On November 16, 2015 Amgen (NASDAQ:AMGN) reported that the Company will present eight IMLYGICTM (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck’s anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research (SMR), to be held on Nov. 18-21 in San Francisco (Press release, Amgen, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112841 [SID:1234508254]).

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"The analyses from our Phase 3 monotherapy trial confirm the clinical significance of durable responses and the benefit IMLYGIC may bring to patients living with metastatic melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "As we advance understanding in the emerging science of oncolytic viral therapy, we are also excited to share early data on the use of IMLYGIC in combination with another immunotherapy."

The Phase 1b data on IMLYGIC in combination with an investigational use of Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with unresectable metastatic melanoma (NCT02263508) has been accepted as a late-breaking abstract. The oral presentation is Saturday, Nov. 21, in Plenary Session 11 (Late Breaking Clinical Updates) between 1:30 to 3:40 p.m. PT in the San Francisco Marriott Marquis Salon 9-15:

Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma (G. Long)

Additionally, the Company will present analyses from OPTiM, the Phase 3 trial that served as the basis of the U.S. Food and Drug Administration’s (FDA) approval of IMLYGIC in October 2015. The following will be presented on Thursday, Nov. 19, from 6 to 8 p.m. PT at the Poster Reception in the San Francisco Marriott Marquis Salon 1-8:

Safety profile of talimogene laherparepvec (T-VEC) in OPTiM, a phase 3 trial for melanoma (F. Collichio)
Long-term follow up from the phase 2 study of talimogene laherparepvec (T-VEC) for metastatic melanoma (J. Nemunaitis)
Durable-response (DR)-associated benefits in patients (pts) with unresected stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) or GM-CSF in OPTiM (H. Kaufman)
Durable complete responses (CR) in patients (pts) with stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) in OPTiM (R. Andtbacka)
Reduced risk of developing visceral/bone metastasis (VM) in patients (pts) with stage IIIB/C/IVM1a melanoma treated with talimogene laherparepvec (T-VEC) vs GM-CSF (R. Andtbacka)
Did patients in OPTiM have truly unresectable disease? Results of an independent review (M. Faries)
Current treatment patterns in patients with metastatic melanoma: A retrospective claims database analysis in the United States (U.S.) (Y. Chen)
Abstracts are available on the SMR website at www.melanomacongress.com/abstracts.

About IMLYGIC (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown.

IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

Important Safety Information

Contraindications

Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
Do not administer IMLYGIC to pregnant patients.
Warnings and Precautions

Accidental exposure to IMLYGIC may lead to transmission of IMLYGIC and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.

Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.

To prevent possible inadvertent transfer of IMLYGIC to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.

Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.

Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.

IMLYGIC is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC. Consider the risks and benefits of IMLYGIC treatment before administering antiviral agents to manage herpetic infection.

Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.

Impaired healing at the injection site has been reported. IMLYGIC may increase the risk of impaired healing in patients with underlying risk factors (e.g., previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.

Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC. Consider the risks and benefits of IMLYGIC before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.

Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC administration in a clinical study. Consider the risks and benefits of IMLYGIC in patients with multiple myeloma or in whom plasmacytoma develops during treatment.

Adverse Reactions

The most commonly reported adverse drug reactions (> 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC treatment, but were more frequent during the first 3 months of treatment.
The most common Grade 3 or higher adverse reaction was cellulitis.

On November 16, 2015 Oncothyreon Inc. (Nasdaq:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of oncology products that can improve the lives and outcomes of patients, reported that data from the company’s ongoing trials of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor being developed for the treatment of metastatic breast cancer, will be presented at the upcoming San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2015 in San Antonio, TX (Press release, Oncothyreon, NOV 16, 2015, View Source [SID:1234508251]).

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"We are looking forward to presenting additional and updated clinical trial data on ONT-380 for the treatment of patients with HER2-positive breast cancer, including an analysis of patients that suffer from central nervous system (CNS) metastases, at SABCS," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "CNS metastases impact up to 50 percent of women with HER2-positive metastatic breast cancer and represent a major unmet medical need. ONT-380 is an exciting molecule that has the potential to provide a much needed treatment option for this patient population."

