On September 26, 2018 ai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, presented results of its open-label study to evaluate the pharmacokinetic (PK) profile of ZL-2306 (niraparib) made in China in Chinese ovarian cancer patients (Press release, Zai Laboratory, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368996 [SID1234530330]). Results from the study show comparable PK profile of the Chinese patients administered ZL-2306 to that of patients evaluated in Tesaro’s global PK study. These data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) on Sept. 21, 2018, at the Xiamen International Conference and Exhibition Center (XICEC) in Xiamen, China.

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The open-label PK Study enrolled 36 Chinese patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients had received no more than two lines of platinum-based therapy and were responsive to the most recent platinum-based treatment. Subjects were randomly assigned to dose levels of 100mg, 200mg and 300mg. The primary objective of the study was to assess the PK profile of ZL-2306 in Chinese patients following both single and multiple doses. The secondary objective was a safety assessment.

The study demonstrated that the drug exposure increased proportionally from 100mg to 300mg, with a Tmax of approximately three hours. Systemic exposure of ZL-2306, as measured by Cmax and AUC, increased approximately proportionally with increased dose. The half-life is 31-37 hrs. There were no unexpected safety issues noted during the trial. All key PK and safety parameters were comparable to those in global studies. The study results and population PK data did not identify ethnicity differences between Chinese and non-Chinese patients.

The positive outcome of this PK study will further enhance ZL-2306 application package in China.

About ZL-2306

ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and plans to launch and commercialize niraparib in Hong Kong in the second half of 2018. Zai Lab believes ZL-2306 has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.

On September 26, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will present a poster entitled, "The Use of Self-delivering RNAi to Enhance NK Cell Cytotoxicity," at the 16th Annual Discovery on Target Conference (Press release, RXi Pharmaceuticals, SEP 26, 2018, View Source [SID1234529593]). The conference is being held September 25-28, 2018 at the Sheraton Boston in Massachusetts.

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Date: Wednesday, September 26, 2018
Location: Sheraton Boston
Title: The Use of Self-delivering RNAi to Enhance NK Cell Cytotoxicity
View the poster here: View Source

On September 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a prospective study conducted by Leiden University Medical Center (LUMC) in The Netherlands of the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases, were presented as a poster at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting this week (Press release, Delcath Systems, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2369022 [SID1234529645]).

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The study—Percutaneous Hepatic Perfusion in Patients with Unresectable Liver Metastases from Ocular Melanoma using Delcath Systems’ Second Generation (GEN 2) Hemofiltration System: A Prospective Phase 2 Study—was conducted by researchers at LUMC reported by T.S. Meijer, MD. The study prospectively evaluated tumor response rate, safety, overall survival (OS), overall progression-free survival (PFS) and hepatic progression-free survival (hPFS) in 35 patients with ocular melanoma liver metastases treated at LUMC from February 2014 to June 2017. In accordance with the study’s protocol, patients were treated with a maximum of two cycles of PHP Therapy and a total 67 PHP treatments were administered to the 35 patients in the study.

Post-treatment assessments were possible in 32 patients. Results of the study, according to RECIST 1.1, showed that a complete response was observed in one patient (3.1%) and a partial response was observed in 21 patients (65.6%), resulting in an objective response rate of 68.7%. Stable disease was observed in four patients (12.5%), for a total disease control rate of 81.2%. Median OS was 15.6 months, median PFS was 8.6 months, and median hPFS was 10.8 months.

In their safety analysis, the researchers reported a total of 14 serious adverse events, including one case of cardiac ischemia, five cases of prolonged hospital admission to treat peri-procedure complications, and eight patients re-hospitalized for a variety of post-procedure symptoms. No deaths occurred on the study. No severe bleeding complications, myocardial or cerebral infarctions were observed. Hematologic toxicities of Grade 3/4 were observed in most patients, with 18 (54.5%) patients experiencing thrombocytopenia and 22 patients (66.7%) experiencing neutropenia. The researchers stated that hematologic events were manageable or self-limiting. Additionally, no grade 3 or 4 hepatic serious adverse events were observed by the researchers. The LUMC investigators concluded that, in their institution’s study, PHP Therapy was shown to have a manageable adverse event profile and to be a potentially valuable treatment for certain patients with ocular melanoma liver metastases.

Commenting on the study, Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Delcath Systems, said, "The results from the LUMC study are very encouraging since they are from a prospective trial with endpoints very similar to those in our amended Registration Trial in this same patient population. The LUMC team intends to submit a more extensive analysis of their data for publication, and we look forward to the publication of those more detailed results."

The CIRSE 2018 annual meeting was held in Lisbon, Portugal September 22-25, 2018.

