Servier Pharmaceuticals LLC is a privately-owned pharmaceutical company based in Boston, Massachusetts. Established in 1954, the company is dedicated to improving patients' lives through innovation and addressing unmet medical needs. Servier specializes in oncology and has developed a portfolio of innovative medicines designed to provide life-saving treatments to a wider range of patients with various types of cancer. The company has significantly increased its investment in research and development, with over 50% of its efforts focused on hard-to-treat cancers. Servier believes in co-creation and has formed alliances, acquisitions, licensing deals, and partnerships to accelerate access to therapies and drive innovation.

Tags

Neoplasms

Hemic and Lymphatic Diseases

Cardiovascular Diseases

Small molecule drug

Enzyme

Universal CAR-T

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	10
Hemic and Lymphatic Diseases	6
Immune System Diseases	5
Nervous System Diseases	4
Endocrinology and Metabolic Disease	3
Infectious Diseases	2

Top 5 Drug Type	Count

Small molecule drug	9
Enzyme	2
Universal CAR-T	1

Top 5 Target	Count

ASN(Asparagine)	2
IDH1 x IDH2	1
DNA-directed DNA polymerase	1
ACE(Angiotensin-converting enzyme)	1
IDH1(Isocitrate dehydrogenase [NADP] cytoplasmic)	1

Drugs associated with Servier Pharmaceuticals LLC

Vorasidenib

Target

IDH1 x IDH2

Mechanism

IDH1 inhibitors [+1]

Active Org.

Servier Laboratories (Australia) Pty Ltd. [+7]

Originator Org.

Celgene Corp.

Active Indication

Diffuse Astrocytoma [+14]

Inactive Indication

Acute Myeloid Leukemia [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Aug 2024

Calaspargase Pegol-MKNL(Shire Plc)

Target

ASN

Mechanism

ASN inhibitors

Active Org.

Servier Pharmaceuticals LLCStartup [+6]

Originator Org.

Shire Plc

Active Indication

Acute Lymphoblastic Leukemia [+9]

Inactive Indication

Pancreatic Ductal Carcinoma [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date20 Dec 2018

Ivosidenib

Target

IDH1

Mechanism

IDH1 inhibitors

Active Org.

Institut de Recherches Intern Servier [+10]

Originator Org.

Celgene Corp.

Active Indication

Myelodysplastic Syndromes [+17]

Inactive Indication

Advanced biliary tract cancer [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date20 Jul 2018

Clinical Trials associated with Servier Pharmaceuticals LLC

NCT05609994 / Not yet recruitingPhase 1IIT

ViCToRy: Vorasidenib in Combination with Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.

Start Date01 Jan 2025

Sponsor / Collaborator

Duke University

[+1]

NCT05615818 / RecruitingPhase 3IIT

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.
The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

Start Date18 Jul 2024

Sponsor / Collaborator

UNICANCER

[+8]

NCT06081829 / Active, not recruitingPhase 2

A Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for advanced disease. All participants will receive ivosidenib daily throughout multiple 28 day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), every other week during Cycles 2 and 3, and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an end of treatment and a post-treatment follow-up visit, and participants will be followed to assess overall survival. Study visits may include a tumor assessment, physical exam, electrocardiogram (ECG), blood and urine analysis, and questionnaires.

Start Date10 Oct 2023

Sponsor / Collaborator

Servier Pharmaceuticals LLCStartup

100 Clinical Results associated with Servier Pharmaceuticals LLC

0 Patents (Medical) associated with Servier Pharmaceuticals LLC

Literatures (Medical) associated with Servier Pharmaceuticals LLC

28 Nov 2024·BLOOD

Antimetabolite dose intensity and adverse outcomes in children with acute lymphoblastic leukemia: a COG-AALL03N1 report

Article

Author: Neglia, Joseph P. ; Landier, Wendy ; Ravindranath, Yaddanapudi ; Wong, F. Lennie ; Dickens, David S. ; Wadhwa, Aman ; Angiolillo, Anne ; Hageman, Lindsey ; Termuhlen, Amanda ; Bhatia, Smita ; Chen, Yanjun

Abstract:

