6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On May 12, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima") and U.S.-based Sydys Corporation, Inc. (OTC: SYYC) ("Sydys"), reported an agreement through which Sydys will license Prima’s CVac immuno-oncology program and oversee its future development (Filing, 6-K, Prima Biomed, MAY 12, 2016, View Source [SID:1234512349]).

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Sydys Corporation (www.sydyscorp.com) is a publicly traded New York company that has been repurposed as a clinical stage biotechnology company in order to develop the CVac assets. Under the terms of the agreement, Sydys will license Prima’s CVac related assets, including manufacturing protocols, clinical data from Phase I and Phase II trials, patents and know-how. Prima will also sell certain assets including some equipment and inventory to Sydys. Dr Sharron Gargosky, the former Chief Technical Officer of Prima who has overseen the development of CVac since 2010, will also transition to Sydys as a consultant to continue the development of CVac. Marc Voigt, Prima’s CEO, will join the Sydys Board of Directors soon after closing.

In this spin out transaction Prima will receive a 9.9% equity stake in Sydys at the time of closing as consideration for the assets being transferred. Given the significant capital requirements for conducting clinical trials, no upfront payment will be received however should CVac be successfully commercialized, Prima could receive over A$400 million (US$293 million) in development, regulatory and commercial milestone payments payable for achievement of set commercial sales targets, in addition to low single digit royalties on sales.

Marc Voigt, Prima’s CEO, commented: "Following extensive discussions with a number of third parties, we have reached what we consider to be an entrepreneurial solution which we believe best positions CVac for clinical success and, hopefully, commercialization. Importantly, this partnership continues the CVac program development without further resource commitment from Prima, while providing the potential for considerable future milestone and royalty payments over time. The ongoing development will be contingent on further successful capital raising for subsequent trials but we are confident that the Sydys team has the ability and connections in the US to undertake this program."

Experienced biotech entrepreneur Joseph Hernandez, the newly appointed Executive Chairman of Sydys Corporation, added: "We believe that the CVac program has tremendous potential, supported by encouraging Phase I and II data in ovarian cancer patients. Studies conducted to date have reinforced CVac’s strong safety profile and demonstrated meaningful improvements in both overall survival and progression-free survival compared to standard-of-care. We look forward to further evaluating the efficacy of CVac with the goal of bringing the treatment to this underserved patient population."

About CVac
CVac therapy is a personalized immunocellular therapeutic that has been investigated for the treatment of epithelial cancers. CVac stimulates the patient’s own immune system to target and destroy tumours. It has been investigated in multiple Phase I and Phase II studies with positive results.
Development highlights for CVac include:

• Completion of a randomized Phase II trial that identified epithelial ovarian cancer patients in second remission (CR2) as the target CVac patient population

• CR2 patients receiving CVac have experienced a clinically meaningful improvement in overall survival (OS), as indicated by final data analysis. These data demonstrated median OS of standard of care patients of 25.53 months, while the CVac arm had not reached a median at 42 months (HR=0.17)

• CR2 patients receiving CVac experienced a clinically significant improvement in progression free survival (PFS) of greater than 12.91 months, compared with a PFS of 4.94 months (HR=0.32) for the standard-of-care
CR2 for ovarian cancer is a high unmet medical need; CVac has obtained Orphan Designation for the treatment of ovarian cancer by both the FDA and EMA and Fast Track Designation with the FDA.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On April 18, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported that it has achieved a first preclinical milestone for CGEN-15022 pursuant to its cancer immunotherapy collaboration with Bayer (Filing, 6-K, Compugen, APR 18, 2016, View Source [SID:1234510994]). The collaboration provides for the research, development, and commercialization of antibody-based cancer therapeutics against two novel Compugen-discovered immune checkpoint regulators, CGEN-15001T and CGEN-15022.

In December 2015, the Company announced the achievement of the third preclinical milestone for CGEN-15001T, the more advanced of the two programs, which at that time was transferred to Bayer’s full control for further preclinical and clinical development activities, and worldwide commercialization, under milestone and royalty bearing licenses from Compugen.

Pursuant to an amendment to the agreement, CGEN-15022’s anti-cancer immune response continues to be evaluated under the joint preclinical research program.

For additional information, please refer to Compugen’s recent Form 6-K filing.

About the Compugen/Bayer Agreement
In August 2013, Compugen and Bayer entered into a collaboration and license agreement for the development and commercialization of antibody-based cancer immune therapeutics against two novel Compugen-discovered immune checkpoint regulator candidates. Compugen received an upfront payment of $10 million and is eligible to receive over $500 million in potential milestone payments for both checkpoint programs, plus the remaining portion of an additional $30 million of potential milestone payments associated with joint preclinical research for the two programs.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On April 14, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported updated results for a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601) (Filing, 6-K, Oncolytics Biotech, APR 14, 2016, View Source [SID:1234510816]).

The study is being sponsored by the U.S. National Cancer Institute ("NCI"). The update is based on data collected up to January 19, 2016 from the NCI and updates information from previous disclosures by the principal investigator.

