On September 24, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported three poster presentations that will be featured at the 40th European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting being held Sept. 25 to 29, 2015 in Vienna, Austria (Press release, Myriad Genetics, SEP 24, 2015, View Source [SID:1234507533]). The presentations include new studies on the myChoice HRD and Tumor BRACAnalysis CDx companion diagnostic tests and final results from the EMPATHY-P clinical utility study on Prolaris.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Myriad continues to place a strong emphasis on molecular diagnostic research with the goal of enabling personalized medicine and improving patient outcomes. We are presenting exciting new data on the unique ability of our companion diagnostics to identify the highest number of patients who may benefit from drugs that target the DNA-repair pathway, such as PARP inhibitors," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad. "We’re also presenting the final results for the EMPATHY-P study that show the Prolaris test provides essential clinical information to help physicians select men with prostate cancer who are good candidates for active surveillance versus those who need more medical treatment based on a genetic evaluation of their tumor."

The list of key Myriad presentations at ESMO (Free ESMO Whitepaper) (#ECC2O15) follows.

myChoice HRD

Title: DNA Repair Deficiencies in Ovarian Cancer: Genomic Analysis of High Grade Serous Ovarian Tumors from the NOVA Study.

Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P108.

Homologous recombination deficiency was assessed on tumors obtained from 318 patients enrolled in the NOVA study, a Phase 3 clinical trial evaluating the PARP inhibitor niraparib as a treatment in patients with platinum-sensitive ovarian cancer. The results show that 100 percent of patients with a germline BRCA mutation and 55 percent of patients without a BRCA mutation were HRD positive as determined by the myChoice HRD test. Importantly, the myChoice HRD test, which uses three novel algorithms of DNA damage (LOH, LST, TAI), more clearly defined the HRD positive population in ovarian cancer than did LOH alone. These findings support the use of the myChoice HRD test to more effectively identify patients who may benefit from therapy with DNA-damaging agents, such as platinum drugs and PARP inhibitors.

Tumor BRACAnalysis CDx

Title: Next Generation Sequencing of BRAC1 and BRCA2 Genes in Ovarian Tumors Captures Germline Mutations and Expands the Potential Treatment Group for the PARP Inhibitor Olaparib.

Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P116.

This study assessed the ability of Tumor BRACAnalysis CDx, a tumor-based next generation sequencing (NGS) test, to detect germline BRAC1/2 mutations in patients with high-grade serous ovarian cancer versus germline testing using Sanger sequencing in a reference laboratory. Tumor tissue was available from 54 patients to evaluate the Tumor BRACAnalysis CDx test. In all 54 cases, Tumor BRACAnalysis CDx correctly identified the deleterious BRAC1/2 mutations, demonstrating 100 percent sensitivity. The study also showed that tumor cells have de novo somatic mutations not identifiable via germline testing alone. For example, Tumor BRACAnalysis CDx found 12 somatic BRCA1/2 mutations, which represents an increase of 22 percent over germline testing in a sample set that had been specifically enriched for germline mutations. Importantly, patients with germline and tumor BRAC1/2 mutations showed similar treatment response to olaparib, suggesting that tumor testing effectively identifies patients appropriate for treatment with PARP inhibitors.

Prolaris

Title: Potential Reduction of Overtreatment of Localized Prostate Cancer Using a Cell Cycle Gene Expression Assay (Prolaris) in Biopsy Specimens: Results from the European Multi-Center EMPATHY-P Study.

Date: Monday, Sept. 28, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P072.

The EMPATHY-P study evaluated the Prolaris test in 502 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. The patients’ biopsy samples also were evaluated using standard clinical pathology methods (D’Amico/AUA risk stratification) that were then compared to the Prolaris test results. The EMPATHY-P data show that overall the Prolaris test identified 54 percent of the European men with a risk profile that was different than would be expected using standard clinical pathology. Specifically, the EMPATHY-P study demonstrated that the Prolaris test score found 24 percent of European men had less aggressive prostate cancer and 30 percent of patients had more aggressive disease compared to standard clinical pathology measurements. These data demonstrate that the Prolaris test score can be used to personalize risk assessment for men with localized prostate cancer and identify good candidates for active surveillance.

