All-comers track meet

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

Retrieved on: 
Monday, October 23, 2023

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.

Immutep Announces Publication of Abstracts at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023

SYDNEY, AUSTRALIA, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the publication of abstracts with data from the TACTI-002 and INSIGHT-003 trials in 1st line non-small cell lung cancer (1L NSCLC) at the 2023 European Society for Medical Oncology (ESMO) Congress.

Key Points: 
  • Notably, new updated data from TACTI-002, including more mature Overall Survival (OS) results, will be presented by Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO), during a Mini Oral session (#1312MO) at ESMO Congress 2023 on Saturday, October 21, 2023, at 9:05 AM CEST.
  • The data in the INSIGHT-003 abstract, with a cut-off date of 18 April 2023, showed a promising 67% overall response rate.
  • The event will feature Immutep CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and Christian Mueller, Senior Vice President Strategic Development.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Immutep Announces Positive Final Data in 2nd Line Metastatic NSCLC Patients Refractory to Anti-PD-(L)1 Therapy at European Lung Cancer Congress 2023

Retrieved on: 
Friday, March 31, 2023

SYDNEY, AUSTRALIA, March 31, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive final data from Part B of the TACTI-002 Phase II trial in 2nd line metastatic non-small cell lung cancer (NSCLC) patients refractory to anti-PD-(L)1 therapy via a Mini Oral presentation at ESMO’s European Lung Cancer Congress (ELCC) 2023.

Key Points: 
  • This unique stimulation of antigen-presenting cells (APC) leads to a broad anti-tumour immune response, and the addition of efti to pembrolizumab may help refractory 2nd line NSCLC patients that have few therapeutic options by reverting their anti-PD-(L)1 resistance.
  • The ORR, PFS, and OS were more pronounced in patients with high PD-L1 expression (N=6) or who were secondary resistant (N=25).
  • For patients with ≥50% PD-L1 TPS expression, mOS was not yet reached, ORR was 33.3%, and 6-month PFS was 50%.
  • Efti plus pembrolizumab was well tolerated without any new safety signals, and there was no treatment discontinuation due to adverse reactions.

InspireMD Provides Highlights from Recent Presentations and Live Case Transmission at LINC 2022

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Thursday, June 9, 2022

TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.

Key Points: 
  • TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.
  • Of particular note, CGuard was featured in a very successful live case that clearly demonstrated the advantages of optimal vessel conformability with sustainable MicroNet mesh protection for best patient outcomes.
  • The patient was a 62 year old asymptomatic male with progressive and calcified internal carotid critical stenosis.
  • The procedure was successfully performed with the 10mm x 30mm CGuard EPS, obtaining an excellent angiographic result.

Immutep Reports Positive Overall Response Rate in its Phase II Clinical Trial in 1st line NSCLC for PD-L1 All-Comers

Retrieved on: 
Friday, June 3, 2022

The data was presented in an Oral Presentation at the American Society of Clinical Oncologys (ASCO) 2022 Annual Meeting.

Key Points: 
  • The data was presented in an Oral Presentation at the American Society of Clinical Oncologys (ASCO) 2022 Annual Meeting.
  • These responses were deep and durable and there has also been a low patient discontinuation rate.
  • By biotech standards, we consider this to be a large patient population for a Phase II trial.
  • The trial reflects a typical patient population for this indication, including a mix of squamous/non-squamous disease and male/female representation.

Inhibrx Announces Initial Phase 1 Dose Escalation Results for INBRX-106, a Novel Hexavalent OX40 Agonist, in Combination with Keytruda® (Pembrolizumab) Along with Updated Single Agent Data

Retrieved on: 
Tuesday, January 4, 2022

Additionally, an update on single agent data from Part 1 (single agent dose escalation) and Part 2 (single agent dose expansion) of the trial was provided.

Key Points: 
  • Additionally, an update on single agent data from Part 1 (single agent dose escalation) and Part 2 (single agent dose expansion) of the trial was provided.
  • INBRX-106 in combination with Keytruda was observed to be well tolerated, with predominantly mild or moderate immune-related toxicities noted.
  • The maximum administered dose of INBRX-106 was 0.3 mg/kg, at which dose-limiting, immune-related toxicities such as dermatitis were observed.
  • Accordingly, 0.1 mg/kg dosed every three weeks was determined to be the maximum tolerated dose (MTD) of INBRX-106 in combination with Keytruda.

Monopar Advances Dosing of Camsirubicin to Higher Level Than Tested In Any Previous Clinical Trial

Retrieved on: 
Wednesday, December 8, 2021

This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial.

Key Points: 
  • This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial.
  • We are eager to continue evaluating progressively escalating dose levels of camsirubicin, which may demonstrate increasing anti-tumor activity.
  • Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.
  • It has been investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial.

Zai Lab Announces Positive Topline Results from Phase 3 PRIME Study of ZEJULA® (Niraparib) as First-Line Monotherapy Maintenance Treatment in Chinese Women with Platinum-Responsive Advanced Ovarian Cancer

Retrieved on: 
Tuesday, November 30, 2021

SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Nov. 30, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy met its primary endpoint. ZEJULA demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status.

Key Points: 
  • Importantly, the PRIME study further underscores the status of ZEJULA as the first and only PARP inhibitor approved globally, including in China, as monotherapy for all-comer patients in the first-line maintenance treatment settings.
  • The study evaluated the efficacy of ZEJULA as a maintenance treatment, with the primary endpoint of PFS as assessed by blinded independent central review.
  • While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women.
  • A Phase 1 pharmacokinetic (PK) study of ZEJULA was conducted in Chinese patients with ovarian cancer.

Global Head and Neck Squamous Cell Carcinoma Drug Market Analysis and Forecasts, 2020-2021 & 2021-2030 - ResearchAndMarkets.com

Retrieved on: 
Monday, November 8, 2021

The "Head and Neck Squamous Cell Carcinoma - Global Drug Forecast and Market Analysis to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Head and Neck Squamous Cell Carcinoma - Global Drug Forecast and Market Analysis to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Head and neck squamous cell carcinoma (HNSCC) was the sixth most common cancer type by worldwide incidence in 2020.
  • There is currently little competition between targeted therapies in the HNSCC market, leaving an area of considerable opportunity for interested newcomers.
  • 1 Head and Neck Squamous Cell Carcinoma: Executive Summary
    1.5 What Do Physicians Think?