behandeling van MPS type VI wordt onderzocht.
Aanvankelijk was het bedrijf van plan om in totaal 24 patiënten aan te werven, maar de teller werd gestopt op 20 patiënten. Niet eens in de marge wijst KBC Securities op de cijfers van sectorgenoot Cymabay, dat teleurstellende resultaten van zijn test met PPAR delta-agonist Seladelpar vrijgaf in de leverziekte NASH.
Koersdoel van 7 euro en “Kopen”-advies blijven behouden.
- And its gone!
- Forum actieveling
- Berichten: 267
- Lid geworden op: 30 Mei 2018 21:25
- waarderingen: 109
June 13, 2019
Daix (France), June 13, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the creation of its Scientific Advisory Board (SAB) to provide external scientific review and high-level advice to the Company’s management with regards to its R&D activities and product portfolio.
The SAB will cover Inventiva’s key areas of research and development with a particular focus on non-alcoholic steatohepatitis (NASH), mucopolysaccharidosis (MPS) and oncology. As such, it will support Inventiva’s management regarding the preclinical and clinical aspects of the Company’s development programs and its global scientific policy, including targets, fields of research, partnerships and market access.
Chaired by Jean-Louis Junien, former Director of Inventiva’s Board of Directors and senior pharmaceutical executive with an extensive experience in the industry, the SAB will bring together the expertise of independent international scientists and clinicians in the above-mentioned fields. An additional member specialized in rare diseases to support the development of odiparcil in MPS should join the SAB shortly. The first two meetings of the SAB have already been scheduled for later this month and will focus on NASH and oncology.
Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, said: “The creation of a Scientific Advisory Board is an important step for our future development as it will help us to both accelerate and secure our discovery programmes and validate our R&D choices. The Board members will bring significant expertise, highly complementary skills and an external perspective, which will be very valuable in informing our strategy as we move forward.”
Jean-Louis Junien, Chairman of Inventiva’s Scientific Advisory Board, commented: “I am honoured to take on the role of Chairman of Inventiva’s Scientific Advisory Board, which gathers internationally recognized experts in the fields of NASH, MPS and oncology. Together, we are looking forward to accompanying Inventiva’s management in its responsibility to make important judgments related to the Company’s R&D activities and product portfolio.”
The expert members of Inventiva’s SAB are:
– Dr Sven Francque, Professor of Medicine at the Faculty of Medicine and Health Sciences at the University of Antwerp and Chairman of the Department of Gastroenterology and Hepatology. His research unit focuses on the pathophysiological mechanisms of NASH.
– Dr Manal Abdelmalek, Professor of Medicine in the Division of Gastroenterology and Hepatology at Duke University and Director of the NAFLD Clinical Research Program at Duke University. She is a standing member of the NASH Clinical Research Network (NASH CRN).
– Dr Glen Clack, Honorary Professor of Translational Medicine of the Department of Oncology and Metabolism at the University of Sheffield and previously Senior Medical Director of the Oncology Translational Medicine Unit of Astra Zeneca.
– Dr Hedy Lee Kindler, Professor of Medicine at the University of Chicago, Director of the Mesothelioma Program and Associate Vice Chair for Clinical Research. She is a past President of the International Mesothelioma Interest Group, the leading international scientific research organization dedicated to this disease.
– Dr. Gérard Zalcman, Professor of Medecine, Head of the Thoracic Oncology Department of Bichat Hospital, Paris (Paris-Diderot University), and member of the U830 INSERM laboratory, “Genetics & Biology of cancers“, at the Research Centre of the Curie Institute.
project Bedrijf Activiteit Proef-ID Notitie
Elafibranor Genfit Alfa/delta-agonist Resolve-It, NCT02704403 Topline-gegevens voor 2019
Seladelpar Cymabay Delta-agonist NCT03551522 Kan levervet niet verminderen door MRI-PDFF
Lanifibranor inventiva Pan-agonist NCT03008070 Gegevens verschuldigd H1 2020
bezafibraat Aralez Pan-agonist Geen in NASH ph II-proef plus Ocaliva in PBC
4 1.446 1,75 ____1,845 2.320 1
1 200 1,74 ____1,85 965 1
1 3.500 1,73 ____1,86 2.000 1
1 300 1,7____ 1,94 704 1
1 150 1,67 ____1,955 800 1
1 200 1,62 ____1,96 60 1
1 25.000 1,555 ____ 1,965 3.000 1
1 1.776 1,52____ 1,97 811 2
3 2.000 1,5____ 1,98 1.000 1
1 198 1,48 ____2 969 4
Pipeline 0,0 euro waard, aangezien we op 31 maart 47.3 miljoen op de rekening hadden en ze ongeveer 3 miljoen per maand verlies maken.
en dat bij een buy van kbc met koersdoel 7 euro. (we noteren precies 1/4 van die koers)
Volgende week dinsdag update.
July 30, 2019
H1 2019 financial information – Revenues and cash
37.1M cash : 22.2M aandelen = 1.67 euro cash per aandeel.
Schrappen fors in personeel (24% moet weg tegen eind dit jaar)
contracts, the Company’s total workforce will be reduced from 118 to approximately 90 employees by the end of the year.
