Cision PR Newswire

• SurVaxM is the first drug product to be produced in UI Pharmaceuticals new facility
• UI Pharmaceuticals is looking forward to supporting the need for larger clinical and commercial lots
• MimiVax is utilizing SurVaxM in a Randomized Phase 2b clinical trial of glioblastoma

BUFFALO, N.Y., Jan. 10, 2025 /PRNewswire/ -- MimiVax, Inc. and UI Pharmaceuticals are proud to announce the successful clinical manufacture of SurVaxM, a novel immunotherapeutic vaccine targeting Glioblastoma (GBM), at UIP's recently qualified $26M sterile manufacturing facility. This collaboration combines MimiVax's innovative research with UIP's expertise in formulation development and sterile production, accelerating the path to potentially transformative therapies for patients.

At MimiVax, our mission is to disrupt cancer. We are dedicated to improving survival and sending hope to cancer patients and this milestone achievement in SurVaxM production brings us one step closer to realizing that mission. Both organizations look forward to the potential impact of SurVaxM on patient outcomes and the future of cancer immunotherapy.

About SurVaxM

SurVaxM is a groundbreaking immunotherapeutic targeting survivin, a cell-survival protein prevalent in glioblastomas and many other cancers. This innovative immunotherapy is engineered to stimulate a patient's immune system to recognize survivin-expressing cancer cells as foreign, thereby controlling tumor growth and recurrence.

Currently, SurVaxM is being evaluated in a randomized Phase 2b clinical trial for glioblastoma at 11 leading cancer centers across the United States. Additional clinical trials are exploring its potential in multiple myeloma, neuro-endocrine tumors (NET), and pediatric relapsed high-grade glioma. MimiVax's Glioblastoma treatment using SurVaxM has also received a fast track drug designation by the US FDA. CEO of MimiVax Michael Ciesielski said: "The receipt of a 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. This designation is a key component in our journey to help patients with glioblastoma to live longer." 

Looking Ahead

As MimiVax continues to push the boundaries of cancer immunotherapy, the company remains committed to exploring SurVaxM's potential across various cancer types. This successful clinical batch manufacture at UIP paves the way for future clinical trials and brings hope for more effective treatments for patients facing challenging cancers.

About MimiVax, Inc.

MimiVax, Inc. is a private, clinical-stage biopharmaceutical company. Focused on developing immunotherapies for cancer treatment, MimiVax has conducted multiple clinical trials to evaluate the safety and efficacy of SurVaxM across various cancer types. SurVaxM has graciously received support from the Roswell Park Alliance Foundation and private investors. For more information, visit www.mimivax.com.

About UI Pharmaceuticals

UI Pharmaceuticals, located within the University of Iowa College of Pharmacy, is a trusted contract drug product development and manufacturing organization with over 50 years of experience. As a full-service CDMO, UI Pharmaceuticals offers formulation development, analytical services, sterile and non-sterile manufacturing capabilities. For business inquiries, contact uipharma-talktous@uiowa.edu.

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SOURCE MimiVax, Inc.