TERAH-7: Innovation in Immunotherapy for HPV-Associated Diseases

• Grant number: 25/02916-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: August 01, 2025
• End date: July 31, 2027
• Field of knowledge: Biological Sciences - Microbiology - Applied Microbiology
• Principal Investigator: Luana Raposo de Melo Moraes Aps
• Grantee: Luana Raposo de Melo Moraes Aps
• Principal investigators: Bruna Felício Milazzotto Maldonado Porchia Ribeiro
• Associated researchers: Mariana de Oliveira Diniz
• Associated research grant: 23/00545-9 - Good practice production and safety evaluation of the TERAH-7 recombinant protein: a step forward on technological development of a therapeutic vaccine to HPV-related cervical cancer, AP.PIPE

Abstract

It is estimated that 8 out of 10 people will be infected with HPV throughout their lifetime, often asymptomatically. However, persistent infections with this virus can trigger cellular changes that, when located in the cervix, result in cervical intraepithelial neoplasia (CIN). These precursor lesions are frequently diagnosed in young women aged 18 to 29 and, if left untreated, can progress to cervical cancer, which is more prevalent in women between 35 and 64 years old. In 2022, cervical cancer was the fourth most common type of cancer among women, with approximately 660,000 new cases, resulting in 350,000 deaths-94% of which occurred in low- and middle-income countries. In light of this scenario, the World Health Organization (WHO) launched a global strategy to eradicate cervical cancer by 2130, highlighting the need for an accessible and effective treatment for 90% of patients as one of its key pillars. Currently, therapeutic options include surgery, chemotherapy, and radiotherapy, which, despite being widely used, have significant limitations such as severe adverse effects and low efficacy in advanced stages of the disease. ImunoTera has developed TERAH-7, an innovative immunotherapy based on the active reprogramming of the immune system. Unlike other approaches, TERAH-7 incorporates a potent immunomodulatory component that activates immune system cells, stimulating the response of T lymphocytes capable of recognizing and eliminating HPV-associated tumor cells. Preclinical studies have demonstrated its efficacy, including synergy with chemotherapy, prevention of recurrences and metastases, and the ability to induce neoplasia regression in a proof-of-concept clinical study. This proposal aims to enable the next phase of TERAH-7's development, advancing towards industrial production, safety and efficacy testing, and regulatory approval for clinical trials. ImunoTera reaffirms its commitment to healthcare innovation through this initiative, promoting the nationalization of the immunotherapy production chain and driving the development of biotechnology in Brazil and worldwide. (AU)