This phase II trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67/M57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.

Start Date15 Dec 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

NCT04978727 / RecruitingPhase 1IIT

A Pilot Study of Safety, Tolerability, and Immunological Effects of SurVaxM in Pediatric Patients With Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Patients will receive a vaccine called SurVaxM on this study. While vaccines are usually thought of as ways to prevent diseases, vaccines can also be used to treat cancer. SurVaxM is designed to tell the body's immune system to look for tumor cells that express a protein called survivin and destroy them. The survivin protein can be found on up to 95% of glioblastomas and other types of cancer but is not found in normal cells. If the body's immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.
SurVaxM will be mixed with Montanide ISA 51 before it is given. Montanide ISA 51 is an ingredient that helps create a stronger immune response in people, which helps the vaccine work better.
This study has two phases: Priming and Maintenance. During the Priming Phase, patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection (a shot under the skin) at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At the same time that patients get the SurVaxM/Montanide ISA 51 injection, they will also get a second subcutaneous injection of a medicine called sargramostim. Sargramostim is given close to the SurVaxM//Montanide ISA 51 injection and works to stimulate the immune system to help the SurVaxM/Montanide ISA 51 work more effectively.
If a patient completes the Priming Phase without severe side effects and his or her disease stays the same or improves, he or she can continue to the Maintenance Phase. During the Maintenance Phase, the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years.
After a patient finishes the study treatment, the doctor and study team will continue to follow his/her condition and watch for side effects up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be seen in clinic every 3 months during the follow-up period.

Start Date01 Jul 2022

Sponsor / Collaborator

National Cancer Institute

[+1]

NCT05163080 / Active, not recruitingPhase 2

Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)

The main purpose of this study is to determine whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone for patients with newly diagnosed glioblastoma. This study is designed to compare the length of survival in patients with newly diagnosed glioblastoma who receive temozolomide plus SurVaxM to that of patients treated with standard-of-care temozolomide plus placebo. This study aims to discover what effects, both good and bad, this combination of drugs may have on you and to see if the study drug (SurVaxM) can create an immune response in your blood that is directed against your cancer cells. This study also aims to determine whether treatment with SurVaxM plus temozolomide improves the survival of glioblastoma patients like yourself compared to treatment with temozolomide alone.

Start Date18 Nov 2021

Sponsor / Collaborator

Mimivax LLC

[+2]

100 Clinical Results associated with SurVaxM

100 Translational Medicine associated with SurVaxM

100 Patents (Medical) associated with SurVaxM

Literatures (Medical) associated with SurVaxM

01 Dec 2024·CURRENT OPINION IN NEUROLOGY

Updates for newly diagnosed and recurrent glioblastoma: a review of recent clinical trials

Review

Author: Fukushima, Corinna M. ; de Groot, John

Purpose of review:

Glioblastoma (GBM) is the most common and devastating primary malignant brain tumor. We summarize recent advances in radiotherapy, immunotherapy, and targeted therapy approaches for the treatment of newly diagnosed and recurrent glioblastoma. We also introduce ongoing clinical trials.

Recent findings:

Recent clinical trials have explored multiple novel strategies to treat GBM including the use of oncoviruses, chimeric antigen receptor (CAR) T cell therapy, vaccines, radiotherapy, and novel drug delivery techniques to improves drug penetrance across the blood brain barrier. Approaches to improve drug delivery to brain tumors have the potential to expand treatment options of existing therapies that otherwise have poor brain tumor penetrance. Immunotherapy has been of keen interest in both newly diagnosed and recurrent glioblastoma. Vaccines SurVaxM and DCVax-L have shown initial promise in phase II and III trials, respectively. CAR T cell therapy trials are in their early phases but hold promise in both newly diagnosed and recurrent glioblastoma.

Summary:

Although progress to improve outcomes for GBM patients has been modest, multiple novel strategies utilizing combination therapies, focused ultrasound to improve drug delivery, and novel immunotherapies are underway.

