European Society for Medical Oncology

Ayala Pharmaceuticals Presents Updated AL102 Results from Phase 2 Clinical Trial in Desmoid Tumors at ESMO Congress 2023

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Monday, October 23, 2023
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REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that new data from the RINGSIDE study evaluating its lead investigational candidate AL102 for the treatment of desmoid tumors (DT) are being presented today at the European Society for Molecular Oncology (ESMO) Congress 2023, taking place October 20th to 24th in Madrid, Spain. The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE). The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK.

Key Points: 
  • The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE).
  • The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK.
  • “The RINGSIDE results continue to improve over time, with more patients in this latest Phase 2 and OLE data cut demonstrating responses to treatment with AL102,” said Kenneth Berlin, President and CEO of Ayala.
  • The safety results appear consistent with the GSI class.”
    The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors.

NANOBIOTIX Announces Updated Preliminary Results From Phase 1 Pancreatic Cancer Trial and New Exploratory Analysis From Completed Phase 1 Head and Neck Cancer Trial at ESMO 2023

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Monday, October 23, 2023
Survival, Patient, RT, ESMO, NBTXR3, MOS, Lymph, Head, PFS, MD, Monroe Dunaway Anderson, Doctor of Philosophy, Duration, CA19-9, Quality of life, NANO, Rated R, Chemoradiotherapy, Clinical trial, Pancreatic cancer, Oncology, University, Nanobiotix, Safety, European Society for Medical Oncology, Cancer, Progression-free survival, MD Anderson Cancer Center, OS, Diagnosis, Medical imaging, Residential care, Pharmaceutical industry, Euronext, LAPC

PARIS and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the “Company”), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced updated data from two presentations at the 2023 Annual Congress of the European Society for Medical Oncology (ESMO).

Key Points: 
  • The 5-year overall survival rate for patients with unresectable locally advanced pancreatic cancer (LAPC) remains less than 5%.
  • Normally, these patients receive the combination of cytotoxic chemotherapy followed by concurrent chemoradiation if no metastatic progression has occurred.
  • Innovative new treatments that might extend survival and avoid additional harmful side effects are an urgent unmet need for this patient population.
  • “With the Phase 1 study now complete, our focus is to ensure that we learn everything we can to anticipate the potential results of NANORAY-312.

Theriva™ Biologics Presents Survival Outcomes Data from Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023
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ROCKVILLE, Md., Oct. 23, 2023 (GLOBE NEWSWIRE) --  Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced new clinical data from the Phase 1 investigator-sponsored study with the Institut Catala d’Oncologia (ICO) evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). These data were presented at the European Society for Medical Oncology (ESMO) Congress, held both virtually and in Madrid, Spain from October 20-24, 2023.

Key Points: 
  • These data were presented at the European Society for Medical Oncology (ESMO) Congress, held both virtually and in Madrid, Spain from October 20-24, 2023.
  • These results build on the previously reported acceptable safety profile seen with sequential dosing of VCN-01 and durvalumab.
  • Key Takeaway: VCN-01 combined with durvalumab showed encouraging overall survival (OS) in patients who previously progressed on anti-PD(L)-1 therapy.
  • VCN-01 combined with durvalumab increased CD8 T cells, a marker of tumor inflammation and the expression of PD(L)-1 in tumors.

Ryvu Therapeutics Provides an Update on the Progress of RVU120 Phase I Studies in Patients with Solid Tumors and AML/HR-MDS, and Presents the Updated Development Plan for RVU120

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Monday, October 23, 2023
Medulloblastoma, Bone marrow, Plasma, AUC, Acute myeloid leukemia, Cmax, ESMO, Erythropoiesis, Principal investigator, Aes, PD, Congress, MD, Adenoid cystic carcinoma, CEST, Ruxolitinib, Cell, Data, Syndrome, All-comers track meet, Phase, SD, Risk, Webcast, Pancreatic cancer, Venetoclax, NPM1, WSE, ADCC, Safety, European Society for Medical Oncology, Patient, AML, Sarcoma, Pharmaceutical industry, Medical imaging, Dietary supplement

The total budget for the Phase II clinical development of RVU120 aligns with the estimates initially announced in the Ryvu Development Plans for 2022-2024.

