Pelareorep

Basilea announces U.S. FDA Orphan Drug Designation granted to lisavanbulin for the treatment of malignant glioma

Retrieved on: 
Thursday, July 29, 2021

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Basileas tumor checkpoint controller, lisavanbulin, for the treatment of malignant glioma (brain cancer).

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Basileas tumor checkpoint controller, lisavanbulin, for the treatment of malignant glioma (brain cancer).
  • Dr. Marc Engelhardt, Chief Medical Officer, commented: The Orphan Drug Designation of lisavanbulin by the U.S. FDA is an important milestone for the development of lisavanbulin.
  • Glioblastoma is associated with a poor prognosis and there are only very limited therapeutic options available.
  • Lisavanbulin, as a targeted treatment, could be a useful new approach to expand the treatment options for patients with this devastating disease.

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA®

Retrieved on: 
Wednesday, June 30, 2021

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.

Key Points: 
  • Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.
  • We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."
  • CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells.
  • Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells.

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA®

Retrieved on: 
Wednesday, June 30, 2021

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.

Key Points: 
  • Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.
  • We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."
  • CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells.
  • Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells.

Marker Therapeutics to Present at the Virtual Raymond James Human Health Innovation Conference

Retrieved on: 
Wednesday, June 16, 2021

HOUSTON, June 16, 2021 /PRNewswire/ -- Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its Chief Financial Officer, Anthony H. Kim, will present at the upcoming virtual Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 9:20 a.m.

Key Points: 
  • HOUSTON, June 16, 2021 /PRNewswire/ -- Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its Chief Financial Officer, Anthony H. Kim, will present at the upcoming virtual Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 9:20 a.m.
  • Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications.
  • Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e.
  • As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Veru Announces Positive Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer Presented at the 2021 ASCO Annual Meeting

Retrieved on: 
Monday, June 7, 2021

The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule.

Key Points: 
  • The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule.
  • The Phase 1b/2 clinical trial enrolled 80 men and is ongoing with patients in both the Phase 1b and 2 components still on study.
  • Two of these patients on continuous daily dosing of sabizabulin have now reached 27 months and 23 months of treatment without prostate cancer progression.
  • (2) Phase 2 clinical study for the treatment of women with metastatic triple negative breast cancer who have become resistant to at least two systemic chemotherapies.

BeiGene Presents Clinical Data from Two Pivotal Trials of Tislelizumab at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

We hope that, with a growing body of clinical evidence, tislelizumab can become a meaningful immunotherapy that can potentially benefit more patients worldwide.

Key Points: 
  • We hope that, with a growing body of clinical evidence, tislelizumab can become a meaningful immunotherapy that can potentially benefit more patients worldwide.
  • In addition, tislelizumab demonstrated a favorable safety profile compared to chemotherapy, with no new safety signals identified.
  • In this pivotal Phase 2 trial, we observed consistent responses across tumor types with tislelizumab and it was generally well tolerated.
  • BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

BriaCell Reports 12.0 Months Overall Survival Benefit in Advanced Breast Cancer; 100% Resolution of ‘Eye-Bulging’ Tumor

Retrieved on: 
Wednesday, June 2, 2021

To more accurately present survival data, BriaCell has included only those women able to mount an immune response.

Key Points: 
  • To more accurately present survival data, BriaCell has included only those women able to mount an immune response.
  • 2) Overall survival of 7.2-9.8 months in similar patients with metastatic breast cancer who have failed 2 prior therapy attempts (third line setting); Kazmi S, et al.
  • After just six months of BriaCells treatment, the orbital tumor had been completely eliminated, and she survived for over 21 months, a significant clinical benefit.
  • In the figure above, and with tumors indicated by white arrows, complete resolution of the orbital tumor was observed after six months on BriaCells treatment.

Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer

Retrieved on: 
Thursday, May 20, 2021

(NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.

Key Points: 
  • (NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.
  • I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers.
  • "\nThe data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster\'s corresponding abstract.
  • This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents.

Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer

Retrieved on: 
Thursday, May 20, 2021

(NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.

Key Points: 
  • (NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.
  • I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers.
  • "\nThe data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster\'s corresponding abstract.
  • This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents.

Marker Therapeutics to Host First Quarter 2021 Operating and Financial Results Conference Call and Webcast on Wednesday, May 12, 2021

Retrieved on: 
Thursday, April 29, 2021

Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics First Quarter 2021 Earnings Call.

Key Points: 
  • Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics First Quarter 2021 Earnings Call.
  • "\nThe archived webcast will be available for replay on the Marker website following the event.\nMarker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications.
  • Marker\'s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e.
  • This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient\'s immune system to produce broad spectrum anti-tumor activity.