On October 17, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported the presentation of data demonstrating progress in the development of a prognostic gene expression profile test for cutaneous squamous cell carcinoma (cSCC), one of the most common types of cancer (Press release, Castle Biosciences, OCT 17, 2018, View Source [SID1234529966]). The goal of the research program is to validate a gene expression profile test that improves upon current staging systems and identifies patients with cSCC with a high risk for recurrence, enabling more informed clinical management decisions. Aaron Farberg, M.D., Icahn School of Medicine at Mount Sinai, New York, presented the study last week during the Reconstructive, Skin Cancer and Mohs Micrographic Surgery session of the 2018 American Society for Dermatologic Surgery Annual Meeting held in Phoenix.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In this multi-center development study, more than 500 primary cSCC specimens were accrued from 14 centers, and gene expression analysis of candidate genes selected based on literature and pathway analysis was performed through reverse transcription polymerase chain reaction (RT-PCR). Predictive modeling with machine learning was performed on a preliminary development set that included both non-recurrent and recurrent cases with verified clinical data and outcomes.

Researchers successfully identified genes that exhibited significant differential expression between non-recurrent and recurrent cases, including several specific to regional/distant metastasis (p<0.05). An average of the top performing preliminary models for predicting metastasis or local recurrence had higher sensitivity and positive predictive value when compared to current staging methods, and maintained or improved comparable specificity and negative predictive value.

In addition to candidate genes selected from the literature, microarray analysis on 80 recurrent and non-recurrent cases permitted an unbiased, genome-wide approach for selection of additional genes through machine learning for validation.

"These study findings demonstrate continued progress in the development of a prognostic test for cSCC that can identify patients with a risk of metastasis more accurately than currently used staging systems," commented Chrysalyne D. Schmults, M.D., Brigham and Women’s Hospital, Boston, an investigator in the study. "Successful validation and clinical application of a test such as this could help inform clinical decision-making regarding the potential need for adjuvant therapy."

Based on demonstrated progress with initial development work, collaborative site recruitment and clinical study activities are actively continuing.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (cSCC), a non-melanoma skin cancer, is one of the most common cancers with an estimated incidence of more than 1,000,000 cases in the U.S. each year. Approximately 20% of patients have high-risk features based on tumor depth, histology, anatomic location and/or immunosuppression. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients each year die from their disease. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients that develop metastatic disease are misidentified as low risk. This leads to over and undertreatment of a substantial number of cSCC patients. To address this clinical need, Castle Biosciences is developing a gene expression profile test to improve upon current staging systems and identify patients with cSCC at high risk for metastasis and death, enabling more informed clinical decisions regarding adjuvant therapy and other management options.

On October 17, 2018 Spherix Incorporated (Nasdaq: SPEX) today provided shareholders with a video demonstration on its website of the potential effectiveness of CBM BioPharma, Inc.’s ("CBM) innovative drug platform (Press release, Spherix, OCT 17, 2018, View Source [SID1234538989]). As previously disclosed on October 11, 2018, Spherix entered into a merger agreement with CBM, a privately held innovative pharmaceutical company focused on the development of drugs in the multibillion-dollar oncology therapeutics market . The notable video, which was recorded at Wake Forest University, visually demonstrates the potential effectiveness of one of CBM’s primary drug candidates known as KPC34. Researchers at Wake Forest have been testing whether KPC34 can be used on mouse subjects to treat Acute Lymphoblastic Leukemia (ALL) that has spread to the nervous system. Once recurrent ALL spreads to the nervous system, patients often experience paralysis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the video, a mouse which suffers from hind leg paralysis as a result of recurrent late staged ALL is shown to improve dramatically from the paralysis within forty-eight hours of being treated with KPC34. Within just twenty-four hours of the first injection of KPC34, the mouse could walk. Forty-eight hours later a second injection was administered and the mouse was able to move about without challenges.