The SABCS presentation details are as follows:

A phase 1b study of ONT 380, an oral HER2-specific inhibitor, combined with ado trastuzumab emtansine (T DM1), in HER2+ metastatic breast cancer (MBC)

First Author: Cristiano Ferrario, Segal Cancer Centre, Jewish General Hospital, Montreal, QC
Date/Time: Friday, December 11, 2015 at 7:30-9:00 a.m. CT
Session: Poster Session 4: Treatment: HER2-Targeted Therapy
Abstract P4-14-20

ONT-380 in the treatment of HER2+ breast cancer central nervous system (CNS) metastases (mets)

First Author: Rashmi Krishna Murthy, MD Anderson Cancer Center, Houston, TX
Date/Time: Friday, December 11, 2015 at 7:30-9:00 a.m. CT
Session: Poster Session 4: Treatment: HER2-Targeted Therapy
Abstract P4-14-19

On November 16, 2015 PharmaMar (MSE:PHM) reported the opening of a new subsidiary in Brussels (Belgium) to strengthen the commercial team operating in the Benelux countries (Belgium, The Netherlands and Luxembourg) (Press release, PharmaMar, NOV 16, 2015, View Source [SID:1234508248]). This enhances the Company’s presence in Europe, one of the world’s leading oncology markets.

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With this new subsidiary in Belgium, PharmaMar now has a presence, with its own structure, in seven European countries. The other subsidiaries are located in Italy, Germany, France, Switzerland, Spain and the United Kingdom, consolidating the
Company’s business and distribution model.

Luis Mora, General Manager of PharmaMar’s oncology unit: "This new subsidiary is a continuation of our expansion strategy and also enables us to operate directly in one of Europe’s principal markets. It is vital for us to have our own teams in certain European countries so as to offer the best service to our customers."

Cancer incidence in Belgium, The Netherlands and Luxembourg

According to Belgian Cancer Registry data, 65,269 new cases of cancer were detected in Belgium in 2012, and it is estimated that around one in three men and one in four women will suffer this disease before the age of 75. The most prevalent types of cancer in Belgium are prostate, lung and colorectal.

As for The Netherlands, the World Health Organisation (WHO) reports that 93,448 new cases of cancer were diagnosed in 2012. The three most common cancers types in men were prostate, colorectal and lung cancer, while in women they were
breast, colorectal and lung cancer.

According to the WHO, cancer was the second most frequent cause of death in Luxembourg in 2012, behind cardiovascular diseaseiii. The three most common cancer types were: prostate, colorectal and lung cancer, among men, and breast,
uterine and colorectal, among women.

On November 16, 2015 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the third quarter ended September 30, 2015 (Press release, BioLineRx, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112560 [SID:1234508243]).

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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "Our focus during the third quarter of 2015 was on continued clinical execution, primarily for BL-8040, our lead platform for the treatment of acute myeloid leukemia (AML) and other oncology and hematology indications. While we continued to advance the development of BL-8040 for the treatment of relapsed or refractory AML, as well as stem cell mobilization for transplantation purposes, in August we initiated a clinical study for BL-8040 as a novel consolidation treatment for AML, and we expect to initiate clinical studies in two additional indications in the upcoming months. We are also currently performing an extensive evaluation of BL-8040’s potential in the exciting immuno-oncology space, expanding upon our unique oncology platform. CXCR4 antagonists have been identified as potentially synergistic with immune checkpoint inhibitors. In this regard, we believe BL-8040’s best-in-class qualities make it a great candidate to explore such combinations."

"Earlier this month we reported positive results from the dose-escalation part of BL-8040’s Phase 2 clinical trial in relapsed or refractory AML, including clinical response (remission) data. The encouraging composite response rate of 38%, which will be presented for the first time at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, together with continued robust mobilization and apoptotic effects, strongly suggest that BL-8040 has potent anti-leukemic activity and, in combination with Ara-C, may improve the response typically achieved in this advanced AML population. We are looking forward to reporting top-line results from this study in early 2016. With regard to BL-8040 as a novel stem cell mobilization treatment, last month we held a meeting with the FDA, which has provided us with substantial clarification regarding the future development plan for this indication. We are gearing up to start a Phase 2 study in stem cell mobilization in the first quarter of 2016.

