Mocravimod hydrochloride

Mocravimod is being investigated in a global MO-TRANS Phase 3 study in patients with acute myeloid leukemia undergoing allogeneic hematopoietic cell transplantation Mocravimod is the only S1P receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers Saint-Louis, France and Dublin, Ireland – 3rd December 2024– Priothera Ltd., a late-stage biopharma company pioneering the development of its oral sphingosine 1 phosphate (S1P) receptor modulator, mocravimod, as an adjunctive and maintenance therapy for hematologic malignancies, announces that it will present a Trial in Progress poster on the MO-TRANS Phase 3 study, at the American Society of Hematology (ASH) Annual Meeting taking place December 7-10, 2024, in San Diego, California. Priothera is investigating the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in the pivotal MO-TRANS Phase 3 study. Mocravimod’s unique dual mechanism of action modulates the S1P receptor 1 to retain alloreactive donor T-cells within lymphoid organs, enhancing the graft-versus-leukemia (GvL) effect to eliminate cancer cells, while preventing T-cell egress to peripheral tissues, thereby reducing the risk of graft-versus-host disease (GvHD). This innovative treatment approach offers a promising solution for patients at high risk of relapse following allo-HCT. The MO-TRANS study (NCT05429632) is a multicenter, global, placebo-controlled trial enrolling patients with AML in complete remission (CR1), including those with intermediate or adverse risk, as well as patients of all risks in second complete remission (CR2). Patients are randomized to receive either mocravimod or a placebo in addition to standard of care. The primary endpoint of the study is relapse-free survival (RFS). Secondary endpoints include overall survival (OS) and the incidence of GvHD. Presentation details are as follows: Title: MO-TRANS: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study of Mocravimod (MOC) as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allogeneic Hematopoietic Cell TransplantationPresenter: Dr. Gabriela Sanchez-Petitto, MD, Hematologist and Assistant Professor at The Ohio State University, Columbus (OSU)Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Poster IIIDate & Time: Monday, December 9, 2024, 6:00 PM–8:00 PM PT Priothera’s abstract can be viewed on ASH’s website here: Priothera ASH Abstract #203080 *** About mocravimodMocravimod (KRP203) is a synthetic S1P receptor modulator being developed for the adjunctive treatment of AML to enhance the curative potential of allo-HCT. Mocravimod’s dual mechanism of action preserves the graft-versus-leukemia (GvL) effect, critical for eliminating cancer cells while reducing the risk of graft-versus-host disease (GvHD), a major complication following allo-HCT. This novel treatment approach – mocravimod being the only S1P receptor modulator treating blood cancers – tackles a high unmet medical need and aims to improve patients’ quality of life. About PriotheraPriothera is a late-stage biopharma company pioneering the development of mocravimod, a potential new standard of care in hematologic cancers, in combination with cellular therapies such as hematopoietic cell transplantation and CAR-T cell therapies. Mocravimod is being developed as an adjunctive and maintenance therapy for hematological malignancies, focusing initially on acute myeloid leukemia (AML), in combination with allogeneic hematopoietic cell transplant (allo-HCT). Mocravimod is currently the only treatment with the potential to reduce transplant side effects of graft-versus-host disease (GvHD) without compromising the graft’s anticancer effect against leukemia (Graft-versus-Leukemia, or GvL), thereby enhancing the curative potential of allo-HCT. Founded in 2020, Priothera operates in France, with headquarters in Dublin. The company is led by a highly experienced management team with deep expertise in hematology, oncology, immunology and cell-based therapies. Priothera is backed by leading international life sciences investors, including Fountain Healthcare Partners, abrdn, EarlyBird Venture Capital, BEI and Bpifrance Grand Est. For more information please visit www.priothera.com or follow Priothera on LinkedIn www.linkedin.com/company/priothera/ Contacts PriotheraFlorent Gros, CEOE: info@priothera.com MEDiSTRAVA ConsultingSylvie Berrebi, Sandi Greenwood, Frazer HallE: priothera@medistrava.comT: +44 (0) 203 928 6900

EUROAPI has begun the implementation of a 5-year development and manufacturing agreement with Priothera, a biotechnology company specializing in molecules for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies. Priothera is headquartered in Dublin, Ireland, and has a subsidiary in Saint-Louis (Haut-Rhin), France. As part of this collaboration, EUROAPI will develop and industrialize the manufacturing process of mocravimod, an innovative oncology molecule, through its Contract Development and Manufacturing Organization (CDMO) activity. This project will be carried out at EUROAPI’s Budapest site, its center of excellence for complex chemistry. “Oncology is a major segment for EUROAPI’s CDMO business. Signing this development and manufacturing agreement with Priothera demonstrates our ability to adapt to state-of-the-art innovation and quality requirements,” said Cécile Maupas, Chief CDMO Officer of EUROAPI. “This contract is a true recognition of EUROAPI’s broad panel of technologies and capabilities to respond to the increasing demand across different modalities.” “Having EUROAPI as a commercial manufacturing partner brings a substantial value to Priothera who is accelerating its late development of mocravimod in a global phase 3 clinical study with a view of worldwide drug registration and commercialization by 2027,” said Florent Gros, Co-Founder and Chief Executive Officer of Priothera. Mocravimod is a S1P receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers, with the objective to reduce relapses and increase survival of patients. It is being developed in a global phase 3 trial which is enrolling approximately 250 adult Acute Myeloid Leukemia patients, and is ongoing in the US, Europe, Asia and Latin America. It has been granted Orphan Drug designation by both EMA and US FDA. Oncology is a growing market worldwide: global spending on cancer medicines is expected to reach USD 375 billion by 2027, up from USD 196 billion in 2022. According to the US National Cancer Institute, approximately 1.6 percent of men and women will be diagnosed with leukemia at some point during their lifetime.