SYS-CON MEDIA Authors: Zakia Bouachraoui, Liz McMillan, Carmen Gonzalez, Roger Strukhoff, David Linthicum

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The Lancet Respiratory Medicine Published Study Shows Ensartinib Holds Promise as a New Treatment Option for ALK-positive Non-Small Cell Lung Cancer (NSCLC)

Xcovery Holdings, Inc., an oncology-focused biopharmaceutical company, today announced that ensartinib, the company’s lead drug candidate, demonstrated efficacy and safety in patients with crizotinib-refractory, anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), including those with brain metastases. The peer-reviewed manuscript of the study, “Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial” was published online in The Lancet Respiratory Medicine.

“These results from the ensartinib China registration trial are very encouraging. They support our ongoing global phase 3 efforts in evaluating ensartinib’s efficacy and safety in the first line setting,” said Li Mao, M.D., Chief Executive Officer of Xcovery, “Our company is dedicated to developing drugs to help cancer patients and we believe ensartinib has the potential to be the best-in-class first line therapy for ALK-positive NSCLC patients.”

The multicenter phase 2 registration study analyzed the efficacy and safety of ensartinib in ALK-positive NSCLC patients that failed prior crizotinib treatment. The study also explored the associations between ensartinib efficacy and crizotinib-resistant mutations.

Ensartinib showed very promising activity in patients with ALK-positive NSCLC whose disease had progressed on previous crizotinib therapy. 52% (95% CI 43–60) of patients had a systemic objective response, whereas 70% (53–83) had an intracranial objective response, as assessed by an independent review committee.

In the study, most treatment-related adverse events were grade 1 or 2 and low proportions of patients required dose modifications or discontinued. Ensartinib also demonstrated activity against a broad array of ALK mutations, including G1202R, G1269A, F1174, C1156Y, and T1151.

D. Ross Camidge, M.D., from the University Of Colorado Department Of Medicine provided the Editorial Comment for the Lancet published study. “The median progression-free survival associated with ensartinib (9.6 months) was remarkably similar to that reported for the same drug at the same dose in a separate US study (9.2 months),” noted Dr. Camidge. “Cross-trial comparison would suggest that ensartinib’s activity is thus likely to be similar, if not marginally superior, to that of alectinib.”

“This data set supports ensartinib as a new option for ALK-positive NSCLC patients in a refractory setting,” said Giovanni Selvaggi, M.D., Chief Medical Officer at Xcovery and co-author of the study. “The high efficacy against brain metastases and the encouraging signal in resistant mutations, including G1202R, make ensartinib a promising treatment in an area where there is still significant unmet medical need.”

To view the article, please visit https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30252-8/fulltext.

For more information on the ensartinib phase 3 clinical trial, please visit clinicaltrials.gov.

About Ensartinib

Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global phase 3 trial for ALK-positive NSCLC in the first line.

About Xcovery

Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. For more information, visit www.xcovery.com.

Forward‐Looking Statements

This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.

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