On July 24, 2017 Spherix Incorporated ("Spherix" or the "Company") (NASDAQ: SPEX), an intellectual property development company committed to fostering of technology, reported that it has closed its previously announced firm commitment underwritten public offering of 1,250,000 shares of its common stock at a price to the public of $2.00 per share (Press release, Spherix, JUL 24, 2017, View Source [SID1234538992]).

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The total gross proceeds of the offering are approximately $2.5 million. After deducting the underwriter’s discount and other offering expenses payable by Spherix, the net proceeds to the Company are approximately $2.1 million.

Anthony Hayes, the Chief Executive Officer of Spherix, stated, "One of the purposes of this offering is to raise capital to explore potential acquisition opportunities. Looking beyond our recent investment in Hoth Therapeutics, we hope to use these proceeds to find other similar opportunities."

Laidlaw & Company (UK) Ltd. acted as the sole underwriter for the offering.

The shares were offered pursuant to a registration statement on Form S-1 (File No. 333-218216) that was declared effective by the Securities and Exchange Commission (SEC) on July 18, 2017. The securities were offered only by means of a prospectus. A final prospectus supplement related to the offering has been filed with the SEC, and is available on the SEC’s website at www.sec.gov and may also be obtained from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 546 Fifth Avenue, 5th Floor, New York, New York 10036, telephone (212) 953-4900, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 24, 2017 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, and the Vancouver Prostate Centre and Vancouver Coastal Health Research Institute (VCHRI) reported, that data on one of H3’s pre-clinical programs focusing on muscle-invasive bladder cancer, has been published in the current issue of Nature Communications (Press release, H3 Biomedicine, JUL 24, 2017, View Source [SID1234519877]). The paper, which is titled "Evasion of immunosurveillance by genomic alterations of PPARγ/RXRα in bladder cancer," can be found at View Source

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"While the majority of the field was focused on manipulating function of immune cells, H3 explored a novel paradigm by focusing on tumor cells and their potential to effectively inhibit immune cell function," said Ping Zhu, Ph. D., Executive Director of Target Discovery at H3 Biomedicine. "Years ago when we built our immuno-oncology platform, our hope was to identify genomically-altered genes in tumors that may extend their reach beyond the tumor cell to influence immune response."

Muscle-invasive bladder cancer is an aggressive form of cancer with limited therapeutic options available to patients. In the past year, agents designed to target the immune system have been approved for bladder cancer; however, the median survival in patients with second-line disease remains less than a year, and less than a third of first-line patients respond to treatment. Based on this unmet need, researchers at H3 Biomedicine took a novel approach to understanding how tumors can overcome the debilitating effects of the immune system.

The publication in Nature Communications reports that a significant proportion of bladder tumors showing focal amplification of PPARγ and hotspot mutations in RXRα, lead to hyperactivity of the peroxisome proliferator-activated receptor gamma (PPARγ) pathway. Deep molecular characterization in cell lines and clinical samples also showed that tumors increased the activity of this pathway to prevent immune cells from infiltrating the tumors increasing the survival of the tumor cells. In collaboration with a team of Drs. Mads Daugaard and Peter Black at the University of British Columbia, the Vancouver Prostate Centre and VCHRI, the scientists further confirmed the association of PPARγ pathway activity with immune evasion in additional cohorts of bladder tumors.

"The fact that PPARγ and its binding partner RXRα can so potently suppress immune cell infiltration into tumors may explain the lack of response to immune-directed therapies in this class of tumor," said Manav Korpal, Ph. D., Senior Investigator at H3 Biomedicine. "One way to potentially combat this class of tumor is to combine immune-directed therapies with compounds that modulate PPARγ function."

On July 24, 2017 Novocure (NASDAQ:NVCR) reported a new arm for a phase 1b study to evaluate the safety of marizomib and temozolomide in combination with Optune, Novocure’s Tumor Treating Fields (TTFields) delivery system, as adjuvant treatment for patients with newly diagnosed glioblastoma (GBM) following radiation therapy with concurrent temozolomide (Press release, NovoCure, JUL 24, 2017, View Source [SID1234519860]). The trial is the first to study Optune in combination with an investigational drug.

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Marizomib is a novel, brain-penetrant proteasome inhibitor developed by Triphase Accelerator Corporation and acquired by Celgene Corporation. Celgene is responsible for marizomib’s development.

"This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM," said Principal Investigator Dr. Roger Stupp, Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "Optune is the first treatment in over a decade to improve survival in GBM. I believe that combining Optune with new pharmacologic treatments in clinical trials, like this phase 1b study, will help advance our understanding of how to treat this devastating disease."

Celgene and Triphase modified their current phase 1b multicenter, open-label study of marizomib in combination with temozolomide and radiotherapy in patients with grade IV malignant gliomas to include Optune. A cohort of 12 GBM patients will be treated with Optune in combination with marizomib and temozolomide after initial treatment with radiation and temozolomide has been completed.

