On November 28, 2016 Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center (Press release, Portola Pharmaceuticals, NOV 28, 2016, View Source;p=RssLanding&cat=news&id=2225808 [SID1234516814]).

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AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.

The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.

AndexXa (andexanet alfa)

Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban

Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib

Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GHNovember 28, 2016) – Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center.

AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.

The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.

AndexXa (andexanet alfa)

Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban

Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib

Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GH

On November 28, 2016 ORN-OncoPep, Inc. reported that a Phase 1b clinical trial is underway to evaluate PVX-410, a multi-peptide therapeutic cancer vaccine, as an adjuvant treatment in patients who have completed all planned therapy for stage II or III triple negative breast cancer (TNBC) (Press release, OncoPep, NOV 28, 2016, View Source [SID1234516819]). The study, led by Steven Isakoff, M.D., Ph.D. at Massachusetts General Hospital, will assess the safety and tolerability of PVX-410 in combination with the checkpoint inhibitor durvalumab.

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"In this Phase 1b clinical trial, we are looking to evaluate the safety of PVX-410 alone and in combination with durvalumab, and to determine whether the vaccine and durvalumab can work together to assist immune system recognition of TNBC," said Dr. Isakoff, Associate Director for Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center and Assistant Professor in Medicine at Harvard Medical School. "We are hopeful that this approach will allow immune system recognition of cancer-associated antigens and result in a targeted immune response that can be utilized as a possible adjuvant treatment for stage II or III TNBC."

"The initiation of this Phase 1b clinical trial of PVX-410 in TNBC marks an important milestone in OncoPep’s development," said Doris Peterkin, Chief Executive Officer of OncoPep. "We are now developing PVX-410 in two oncology indications, TNBC and smoldering multiple myeloma, in which we are hopeful that the vaccine will provide enhanced immune targeting of cancer cells for improved patient outcomes."

The multi-center, open label Phase 1b study is designed to evaluate the safety, tolerability, and immune response to PVX-410 alone and in combination with durvalumab in an adjuvant setting in patients who have completed all planned therapy for stage II or III TNBC. Patients will receive six bi-weekly intramuscular injections of PVX-410, which will be given in combination with an intravenous infusion of durvalumab on the day of the 4th and 6th PVX-410 injection. The study is expected to enroll approximately 20 patients at multiple treatment centers, including Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and Dana-Farber Cancer Institute. More information on the trial can be found at clinicaltrials.gov, identifier number NCT02826434.

About Triple Negative Breast Cancer
Triple negative breast cancer (TNBC) is a form of breast cancer that lacks the three receptors found most commonly on breast cancer cells: estrogen receptor (ER), progesterone receptor (PR), and hormone epidermal growth factor receptor 2 (HER-2). TNBC accounts for approximately 15-20% of all breast cancer cases and is more likely to spread and recur than other forms of breast cancer.

About PVX-410
PVX-410 is a novel therapeutic cancer vaccine currently in Phase 1b clinical trials in smoldering multiple myeloma and triple negative breast cancer. PVX-410 consists of four peptides from unique regions of three cancer-associated antigens and is designed to elicit an immune response to the targeted tumor antigens. PVX-410 was granted orphan drug designation from the U.S. Food and Drug Administration in 2013.

On November 28, 2016 Zymeworks Inc., a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that its abstract has been accepted for Poster Presentation at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held from December 3-6, 2016 in San Diego, California (Press release, Zymeworks, NOV 28, 2016, View Source [SID1234516820]).

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Zymeworks will present at the following session:

Session Information: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I
Abstract Title: ZW38, a Novel Azymetric Bispecific CD19-Directed CD3 T Cell Engager Antibody Drug Conjugate with Controlled T Cell Activation and Improved B Cell Cytotoxicity
Date: December 3, 2016
Time: 5:30 p.m. – 7:30 p.m. PST
Location: San Diego Convention Center, Hall GH

On November 25, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, reported financial results for the nine months ended September 30, 2016 and updates on its drug development programs (Filing, Q3, Can-Fite BioPharma, 2016, NOV 25, 2016, View Source [SID1234516799]).

Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – EMA Clearance Received for Phase III Trials in Rheumatoid Arthritis & Psoriasis to Commence in 2017

Rheumatoid Arthritis: Piclidenoson is being developed as a first line therapy and replacement for the current gold standard, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The Company plans to submit its study protocol to Institutional Review Boards (IRBs) of clinical sites in the first quarter of 2017.

Rheumatoid arthritis is a treatment market forecast to reach $38.5 billion by 2017.

Psoriasis: Can-Fite reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase III trial for Piclidenoson in the treatment of psoriasis. The Phase III trial, expected to commence enrollment in the second half of 2017, will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis.

During the third quarter, Can-Fite received a Notice of Allowance from the European Patent Office indicating the patent titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) for Treatment of Psoriasis" will be granted.

The Journal of Drugs in Dermatology published data in August from Can-Fite’s Phase II/III trial of Piclidenoson in the treatment of moderate to severe psoriasis. The study is titled "Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial."

The psoriasis market is forecast to be $8.9 billion in 2018.

● Namodenoson (CF102) – Distribution deal in South Korea; Ongoing Phase II in Liver Cancer & Phase II NAFLD/NASH Protocol Submitted to IRB

In October, Can-Fite signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) for the exclusive right to distribute Namodenoson for the treatment of liver cancer in South Korea. The deal includes up to $3,000,000 in upfront and milestone payments, plus a percentage of royalties on net sales in the low twenties. CKD also negotiated for a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma, the most common form of liver cancer. A total of approximately 78 patients are expected to be enrolled in the U.S., Europe, and Israel.

Molecular Medicine Report published an article titled, "A3 adenosine receptor agonist, CF102, protects against hepatic ischemia/reperfusion injury following partial hepatectom" during the third quarter. The article reports the results of preclinical studies conducted by Can-Fite, showing Namodenoson protects the liver from ischemia/reperfusion injury and regenerates liver cells following partial hepatectomy.

Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.

NAFLD/NASH: In conjunction with world renowned Key Opinion Leaders in the field of liver diseases, Can-Fite completed the study design of its upcoming Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

This Phase II clinical trial protocol was submitted to leading Institutional Review Boards (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.

By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

● CF602 – Broad Patent Estate in Sexual Dysfunction & Other Indications

A Notice of Allowance was granted to Can-Fite by the U.S. Patent and Trademark Office in November for the Company’s patent application covering A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction. The patent addresses methods for treating erectile dysfunction with different A3AR ligands including Can-Fite’s erectile dysfunction drug candidate, CF602. With this new broader patent protection, Can-Fite has made a strategic decision to investigate additional compounds, owned by the Company, for the most effective and safest profile in this indication. As such, the Company will postpone its planned Investigational New Drug (IND) submission for this indication.

"Today Can-Fite stands poised to enter two pivotal Phase III trials in autoimmune disease where there is a clear need for an effective oral drug that can be taken safely, on a long-term basis. In the treatment of liver diseases, we look forward to completing our Phase II trial in liver cancer and commencing a Phase II trial in NAFLD/NASH. We believe our small molecule oral drug candidates offer very clear advantages over other drugs on the market that patients cannot tolerate longer term due to safety and IV administration issues. Along with benefits to patients, it is our strong belief that our drug candidates will improve healthcare economics and create growing value for our shareholders," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the nine months ended September 30, 2016 were NIS 0.64 million (U.S. $0.17 million) compared to NIS 0.54 million (U.S. $0.14 million) in the first nine months of 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2016 were NIS 15.45 million (U.S. $4.11 million) compared with NIS 9.58 million (U.S. $2.55 million) for the same period in 2015. Research and development expenses for the first nine months of 2016 comprised primarily of expenses associated with the Phase II study for CF102, preclinical study for CF602, as well as expenses for ongoing studies of CF101. The increase is due to costs associated with preparations of the aforementioned studies.

General and administrative expenses were NIS 7.88 million (U.S. $2.1 million) for the nine months ended September 30, 2016 compared to NIS 6.79 million (U.S. $1.81 million) for the same period in 2015. The increase is primarily due to an increase in share based compensation expense.

