ESMO

BPGbio Announces Phase 2 BPM31510 Glioblastoma Trial-in-Progress Update at Society for Neuro-Oncology Annual Meeting

Retrieved on: 
Thursday, November 16, 2023

"The information gathered from preclinical and clinical research has offered valuable insights into treatment for GBM, and we eagerly anticipate continuing to advance our discoveries with neoadjuvant BPM31510."

Key Points: 
  • "The information gathered from preclinical and clinical research has offered valuable insights into treatment for GBM, and we eagerly anticipate continuing to advance our discoveries with neoadjuvant BPM31510."
  • The ongoing first-line Phase 2b trial ( NCT04752813 ) follows a successful 104-patient Phase 1a/b clinical trial, which demonstrated both the safety and efficacy of BPM31510.
  • The Phase 1a/b data , which were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2019, helped the BPGbio team plan for a Phase 1b trial in advanced GBM patients, where BPM31510 was well tolerated.
  • BPGbio is planning to expand the Phase 2b trial to new clinical sites in the United States and the United Kingdom.

RenovoRx Expands Scientific Advisory Board with Appointment of Michel Ducreux, M.D., Ph.D.

Retrieved on: 
Thursday, November 16, 2023

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced the appointment of Michel Ducreux, M.D., Ph.D. to the Company’s Scientific Advisory Board (SAB).

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced the appointment of Michel Ducreux, M.D., Ph.D. to the Company’s Scientific Advisory Board (SAB).
  • Dr. Ducreux was trained in medicine, gastroenterology, and gastrointestinal tract oncology at the University of Paris Sud.
  • Dr. Ducreux earned his master’s degree in biological sciences and PhD in health sciences.
  • “I am excited to be working with my distinguished colleagues on RenovoRx’s Scientific Advisory Board,” stated Dr. Ducreux.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Retrieved on: 
Friday, December 15, 2023

TOKYO and NEW YORK, Dec. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Key Points: 
  • This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
  • "Today's FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease.
  • "Despite advances in the treatment of advanced bladder cancer, there remains a need for therapies that extend patients' lives.
  • Our network is thrilled that the FDA has approved a new treatment option, and we are excited about the hope it will provide to members of the bladder cancer patient community."

PDC*line Pharma Completes Enrolment of Four Cohorts of Patients in PDC-LUNG-101 Phase I/II Clinical Trial

Retrieved on: 
Wednesday, December 6, 2023

The objectives of the phase I/II trial (PDC-LUNG-101) were to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients.

Key Points: 
  • The objectives of the phase I/II trial (PDC-LUNG-101) were to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients.
  • The trial was conducted at 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland.
  • “We are pleased to have achieved full patient enrolment in the PDC-LUNG-101 clinical trial, a key step in the product’s clinical development and another important milestone for PDC*line Pharma.
  • “I would like to extend my gratitude to the investigators and patients across the five countries included in our clinical trial.

FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer

Retrieved on: 
Wednesday, December 13, 2023

THOUSAND OAKS, Calif., Dec. 13, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.

Key Points: 
  • Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
  • The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists.
  • Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.
  • The application is being reviewed by the FDA under the Project Orbis framework and Real Time Oncology Review (RTOR).

Qilu Pharmaceutical Announces Results from Phase I Clinical Study for Its Novel Bispecific Antibody QLS31905 at ESMO Immuno-Oncology Congress

Retrieved on: 
Tuesday, December 12, 2023

QLS31905, developed by Qilu Pharmaceutical, is a bispecific T cell engager (BiTE) that targets Claudin18.2.

Key Points: 
  • QLS31905, developed by Qilu Pharmaceutical, is a bispecific T cell engager (BiTE) that targets Claudin18.2.
  • The primary objective of this trial was to evaluate the safety, tolerability, and preliminary antitumor activity of QLS31905 in patients with advanced solid tumors.
  • During the dose-escalation phase, 22 participants received QLS31905 at 0.5 μg/kg QW to 350 μg/kg QW.
  • The Phase II clinical trial are now in progress to further assess the efficacy and safety of QLS31905.

Updated clinical safety and efficacy data for iOnctura's roginolisib presented at ESMO Immuno-Oncology Congress 2023

Retrieved on: 
Friday, December 8, 2023

Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.

Key Points: 
  • Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.
  • Mass cytometry data showed treatment with roginolisib led to an increase in activated anti-cancer CD8+ T-cells and natural killer (NK) cells, increased interferon signalling and a decrease in cancer-promoting Regulatory T-cells.
  • Boosting of antitumoral immunity was observed in patients with long-term disease control after roginolisib treatment but not patients with progressive disease.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "These safety and clinical efficacy data demonstrate iOnctura's progression of roginolisib.

Updated clinical safety and efficacy data for iOnctura's roginolisib presented at ESMO Immuno-Oncology Congress 2023

Retrieved on: 
Friday, December 8, 2023

Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.

Key Points: 
  • Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.
  • Mass cytometry data showed treatment with roginolisib led to an increase in activated anti-cancer CD8+ T-cells and natural killer (NK) cells, increased interferon signalling and a decrease in cancer-promoting Regulatory T-cells.
  • Boosting of antitumoral immunity was observed in patients with long-term disease control after roginolisib treatment but not patients with progressive disease.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "These safety and clinical efficacy data demonstrate iOnctura's progression of roginolisib.

Bugworks Research Inc. to Present Poster at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2023, in Geneva, Switzerland

Retrieved on: 
Thursday, December 7, 2023

The poster highlights two lead molecules discovered from structure and property-guided drug discovery platform.

Key Points: 
  • The poster highlights two lead molecules discovered from structure and property-guided drug discovery platform.
  • Bugworks Research is at the forefront of developing novel small molecule drugs to combat hard-to-treat cancers and drug-resistant bacterial infections.
  • The company is building a deep pipeline of differentiated oncology programs that target critical pathways involved in cancer progression and treatment evasion.
  • Attendees are invited to visit the Bugworks poster on December 7th, 2023, between 12.00-1.00 CET.

Bugworks Research Inc. to Present Poster at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2023, in Geneva, Switzerland

Retrieved on: 
Thursday, December 7, 2023

The poster highlights two lead molecules discovered from structure and property-guided drug discovery platform.

Key Points: 
  • The poster highlights two lead molecules discovered from structure and property-guided drug discovery platform.
  • Bugworks Research is at the forefront of developing novel small molecule drugs to combat hard-to-treat cancers and drug-resistant bacterial infections.
  • The company is building a deep pipeline of differentiated oncology programs that target critical pathways involved in cancer progression and treatment evasion.
  • Attendees are invited to visit the Bugworks poster on December 7th, 2023, between 12.00-1.00 CET.