The association between antimetabolite dose intensity (DI) and adverse events among children receiving maintenance therapy for acute lymphoblastic leukemia (ALL) remains unclear, especially in the context of antimetabolite adherence. Using Children’s Oncology Group AALL03N1 data, we examined the association between high DI during the first 4 study months and (i) treatment-related toxicities during the subsequent 2 study months; and (ii) relapse risk. Patients were classified into a high DI phenotype (either 6-mercaptopurine [6-MP] or methotrexate [MTX] DI ≥110% during the first 4 study months, or 6-MPDI or MTXDI 100%-110% at study enrollment and ≥25% increase over the 4 study months) and normal DI phenotype (all others). Only patients with wild-type TPMT and NUDT15 were included. 6-MP adherence data were available for 63.7% of study participants and used to stratify as adherent (median adherence ≥85%) and nonadherent (median adherence <85%) participants. Multivariable analyses were adjusted for sociodemographic and clinical prognosticators. Of the 644 patients, 29.3% were exposed to high DI. High DI was associated with a 2.1-fold greater odds of hematologic toxicity (95% confidence interval [CI] = 1.4-3.1; reference: normal DI) in the entire cohort and 2.9-fold higher among adherers (95% CI = 1.6-5.1); odds were comparable among nonadherers (2.1-fold; 95% CI = 0.4-10.1). Although high DI was not associated with relapse in the entire cohort (adjusted hazard ratio [aHR] = 1.4; 95% CI = 0.8-2.4), it was associated with a greater hazard of relapse among adherent participants (aHR = 2.4; 95% CI = 1.0-5.5) but not among nonadherent participants (aHR = 0.9; 95% CI = 0.2-3.8). Dose escalation above protocol doses during maintenance therapy for ALL should be done cautiously after assessing adherence to prescribed therapy.

01 Nov 2024·LEUKEMIA

Determinants of survival after first relapse of acute lymphoblastic leukemia: a Children’s Oncology Group study

Article

Author: Loh, Mignon L. ; Asselin, Barbara L. ; Brown, Patrick ; Dreyer, ZoAnn E. ; Dreyer, ZoAnn E ; Angiolillo, Anne L ; Raetz, Elizabeth A. ; Hilden, Joanne M ; Bowman, W. Paul ; Rheingold, Susan R ; Winick, Naomi J ; Carroll, William L ; Bowman, W Paul ; Winter, Stuart S ; Maloney, Kelly ; Carroll, William L. ; Dunsmore, Kimberly P ; Heerema, Nyla A. ; Winick, Naomi J. ; Angiolillo, Anne L. ; Devidas, Meenakshi ; Hilden, Joanne M. ; Matloub, Yousif ; Carroll, Andrew J ; Kairalla, John A ; Shago, Mary ; Xu, Xinxin ; Asselin, Barbara L ; Hunger, Stephen P ; Mattano, Leonard A. ; Rheingold, Susan R. ; Dunsmore, Kimberly P. ; Wood, Brent L ; Borowitz, Michael ; Heerema, Nyla A ; Carroll, Andrew J. ; Mattano, Leonard A ; Raetz, Elizabeth A ; Breidenbach, Heather ; Hunger, Stephen P. ; Loh, Mignon L ; Wood, Brent L. ; Gore, Lia ; Winter, Stuart S. ; Kairalla, John A. ; Larsen, Eric ; Bhojwani, Deepa ; Ji, Lingyun

Abstract:

Limited prognostic factors have been associated with overall survival (OS) post-relapse in childhood Acute Lymphoblastic Leukemia (ALL). Patients enrolled on 12 Children’s Oncology Group frontline ALL trials (1996–2014) were analyzed to assess for additional prognostic factors associated with OS post-relapse. Among 16,115 patients, 2053 (12.7%) relapsed. Relapse rates were similar for B-ALL (12.5%) and T-ALL (11.2%) while higher for infants (34.2%). Approximately 50% of B-ALL relapses occurred late (≥36 months) and 72.5% involved the marrow. Conversely, 64.8% of T-ALL relapses occurred early (<18 months) and 47.1% involved the central nervous system. The 5-year OS post-relapse for the entire cohort was 48.9 ± 1.2%; B-ALL:52.5 ± 1.3%, T-ALL:35.5 ± 3.3%, and infant ALL:21.5 ± 3.9%. OS varied by early, intermediate and late time-to-relapse; 25.8 ± 2.4%, 49.5 ± 2.2%, and 66.4 ± 1.8% respectively for B-ALL and 29.8 ± 3.9%, 33.3 ± 7.6%, 58 ± 9.8% for T-ALL. Patients with ETV6::RUNX1 or Trisomy 4 + 10 had median time-to-relapse of 43 months and higher OS post-relapse 74.4 ± 3.1% and 70.2 ± 3.6%, respectively. Patients with hypodiploidy, KMT2A-rearrangement, and TCF3::PBX1 had short median time-to-relapse (12.5-18 months) and poor OS post-relapse (14.2 ± 6.1%, 31.9 ± 7.7%, 36.8 ± 6.6%). Site-of-relapse varied by cytogenetic subtype. This large dataset provided the opportunity to identify risk factors for OS post-relapse to inform trial design and highlight populations with dismal outcomes post-relapse.