About myChoice HRD

Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.

About Tumor BRACAnalysis CDx

Myriad’s Tumor BRACAnalysis CDx is a companion diagnostic test for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor BRACAnalysis CDx has undergone significant analytic validation and has been shown to identify 44 percent more patients with cancer-causing BRCA1/2 mutations compared to germline testing alone. Myriad is actively collaborating with leading pharmaceutical companies to develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents. The test is currently available in Europe and will be performed at the Company’s Munich laboratory. Prescribing physicians will receive Tumor BRACAnalysis CDx test results in approximately two weeks.

About Prolaris

Prolaris is a prognostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris is the only test that provides insight into meaningful oncologic endpoints by predicting 10-year prostate cancer-specific mortality, thereby guiding medical management.

On September 24, 2015 AstraZeneca, along with MedImmune, the company’s global biologics research and development arm, reported that they will illustrate the strength and depth of research underpinning its scientific leadership in oncology, at the European Cancer Congress (ECC) 2015 in Vienna, Austria (25-29 September 2015) (Press release, AstraZeneca, SEP 24, 2015, View Source;astrazeneca-advance-oncology-research-ecc [SID:1234507528]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

19 oral and poster presentations, including data on AZD9291, durvalumab and olaparib, will provide confirmation and complementary analysis of previously presented results, as well as new data on:

AZD9291: pooled Phase II efficacy and safety data in pre-treated patients with non-small cell lung cancer (NSCLC) (Abstract # 3113) and analysis of patients with and without brain metastases (Abstract # 3083)
Durvalumab (MEDI4736) monotherapy: preliminary results investigating tumour indicators of response in patients with NSCLC (Late Breaker Presentation Abstract # 15LBA)
Olaparib: tumour biomarkers to suggest potential treatment activity in women with ovarian cancer without a BRCA1/2 mutation (Abstract # 435)
Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "Data published at ECC 2015 confirm the strength and rapid progress of our development plan in oncology. Our large and growing dataset for AZD9291 is a great example of this, as it highlights the robustness and consistency of the results we are seeing across a broad population of pre-treated non-small cell lung cancer patients."

AZD9291 in pre-treated patients with NSCLC

Data from an analysis of the AURA Phase II studies (AURA extension and AURA2) in pre-treated patients with NSCLC (Abstract # 3113) confirm findings already reported at previous congresses for AZD9291, a highly selective, irreversible inhibitor of both the activating epidermal growth factor receptor mutation (EGFRm) and the resistance mutation, T790M. Pooled data from over 400 pre-treated patients with EGFRm T790M showed an objective response rate (ORR) of 66% (95% confidence interval (CI) 61% to 71%). ORR was consistent across all sub-groups treated with AZD9291 including ethnicity, tumour mutation types and presence/absence of brain metastases. Preliminary median progression free survival (PFS) was 9.7 months (95% CI 8.3 months to non-calculable [NC]) and median duration of response (DoR) was non-calculable (95% CI 8.3 months to NC).

The safety profile was also in line with previous data readouts. The most common all-causality adverse events (AEs) were diarrhoea, 42% (1% ≥Grade 3) and rashes (grouped terms), 41% (1% ≥Grade 3).

Reported AEs of hyperglycaemia, interstitial lung disease (ILD) and QT prolongation remained consistent with data previously presented: ILD and pneumonitis 3% (2% ≥Grade 3), hyperglycaemia 1% (0% ≥Grade 3), QT prolongation 4% (1% ≥Grade 3). There was a low discontinuation rate: 4% of patients discontinued AZD9291 due to drug-related AEs (as assessed by the investigator).

