Oncology | Phase I/ Phase II Developments | SWITZERLAND

Helsinn

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Helsinn announces FDA acceptance of IND application for TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

Lead Product(s): HM06

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Taiho Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

Details:

The FDA completed the review of the Investigational New Drug application for TAS0953/HM06 and released a "Study May Proceed" letter for the Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities.

Debiopharm

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FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143

Lead Product(s): Debio 1143,Cisplatin

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2020

Details:

The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination with chemo-radiotherapy presented in September 2019 at the ESMO congress.

Basilea Pharmaceutica

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Basilea announces clinical supply agreement for its planned study FIDES-03 with derazantinib in gastric cancer

Lead Product(s): Derazantinib,Atezolizumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 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.

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Switzerland

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Helsinn

Helsinn announces FDA acceptance of IND application for TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

Debiopharm

FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143

Basilea Pharmaceutica

Basilea announces clinical supply agreement for its planned study FIDES-03 with derazantinib in gastric cancer