13 Aug 2024·Blood advances

Final phase 1 substudy results of ivosidenib for patients with mutant IDH1 relapsed/refractory myelodysplastic syndrome

Article

Author: Roboz, Gail J ; Stein, Anthony ; Hossain, Mohammad ; Baratam, Praneeth ; Patel, Prapti A ; Foran, James M ; Prince, Gabrielle T. ; Garcia-Manero, Guillermo ; Patel, Prapti A. ; Watts, Justin M. ; Foran, James M. ; Kapsalis, Stephanie M. ; de Botton, Stéphane ; Arellano, Martha L ; Watts, Justin M ; Marchione, Dylan M ; Marchione, Dylan M. ; DiNardo, Courtney D. ; Sallman, David A. ; Prince, Gabrielle T ; Fathi, Amir T. ; Madanat, Yazan F. ; Roboz, Gail J. ; Kapsalis, Stephanie M ; Arellano, Martha L. ; Bai, Xiaofei ; Sallman, David A ; DiNardo, Courtney D ; Madanat, Yazan F ; Fathi, Amir T

Abstract:

Ivosidenib is a first-in-class mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor with efficacy and tolerability in patients with advanced mIDH1 hematologic malignancies, leading to approval in frontline and relapsed/refractory (R/R) mIDH1 acute myeloid leukemia. We report final data from a phase 1 single-arm substudy of once-daily ivosidenib in patients with R/R mIDH1 myelodysplastic syndrome (MDS) after failure of standard-of-care therapies. Primary objectives were to determine safety, tolerability, and clinical activity. The primary efficacy end point was the complete remission (CR) + partial remission (PR) rate. Nineteen patients were enrolled; 18 were included in the efficacy analysis. Treatment-related adverse events occurred in 8 (42.1%) patients, including a grade 1 QT interval prolongation in 1 (5.3%) patient and grade 2 differentiation syndrome in 2 (10.5%) patients. Rates of CR + PR and objective response (CR + PR + marrow CR) were 38.9% (95% confidence interval [CI], 17.3-64.3) and 83.3% (95% CI, 58.6-96.4), respectively. Kaplan-Meier estimates showed a 68.6% probability of patients in CR achieving a remission duration of ≥5 years, and a median overall survival of 35.7 months. Of note, 71.4% and 75.0% baseline red blood cell (RBC)- and platelet-transfusion-dependent patients, respectively, became transfusion independent (TI; no transfusion for ≥56 days); 81.8% and 100% of baseline RBC and platelet TI patients, respectively, remained TI. One (5.3%) patient proceeded to a hematopoietic stem cell transplant. In conclusion, ivosidenib is clinically active, with durable remissions and a manageable safety profile observed in these patients. This trial was registered at www.ClinicalTrials.gov as #NCT02074839.

News (Medical) associated with Servier Pharmaceuticals LLC

19 Nov 2024

·www.prnewswire.com

Servier Partners With Local Cancer Center to Support Research Graduate Students in the Boston Area

BOSTON, Nov. 19, 2024 /PRNewswire/ -- Servier, a leader in delivering transformative new therapies to patients, and Dana-Farber Cancer Institute, a world leader in adult and pediatric cancer treatment and research, are proud to announce the enrollment of the first PhD student from Dana-Farber in the SHINEDocs program funded by Servier. This agreement marks the initiation of the SHINEDoc program in the U.S. where the PhD student will start in the program this November. The SHINEDoc program, standing for " Servier Highlighting Innovation through its NEtwork of PhD students and Post- Docs," is a dynamic, international community of more than 70 PhD and postdoctoral students working in either Servier laboratories or with Servier's partners. Those in the SHINEDoc program receive specific trainings to build their research acumen and soft skills, career support and networking opportunities within and outside of Servier. "Dana-Farber's clinical and scientific expertise are recognized worldwide, and we are excited to continue to build upon our relationship with the organization," said Walid Kamoun, Vice President, Global Head of R&D Oncology at Servier. "This collaboration is based not only on the shared vision of developing transformative therapies for cancer patients through scientific innovation, but to support up-and-coming researchers in the Boston area as well. Following the initiation of this partnership, we hope to include other U.S. organizations and universities in the SHINEDoc program." The first phase of this program will focus on the training of one PhD student in basic research in the field of oncology and neurological diseases. Over the course of the three-year program, the PhD student will join the international community of fellow doctoral students and postdocs to share knowledge, develop soft skills and build their international network. The aim of this program is to ultimately develop new technologies and characterize new therapeutic targets for the benefit of patients across the globe. "I am deeply grateful to Servier Pharmaceuticals for providing this opportunity to our graduate student," said Kevin Haigis, PhD., Chief Scientific Officer, Dana-Farber Cancer Institute. "This program not only provides critical financial assistance, but a strong commitment to mentor and support young scientists in their early career growth. The offerings provided via the SHINEDocs program cater to all facets of development from networking to training, career support and workshops. I am excited to partner with Servier Pharmaceuticals to share in the advancement of future talent at Dana-Farber." About Servier Pharmaceuticals Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. Servier is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time. Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio. For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.us. Media Contact : [email protected] SOURCE Servier Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