An analysis of AURA Phase II studies (Abstract # 3083) will demonstrate the consistent activity of AZD9291 in patients with EGFRm T790M NSCLC with and without brain metastases; clinical anecdotes suggest that AZD9291 may have activity in the brain. Pre-clinical data showing that AZD9291 penetrates the blood-brain-barrier were recently presented at the World Congress on Lung Cancer (WCLC Abstract # ID410). The BLOOM (NCT02228369) study is investigating further the potential activity of AZD9291 in the brain.

The AZD9291 ASTRIS study (NCT02474355) is recruiting pre-treated patients with advanced or metastatic EGFRm T790M NSCLC in a real-world setting at multiple sites in Europe. In the US, an expanded access programme (NCT02451852) for AZD9291 for patients with advanced or metastatic EGFRm T790M NSCLC is available. AZD9291 is an investigational therapy and is not yet approved for any indication in any market.

Immuno-oncology programme progresses at pace

MedImmune will demonstrate advances in biomarker research that may identify patients most likely to respond to immunotherapies. The research will demonstrate the potential association between increased tumour expression of programmed death ligand-1 (PD-L1) and gamma interferon and response to the PD-L1 mAb, durvalumab (MEDI4736) (Abstract # 15LBA).

The new research is part of the extensive durvalumab clinical development programme in NSCLC, which includes the PACIFIC (NCT02125461), ATLANTIC (NCT02087423), ARCTIC (NCT02352948), MYSTIC (NCT02453282) and NEPTUNE (NCT02542293) trials discussed recently at WCLC and other conferences this year.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca, said: "Advances in our biomarker development will enable us to effectively identify patients who could benefit most from durvalumab monotherapy as well as those for whom the combination with other immunotherapies such as our anti- CTLA-4 inhibitor (tremelimumab) would be more effective. These insights will support progress with our extensive late-stage immuno-oncology programme, which now includes 17 clinical studies and more than 9,000 patients in lung, bladder, head and neck, and other cancers."

Olaparib shows activity beyond BRCA mutations

Exploratory biomarker data from a Phase II study of olaparib are contributing to an enhanced scientific understanding of why some women with ovarian cancer without a BRCA1/2 mutation demonstrate anti-tumour activity with poly ADP-ribose polymerase (PARP) inhibitor treatment (Abstract # 435). The data suggest that these women have tumours with mutations in other homologous recombination repair (HRR) genes that behave in a similar way to BRCA mutations.

The new biomarker analysis was carried out on tumour samples from 209 patients who took part in a Phase II trial of olaparib in platinum-sensitive relapsed serous ovarian cancer (NCT00753545, Study 19). In a sub-set of patients whose tumours did not carry the BRCA mutation, there was a trend towards greater olaparib efficacy in 21 women with other HRR gene mutations compared to 58 patients with no detectable mutations in other HRR genes.

Olaparib is the cornerstone of AstraZeneca’s industry-leading pipeline of personalised treatments targeting DNA damage and repair mechanisms in cancer cells. The potential of olaparib to target tumours with HRR mutations beyond those in BRCA genes is under investigation in ongoing clinical trials.

AstraZeneca delivering on oncology strategy

ECC marks another successful milestone for AstraZeneca and MedImmune in 2015, following the launch of LYNPARZA (olaparib) in the U.S. and Europe, the approval of IRESSA (gefitinib) in the US, rapid US and EU filings for AZD9291, key regulatory designations for further investigational compounds, and encouraging data supporting the company’s focus on combinations across immuno-oncology and small molecules.

As progress continues, the company is deepening its understanding of cancer biology and extending its research into a wider range of tumour types, with new data expected at congresses throughout 2016. AstraZeneca remains on track to achieve its bold ambition of delivering six new cancer medicines to patients by 2020.

AstraZeneca presents advances in oncology research at ECC 2015 with data on AZD9291, durvalumab and LYNPARZA (olaparib)

Thursday, 24 September 2015

AstraZeneca, along with MedImmune, the company’s global biologics research and development arm, will illustrate the strength and depth of research underpinning its scientific leadership in oncology, at the European Cancer Congress (ECC) 2015 in Vienna, Austria (25-29 September 2015).

