Checkpoint Therapeutics: Beat The System

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  • CKPT expects to submitt a BLA for cosibelimab in 2021.
  • CK-101 data update is expected in early 2020.
  • The possibility of fast approval justifies the decision to focus initially on cSCC.


Checkpoint Therapeutics (NASDAQ:CKPT) is a majority-controlled subsidiary of Fortress Biotech (FBIO). The Company is focused on the acquisition, development, and commercialization of novel treatments for patients with solid tumors. Its lead candidates are CK-101, which is in Phase 1/2 clinical trial for the treatment of patients with EGFR+ non-small cell lung cancer (or NSCLC) and CK-301, an anti-PD-L1 antibody which is in an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic tumors.



CK-101 (formerly known as RX518) is an orally available third-generation and selective inhibitor of specific epidermal growth factor receptor (EGFR) activating mutations, including T790M, and the L858R and exon 19 deletion (del 19) mutations. Suzhou NeuPharma originally developed it, and in 2015 the Chinese biotech company granted a global development and commercialization license (excluding certain Asian countries) to Coronado Biosciences (now Fortress Biotech). Subsequently, Coronado assigned the newly acquired program to Checkpoint Therapeutics.

Identification of EGFR as a target has completely changed the treatment of metastatic NSCLC from chemotherapy to personalized, targeted therapy.

Since their introduction, first-generation EGFR inhibitors - such as gefitinib or erlotinib - significantly improved overall response rate (ORR) and progression-free survival (PFS) in NSCLC patients with EGFR mutations. However, the T790M mutation decreases the affinity of first-generation inhibitors to EGFR kinase domain, rendering the drugs ineffective.

Second-generation EGFR inhibitors (afatinib and dacomitinib) have not provided meaningful benefits in NSCLC patients due to toxicity from also inhibiting wild-type EGFR.

Osimertinib is one of the most advanced third-generation EGFR inhibitors. In phase 3 FLAURA clinical trial osimertinib demonstrated to have longer PFS over both erlotinib and gefitinib in the first-line setting.

Other third-generation drugs in development are rociletinib, olmutinib, nazartinib, naquotinib, mavelertinib, and abivertinib.

In short, this is the situation today:

  • In 2016 Clovis has terminated enrollment

This article was written by

falsoguaritore profile picture
I have been a businessman for over twenty years, a long-term blogger, an investor and a consultant with a focus in the field of biotechnology. My main interest is related to small and medium-sized companies with high growth potential, and a particularly innovative structure.

Disclosure: I am/we are long CKPT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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