Dr. Savitsky continued, "After successfully completing a Phase 1/2 study for BL-7010 for the treatment of celiac disease, we are waiting for a response from the EU regulatory authorities regarding classification of BL-7010 as a medical device in Europe. Contingent upon this decision, we are planning to start the next efficacy study in celiac disease in the first half of 2016. In parallel, we are investing considerable efforts in examining alternative development and commercialization pathways for this promising product, including as a food supplement, in order to potentially address the multi-billion dollar market for gluten sensitivity, which also has a significantly shorter time to market, especially in the US.

"Our partner Omega Pharma, now part of Perrigo, is swiftly progressing in the development of BL-5010 as an OTC solution for the non-surgical removal of benign skin lesions. In September, they submitted an application for CE Mark designation for this product. Assuming successful completion of the CE Mark registration process, we expect the first sales in Europe to begin in 2016."

Dr. Savitsky concluded, "We continue to pursue various collaboration agreements to maximize the value of our current pipeline assets, including discussions with additional partners for the purpose of monetizing some of our non-core programs. In parallel to our internal pipeline development, we continue to screen potential assets to develop under our strategic partnership with Novartis, and we look forward to in-licensing promising therapeutic candidates for development under the collaboration in the near future. Finally, with over $50 million on our balance sheet, we remain well capitalized to execute on our development program and to achieve significant milestones across our expanded therapeutic pipeline well into 2018, and we look forward to demonstrating our enhanced value proposition over the coming months."

Financial Results for Quarter and Nine Months Ended September 30, 2015

Research and development expenses for the three months ended September 30, 2015 were $2.6 million, a decrease of $0.4 million, or 13.4%, compared to $3.0 million for the three months ended September 30, 2014. The decrease resulted primarily from decreased spending on BL-1110, BL-7010 and BL-5010 in the 2015 period, partially offset by increased spending on BL-8040. Research and development expenses for the nine months ended September 30, 2015 were $8.7 million, an increase of $0.2 million, or 2.3%, compared to $8.5 million for the nine months ended September 30, 2014. The small increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-7040, BL-5010 and BL-8020.

Sales and marketing expenses for the three months ended September 30, 2015 were $0.3 million, substantially similar to the comparable period in 2014. Sales and marketing expenses for the nine months ended September 30, 2015 were $0.8 million, a decrease of $0.1 million, or 13.9%, compared to $0.9 million for the nine months ended September 30, 2014. The decrease resulted primarily from significant professional fees related to a number of material business development activities carried out during the nine-month period in 2014, which resulted in collaboration and outlicensing agreements.

General and administrative expenses for the three months ended September 30, 2015 were $0.8 million, substantially similar to the comparable period in 2014. General and administrative expenses for the nine months ended September 30, 2015 were $2.6 million, substantially similar to the comparable period in 2014.

The Company’s operating loss for the three months ended September 30, 2015 amounted to $3.6 million, compared with an operating loss of $4.1 million for the corresponding 2014 period. The Company’s operating loss for the nine months ended September 30, 2015 amounted to $12.1 million, substantially similar to the corresponding 2014 period.

Net non-operating income amounted to $2.0 million for the three months ended September 30, 2015, an increase of $0.6 million, compared to net non-operating income of $1.4 million for the three months ended September 30, 2014. Net non-operating income amounted to $1.1 million for the nine months ended September 30, 2015, a decrease of $2.3 million, compared to net non-operating income of $3.4 million for the nine months ended September 30, 2014. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of liabilities on account of the warrants issued in the private and direct placements which we conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by our share price at each period end (revaluation date).

Net financial income was immaterial for the three months ended September 30, 2015, compared to net financial income of $2.0 million for the three months ended September 30, 2014. Net financial income amounted to $0.3 million for the nine months ended September 30, 2015, compared to net financial income of $1.8 million for the nine months ended September 30, 2014. Net financial income (expenses) for the 2015 period primarily relates to investment income earned on our bank deposits, as well as banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate.

The Company’s net loss for the three months ended September 30, 2015 amounted to $1.6 million, compared with a net loss of $0.7 million for the corresponding 2014 period. The Company’s net loss for the nine months ended September 30, 2015 amounted to $10.7 million, compared with a net loss of $6.9 million for the corresponding 2014 period.