19 oral and poster presentations, including data on AZD9291, durvalumab and olaparib, will provide confirmation and complementary analysis of previously presented results, as well as new data on:

AZD9291: pooled Phase II efficacy and safety data in pre-treated patients with non-small cell lung cancer (NSCLC) (Abstract # 3113) and analysis of patients with and without brain metastases (Abstract # 3083)
Durvalumab (MEDI4736) monotherapy: preliminary results investigating tumour indicators of response in patients with NSCLC (Late Breaker Presentation Abstract # 15LBA)
Olaparib: tumour biomarkers to suggest potential treatment activity in women with ovarian cancer without a BRCA1/2 mutation (Abstract # 435)
Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "Data published at ECC 2015 confirm the strength and rapid progress of our development plan in oncology. Our large and growing dataset for AZD9291 is a great example of this, as it highlights the robustness and consistency of the results we are seeing across a broad population of pre-treated non-small cell lung cancer patients."

AZD9291 in pre-treated patients with NSCLC

Data from an analysis of the AURA Phase II studies (AURA extension and AURA2) in pre-treated patients with NSCLC (Abstract # 3113) confirm findings already reported at previous congresses for AZD9291, a highly selective, irreversible inhibitor of both the activating epidermal growth factor receptor mutation (EGFRm) and the resistance mutation, T790M. Pooled data from over 400 pre-treated patients with EGFRm T790M showed an objective response rate (ORR) of 66% (95% confidence interval (CI) 61% to 71%). ORR was consistent across all sub-groups treated with AZD9291 including ethnicity, tumour mutation types and presence/absence of brain metastases. Preliminary median progression free survival (PFS) was 9.7 months (95% CI 8.3 months to non-calculable [NC]) and median duration of response (DoR) was non-calculable (95% CI 8.3 months to NC).

The safety profile was also in line with previous data readouts. The most common all-causality adverse events (AEs) were diarrhoea, 42% (1% ≥Grade 3) and rashes (grouped terms), 41% (1% ≥Grade 3).

Reported AEs of hyperglycaemia, interstitial lung disease (ILD) and QT prolongation remained consistent with data previously presented: ILD and pneumonitis 3% (2% ≥Grade 3), hyperglycaemia 1% (0% ≥Grade 3), QT prolongation 4% (1% ≥Grade 3). There was a low discontinuation rate: 4% of patients discontinued AZD9291 due to drug-related AEs (as assessed by the investigator).

An analysis of AURA Phase II studies (Abstract # 3083) will demonstrate the consistent activity of AZD9291 in patients with EGFRm T790M NSCLC with and without brain metastases; clinical anecdotes suggest that AZD9291 may have activity in the brain. Pre-clinical data showing that AZD9291 penetrates the blood-brain-barrier were recently presented at the World Congress on Lung Cancer (WCLC Abstract # ID410). The BLOOM (NCT02228369) study is investigating further the potential activity of AZD9291 in the brain.

The AZD9291 ASTRIS study (NCT02474355) is recruiting pre-treated patients with advanced or metastatic EGFRm T790M NSCLC in a real-world setting at multiple sites in Europe. In the US, an expanded access programme (NCT02451852) for AZD9291 for patients with advanced or metastatic EGFRm T790M NSCLC is available. AZD9291 is an investigational therapy and is not yet approved for any indication in any market.

Immuno-oncology programme progresses at pace

MedImmune will demonstrate advances in biomarker research that may identify patients most likely to respond to immunotherapies. The research will demonstrate the potential association between increased tumour expression of programmed death ligand-1 (PD-L1) and gamma interferon and response to the PD-L1 mAb, durvalumab (MEDI4736) (Abstract # 15LBA).

