olafertinib (CK-101) / Suzhou NeuPharma, Checkpoint Therapeutics - LARVOL DELTA

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=136 | Completed | Sponsor: Checkpoint Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=136; Active, not recruiting; Sponsor: Checkpoint Therapeutics, Inc.; Trial completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

CK-101 (RX518), a Third Generation Mutant-Selective Inhibitor of EGFR in NSCLC: Results of an Ongoing Phase I/II Trial (IASLC-WCLC 2018) - P1/2; "Durable anti-tumor activity was observed, particularly in treatment-naïve pts. Further study is ongoing to establish the optimal dose to maximize therapeutic effect in a planned Phase 3 study in treatment-naïve EGFR-mutant NSCLC pts. "

P1/2 data • Brain Cancer • Non Small Cell Lung Cancer

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=136; Active, not recruiting; Sponsor: Checkpoint Therapeutics, Inc.; Trial completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Checkpoint Therapeutics Reports First Quarter 2021 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "...'Enrollment in our registration-enabling study for cosibelimab in metastatic cutaneous squamous cell carcinoma ('mCSCC') is nearly complete and the study remains on track to report top-line results by year-end. With a successful study, we anticipate submitting our first application for marketing approval for cosibelimab next year...Olafertinib (CK-101)...continues to enroll patients as planned into a Phase 3, registration-enabling study in first-line, EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer ('NSCLC'). We intend to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use to support a New Drug Application submission in the United States'."

Enrollment status • FDA event • P1 data • Regulatory • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma

Fortress Biotech Reports Record 2020 Financial Results and Recent Corporate Highlights (Fortress Biotech Press Release) - "CK-101 (Third-generation Epidermal Growth Factor Receptor ('EGFR') Inhibitor): We plan to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use, upon a successful study, to support a new drug application submission in the United States."

FDA event • Oncology

Checkpoint Therapeutics Announces Formation of Scientific Advisory Board (GlobeNewswire) - "Checkpoint Therapeutics, Inc...announced the formation of an independent Scientific Advisory Board comprising leaders in the fields of immunotherapy, lung and skin cancers. The Scientific Advisory Board will work closely with Checkpoint leadership to further develop Checkpoint's novel treatments for patients with solid tumor cancers, including cosibelimab and CK-101."

Clinical • Lung Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=136; Active, not recruiting; Sponsor: Checkpoint Therapeutics, Inc.; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

NeuPharma's 3rd-gen EGFR-TKI enters Phase III in NSCLC (GBI Health) - "China’s Suzhou NeuPharma Co., Ltd, announced first patient dosing at Shanghai Chest Hospital in a Phase III clinical study evaluating RX518, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). The drug is being assessed as a first-line treatment of non-small cell lung cancer (NSCLC)."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Checkpoint Therapeutics reports full-year 2019 financial results and recent corporate highlights (Fortress Biotech Press Release) - "The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions."

Patent

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=92; Recruiting; Sponsor: Checkpoint Therapeutics, Inc.

Clinical • New P1/2 trial

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=136; Active, not recruiting; Sponsor: Checkpoint Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2019 ➔ Jun 2020

Clinical • Enrollment closed • Trial primary completion date

Checkpoint Therapeutics Reports Second Quarter 2019 Financial Results and Recent Corporate Highlights (GlobeNewswire, Checkpoint Therapeutics, Inc) - We look forward to reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor (“EGFR”) inhibitor, before year-end, with the goal of commencing a Phase 3 clinical trial in first-line EGFR mutation-positive non-small cell lung cancer (“NSCLC”) in 2020. In May, we announced positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, showing anti-tumor activity across multiple advanced cancers.

Clinical data • IO Biomarker • PD(L)-1 Biomarker

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=122; Recruiting; Sponsor: Checkpoint Therapeutics, Inc.; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Trial primary completion date

Checkpoint Therapeutics Reports First Quarter 2019 Financial Results and Recent Corporate Highlights (GlobeNewswire, Checkpoint Therapeutics, Inc) - “…CK-101, our novel, oral, third-generation EGFR inhibitor, was active in patients with treatment-naïve and relapsed/refractory EGFR mutation-positive lung cancer…Our plan is to commence a phase 3 trial in first-line EGFR mutation-positive non-small cell lung cancer later this year.”

Clinical data • IO Biomarker • New trial • PD(L)-1 Biomarker

"#CheckpointTherapeutics Announces Issuance of Two New Patents for #EGFRInhibitor #CK101 $CKPT https://t.co/NoZZSrgKgk" (@1stOncology)

Checkpoint Therapeutics Reports Full-Year 2018 Financial Results and Recent Corporate Highlights (GlobeNewswire, Checkpoint Therapeutics, Inc) - James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “During 2018, we continued to advance our lead clinical programs, CK-101, a third-generation epithelial growth factor receptor (“EGFR”) tyrosine kinase inhibitor (“TKI”), and CK-301, a fully human anti-PD-L1 antibody, and presented our first interim clinical data for CK-101 in an oral presentation at the World Conference on Lung Cancer. We look forward to presenting our first interim safety and efficacy data from the ongoing CK-301 study in the second quarter as we continue to enroll potential registration-enabling expansion cohorts in endometrial and colorectal cancers, and plan to initiate a registration trial for CK-101 by year-end.

Clinical data • Enrollment status • New trial

Checkpoint Therapeutics Announces Issuance of Two New Patents for EGFR Inhibitor CK-101 (GlobeNewswire, Checkpoint Therapeutics, Inc) - “Checkpoint Therapeutics…announced that the European Patent Office (EPO) has issued a composition of matter patent for CK-101 (also known as RX518). CK-101 is Checkpoint’s third-generation epidermal growth factor receptor (EGFR) inhibitor that is under development for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC)….The U.S. Patent and Trademark Office previously issued a U.S. counterpart composition of matter patent for CK-101 (U.S. Patent No. 9,550,770). Together, the patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extension in the U.S. under the Hatch-Waxman Act.”

Patent