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

On December 11, 2015 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported important progress in its collaboration with NEC Corporation and Yamaguchi University in Japan (Filing, 6-K, Prima Biomed, DEC 11, 2015, View Source [SID:1234508536]). In this collaboration, first announced in May 2015, Prima’s IMP321 Antigen Presenting Cell activator (APC) is being combined with a therapeutic vaccine for different carcinoma types that was developed at Yamaguchi University.

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The Yamaguchi/Prima collaboration resulted from evidence that IMP321 at low doses can be used as a T cell adjuvant for cancer vaccines because of IMP321’s ability to activate dendritic cells1. Under the original May 2015 agreement, scientists at Yamaguchi University and NEC have designed and conducted in vivo studies of the combination, in work supported by NEC Corporation.
Favourable safety data from these studies has now resulted in a decision to progress the vaccine into clinical research. Under a new Material Transfer Agreement (MTA), Yamaguchi University will now work towards clinical research in cancer patients, which will be initiated in Japan in the first quarter of 2016. As with the in vivo work, this proof-of-concept research will be supported by NEC Corporation.

Marc Voigt, Chief Executive of Prima, welcomed the signing of the new MTA: "We are very pleased with the progress our collaborators at Yamaguchi University have made in just six months of work. We see significant upside from this work for cancer patients, given the current limited treatment options for many tumour types and the ease with which we think IMP321 can be used in combination with other therapies".

Yamaguchi University President Dr Masaaki Oka commented, "I am proud of our teams’ work in cancer vaccines, given the increasing importance of immuno-oncology to the future of cancer medicine. We thank Prima BioMed and NEC Corporation for their support and look forward to continued progress".

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response. IMP321 has been shown in an open-label Phase I study to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel, from a 25% historic response rate (RECIST criteria)2 to 50% when combined with IMP3213.

ARIAD Announces Pricing and Reimbursement Negotiations for Iclusig in France to Continue into 2016

On December 11, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it will continue negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) into 2016 (Press release, Ariad, DEC 11, 2015, View Source;p=RssLanding&cat=news&id=2121970 [SID:1234508534]). The Company had previously anticipated reaching agreement by year-end 2015. As a result, ARIAD now expects its global product revenue for Iclusig in 2015 to be $110 million to $115 million, excluding France, compared to our previous guidance of $130 million to $140 million. The Company estimates shipments of Iclusig to patients in France for 2015 to be approximately $9 million, and the cumulative value of shipments through year-end 2015 to be approximately $26 million.

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"We are pleased with the continued growth of our business in France as evidenced by increasing product shipments and look forward to successful resolution of price," stated Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "We continue to promote and sell Iclusig in France with the objective of helping patients and driving long-term brand value for key stakeholders."

ARIAD’s previously stated revenue guidance for 2015 assumed the completion of pricing and reimbursement negotiations in France by year-end. ARIAD will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations, net of any amounts that will be refunded to the French health authorities as a result of these negotiations, which we now anticipate will be completed in 2016.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

About ARIAD

FDA Grants Genentech’s Alecensa (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer

On December 11, 2015 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Press release, Genentech, DEC 11, 2015, View Source [SID:1234508539]).

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In the pivotal studies, Alecensa shrank tumors in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60 percent of people (CNS ORR of 61 percent [95 percent CI 46-74]).

"Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Sixty percent of people enrolled in our studies had tumors that had spread to their central nervous systems, and Alecensa shrank tumors in many people in a subset of patients with CNS disease."

Possible serious side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids.

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Alecensa will be available to people in the United States within two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Alecensa through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at View Source." target="_blank" title="View Source." rel="nofollow">View Source

In addition, Alecensa is being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC. ALEX is a global, randomized Phase III study comparing Alecensa to crizotinib as an initial treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Diagnostics. This study is part of the company’s commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.

About NP28761 (Study 1) and NP28673 (Study 2)

Study 1 is a Phase II North American, single-arm, open-label, multicenter trial evaluating the safety and efficacy of Alecensa (600 mg orally twice daily) in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. Study 2 is a Phase I/II global, single-arm, open-label, multicenter trial evaluating the safety and efficacy of Alecensa (600 mg orally twice daily) in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. People in the Phase II studies received 600 mg of Alecensa orally twice daily. In both trials, the primary endpoint was ORR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as evaluated by an Independent Review Committee (IRC). Secondary endpoints included DOR and efficacy against disease that had spread to the CNS (CNS ORR and CNS DOR). See full press release for a summary of the efficacy and safety data from both studies that support this approval
aOf 51 people in the subgroup, 35 (69 percent) had received prior brain radiation, including 25 (49 percent) who completed radiation treatment at least 6 months before starting treatment with Alecensa.