The new research is part of the extensive durvalumab clinical development programme in NSCLC, which includes the PACIFIC (NCT02125461), ATLANTIC (NCT02087423), ARCTIC (NCT02352948), MYSTIC (NCT02453282) and NEPTUNE (NCT02542293) trials discussed recently at WCLC and other conferences this year.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca, said: "Advances in our biomarker development will enable us to effectively identify patients who could benefit most from durvalumab monotherapy as well as those for whom the combination with other immunotherapies such as our anti- CTLA-4 inhibitor (tremelimumab) would be more effective. These insights will support progress with our extensive late-stage immuno-oncology programme, which now includes 17 clinical studies and more than 9,000 patients in lung, bladder, head and neck, and other cancers."

Olaparib shows activity beyond BRCA mutations

Exploratory biomarker data from a Phase II study of olaparib are contributing to an enhanced scientific understanding of why some women with ovarian cancer without a BRCA1/2 mutation demonstrate anti-tumour activity with poly ADP-ribose polymerase (PARP) inhibitor treatment (Abstract # 435). The data suggest that these women have tumours with mutations in other homologous recombination repair (HRR) genes that behave in a similar way to BRCA mutations.

The new biomarker analysis was carried out on tumour samples from 209 patients who took part in a Phase II trial of olaparib in platinum-sensitive relapsed serous ovarian cancer (NCT00753545, Study 19). In a sub-set of patients whose tumours did not carry the BRCA mutation, there was a trend towards greater olaparib efficacy in 21 women with other HRR gene mutations compared to 58 patients with no detectable mutations in other HRR genes.

Olaparib is the cornerstone of AstraZeneca’s industry-leading pipeline of personalised treatments targeting DNA damage and repair mechanisms in cancer cells. The potential of olaparib to target tumours with HRR mutations beyond those in BRCA genes is under investigation in ongoing clinical trials.

AstraZeneca delivering on oncology strategy

ECC marks another successful milestone for AstraZeneca and MedImmune in 2015, following the launch of LYNPARZA (olaparib) in the U.S. and Europe, the approval of IRESSA (gefitinib) in the US, rapid US and EU filings for AZD9291, key regulatory designations for further investigational compounds, and encouraging data supporting the company’s focus on combinations across immuno-oncology and small molecules.

As progress continues, the company is deepening its understanding of cancer biology and extending its research into a wider range of tumour types, with new data expected at congresses throughout 2016. AstraZeneca remains on track to achieve its bold ambition of delivering six new cancer medicines to patients by 2020.

NOTES TO EDITORS

About AZD9291

AZD9291 is a highly selective, irreversible inhibitor of both activating sensitising EGFRm and the resistance mutation, T790M, while sparing the activity of wild type EGFR. AZD9291 is designed to achieve minimal or no activity against two biological receptors, known as the
insulin receptor (IR) and insulin-like growth factor receptor (IGFR), in order to minimise the potential for hyperglycaemia (high blood sugar). Hyperglycaemia can lead to patients requiring treatment with additional medications.

Patients who have the EGFRm form of NSCLC, which occurs in 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two-thirds of patients treated with the approved EGFR-TKIs, gefitinib or erlotinib or afatinib, this resistance is caused by the secondary mutation, T790M. There are currently no targeted therapies approved for the treatment of tumours with this resistance mutation.

Marketing authorisation applications for AZD9291 for the treatment of EGFRm T790M NSCLC have been submitted to the US Food and Drug Administration (FDA), the European Medical Agency (EMA) and other regulatory authorities. Recently, the FDA granted Priority Review to AZD9291, adding to the Breakthrough Therapy designation, Orphan Drug and Fast Track status already assigned by the regulatory body. AZD9291 has also been granted Accelerated Assessment by the EMA.

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Durvalumab blocks these signals, countering the tumour’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, gastric, pancreatic, bladder and blood cancers.

About LYNPARZA

Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies.

Olaparib is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the U.S. and Europe, with ongoing regulatory submissions across multiple markets.

In Europe, ovarian cancer is the fifth most commonly diagnosed cancer in women and the sixth leading cause of cancer death among women. Up to 15% of women with ovarian cancer have a BRCA mutation, which is the most common cause of homologous repair deficiency (HRD).

In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.

