Baxalta and Award-winning Photographer Debut Unique Exhibition Showcasing Perspectives of Those Impacted by Rare Cancers

On May 31, 2016 Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported the unveiling of an initiative that illustrates the perspectives of those impacted by rare cancers, created in partnership with photographer Rick Guidotti of Positive Exposure (Press release, Baxalta, MAY 31, 2016, View Source [SID:1234512924]). The photo exhibit, Rare Cancer Illuminated: a View From Within, debuts on June 2 in Chicago as part of The Atlantic’s "The Search for Answers: Fighting Rare Cancers," which Baxalta is underwriting.

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"The Search for Answers: Fighting Rare Cancers"
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People living with rare and underserved cancers often experience difficulty with disease recognition, late or inaccurate diagnosis,1 limited treatment options, and scarcity of clinical trial availability or registries.2 Through photography, Guidotti and Baxalta aim to raise awareness and understanding of the unique challenges that rare cancer communities face and encourage greater collaboration to achieve more efficient diagnoses, treatment, access, and support.

The exhibit gathers individuals connected by various types of rare adult, pediatric, and adolescent cancers, such as pancreatic cancer, myelodysplastic syndromes (MDS), and acute lymphoblastic leukemia (ALL), and aims to illuminate the passion that drives them daily. While there is no international consensus on the definition of rare cancer, it is defined as fewer than 15 per 100,000 cases per year in the U.S.3 In Europe, rare disease is defined as those with a prevalence of fewer than 50 per 100,000 cases.3 Underserved cancers are typically referred to as those receiving inadequate physical or emotional resources.

"At Baxalta, our mission is to improve the lives of individuals affected by rare cancers through the use of innovative technologies and approaches, such as harnessing the body’s immune system," said David Meek, Executive Vice President and President, Oncology, Baxalta. "Our collaboration with Positive Exposure aims to raise awareness of rare cancers and to unite the community to drive action."

Guidotti founded the not-for-profit organization, Positive Exposure, in 1998, to celebrate and understand human diversity. Using photography, Guidotti aims to change public perception by helping people to see beyond standard definitions of beauty and arrive at their own interpretation. Rare Cancer Illuminated: a View From Within features photographs by Guidotti of rare cancer community members including those who have been diagnosed with cancer, their family and friends, advocacy organizations, and healthcare professionals. The exhibit will travel to Europe later this year.

"Baxalta’s commitment to serving rare cancer communities aligns with my vision to see beyond disease or diagnosis and celebrate our shared humanity," said Guidoitti, Founder, Positive Exposure. "We hope that people who experience this exhibit are able to take away a greater sense of understanding and compassion for communities that are up against these challenges, and feel empowered to learn more and become part of the effort to bring solutions."

The exhibit includes representation from leading advocacy organizations including: American Cancer Society Cancer Action Network; Austrian Childhood Cancer Organization; the Myelodysplastic Syndromes (MDS) Foundation, Inc.; PAN-Austria (Patient Advocacy for Adolescents and Young Adults with Neoplasia); Pancreatic Cancer Action; Stupid Cancer, Inc.; and TEB e.V. Germany (translated to Tumors and Diseases of the Pancreas). Together, their stories focus on the need for improved delivery and access to critical resources and support worldwide.

The Atlantic’s "The Search for Answers: Fighting Rare Cancers," underwritten by Baxalta, will take place on June 2 from 2:00-5:00 p.m. CDT in Chicago ahead of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The event will focus on topics such as the fight against rare cancer, the role of advocacy organizations, the White House’s Moonshot Initiative, patient access, and support networks. Confirmed speakers include: Richard Schilsky, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Chief Medical Officer and co-author of Value Framework; American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld; and Kim Thiboldeaux, President and Chief Executive Officer of the Cancer Support Community.

This event is open to media; please RSVP directly to The Atlantic’s Sydney Simon ([email protected]; 202-266-7338) to attend. A live stream of the afternoon’s conversations will be available beginning at 2:30 p.m. CDT on June 2 on AtlanticLIVE’s website where it will be archived for later viewing.