Update Highlights

Overall survival ("OS") of control, test, crossover, and combined test and crossover arms

Arm Median OS
(months) 1-year OS
(%) 2-year OS
(%) 3-year OS
(%)
Control (n = 20) 6.57 25.0 0 0
Test (n = 36) 7.33 29.6 17.7 8.87
Crossover (n = 16) 10.97 25.0 12.5 6.25
Combined Test and
Crossover
(n = 52) 8.73 28.1 16.0 8.02
Source: NCI Clinical Trial Summary: Response Information Report

The Company performed an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years. The analysis showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004). At the time of the data cut off (January 19, 2016), there were five survivors on study in the test arm, and one survivor on study in the crossover arm. As a result, the two- and three-year survival for the arms may continue to evolve.

"These data clearly illustrate that patients receiving REOLYSIN, whether in the test arm or crossing over after progressing in the control arm, received a benefit in longer-term overall survival," said Dr. Brad Thompson. "The overall survival findings in this study build on what we saw in our REO 017 study, where the combination of REOLYSIN and gemcitabine, also produced a clear longer-term overall survival benefit, despite having limited impact on progression free survival. This is characteristic of clinical studies where the immune system affects patient outcomes. Based on these combined results, we are currently enrolling pancreatic cancer patients in a study incorporating REOLYSIN plus the checkpoint inhibitor KEYTRUDA to determine the effect of the immune system on patient outcomes."

This was one in a series of randomized Phase 2 studies with REOLYSIN that were designed and sponsored by third parties to test their specific hypotheses, and the Company intends to use these findings to further advance its own clinical program.

Study Design Summary
The study was an open-label, multi-institution, two-arm Phase 2 randomized study of patients with metastatic pancreatic cancer. Patients were randomized to receive either carboplatin, paclitaxel and REOLYSIN (test arm) or carboplatin and paclitaxel alone (control arm). Patients in both arms received treatment every three weeks (21-day cycles) and standard intravenous doses of paclitaxel and carboplatin on day one only. In the test arm, patients also received intravenous REOLYSIN at a dose of 3×1010 TCID50 on days one through five. Tumor response was assessed by computed tomography (CT) scan and conducted every eight weeks. Patients who progressed on carboplatin and paclitaxel (control arm) had REOLYSIN added (crossover arm). If patients experienced significant toxicity related to carboplatin and/or paclitaxel, they could continue with single agent REOLYSIN.

The primary endpoint of the trial is to assess improvement in progression free survival with REOLYSIN, carboplatin and paclitaxel relative to carboplatin and paclitaxel alone in patients with metastatic pancreatic cancer. Secondary endpoints include safety, overall response rate, overall survival, immune factors and to prospectively establish and validate the relationship between Ras mutations in tumor samples and response to REOLYSIN. For this analysis, the control arm is patients receiving carboplatin and paclitaxel alone, the test arm is patients receiving carboplatin, paclitaxel, and REOLYSIN, and the crossover arm is patients initially treated with carboplatin and paclitaxel alone, who progressed and subsequently had REOLYSIN added to their treatment regime.

About Oncolytics Biotech Inc.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On March 21, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported an update for a randomized Phase II clinical trial of its lead product, REOLYSIN, in combination with paclitaxel in patients with ovarian cancer (GOG-0186H) (Filing, 6-K, Oncolytics Biotech, MAR 21, 2016, View Source [SID:1234509813]).

The study is being sponsored by the US National Cancer Institute ("NCI"). The update includes data from a Gynecologic Oncology Group (GOG) study summary report, and follows a presentation made by the principal investigator regarding the study at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, which runs from March 19-22 in San Diego, CA.

Update Highlights

Response Using CA-125 Measurements by Treatment Among all Patients

CA-125 Response Treatment
Paclitaxel Paclitaxel+REOLYSIN Total
Full Response 1 (1.85%) 5 (9.26%) 6
Partial Response 9 (16.67%) 7 (12.96%) 16
Stable Disease 3 (5.56%) 12 (22.22%) 15
Progressive Disease 0 (0.00%) 2 (3.70%) 2
Indeterminate 16 (29.63%) 13 (24.07%) 29
Not Evaluable 25 (46.30%) 15 (27.78%) 40
Total 54 54 108
Source: GOG Study Summary Report

The Company performed an intent-to-treat analysis of tumour response, as assessed by CA-125 antigen levels, which showed statistically significantly higher full response rates and stable disease or better rates in the test arm versus the control arm. The rate of full responses in the test arm was 9.26%, compared with 1.85% in the control arm (p = 0.0196). The rate of stable disease or better in the test arm was 44.44%, compared with 24.08% in the control arm (p = 0.0096). The response rates were defined using a modified Rustin’s criteria. CA-125 levels are commonly used in clinical practice to assess response in ovarian cancer patients.

Response rates as measured by RECIST were performed on patients with measurable disease (n = 68 (of 108)). The proportion responding on the test arm was 17% whereas the proportion responding on the control arm was 20%.

An analysis of progression free survival ("PFS") stratified by measurable disease and platinum-free interval (test arm: n = 54, 43 events (progressions), and control arm: n = 54, 48 events) was performed and demonstrated a median PFS of 4.4 months for the test arm, and 4.3 months for the control arm.

An interim analysis of overall survival ("OS") (test arm: n = 54, 32 events (deaths), and control arm: n = 54, 32 events) was performed and demonstrated a median OS of 12.9 months for the test arm, and 15.0 months for the control arm. The OS was an interim analysis, as 44 (41%) patients out of a total of 108 patients were alive at the time of analysis. Given the number of patients still alive on the test and control arms with current survival less than the median, final median OS results are expected to change.