13 Mar 2023·Vaccines

Survivin (BIRC5) Peptide Vaccine in the 4T1 Murine Mammary Tumor Model: A Potential Neoadjuvant T Cell Immunotherapy for Triple Negative Breast Cancer: A Preliminary Study.

Article

Author: Rubsamen, Reid M ; Harris, Paul E ; Carback, Richard T ; Herst, Charles V ; Burkholz, Scott R

A triple negative breast cancer model using the murine 4T1 tumor cell line was used to explore the efficacy of an adjuvanted survivin peptide microparticle vaccine using tumor growth as the outcome metric. We first performed tumor cell dose titration studies to determine a tumor cell dose that resulted in sufficient tumor takes but allowed multiple serial measurements of tumor volumes, yet with minimal morbidity/mortality within the study period. Later, in a second cohort of mice, the survivin peptide microparticle vaccine was administered via intraperitoneal injection at the study start with a second dose given 14 days later. An orthotopic injection of 4T1 cells into the mammary tissue was performed on the same day as the administration of the second vaccine dose. The mice were followed for up to 41 days with subcutaneous measurements of tumor volume made every 3-4 days. Vaccination with survivin peptides was associated with a peptide antigen-specific gamma interferon enzyme-linked immunosorbent spot response in the murine splenocyte population but was absent from the control microparticle group. At the end of the study, we found that vaccination with adjuvanted survivin peptide microparticles resulted in statistically significant slower primary tumor growth rates in BALB/c mice challenged with 4T1 cells relative to the control peptideless vaccination group. These studies suggest that T cell immunotherapy specifically targeting survivin might be an applicable neoadjuvant immunotherapy therapy for triple negative breast cancer. More preclinical studies and clinical trials are needed to explore this concept further.

01 Mar 2023·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma

Article

Author: Curry, William T. ; Birkemeier, Meaghan T. ; Dharma, Sanam S. ; Ciesielski, Michael J. ; Dhawan, Andrew ; Abad, Ajay P. ; Ahluwalia, Manmeet S. ; Peereboom, David M. ; Mechtler, Laszlo L. ; Mogensen, Kathleen M. ; Qiu, Jingxin ; Belal, Ahmed N. ; Fenstermaker, Robert A. ; Casucci, Danielle M. ; Hutson, Alan D. ; Withers, Henry G. ; Liu, Song ; Wong, Eric T. ; Reardon, David A. ; Figel, Sheila A.

PURPOSE:

Despite intensive treatment with surgery, radiation therapy, temozolomide (TMZ) chemotherapy, and tumor-treating fields, mortality of newly diagnosed glioblastoma (nGBM) remains very high. SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells. We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials.gov identifier: NCT02455557 ).

METHODS:

Sixty-four patients with resected nGBM were enrolled including 38 men and 26 women, in the age range of 20-82 years. Following craniotomy and fractionated radiation therapy with concurrent TMZ, patients received four doses of SurVaxM (500 μg once every 2 weeks) in Montanide ISA-51 plus sargramostim (granulocyte macrophage colony-stimulating factor) subcutaneously. Patients subsequently received adjuvant TMZ and maintenance SurVaxM concurrently until progression. Progression-free survival (PFS) and overall survival (OS) were reported. Immunologic responses to SurVaxM were assessed.

RESULTS:

SurVaxM plus TMZ was well tolerated with no serious adverse events attributable to SurVaxM. Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point). Median PFS was 11.4 months and median OS was 25.9 months measured from first dose of SurVaxM. SurVaxM produced survivin-specific CD8+ T cells and antibody/immunoglobulin G titers. Apparent clinical benefit of SurVaxM was observed in both methylated and unmethylated patients.

CONCLUSION:

SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress.

