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BioLineRx Completes Recruitment in Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients with Second-Line Metastatic Pancreatic Cancer

On January 22, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported the completion of patient recruitment in the triple combination arm of its ongoing Phase 2a COMBAT/KEYNOTE-202 study (Press release, BioLineRx, JAN 22, 2020, View Source [SID1234553404]).

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"We are pleased to see the triple combination arm of our Phase 2a pancreatic study advance according to plan," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This follows very promising initial results that were presented last month at the ESMO (Free ESMO Whitepaper) IO conference, demonstrating robust and durable responses to the triple combination treatment. As previously stated, we remain on track to announce progression-free and overall survival data from the triple combination arm in mid-2020."

A total of 40 patients diagnosed with unresectable stage IV metastatic pancreatic adenocarcinoma (PDAC), who have progressed following first-line gemcitabine-based therapy, were enrolled as planned in the triple combination arm focusing on second-line pancreatic cancer patients. Patients receive Motixafortide (BL-8040) monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and Motixafortide until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

Last month, the Company shared preliminary data at the ESMO (Free ESMO Whitepaper) IO conference showing that the triple combination demonstrated a 32% overall response rate (ORR) and a 77% disease control rate (DCR) out of 22 evaluable patients at the time. This compares favorably to the current chemotherapy standard-of-care treatment in second-line patients with ORR of 17% and DCR of 52%. In addition, the median duration of clinical benefit for all 17 patients with disease control (7 partial response and 10 stable disease patients) was 7.8 months, compared to approximately three months of response duration with other treatments for second-line pancreatic cancer.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of Motixafortide and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of Motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

AstraZeneca Young Health Programme to partner with UNICEF to prevent non-communicable diseases among young people

On January 22, 2020 AstraZeneca reported that it will support UNICEF with a $12.5 million grant to support programming which will reach more than five million young people, train 1,000 youth advocates, and positively shape public policy around the world, over the next six years (Press release, AstraZeneca, JAN 22, 2020, View Source [SID1234553403]).

The announcement follows AstraZeneca’s decision in October 2019 to continue to fund its Young Health Programme to 2025 with an overall commitment of $35m (£28m).

The AstraZeneca Young Health Programme will work with UNICEF and other partners to raise awareness of the risks and effects of non-communicable diseases (NCDs) such as cardiovascular disease, preventable cancers and mental health conditions among young people and key decision-makers.

The World Health Organisation (WHO) identifies NCDs as the number one cause of death worldwide1 and found that 70% of premature deaths from NCDs can be linked back to behaviours that first appear in adolescence2. Similarly, the World Economic Forum (WEF) has predicted that NCDs will cost the worldwide economy more than $47 trillion in lost productivity and wages by 20303.

Pascal Soriot, Chief Executive Officer, said: "We believe in the power of young people to change the trajectory of the staggering burden of disease we face today, all over the world. Improving the health outcomes of future generations is a critical part of developing strong and stable healthcare systems, which in turn support sustainable markets and the economic prosperity of nations."

Since its launch in 2010, the Young Health Programme has reached more than 3.5 million young people across six continents and trained more than 50,000 peer educators.

Gary Stahl, Director, UNICEF Private Fundraising and Partnerships, said: "The health and futures of young people must not be compromised by unhealthy lifestyles and behaviours. I am happy that UNICEF is joining a coalition of committed partners with the support of AstraZeneca to bring attention to NCDs which are now the world’s biggest killers. The burden of these diseases is closely linked to socio-economic factors and more work needs to be done on delivering the right messages through the right channels in countries to encourage healthy behaviours."

The other allies in the Young Health Programme are founding partner, and community-based programming lead, Plan International, youth engagement and development lead One Young World, and more than 30 other non-profit partners around the world, all working to improve health outcomes for young people through thoughtful programming, research and youth engagement activities.

The Young Health Programme

Since 2010 the Young Health Programme has reached over three million young people, through a mix of programmes, advocacy and research activities designed to increase awareness and understanding of NCD prevention. These have ranged over 24 countries and six continents from Australia to Zambia. Programmes range from one-to-one mentoring in Sweden, to long-running community-based behaviour change programmes involving hundreds of thousands of young people in Brazil and India. The methods may vary, but the drive is always the same – to help young people to lead longer, happier and healthier lives. For more information please visit younghealthprogrammeyhp.com.

Sierra Oncology Announces Reverse Stock Split

On January 22, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that its board of directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-40 (Press release, Sierra Oncology, JAN 22, 2020, View Source [SID1234553398]). The reverse stock split will be effective today at 4:30 p.m. Eastern Time. At the market open on January 23, 2020, the Company’s common stock will continue to trade on The Nasdaq Global Market under the symbol "SRRA," but will be assigned a new CUSIP number (82640U404) and will trade on a split-adjusted basis.