"This is one of a total of six randomized Phase II studies with REOLYSIN that were designed and sponsored by third parties. The results from these studies will determine clinical targets, endpoints, and study designs for follow on and registration studies conducted by Oncolytics. In the case of this ovarian cancer study, we are pleased that REOLYSIN has demonstrated a statistically significant reduction in tumour burden in ovarian cancer patients as measured by CA-125 levels," said Dr. Brad Thompson, President and CEO of Oncolytics. "This adds to our results in other indications that have shown improvement in tumour responses. In order to further our understanding of how REOLYSIN interacts with the immune system, we hope, in conjunction with the principal investigator, to analyze the PD-1 and CD8+ T lymphocyte levels of patients on entry and correlate these with overall survival and progression free survival."

Study Design Summary
The study (GOG-0186H) is a randomized Phase 2 clinical trial of paclitaxel versus paclitaxel plus REOLYSIN in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer. Patients received paclitaxel on days 1, 8 and 15 of each 28-day treatment cycle, with either REOLYSIN (test arm) or placebo (control arm) administered on days 1 through 5. One hundred and eight patients were randomized (1:1, 54 patients in the control arm, 54 patients in the test arm). The NCI study did not stratify on entry according to PD-L1 levels or infiltrating CD8+ T lymphocyte levels, nor were either of those levels measured post-treatment. However, pre-treatment tumour biopsies were taken from the majority of patients. The primary objectives are PFS and toxicity. The secondary objectives are median overall OS by treatment group, median PFS by treatment group, and tumour response as measured by RECIST criteria and CA-125 antigen levels. The study was sponsored by the US National Cancer Institute and conducted by the former GOG, now incorporated into NRG Oncology.

Analysis of the Relationship between Ovarian Cancer Patients’ Immune Status upon Study Entry and Survival
In order to further understand the effects of a patient’s immune status prior to treatment with REOLYSIN on PFS and OS, the principal investigator and the Company are working to quantify the levels of PD-L1 and CD8+ T lymphocytes in tumours at the time of enrolment. The Company wishes to conduct this analysis to be able to determine what component of PFS and OS is attributable to PD-L1 and CD8+ T lymphocyte levels on study entry, and what is attributable to REOLYSIN therapy.

The basis for this analysis is Hamanishi et al. (2007) (Programmed cell death 1 ligand 1 and tumour-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. PNAS 104(9):3360-3365), which found that the overall survival rates and progression free survival rates for ovarian cancer patients with high PD-L1 expression on entry were statistically significantly worse than those of patients with low PD-L1 expression on entry. They also noted that the overall survival rates and progression free survival rates for ovarian cancer patients with high intraepithelial CD8+ T lymphocyte counts on entry were statistically significantly better than those of patients with low CD8+ T lymphocyte counts.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On March 10, 2016 Trillium Therapeutics Inc. (Nasdaq:TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has entered into a collaboration agreement with University Health Network and the Hospital for Sick Children to fund and undertake a research program entitled "SIRPaFc: Translating Genomics Research Into a Novel Cancer Immunotherapy (Filing, 6-K, Trillium Therapeutics, MAR 10, 2016, View Source [SID:1234509472]).

" Importantly, this project has been approved for funding by Genome Canada under the Genomic Applications Partnership Program (GAPP). In addition, The Ontario Ministry of Research and Innovation is supporting the project with a grant matching Genome Canada’s contribution, providing the collaboration with 3-year budget of approximately $3.4 million.

"Predictive prognostic or pharmacodynamic biomarkers are critical for the development of new therapeutic cancer agents, especially those targeting the immune system," commented Trillium’s Chief Executive Officer, Dr. Niclas Stiernholm. "This new matching funding will allow us to substantially expand our translational research efforts, focusing primarily on acute myeloid leukemia, which is ultimately likely to enhance our clinical programs."

Trillium’s lead program, TTI-621, is currently being tested as a single-agent in patients with relapsed or refractory hematologic malignancies. During the dose escalation phase set to enroll up to 36 subjects, we intend to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics to determine the optimal dose for subsequent enrollment in the expansion phase. In this second part of the trial, we intend to explore the safety and preliminary antitumor activity of TTI-621 at the optimal dose identified in the escalation phase in 12–15 subjects per hematologic malignancy type: indolent B-cell lymphoma, aggressive B-cell lymphoma, T-cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On February 3, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has initiated dosing in its Phase 1 clinical trial of TTI-621 (SIRPaFc), a novel checkpoint inhibitor of the innate immune system, in relapsed or refractory hematologic malignancies (Filing, 6-K, Trillium Therapeutics, FEB 3, 2016, View Source [SID:1234508956]).

TTI-621 is an antibody-like fusion protein that blocks the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPa on macrophages and delivers a "do not eat" signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-621 has anti-tumor activity across a range of hematologic tumors.

"This is an exciting time for Trillium as we now emerge as a clinical stage oncology company evaluating a novel immune checkpoint inhibitor," commented Dr. Eric Sievers, Trillium’s Chief Medical Officer. "At a fundamental level, a cancer patient’s ineffective immune response allows the tumor to propagate unchecked. By blocking CD47, a key cell-surface protein that inhibits phagocytosis, we hope to summon a durable anti-tumor response in patients who are beset by cancer."

