Institut Gustave Roussy

MaaT Pharma indicates completion of Patient Recruitment for the Phase 2a Investigator-Sponsored Randomized Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors in Metastatic Melanoma

Retrieved on: 
Tuesday, March 5, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PICASSO, Week, Directorate, Neoplasm, Institut Gustave Roussy, PHRC, Ipilimumab, Nivolumab, ICI, National Cancer Institute, INRAE, Safety, MET, Patient, Survival, Cancer, Pharmaceutical industry

A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.

Key Points: 
  • A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.
  • The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint® research engine.
  • The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety.
  • Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.

Enterome Presents Positive Data from Phase 1/2 SPENCER Trial of EO2401 in Adrenal Tumors at ESMO 2023 Congress

Retrieved on: 
Monday, October 23, 2023
ESMO, MSS, Nivolumab, Congress, European Society for Medical Oncology, Inflammation, Adrenocortical carcinoma, Adrenal tumor, CD8, Service provider, Neoplasm, CT, Oncology, MPP, Patient, Peptide, Associate, Memory, Institut Gustave Roussy, ACC, Medical imaging, Pharmaceutical industry

PARIS, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced updated, encouraging results from Phase 1/2 SPENCER trial of EO2401 in combination with nivolumab in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP), two forms of adrenal tumors. EO2401 is composed of three non-self, microbiome-derived HLA-A2 restricted peptides, designed to activate memory CD8 T cells targeting tumor-associated antigens (TAAs) upregulated in adrenal tumors.

Key Points: 
  • EO2401 is composed of three non-self, microbiome-derived HLA-A2 restricted peptides, designed to activate memory CD8 T cells targeting tumor-associated antigens (TAAs) upregulated in adrenal tumors.
  • The data was featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.
  • “We are excited to share positive, updated results from the SPENCER trial at this year’s ESMO Congress,” said Pierre Belichard, Chief Executive Officer of Enterome.
  • “EO2401 in combination with nivolumab continues to demonstrate a meaningful anti-tumor activity in patients with adrenal tumors.

Celcuity to Host Virtual Science Day for Investors

Retrieved on: 
Thursday, September 7, 2023
University, MOA, Senior, Hematology, University of Washington Department of Global Health, Phase 3, Breast, Patient, Breast cancer, Division, CELC, Maghreb Virtual Science Library, Webcast, Institut Gustave Roussy, Oncology, Fred Hutchinson Cancer Research Center, UCLA, Gustav, Disease, Prostate cancer, Pharmaceutical industry, Medical imaging

ET on September 21, 2023

Key Points: 
  • ET on September 21, 2023
    MINNEAPOLIS, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will host a Virtual Science Day for analysts and investors from 10:00 a.m. – 12:00 p.m.
  • In early 2024, Celcuity expects to initiate the Phase 1b/2 CELC-G-201 trial of gedatolisib in combination with the androgen receptor inhibitor Nubeqa® (darolutamide) in metastatic castration resistant prostate cancer.
  • Celcuity’s Virtual Science Day for analysts and investors will take place on Thursday, September 21, 2023, from 10:00 a.m. to 12:00 p.m.
  • A replay of the webcast will be available on the “Events & Presentations” section of Celcuity’s website following the event.

Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer

Retrieved on: 
Tuesday, August 22, 2023
Science, Disease, Q&A, RPF, Doctor of Philosophy, MD, Patient, Institut Gustave Roussy, CELC, Maghreb Virtual Science Library, Webcast, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, Prostate cancer, Pharmaceutical industry, Medical imaging, Medicine

MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024.

Key Points: 
  • Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC.
  • The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024.
  • “We are excited to initiate the clinical development of gedatolisib in prostate cancer,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity.
  • A replay of the webcast will be available on the “Events & Presentations” section of Celcuity’s website for a limited time following the event.

