Quarterly update
2024-07-05
July 05, 2024
Key Highlights – April to Early July 2024
- European Orphan Drug Designation (ODD) - NeoImmuneTech (NIT) secured European ODD for NT-I7 for the treatment of Acute Radiation Syndrome (ARS).
- Positive clinical trial data - Interim positive results from the NIT-110 study demonstrated improved efficacy of NT-I7 in combination with Keytruda in solid tumors
- SME status - NIT's Polish subsidiary obtained SME status granted by the European Medicines Agency (EMA), facilitating expedited drug development
In the second quarter 2024, under the new leadership of Luke Oh, President and CEO, NeoImmuneTech has dynamically pursued its strategic goals, communicated in April 2024:
- advancing towards the fastest FDA approval possible for NT-I7
- accelerating development in promising indications
- establishing foundations for new pipelines alongside NT-I7.
Fast-Tracking NT-I7 approval for ARS
On May 12, NIT announced that Duke University (North Carolina) has been awarded up to $6 million from NIAID to study NT-I7 for the treatment of Hematopoietic Acute Radiation Syndrome (H-ARS) in animal models. The contract will support research led by Dr. Benny Chen’s team on the benefits of rapid T cell recovery following NT-I7 administration after radiation exposure.
On June 4, NIT announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NT-I7 for the treatment of Acute Radiation Syndrome (ARS). This regulatory milestone follows the ODD granted to NT-I7 by the FDA in the US for the same indication (November 2023). It is the second ODD received by NT-I7 from the EMA, following the one granted in Idiopathic CD4+ Lymphocytopenia (ICL) in May 2017. The ODD provides incentives to advance the development of NT-I7 in ARS, including reduced fees for multiple steps in the development process, such as protocol assistance, marketing authorization applications, and inspections before authorization.
Accelerating NT-I7 development in promising indications
On May 30, NIT announced that its Polish subsidiary has been granted SME status by the European Medicines Agency (EMA). This recognition is an important milestone for NeoImmuneTech, providing financial and regulatory support that will accelerate the development of its lead drug candidate NT-I7 for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL). This status qualifies NeoImmuneTech for the EMA's Priority Medicines (PRIME) scheme, opening the door for expedited development of innovative treatments.
On June 3, NIT announced promising interim results of its major clinical trial NIT-110 of NT-I7, at the 2024 American Society of Clinical Oncology (ASCO) global meeting. The data underscores the improved efficacy of the NT-I7 and Keytruda combination over existing standard of care treatments. Data showed a median overall survival (mOS) of 11.1 months among the 48 pancreatic cancer patients included in the study. The mOS for pancreatic cancer patients who have received a second-line standard of care treatment is currently known to be 6.1 months. This mOS improvement is particularly noteworthy considering that 93.75% of the patients are receiving the combination treatment as third-line or beyond. In the microsatellite-stable (MSS) colorectal cancer arm of the study, the mOS for the 50 patients was 13.2 months. The mOS for the current standard of care treatment is 10.8 months.
A separate poster from trial NIT-110 revealed a correlative analysis identifying a potentially predictive biomarker. These biomarkers may help identify patient populations more likely to benefit clinically from the NT-I7 and Keytruda combination.
Expanding NIT’s pipeline
On April 9, NIT presented a poster at the 2024 American Association for Cancer Research (AACR) Annual Meeting on a pre-clinical study that opens a new field of potential applications for NT-I7. The study explored the efficacy of NT-I7 in combination with FOLFOX® (a combination of 5-fluorouracil, leucovorin, and oxaliplatin), a first-line standard of care (SoC) for colorectal cancer, in an animal model of colorectal cancer (MC38, C57BL/6 mice). The study’s findings suggest a significant improvement in treatment outcomes when NT-I7 is used alongside FOLFOX®, demonstrating a 69% reduction in tumor size compared to the administration of FOLFOX® alone. While the overall Absolute Lymphocyte Count (ALC) in the blood was reduced by FOLFOX® treatment, the number of anti-cancer specific T cells in the tumor was significantly increased in the combination group compared to FOLFOX® alone.
On July 04, NIT announced that it has developed and secured a platform technology capable of creating various forms of multispecific antibodies, including bispecific antibodies. NIT has filed a Patent Cooperation Treaty (PCT) application for this technology that is already being used to expand NIT’s pipeline, with assets such as NT30, a new T cell engager.
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