On January 31, 2017 Morphogenesis, Inc., a biotechnology company focused on the development of cell and gene therapies for the treatment of cancer, reported that the United States Patent and Trademark Office has issued US Patent 9,555,088 covering methods f or treating cancer using gene therapy (Press release, Morphogenesis, JAN 31, 2017, View Source [SID1234517642]).This proprietary technology is applicable to multiple cancer types and uses a single gene in the form of a small DNA known as a plasmid. Plasmid DNA is considered extremely safe because no live bacteria or viruses are needed for delivery.

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The issued patent is an important component of Morphogenesis’ exclusive intellectual property portfolio that includes more than 25 issued patents and patent applications. The DNA patent was awarded under the Cancer Immunotherapy Pilot program, also known as Patents 4 Patients. This program supports the National Cancer Moonshot initiative brought to the forefront by former Vice President Biden and includes fast – track review for cancer immunotherapy – related patent applications without the extra petition fees. From filing to issuance, the patent process took months instead of years.

Morphogenesis’ DNA vaccine has a unique mode of action and is being developed as a direct intratumoral injection. Direct injection is convenient, pain – free, an d well – suited for accessible tumors like melanoma. Moreover, the DNA vaccine is relatively inexpensive to manufacture, has a long shelf – life and can be used to treat many different types of cancer.

"This patent is an important component of Morphogenesis’ formidable intellectual property portfolio covering its cancer vaccine technology and provides the Company with 18 year’s protection as it goes into human clinical trials," said Patricia Lawman, PhD, CEO of Morphogenesis. "The current trend in expedited patent and regulatory review will be extremely beneficial for terminally ill cancer patients and will allow companies to produce products with long – term market exclusivity."

On January 31, 2017 Kyowa Hakko Kirin Co., Ltd., an R&D-based life sciences company with special strengths in biotechnology, reported financial results for the fiscal year ended December 31, 2016 (Report, Kyowa Hakko Kirin, JAN 31, 2017, View Source [SID1234517603]).

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Net worldwide sales for the fiscal year ended December 31, 2016 were 343.0 billion yen, a 6% decrease from that of 364.3 billion yen for the fiscal year ended December 31, 2015. Regional Sales for the fiscal year ended December 31, 2016 were as follows: Japan 246.7 bn yen, Americas 17.7 bn yen, Europe 49.1 bn yen, Asia, 28.1 bn yen and other regions amounted to 1.1 bn yen.

For Kyowa Hakko Kirin Co., Ltd’s detailed reported for the fiscal year ended December 31, 2016, visit: View Source

On January 31, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported the advance online publication of an article in Nature Reviews Clinical Oncology (Press release, Cellectar Biosciences, JAN 31, 2017, View Source [SID1234517610]). In addition, the company anticipates an oral presentation on its drug delivery platform at the Academic Surgical Congress on February 8, 2017, at the Encore Hotel, Las Vegas. Each publication increases our understanding regarding the unique tumor targeting ability of the company’s phospholipid drug conjugates (PDCs) with fluorescent payloads.

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The Nature Reviews Clinical Oncology article, titled "Beyond the Margins: Real-Time Detection of Cancer Using Targeted Fluorophores," evaluates the current use of fluorescent molecules in cancer diagnostics and fluorescence-guided surgical resection of tumors. It focuses on the need for the use of targeted delivery of fluorescent molecules to malignant tissue. Specifically, it highlights near-infrared fluorescent molecules such as CLR 1502 in order to provide clear margins between healthy tissue and tumor tissue, thereby potentially improving patient outcomes post-surgical resection.

During the Academic Surgical Conference, John S. Kuo, M.D., Ph.D., associate professor, Neurosurgery, University of Wisconsin-Madison School of Medicine and Public Health, will discuss abstract #ASC20171140 titled "Effects of Intralipid on Serum Partitioning of Cancer-targeting Alkylphosphocholine Analogs." The presentation will take place during the "Basic Science: Oncology 1 Quickshot" session at 2:30 PM PT in the Encore Hotel’s Beethoven Room 1. Dr. Kou’s presentation will demonstrate how changes in plasma lipid concentrations can alter the protein binding of PDC molecules and potentially result in more rapid and increased delivery of PDCs like CLR 1501 and CLR 1502 to malignant tissue.

"The peer reviewed data in these two reports contribute to our understanding of the PDC delivery platform; particularly, the potential clinical utility of our imaging assets," said Jim Caruso, president and CEO of Cellectar Biosciences. "These two prestigious venues provide additional validation of the unique potential and varied utility of our platform."

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

On January 31, 2017 VBL Therapeutics (NASDAQ:VBLT), reported the publication of a paper discussing MOSPD2, a potential novel immuno-oncology target (Press release, VBL Therapeutics, JAN 31, 2017, View Source [SID1234517609]). The paper, entitled, "Identification of Motile Sperm Domain–Containing Protein 2 as Regulator of Human Monocyte Migration" by Mendel et al., is published online in The Journal of Immunology. VBL’s manuscript reveals that MOSPD2, a protein with a previously unknown function, regulates cell migration in human monocytes. While this first manuscript focuses on the importance of MOSPD2 in immune cells, research conducted by VBL has explored the relevance of MOSPD2 in motility and metastasis of tumor cells. These oncology-related data will be presented at the forthcoming American Association of Cancer research (AACR) (Free AACR Whitepaper) conference in Washington, DC, April 1-5, 2017.

