💫 Proud to see our portfolio company Enterome receive U.S. #FDA Orphan Drug Designation for EO2463, its OncoMimics™ immunotherapy candidate for indolent non-Hodgkin lymphoma in the “watch-and-wait” setting. ✨ A meaningful regulatory #milestone, following Fast Track designation, and another step toward addressing a clear unmet need for patients who today are often monitored until disease progression. ⚡ Congratulations to the entire Enterome team. #Biotech #Oncology #Immunotherapy #HealthcareInnovation #PrimoCapital Michele Cerqua Gianluca Dettori Antonio Concolino
The FDA has granted Orphan Drug Designation to our EO2463 OncoMimics™ immunotherapy. This is an important regulatory milestone for Enterome, and good news for patients with indolent non-Hodgkin lymphoma (iNHL) in the “watch-and-wait” setting. ODD status – granted to therapies for rare diseases - brings several regulatory, financial and strategic advantages. For example, orphan-designated products receive 7 years of market exclusivity in the U.S. upon marketing approval. The FDA had already granted Fast Track designation to EO2463 in October 2025. “It is gratifying to see the U.S. regulatory agency recognizes that ‘watch-and-wait’ patients deserve a real treatment option like EO2463,” Enterome CEO Belichard Pierre said. Non-symptomatic low tumor-burden “watch-and-wait” iNHL patients currently are offered no treatment other than being observed until the cancer progresses. This is an unacceptable situation that places undue stress on patients and their families. OncoMimics™ like EO2463 - a new class of off-the-shelf, multi-targeted in vivo immune therapies - offer hope. EO2463 has shown potentially disease-modifying activity in clinical testing in watch-and-wait iNHL patients. It has also shown complementary efficacy to rituximab and other cancer drugs in more advanced iNHL patients. To read our press release, click here : https://lnkd.in/ehfRSAcC #OncoMimics #cancer #immunotherapies #oncology #hematology