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On February 27, 2025, ImmunityBio, Inc. (NASDAQ: IBRX) announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for its therapeutic candidates ANKTIVA® (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK). This designation applies to two specific indications:? ImmunityBio+3Press Release Services+3OncLive+3
- Reversal of Lymphopenia: In patients undergoing standard-of-care chemotherapy and/or radiotherapy.?
- Treatment of Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer: Addressing a critical need in a patient population with limited treatment options.? Friends of Cancer Research+1Beacon Therapeutics+1
The RMAT designation, established under the 21st Century Cures Act, is designed to expedite the development and review processes for regenerative medicine therapies intended to treat serious or life-threatening conditions. To qualify, a therapy must demonstrate preliminary clinical evidence indicating its potential to address unmet medical needs. Benefits of RMAT designation include:? Wilson Sonsini+10ir.4dmoleculartherapeutics.com+10U.S. Food and Drug Administration+10 U.S. Food and Drug Administration+7PMC+7ir.tayshagtx.com+7
- Enhanced FDA Interaction: Opportunities for more frequent and in-depth discussions with the FDA, facilitating guidance on efficient drug development.?
- Eligibility for Accelerated Approval: Potential to use surrogate or intermediate clinical endpoints to support approval, which can expedite the availability of the therapy to patients.? Wikipedia+1ImmunityBio+1
- Priority Review: Consideration for priority review of the Biologics License Application (BLA), reducing the standard review period.? ImmunityBio+1AskBio+1
ImmunityBio's receipt of RMAT designation for ANKTIVA and CAR-NK is based on encouraging data from their QUILT (Quantitative Lifelong Trial) series of studies. These trials have shown a correlation between the reversal of lymphopenia and improved overall survival across multiple tumor types, including metastatic pancreatic cancer and checkpoint inhibitor-relapsed non-small cell lung cancer. Specifically, the administration of ANKTIVA, an IL-15 superagonist, has demonstrated the ability to proliferate and activate natural killer (NK) cells, CD4+ T cells, CD8+ T cells, and memory T cells without upregulating suppressive T regulatory cells. ? Press Release Services+7OncLive+7ImmunityBio+7 ImmunityBio+1OncLive+1
In response to the RMAT designation, ImmunityBio plans to:? ImmunityBio+2BioInformant+2Targeted Oncology+2
- Submit a Biologics License Application (BLA): For the use of ANKTIVA and CAR-NK in the reversal of lymphopenia and the treatment of locally advanced or metastatic pancreatic cancer.?
- Implement an Expanded Access Policy (EAP): Within 15 days of the announcement, allowing eligible patients to access ANKTIVA and PD-L1 t-haNK in combination with standard chemotherapy or radiotherapy.? Targeted Oncology
The significance of this RMAT designation for ImmunityBio includes:? ImmunityBio
- Validation of Therapeutic Approach: The designation acknowledges the potential of ANKTIVA and CAR-NK to address critical unmet needs in oncology, particularly for patients with limited treatment options.? AskBio+1Beacon Therapeutics+1
- Competitive Advantage: Enhanced interactions with the FDA and potential for accelerated approval processes may position ImmunityBio ahead of competitors in bringing these therapies to market.?
- Increased Investor Confidence: Regulatory milestones like RMAT designation can bolster investor confidence, potentially leading to positive movements in stock performance.?
As of March 27, 2025, ImmunityBio's stock (IBRX) is trading at $3.01, reflecting a change of $0.23 (8.27%) from the previous close. The intraday high is $3.02, with a low of $2.78, on a volume of 1,323,000 shares.?
In conclusion, the FDA's RMAT designation for ANKTIVA and CAR-NK represents a pivotal development for ImmunityBio, potentially accelerating the availability of these therapies to patients in need and enhancing the company's position in the biopharmaceutical landscape.? ImmunityBio |