13 Nov 2024

·www.prnewswire.com

Servier to Present Data Across its Hematology Portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting

Servier's presence at the 2024 ASH congress includes seven company-sponsored abstracts including one oral presentation Data supports Servier's unwavering commitment to patients living with IDH-mutated blood cancers BOSTON, Nov. 13, 2024 /PRNewswire/ -- Servier today announced that it will present data at the Annual Meeting for the American Society of Hematology (ASH), December 7-10, 2024 in San Diego, California. Data presentations will focus on the company's clinical and preclinical studies in IDH-mutated acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), providing new insights on existing programs and a better understanding of the challenges faced by people living with hematological malignancies. "Servier is driven to deliver innovative therapies for diseases where patient needs are not yet sufficiently met and where we believe we can have the greatest positive impact," said Becky Martin, PhD, Chief of Medical at Servier Pharmaceuticals. "We look forward to sharing data at this year's ASH annual meeting that build upon our expertise in developing medicines for patients living with hematological malignancies, including IDH-mutated AML and MDS." A full list of company-sponsored abstracts can be found here. About Servier in Oncology Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. Servier is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time. Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio. For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.us. Media Contact Sara Noonan [email protected] SOURCE Servier Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASH

12 Nov 2024

·www.prnewswire.com

Servier to Present Data on IDH-mutant Glioma at the 2024 Society for Neuro-Oncology (SNO) Congress

Servier's presence at the 2024 SNO congress includes six company-sponsored abstracts including three oral presentations BOSTON, Nov. 12, 2024 /PRNewswire/ -- Servier today announced that it will present data at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO), November 21-24, 2024, in Houston, Texas. Data presentations will focus on the company's neuro-oncology development program, including three oral-presentations, and reinforce our understanding of the burdens and experiences of people living with IDH-mutant glioma. "At Servier, we are dedicated to delivering transformative, life-changing therapies to patients living with cancer who have little-to-no options available," said Claude Bertrand, Executive Vice President Research and Development, Chief Scientific Officer, at Servier. "Our presentations at this year's Society for Neuro-Oncology Conference reinforce our commitment to people living with IDH-mutant gliomas, who had, until recently, limited therapeutic options to treat this devastating disease. We look forward to sharing results with the community, including updated Phase 3 data that supports our recently approved medication for Grade 2 IDH-mutant gliomas." A full list of company-sponsored abstracts can be found here. About Glioma1 Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories: Astrocytoma, IDH-mutant (CNS WHO grades 2-4) Oligodendroglioma, IDH-mutant and 1p19q-codeleted (CNS WHO grades 2-3) Glioblastoma, IDH-wildtype (CNS WHO grade 4) About Servier in Oncology Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. Servier is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time. Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio. For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.us. Media Contact Sara Noonan [email protected] Ken DiCienzo [email protected] References 1 Mellinghoff, I. K., van den Bent, M. J., Blumenthal, D. T., Touat, M., Peters, K. B., Clarke, J., Mendez, J., Yust-Katz, S., Welsh, L., Mason, W. P., Ducray, F., Umemura, Y., Nabors, B., Holdhoff, M., Hottinger, A. F., Arakawa, Y., Sepulveda, J. M., Wick, W., Soffietti, R., … Cloughesy, T. F. (2023). Vorasidenib in idh1- or IDH2-mutant low-grade glioma. New England Journal of Medicine, 389(7), 589–601. SOURCE Servier Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOPhase 3

100 Deals associated with Servier Pharmaceuticals LLC

100 Translational Medicine associated with Servier Pharmaceuticals LLC

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Pipeline

Pipeline Snapshot as of 26 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1

Phase 2

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Perindopril Erbumine ( ACE )	Heart Failure More	Approved
Pegaspargase ( ASN )	Acute Lymphoblastic Leukemia More	Approved
Calaspargase Pegol-MKNL(Shire Plc) ( ASN )	Acute Lymphoblastic Leukemia More	Approved
Ivosidenib ( IDH1 )	IDH1 Mutation Acute Myeloid Leukemia More	Approved
Vorasidenib ( IDH1 x IDH2 )	Astrocytoma, IDH-Mutant More	Approved

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