ASLAN003

ASLAN003 is a small molecule inhibitor of DiHydroOrotate DeHydrogenase (DHODH), an enzyme which catalyses the key rate-limiting step in the synthesis of pyrimidines in mammalian cells (Company Pipeline, ASLAN Pharmaceuticals, MAY 31, 2016, View Source [SID:1234512877]). In studies conducted to date, ASLAN003 has generated promising emerging preclinical data in oncology indications where the mechanism is linked with induction of p53 and apoptosis. ASLAN plans to develop ASLAN003 in several oncology indications as monotherapy and in combination with other targeted agents.

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ASLAN004

ASLAN004 is a fully human therapeutic monoclonal antibody that neutralises both interleukin 4 (IL-4) and interleukin 13 (IL-13) by binding to the IL-13Rα1 (Company Pipeline, ASLAN Pharmaceuticals, MAY 31, 2016, View Source [SID:1234512886]). The IL-13Rα1 is a key component of the type II receptor dimer that is expressed in epithelial cells, airway smooth muscle, alternatively activated (M2) macrophages, NKT cells, mast cells, eosinophils and basophils. In allergic diseases such as asthma and atopic eczema, IL-4 and IL-13 play a pivotal role in causing airway hyperresponsiveness, pulmonary inflammation, mucus hypersecretion, lung oeosinophilia and increases in allergen specific circulating IgE.

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In oncology, IL-13 signaling is emerging as a key driver of proliferation in cutaneous T-cell lymphoma. More generally in oncology, agonsim of IL-13Rα1 via IL-13 is recognised as a key driver in a shift from an M1 (proinflammatory) to M2 (regulatory/repair) macrophage phenotype that is used by tumour cells to evade killing via host immune surveillance. IL-13Rα1 is a specific marker for the M2 macrophage and mouse studies demonstrate that bone marrow cells from IL-13Rα1 knockout mice preferentially differentiate to an M1 macrophage phenotype. Similarly, knockout of IL-13 or knockdown of IL-13Rα1 via miRNA-155 triggers a switch to an M1 macrophage phenotype (Dhakal et al, 2014, Martinez-Nunez et al, 2011). Consequently, inhibition of IL-13 signalling is emerging as an immune checkpoint for tumour evasion of host immune surveillance and hence an important mechanism for enhancing the immune infiltrate in the tumour microenvironment.

ASLAN004 is the only therapeutic antibody that targets IL-13Rα1, and is progressing into a range of allergic disorders and oncology indications as both monotherapy and in combination with existing immunotherapies.

Janssen’s IMBRUVICA® (ibrutinib) Approved by European Commission for Patients with Newly Diagnosed Chronic Lymphocytic Leukaemia

On May 31, 2016 Janssen-Cilag International NV (Janssen) reported that the European Commission (EC) has approved IMBRUVICA (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (Press release, Johnson & Johnson, MAY 31, 2016, View Source [SID:1234512902]).1 This broadens the indication beyond the initial CLL approval by the EC in October 2014. Ibrutinib is now approved for all patients with CLL, expanding the number of patients who may benefit from this treatment.

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The expanded ibrutinib indication is based on data from the Phase 3, randomised, open-label RESONATE-2 trial, as published in The New England Journal of Medicine (NEJM) in 2015.

"Ibrutinib has shown remarkable improvements in overall survival, progression-free survival and response rates compared with chlorambucil," said Professor Paolo Ghia, Associate Professor of Internal Medicine at Università Vita-Salute San Raffaele in Milan, Italy. "The RESONATE-2 data indicate that ibrutinib can provide a much-needed first line treatment alternative for many patients."

Results from the RESONATE-2 study showed that ibrutinib significantly prolonged overall survival (OS) (HR=0.16, 95 percent CI 0.05 to 0.56; P=0.001), with 98 percent of patients still alive after two years, compared to 85 percent for patients randomised to the chlorambucil arm.2 The median progression-free survival (PFS) was not reached for patients receiving ibrutinib versus 18.9 months for those in the chlorambucil arm, representing a statistically significant 84 percent reduction in the risk of death or progression in the ibrutinib arm (HR=0.16, 95 percent CI 0.09 to 0.28; P<0.001).2 The overall safety of ibrutinib in the treatment-naïve CLL patient population was consistent with previously reported studies.3 The most common adverse reactions (ARs) (=20 percent) of any Grade in the RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30 percent), cough (22 percent) and nausea (22 percent).2

"The availability of a targeted therapy as an initial treatment is a tremendous step forward for people affected by CLL and has been long-awaited by the CLL community," said Nick York, patient advocate, CLL Advocates Network (CLLAN). "Many patients are considered unsuitable for the current first line standard of care so there is a real need for new, effective treatment options for these patients."