Key Points: 
  • The total budget for the Phase II clinical development of RVU120 aligns with the estimates initially announced in the Ryvu Development Plans for 2022-2024.
  • The presented RVU120 development plan aligns with the budget outlined in Ryvu Development Plans for 2022-2024 and targets multi-billion-dollar market potential.
  • At the ESMO Congress 2023, Ryvu announced updated clinical Phase I data from Phase I/II study of RVU120 in relapsed/refractory metastatic advanced solid tumors.
  • Ryvu will host a webinar today (Monday, October 23) at 9:00 am CEST to discuss further RVU120 development plans.

Artios Presents Positive Initial Phase 1/1b Clinical Monotherapy Data for ATR Inhibitor ART0380 in Advanced Solid Tumors at the European Society of Medical Oncology Congress 2023

Retrieved on: 
Monday, October 23, 2023
Irinotecan, Phase II, DDR, ATM, Ovarian cancer, ESMO, MD, Ataxia–telangiectasia, Drug development, Pharmacokinetics, PK, Biology, Cancer, DNA repair, Platinum, University, Safety, European Society for Medical Oncology, ATR, MD Anderson Cancer Center, Patient, Toxicity, DNA, Medical imaging, Pharmaceutical industry, Casting Society of America

CAMBRIDGE, United Kingdom and NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Artios Pharma Limited (Artios), a clinical-stage biotech company led by pioneers of DNA damage response (“DDR”) drug development, presented promising monotherapy data from the Phase 1/1b portion of the ongoing Phase 1/2a study (NCT04657068) of its ataxia telangiectasia and Rad-3 related (“ATR”) kinase inhibitor ART0380 in advanced or metastatic solid tumors as part of a poster presentation at the European Society of Medical Oncology Congress (ESMO) 2023. ART0380 is a clinically advanced, oral, highly potent, and selective ATR inhibitor with best-in-class potential. The Phase 1/1b portion of the trial presented at ESMO assessed the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ART0380 monotherapy in patients with advanced or metastatic solid tumors. The patient population was enriched for cancers harboring DNA damage response deficiencies as identified by the Artios DcoDeR platform (n = 49).

Key Points: 
  • ART0380 is a clinically advanced, oral, highly potent, and selective ATR inhibitor with best-in-class potential.
  • The Phase 1/1b portion of the trial presented at ESMO assessed the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ART0380 monotherapy in patients with advanced or metastatic solid tumors.
  • The patient population was enriched for cancers harboring DNA damage response deficiencies as identified by the Artios DcoDeR platform (n = 49).
  • Our next-generation ATR inhibitor ART0380 has demonstrated highly encouraging molecular and clinical responses as a monotherapy particularly in patients with DDR deficiency and high replication stress alterations.

Merus’ Zeno Interim Data Continues to Demonstrate Robust and Durable Responses in NRG1+ Cancer

Retrieved on: 
Monday, October 23, 2023
EAP, NSCLC, Principal investigator, ESMO, Publication, HER2, Congress, Data, European Society for Medical Oncology, Memorial Sloan Kettering Cancer Center, Cancer, NRG1, Oncology, RECIST, Lung cancer, Safety, PDAC, Patient, BLA, Financial toxicity, Pharmaceutical industry, Vaccine, Telescope

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer presented by Principal Investigator, Dr. Alison Schram* of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • “I’ve been impressed by the consistency of the Zeno clinical data and am convinced Zeno has the potential to be both a first and best in class treatment for NRG1+ cancer,” said Dr. Andrew Joe, Chief Medical Officer at Merus.
  • With Zeno’s durable efficacy and excellent safety profile reported at ESMO, I believe Zeno could be an important, new standard of care for patients with NRG1+ cancer.”
    The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
  • Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
    Observations in the presentation include:
    As of July 31, 2023 data cutoff date, 105 patients with NRG1+ NSCLC were treated with Zeno.
  • Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
    Observations in the presentation include:
    As of July 31, 2023 data cutoff date, 44 patients with NRG1+ PDAC were treated with Zeno.

PDS Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO

Retrieved on: 
Monday, October 23, 2023
MA, Neoplasm, Society for Immunotherapy of Cancer, ESMO, Infection, Vaccine, CD4, HPV, MD, Cytokine, Doctor of Philosophy, Cervical cancer, TH1, HNSCC, CD8, Biotechnology, Immunotherapy, Radiation, Chemokine, Oncology, Blood, Safety, European Society for Medical Oncology, Royal Marsden Hospital, Patient, PDSB, Cancer

The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.