The two-part clinical trial is designed as a multi-center, open-label Phase 1a/1b trial, evaluating TTI-621 as a single-agent in patients with relapsed or refractory hematologic malignancies. During the dose escalation phase set to enroll up to 36 subjects, the safety, tolerability, pharmacokinetics and pharmacodynamics will be characterized to determine the optimal dose for subsequent enrollment in the expansion phase. In this second part of the trial, the safety and preliminary antitumor activity of TTI-621 at the optimal dose identified in the escalation phase will be explored in 12–15 subjects per hematologic malignancy type: indolent B-cell lymphoma, aggressive B-cell lymphoma, T-cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Trillium has proposed five trial sites including the Mayo Clinic, Columbia University Medical Center, City of Hope National Medical Center, The Colorado Blood Cancer Institute, and Tennessee Oncology.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On January 19, 2016 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) reported that the first patients have been treated in a Phase 1b study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma (REO 024) (Filing, 6-K, Oncolytics Biotech, JAN 19, 2016, View Source [SID:1234508813]).

"Checkpoint inhibitors are an emerging class of therapeutic that allows the immune system to better recognize and target tumors, and the goal of this study is to assess their potential in combination with REOLYSIN," said Dr, Brad Thompson, President and CEO of Oncolytics. "Based on our early research it is possible that checkpoint inhibitors could support improved survival outcomes for patients treated with oncolytic viral therapy."

The study is enrolling patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase Ib trial designed to determine the safety and dose-limiting toxicities of REOLYSIN and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician’s preference) in combination with pembrolizumab. Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment treatment biopsies and blood-based immune markers. Following an initial six to nine patient safety run-in, up to an additional 15 patients may be enrolled for further evaluation of safety and efficacy.

About Pancreatic Cancer
The American Cancer Society estimates that 53,070 Americans will be diagnosed with pancreatic cancer and an estimated 41,780 Americans will die from the disease in 2016. The prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year survival rate for all stages combined is approximately seven percent.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On January 11, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction reported its anticipated clinical milestones for calendar year 2016 (Filing, 6-K, Can-Fite BioPharma, JAN 11, 2016, View Source [SID:1234508712]).

Q1 2016 Rheumatoid Arthritis Phase III EMA Submission for CF101

In the first quarter of 2016, Can-Fite plans to file its Phase III protocol with the European Medicines Agency (EMA) for CF101 in the treatment of rheumatoid arthritis. Initiation of patient enrollment is anticipated in the second or third quarter of 2016. Can-Fite recently filed a trial protocol with the institutional review board (IRB) of Barzilai Medical Center in Israel, one of the planned clinical sites for the international trial to be conducted in Israel, Europe, Canada and the U.S. The Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional drugs. The study will have three arms, a 1 mg CF101 dose, a 2 mg CF101 dose, and placebo, given orally twice daily in the form of tablets. Approximately 456 patients are expected to be enrolled in the study. According to Visiongain, the global rheumatoid arthritis market is forecasted to reach $38.5 billion by 2017.

H1 2016 Psoriasis Phase III EMA Submission for CF101

Can-Fite is now completing the design of its Phase III study protocol for CF101 in the treatment of psoriasis which the Company plans to file with the EMA in the first half of 2016 and anticipates initiating patient enrolment in the fourth quarter of 2016. The Company previously reported positive data from further analysis of its completed Phase II/III study that suggests CF101 as a potential systemic therapy for patients with moderate-severe psoriasis, this despite the study not meeting its primary endpoint. The psoriasis drug market is forecast to grow to $8.9 billion by 2018, according to estimates of Visiongain.

H1 2016 Liver Cancer Phase II Completion of Patient Enrollment for CF102

Can-Fite anticipates completing enrollment of approximately 78 patients during the first half of 2016, in its Phase II trial for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The randomized, double-blind, placebo controlled trial is being conducted in the U.S., Europe and Israel. CF102 received Fast Track Designation from the U.S. FDA as a second line treatment for HCC in patients who have previously received Nexavar (sorafenib). The drug has Orphan Drug Status in the U.S. and in Europe for the treatment of HCC. CF102 is approved for Compassionate Use for liver cancer by Israel’s Ministry of Health. According to Global Industry Analysts the global market for liver cancer was projected to exceed $2 billion by 2015.

Q2 2016 NASH Phase II Study Protocol Submission to IRBs for CF102

Can-Fite plans to file a Phase II study protocol with IRBs for its first human clinical study of CF102 in the treatment of non-alcoholic steatohepatitis (NASH), a new indication identified by the Company for its liver cancer drug. In November 2015, Can-Fite announced compelling pre-clinical data on CF102 in the treatment of NASH, a disease for which no FDA approved therapies currently exist. By 2025, Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size.

Q2 2016 Glaucoma Phase II Data Report for CF101

Can-Fite expects data from its Phase II study of CF101 in the treatment of glaucoma to be reported during the second quarter. Enrollment of 88 patients was recently completed in the study which is being conducted in two European countries and Israel by Can-Fite’s subsidiary OphthaliX Inc. The treatment market for glaucoma in the seven major markets is estimated to reach approximately $3 billion by 2023 according to GlobalData and CF101 is one of only a few oral drugs being developed for glaucoma. The market currently consists primarily of generic eye drop drugs. Oral administration is expected to improve patient compliance.

Q4 2016 Sexual Dysfunction IND/Phase I Study Filing with U.S. FDA for CF602

Can-Fite has an active pre-clinical development program for its next generation drug CF602 in the treatment of sexual dysfunction and is currently developing a working plan to file an investigational new drug (IND) application with the U.S. FDA for a Phase I study during the fourth quarter of 2016. Can-Fite received positive pre-clinical data from experimental animal models demonstrating that CF602 improved sexual dysfunction in a dose dependent manner. GlobalData estimates the value of the erectile dysfunction therapeutic market to be approximately $2.6 billion by 2018 with few drugs on the market which includes Viagra, Cialis and Levitra.

"We are very encouraged by the clinical and preclinical data from each of our drugs to date which indicate their efficacy across six major indications. We are moving towards initiating pivotal Phase III trials in two autoimmune diseases. As we look forward to announcing Phase II results for glaucoma and completing Phase II enrollment for liver cancer, we are preparing to enter human clinical studies in two new indications, NASH and sexual dysfunction. We expect 2016 will be a very active year," stated Can-Fite CEO Dr. Pnina Fishman.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On January 6, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, reported the signing of an agreement with Mirna Therapeutics (NASDAQ: MIRN), for a worldwide sublicense to Rosetta’s patents related to therapeutic uses of certain microRNA technologies (Filing, 6-K, Rosetta Genomics, JAN 6, 2016, View Source [SID:1234508680]).

The agreement includes an exclusive sublicense related to Mirna’s MRX34 product candidate, a mimic of naturally occurring microRNA-34 being evaluated in clinical studies for a variety of cancers.

Under the terms of the agreement, Rosetta Genomics will receive an upfront payment of $1.6 million from Mirna, and is eligible for low single-digit royalties on product sales and potential milestone payments and sublicense fees. The sublicensed patents are jointly owned by YEDA Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science, and Rosetta Genomics. As such, YEDA is entitled to a portion of these and other proceeds Rosetta may receive under the agreement with Mirna.

"We are pleased to execute this agreement with Mirna as it underscores the value of our leading intellectual property position in microRNA technology and represents a new avenue through which we can create value by leveraging our extensive patent portfolio," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We look forward to Mirna pursuing the potential of microRNAs as new and effective cancer therapeutics and believe microRNAs can play an important role in developing treatments for different cancers."

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On November 20, 2015 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) (Aptose or the Company), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported that the Food and Drug Administration (FDA), following a voluntary suspension of dosing by the Company and discussions with the Company, placed the Phase Ib clinical trial of APTO-253 in patients with hematologic cancers on clinical hold (Filing, 6-K, Aptose Biosciences, NOV 20, 2015, View Source [SID:1234508301]). This hold is intended to ensure patient safety on the trial and to ensure manufacturing and dosing procedures are consistent with the appropriate documented quality standards.

The voluntary suspension of dosing by the Company was initiated as a result of a planned preliminary review, which was accelerated to evaluate manufacturing processes and procedures upon the report of an operational difficulty with an IV infusion pump at a clinical site. The pump experienced back pressure during IV patient dosing at the point of the filter. Further review discovered preliminary concerns regarding the documentation records of the manufacturing procedures of the drug product associated with APTO-253.

The Company stated that a complete safety review of all patient files had been completed prior to initial discovery of the manufacturing documentation irregularities, and there have been no drug-related serious adverse events (SAEs) reported. The observed pharmacokinetic levels in the patients treated were within the expected range.

"We are disappointed by these events and have engaged an independent third party review. Importantly, this finding does not undermine the positive safety profile that APTO-253 has demonstrated in clinical development, and we remain confident in its potential as a promising therapeutic option for patients with acute myeloid leukemia and other hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and CEO. "While we expect some delay in the clinical trial, we are committed to ensuring that upon re-initiation of clinical dosing the drug product is of the highest standards. We plan to provide updated timeline guidance as soon as practical."

Key Points:

An internal review identified potential documentation irregularities and the Company voluntarily and immediately suspended dosing of patients out of an abundance of caution to ensure safety.

Aptose currently possesses a sufficient supply of API to create fresh batches of drug product for the resumption of clinical dosing upon FDA approval and guidance.

New contract manufacture organizations have been identified to manufacture fresh batches of cGMP clinical supply upon completion of investigation and in coordination with FDA guidance.

Overall effect to the Phase Ib trial timeline is expected to be partially mitigated by initiation of the new trial sites and updated timeline will be reported as soon as determined.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On November 13, 2015 AstraZeneca reported that the US Food and Drug Administration (FDA) has approved TAGRISSO (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy (Filing, 6-K, AstraZeneca, NOV 13, 2015, View Source [SID:1234508241]).

AZD9291 is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR).

AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options.

Pasi A Jänne MD, PhD, Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, Scientific Director, Belfer Center for Applied Cancer Science and Professor of Medicine, Harvard Medical School, said: "In the AURA clinical studies, AZD9291 has demonstrated compelling early efficacy and tolerability in patients with EGFRm T790M metastatic non-small cell lung cancer. This treatment has the potential to become the standard of care for patients living with EGFRm T790M non-small cell lung cancer. The accelerated approval of AZD9291 highlights its clinical promise for a targeted group of patients and gives healthcare providers an important new option."