At the effective time of the reverse stock split, every 40 shares of the Company’s issued and outstanding common stock will be automatically combined and reclassified into one issued and outstanding share of common stock. The reverse stock split will not affect any stockholder’s ownership percentage of the Company’s common stock, alter the par value of the Company’s common stock, have any direct impact on the market capitalization of the Company, or modify any voting rights or other terms of the common stock.

The reverse stock split was approved by Sierra Oncology stockholders on January 21, 2020. Additional information regarding the reverse stock split, other matters voted upon, and the certified voting results will be filed on Form 8-K with the U.S. Securities and Exchange Commission.

As previously announced, shortly following the reverse stock split:

The Series A convertible voting preferred stock issued in the recently completed $103.0 million financing (gross proceeds) will be converted into shares of common stock, subject to the applicable beneficial ownership limitation.
Gilead Sciences, Inc. (Gilead) will be issued approximately 725,000 shares of common stock (on a post-split basis) and a warrant to purchase an equivalent amount of common stock, in consideration for amending the royalty rates and milestones in an Asset Purchase Agreement with Gilead for momelotinib.
Following the reverse stock split, assuming the conversion of all outstanding Series A convertible preferred voting shares to common stock, and the issuance of common stock to Gilead, there are expected to be approximately 10,394,600 total shares of common stock outstanding and warrants to purchase approximately 11,104,000 total shares of common stock outstanding on a post-split basis. Of these warrants, warrants to purchase approximately 2,574,700 shares of common stock (the Series B warrants) may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from Sierra Oncology’s ongoing Phase 3 clinical trial of momelotinib. If Series B warrants were fully exercised, the company would receive approximately $34.0 million in proceeds.

Sierra Oncology previously reported its cash and cash equivalents totaled $67.7 million as of September 30, 2019, and that subsequently it had closed an underwritten public offering with gross proceeds to Sierra Oncology of $103.0 million. Prior to the end of 2019, a term loan of $5.0 million was repaid to Silicon Valley Bank.

Oncolytics Biotech® Announces Publication of an Abstract for the 2020 Gastrointestinal Cancers Symposium Highlighting CEACAM6 as a Potential Prognostic Biomarker Candidate for Pancreatic Cancer

On January 22, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that abstract for a poster to be presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) in San Francisco, has been published (Press release, Oncolytics Biotech, JAN 22, 2020, View Source [SID1234553397]). The abstract highlights new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer.

The abstract, CEACAM6 is a candidate biomarker for Reolysin (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

Data in the abstract associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS improving from 5.72 months to 10.32 months (p=0.05). This effect was not seen in non-pelareorep treated patients. Consequently, CEACAM6 may serve as a prognostic biomarker for sensitivity of pancreatic tumors to pelareorep treatment. Additional data will be announced following the poster presentation.

Abstracts are available on the ASCO (Free ASCO Whitepaper) meeting library website at View Source The poster will be added to the Oncolytics corporate website shortly after the presentation.

Abstract ID: 285103
Abstract Number: 746
Poster Board: M13
Abstract Title: CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)

Session Information: Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer

Session Date & Time: January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

Abbott Reports Fourth-Quarter 2019 Results; Announces Strong Forecast for 2020

On January 22, 2020 Abbott (NYSE: ABT) reported financial results for the fourth quarter and full year ended Dec. 31, 2019 (Press release, Abbott, JAN 22, 2020, View Source [SID1234553396]).

Fourth-quarter worldwide sales of $8.3 billion increased 7.1 percent on a reported basis and 8.5 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.59 in the fourth quarter. Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.95, an increase of 17.3 percent versus prior year1.
Abbott issues full-year 2020 guidance for organic sales growth of 7.0 to 8.0 percent2, which excludes the impact of foreign exchange, and diluted EPS from continuing operations on a GAAP basis of $2.35 to $2.45. Projected full-year adjusted diluted EPS from continuing operations is $3.55 to $3.65, reflecting double-digit growth at the mid-point.
Medical Devices sales increased 9.7 percent on a reported basis and 11.3 percent on an organic basis in the fourth quarter. Sales performance was led by double-digit organic sales growth in Heart Failure, Electrophysiology, Structural Heart and Diabetes Care.
Established Pharmaceuticals sales increased 7.8 percent on a reported basis and 10.0 percent on an organic basis in the fourth quarter. Sales performance was led by growth across several countries in Latin America and Asia.
Core Laboratory Diagnostics sales increased 8.4 percent on a reported basis and 10.0 percent on an organic basis in the fourth quarter. Sales performance was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments.
"Our focus on organic growth is driving top-tier performance," said Miles D. White, chairman and chief executive officer, Abbott. "We’re entering 2020 with very good momentum and targeting continued strong growth."

* See note on organic growth below.

FOURTH-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.

Organicsales growth:

Excludes the results for a non-core business within U.S. Adult Nutrition during the first nine months of 2018 as this business was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the fourth quarter and full year 2019:

* Total Q4 2019 Abbott sales from continuing operations include Other Sales of $10 million.

