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Details:
US FDA grants fast track designation to VBI-1901 for the treatment of recurrent GBM patients with first tumor has achieved progression-free survival beyond 86 weeks, demonstrating 93% tumor reduction relative to baseline recurrence.
Lead Product(s): VBI-1901,GM CSF
Therapeutic Area: Oncology Product Name: VBI-1901
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2021
Details:
GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2’s mechanism of action.
Lead Product(s): GP2 Peptide,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2021
Details:
The broad based immune response suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy.
Lead Product(s): GP2 Peptide,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2021
Details:
GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center Phase IIb clinical trial, no recurrences were observed after median 5 years of follow-up.
Lead Product(s): GP2 Peptide,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2021
Details:
Funding will help advance Gliknik clinical and pre-clinical programs, including: A randomized double-blind, placebo-controlled phase 2 study of Gliknik immuno-oncology compound biropepimut-S, which is nearing completion.
Lead Product(s): Biropepimut-S,GM CSF,Cyclophosphamide
Therapeutic Area: Oncology Product Name: GL-0817
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: First In Ventures
Deal Size: $11.5 million Upfront Cash: Undisclosed
Deal Type: Series C Financing June 24, 2021
Details:
GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. Final safety conclusions are that GP2 immunotherapy is well tolerated and that no serious adverse events related to GP2 immunotherapy were reported over the full 5 year follow-up period.
Lead Product(s): GP2,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
According to Greenwich, Kaplan-Meier curves show the disease-free survival (DFS) rate was 100% at the final five-year median follow-up in HER2/neu 3+ patients treated with GP2 plus GM-CSF following adjuvant Herceptin, versus 89.4% for GM-CSF alone.
Lead Product(s): GP2,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
U.S. Food and Drug Administration has approved DANYELZA (naxitamab-gqgk) 40mg/10ml. DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.
Lead Product(s): Naxitamab,GM CSF
Therapeutic Area: Oncology Product Name: Danyelza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
Details:
The study aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received trastuzumab after surgery.
Lead Product(s): GP2,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Interim data show promising disease control rates in patients vaccinated with VBI-1901 combined with the GM-CSF adjuvant (40%), and with VBI-1901 combined with GSK’s adjuvant AS011 (56%).
Lead Product(s): VBI-1901,GM CSF
Therapeutic Area: Oncology Product Name: VBI-1901
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
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