The most common Grade 3 or higher adverse events in the pooled analysis of both studies were an increase in muscle enzymes (creatine phosphokinase; 4.6 percent), shortness of breath (dyspnea; 3.6 percent), increased liver enzymes (aspartate transaminase; 3.6 percent, and alanine transaminase; 4.8 percent), evidence of liver dysfunction (hyperbilirubinemia; 2.4 percent), increased blood glucose (hyperglycemia; 2 percent), decreased levels of minerals (hypokalemia; 4 percent, hypophosphatemia; 2.8 percent, and hyponatremia; 2 percent), decreased red blood cells (anemia; 2 percent) and decreased white blood cells (lymphopenia; 4.6 percent).

About Lung Cancer

According to the American Cancer Society, it is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages. Approximately 5 percent of people with NSCLC in the United States are ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.

About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 350 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit View Source for more information.

About Alecensa

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

This indication is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 2 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

Feeling tired
Feeling less hungry than usual
Yellowing of the skin or whites of the eyes
Dark urine
Itchy skin
Nausea or vomiting
Pain on the right side of stomach area
Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:

Trouble breathing
Shortness of breath
Fever
Cough

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:

Have liver problems
Have lung or breathing problems
Have a slow heartbeat
Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant
Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of Alecensa
Men who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa
Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their dotcotr about the best way to feed their baby during this time.

Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

Tiredness
Constipation
Swelling in hands, feet, ankles, and eyelids

These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or View Source Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have three approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

Biothera Announces Clinical Study to Evaluate Combination Therapy of Imprime PGG and Merck’s Checkpoint Inhibitor Keytruda in Patients with Non-Small Cell Lung Cancer

On December 10, 2015 Biothera Pharmaceutical Inc., reported plans for a Phase 1b/2 clinical study in non-small lung cancer (NSCLC) patients to evaluate the ability of Biothera’s Imprime PGG to enhance responses to pembrolizumab (Keytruda), the anti-PD-1 antibody from Merck (NYSE:MRK), known as MSD outside the United States and Canada (Press release, Biothera Pharmaceuticals, DEC 10, 2015, View Source [SID1234562110]). Merck will provide funding and clinical supplies of pembrolizumab for the investigator-initiated study under the direction of Lawrence Feldman, M.D., of the University of Illinois at Chicago. The trial is expected to begin in the first quarter of 2016.

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Imprime PGG is a first-in-class, systemically administered beta glucan PAMP (pathogen associated molecular pattern) that triggers a robust, integrated immune response shown to enhance the anti-tumor efficacy of checkpoint inhibitors (PD-1, PD-L1 antibodies), anti-angiogenic antibodies and tumor-targeting monoclonal antibodies (mAbs). To date, Imprime PGG has shown promising efficacy in combination with mAbs in two Phase 2 studies of patients with NSCLC.

"Preclinical results for the combination therapy with Imprime PGG show the potential to expand the number of patients who can respond to Keytruda, as well as enhance the robustness of their response," said Dr. Feldman, Associate Professor of Medicine, College of Medicine at the University of Illinois at Chicago and principal investigator for the study. "The results for combination therapy with Imprime PGG have been encouraging, and I look forward to the progress of the upcoming study."

Biothera research has demonstrated that Imprime PGG activates key immune responses, including enhancement of dendritic cell maturation and presentation of antigen and co-stimulatory signals to T cells. The effect is to establish a critical link between the innate and adaptive immune systems, resulting in an expansion of T cell populations and inducing the production of the anti-tumor cytokine interferon gamma (IFN-γ). Imprime PGG also has been demonstrated to increase PD-L1 expression on tumor cells and tumor-associated macrophages, which also may enhance patient responses to pembrolizumab.

"Imprime PGG acts as an ignition switch to drive a coordinated response involving both the innate and adaptive immune systems to recognize and kill cancer cells," said Jose Iglesias, M.D., Chief Medical Officer, Biothera Pharmaceutical Inc. "In the anticipated Phase 1b/2 study, Imprime is expected to perform a dual role of enhancing antigen presentation, which helps more T cells target cancer, and upregulating PD-L1 expression to provide pembrolizumab more opportunities to disrupt or inhibit PD-1/PD-L1 interaction."

The Phase 1b/2 study is scheduled to begin dosing of patients in Q1 2016, with plans to enroll up to 58 patients with NSCLC following their progression on first line platinum-based chemotherapy. The phase 1b element of the trial is a dose-escalation study of up to 12 patients receiving Imprime PGG in combination with pembrolizumab. The phase 2 element of the study will test whether the addition of Imprime PGG to pembrolizumab increases median progression free survival and overall survival in up to 46 subjects.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Peregrine Pharmaceuticals, DEC 10, 2015, View Source [SID:1234508531])

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