On March 14, 2016 SRI International reported that it has been awarded a contract worth up to US$19.8m from the National Cancer Institute (NCI) in the US to support the development of potential preventative cancer agents or vaccines (Press release, SRI International, MAR 14, 2016, View Source [SID:1234509560]).

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Under the three-year contract, which is part of the PREVENT Cancer Preclinical Drug Development Programme, the Menlo Park, CA-based firm’s SRI Biosciences will conduct preclinical studies to assess the efficacy of specific compounds or vaccines for preventing invasive-cancer development.

Researchers will also identify biomarkers to help quantify the effectiveness of the experimental compounds and vaccines.

The PREVENT Cancer Drug Development Program is an NCI-supported pipeline to bring new cancer preventing interventions and biomarkers through preclinical development towards clinical trials.

‘The discovery and development of cancer preventative agents is an area that is underserved, primarily because the length of required clinical trials can be resource-prohibitive for many companies. Our work in biomarker discovery may provide validated surrogate endpoints that can help to shorten clinical trials in cancer prevention,’ said Lidia Sambucetti, Senior Director of Cancer Biology, Centre for Discovery Technologies, SRI Biosciences, and principal investigator for the NCI contract. ‘The PREVENT programme is an opportunity to identify and advance novel strategies for cancer prevention.’

Under the PREVENT programme, for efficacy and biomarker testing, two NCI task orders in the area of cancer prevention have already been awarded to SRI Biosciences: the first to develop a mesothelin-based vaccine against ovarian cancer, and another to develop novel models for testing preventative agents against ovarian cancer.

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For the ovarian cancer programme, SRI Biosciences optimised a vaccine strategy designed to mount both antibody-based and cellular immunity against mesothelin tumour antigen. SRI researchers are currently testing whether the vaccine can help prevent ovarian cancer. In addition, SRI generated encouraging data supporting the development of a new model that will be used to test experimental drugs for ovarian cancer prevention.

On March 14, 2016 Janssen-Cilag International NV reported that data from a post-hoc analysis of the Phase 3 COU-AA-302 trial showed that ZYTIGA (abiraterone acetate) plus prednisone provided an 11.8 months overall survival (OS) benefit (53.6 months vs 41.8 months; HR = 0.61 [95% CI, 0.43-0.87]; p = 0.0055), compared to an active control of placebo plus prednisone, in men with early and less aggressive chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) (Press release, Johnson & Johnson, MAR 14, 2016, View Source [SID:1234509557]).1

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Data from the post-hoc analysis, presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated almost triple the OS benefit previously shown (4.4 months) in the final analysis of the COU-AA-302 trial (34.7 months ZYTIGA plus prednisone vs 30.3 months placebo plus prednisone; HR = 0.81 [95% CI, 0.70-0.93]; p = 0.0033). The final analysis was originally presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2014 Congress and included a broader range of men with asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC.2

The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in Group 1 were in an earlier, less advanced and less symptomatic stage of the disease (which was defined as having a Brief Pain Inventory [BPI] Short Form score of 0-1, prostate-specific antigen [PSA] below 80 ng/ml and a Gleason score [GS] of below 8). Those in Group 2 were in a later, more advanced and more symptomatic stage of the disease (defined as a having a BPI of 2 or over and/or PSA of 80 ng/ml or above, and/or a GS of 8 or more). The analysis revealed that patients in both groups experienced an OS benefit when treated with ZYTIGA plus prednisone, compared to placebo plus prednisone (Group 1: 11.8 months; HR = 0.61 [95% CI, 0.43-0.87]; p = 0.0055) (Group 2: 2.8 months; HR = 0.84 [95% CI, 0.72-0.99]; p = 0.0321).1

"Post-hoc analyses such as this are very important in helping us to identify the patients who could benefit most from therapies such as novel hormone agents, and at what stage of a patient’s disease they could be most effective." said Professor Kurt Miller, Department of Urology, Chariteì Berlin, Berlin, Germany. "As men with prostate cancer are living longer, quality of life is an increasingly important factor for them and their families. It is therefore encouraging to see that when used earlier, patients can stay on ZYTIGA for longer and delay the need for additional, more invasive treatments," he continued.

