On February 18, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host the 2019 New York GU: 12th Annual Interdisciplinary Prostate Cancer Congress and Other Genitourinary Malignancies meeting on March 15 and 16 at The Westin New York at Times Square in New York City (Press release, Physicians’ Education Resource, FEB 18, 2019, View Source [SID1234533374]).

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This dynamic prostate cancer congress will be co-chaired by Daniel P. Petrylak, M.D., professor of medicine and urology, co-director of the Signal Transduction Research Program, Yale Cancer Center, and Leonard G. Gomella, M.D., FACS, the Bernard W. Godwin, Jr. professor of prostate cancer; chairman, department of urology, Jefferson Medical College; clinical director and senior director for clinical affairs, Jefferson Kimmel Cancer Center Network.

"We look forward to presenting our New York GU meeting again this year," said Phil Talamo, president of PER. "This educational activity will outline the use of patient- and disease-specific characteristics to inform clinical decision-making in the management of patients with genitourinary malignancies along with discussing current strategies and practice-changing evidence for the management of patients across multiple lines of care through many interactive sessions."

The New York GU (NYGU) congress is a two-day educational meeting that provides clinicians with valuable knowledge and confidence to maintain state-of-the-art care and optimize outcomes for patients with genitourinary malignancies. During the congress, faculty experts will review the latest advances in the management of genitourinary malignancies and the optimal use of chemotherapeutic and local therapies, androgen-deprivation therapies, targeted therapies, radiopharmaceuticals and immunotherapies. Coverage will also include discussions of prognostic/predictive marker application and proactive mitigation of predictable treatment-related side effects. Attendees will also be able to address key concerns regarding the application of landmark clinical trial data (for example, prostate specific antigen screening and decision-making for castrate-sensitive prostate cancer).

This live activity is accredited by the Accreditation Council for Continuing Medical Education for 12.75 AMA PRA Category 1 Credits for physicians. For more information and to register, click here.

On February 18, 2019 Oncopeptides AB (Nasdaq Stockholm, ONCO) reported that the Company will release its Year-end Report on 22 February at 8:00 am CET (Press release, Oncopeptides, FEB 18, 2019, View Source [SID1234533530]). The report will be available on the Company’s web site at www.oncopeptides.com.

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The company’s CEO Jakob Lindberg will summarize the financial year 2018 and address questions from investors, analysts and media at 14:00 CET, 22 February.

An audiocast to the presentation will be available at:

View Source

Time for webcast – 14:00 (CET) on 22 February
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On February 18, 2019 Xspray Pharma AB reported the results of a clinical Phase I pilot study with its HyNap-Sora drug candidate (Press release, Xspray, FEB 18, 2019, View Source [SID1234649548]). The study examined HyNap-Sora’s bioavailability compared to the sorafenib cancer drug, currently marketed as Nexavar for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Both investigated HyNap compositions demonstrated significantly increased bioavailability. The variability between subjects in AUC and Cmax was reduced to half compared to Nexavar for one of the HyNap-Sora formulations.
In the completed Phase I clinical trial in 14 healthy subjects, bioavailability of two different formulations of HyNap-Sora was assessed in comparison with Nexavar. The results are positive and the study achieved its primary purpose to show increased bioavailability compared to the originator product. In addition, and as shown in earlier studies with Xspray’s lead product candidate, HyNap-Dasa, the study also showed reduced between subject variability.

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"Sorafenib has a very different pharmacokinetic profile than our product candidates based on nilotinib and dasatinib. Therefore, I’m very pleased that we achieved the primary purpose of this study with sorafenib which enables continuation of the development program. It confirms and strengthens our belief that HyNap formulations of PKIs have the potential to improve both present and upcoming products with poor solubility, improving efficacy and safety enhancing patients’ quality of life during this type of therapy," says Per Andersson, CEO of Xspray.

The clinical results in summary:

• The HyNap formulations were administered at half the dose compared to Nexavar to account for expected increase in bioavailability

• Area under the curve (AUC) was approximately 80 % for the HyNap-Sora formulations compared to Nexavar, indicating that the bioavailability of Sorafenib from HyNap-Sora was 1.6-fold higher

• The maximum concentration of Sorafenib in plasma (Cmax) was approximately 95 % compared to Nexavar.

• The variability between subjects in AUC and Cmax was reduced to half compared to Nexavar for one of the HyNap-Sora formulations.

Sorafenib is a compound with low aqueous solubility and low bioavailability from the sorafenib tablet (Nexavar). The present study demonstrates that the HyNap technology can increase the extent of absorption of sorafenib and reduce between subject variability by improving the solubility.

On February 17, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported the signing of a collaboration agreement with Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences) to evaluate the safety and tolerability of the combination therapy of Innovent’s Tyvyt (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody and IBI305, a biosimilar product candidate of bevacizumab and a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, with Chipscreen Biosciences’ Chidamide, a benzamide-based selective inhibitor of class I (subtypes 1, 2, 3) and IIb (subtype 10) histone deacetylases (HDACs), in patients with advanced colorectal cancer (Press release, Innovent Biologics, FEB 17, 2019, View Source [SID1234533367]).

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Under the terms of the agreement, Chipscreen Biosciences and Innovent will jointly in China to explore potential applications of this combination on colorectal cancer and to evaluate its safety and tolerability.

"There are significant unmet medical needs for patients with advanced colorectal cancer, and the combination treatment with different targeted therapies may serve as an additional solution to these patients", said Chipscreen Biosciences’s Executive Vice President, Dr. Zhiqiang Ning. "We look forward to partnering with Innovent to explore a potential clinical application with the combination regimen of immune check-point inhibitor, angiogenesis inhibitor and epigenetic modulator in this indication."