News (Medical) associated with SurVaxM

30 May 2024

·www.prnewswire.com

US FDA awards Supplemental Orphan Drug Designation to SurVaxM to now include treatment of Malignant Glioma

The U.S. Food and Drug Administration (FDA) has granted supplemental orphan-drug designation (ODD) to SurVaxM for use in patients with malignant gliomas. New orphan designation broadens the patient population for potential use of SurVaxM to include forms of adult and pediatric malignant gliomas other than glioblastoma. ODD expands market exclusivity of SurVaxM beyond its previous designation of adult glioblastoma. BUFFALO, N.Y., May 30, 2024 /PRNewswire/ -- MimiVax Inc, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, today announced that the United States Food and Drug Administration (FDA) has awarded a supplemental orphan drug designation to MimiVax's SurVaxM vaccine to now include malignant glioma. Currently, SurVaxM vaccine is being studied as a treatment for newly diagnosed glioblastoma (nGBM) in a phase 2b randomized clinical study (the SURVIVE trial) which will assess the efficacy of SurVaxM in a large patient population with nGBM. This supplemental orphan drug designation greatly expands the potential for SurVaxM's use in other forms of pediatric and adult malignant gliomas. An orphan drug designation plays a critical role in encouraging the development of treatments for rare diseases, ultimately improving the lives of patients who might otherwise have few or no treatment options. (PRNewsfoto/MimiVax, LLC)

Orphan DrugPhase 2ImmunotherapyVaccine

09 Jan 2024

·www.prnewswire.com

MimiVax Announces New Investments to Support Clinical Development of SurVaxM in Glioblastoma

Investors feature leading brain tumor venture philanthropy funds including the Brain Tumor Investment Fund (BTIF) and The Sontag Innovation The along with MEDA Angels, Varia Ventures and private investors. Investment catalyzed by positive results from Phase 2a study of SurVaxM in newly diagnosed glioblastoma (ndGBM) published in the Journal of Clinical Oncology. Funding will support the ongoing Phase 2b clinical study and subsequent registration-related initiatives. BUFFALO, N.Y., Jan. 9, 2024 /PRNewswire/ -- MimiVax, Inc., a biotechnology company focused on the development of SurVaxM, a survivin-targeted vaccine therapy for glioblastoma and other cancers, today announced new investments from the venture philanthropy arms of leading brain tumor patient organizations, VC, private and existing investors. Continue Reading MimiVax Announces New Investments to Support Clinical Development of SurVaxM in Glioblastoma Post this (PRNewsfoto/MimiVax, LLC) The investments from the Brain Tumor Investment Fund (BTIF), an affiliate of the National Brain Tumor Society (NBTS), the Sontag Innovation Fund, LLC, a subsidiary of the Sontag Foundation, the MEDA Angels, LLC, Varia Ventures and private investors will support the ongoing phase 2b clinical study, subsequent registration-related work and prepare the company for commercialization of SurVaxM for ndGBM. Glioblastoma is a rare but deadly cancer with median overall survival of only about 16 months. SurVaxM was developed to bring a paradigm shift to a field that has seen little advancement in decades. MimiVax is rapidly enrolling subjects in its SURVIVE trial [NCT05163080], a randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM among patients with ndGBM at 11 cancer centers across the USA. This follows the successful Phase 2a study published in the Journal of Clinical Oncology having met its primary endpoint, achieving a median overall survival (mOS) of 25.9 months – and further reporting that 41% of the patients receiving SurVaxM survived at least 3 years, with several long term progression-free survivors. Investment funding is designed to help MimiVax achieve its goal of revolutionizing the landscape of brain tumor treatment. "We are honored to receive significant investments from The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures along with our private investors. "Their confidence in our mission further propels our efforts to make a meaningful impact in the lives of those affected by brain tumors," said Michael Ciesielski, CEO, MimiVax, Inc. The Brain Tumor Investment Fund, known for its dedication to funding pioneering solutions in neuro-oncology, expressed enthusiasm about the partnership. "Brain tumor patients and caregivers desperately need better outcomes. The results seen in previous trials of SurVaxM make us optimistic for the SURVIVE Phase 2b trial and the potential for a new treatment on the horizon" said John Higgins, Managing Director of BTIF. The MEDA Angels, (part of the Tech Coast Angels (TCA) network) are a health-care focused investor group founded by physician, payers and scientist-angel investors, supported by a team of regulatory, reimbursement, legal and financial advisors. "We knew the grave unmet need for game-changing therapy for glioblastoma, a devasting brain cancer with so limited average survival time of 16 months. After review of MimiVax' approach, targeting a strong epitope and the data through their Phase 2a, we became confident they were well worth backing." -MEDA Angels The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is proud to have MimiVax as a portfolio company. "There is an extraordinary unmet need for new treatments that make a major impact in the brain tumor space. We are excited to play a role in the development of promising therapies like SurVaxM" said Scott Davis, Managing Director of the Sontag Innovation Fund. MimiVax extends its gratitude to The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures and our private investors for their support and confidence in the company's vision. This investment fortifies MimiVax's position as a key player in the quest for innovative solutions in the fight against brain tumors. About MimiVax, Inc MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. The Company was formed to develop and commercialize its lead candidate SurVaxM. For more information on MimiVax, visit or email [email protected]. About SurVaxM SurVaxM is a first-in-class, patented immunotherapy that targets survivin, a cell-survival protein. SurVaxM is delivered subcutaneously and stimulates a patients' own immune response to control tumor growth and prevent future disease recurrence. Because survivin is present in many forms of cancer, SurVaxM could potentially have wide therapeutic applicability. About the Brain Tumor Investment Fund The Brain Tumor Investment Fund (BTIF) is the non-profit venture philanthropy arm of the National Brain Tumor Society (NBTS), the largest patient advocacy organization in the United States committed to curing brain tumors and improving the lives of patients and families. BTIF BTIF) invests in innovative biotechnology, pharmaceutical, and medical device companies developing promising new treatment opportunities for patients with brain cancer. () About The Sontag Innovation Fund The Sontag Innovation Fund, a wholly-owned venture subsidiary of The Sontag Foundation, one of the largest private funders of brain cancer research in the United States, made the investment. The Sontag Innovation Fund invests in early stage and innovative technologies with the potential to drive cures and improve the quality of life or life expectancy for brain cancer patients. () About MEDA Angels The MEDA Angels are a healthcare-focused angel investor group that invests liberally across mid-seed and Series A healthcare opportunities: both disease management and prevention. Importantly, many startups see an investment by MEDA as validation of the merits of their technology, as potential users, and payer friendly products. () About Varia Ventures Varia Ventures is a next generation venture capital platform for professional organizations interested in building wealth for themselves and their members through investing in a portfolio of highly curated, emerging companies, originating from their organizations. Varia's platform blends insights from key opinion leaders, strategic partners, and industry experts through its "end-to-end" technology solution designed to support early stage companies while providing compelling investment opportunities to its investors. () SOURCE MimiVax, Inc.

Phase 2ImmunotherapyVaccine

12 Oct 2023

·www.prnewswire.com

MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma

BUFFALO, N.Y., Oct. 12, 2023 /PRNewswire/ -- MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced today that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax's SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM). Continue Reading MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma. Tweet this (PRNewsfoto/MimiVax, LLC) A randomized, blinded placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers across the USA (Roswell Park Comprehensive Cancer Center, Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, NYU, Northwell Health and UCSF). See clinicaltrials.gov for enrollment details and locations. Positive Final Data from the previous Phase 2a Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least 2 years and 41% survived at least 3 years. The median Overall Survival of 25.9 months with nGBM in this study is considerably higher than would be expected with standard therapy alone. MimiVax is focused on completing the Phase 2b SURVIVE study and securing funding necessary to bring SurVaxM through the FDA approval process. Glioblastoma is a rare disease with great unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advances in recent years. "The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO of MimiVax. "This designation is a key component in our journey to help patients with glioblastoma to live longer." Fast Track is a process designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need. Significant benefits of FTD include: Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of SurVaxM. Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval. FTD also allows for a 'rolling review' in which MimiVax may submit completed sections of the SurVaxM NDA as they become available, rather than at the end development. About MimiVax, Inc.: MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. The Company was initially formed as a spin-off from Roswell Park to develop and commercialize its lead candidate SurVaxM, which has been graciously supported by donations to Roswell Park. For more information on MimiVax, visit . About SurVaxM: SurVaxM is a first-in-class, patented peptide mimic immunogen that targets survivin, a cell-survival protein present in 95% of glioblastomas and in many other cancers. SurVaxM stimulates a patient's own immune response in an effort to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in other cancers. SOURCE MimiVax, Inc.