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "The FDA approval of TAGRISSO marks an important milestone for lung cancer patients who urgently need new treatment options. We have built on our heritage in this area and acted on the breakthrough clinical evidence to ensure this next-generation medicine reaches patients in record time. As we advance our comprehensive lung cancer portfolio, we have the opportunity to treat greater numbers of patients across all stages of this disease through precision medicines, immunotherapies and novel combinations."

AstraZeneca has collaborated with Roche to develop the cobas EGFR Mutation Test v2 as the companion diagnostic for AZD9291. The cobas EGFR Mutation Test v2 is intended to identify a range of EGFR mutations in patients with non-small cell lung cancer, including T790M.

AZD9291 was granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval status by the FDA. In Europe and Japan, AZD9291 was granted Accelerated Assessment and Priority Review status respectively. Interactions with regulatory authorities in the rest of the world are ongoing.

The FDA approval of AZD9291 is based on data from the two AURA Phase II studies (AURA extension and AURA2) which demonstrated efficacy in 411 EGFRm T790M NSCLC patients that had progressed on or after an EGFR TKI. In those trials, overall objective response rate ((ORR) a measurement of tumor shrinkage) was 59% (95% CI: 54% to 64%). In a supportive Phase I study in 63 patients, ORR was 51% and median duration of response was 12.4 months.

The AZD9291 tolerability profile showed that no individual severe grade 3+ adverse events occurred at ≥ 3.5%.The most common adverse events were generally mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4), and nail toxicity (25% all grades; 0% Grade 3/4). There are no contraindications for AZD9291. Warnings and precautions include interstitial lung disease, QT interval prolongation, cardiomyopathy and embryofoetal toxicity.

AZD9291 Development Programme
AZD9291 is being studied in the confirmatory trial, AURA3, an open label, randomised Phase III study designed to assess the efficacy and safety of AZD9291 versus platinum-based doublet chemotherapy in patients with EGFR T790M positive, locally advanced, or metastatic NSCLC who have progressed following prior therapy with an EGFR-TKI. AZD9291 is also being investigated in the adjuvant setting and in the metastatic first-line setting, including in patients with brain metastases, as well as in combination with other compounds.

NOTES TO EDITORS

About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, more than breast, prostate and colorectal cancers combined. Lung cancer has a five-year survival rate that is less than 20%. Approximately 85% of all lung cancers in the US are NSCLC; 10% to 15% of these are EGFR mutation-positive. Approximately two-thirds of patients treated with EGFR TKI therapy will acquire resistance related to the T790M mutation.

About AZD9291
AZD9291 80mg once-daily tablet is the first medicine indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Non-clinical in vitro studies have demonstrated that AZD9291 has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines with significantly less activity against EGFR in wild-type cell lines.

Osimertinib has recently been published by the World Health Organisation (WHO) as the proposed International Non-proprietary Name (INN) for AZD9291, and may become formally adopted during November 2015. In the US, the American Medical Association accepted osimertinib as the United States Adopted Name (USAN).

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On September 30, 2015 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has completed the manufacture of clinical-grade drug product, concluded a comprehensive IND-enabling non-clinical safety assessment program, and has proposed a design for its first-in-human clinical trial with TTI-621 (SIRPaFc) (Filing, 6-K, Trillium Therapeutics, SEP 30, 2015, View Source [SID:1234507616]).

The Company plans to conduct a Phase I trial with a dose-escalation stage that will enroll patients with relapsed or refractory lymphoma who are transfusion independent with relatively normal baseline blood counts, thus better enabling characterization of potential changes in hematologic parameters that could occur upon CD47 blockade. Once the optimal dose and schedule of TTI-621 administration have been established, the Company expects to study safety and anti-tumor activity in a variety of expansion cohorts of patients. These will include patients with acute myeloid leukemia, myelodysplastic syndrome, as well as several other advanced hematologic malignancies.

"The Investigational New Drug application was submitted as planned and we have secured enthusiastic commitments from multiple investigators at key cancer treatment centers in the United States," commented Dr. Eric Sievers, Trillium’s Chief Medical Officer. "We have been gratified by considerable interest from the oncology community to evaluate a novel checkpoint inhibitor of the innate immune system."

Additional in vitro and in vivo preclinical studies have been completed. These have demonstrated that TTI-621 has potent anti-tumor activity across a range of hematological tumors, and have provided guidance for the expansion cohorts in the first-in-human clinical study. The Company expects to present some of these data at an upcoming scientific meeting.

The Company also continues to explore the therapeutic potential of TTI-621 in a variety of solid tumor models, both as monotherapy and in combination with other therapeutic agents. Based on the results of these studies, as well as on third party data reported in the literature, additional clinical trials will be designed.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 8, 2015 Compugen reported it will disclose an additional novel immune checkpoint target candidate, CGEN-15029, and initial experimental validation data for this candidate at its Analyst and Investor Day in New York City today (Filing, 6-K, Compugen, JUN 8, 2015, View Source [SID:1234505375]).

In addition, the Company will disclose a new computational infrastructure, LINKS, which is designed for the comprehensive and comparative assessment of drug targets. Initial usage of this new infrastructure resulted in the selection of five target candidates, including CGEN-15029, as the highest priority immune checkpoint target programs to be advanced by the Company.