Appia Bio Expands Leadership Team With Sylvaine Cases, Ph.D. Appointed Chief Business Officer and Alex Babayan, Ph.D. as Vice President, Head of Regulatory Affairs

Retrieved on: 
Wednesday, June 28, 2023
Amgen, Private sector, ACUA, University, University of California, Irvine academics, Cancer research, Cancer, Axicabtagene ciloleucel, Janssen, Head, University of California, Allotransplantation, Research, Stem cell, TCR, Institut Gustave Roussy, Health, Arete, CAR, Metabolism, Patient, Investment, CBO, Biology, LOS, Gladstone Institutes, Therapy, Kite, BLA, IND, Tumor microenvironment, Bangladesh Technical Education Board, Pharmacology, Pharmaceutical industry, Sanofi

LOS ANGELES, June 28, 2023 /PRNewswire/ -- Appia Bio, Inc., a biotechnology company developing allogeneic chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-NKT) cell therapies from hematopoietic stem cells (HSCs) for patients with cancer, today announced the appointments of Sylvaine Cases, Ph.D. as chief business officer (CBO) and Alex Babayan, Ph.D. as vice president, head of regulatory affairs.

Key Points: 
  • "We are delighted to have Sylvaine and Alex join the Appia Bio team.
  • Sylvaine is a thoughtful business executive with deep understanding of our industry from both sides of the table.
  • Alex brings long-term considered insight based on his broad global regulatory affairs experience in cell therapy.
  • Dr. Babayan joins Appia Bio from Instil Bio where he was vice president and head of regulatory affairs.

Cytovation appoints Iman Barilero as Chief Development Officer

Retrieved on: 
Tuesday, March 21, 2023
Antigen, Doctor of Pharmacy, Drug development, University, Tufts Center for the Study of Drug Development, Roche, Big Pharma, Cancer, Bristol Myers Squibb, Doctor of Philosophy, CNS, Institut Gustave Roussy, MD, Central nervous system disease, Immune system, Sanofi, Merck, Merck & Co., Pembrolizumab, Pharmacology, Merck Sharp & Dohme Federal Credit Union, Pharmaceutical industry

Bergen, Norway, 21 March 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces that Dr. Iman Barilero has joined the company as Chief Development Officer.

Key Points: 
  • Bergen, Norway, 21 March 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces that Dr. Iman Barilero has joined the company as Chief Development Officer.
  • Dr. Barilero brings three decades of experience as a strategic executive in the global healthcare industry, successfully designing innovative and integrated patient-centric and value-based regulatory development pathways, in all phases of drug development and across all major global pharmaceutical markets.
  • Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We’re delighted to have someone with Iman’s wealth of experience join Cytovation as we progress CyPep-1 through clinical development.
  • Iman has worked across Big Pharma and biotech, and her support will be invaluable as the company enters its important next stages of development and growth.”
    Iman Barilero, PharmD, PhD, Cytovation’s Chief Development Officer, added: “CyPep-1 represents an exciting new approach to cancer immunotherapy, and it’s great to be joining Cytovation at a time when the asset has such strong clinical momentum backed by promising early data.

NKGen Biotech Appoints Paul Y. Song, MD as Chief Executive Officer

Retrieved on: 
Tuesday, January 10, 2023
Disease, Neurodegeneration, University, The Institute, Therapy, Cedars-Sinai Medical Center, Biotechnology, MD, Radiation, Patient, George Washington University, Institut Gustave Roussy, Research, Cancer, ASTRO, CMO, Carl Berg, Chicago (franchise), Pharmaceutical industry, NK

Song, MD as Chief Executive Officer (CEO) and Vice Chairman of the Board of Directors, effective January 10, 2023.

Key Points: 
  • Song, MD as Chief Executive Officer (CEO) and Vice Chairman of the Board of Directors, effective January 10, 2023.
  • “We are thrilled to welcome Paul as our new CEO and the experience, vision and leadership Paul brings to NKGen Biotech,” said Sangwoo Park, Founder and Chairman of NKGen Biotech.
  • “Paul will play a critical role in leading our company’s corporate strategy and the advancement of our potentially life-changing clinical portfolio in oncology and neurodegenerative disease.
  • Song, MD, CEO of NKGen Biotech.