Financial income, net for the nine months ended September 30, 2016 aggregated NIS 3.12 million (U.S. $0.83 million) compared to financial expenses, net of NIS 4.7 million (U.S. $1.25 million) for the same period in 2015. The increase in financial income, net in the first nine month of 2016 was mainly due to a decrease in the fair value of warrants that are accounted for as financial liability as compared to an increase in the fair value of these warrants in the same period in 2015. In addition, the increase in financial income, net in the first nine months of 2016 was offset by an increase in financial expenses due to exchange rate differences as compared to insignificant financial income from exchange rate differences and capital issuance expenses for the same period in 2015.

Can-Fite’s net loss for the nine months ended September 30, 2016 was NIS 19.56 million (U.S. $5.2 million) compared with a net loss of NIS 20.53 million (U.S. $5.46 million) for the same period in 2015. The decrease in net loss for the first nine month of 2016 was primarily attributable to an increase in financial income, net offset by an increase in research and development expenses.

As of September 30, 2016, Can-Fite had cash and cash equivalents of NIS 37.57 million (U.S. $10 million) as compared to NIS 66.03 million (U.S. $17.57 million) at December 31, 2015. The decrease in cash during the nine months ended September 30, 2016 is due to operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on September 30, 2016 (U.S. $1 = NIS 3.758).

The Company’s consolidated financial results for the nine months ended September 30, 2016 are presented in accordance with International Financial Reporting Standards.

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On November 24, 2016 Kymab Group Limited ("Kymab"), a leading monoclonal antibody biopharmaceutical group, reported that it has successfully secured a US$100 million (£81 million) Series C financing (Press release, Kymab, NOV 24, 2016, View Source [SID1234537010]). The financing was led by new investors ORI Healthcare Fund L.P. ("ORI Fund") with participation by Shenzhen Hepalink Pharmaceutical Co., Ltd ("Hepalink") as well as follow-on investments from existing shareholders: Wellcome Trust, Bill & Melinda Gates Foundation, Malin Corporation plc, CF Woodford Equity Income Fund and Woodford Patient Capital plc.

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The funds will enable Kymab to advance its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies the first of which is commencing clinical development in 2017.

"We are delighted to welcome new investors ORI Fund and Hepalink and would like to thank our existing investors for their continued support in our goal of building Kymab into a sustainable global biopharmaceutical company with a pipeline of products in four main therapeutic areas: immuno-oncology, auto-immunity, haematology and infectious disease," says Dr Dave Chiswell, CEO of Kymab.

"ORI Fund and Hepalink bring deep experience of the pharmaceutical industry. Hepalink has a global reach for their products and have biologics manufacturing capability in the US. This investment will help us maximise the potential of the Kymab pipeline as we develop and commercialise monoclonal antibody medicines for patients world-wide."

"We are very fortunate to have the opportunity to invest in Kymab which is equipped with world class technologies, world class programs, a world class team and world class investors," says Ms Simone Song, Senior Partner of ORI Fund. "We look forward to working with Dave and his team to fully realise the potential of Kymab as it enters into the clinic with a global presence."

"We have had a biologics strategy for a number of years and believe Kymab has one of the most comprehensive humanised transgenic antibody platforms which is already delivering first-in-class antibodies," explains Mr Li Li, President and Chairman of Hepalink. "We are pleased to invest in a world leading antibody company and look forward to potential collaborative opportunities with Kymab"

Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Data published in Nature Biotechnology demonstrate that the Kymouse technology yields an antibody library constituted from 100 trillion different antibodies. From this deep library rare high-quality antibodies can be selected and developed into therapeutics.

Five of the top ten best-selling drugs are antibodies. This is because antibodies are natural products with exquisite specificity and potency, and generally have superior safety profiles. The challenge has been to capture the full human antibody repertoire and to recapitulate all its attributes.

The Series C follows the US$120 million Series A and B financings.

Notes to Editors
Issued 24 November, 2016