Advaxis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Advaxis, 2017, DEC 20, 2017, View Source [SID1234522739]).

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On December 21 , 2017 Takara Bio Inc. (Takara Bio) reported it has entered into an agreement with Huntsman Cancer Institute (HCI) at the University of Utah to supply its lead product candidate, oncolytic virus HF10 as an investigational drug (Press release, Takara Bio, DEC 20, 2017, View Source [SID1234522738]). Under the agreement HCI will conduct an investigator-initiated clinical trial of combined treatment of HF10 and cancer drug, nivolumab, in patients with resectable Stage IIIB, IIIC and IVM1a melanoma.

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Takara Bio is currently conducting clinical development of HF10, and obtained positive results on safety and efficacy in the phase II trial of HF10 in combination with cancer drug, ipilimumab, for patients with unresectable melanoma in US. The clinical trial conducted at HCI, will evaluate safety and efficiency of HF10 in combination with nivolumab which is accepted as one of the standard therapies for cancer. Takara Bio expects to expand the usage of HF10 through the clinical trial at HCI.

Takara Bio promotes development of HF10 as a drug for melanoma and pancreatic cancer, and attempts to achieve the accelerated approval utilizing the conditional and term-limited approval system for regenerative medicine under The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, for early commercialization in Japan.

【Overview of the clinical trial】

Study name Phase II Clinical Trial for preoperative immunotherapy of HF10 and nivolumab combination in patients with resectable melanoma (stage IIIb, IIIIc and IVM1a)
Condition Patients with resectable melanoma (stage IIIb, IIIIc and IVM1a)
Main Endpoint Pathological response rate of preoperative immunotherapy for 12 weeks
Estimated Enrollment 20
Duration Jan 2018 – October 2022
Site Huntsman Cancer Institute

On December 19, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has requested that the Scientific Advisory Group (SAG) on Oncology provide an opinion on aspects of the ongoing Marketing Authorization Application (MAA) relating to a potential conditional approval for rucaparib (Press release, Clovis Oncology, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323324 [SID1234522703]). The exact date for the SAG meeting has not yet been set but we expect it to take place in early February 2018.

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The SAG on Oncology is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue relevant to the work of the Agency that relates to this area.

"We continue to have as our priority the submission and potential approval for the maintenance treatment indication in advanced ovarian cancer in the EU," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We anticipate that initiating the process to submit a new MAA for maintenance next month is the quickest path to provide the potential benefit of rucaparib to more women in the EU with advanced disease. Of course, if we receive an approval for the treatment indication in the second quarter, and we file a variation to the treatment MAA, we anticipate the potential maintenance approval would be swifter."

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All 106 patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Both the variation to the MAA or a new MAA submission will be based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant; 2) HRD-positive; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. Both the variation to the MAA or the new MAA filing will be directed at the broader intent-to-treat or "all comers" population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the US Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for rucaparib for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In December 2017, the CHMP referred the rucaparib MAA for the ovarian cancer treatment indication to the SAG on Oncology for review. The SAG meeting to discuss the rucaparib MAA is anticipated in February 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib.

On December 19, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma has completed its pre-specified review of safety data for treated patients in the trial (Press release, Delcath Systems, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323336 [SID1234522704]). The DSMB has recommended that the study continue without modification.

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The FOCUS Trial is evaluating the efficacy, safety and pharmacokinetics of Melphalan/HDS versus best alternative standard of care in 240 patients with metastatic ocular melanoma (OM). The primary objective of the study is a comparison of overall survival between the Melphalan/HDS treatment arm and best alternative care arm comprised of selected therapies; secondary objectives include overall progression-free survival and objective response rate, each as determined by the Investigator, while exploratory objectives include progression-free survival, objective response rate, hepatic progression free survival and hepatic objective response rate all as determined by blinded Independent Central Review, and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.

"The DSMB’s recommendation to proceed without modification with the FOCUS Trial as planned confirms our own observations of the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "Importantly, this initial independent evaluation of the safety profile of melphalan/HDS used the Generation Two filter configuration of the device and the current version of the procedure protocol, and so provides confidence in both our product and procedure. Given that safety concerns with the previous generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased to have successfully passed this important milestone.

ON December 19, 2017 Tanvex rported that its recently completed pharmacokinetics (PK) study of the company’s biosimilar product candidate, TX16, showed favorable results supporting PK similarity of TX16 and the reference product, US-licensed Avastin (Press release, Tanvex BioPharma, DEC 19, 2017, View Source [SID1234524595]). In a prospective, single dose, double blinded, parallel group study conducted in 69 healthy adult male subjects, the test to reference ratio of geometric least squares (LS) mean and corresponding 90% confidence interval (CI) for the primary endpoint, AUC 0-∝, were within the acceptance range of 80.00 to 125.00%. In addition the test to reference ratios of geometric LS means and corresponding 90% CIs of the other PK endpoints, AUC 0-t and C max, were also within the acceptance range of 80.00% to 125.00% demonstrating similar peak concentrations and extent of exposure between TX16 and Avastin.

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Overall, both TX16 and Avastin were generally safe and well tolerated by the study subjects, with mild to moderate treatment-emergent adverse events and no severe or serious adverse events reported.

Avastin (bevacizumab) is a vascular endothelial growth factor-specific angiogenesis inhibitor approved in the US for the treatment of multiple indications in combination with other agents, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

According to IMS data, US sales of Avastin were US$3.1 billion in 2016.