Key Points: 
  • The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.
  • “Generation of multifunctional, anti-tumor T cells with the relevant cytokine and chemokine profiles are necessary for effective long-term control of tumor growth and clinical outcomes.
  • This initial study focused on understanding the immunological profile of advanced head and cancer patients in the blood,” said Kevin Harrington, PhD, Professor of Biological Cancer Therapies, The Royal Marsden.
  • “This preliminary study suggests that PDS0101 may promote a TH1 predominant cytokine profile as well as induction of important T cell activating chemokines.

Galecto Presents Updated Clinical Data at ESMO Congress 2023 and Provides Update on Phase 1b/2a GALLANT-1 Trial

Retrieved on: 
Monday, October 23, 2023
First grade, NSCLC, Galecto Biotech, ESMO, Providence Portland Medical Center, Congress, European Society for Medical Oncology, Fibrosis, Poster, Clinical trial, Oncology, Rash, RECIST, Lung cancer, Safety, Cancer, Hepatology, Patient, Pharmaceutical industry

The Company believes that GALLANT-1 is the first clinical trial to show that combining an oral galectin-3 inhibitor with a checkpoint inhibitor may enhance the effect of checkpoint inhibitors.

Key Points: 
  • The Company believes that GALLANT-1 is the first clinical trial to show that combining an oral galectin-3 inhibitor with a checkpoint inhibitor may enhance the effect of checkpoint inhibitors.
  • Importantly, these skin rashes were not observed at the recommended Phase 2 dose level of 100 mg GB1211 twice daily.
  • Galecto will continue to supply GB1211 100 mg for the upcoming investigator-initiated Phase 2 trial at Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI).
  • Following the poster presentation at the ESMO Congress, the poster will be available on the Scientific Conferences page of Galecto’s investor relations website at https://ir.galecto.com/news-and-events/scientific-events .

Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome

Retrieved on: 
Monday, October 23, 2023
Ageing, Incidence, CHMP, Itch, Committee, ADR, European Directive on Traditional Herbal Medicinal Products, European Medicines Agency, PFIC, Development, COMP, Phase, Medicine, IPN, EMA, Cholestatic pruritus, Nutrition, Biliary atresia, Committee for Medicinal Products for Human Use, Safety, European Society for Medical Oncology, Ipsen, Odevixibat, Patient, Diagnosis, Pharmaceutical industry, Euronext, Research, Alagille syndrome, ALGS

This is despite a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2023.

Key Points: 
  • This is despite a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2023.
  • Orphan designation has a strong influence on the reimbursement mechanisms and access for patients to medicines in some countries in the E.U.
  • “We are disappointed with the opinion of the COMP as the Orphan Medicinal Product Regulation aims to stimulate research and development for rare diseases.
  • In the trial, there were no patient discontinuations and 96% of patients rolled over into the open-label extension trial.

Potential of Arvinas’ PROTAC® AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC

Retrieved on: 
Sunday, October 22, 2023
Neoplasm, Yale School of Medicine, LBD, ESMO, Trae Elston, EDT, Vomiting, Yale school, RPF, Urology, Diarrhea, Congress, Prevalence, PFS, CEST, Prostate cancer, Nausea, PROTAC, Webcast, Interim, Oncology, ARVN, NHA, European Society for Medical Oncology, AR, Patient, Prostate, Mutation, Fatigue, Pharmaceutical industry, Flour, Medical imaging, Gaius Papirius Carbo Arvina, Medicine

NEW HAVEN, Conn., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the presentation of interim data from the Company’s Phase 1/2 clinical trial for bavdegalutamide (ARV-110), a novel PROTAC® protein degrader targeting the androgen receptor (AR), in a poster session at the European Society for Medical Oncology Congress being held in Madrid from October 20 – 24, 2023. The Company will host a conference call to discuss these data and present new data from an updated analysis of its ongoing Phase 1/2 clinical trial with its second-generation PROTAC AR degrader, ARV-766, showing clinical activity extending across patients harboring tumors with AR LBD mutations and a tolerability profile that is superior to bavdegalutamide.

Key Points: 
  • AR L702H is a common AR ligand-binding domain (LBD) mutation that is not potently degraded by bavdegalutamide.
  • In patients with tumors harboring any AR LBD mutation except L702H alone, bavdegalutamide showed an rPFS of 8.2 months.
  • Our second generation PROTAC AR degrader, ARV-766, has demonstrated a broader efficacy profile and even better tolerability compared to bavdegalutamide in clinical settings.
  • ARV-766 was designed to improve upon the degradation profile of bavdegalutamide by also degrading AR L702H.