NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

Excellent post by
@d_stock07734

A hypothetical question:

Assuming the collaboration trial between Merck and NWBO is real, can Merck file for FDA approval for the combination on colorectal cancer?

A multi-center, Phase II clinical trial evaluating DCVax-L (autologous dendritic cells pulsed with tumor lysate antigen) and pembrolizumab (an anti–PD-1 monoclonal antibody) for subjects with liver metastases of primary colorectal carcinoma
https://rlp-forschung.de/public/facilities/2807/research_projects/22146

Merck filed for FDA approval of an ADC based on a phase 2 trial which was solely run by Daiichi Sankyo. But Merck did sign a deal with Daiichi about this specific ADC last October. That's why I was wondering whether Merck can for FDA approval based on the results from the collaboration trial.

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer
https://merck.com/news/patritumab-deruxtecan-bla-submission-receives-complete-response-letter-from-fda-due-to-inspection-findings-at-third-party-manufacturer/

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
https://clinicaltrials.gov/study/NCT04619004

https://daiichisankyo.us/press-releases/-/article/patritumab-deruxtecan-demonstrated-clinically-meaningful-and-durable-responses-in-patients-with-egfr-mutated-metastatic-non-small-cell-lung-cancer-in-

https://merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/

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