In addition to OS benefit, the post-hoc analysis data also revealed that both groups showed improvement in disease progression, cancer-related pain and treatment duration when treated with ZYTIGA plus prednisone, compared to placebo plus prednisone:

Time to chemotherapy use was increased by 12.7 months in Group 1 and 8.8 months in Group 2
Group 1: 37.0 months vs 24.3 months; HR = 0.64 [95% CI, 0.46-0.89]; p = 0.0073
Group 2: 23.3 months vs 14.5 months; HR = 0.71 [95% CI, 0.60-0.85]; p = 0.0001

There was an improvement in median time to opiate use for cancer-related pain in both groups
Group 1: not reached vs 41.0 months; HR = 0.69 [95% CI, 0.48-0.99]; p = 0.0409
Group 2: 30.5 months vs 19.3 months; HR = 0.70 [95% CI, 0.59-0.84]; p = 0.0001

Median time on treatment almost doubled in both groups
Group 1: 20.4 months vs 11.2 months; HR = 0.41 [95% CI, 0.31-0.54]; p < 0.0001
Group 2: 12.3 months vs 7.2 months; HR = 0.54 [95% CI, 0.46-0.62]; p < 0.0001

Jane Griffiths, Company Group Chairman, Janssen Europe, the Middle East and Africa (EMEA) said: "Janssen is proud that this study continues to deliver valuable insights as to how best to treat different stages of advanced prostate cancer. We hope that this additional analysis will help healthcare professionals to define the most effective treatment pathway for individual patients. We remain committed to continuing our research in this area with the aim of helping to improve outcomes for men affected by this disease now and in the future."

-ENDS-
NOTES TO EDITORS

About the COU-AA-302 study

COU-AA-302 is an international, randomised, double-blind, placebo controlled Phase 3 study that included 1,088 men with mCRPC who had not received prior chemotherapy and were randomised to receive ZYTIGA (abiraterone acetate) 1,000 milligrams (mg) administered orally once-daily plus prednisone 5 mg administered twice-daily or placebo plus prednisone 5 mg administered twice-daily. The co-primary endpoints of the study were rPFS and OS. Key secondary endpoints included time to opiate use, time to initiation of chemotherapy, time to Eastern Cooperative Oncology Group (ECOG) performance status deterioration and time to PSA progression. The final analysis was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2014 Congress.

The post-hoc analysis used the final dataset for the intent-to-treat population (n = 1088), to stratify patients into Group 1 (BPI 0-1, PSA < 80 ng/ml and GS < 8) and Group 2 (BPI = 2 and/or PSA = 80 ng/ml and/or GS = 8). OS, radiographic progression-free survival (rPFS), time to CT use, time to opiate use, and time on treatment with ZYTIGA plus prednisone vs placebo plus prednisone were analysed by the Kaplan–Meier method and Cox proportional hazards regression.

About ZYTIGA (abiraterone acetate)

ZYTIGA is the only approved therapy that inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex present at three sources: the testes, adrenals and the tumour itself.

ZYTIGA has been approved in more than 90 countries and to date, has been prescribed to more than 269,500 men worldwide.

Indication3

In 2011, ZYTIGA in combination with prednisone/prednisolone was approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

In December 2012, the EC granted an extension of the indication for ZYTIGA permitting its use, in combination with prednisone or prednisolone, for the treatment of mCRPC, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.3

Further Information3

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ZYTIGA, please refer to the summary of product characteristics, which is available at: View Source;mid=WC0b01ac058001d124

On March 14, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended December 31, 2015 (Filing, Q4/Annual, Stemline Therapeutics, 2015, MAR 14, 2016, View Source [SID:1234509551]).

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "During the fourth quarter, we made significant progress across all three of our development programs. Key achievements included 1) generating and presenting data from our ongoing Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) which we have designed to support potential registration, 2) treating our first patient in the second stage of our Phase 2 program of SL-701 in advanced brain cancer, and 3) the opening of our IND for SL-801 on schedule. At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December, we presented very strong data from our ongoing SL-401 trial in BPDCN, demonstrating a high overall response rate in BPDCN, with multiple complete responses. We are also very pleased with the pace of enrollment in BPDCN, and note that we are tracking in-line with our expectations. We look forward to sharing key clinical and regulatory updates on SL-401 throughout this year."

Dr. Bergstein continued, "We continue to evaluate SL-401 in several additional malignancies that overexpress IL-3R. Specifically, we have single agent trials enrolling AML patients with minimal residual disease and patients with advanced high-risk myeloproliferative neoplasms. We also expect our first clinical studies that combine SL-401 with other therapies will begin this year."

Dr. Bergstein concluded, "Our other pipeline candidates, SL-701 and SL-801, continue to advance. Our SL-701 trial is currently enrolling patients and we expect updates from this program in the second half of the year. The SL-801 IND is open, and we are on track to treat our first patient this quarter. With our strong cash position, we believe we have sufficient financial resources to achieve significant clinical and regulatory milestones this year and beyond."

