On July 14, 2015 ProMIS Neurosciences Inc. ("ProMIS Neurosciences" or, the "Company") (formerly, Amorfix Life Sciences Ltd.), reported that it has effected its name change to ProMIS Neurosciences Inc. on July 8, 2015 and shares will begin trading under the new name on July 14, 2015 (Press release, ProMIS Neurosciences, JUL 14, 2015, View Source [SID:1234510740]).
TORONTO, Ontario – July 14, 2015 – the common shares of the Company will commence trading on the Toronto Stock Exchange under the new name "ProMIS Neurosciences Inc." and the new stock symbol "PMN" at the opening of trading on July 14 2015. The new CUSIP number is 74346M109 and the new ISIN number is CA 74346M1095.

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On July 13, 2015 Roche reported that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) shrank tumours (objective response rate, ORR, the primary end point of this Phase II study) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment (second-line or later) (Press release, Hoffmann-La Roche , JUL 13, 2015, View Source [SID:1234506320]).

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High amounts of PD-L1 (Programmed Death Ligand-1) expression by a person’s cancer correlated with increased response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab.

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"We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study because minimal progress has been made in advanced bladder cancer for nearly 30 years," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible."

Last year, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for atezolizumab in people whose metastatic bladder cancer expressed PD-L1. This designation is designed to expedite the development and review of medicines intended to treat serious diseases.

About IMvigor 210
IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or metastatic UBC, regardless of PD-L1 expression. People in the study were enrolled into one of two cohorts. Cohort 1 consisted of people who had received no prior therapies for locally advanced or metastatic UBC, but who were ineligible for first-line cisplatin-based therapy; results from this cohort are not yet mature. Cohort 2, for which results were announced today, included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen (second-line or later). People received a 1200-milligram intravenous dose of atezolizumab on day one of 21-day cycles until progressive disease (Cohort 1) or loss of clinical benefit (Cohort 2). The primary endpoint of the study was ORR. Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety. PD-L1 expression was assessed using an investigational immunohistochemistry (IHC) test being developed by Roche Diagnostics.
In addition to the IMvigor 210 study, Roche has an ongoing randomised Phase III study, IMvigor 211, comparing atezolizumab with standard-of-care chemotherapy in people who have relapsed UBC, and a planned Phase III study, IMvigor 010, that will evaluate atezolizumab compared with observation in people with early-stage muscle-invasive bladder cancer who are selected for PD-L1 expression and are at risk for recurrence (adjuvant). All studies include the evaluation of a companion test developed by Roche Diagnostics to determine PD-L1 status.

About metastatic urothelial bladder cancer
Metastatic urothelial bladder cancer is associated with a poor prognosis and limited treatment options. It is a disease that has seen no major advancements for nearly 30 years. Bladder cancer is the ninth most common cancer worldwide, with 430,000 new cases diagnosed in 2012, and it results in approximately 145,000 deaths globally each year. Men are three times more likely to suffer from bladder cancer compared with women and it is also three times more common in developed countries than in less developed countries.

About atezolizumab
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. Atezolizumab is designed to target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.
All studies of atezolizumab include the evaluation of an investigational IHC test that uses the antibody SP142 to measure PD-L1 expression on both tumour cells and infiltrating immune cells. The goal of PD-L1 as a biomarker is to identify those people most likely to benefit when treated with atezolizumab alone, and to determine which people may benefit most from a combination of atezolizumab and another medicine. There are 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer.

On July 13, 2015 AstraZeneca today reported that the US Food and Drug Administration (FDA) has approved IRESSA (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test (Press release, AstraZeneca, JUL 13, 2015, View Source [SID:1234506348]).

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IRESSA is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the growth and survival of cancer cells. IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive NSCLC.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: "The approval of IRESSA provides physicians and patients in the US with a new choice of first-line treatment for metastatic non-small cell lung cancer. AstraZeneca is at the forefront of research into targeted therapies for EGFR mutated lung cancer and is committed to improving the outlook for patients at all stages of the disease."

AstraZeneca has partnered with QIAGEN to provide the therascreen EGFR companion diagnostic test for IRESSA in the US. The test rapidly identifies EGFR mutation status through a tumour tissue sample, in order to guide the use of IRESSA in the treatment of patients with metastatic NSCLC.

