The shares of Mustang Bio, Inc. (NASDAQ: MBIO) surged 180.67% on Monday, closing at $3.34, following the announcement of a major regulatory milestone. The increase followed the announcement that the U.S. Food and Drug Administration (FDA) has designated MB-101, MBIO’s investigational IL13Ra2-targeted CAR T-cell treatment, as an Orphan Drug to treat glioblastoma (GBM) and recurrent diffuse and anaplastic astrocytoma.
Strategic Value Is Enhanced by FDA Recognition
The FDA’s Orphan Drug Designation is available to medications intended to treat uncommon diseases that affect fewer than 200,000 people in the US. Numerous advantages come with this status for the sponsor, including tax deductions for clinical trial costs, exemption from various FDA fees, and seven years of post-approval market exclusivity that has nothing to do with patent protection.
In Mustang Bio’s instance, MB-101’s designation was more expansive than first thought, indicating a high level of trust in the therapeutic’s potential. Additionally, Mustang Bio had already been designated as an Orphan Drug for MB-108, a treatment that showed promise. Now that MB-101 and MB-108 have this status, regulatory bodies are further confirming the company’s scientific orientation.
Developing New Combination Therapies
Mustang Bio intends to develop a combination MB-101 and MB-108 therapy approach for patients with high-grade astrocytomas and recurrent GBM, among other malignant gliomas. The dual-therapy strategy effectively turns “cold” tumors into “hot” ones by altering the tumor microenvironment (TME) with the help of the oncolytic virus MB-108.
The goal of this modification is to improve the therapeutic effectiveness of MB-101 CAR-T therapy, which targets antigens unique to tumors. The American Association for Cancer Research (AACR) 2022 Annual Meeting featured preclinical data in favor of this combo strategy. In patients with recurrent GBM, independent evidence for MB-101 and MB-108 also showed good safety profiles.
Finances and Upcoming Development Opportunities
Notwithstanding the regulatory advancements, Mustang Bio stressed that obtaining more funding or establishing a strategic alliance are necessary to continue its MB-109 development program, which combines MB-101 and MB-108. The new FDA classification is an important milestone in MBIO”S quest to treat aggressive and challenging brain tumors as it investigates these avenues.