Fourth Quarter 2015 Financial Results Review

Stemline ended the fourth quarter of 2015 with $97.5 million in cash, cash equivalents and investments, as compared to $104.0 million as of September 30, 2015, which reflects a cash burn of $6.5 million for the quarter. The company ended the fourth quarter of 2015 with 18.2 million shares outstanding.

For the fourth quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.9 million, or $0.53 per share, for the same period in 2014. The net loss for full year 2015 was $37.2 million, or $2.15 per share, as compared with a net loss of $28.8 million, or $2.23 per share, in the prior year.

Research and development expenses were $7.9 million for the fourth quarter of 2015, which reflects an increase of $2.8 million, or 56%, compared with $5.1 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to the ramp up in our clinical trial activities for SL-401 and SL-801.

General and administrative expenses were $2.6 million for the fourth quarter of 2015, which reflects an increase of $0.6 million, or 30%, compared with $2.0 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to an increase in compensation expense relating to administrative employees.

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On March 14, 2016 Oncothyreon Inc. (NASDAQ:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, reported a corporate update and reported financial results for the year and quarter ended December 31, 2015 (Press release, Oncothyreon, MAR 14, 2016, View Source [SID:1234509544]).

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"2015 was a significant year for Oncothyreon, with the company reporting encouraging data from two combination trials of ONT-380 demonstrating that this product candidate may be impactful on HER2-positive breast cancer patients, including those with brain metastases – a patient population in desperate need of new treatment options," said Christopher S. Henney, Chairman and interim CEO of Oncothyreon. "We believe our clinical results to date provided a strong foundation for us to advance ONT-380 into our recently initiated randomized, double-blind, placebo-controlled Phase 2 trial in combination with Herceptin and Xeloda, which includes enrolling patients with progressing central nervous system disease."

Corporate Update & Recent Highlights

Clinical Development:

ONT-380 Phase 2 Combination Trial Underway in Patients with HER2-Positive Breast Cancer. The randomized, double-blind, placebo control trial is evaluating ONT-380 in combination with Herceptin (trastuzumab) and Xeloda (capecitabine). ONT-380 is an oral, HER2-selective, central nervous system (CNS)-active tyrosine kinase inhibitor. The trial is targeted to enroll approximately 180 heavily pretreated patients with advanced HER2-positive breast cancer who present with or without brain metastases. Building on encouraging Phase 1b results, the primary and secondary endpoint objectives are designed to measure ONT-380’s contribution on both systemic and CNS disease, an area of unmet need for patients.

Data from Ongoing ONT-380 Phase 1b Combination Trials Show Objective, Durable Responses and Favorable Tolerability Profile. During 2015, data from two ongoing trials of ONT-380 were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the San Antonio Breast Cancer Symposium (SABCS).

ONT-380 in combination with Xeloda and/or Herceptin:
This Phase 1b trial enrolled patients with metastatic HER2-positive breast cancer with progression following prior treatment with Herceptin and Kadcyla (ado-trastuzumab emtansine or T-DM1). In addition to patients without a prior history of CNS disease, patients with untreated, asymptomatic CNS disease and patients with progressing CNS disease after prior local therapy were allowed to enroll in the trial and were followed for responses both systemically and in the CNS. Overall, ONT-380 in combination with Xeloda, Herceptin or both Xeloda and Herceptin has been well tolerated. As reported at ASCO (Free ASCO Whitepaper) 2015, in a total of 32 patients treated with these combinations, the majority of adverse events were Grade 1 or 2 in severity, with no reported Grade 3 diarrhea. As reported at SABCS 2015, the objective response rate across treatment groups was 42 percent and the CNS response rate was 33 percent, providing encouraging data to support moving forward with a follow-on Phase 2 study of ONT-380 in combination with Xeloda and Herceptin.

ONT-380 in combination with Kadcyla:
This Phase 1b trial enrolled patients with metastatic HER2-positive breast cancer with progression following prior treatment with Herceptin and a taxane. Patients may have received prior treatment with Perjeta (pertuzumab) and Tykerb (lapatinib). Patients with or without brain metastases were eligible. This trial has completed enrollment, but is ongoing with patients continuing to receive treatment. Clinical data from this trial were presented at SABCS 2014 and 2015, and at ASCO (Free ASCO Whitepaper) 2015. Overall, the combination of ONT-380 and Kadcyla was clinically well tolerated in 50 patients treated at the maximum tolerated dose of ONT-380, with the majority of adverse events either Grade 1 or Grade 2 in severity. Grade 3 diarrhea was reported in 4 percent of patients. Durable ( > 6 months) systemic and CNS responses and disease stabilization were seen, with an objective response rate of 41 percent and a CNS response rate of 33 percent.