The FDA approval of IRESSA is based on data from the Phase IV IFUM1 (IRESSA Follow-Up Measure) study, assessing IRESSA as a first-line treatment for Caucasian patients with locally advanced or metastatic EGFR mutation-positive NSCLC. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial.

IRESSA is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC. The safety profile of IRESSA is well established through a large, global clinical programme and extensive real world evidence. The most commonly reported adverse events for IRESSA are diarrhoea and skin reactions including rash, acne, dry skin and pruritus.

AstraZeneca is also studying IRESSA in combination with other investigational medicines, including the company’s anti-PD-L1 monoclonal antibody, durvalumab (MEDI4736) to assess its potential as a combination treatment for a broader range of lung cancer patients.

On July 13, 2015 CRT reported it has been highlighted in the Dowling Review of Business-University Research Collaborations (Press release, Cancer Research Technology, JUL 13, 2015, View Source [SID1234523515]). The report states:

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A good example [for TTOs] is provided by Cancer Research Technology (CRT), which works in partnership with Cancer Research UK to identify innovative scientific and business solutions to unmet needs in cancer, embodied in the vision ‘Advancing Discoveries to Beat Cancer’. CRT’s development and commercialisation activities are focused on driving delivery of the new Cancer Research UK research strategy, and this is also reflected in the metrics used to measure CRT’s performance. While CRT may not be a typical TTO, there is no reason why the principles underpinning its approach should not be more widely applicable. It is also worth noting that TTOs should measure their success over suitably long timescales: focusing on near-term results can drive behaviours that are counterproductive over the timescales that matter.

On July 13, 2015 OncoGenex Pharmaceuticals reported that its Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC) (Press release, OncoGenex Pharmaceuticals, JUL 13, 2015, View Source [SID:1234506323]). This decision was based upon completion of the second and final planned interim futility analysis.

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"Passing this important milestone strengthens our belief in custirsen and its potential to provide clinical benefit in this patient population with advanced disease and limited treatment options," said Scott Cormack, President and CEO of OncoGenex. "While the ENSPIRIT results remain blinded, this news is particularly exciting following the protocol amendment, which set a high bar for continuing the trial."

Two interim analyses were originally planned to evaluate whether to stop the trial for futility. OncoGenex filed an amendment with the U.S. Food and Drug Administration amending the statistical design and analysis plan that included a more rigorous and expedient evaluation of the potential survival benefit associated with custirsen in NSCLC. Based on current enrollment, initial ENSPIRIT results could be available in the second half of 2016.

"While advancements have been made for NSCLC patients with specific mutations and biomarkers, treatment resistance continues to be a challenge and combination chemotherapy remains the therapeutic backbone for the majority of patients with lung cancer," said Cindy Jacobs, PhD, MD, Chief Medical Officer and Executive Vice President of OncoGenex. "As we continue to gain a better understanding of the patients most likely to benefit from custirsen, we look forward to the results of our two Phase 3 trials in the lung and prostate cancer settings."

Recent findings from a retrospective analysis of data from the Phase 3 SYNERGY trial showed a benefit with custirsen therapy when added to first-line docetaxel chemotherapy in men with metastatic castrate-resistant prostate cancer (CRPC) who had a poor prognosis. The analysis showed that over 40 percent of men in the trial had at least 2 of the 5 common risk factors for poor prognosis. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone. Subject to finalizing the pending protocol amendment, timing for the final analysis of the poor prognosis subpopulation in the Phase 3 AFFINITY trial is projected to occur by the end of 2015, while the final analysis for the intent-to-treat population is projected to occur in the second half of 2016.

About the Phase 3 ENSPIRIT Trial
The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate custirsen for the treatment of advanced or metastatic NSCLC in 700 patients who have progressed after initial chemotherapy treatment, with a hypothesized hazard ratio (HR) of 0.75 and a critical HR of 0.84. The trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients. The trial is expected to enroll patients at approximately 50 sites globally. OncoGenex has filed an amendment with the FDA and regulatory agencies in all countries where it is the sponsor. The company will file in two remaining countries as it becomes the sponsor. For more information on the ENSPIRIT trial, please visit View Source

About Custirsen
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.

Custirsen has Fast Track designation by the U.S. Food and Drug Administration for NSCLC and metastatic CRPC.