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

Mocravimod is the only S1P receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers Mocravimod is being investigated in a global registration-enabling Phase 3 trial This is the second Orphan Drug designation for mocravimod Priothera Ltd., a Phase 3 clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation (ODD) to mocravimod for the ‘treatment to improve outcome following hematopoietic stem cell transplantation in hematologic malignancies’. This ODD aims to potentially increase leukemia-free survival by enhancing a graft-versus-leukemia (GvL) response. Florent Gros, Co-Founder and CEO of Priothera, commented: “We are very pleased that the US FDA granted mocravimod this Orphan Drug designation. This designation emphasizes the importance of developing novel therapeutic options to improve the outcome and success of maintenance therapy following allo-HSCT in blood cancer patients. This is an important milestone as this ODD complements the first ODD granted for prevention of graft-versus-host disease. “The two ODDs highlight mocravimod’s dual mode of action which for the first time is being leveraged to improve the allo-HSCT treatment outcomes in hematological malignancies to potentially increase the leukemia free survival – graft-versus-leukemia response - while reducing tissue damage resulting from the graft-versus-host disease.” The first ODD granted for mocravimod by the US FDA was for the ‘prevention of graft-versus-host disease (GvHD)’ – see press release here. Mocravimod, a sphingosine-1-phosphate (S1P) receptor modulator, is being investigated in a pivotal global Phase 3 study - MO-TRANS (NCT05429632) - evaluating the efficacy and safety of mocravimod as an adjunctive and maintenance therapy to allo-HSCT. The study which is enrolling approximately 250 adult Acute Myeloid Leukemia (AML) patients, is ongoing in the US, Europe, Southeast Asia and Latin America. Mocravimod, which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allo-HSCT. Moreover, it has shown a clinically meaningful outcome in a Phase 1b/2a study1 in patients with hematologic malignancies undergoing allo-HSCT. Mocravimod (also known as KRP203) is a synthetic, S1P receptor modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers and the improvement of CAR-T cell therapy. Mocravimod is currently being investigated as an adjunctive and maintenance treatment in a Phase 3 study for patients with AML receiving allogeneic HSCT. Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates. Priothera leverages mocravimod’s dual mode of action to maintain the beneficial graft-versus-leukemia/lymphoma (GvL) activity, while reducing tissue damage resulting from graft-versus-host disease (GvHD), both a consequence of allo-HSCT. 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. Priothera is leading the way in developing orally applied S1P receptor modulators for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Unlike immunosuppressive drugs, mocravimod does not suppress the GvL benefits in patients receiving allogeneic HSCT while inhibiting GvHD. Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with a subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden), EarlyBird Venture Capital (Berlin, Germany), as well as non-dilutive financing in the form of loans from the European Investment Bank under its Venture Debt Instrument and Bpifrance (Grand Est Bpifrance) in the form of a R&D innovation loan. The content above comes from the network. if any infringement, please contact us to modify.