"Epigenetic aberrations appear to be one of the major causes of resistance to immune-oncological therapies. Chidamide, a novel epigenetic modulating agent discovered in China, seems to reverse patient resistance to immune therapy in early clinical studies," said Innovent’s Chief Scientific Officer, Dr. Kerry Blanchard. "We are pleased to be partnering with Chipscreen Biosciences to explore combination therapy with Sintilimab, IBI305, and Chidamide in colorectal cancer. We hope this collaboration will eventually benefit those patients in need."

About Chidamide

Chidamide, a benzamide-based selective inhibitor of class I (subtypes 1, 2, 3) and IIb (subtype 10) histone deacetylases (HDACs), reverses epigenetic abnormalities related to tumorigenesis. Chidamide induces chromatin remodeling by inhibiting specific subtypes of HDACs which leads to increased acetylation of histones (i.e., epigenetic changes), therefore modifying gene expression in multiple signal transduction pathways. Chidamide directly inhibits the cell cycle and induces apoptosis of tumor cells from the blood and lymphatic system. It can induce and activate tumor killing by natural killer cells (NK) and antigen-specific cytotoxic T-cells (CTL), and modulates the anti-tumor cellular immunity of bodies. Chidamide also induces the differentiation of tumor stem cells and reverses epithelial mesenchymal phenotype transformation (EMT) of tumor cells through epigenetic regulation mechanisms, thereby playing a potential role in restoring the drug sensitivity of drug-resistant tumor cells, and inhibiting tumor metastasis and recurrence. It is a new molecular entity with global patent protection developed by Chipscreen Biosciences, China’s first international-recognized subtype selective histone deacetylation enzyme (HDAC) oral inhibitor, and a national class 1.1 drug. In December 2014, it was approved for marketing by the China Food and Drug Administration (CFDA). Its first indication is relapsed and refractory peripheral T-cell lymphoma. Meanwhile, clinical studies on other blood tumors, solid tumors and HIV with either a single drug or combined with other drugs are being carried out simultaneously in the United States, Japan, Mainland China and Taiwan, as well as in other countries and regions.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). There are currently more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on other solid tumors.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, therefore inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on 29 January 2019.

On February 16, 2019 AVEO Oncology (NASDAQ:AVEO) reported the presentation of data from the Phase 3 TIVO-3 study of tivozanib (FOTIVDA) versus sorafenib in refractory advanced or metastatic renal cell carcinoma (RCC) (Press release, AVEO, FEB 16, 2019, View Source [SID1234533366]). The data were presented by Brian Rini, MD, Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and Director, Cleveland Clinic Genitourinary Cancer Program, during an oral presentation titled, "TIVO-3: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma (RCC)" at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium held February 14-16, 2019 in San Francisco. A copy of the presentation will be available in the Publications & Presentation section of the Company’s website.

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"Tivozanib continues to demonstrate a unique activity and tolerability profile among VEGF TKIs in the treatment of kidney cancer," said Dr. Rini. "This is underscored by a significant improvement in progression free survival and overall response rate compared to sorafenib in patients with treatment-refractory advanced RCC. I look forward to understanding how this improvement impacts overall survival as the TIVO-3 study continues to mature."

"We remain committed to our goal of improving outcomes and patient experience in RCC," said Michael Bailey, president and chief executive officer of AVEO. "The improvement in progression free survival in the TIVO-3 study, particularly in patients who received prior immunotherapy, is noteworthy. We are hopeful that these positive PFS outcomes translate into an improved overall survival hazard ratio when we report a more mature interim OS outcome in the fourth quarter of 2019. We expect to make a new drug application filing decision following the availability of more mature OS results."

TIVO-3 Topline Study Results

The TIVO-3 trial is a Phase 3 randomized, controlled, multi-center, open-label study designed to compare tivozanib (FOTIVDA) to sorafenib in 350 subjects with highly refractory advanced or metastatic renal cell carcinoma (RCC). The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS). Tivozanib demonstrated a 44% improvement in median PFS and 26% reduction in the risk of progression or death (Hazard Ratio [HR]=0.74, p=0.02, see Figure 1). Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib.

The TIVO-3 trial enrolled patients with RCC who have failed at least two prior regimens. Among these, approximately 26% of patients received checkpoint inhibitor (CPI) therapy in earlier lines of treatment. PFS for tivozanib was longer than sorafenib both in patients who received prior CPI therapy and those who received two prior VEGF TKI therapies. Patients who received prior CPI therapy had a median PFS of 7.3 months with tivozanib and 5.1 months with sorafenib (HR=0.55, p=0.03, see Figure 2). One- and two-year PFS in patients who received tivozanib following CPI therapy was 35% and 25%, respectively, and 4% and n/a for patients receiving sorafenib following CPI therapy at those respective time periods.

The secondary endpoint of overall response rate for patients receiving tivozanib was 18% compared to 8% for patients receiving sorafenib (p=0.02). Median duration of response (DOR) in patients receiving tivozanib was not reached (95% CI:12.9,—) and was 5.7 months for patients receiving sorafenib (95% CI:5.6,—). DOR probability at 1 year was 71% and 46% for tivozanib and sorafenib, respectively, and 55% and 0% at two years.

The analysis of the secondary endpoint of overall survival (OS) was not mature at the time of the final PFS analysis, and currently reflects ~50% of potential OS events. As previously disclosed, the updated preliminary OS analysis conducted at an October 4, 2018 data cutoff date, which included additional patients previously lost to follow-up, showed a non-statistically significant difference in OS favoring sorafenib (HR=1.12, p=0.44). The Company intends to conduct an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019.

Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers.