Mimivax LLC

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)

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.

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.