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Details:
BAL087 (derazantinib), an orally administered small-molecule FGFR inhibitor has demonstrated clinically meaningful efficacy with 74% disease control rate and median progression-free survival was 7.3 months in FIDES-01 study in patients iCCA.
Lead Product(s): Derazantinib
Therapeutic Area: Oncology Product Name: BAL087
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 January 24, 2022
Details:
The synergistic effect between derazantinib and paclitaxel is particularly encouraging as we are exploring derazantinib alone and in combination settings, including paclitaxel, in our clinical phase 1/2 study FIDES-03 in patients with gastric cancer.
Lead Product(s): Derazantinib,Paclitaxel,Ramucirumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2021
Details:
Derazantinib is investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3. FIDES-01 study evaluated derazantinib, in patients with FGFR2 fusion-positive advanced or metastatic intrahepatic cholangiocarcinoma.
Lead Product(s): Derazantinib
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 17, 2021
Details:
The derazantinib-atezolizumab combination was well tolerated and no dose-limiting toxicities were observed. Finding from the cohort in the FIDES-02 study were presented at the virtual American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2021).
Lead Product(s): Derazantinib,Atezolizumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
Clinical proof of concept achieved for derazantinib monotherapy in FGFR2 gene fusion-positive iCCA. Derazantinib has shown a well manageable safety profile.
Lead Product(s): Derazantinib
Therapeutic Area: Oncology Product Name: BAL087
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 February 10, 2021
Details:
The FIDES-03 study will assess the efficacy and safety of derazantinib as monotherapy and combination therapy with ramucirumab and paclitaxel or with Roche’s PD-L1 checkpoint inhibitor atezolizumab.
Lead Product(s): Ramucirumab,Derazantinib,Paclitaxel
Therapeutic Area: Oncology Product Name: Cyramza
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Basilea Pharmaceutica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 28, 2020
Details:
The presented data from several preclinical models demonstrate that derazantinib has an anti-angiogenic effect, which may contribute to its overall anti-tumor activity in FGFR-driven cancers.
Lead Product(s): Derazantinib,Ramucirumab,Paclitaxel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Successful completion of phase 1b part of FIDES-02 exploring the safety and tolerability of combining derazantinib with PD-L1 checkpoint inhibitor atezolizumab.
Lead Product(s): Derazantinib,Atezolizumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
FGFR inhibitors, including derazantinib, have showed clinical antitumor activity in patients with FGFR2 gene fusion-positive iCCA. To date there is limited clinical evidence for the benefit of FGFR inhibitors in iCCA patients with FGFR2 gene mutations and amplifications.
Lead Product(s): Derazantinib
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 October 12, 2020
Details:
The preclinical derazantinib data may provide an explanation for differences in reported adverse event profiles between various FGFR kinase inhibitors. Furthermore, derazantinib shows promising efficacy in patient-derived tumor models with gene aberrations in FGFR1-3.
Lead Product(s): Derazantinib,Erdafitinib
Therapeutic Area: Oncology Product Name: ARQ 087
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Details:
The FIDES-01 study is a multi-center, open-label phase 2 registrational study of once-daily oral derazantinib for the treatment of patients with inoperable or advanced iCCA and FGFR2 gene fusions or FGFR2 gene mutations or amplifications.
Lead Product(s): Derazantinib
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 20, 2020
Details:
Both companies will conduct a study which will assess the efficacy and safety of derazantinib as mono- and combination therapy in the second-line setting.
Lead Product(s): Derazantinib,Atezolizumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2020
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