Despite the availability of effective first line chemo-immunotherapy regimens for CLL, many patients, especially the elderly, cannot tolerate their adverse effects.3 CLL is generally a slow-growing blood cancer of the white blood cells.4 The prevalence rate of CLL in Europe among men and women is approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.5,6 CLL is predominantly a disease of the elderly, with a median age of 72 at diagnosis.7

"The body of clinical and real-world evidence in support of ibrutinib’s patient benefits continues to grow, and with this first line approval we are so pleased to be able to alter the treatment landscape and options for CLL patients," said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. "We now look forward to working with health authorities across the region to make ibrutinib available to patients in this indication as soon as possible."

This latest EC approval follows the decision by the U.S. Food and Drug Administration on 04 March 2016 to approve the expanded use of ibrutinib capsules for treatment-naïve patients with CLL.

Ibrutinib is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie company. Janssen affiliates market ibrutinib in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where Janssen Biotech, Inc. and Pharmacyclics co-market it. Janssen and Pharmacyclics continue to support an extensive clinical development program for ibrutinib, including Phase 3 study commitments in multiple patient populations.

#ENDS#
About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9

Ibrutinib is currently approved in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL); for previously untreated adult patients with chronic lymphocytic leukaemia (CLL) or those who have received at least one prior therapy; and in adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.10

Additional uses are under clinical investigation but have not yet been granted regulatory approval.

Please see the ibrutinib summary of product characteristics for further information.

About CLL

CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.11 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options each time. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On May 27, 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 three months ended March 31, 2016 and updates on its drug development programs (Filing, Q1, Can-Fite BioPharma, 2016, MAY 27, 2016, View Source [SID:1234512832]).

Clinical Development Program and Corporate Highlights Include:

● CF101 – Phase II Glaucoma Results Expected in June; Phase III Trials in Rheumatoid Arthritis & Psoriasis Scheduled to Commence in 2016

In June 2016, Can-Fite plans to report data from a Phase II trial of CF101, conducted by its subsidiary OphthaliX, in the treatment of glaucoma and related syndromes of ocular hypertension.

During the first quarter of 2016, Can-Fite submitted a Phase III trial protocol for CF101 in the treatment of rheumatoid arthritis to the European Medicines Agency (EMA) and is currently expecting EMA input.

On March 7, 2016, Can-Fite presented data at the American Academy of Dermatology’s 74th Annual Meeting in Washington D.C. in a poster titled, "Treatment of Plaque-type Psoriasis with Oral CF101: Data from a Phase II/III Clinical Trial." The Company plans to file a Phase III trial protocol for CF101 in the treatment of psoriasis with the EMA in the first half of 2016 and commence the study by the end of 2016.

● CF102 – Conducting Phase II Trial in Liver Cancer & Plans to Commence Phase II Trial in NASH

Can-Fite continues to enroll and dose patients in its global Phase II liver cancer study in the U.S., Europe, and Israel. Completion of enrollment with approximately 78 patients is expected in the second half of 2016. The Company is preparing to file its Phase II protocol for CF102 in the treatment of non-alcoholic steatohepatitis (NASH), with institutional review boards (IRBs) in the second quarter of 2016.

● CF602 – Reports New Pre-Clinical Data & Preparing to Submit an IND to FDA for Treatment of Sexual Dysfunction

Following the end of the first quarter, in April 2016 Can-Fite reported new data for CF602, showing a statistically significant full recovery from erectile dysfunction after one single dose treatment in a pre-clinical diabetic model.

Can-Fite plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for a Phase I study of CF602 in the treatment of sexual dysfunction during the fourth quarter of 2016.

