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Black Diamond Reports US FDA’s IND Clearance for BDTX-1535 to Treat Gliobastoma and Non-Small Cell Lung Cancer

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Black Diamond Reports US FDA’s IND Clearance for BDTX-1535 to Treat Gliobastoma and Non-Small Cell Lung Cancer

Shots:

  • The US FDA has cleared an IND application to initiate a P-I study of BDTX-1535 (master key inhibitor of EGFR) in patients with Gliobastoma & NSCLC. The study is expected to initiate in Q1’22 & clinical update in H2’23
  • In pre-clinical studies, the therapy showed an oncogenic alteration of EGFR in GBM resulted in distinct conformations with pharmacology & drug resistance. In cell-based assays, BDTX-1535 showed selective inhibitor of EGFR mutations in GBM & NSCLC, favorable brain-penetrant PK profile in animal models
  • The results showed dose-dependent tumor growth inhibition & complete regression in intracranial GBM & lung cancer drug resistance models that expressed targeted EGFR mutations

Ref: Globe Newswire | Image: PR Newswire

Click here to­ read the full press release 

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