Anthony Hayes, CEO of Spherix, stated, "This remarkable video demonstrates the tremendous potential for this drug to treat ALL. The video was part of a written submission on KPC34 to PLOS OneTM a peer reviewed medical journal. We are collecting additional information to continually provide our shareholders with updates to help better educate them on these compounds and the biotechnology space generally. We anticipate further updates in the future."

On October 17, 2018 Transgene (Paris: TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops viral vector-based immunotherapies, reported the treatment of the first patient in the TG6002 Phase 1/2 trial in patients with advanced gastrointestinal tumors such as colon cancer, in the Léon Bérard center (Lyon) (Press release, Transgene, OCT 17, 2018, View Source [SID1234529952]). This multicenter trial is authorized in France, Belgium and Spain. It will include up to 59 patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TG6002 is a new generation multi-functional oncolytic virus that can be administered intravenously and combines several mechanisms of action . It was designed to combine the mechanism of oncolysis (destruction of the cancer cell) with local production of chemotherapy (5-FU), directly into the tumor. Induction of an immune response against tumor cells is another expected effect. TG6002 expresses the patented FCU1 gene in tumor cells that it has infected, leading to the local conversion of 5-FC (administered orally) to 5-FU. This is particularly important because of the sensitivity of most gastrointestinal tumors to 5-FU.

TG6002 has demonstrated in preclinical its ability to induce a response in the primary tumor as well as a distant effect on metastases by causing immunogenic cell death.

Dr. Philippe Cassier, PhD, principal investigator of the trial and head of the early phase trial unit at the Léon Bérard Center, explains: "Despite the improved prognosis of patients over the last 20 years, the median survival of metastatic colorectal cancer (CRC) patients remains below three years. Patients receive up to four successive treatment lines, which can be associated with significant side effects. In addition, the majority of these do not respond to immune checkpoint inhibitors. For this reason, 5-FU-based chemotherapy remains the standard treatment for this disease. TG6002, an oncolytic virus that destroys cancer cells and produces 5-FU at the heart of the tumor, is a promising therapy with the potential to be more effective and better tolerated by patients. "

Dr. Maud Brandely, PhD, Director, Clinical Development, Clinical Operations & Regulatory Affairs at Transgene, adds, "With its multiple mechanisms of action, TG6002 is an extremely promising oncolytic virus that is administered intravenously in this trial. The destruction of cancer cells, the production of chemotherapy in the tumor and the induction of a targeted immune response are all complementary approaches to better attack this disease. We look forward to the results that the oncolytic virus TG6002 will generate in this clinical trial. "

This half-open, single-arm trial is being conducted in Europe. It evaluates the safety and tolerability of multiple and increasing doses of intravenously administered TG6002 in combination with orally administered 5-FC. 5-FC is a non-cytotoxic precursor that can be converted to 5-FU. The primary endpoint of the Phase 1 part of the trial is safety; that of Phase 2 is efficiency. This trial will also evaluate the pharmacokinetic properties and biodistribution of TG6002, as well as the immune modulation of the tumor microenvironment.

About TG6002 A
new generation of oncolytic immunotherapy, TG6002 has been designed to induce the destruction of cancer cells (oncolysis) and to allow the production of 5-FU directly in the tumor. TG6002 is a modified, double-deleted Vaccinia virus (TK-RR-), expressing the patented FCU1 gene in tumor cells that it has infected in order to locally convert 5-FC (flucytosine), into 5-FU, a chemotherapy commonly used. Oncolytic virus TG6002 has shown its efficacy and good tolerability profile in several preclinical models. For Transgene, TG6002 represents a new therapeutic option for patients with recurrent solid tumors.
Another trial of TG6002 is underway in France in recurrent glioblastoma.

