Enadenotucirev

IconOVir Bio to Present at Jefferies Healthcare Conference

Retrieved on: 
Thursday, May 27, 2021

IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, today announced that Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir, will present a corporate overview at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 3:00 p.m.

Key Points: 
  • IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, today announced that Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir, will present a corporate overview at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 3:00 p.m.
  • IconOVir is a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus therapy to improve the treatment of patients with cancer.
  • IconOVirs proprietary oncolytic virus platform is based on technology developed by scientific founder Clodagh OShea, Ph.D., of the Salk Institute.
  • It is designed to address key limitations of first- and second-generation oncolytic viruses and provide a personalized therapy for cancer patients.

BioInvent and Transgene receive IND approval from the U.S. FDA for BT-001, a novel oncolytic virus for the treatment of solid tumors

Retrieved on: 
Thursday, May 27, 2021

This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.

Key Points: 
  • This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.
  • In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity.
  • "We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent's fourth clinical program.
  • The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.

BioInvent and Transgene receive IND approval from the U.S. FDA for BT-001, a novel oncolytic virus for the treatment of solid tumors

Retrieved on: 
Thursday, May 27, 2021

This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.

Key Points: 
  • This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.
  • In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity.
  • "We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent's fourth clinical program.
  • The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.

PsiOxus Therapeutics Updates Agreement with Bristol Myers Squibb to Advance their Clinical Stage Immuno-Oncology Collaboration

Retrieved on: 
Wednesday, April 7, 2021

PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an updated agreement to advance its clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus tumor re-engineering platform, in combination with Bristol Myers Squibbs PD-1 immune checkpoint inhibitor Opdivo (nivolumab) to treat a range of tumor types in late-stage cancer patients.

Key Points: 
  • PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an updated agreement to advance its clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus tumor re-engineering platform, in combination with Bristol Myers Squibbs PD-1 immune checkpoint inhibitor Opdivo (nivolumab) to treat a range of tumor types in late-stage cancer patients.
  • The revised collaboration announced today will build upon the initial study data and will combine Opdivo with PsiOxus NG-641.
  • NG-641, is a tumor re-engineering product using PsiOxus proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform based upon the enadenotucirev vector.
  • We are delighted to continue our collaboration with Bristol Myers Squibb and to investigate the clinical combination of NG-641 with Opdivo in several tumor types, stated John Beadle, M.D., Chief Executive Officer, PsiOxus.

Global Immuno-Oncology Market Report 2021: Analysis, Trends, Opportunities and Unmet Needs - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 25, 2021

The "Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research" report has been added to ResearchAndMarkets.com's offering.
  • Immuno-Oncology report provides the landscape of marketed and pipeline immuno-oncology drugs across the five major classes (bispecific antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses), opportunities, challenges, and unmet needs.
  • Immuno-oncology (IO) describes the treatment of various cancers with the use of bispecific-antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses.
  • These classes of IO therapies achieved sales of ~$30B in 2019, which is projected to reach ~$95B by 2026.

Mustang Bio Announces Positive Opinion from the European Medicines Agency on Orphan Drug Designation for Its Lentiviral Gene Therapy for the Treatment of X-linked Severe Combined Immunodeficiency (“XSCID”)

Retrieved on: 
Tuesday, November 24, 2020

The European Medicines Agency (EMA) previously granted Advanced Therapy Medicinal Product classification to MB-107 in April 2020.

Key Points: 
  • The European Medicines Agency (EMA) previously granted Advanced Therapy Medicinal Product classification to MB-107 in April 2020.
  • The U.S. Food and Drug Administration (FDA) also previously granted Rare Pediatric Disease and Orphan Drug Designations to MB-107 and MB-207, as well as Regenerative Medicine Advanced Therapy Designation to MB-107.
  • Orphan Drug Designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medicines Agency Committee for Orphan Medicinal Products (EMA COMP).
  • Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, We are very pleased to receive a positive opinion from the EC on Orphan Drug Designation for our lentiviral gene therapy for XSCID.

Zymeworks Receives Orphan Drug Designation From the European Commission for HER2-Targeted Bispecific Antibody Zanidatamab in Patients With Gastric Cancer

Retrieved on: 
Thursday, November 19, 2020

Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the companys investigational HER2-targeted bispecific antibody, in patients with gastric cancer.

Key Points: 
  • Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the companys investigational HER2-targeted bispecific antibody, in patients with gastric cancer.
  • The European Commissions granting of Orphan Drug designation for zanidatamab represents an important step towards bringing this promising investigational medicine to patients in Europe and around the world.
  • Zymeworks previously received Orphan Drug designations for zanidatamab in gastric, biliary tract and ovarian cancers from the US FDA, as well as two Fast Track designations from the FDA for zanidatamab.
  • Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the US FDA, in addition to Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency

Retrieved on: 
Monday, March 23, 2020

LAWRENCEVILLE, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer.

Key Points: 
  • LAWRENCEVILLE, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer.
  • GEN-1 previously received orphan designation from the U.S. Food and Drug Administration and is currently being evaluated in a Phase I/II clinical trial (the OVATION 2 Study) for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer.
  • "EMA's orphan drug designation for GEN-1 recognizes the urgent need for new therapies to treat ovarian cancer, an aggressive, rapidly progressing disease with few effective treatment options," stated Michael H. Tardugno, Celsion's chairman, president and chief executive officer.
  • Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

BioInvent and Transgene to Present Data on BT-001, an Oncolytic Virus Encoding for an Anti-CTLA4 Antibody, at Upcoming Congresses

Retrieved on: 
Tuesday, March 3, 2020

BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent.

Key Points: 
  • BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent.
  • It is based on Transgene's Invir.IO platform and patented, large-capacity VVcopTK-RR- oncolytic virus.
  • "With BT-001, we are looking to combine Transgene's potent oncolytic virus with the local production of a high concentration of an anti-CTLA4 antibody.
  • With its proprietary platform Invir.IO, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.

BioInvent and Transgene to Present Data on BT-001, an Oncolytic Virus Encoding for an Anti-CTLA4 Antibody, at Upcoming Congresses

Retrieved on: 
Tuesday, March 3, 2020

BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent.

Key Points: 
  • BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent.
  • It is based on Transgene's Invir.IO platform and patented, large-capacity VVcopTK-RR- oncolytic virus.
  • "With BT-001, we are looking to combine Transgene's potent oncolytic virus with the local production of a high concentration of an anti-CTLA4 antibody.
  • With its proprietary platform Invir.IO, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.