Syros Pharmaceuticals Announces Publication in Blood Advances Demonstrating the Potential of Tamibarotene in Patients with RARA Gene Overexpression, Supporting Ongoing Clinical Development in AML and MDS

Retrieved on: 
Monday, December 12, 2022
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Genome, Security (finance), ORR, Observation, Freedom, Azacitidine, Venetoclax, Institut Gustave Roussy, Patient, CR, Toxicity, Tamibarotene, Annual report, Compte rendu, Biology, Aplastic anemia, Arsenic trioxide, Myelodysplastic syndrome, Government, COVID-19, AML, Clinical trial, Safety, CDK7, Workforce, MDS, Acute myeloid leukemia, Gene, AES, RARA, Acute promyelocytic leukemia, Pharmaceutical industry, Syros

These findings support Syros ongoing evaluation of tamibarotene for the treatment of AML and myelodysplastic syndrome (MDS) patients with RARA overexpression.

Key Points: 
  • These findings support Syros ongoing evaluation of tamibarotene for the treatment of AML and myelodysplastic syndrome (MDS) patients with RARA overexpression.
  • The biomarker test successfully identified AML patients positive for RARA overexpression who were enriched for response to tamibarotene and azacitidine relative to those patients who were negative for RARA overexpression.
  • This observation further demonstrates that the activity of tamibarotene is dependent on the biology of RARA overexpression.
  • Based on RARA expression levels, each patient was classified as positive for RARA overexpression (22 patients) or negative for RARA overexpression (29 patients).

Immutep Appoints LAG-3 Pioneer, Frédéric Triebel to Board

Retrieved on: 
Tuesday, September 13, 2022
ASX, Institut Gustave Roussy, Institute, Autoimmune disease, Australian Securities Exchange, Publication, University of Paris, Antibody, Acquisition, IMM, Immunotherapy, Â, Patient, Cancer, Technology, NASDAQ, Board, GLOBE, PD-1, Immunogenetics, Russell, APC, IGR, Pharmaceutical industry, Vaccine, Immunology, Immutep, LAG-3

Prof. Triebel will join the Immutep Board with immediate effect.

Key Points: 
  • Prof. Triebel will join the Immutep Board with immediate effect.
  • He founded Immutep S.A. in 2001 to develop LAG-3 product candidates as human medicines and became Chief Medical Officer and Chief Scientific Officer of Immutep following the Companys acquisition of Immutep S.A in December 2014.
  • Immutep Chair, Russell Howard said: It is a privilege to welcome Frdric to Immuteps Board.
  • I look forward to working as part of the Board to realise the value of this promising product candidate.

Gustave Roussy Renews TrialMaster EDC Agreement with Anju Software to Accelerate Complex Oncology Clinical Studies

Retrieved on: 
Wednesday, January 12, 2022
Research, Patient, Institute, EDC, Education, EMEA, Data management, Department, Health, Cancer, Institut Gustave Roussy, Neoplasm, Workflow, Senior, Trial of the century, List of life sciences, Medical imaging, Medical device, Biostatistics, Epidemiology

TrialMaster EDC is the most intuitive EDC Suite on the market -- delivering superior usability and flexibility. This innovative software platform is a comprehensive EDC solution for Phase I-IV clinical trials -- improving efficiencies and reducing workflow while enhancing data quality, resulting in faster study submission times.

Key Points: 
  • Gustave Roussy has utilized TrialMaster successfully for the past five years to accelerate and drive oncology trial efficiencies across a myriad of clinical trial designs.
  • Under the agreement, Gustave Roussy continues to work with Anju Software to advance its cancer clinical research leveraging the TrialMaster electronic data capture and clinical study data management platform.
  • Gustave Roussy brings together the skills essential for the highest quality research in oncology: a quarter of patients treated are included in clinical trials.
  • Anju Software provides an adaptive platform for clinical trials, medical affairs, and a newly designed, state-of-the-art clinical content and data repository.