* Total 12M 2019 Abbott sales from continuing operations include Other Sales of $57 million.

n/a = Not Applicable.

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.

Fourth-quarter 2019 worldwide sales of $8.3 billion increased 7.1 percent on a reported basis. On an organic basis, worldwide sales increased 8.5 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 5.2 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 5.8 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 2.4 percent on a reported basis in the fourth quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 2.8 percent on an organic basis. International sales increased 3.4 percent on a reported basis and 4.1 percent on an organic basis. Sales growth was led by Abbott’s market-leading toddler brands, PediaSure and Pedialyte.

Worldwide Adult Nutrition sales increased 8.9 percent on a reported basis in the fourth quarter and increased 9.9 percent on an organic basis. International Adult Nutrition sales increased 9.9 percent on a reported basis and 11.5 percent on an organic basis in the fourth quarter. Sales performance in the quarter 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.

Worldwide Diagnostics sales increased 5.0 percent on a reported basis in the fourth quarter, including an unfavorable 1.4 percent effect of foreign exchange, and increased 6.4 percent on an organic basis.

Core Laboratory Diagnostics sales increased 8.4 percent on a reported basis and 10.0 percent on an organic basis in the fourth quarter. Sales performance was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments. During the quarter, Abbott announced the Australian Red Cross Blood Services selected its Alinity-S system for the country’s blood and plasma screening.

Molecular Diagnostics sales decreased 5.7 percent on a reported basis in the fourth quarter, including an unfavorable 1.3 percent effect of foreign exchange, and decreased 4.4 percent on an organic basis.

Point of Care Diagnostics sales decreased 0.5 percent on a reported basis in the fourth quarter, including an unfavorable 0.3 percent effect of foreign exchange, and decreased 0.2 percent on an organic basis.

Rapid Diagnostics sales increased 1.5 percent on a reported basis in the fourth quarter, including an unfavorable 1.2 percent effect of foreign exchange, and increased 2.7 percent on an organic basis. Organic sales growth was led by infectious disease testing in developed markets and cardio-metabolic testing globally, partially offset by lower infectious disease testing sales in Africa.

Established Pharmaceuticals sales increased 7.8 percent on a reported basis in the fourth quarter, including an unfavorable 2.2 percent effect of foreign exchange, and increased 10.0 percent on an organic basis.

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 increased 7.0 percent on a reported basis in the fourth quarter and increased 9.5 percent on an organic basis, which excludes an unfavorable 2.5 percent effect of foreign exchange. Organic sales growth was led by performance across several geographies in Latin America and Asia.

Other sales increased 10.4 percent on a reported basis in the fourth quarter, including an unfavorable 1.2 percent effect of foreign exchange, and increased 11.6 percent on an organic basis.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Note: Insertable Cardiac Monitor (ICM) sales, which had previously been reported in Electrophysiology, are now included in Rhythm Management. Historical periods have been adjusted to reflect this change.

Worldwide Medical Devices sales increased 9.7 percent on a reported basis in the fourth quarter and increased 11.3 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, growth was led by strong performance in cardiac diagnostic and ablation catheters, which are used to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, double-digit growth was driven by market adoption of Abbott’s HeartMate 3 left ventricular assist device, which has been shown to improve survival and clinical outcomes in patients with advanced heart failure.

Growth in Structural Heart was led by MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, or a leaky mitral heart valve. Worldwide sales of MitraClip were $191 million in the fourth quarter, an increase of 27.1 percent on a reported basis and 28.8 percent on an organic basis versus the prior year.

In Diabetes Care, sales increased 30.5 percent on a reported basis and 33.7 percent on an organic basis in the fourth quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $534 million, an increase of 58.5 percent on a reported basis and 62.4 percent on an organic basis versus the prior year.

ABBOTT ISSUES GUIDANCE FOR 2020
Abbott is issuing full-year 2020 guidance for organic sales growth of 7.0 to 8.0 percent2, which excludes the impact of foreign exchange, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $2.35 to $2.45. Abbott forecasts net specified items for the full year 2020 of $1.20 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 $3.55 to $3.65 for the full year 2020.

Abbott is issuing first-quarter 2020 guidance for diluted earnings per share from continuing operations under GAAP of $0.40 to $0.42. Abbott forecasts specified items for the first quarter 2020 of $0.29 per share 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 $0.69 to $0.71 for the first quarter.

ABBOTT ANNOUNCES INCREASE IN QUARTERLY DIVIDEND
On Dec. 13, 2019, the board of directors of Abbott increased the company’s quarterly dividend to $0.36 per share from $0.32 per share, an increase of 12.5 percent. Abbott’s cash dividend is payable Feb. 14, 2020, to shareholders of record at the close of business on Jan. 15, 2020.

Abbott has increased its dividend payout for 48 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.