About gastrointestinal tumors
Gastrointestinal cancers include several forms of cancers of the digestive system. They include cancers of the esophagus, gall bladder, liver, pancreas, stomach, small bowel, colon, rectum and anus. Colorectal cancer (CRC) is the second most frequently diagnosed cancer in Europe and one of the leading causes of death in Europe and worldwide. In 2012, 447,000 new cases of CRC were reported in Europe, with 215,000 deaths. Worldwide, this represented 1.4 million new cases and 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Over the last decade, the prognosis of patients with metastatic CRC has improved

On October 17, 2018 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2018 (Press release, Abbott, OCT 17, 2018, View Source [SID1234529970]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third-quarter worldwide sales of $7.7 billion increased 12.1 percent on a reported basis and 7.8 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.31 in the third quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.75.
Abbott narrowed its full-year 2018 diluted EPS guidance range from continuing operations on a GAAP basis to $1.33 to $1.35 and adjusted diluted EPS from continuing operations to $2.87 to $2.89.
In the U.S., Abbott received FDA approval of its FreeStyle Libre 14 day sensor, making it the longest lasting wearable glucose sensor available. In October, Abbott obtained CE Mark for its FreeStyle Libre 2 system, a next-generation product offering with optional real-time alarms.

FreeStyle Libre achieving rapid market uptake, with third-quarter worldwide sales of $304 million, an increase of 101 percent versus prior year.
In July, Abbott received U.S. FDA approval for its third-generation version of its minimally invasive MitraClip heart valve repair device. This new version includes design advancements that simplify the procedure and enable more patients to be treated with MitraClip.
In September, Abbott announced positive clinical results from its landmark COAPT study, which demonstrated that its minimally invasive MitraClip heart valve repair device improved survival and clinical outcomes for select patients with functional mitral regurgitation, a leaky heart valve resulting from advanced heart failure. The COAPT study data will be submitted to the U.S. FDA to support consideration of an expanded indication for MitraClip.
"We achieved another quarter of strong growth and our new product pipeline continues to be highly productive," said Miles D. White, chairman and chief executive officer, Abbott. "In spite of increasing currency headwinds, we’re well-positioned to achieve the upper end of our initial full-year guidance."

* See note on organic growth below.

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;
Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the third quarter and first nine months of 2018:

* Total 2018 Abbott sales from continuing operations include Other Sales of $45 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2018 worldwide sales of $7.7 billion increased 12.1 percent on a reported basis. On an organic basis, worldwide sales increased 7.8 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 4.0 percent on a reported basis in the third quarter, including an unfavorable 2.1 percent effect of foreign exchange, and increased 6.1 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.6 percent on a reported basis in the third quarter, including an unfavorable 1.9 percent effect of foreign exchange, and increased 8.5 percent on an organic basis. International pediatric sales increased 7.4 percent on a reported basis, including an unfavorable 3.5 percent effect of foreign exchange, and increased 10.9 percent on an organic basis. Strong performance in the quarter was led by above-market growth in the U.S. and double-digit growth in both Asia and Latin America.

Worldwide Adult Nutrition sales increased 0.8 percent on a reported basis in the third quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 3.2 percent on an organic basis. International adult sales increased 2.9 percent on a reported basis, including an unfavorable 4.2 percent effect of foreign exchange, and increased 7.1 percent on an organic basis. Sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand. U.S. sales were negatively impacted by Abbott’s wind down of a non-core product line.

Diagnostics

* Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

* Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

Worldwide Diagnostics sales increased 42.6 percent on a reported basis in the third quarter. On an organic basis, sales increased 7.5 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 5.2 percent on a reported basis in the third quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 8.1 percent on an organic basis, reflecting above-market growth in the U.S. and internationally.

Molecular Diagnostics sales increased 4.7 percent on a reported basis in the third quarter, including an unfavorable 1.4 percent effect of foreign exchange, and increased 6.1 percent on an organic basis. Worldwide sales were led by growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market.

Point of Care Diagnostics sales increased 3.7 percent on a reported basis in the third quarter, including an unfavorable 0.3 percent effect of foreign exchange, and increased 4.0 percent on an organic basis, led by strong international growth of Abbott’s i-STAT handheld system.

Rapid Diagnostics worldwide sales of $481 million were led by cardiometabolic testing.