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This novel platform technology enriches VBL’s capabilities, which include the Vascular Targeting System (VTS) gene-therapy-based platform technology lead by the Phase 3 drug candidate VB-111 (ofranergene obadenovec) and the Lecinoxoids family of small molecules which have potential applications in cardiovascular, NASH and fibrotic diseases.

"We have been working on this project in house for several years, ever since we learned that some of our Lecinoxoid molecules inhibit monocyte migration," said Eyal Breitbart, PhD, VP for Research at VBL. "Our experiments led to identification of MOSPD2 as a regulator of cell motility in monocytes and neutrophils, but moreover, they imply that MOSPD2 might be playing a similar role in certain tumor cells."

The company believes that targeting of MOSPD2 may have several therapeutic applications, including inhibition of monocyte migration in chronic inflammatory conditions, inhibition of tumor cell metastases and targeting of MOSPD2+ tumor cells. VBL’s "VB-600 series" of pipeline candidates is being developed towards these applications. The company expects to report additional findings related to MOSPD2 in Q2 2017.

On January 31, 2017 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the European Commission has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations (Press release, Merck & Co, JAN 31, 2017, View Source [SID1234517608]).

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"The approval of KEYTRUDA as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated," said Dr. Roy Baynes, senior vice president, head of clinical development, and chief medical officer, Merck Research Laboratories. "We are committed to ensuring that patients in Europe – who are in need of new treatment options – are able to quickly gain access to KEYTRUDA."

The approval is based on phase 3 data which demonstrated superior overall survival (OS) and progression-free survival (PFS) with KEYTRUDA compared to chemotherapy, the current standard of care for advanced NSCLC. The approval allows marketing of KEYTRUDA in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity. In August 2016, KEYTRUDA (pembrolizumab) (2 mg/kg every three weeks) was approved in Europe for previously-treated patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) and who have received at least one prior chemotherapy regimen.

"The data demonstrate that KEYTRUDA provided meaningful improvements in survival versus the current standard of care in patients whose tumors express high levels of PD-L1," said Dr. Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. "These findings supporting the approval also provide further rationale for biomarker testing in order to identify those patients more likely to benefit the most from treatment with KEYTRUDA."

About KEYNOTE-024

The European Commission’s approval is based on data from KEYNOTE-024, a randomized, open-label, phase 3 study evaluating KEYTRUDA monotherapy at a fixed dose of 200 mg compared to standard of care platinum-containing chemotherapy (pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin) for the treatment of patients with both squamous and non-squamous metastatic NSCLC. The study enrolled 305 patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumors had high PD-L1 expression with no EGFR or ALK aberrations. The primary endpoint was PFS; additional efficacy outcome measures were OS and objective response rate (ORR).

In the study, KEYTRUDA reduced the risk of disease progression or death by 50 percent compared to chemotherapy (HR, 0.50 [95% CI, 0.37, 0.68]; p<0.001). The median PFS for KEYTRUDA was 10.3 months (95% CI, 6.7-not reached) compared to 6.0 months for chemotherapy (95% CI, 4.2-6.2). At six months and 12 months, respectively, 62 percent and 48 percent of patients treated with KEYTRUDA were alive and had no disease progression compared to 50 percent and 15 percent of those receiving chemotherapy.

Additionally, KEYTRUDA resulted in a 40 percent reduction in the risk of death compared to chemotherapy (HR, 0.60 [95% CI, 0.41, 0.89]; p=0.005); this finding includes the 66 patients (43.7%) on the chemotherapy arm who crossed over in-study to receive KEYTRUDA once their cancer had progressed; median OS was not reached in either group. The OS rate at six months and 12 months, respectively, was 80 percent and 70 percent in patients treated with KEYTRUDA compared to 72 percent and 54 percent in those receiving chemotherapy.

Further, ORR was 45 percent for patients receiving KEYTRUDA (pembrolizumab) (95% CI, 37-53), including six complete responses, compared to 28 percent with chemotherapy (95% CI, 21-36), including one complete response.

The safety analysis supporting the European approval of KEYTRUDA was based on 2,953 patients with advanced melanoma or NSCLC across four doses (2 mg/kg every three weeks, 200 mg every three weeks, or 10 mg/kg every two or three weeks) in studies KEYNOTE-001, KEYNOTE-002, KEYNOTE-010 and KEYNOTE-024 combined. The most common adverse reactions (≥10%) with KEYTRUDA were fatigue (24%), rash (19%), pruritus (17%), diarrhea (12%), nausea (11%) and arthralgia (10%). The majority of adverse reactions reported were of Grade 1 or 2 severity. The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions.

About KEYTRUDA (pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA for injection is supplied in a 100 mg single use vial.

KEYTRUDA Indications and Dosing in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a dose of 2 mg/kg every three weeks until disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA (pembrolizumab).

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%) pneumonitis, and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

KEYTRUDA (pembrolizumab) can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism, hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%) hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse reactions. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma.

KEYTRUDA (pembrolizumab) can cause severe or life-threatening infusion-related reactions, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and symptoms of infusion-related reactions, including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC. The most common adverse event resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.8%). Adverse reactions leading to interruption of KEYTRUDA occurred in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation (1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most common adverse reactions (occurring in at least 20% of patients and at a higher incidence than with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon, breast, and prostate cancers combined. The two main types of lung cancer are non-small cell and small cell. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be two percent.