A live webcast of the Analyst and Investor Day event will be available on the investor section of Compugen’s website beginning at 9:00 a.m. ET today. An archived replay of the webcast will be available on the website for 30 days after the event.

Dr. Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "We are very excited to disclose the initial validation of this additional novel immune checkpoint candidate, along with identification of its binding partner. These initial biological studies provide a better understanding of the mechanism of action of this candidate and should support a clear path to therapeutic antibody discovery and development."

Dr. Cohen-Dayag continued, "In addition, the recent development and application of our LINKS infrastructure provided new insights into the therapeutic potential of our novel target candidates and further enhanced our capabilities. Establishing our unique target discovery capabilities required many years of pioneering multi-disciplinary research, however, once established, the in silico discovery of multiple B7/CD28-like immune checkpoint candidates took only several months. We believe that further validation and clinical advancement of the multiple target candidates resulting from the initial usage of our discovery infrastructure will continue to demonstrate a level of predictive accuracy that is unprecedented in pharmaceutical research in terms of the quality and quantity of the candidates."

CGEN-15029 is one of eleven novel B7/CD28-like immune checkpoint candidates discovered by Compugen. Initial validation studies show that expression of CGEN-15029 in T-cells inhibits their activation by melanoma cells, consistent with an immune suppressive role of the target in the tumor microenvironment. The target possesses signature immune-checkpoint receptor characteristics, including expression in relevant subsets of T- and NK-cells, with particularly high expression in lymphocytes that populate the tumor microenvironment (known as tumor infiltrating lymphocytes or TILs). A binding partner for CGEN-15029 has also been identified, which enables a clear path towards selection of inhibitory antibodies and their therapeutic development.

The LINKS infrastructure is a novel, proprietary, in silico platform designed to allow comprehensive characterization and differentiation of drug target candidates. LINKS was designed to integrate and analyze extremely large amounts of patients’ disease and clinical data to associate novel drug targets with specific disease conditions, clinical attributes and disease-associated mechanisms of action. During the past several months, this new infrastructure was applied to analyze Compugen’s pipeline of immune checkpoint target candidates and to compare them to one another as well as to differentiate them from known immune checkpoints. This analysis included immune subpopulations, regulatory mechanisms and cancer-specific immune signatures, and enabled Compugen to compare and differentiate its large portfolio of novel immune checkpoint programs, other than the two that are subject to a collaboration agreement with a pharma partner. Based on this assessment, as well as experimental data for the target candidates, Compugen selected five target programs as highest priority, including CGEN-15029, representing various aspects of cellular immune biology and therefore potentially addressing multiple therapeutic applications and indications.

About Immune Checkpoints
Immune checkpoints are inhibitory receptors and their ligands, which are crucial for the maintenance of self-tolerance (that is, the prevention of autoimmunity) and for the protection of tissues from damage when the immune system is responding to pathogenic infection or other injuries. These immune checkpoints, which are "hijacked" by tumors to block the ability of the immune system to destroy the tumor (immune resistance), have emerged as promising targets for cancer immunotherapy, and have shifted the treatment paradigms for several major cancer types. Therapeutic blockade of immune checkpoints boost anti-tumor immunity, enabling the patient’s immune system to recognize and attack the tumor cells, and mount durable anti-tumor responses and tumor destruction. Although to date the blockade of immune checkpoints has proven effective for only a minority of patients in a limited, but growing number of cancer types, it has provided impressive clinical benefits, enabling long-term survival, even for end-stage patients, and is transforming cancer therapeutics.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 2, 2015 Weill Cornell Medical College and Cellectis reported they have entered into a strategic translational research alliance to accelerate the development of a targeted immunotherapy for patients with acute myelogenous leukemia (AML), a deadly blood cancer (Filing, 6-K, Cellectis, JUN 2, 2015, View Source [SID:1234505216]). The alliance will foster the development of Cellectis’ lead product candidate in AML, called UCART123.

The collaboration combines Weill Cornell’s broad expertise and resources in translational stem cell science and developmental therapeutics with Cellectis’ work in development and manufacturing of gene edited CAR-T cell product candidates, a special kind of immune cell that includes an antibody-derived receptor.

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The research will be led by co-principal investigators Dr. Gail J. Roboz, director of the leukemia program and an associate professor of medicine at Weill Cornell, and Dr. Monica Guzman, an assistant professor of pharmacology in medicine at Weill Cornell. Dr. Roboz is an internationally recognized leader in the field of acute leukemia and will design and implement clinical testing of UCART123 in patients with AML. Dr. Guzman is a renowned leukemia stem cell biologist who specializes in preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.

The alliance will seek to accelerate the development of Cellectis’ UCART123 in AML. Cellectis’ proprietary allogeneic CAR T-cell platform utilizes T-cells (immune cells) from healthy donors. The T-cells are engineered with a Chimeric Antigen Receptor (CAR), which enables them to detect specific proteins (antigens) expressed on malignant tumors. Large numbers of allogeneic CAR-modified T-cells are grown in the laboratory and then infused into a patient. The enhanced cells are designed to recognize and attack stem cells harboring the CD123 antigen, which is present on AML blast and stem cells. To enhance safety and minimize toxicity for patients, the company’s gene-editing process features customized control properties that seek to prevent the T cells from inappropriately attacking healthy tissues. Cellectis hopes to develop a cost-effective, "off-the-shelf" allogeneic CAR T-cell product, designed for efficient storage and distribution to patients around the globe.