The primary objective for the Optune portion of the study is to determine the safety of the combination of marizomib and temozolomide with the addition of Optune in patients entering the adjuvant treatment phase. Secondary objectives for the Optune portion of the study include assessing preliminary clinical activity of the combination of Optune, marizomib and temozolomide in patients entering adjuvant therapy, progression-free survival and overall survival. The protocol has been submitted to an institutional review board, and this arm of the trial is expected to open in the third quarter of 2017.

"We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "As innovators in cancer treatment, we know collaboration is essential to improve patient outcomes. We hope this is the first collaboration of many."
Tumor Treating Fields in combination with temozolomide and marizomib is experimental for the treatment of glioblastoma. Limited by law to investigational use only.

On July 24, 2017 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the pivotal phase 3 KEYNOTE-040 trial investigating KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) did not meet its pre-specified primary endpoint of overall survival (OS) (HR, 0.82 [95% CI, 0.67-1.01]; p = 0.03 [one-sided]). The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of KEYTRUDA; no new safety signals were identified.

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In August 2016, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. The current indication remains unchanged and clinical trials continue, including KEYNOTE-048 (ClinicalTrials.gov, NCT02358031), a phase 3 clinical trial of KEYTRUDA in the first-line treatment of recurrent or metastatic HNSCC.
"We are encouraged by the positive impact that KEYTRUDA has had on many cancer patients, including those with previously treated recurrent or metastatic head and neck cancer, and we remain confident that KEYTRUDA is an important therapy for this difficult-to-treat cancer," said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "We look forward to sharing the comprehensive data analysis from KEYNOTE-040 with the scientific community at an upcoming medical meeting."

The KEYTRUDA clinical development program includes more than 30 tumor types in more than 500 clinical trials, including more than 300 trials that combine KEYTRUDA with other cancer treatments. Specific to head and neck cancer, Merck’s broad clinical development program encompasses multiple registration-enabling or supportive studies investigating KEYTRUDA (pembrolizumab) as monotherapy and in combination with other cancer treatments across multiple lines of therapy.

About KEYNOTE-040
KEYNOTE-040 is a randomized, multi-center, pivotal phase 3 study (ClinicalTrials.gov, NCT02252042) investigating KEYTRUDA as a monotherapy versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic HNSCC. The primary endpoint is OS; secondary endpoints include progression-free survival (PFS) and overall response rate (ORR). The study, which opened in November 2014, enrolled 495 patients to receive KEYTRUDA (200 mg fixed dose every three weeks) or investigator-choice chemotherapy (methotrexate [40 mg/m2 on Days 1, 8, and 15 of each 3-week cycle], docetaxel [75 mg/m2 on Day 1 of each 3-week cycle], or cetuximab [400 mg/m2 loading dose on Day 1 and 250 mg/m2 IV on Days 8 and 15 of Cycle 1], followed by cetuximab [250 mg/m2 on Days 1, 8, and 15 of each subsequent 3-week cycle]). Patients enrolled in the study had been previously treated with 1-2 platinum-containing systemic regimens.

About Head and Neck Cancer
Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. The leading modifiable risk factors for head and neck cancer include tobacco and heavy alcohol use. Other risk factors include infection with certain types of HPV, also called human papillomaviruses. Each year there are approximately 400,000 cases of cancer of the oral cavity and pharynx, in addition to approximately 160,000 cancers of the larynx, resulting in approximately 300,000 deaths.

About KEYTRUDA (pembrolizumab) Injection
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that 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.
Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The KEYTRUDA (pembrolizumab) clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including the exploration of several different biomarkers across a broad range of tumors.

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-dose vial.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

Lung Cancer
KEYTRUDA, as a single agent, 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, as a single agent, 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.

KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.

Head and Neck Cancer
KEYTRUDA (pembrolizumab) 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.

Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. 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 adults with cHL, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In locally advanced or metastatic urothelial carcinoma, KEYTRUDA (pembrolizumab) is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
· solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
· colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

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. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

In adult patients with MSI-H cancer, 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. In pediatric patients with MSI-H cancer, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or 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 (pembrolizumab) for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

KEYTRUDA (pembrolizumab) 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 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. The incidence of new or worsening hypothyroidism was higher in patients with HNSCC, occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3 (0.5%) 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 (pembrolizumab) for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse reactions. These immune-mediated reactions may occur in any organ system. 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. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Solid organ transplant rejection has been reported in postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, 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.

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after being treated with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with KEYTRUDA on any trial, 6 patients (26%) developed graft-versus-host-disease (GVHD), one of which was fatal, and 2 patients (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, one of which was fatal. Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Based on its mechanism of action, KEYTRUDA (pembrolizumab) 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 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (reported in at least 20% of patients) were fatigue (46%), decreased appetite (22%), and dyspnea (20%).

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.