Established Pharmaceuticals sales decreased 0.9 percent on a reported basis in the third quarter, including an unfavorable 6.8 percent effect of foreign exchange, and increased 5.9 percent on an organic basis. As expected, sales growth in the quarter was negatively impacted by a comparison versus the third-quarter 2017, when sales were higher than normal due to channel restocking across the market after implementation of a new tax system in India.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 2.1 percent on a reported basis in the third quarter, including an unfavorable 8.9 percent effect of foreign exchange, and increased 6.8 percent on an organic basis. Sales growth was led by double-digit growth in China and Russia. Excluding the negative impact from prior year purchasing patterns associated with the implementation of a new tax system in India, Abbott’s Key Emerging Markets sales would have increased high-single digits on an organic basis in the third quarter.

Worldwide Medical Devices sales increased 8.4 percent on a reported basis in the third quarter. On an organic basis, sales increased 9.8 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation catheters as well as strong growth of Abbott’s Confirm RxTM Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZERTM PFO Occluder, a device designed to close a hole-like opening in the heart, and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, a leaky heart valve. In September, Abbott announced positive clinical results from its landmark COAPT study, which demonstrated that MitraClip improved survival and clinical outcomes for select patients with functional mitral regurgitation. The COAPT study data will be submitted to the U.S. FDA to support consideration of an expanded indication for MitraClip.

In Diabetes Care, sales increased 37.4 percent on a reported basis and 39.8 percent on an organic basis, led by rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, which removes the need for routine fingersticks1 for people with diabetes. During the quarter, Abbott received U.S. FDA approval of its FreeStyle Libre 14 day sensor, the longest lasting glucose wearable sensor available. In October, Abbott obtained CE Mark for its FreeStyle Libre 2 system, a next-generation product offering optional real-time alarms.

ABBOTT’S FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott is narrowing its 2018 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $1.33 to $1.35.

Abbott forecasts net specified items for the full year 2018 of approximately $1.54 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses.

Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $2.87 to $2.89 for the full year 2018.

Abbott is issuing fourth-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.39 to $0.41. Abbott forecasts specified items for the fourth quarter 2018 of $0.41 primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.80 to $0.82 for the fourth quarter.

ABBOTT DECLARES 379TH CONSECUTIVE QUARTERLY DIVIDEND

On Sept. 13, 2018, the board of directors of Abbott declared the company’s quarterly dividend of $0.28 per share. Abbott’s cash dividend is payable Nov. 15, 2018, to shareholders of record at the close of business on Oct. 15, 2018.

Abbott has increased its dividend payout for 46 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 17, 2018 Invenra, an antibody drug discovery and development company with novel multispecific platforms and product candidates, reported the close of a $7M Series B financing round (Press release, Invenra, OCT 17, 2018, View Source [SID1234570587]). The financing will be used to expand the company to meet growing demand for partnerships using its’ B-Body multispecific technology as well as continuing development of its internal pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Venture Investors led the round with participation from existing investors including Series A leader Wisconsin Investment Partners. The State of Wisconsin Investment Board (SWIB) also joined as a new investor. Additionally, Paul Weiss, Managing Director at Venture Investors, will join Invenra’s Board of Directors.

"Invenra’s discovery and development platform for bispecific antibodies has the potential to make meaningful contributions to the advancement of immuno-oncology", said Paul Weiss. "We already knew the capability of the team from our experience in backing Roland Green and members of the Board at NimbleGen Systems. We look forward to the opportunity to work together again on the important mission of Invenra."

Roland Green, CEO of Invenra, says "Invenra is excited to have Venture Investors and SWIB as part of our team. We look forward to working with Paul on our board as we develop our pipeline and partnerships. The additional funding will allow us to further leverage the B-Body platform for the high-throughput assessment of multispecific antibodies. This throughput and performance unlocks new and important therapeutic targets and mechanisms of action that were previously impractical through traditional methods. This funding along with milestones from partnerships will allow us to advance the preclinical development of our lead product candidates, namely our Biparatopic OX40 Agonist B-Body program and our tumor-specific Treg depleter SNIPER program."