Quarterly update
2024-04-04
Key Highlights – January to End of March 2024
1. Progress both on the development and regulatory fronts for NT-I7 (efineptakin alfa)
2. Towards a subsidiary in Poland
3. A new President and CEO to lead NeoImmuneTech
In the first quarter 2024, NeoImmuneTech highlighted the continued progress of NT-I7 in head and neck cancer and the Orphan Drug Designation (ODD) granted by the FDA for the treatment of pancreatic cancer. Dr. Luke Oh, Ph.D. was appointed as President and Chief Executive Officer (CEO) of the company, while NIT’s Board of Directors also decided to establish a Polish subsidiary to support NT-I7’s development program in EU.
On January 29, NIT announced the expansion of a phase II study investigating NeoimmuneTech’s NT-I7 in head and neck cancer through the addition of three additional cohorts each comprising of 15 patients. The Phase 2 neoadjuvant study examines the vaccine GX-188E (tirvalimogene teraplasmid) in combination with GX-I7/NT-I7 (efineptakin alfa) and Keytruda® (pembrolizumab). It targets patients with HPV 16/18 positive, resectable, locally advanced head and neck squamous cell carcinoma (LA HNSCC). This expansion was decided based on the initial results of the study that showed 63.6% (seven patients) achieved a major pathologic response (MPR) and 36.3% (four patients reached pathologic complete response (pCR), confirming the primary efficacy and safety of the triple combination. The additional cohorts aim to further explore each investigational drug's role in the triple combination, assess combined effects, and evaluate overall safety and major pathologic responses.
On January 30, NIT announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 Orphan Drug Designation (ODD) for the treatment of pancreatic cancer. This decision adds further credibility to the existing evidence that NT-I7 has the potential to bring a much-needed therapy option to people suffering from pancreatic cancer. Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.
On March 15, NIT’s Board of Directors Board of Directors decided to establish a Polish subsidiary to support the full-scale clinical development of NT-I7 in Europe. By operating in Europe as a European “small and medium sized enterprise” (SME), NIT could be eligible for benefits from the European Medicines Agency (EMA) across its development programs. The SME designation is particularly advantageous for qualifying for the EMA's Priority Medicines (PRIME) program.
On April 2, NIT announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc., effective from March 29, 2024 (EDT). This appointment follows the nomination of Dr. Luke Oh as president of the company in January 2024. Dr. Oh succeeds Dr. Se Hwan Yang, Ph.D., as Chief Executive Officer of NeoImmuneTech, Inc. In his new role, he will lead NeoImmuneTech from its Rockville headquarters and overview all the operations in Korea.
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