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Details:
HM781-36B (poziotinib) is a novel, oral EGFR TKI that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4, which, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
HM781-36B (poziotinib) is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2022
Details:
HM781-36B (poziotinib) is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
HM781-36B (Poziotinib), novel, oral epidermal growth factor receptor tyrosine kinase inhibitor that inhibits tyrosine kinase activity of EGFR, HER2 and HER4. Importantly this, in turn, leads to inhibition of proliferation of tumor cells that overexpress these receptors.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
In pre-clinical models of cancer, poziotinib, an investigational, orally administered, irreversible tyrosine kinase inhibitor was shown to inhibit kinase activity of EGFR and HER2 with exon 20 insertion mutations, inhibiting proliferation, leading to cancer cell death.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
ZENITH 20 study demonstrated positive results for Poziotinib, met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%, showed a confirmed objective response rate of 41% in patients with non-small lung cancer.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: HM781-36B
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib,for use in patients with previously treated locally advanced or metastatic non-small cell lung cancer.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
Spectrum Pharmaceuticals is going to present a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2021
Details:
U.S. FDA has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations. Spectrum plans to submit a new drug application (NDA) for poziotinib later this year.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
FDA agrees to the submission of an NDA for poziotinib for non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations, NDA submission planned for 2021.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2020
Details:
Cohort 2 of the ZENITH20 trial evaluated an oral once daily dose of 16 mg of poziotinib in 90 patients. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8%.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2020
Details:
Spectrum Pharmaceuticals met the pre-specified primary endpoint in the ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2).
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
Cohort 1 from Spectrum's Phase 2 clinical trial, ZENITH20 is evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2020
Details:
Presentation will show results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer patients with EGFR exon 20 mutations.
Lead Product(s): Poziotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2020
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