Cellectis in April opened a new research and development facility in New York City, located in close proximity to the Weill Cornell campus.

"We are pleased to collaborate with Cellectis to develop and advance next-generation treatments for patients with this devastating form of leukemia," said Dr. Laurie H. Glimcher, the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College. "Cellectis’ proficiency in genome engineering and our complementary expertise in translational research will help us realize our common goal of improving human health in New York and around the globe."

"CAR-T cells have shown remarkable promise in the treatment of acute lymphoblastic leukemia," Dr. Roboz said. "Cellectis has interesting preclinical data on UCART123 and our alliance will seek to build on these findings to better understand the clinical potential of this therapy. Our patients are anxiously awaiting the start of clinical trials."

"Weill Cornell offers unsurpassed expertise in translational research, with a wealth of leading-edge technologies and resources to help advance our pipeline of unique CAR-T product candidates," said Dr. Mathieu Simon, executive vice president and chief operating officer at Cellectis. "We are excited by the prospect of working with Dr. Roboz, Dr. Guzman and other premier investigators in leukemia stem cell research."

Weill Cornell’s Office of BioPharma Alliances and Research Collaborations negotiated the three-year alliance. In the program’s pre-clinical phase, Weill Cornell researchers will perform multiple analyses, including data mining of primary AML samples, immune profiling of AML patients and in vitro evaluation of allogeneically derived anti-CD123 CAR-T cells. In the alliance’s second phase, Weill Cornell and Cellectis will jointly develop protocols to facilitate early-phase testing, including phase 1 clinical trials.

"Cellectis believes the CAR-T platform has the potential to transform the way cancer patients are treated. We are confident that our broad, cross-discipline collaboration with Weill Cornell will foster creativity and speed in drug development for the benefit of clinicians and patients living with AML," said Dr. André Choulika, chief executive officer of Cellectis.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On May 11, 2015 Can-Fite BioPharma reported it recently received clearance from the European Medicines Agency to commence dosing patients in Europe in its global Phase II trial for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Filing, 6-K, Can-Fite BioPharma, MAY 11, 2015, View Source [SID:1234504176]). Shortly after receiving approval, the first patient in Europe was dosed.

The Phase II randomized, double-blind, placebo controlled trial is being conducted in the U.S., Israel, and Europe. The trial protocol has been approved by regulatory agencies in all three regions and patients have been dosed in Israel and Europe. The study plans to enroll 78 HCC patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

CF102 has already been granted Orphan Drug Status for the treatment of HCC by the FDA. CF102 is also approved for Compassionate Use by Israel’s Ministry of Health.

"There are no treatment options for patients with advanced liver cancer who have not benefitted from treatment with Nexavar, the only FDA-approved drug on the market for this indication. As patients, who have virtually no other options, are being dosed with CF102, it is certainly our hope that the drug will be of benefit to them," stated Can-Fite CEO Dr. Pnina Fishman.

According to Global Industry Analysts, the global market for liver cancer is projected to exceed $2 billion in 2015. Based on data reported in industry publications, Nexavar annual sales were approximately $1 billion in 2012 and 2013.

About CF102

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On July 7, 2014 Compugen reported that it has achieved the initial milestone in the cancer immunotherapy collaboration it entered last year with Bayer HealthCare (Bayer) (Filing 6-K , Compugen, JUL 7, 2014, View Source [SID:1234500619]). The collaboration provides for the development and commercialization of therapeutic antibodies against two checkpoint protein candidates discovered by Compugen. The milestone being announced today relates to the first preclinical milestone for one of two checkpoint protein candidates for which Compugen will receive a $1.2 million payment out of the $30 million potential milestone payments associated with joint preclinical research for the two programs.

Dr. Anat Cohen Dayag, Compugen’s President and CEO, stated, “We are very pleased by the achievement of this initial drug development milestone for one of the two programs in our collaboration with Bayer. After investing more than a decade of extensive multidisciplinary research in establishing our broadly applicable predictive discovery infrastructure, we selected the area of checkpoint-based cancer immunotherapy as our first focused discovery effort. Therefore, it is extremely satisfying to see our growing competitive position, in terms of both advancement of our therapeutic programs in immuno-oncology and continuing discoveries of novel targets in this exciting area, which is increasingly being viewed as a potential major breakthrough in cancer treatment.”

About the Bayer HealthCare/Compugen Collaboration and License Agreement
The collaboration and license agreement provides the framework for the research, development, and commercialization of antibody-based therapeutics for cancer immunotherapy against two novel Compugen-discovered immune checkpoint regulators. Under the terms of the agreement, Bayer and Compugen are jointly pursuing a preclinical research program for each of the two candidates. Subsequently, Bayer will have full control over further development and have worldwide commercialization rights for potential cancer therapeutics.

Under the terms of the agreement, Compugen has received an upfront payment of $10 million and is eligible to receive over $500 million in potential milestone payments for both checkpoint programs, plus an additional $30 million of potential milestone payments associated with joint preclinical research for the two programs. Compugen is also eligible to receive royalties on global net sales from any resulting products under the collaboration.

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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

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