On September 24, 2015 Nerviano Medical Sciences and Servier together reported the start of a first in Human clinical trial of the drug S 81694 (NMS-P153), an inhibitor of the mitotic checkpoint kinase MPS1 discovered by Nerviano Medical Sciences and thereafter acquired and further developed by Servier (Press release, Nerviano Medical Sciences, SEP 24, 2015, View Source [SID1234522435]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study is an open-label, non-randomized, multicenter international trial in patients with advanced or metastatic solid tumors who have failed previous therapies. An initial dose-escalation stage will be followed by expansion in specific solid tumors. The study is designed to confirm the safety and pharmacokinetics of S 81694, administered as a single agent. Secondary objectives include initial assessment of efficacy and determination of the recommended dose for phase 2.
Servier is the sponsor of the study, which is being conducted in Belgium and The Netherlands by Nerviano’s clinical affiliate Clioss. S 81694 is supplied by Nerpharma, the CMO affiliate of Nerviano.

Jean-Pierre Abastado, Ph.D., Director of the Oncology Innovation Therapeutic Pole at Servier, said: "We are very enthusiastic about the initiation of this study as S 81694 (NMS-P153) is a novel potent inhibitor of MPS1. MPS1 represents an original target overexpressed during the M phase in many types of cancers. S 81694 is highly selective for MPS1 and a brief exposure to S 81694 is sufficient to commit cancer cells to death".

Emmanuel Canet, M.D., PhD, President of Servier R&D stressed that "With the entry in clinical phase of this new antitumoral compound, Servier is reinforcing its commitment to provide innovative therapeutic solutions for unmet needs in patients with serious illnesses".

Arturo Galvani, Ph.D., Director of Drug Discovery at Nerviano Medical Sciences commented: "we have been working together with Servier, a company engaged in cutting-edge research in oncology, in an outstanding collaboration to successfully advance S81694 to clinical development and hope that this first step will further translate into clinical benefit for patients with cancer".

About MPS1:
MPS1 (also known as TTK) is a conserved kinase which is highly expressed in a number of human tumors of different origin. MPS1 plays a critical role in the control of a stage of the cell division cycle known as mitosis. During mitosis, MPS1 is involved in regulation of the spindle assembly checkpoint, a mechanism required for chromosome alignment and segregation. The activity of this checkpoint has been shown to be up-regulated in aneuploid tumors, comprising approximately 90% of solid and 70% of hematological cancers. In accelerating mitosis, MPS1 inhibitors have a novel mode of action as compared to currently available drugs targeting this stage of cell division.

On September 24, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported that the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, has awarded the Company $19.9 million to support the ICT-107 phase 3 registration trial in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, SEP 24, 2015, View Source [SID:1234507542]). The $19.9 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. ICT-107 qualified for grant consideration on the basis of being specifically engineered as an immunotherapy that preferentially targets and kills cancer tumor stem cells with the goal of preventing tumor recurrence following standard-of-care treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ImmunoCellular is on track to initiate the phase 3 ICT-107 trial in the fourth quarter of 2015, which will include approximately 120 clinical sites in the US, Europe and Canada, and will recruit about 400 patients. ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. The $19.9 million CIRM grant funds will be received by the Company over the duration of the trial as specified milestones are achieved.

"We are deeply appreciative to CIRM for their generous support and validation of the therapeutic potential of our ICT-107 dendritic cell-based immunotherapy. We share CIRM’s commitment to advancing potential breakthrough stem cell-based therapies to patients with unmet medical needs," said Andrew Gengos, ImmunoCellular President and Chief Executive Officer. "We are excited to be close to initiating our phase 3 registration trial. With this important grant of non-dilutive capital and our current cash, we are in position to cover the full external cost of conducting the trial and ensure high quality trial execution. Our strategic focus going forward will be on advancing our Stem-to-T-cell immunotherapy platform and pursuing additional related technologies to grow our pipeline – strategies that are key to achieving our goal of building a leading cancer immunotherapy company."