On September 26, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported that Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., will present pre-clinical data on NT219, an anti-tumor resistance drug candidate, in a poster session at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, Kitov Pharmaceuticals , SEP 26, 2018, View Source [SID1234529665]): Translating Science into Survival, to be held September 30 – October 3, 2018, in New York.

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"We are pleased to have been chosen to present an abstract at the upcoming AACR (Free AACR Whitepaper) meeting. These very exciting data, which we had also presented at a cancer conference earlier this year, hold great promise for mobilizing the patient’s immune system against tumors," Dr. Reuveni commented. "In the future, tumors in patients who have functional immune systems may respond to NT219 both by blocking feedback pathways, overcoming drug resistance, and by removing the ‘protective shield’ from the tumor, allowing anti-tumor immune attack."

The poster demonstrates NT219’s efficacy in synergy with immuno-oncology therapies, which are widely used today, but to which unfortunately most patients still do not respond. In double autologous PDX models, dosing with NT219 converted tumors that were resistant to pembrolizumab (Keytruda) into responsive tumors. The models also demonstrated the efficacy of NT219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).

Abstract: B127
Abstract Title: NT219, A Novel Dual Inhibitor of STAT3 and IRS1/2, Converts Immuno-Oncology Resistant Tumors to Responders
Session Date: Tuesday, October 2, 2018
Session Time: 12.45 p.m. – 3.15 p.m. EDT
Session Location: Poster Session B, New York Marriott Marquis, Westside Ballroom

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is developed by TyrNovo Ltd., a Kitov Pharma company. For more information on TyrNovo please visit View Source

On September 26, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported its interim results of its Phase 2 study of ZL-2301 (brivanib) in Chinese patients with previously-treated advanced hepatocellular carcinoma (HCC) (Press release, Zai Laboratory, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368997 [SID1234530331]). Results from the study show ZL-2301 continues to demonstrate evidence of anti-tumor activity with a manageable safety profile in Chinese patients. The interim data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) on Sept. 22, 2018, at the Xiamen International Conference and Exhibition Center (XICEC) in Xiamen, China.

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In the multi-center, open-label Phase 2 trial, 90 patients were enrolled to receive either 800 mg of ZL-2301 once-daily (QD) or 400 mg of ZL-2301 twice-daily (BID), administered orally. The primary endpoints in the trial are: (1) disease control rate (DCR) at 12 weeks from randomization, defined as the percentage of patients with a complete response, partial response or stable disease, and (2) time to disease progression (TTP).

The interim analysis was based on 75 patients (36 on 800mg QD; 39 on 400mg BID). The 12 weeks DCR was 41.7% in the 800mg QD arm and 35.9% in the 400mg BID arm. TTP was 4.2 months (95% CI, 2.8-4.2) in 800mg QD arm and 2.8 months (95% CI, 1.4-4.2) in the 400mg BID arm. ZL-2301 was relatively well-tolerated in the study; its toxicity profile appears in-line with that of the VEGFR inhibitor drug class.

Dr. Shukui Qin, Executive Member of the Asian Clinical Oncology Society, Senior Vice President of Chinese Society of Clinical Oncology and Lead Investigator for ZL-2301 study, commented, "This is a well conducted clinical trial that produced additional data to better characterize the clinical profile of ZL-2301 in Chinese patients. The data helped to set the foundation for further development of ZL-2301 as a potential therapy for HCC which are still in dire need of additional treatment options."

The efficacy and tolerability results of the study are in-line with our expectations in this heavily pre-treated HCC population. Given the large, unmet needs in HCC, a common, difficult to treat cancer, primarily driven by hepatitis B infection in China, and the rapidly changing landscape in HCC, Zai Lab plans to conduct a combination study to evaluate ZL-2301 with anti-PD1 therapy for HCC patients in China.

About ZL-2301 (brivanib)

ZL-2301 (brivanib) is an oral, small molecule dual target tyrosine kinase inhibitor, or TKI. Zai Lab licensed exclusive rights for China, Hong Kong, Macau and Taiwan from Bristol Myers Squibb. ZL-2301 has been tested in four Phase III studies in hepatocellular cancer (HCC) and showed anti-tumor activity and a manageable safety profile. Based on Zai Lab’s review of the results from Bristol-Myers Squibb’s development program for ZL-2301, its understanding of the etiology and current standard of care of HCC in Chinese patients and its ongoing research, Zai Lab believes that ZL-2301 has the potential to be an effective treatment option for Chinese HCC patients and merits further clinical development. In the second quarter of 2017 Zai Lab initiated a Phase II trial of ZL-2301 as a second-line treatment for advanced HCC patients in China.