Oncology | Phase I/ Phase II Developments | SWITZERLAND

ADC Therapeutics

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ADC Therapeutics Dosed First Patient in Pivotal Ph 2 Portion of LOTIS 3 Trial of Loncastuximab Tesirine in Combination With Ibrutinib

Lead Product(s): Loncastuximab Tesirine,Ibrutinib

Therapeutic Area: Oncology Product Name: Lonca

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 17, 2020

Details:

Based on the encouraging interim data Lonca and ibrutinib demonstrated in Phase 1, the trial was amended to a Phase 1/2 protocol intended to support the submission of a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

F. Hoffmann-La Roche

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Immunomedics Expands Collaboration with Roche Evaluating TrodelvyTM

Lead Product(s): Sacituzumab Govitecan,Atezolizumab

Therapeutic Area: Oncology Product Name: Trodelvy

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

Partner/Sponsor/Collaborator: Immunomedics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration July 13, 2020

Details:

Collaboration aims to evaluate Trodelvy in combination with Tecentriq in patients with metastatic urothelial cancer and metastatic non-small cell lung cancer. Roche will be conducting two open-label, randomized Phase 1b/2 studies using its MORPHEUS platform.

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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ADC Therapeutics

ADC Therapeutics Dosed First Patient in Pivotal Ph 2 Portion of LOTIS 3 Trial of Loncastuximab Tesirine in Combination With Ibrutinib

F. Hoffmann-La Roche

Immunomedics Expands Collaboration with Roche Evaluating TrodelvyTM

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