The Company held $50.7 million in cash, cash equivalents and short-term bank deposits as of September 30, 2015.

Net cash used in operating activities was $11.0 million for the nine months ended September 30, 2015, substantially similar to the comparable period in 2014.

Net cash used in investing activities for the nine months ended September 30, 2015 was $18.7 million, compared to net cash used in investing activities of $15.6 million for the nine months ended September 30, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the nine months ended September 30, 2015 was $29.3 million, compared to net cash provided by financing activities of $22.6 million for the nine months ended September 30, 2014. The cash flows from financing activities primarily reflect the underwritten public offerings of our ADSs in March 2015 and 2014.

On November 16, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the third quarter ended September 30, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, NOV 16, 2015, View Source [SID:1234508242]).

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"We continue to advance toward our goal of becoming a fully-integrated commercial biotechnology company," said Jeff Abbey, president and chief executive officer. "We successfully completed enrollment in our phase 3 ADAPT trial of AGS-003 in metastatic renal cell carcinoma. The ADAPT trial continues to progress in line with our expectations and we anticipate the next interim data analysis, at approximately fifty percent of events, to occur in the first half of 2016. Additionally, an early stage investigator-initiated RCC trial of AGS-003 was begun at Roswell Park Cancer Institute in Buffalo, NY. With this study, for the first time we will be able to assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body. This is an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumor collection prior to surgery, while directly studying immune changes within the primary tumor before and after administration of AGS-003."

"Also during the quarter, Argos formed its first Scientific Advisory Board to assist us with the continued advancement of our clinical development programs. We look forward to working closely with these renowned scientists and physicians as we design new trials of AGS-003 over the coming quarters in a variety of tumor types." Mr. Abbey went on, "We continue to take the steps and make the necessary investments in our centralized commercial manufacturing facility here in Durham. Lastly, as part of our debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC, we drew down the second and final tranche of $12.5 million, which has helped provide us with additional capital to conduct critical operational activities."

Recent Operational Highlights:

In July 2015, the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of mRCC reached its enrollment goal of at least 450 randomized patients.

The breakdown of patients enrolled in the ADAPT study is approximately 73% intermediate risk patients, meaning they present with 1 or 2 risk factors at diagnosis, and approximately 27% poor risk patients, meaning they present with either 3 or 4 risk factors at diagnosis
In July 2015, the Company established a Scientific Advisory Board (SAB)
Inaugural members include distinguished oncologists and immunologists to provide perspectives in further research and development of AGS-003.

In July 2015 an investigator-initiated early stage RCC trial of AGS-003 commenced at Roswell Park Cancer Institute in Buffalo, NY.
In August 2015, the Company received the second and final tranche of $12.5 million under its debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC.

Selected Third Quarter 2015 Financial Results

Net loss attributable to common stockholders for the three months ended September 30, 2015 was $20.1 million, or $0.97 per share, compared to a net loss attributable to common stockholders of $15.1 million, or $0.77 per share, for the same period in 2014. Net loss attributable to common stockholders for the nine months ended September 30, 2015 was $57.2 million, or $2.81 per share, compared to a net loss attributable to common stockholders of $37.9 million, or $2.29 per share, for the same period in 2014.

Revenue for the three months ended September 30, 2015 totaled $0.2 million compared to $0.4 million for the same period in 2014. Revenue for the nine months ended September 30, 2015 totaled $0.4 million compared to $1.7 million for the same period in 2014.

Research and development expense for the three months ended September 30, 2015 totaled $17.2 million compared to $13.0 million for the same period in 2014. Research and development expense for the nine months ended September 30, 2015 totaled $48.1 million compared to $32.0 million for the same period in 2014.

General and administrative expense for the three months ended September 30, 2015 totaled $2.7 million compared to $2.3 million for the same period in 2014. General and administrative expense for the nine months ended September 30, 2015 totaled $8.0 million compared to $6.1 million for the same period in 2014.

As of September 30, 2015, Argos’ cash, cash equivalents and short-term investments totaled $23.1 million compared to $56.2 million as of December 31, 2014.