were skin reactions (43%), electric sensation (tingling; 14%) and heat sensation (warmth; 12%). Most treatment-related adverse events were manageable localized, non-serious skin events.

We're glad to announce the FDA recently approved the Expanded Access Program (EAP) for gallium maltolate, an investigational therapy for glioblastoma. The EAP details can be found here and our webinar on the therapy is available here. If you are interested in participating, please email eap@imagingbiometrics.com.

The Musella Foundation gave a grant to help get the EAP started, but our grant covers only part of the program costs. Patients will still be charged a portion of the costs. If any organizations or individuals want to help us with further funding in order to make the EAP free for patients, please contact me! Donations directly to the fund can be made here.

 Our copay assistance program is now open - at Braintumorcopays.org.  If you think you may need help, apply. Never be shy or embarrassed to ask for help.  We went through this and understand the financial pressures that a malignant brain tumor can cause, even if you were OK financially before. We are here to take some of the stress off of you and try to make the process easy.  If you have questions or any trouble with the application, contact us by using the 'Contact Us' link on the website or call us at 888-295-4740.

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.