Phase 3 Results for Personalized mRNA Cancer VaccineModerna and MSD announced on the 19th (local time) that they had secured positive topline results from the
Phase 3“INTerpath-001” clinical trial, which evaluated the combination therapy of the personalized mRNA cancer vaccine “Intismeran Autogen” and the immunotherapy “Keytruda.”
This trial was conducted on 1,137 high-risk melanoma patients who had undergone complete resection. Compared to the Keytruda monotherapy group, the Intismeran plus Keytruda combination group demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint, recurrence-free survival (RFS). The trial also met its key secondary endpoint, distant metastasis-free survival (DMFS). No new safety concerns were identified.
This marks the first time a personalized neoantigen therapy and an mRNA-based cancer treatment has yielded positive results in a large-scale Phase 3 clinical trial. However, specific figures—such as the hazard ratio (HR) indicating the magnitude of the reduction in the risk of recurrence or metastasis, the recurrence rate, and p-values—have not yet been disclosed. The trial is ongoing to evaluate the remaining endpoints, including overall survival (OS).
Intismeran is a personalized therapy produced specifically for each patient by analyzing the patient’s tumor tissue and blood to identify up to 34 neoantigens—mutated antigens that appear exclusively on cancer cells. This enables immune cells to learn the characteristics of cancer cells and be guided to locate and attack micrometastatic cancer cells remaining after surgery.
The market reacted immediately to these results. On the day of the announcement, Moderna’s stock price surged nearly 177% on the New York Stock Exchange, and MSD’s stock also showed strong gains. In the domestic market, SAMYANG BIOPHARM CORPORATION—which possesses its own nucleic acid delivery platform and mRNA cancer vaccine candidates—hit the daily price limit. Interest also spread to companies related to mRNA platforms, raw materials, and delivery systems, such as ST Pharm Co., Ltd. and Pharmicell.
However, given that most domestic pipelines are still in the early stages of development, the prevailing view is that it remains to be seen whether Moderna’s clinical success will translate into direct business results in the short term. A bioindustry official stated, “The fact that we’ve confirmed the potential for mRNA technology to expand its scope from infectious disease prevention to cancer treatment is significant in itself,” adding, “Although the domestic sector is still in its early stages, opportunities for collaboration and technology transfer could expand in the future for Korean companies possessing relevant platforms and delivery technologies.”
NeoImmuneTech,Inc
. Draws Attention with First Technology Transfer Announcement Since IPONeoImmuneTech
,Inc. announced on the 19th that it had signed an agreement with U.S. biotech firm Tolerance Bio to transfer exclusive development and commercialization rights for “NT-I7.” This marks the company’s first licensing-out achievement since its KOSDAQ listing in 2021.
The agreement covers thymus hypofunction, including immune reconstitution in individuals infected with the human immunodeficiency virus (HIV). Tolerance Bio has secured exclusive rights to develop and commercialize NT-I7 for these indications in North America, Central and South America, and Europe.
NeoImmuneTech, Inc. will receive a 4% stake in Tolerance Bio’s common stock in lieu of a cash upfront payment. It will subsequently receive milestone payments totaling up to $260 million (approximately 366.9 billion won) based on clinical development and sales achievements, and will separately receive tiered running royalties linked to annual net sales following commercialization.
A key feature of this agreement is that NeoImmuneTech, Inc. has transferred the rights to an indication it did not develop in-house to an external partner. This demonstrates that NT-I7’s platform scalability and commercial value have been recognized not only for existing indications but also in new therapeutic areas.
Tolerance Bio was founded by the founding team of Prevention Bio, which led the U.S. Food and Drug Administration (FDA) approval of “TGLD,” a treatment for type 1 diabetes. Prevention Bio was acquired by Sanofi in 2023 for approximately $2.9 billion.
Meanwhile, following the news, NeoImmuneTech, Inc.’s stock price closed at the daily price limit on both the 20th and 21st. As of the previous day, NeoImmuneTech, Inc.’s stock price stood at 2,850 won, up 29.84% (655 won) from the previous trading day.
