Quarterly update
2024-11-04
November 04, 2024
Key Highlights – July to Early October 2024
- Issuance of Convertible bond - NeoImmuneTech (NIT) announced the issuance of 12 billion Korean won convertible bonds, the first raise since IPO in 2021.
- Positive Interim Clinical Trial Results - NIT announced promising interim results from its Phase 1b trial combining NT-I7 with CAR-T cell therapies in large B-cell lymphoma (LBCL) patients at ESMO.
- FDA Type C Meeting Completion - NIT successfully completed a Type C meeting with the FDA for the development of NT-I7 as a treatment for Idiopathic CD4 Lymphocytopenia (ICL), accelerating orphan drug development in the U.S. and Europe.
Throughout the third quarter of 2024, NeoImmuneTech has made significant progress in advancing its immunotherapy pipeline, securing intellectual property, and accelerating regulatory pathways.
Advancing NT-I7 in Combination Therapies
On September 9, NeoImmuneTech presented interim results from its Phase 1b clinical trial combining NT-I7 (efineptakin alfa) with CAR-T cell therapies at the European Society for Medical Oncology (ESMO) in Barcelona, Spain. The study evaluated the safety and efficacy of administering NT-I7 following CAR-T therapies—Kymriah®, Yescarta®, or Breyanzi®—in patients with large B-cell lymphoma (LBCL).
The interim results showed an overall response rate (ORR) of 81.1% among LBCL patients, with 7 out of 11 achieving complete responses (CR) and 2 achieving partial responses (PR). Notably, patients treated with Kymriah® and NT-I7 had a higher treatment response compared to historical data for Kymriah® alone, with 7 out of 9 patients responding and 6 achieving CR. The combination therapy demonstrated an excellent safety profile, with no reported cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). These findings suggest that NT-I7 can enhance the efficacy of CAR-T treatments without safety concerns.
Accelerating Development of NT-I7 for Rare Diseases
On August 30, NeoImmuneTech announced the successful completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development of NT-I7 as a treatment for Idiopathic CD4 Lymphocytopenia (ICL). Through this meeting, NeoImmuneTech confirmed the positive feedback of the FDA on the possibility of accelerated approval of NT-I7 for the development of ICL treatment and setting "T cell amplification" as a surrogate endpoint in clinical trials.
This result of the meeting is significant as it may expedite the following approval process, leveraging NT-I7's proven efficacy to amplify T cells as the surrogate endpoint. NT-I7 has received Orphan Drug Designation for ICL from both the FDA (2019) and the European Medicines Agency (EMA) (2017). With the FDA's positive feedback, NeoImmuneTech is poised to accelerate its clinical programs, potentially bringing a much-needed therapy to patients with this rare condition sooner than anticipated.
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