Priothera to Present Trial in Progress Poster for Mocravimod at 2024 American Society of Hematology (ASH) Annual Meeting

by admin | Dec 2, 2024 | Press Release

NEWS

June 2024

Priothera to Present Trial in Progress Poster for Mocravimod at 2024 American Society of Hematology (ASH) Annual Meeting

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 Transplantation
Presenter: 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 III
Date & 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 mocravimod

Mocravimod (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 Priothera

Priothera 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 click here, or follow Priothera on LinkedIn www.linkedin.com/company/priothera/

Contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0) 203 928 6900

LMA : Phase III et levée de fonds en cours pour Priothera

by admin | Nov 18, 2024 | News

Par Pierre Havez

LMA : phase III et levée de fonds en cours pour Priothera

En phase 3 d’une étude clinique internationale, la biotech basée à St-Louis (68) prépare une levée de fonds de 60 M€ pour soutenir et diversifier son développement clinique.

Le CEO de Priothera, Florent Gros, a créé plusieurs biotechs au cours de sa carrière et dirigé plusieurs fonds d’investissement au sein de Sanofi, Novartis Venture Fund et Earlybird Venture Capital.

Au fil de la confirmation des promesses de son candidat médicament pour le traitement des cancers du sang et de la moelle, la discrète biotech installée à la frontière franco-suisse sort du bois. L’entreprise, fondée en 2020 par des anciens de Novartis à partir d’une molécule – le mocravimod – développée et testée en phase 2 par le laboratoire suisse, fait valoir depuis sa création des perspectives encourageantes. « Les patients atteints de LMA (leucémie aiguë myéloïde) qui ont aujourd’hui la chance d’être traités par desgreffes de cellules souches sont exposés à une probabilité de décès de 10 % à un an, et de30 %à deux ans, en raison d’un risque élevé d’effets secondaires, le GvHD, lorsque le greffon se retourne contre son hôte et attaque ses tissus » , explique le CEO et cofondateur de la biotech, Florent Gros, qui a lui-même vécu cette situation de donneur pour sa soeur atteinte de ce cancer du sang. « L’avantage de notre molécule est qu’elle traite à lafois cet effet secondaire tout en conservant un effet anti cancer prononcé. » Selon les études de Novartis, le mocravimod améliore ainsi le taux de survie des malades jusqu’à 40 % à deux ans par rapport aux traitements actuels, en diminuant la réaction du greffon contre l’hôte, et ce, sans réduire l’activité anti-cancer, ni entraîner d’effets secondaires.

9

Avec un taux de pénétration élevé d'environ 70 %, notre technologie cible un marché d'i Md$, rien qu'en Europe, au Japon et aux États-Unis.

Une phase 3 à deux objectifs

Pour valider ces premiers résultats, Priothera vient de lancer une étude clinique de phase 3 sur deux doses en aveugle auprès de 250 patients dans une centaine d’hôpitaux dans le monde : États-Unis, France, Royaume-Uni, Japon, Taïwan, Amérique latine, etc. « Cette phase vise deux objectifs : une diminution de 20 % du risque de récidive à un an et/ou une augmentation de 20 % de la survie des patients à deux ans », précise le dirigeant. Les résultats définitifs seront donc connus fin 2026, pour une mise sur le marché envisagée fin 2027.

Afin de financer ces études, l’entreprise espère finaliser d’ici le premier trimestre 2025 une levée de fonds d’environ 60 M€, soit l’équivalent de la somme déjà récoltée depuis son démarrage. « Les discussions de financement progressent positivement auprès de nos investisseurs historiques le fonds suédois HealthCap, l’Irlandais Fountain Partners, le fonds Abrdn à Boston et Earlybird à Berlin – ainsi que la Banque Européenne d’Investissement (BEL). Pour le tiers du financement restant à lever, nous visons des nouveaux fonds de capital-risque en Europe ou aux États Unis », confie Florent Gros. Outre l’étude de phase 3 en cours contre la LMA, ces fonds serviront également à initier une nouvelle étude pour le même principe de traitement par cellules souches appliqué cette fois aux cellules CAR-T, dans la lutte contre les lymphomes diffus à grandes cellules B (une autre forme de cancer du sang), en France et en Allemagne, l’année prochaine.

Un marché d’i à 2 Mds$

L’accélération du développement clinique de Priothera vise à offrir une nouvelle forme de traitement effkace à des malades aujourd’hui dépourvus d’alternative.
La leucémie aiguë myéloïde touche aujourd’hui environ 20 000 malades en Europe, dont la moitié seulement bénéficie de transplantations, malgré les risques de rejet que ces interventions représentent. Or, un seul concurrent, le laboratoire AbbVie, se positionne actuellement en phase 3 pour une molécule relativement ancienne et toxique, pouvant fragiliser les patients. « Le besoin médical est très important, insiste Florent Gros, personnellement concernépar la maladie au sein de sa famille. Avec un taux de pénétration élevé d’environ 70 %, notre technologie cible un marché d’1 Md$, rien qu’en Europe, au Japon et aux États-Unis, le coût du traitement étant estimé dans une fourchette de 100 000 à 200 000 $ selon lespays ».
À terme, une fois validé pour la LMA, le même principe de traitement par cellules souches pourrait s’appliquer à d’autres maladies du sang (MDS, LHL, ALL), soit un potentiel global de 2 Mds$.

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Booster l’efficacité des thérapies cellulaires

by admin | Nov 7, 2024 | News

Par Julie Wierzbicki

Booster l’efficacité des thérapies cellulaires

Sur le marché des immunomodulateurs, Priothera compte se faire une place dans le champ des cancers hématologiques avec une molécule actuellement en phase III, dont le développement a connu de nombreux rebondissements.

LSX – Investival Showcase

by admin | Oct 10, 2024 | Events

EUROAPI and Priothera enter into CDMO collaboration to advance oncology project

by admin | Jun 19, 2024 | Press Release

NEWS

June 2024

EUROAPI and Priothera enter into CDMO collaboration
to advance oncology project

EUROAPI and Priothera, a biotechnology company specializing in the treatment of hematological malignancies and the improvement of CAR-T cell therapies, have signed a 5-year CDMO agreement

EUROAPI will develop and industrialize the manufacturing process of innovative complex molecule for blood cancers

Paris – June 18, 2024 – EUROAPI announces today 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[1] 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 $375 billion by 2027, up from $196 billion in 2022[2]. 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[3].

1 sphingosine-1-phosphate
2 Source: Iqvia data, https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2023
3 Source: SEER Cancer Stat Facts: Leukemia. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/leuks.html

About EUROAPI

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn.

About Priothera

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. Mocravimod is increasing 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 an operational 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.

For more information please visit www.priothera.com or follow Priothera on LinkedIn www.linkedin.com/company/priothera/

EUROAPI contacts

Media Relations:
Laurence Bollack
Tel.: +33 (0)6 81 86 80 19
mr@euroapi.com

Investor Relations:
Sophie Palliez-Capian
Tel.: +33 (0)6 87 89 33 51
Sophie.palliez@euroapi.com

Camille Ricotier
Tel.: +33 (0)6 43 29 93 79
Camille.ricotier@euroapi.com

Priothera contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0) 203 928 6900