Phase 2Fast TrackImmunotherapyVaccineClinical Result

100 Deals associated with SurVaxM

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 2	US	Roswell Park Comprehensive Cancer Center	15 Dec 2024
Malignant Solid Neoplasm	Phase 2	US	Roswell Park Comprehensive Cancer Center	15 Dec 2024
Neuroendocrine neoplasm of lung	Phase 2	US	Roswell Park Comprehensive Cancer Center	15 Dec 2024
Neuroendocrine tumor of pancreas	Phase 2	US	Roswell Park Comprehensive Cancer Center	15 Dec 2024
Glioblastoma	Phase 2	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	21 Sep 2022
Glioblastoma Multiforme	Phase 2	US	Roswell Park Comprehensive Cancer Center	04 May 2015
Gliosarcoma	Phase 2	US	Roswell Park Comprehensive Cancer Center	04 May 2015
Carcinoid Tumor	Phase 1	US	Roswell Park Comprehensive Cancer Center	17 Jun 2019
Pancreatic neuroendocrine tumour metastatic	Phase 1	US	Roswell Park Comprehensive Cancer Center	17 Jun 2019
Plasma Cell Leukemia	Phase 1	US	Celgene Corp.	13 Apr 2017

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02455557 (Pubmed \| J Clin Oncol)	Phase 2	Glioblastoma Adjuvant	66	SurVaxM plus adjuvant TMZ	jmsqrsdoeu(hhhrjraimc) = reaowvkdgo rgosxtrwti (jizemzdfmn ) View more	Positive	15 Dec 2022
NCT02455557 (ASCO2022)	Phase 2	Glioblastoma	63	SurVaxM	apfoywabpc(ehdgisxuvl) = itbjowohdl lggsxypjwq (ndsvzktvwy )	Positive	02 Jun 2022
NCT02455557 (CTgov)	Phase 2	Glioblastoma Multiforme \| Gliosarcoma \| Glioblastoma	66	Laboratory Biomarker Analysis+Temozolomide+Montanide ISA 51 VG+Sargramostim+SVN53-67/M57-KLH Peptide Vaccine	llndqnzjua(vmxlkayaqo) = evgqmvykdq urexzvflnd (eruvdfrded, vuckmwudbu - vneusoseoy) View more	-	01 Feb 2021
NCT02455557 (ASCO2019) Manual	Phase 2	Glioblastoma First line survivin positive	63	standard therapy+SurVaxM (methylated MGMT)	msotfwjage(amjhgqqrnl) = injection site reactions qzgbirfimh (lqsdxvimrg )	Positive	26 May 2019
NCT02455557 (ASCO2019) Manual	Phase 2	Glioblastoma First line survivin positive	63	standard therapy+SurVaxM (unmethylated MGMT)		Positive	26 May 2019
NCT02455557 (ASCO2018)	Phase 2	Glioblastoma	63	Standard therapy plus SurVaxM	euclikxbkg(jdkecsrlcz) = immunization-related adverse events were mild with no serious adverse events attributable to SurVaxM dumrkdkuoq (iaryempqvi )	Positive	01 Jun 2018

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