Key milestones expected
▪ Completion of patient recruitment in the NATIVE Phase IIb clinical study evaluating lanifibranor for the treatment of NASH
▪ Completion of patient recruitment in the Phase II clinical study evaluating lanifibranor for the treatment of NAFLD in patients with type 2 diabetes
▪ Launch of a new biomarker study in patients with MPS VI
▪ Results of the iMProveS Phase IIa clinical study
▪ Selection of the clinical candidate for the YAP-TEAD oncology program
Upcoming investor conferences
▪ Portzamparc Biotech Conference, Paris, September 10, 2019
▪ SFAF Meeting, Paris, September 17, 2019
▪ Forum Lyon Pôle Bourse, Lyon, September 25, 2019
▪ KBC Biotech Conference, Brussels, September 27, 2019
▪ Large & MidCap Event, Paris, October 14-15, 2019
▪ HC Wainwright NASH Conference, New York, October 21, 2019
▪ Gilbert Dupont NASH Day, Paris, October 29, 2019
▪ KOL and investors’ meeting at the American Association for the Study of Liver Diseases (AASLD) conference, Boston, November 9, 2019
▪ Jefferies 2019 London Healthcare Conference, London, November 20-21, 2019
Key highlights of the second quarter
Lanifibranor for the treatment of non-alcoholic steatohepatitis (“NASH”)
In May, the U.S. Food and Drug Administration (FDA) lifted for lanifibranor the clinical hold in place on the peroxisome proliferator-activated receptor (PPAR) target class. This decision enables Inventiva to conduct clinical trials equal to or longer than six months evaluating lanifibranor for the treatment of NASH. It followed the review of the two-year carcinogenicity studies by the FDA’s Executive Carcinogenicity Assessment Committee (ECAC). This decision confirms lanifibranor’s benign safety profile and represents a key milestone for Inventiva as it removes a key obstacle that had prevented the Company from initiating long-term Phase III clinical trials necessary to obtain marketing approval with lanifibranor for the treatment of NASH.
1 Financial information not audited in accordance with IFRS standards.
The NATIVE (NASH Trial To Validate IVA337 Efficacy) Phase IIb clinical study is progressing as planned and, at the end of June, 211 patients out of a target of 225 had been randomized in the study. The results will be published, as expected, in the first half of 2020.
Odiparcil for the treatment of mucopolysaccharidoses (“MPS”)
Early June, Inventiva announced the completion of patient recruitment in its iMProveS (improve MPS treatment) Phase IIa clinical study in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI).
The patients participating in the trial are distributed among the various arms, with fifteen patients being treated with enzyme replacement therapy (ERT) and receiving one of the two doses of odiparcil or placebo and five patients not being treated with ERT and only receiving the high dose of odiparcil. The headline results of the fifteen ERT-treated patients are expected by the end of the year. The results of the five patients not being treated with ERT are expected during the first quarter of 2020.
YAP-TEAD in the field of oncology
In May, Inventiva presented new reslts from its YAP-TEAD oncology program at the AACR Special Conference on The Hippo Pathway: Signaling, Cancer, and Beyond. These results showed that Inventiva’s YAP-TEAD inhibitors significantly reduced tumor growth in Malignant Pleural Mesothelioma (MPM) xenograft and orthotopic models. In addition, synergistic effects were seen in a three-dimensional spheroid model suggesting that Inventiva’s YAP-TEAD inhibitors, when used in combination with existing chemotherapeutics, could attenuate multidrug resistance and re-sensitize chemo-resistant cancer cells.
Following these promising results, Inventiva has decided to expand its research to other cancer indications as well as other combination strategies where standard of care agents are proven to be ineffective and where YAP is activated.
ABBV-157 for the treatment of moderate to severe psoriasis
AbbVie has initiated a new clinical study with ABBV-157, the drug candidate resulting from its collaboration with Inventiva, aiming at assessing the compound’s pharmacokinetics, safety and tolerance in healthy volunteers and in patients with chronic plaque psoriasis. Inventiva could receive milestone payments as well as royalties on future sales. For further information on the new clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03922607
Creation of a Scientific Advisory Board
Inventiva recently announced the creation of its Scientific Advisory Board (SAB) to provide scientific review and advice to the Company’s management with regards to its R&D activities and product portfolio. The SAB covers Inventiva’s key areas of research and development with a particular focus on NASH, MPS and oncology. The SAB also supports Inventiva’s management regarding the preclinical and clinical aspects of the Company’s development programs and its global scientific policy, including targets, fields of research, partnerships and market access.
Approval and implementation of a redundancy plan following the termination of the systemic sclerosis (“SSc”) program
Following the termination of the SSc program in February 2019 due to the failure to meet the primary endpoint of the FASST Phase IIb clinical study, the Company implemented a redundancy plan in the second quarter which was subject to a corporate agreement signed on June 11, 2019; combined with the non-renewal of fixed-term
Dit had kbc deze morgen te vertellen.
Biotechbedrijf Inventiva liet in zijn halfjaarupdate weten dat de NATIVE-studie bijna alle patiënten heeft kunnen werven. De lopende fase IIb proef met Lanifibranor in NASH vordert zoals gepland en ook aan de werving in het kader van de fase II IMPROVES-studie wordt gewerkt. Maar de kaspositie van 37,1 miljoen euro is wat nijpend omdat er zo’n 10 miljoen euro per kwartaal verstookt wordt en dus moeten er zo’n 20 van de 118 werknemers vertrekken. Die info ligt allemaal in lijn met de schattingen. Wachten op testdata, met een koersdoel van 7 euro en een “Kopen”-advies.
Koersdoel ligt nu al bijna 4 keer hoger dan de huidige koers.
Moet toch wel 1 van de slechtste bio aandelen van europa zijn.
Dit jaar al ruim 80% van de koers.
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