Internal Research & Discovery Collaborations:

Research Collaboration Moving Chk1 Inhibitors Forward. During 2015, Oncothyreon continued preclinical activities to develop a small molecule against the checkpoint kinase 1 (Chk1) target in collaboration with Sentinel Oncology. IND-enabling studies are expected to begin in 2017.

Protocell Research Program Progressing. During 2015, Oncothyreon continued research on protocells, a novel nanoparticle platform technology that may enable the targeted delivery of a variety of therapeutic agents.

Leadership:

Expanded Leadership Team, CEO Search Underway. In January 2016, Oncothyreon announced the appointment of Christopher S. Henney, the company’s chairman, as interim CEO. The company’s comprehensive search for a new CEO is actively ongoing. Additionally, Oncothyreon appointed three new members to its Board of Directors: Steven P. James in March 2015 and Mark Lampert and Gwen Fyfe, M.D. in January 2016.

Full Year and Fourth Quarter 2015 Financial Highlights

Cash, cash equivalents and investments totaled $56.4 million as of December 31, 2015, compared to $63.7 million at December 31, 2014, a decrease of $7.3 million, or 11.5%. The decrease was primarily attributable to $28.9 million of cash used in operations during the year ended December 31, 2015, partially offset by the net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015.

Research and development expenses for the fourth quarter of 2015 decreased by $19.1 million to $6.9 million from $26.0 million in the fourth quarter of 2014. Full year research and development expenses decreased by $18.4 million to $23.5 million in 2015 from $41.9 million in 2014. The fourth quarter and full year decrease in expense was primarily the result of the one-time upfront payment made to Array Biopharma in December 2014.

General and administrative expenses for the fourth quarter of 2015 increased by $0.4 million to $2.3 million, from $1.9 million in the fourth quarter of 2014. Full year 2015 general and administrative expenses were $9.3 million, an increase of $0.3 million from $9.0 million in 2014. This increase was primarily due to patent expenses related to our product candidates.

Net loss for the year ended December 31, 2015 was $32.6 million, or $0.34 per basic and diluted share, compared with a net loss of $50.0 million, or $0.64 per basic and diluted share, for the comparable period in 2014. Net loss for the three months ended December 31, 2015 was $9.1 million, or $0.10 per basic and diluted share, compared with a net loss of $27.6 million, or $0.30 per basic and diluted share, for the comparable period in 2014. The decrease in net loss for the year and quarter was primarily attributable to a $20.0 million upfront payment Oncothyreon made to Array BioPharma upon entering into an exclusive license agreement in December 2014. The decrease in net loss was partly offset by slightly higher general and administrative expenses and lower non-cash income from the change in the fair value of our warrant liability.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2016 to be higher than in 2015. This increase will primarily be related to expenditures associated with the Phase 2 trial of ONT-380. Oncothyreon currently expects cash used in operations in 2016 to be approximately $38.0 million to $40.0 million. With cash, cash equivalents and investments of $56.4 million as of December 31, 2015, Oncothyreon estimates that its cash, cash-equivalents and investments will be sufficient to fund operations for at least the next 12 months.

On March 14, 2016 Immunomedics, Inc., (Nasdaq:IMMU) reported that the Company is terminating the Phase 3 PANCRIT-1 trial with yttrium-90-labeled (90Y) clivatuzumab tetraxetan in patients with metastatic pancreatic cancer who had received at least two prior therapies, one of which must have been a gemcitabine-containing regimen (Filing, 8-K, Immunomedics, MAR 14, 2016, View Source [SID:1234509542]).

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The decision to terminate the trial early is based on the recommendation from the independent Data and Safety Monitoring Board (DSMB), following a planned interim analysis of data on overall survival (OS) after more than 50% of the required 371 deaths had occurred. The interim analysis showed that the treatment arm of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care did not demonstrate a sufficient improvement in OS as compared to placebo plus low-dose gemcitabine and best supportive care.

"Given the significant unmet medical need in pancreatic cancer, we are disappointed that clivatuzumab tetraxetan did not produce the desired outcome and will review our future strategy for this antibody with key opinion leaders," remarked Cynthia L. Sullivan, President and Chief Executive Officer. "We would like to thank our clinical investigators and their patients and families for participating in this study. Pancreatic cancer is a challenging disease to treat but we remain fully committed to bringing innovative products, such as IMMU-132 (antibody-drug conjugate, sacituzumab govitecan) and (E1)-3s (T-cell redirecting immuno-oncology bispecific antibody), to address this unmet need," Ms. Sullivan added. "Both these other products have shown activity in pancreatic cancers, either clinically (IMMU-132) or preclinically [(E1)-3s]," Ms. Sullivan commented further.