"During the first quarter, we made advancements in both our drugs heading into Phase III and our earlier stage indications. For CF101, we look forward to reporting data from our Phase II glaucoma trial and anticipate receiving input from the EMA on our pivotal Phase III rheumatoid arthritis trial in the coming month," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the three months ended March 31, 2016 were NIS 0.21 million (U.S. $0.06 million). We did not record any revenues during the three months ended March 31, 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 three months ended March 31, 2016 were NIS 4.08 million (U.S. $1.08 million) compared with NIS 2.33 million (U.S. $0.62 million) for the same period in 2015. Research and development expenses for the first quarter of 2016 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The increase is primarily due to costs associated with preparations of the CF101 Phase III studies in the treatment of rheumatoid arthritis and psoriasis.

General and administrative expenses were NIS 2.36 million (U.S. $0.63 million) for the three months ended March 31, 2016 compared to NIS 2.48 million (U.S. $0.66 million) for the same period in 2015. The minimal decrease is primarily due to a reduction in professional services expenses.

Financial income, net for the three months ended March 31, 2016 aggregated NIS 0.44 million (U.S. $0.12 million) compared to financial income, net of NIS 3.3 million (U.S. $0.88 million) for the same period in 2015. The decrease in financial income, net in the first quarter of 2016 was mainly due to a smaller decrease in the fair value of warrants that are accounted as financial liability as compared to the same period in 2015. In addition, the decrease in financial income, net in the first quarter of 2016 was attributable to an increase in expenses due to exchange rate differences as compared to the same period in 2015.

Can-Fite’s net loss for the three months ended March 31, 2016 was NIS 5.79 million (U.S. $1.54 million) compared with a net loss of NIS 1.51 million (U.S. $0.40 million) for the same period in 2015. The increase in net loss for the first quarter of 2016 was primarily attributable to an increase in research and development expenses and a decrease in financial income, net.

As of March 31, 2016, Can-Fite had cash and cash equivalents of NIS 56.61 million (U.S. $15.03 million) as compared to NIS 66.03 million (U.S. $17.53 million) at December 31, 2015. The decrease in cash during the three months ended March 31, 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 March 31, 2016 (U.S. $1 = NIS 3.766).

The Company’s consolidated financial results for the three months ended March 31, 2016 are presented in accordance with International Financial Reporting Standards.

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INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)

Convenience translation into
U.S. dollars

March 31, March 31, December 31,
2016 2016 2015
Unaudited
USD NIS

ASSETS

CURRENT ASSETS:

Cash and cash equivalents 15,032 56,610 66,026
Other receivable and prepaid expenses 1,384 5,213 2,419

Total current assets 16,416 61,823 68,445

NON-CURRENT ASSETS:

Lease deposits 7 27 27
Property, plant and equipment, net 68 254 236

Total long-term assets 75 281 263

Total assets 16,491 62,104 68,708

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)


Convenience translation into
U.S. dollars

March 31, March 31, December 31,
2016 2016 2015
Unaudited
USD NIS

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables 1,005 3,784 1,803
Deferred revenues 227 857 857
Other accounts payable 843 3,174 4,279

Total current liabilities 2,075 7,815 6,939

NON-CURRENT LIABILITIES:

Warrants exercisable into shares 3,968 14,942 16,725
Deferred revenues 910 3,427 3,641
Severance pay, net 169 636 630

Total long-term liabilities 5,047 19,005 20,996

CONTINGENT LIABILITIES AND COMMITMENTS

EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:

Share capital 1,867 7,030 7,030
Share premium 88,389 332,873 332,873
Capital reserve from share-based payment transactions 5,192 19,552 19,288
Warrants exercisable into shares (series 10-12) 2,385 8,983 8,983
Treasury shares, at cost (964 ) (3,628 ) (3,628 )
Accumulated other comprehensive loss (366 ) (1,380 ) (1,401 )
Accumulated deficit (87,267 ) (328,647 ) (322,876 )

Total equity attributable to equity holders of the Company 9,236 34,783 40,269

Non-controlling interests 133 501 504

Total equity 9,369 35,284 40,773

Total liabilities and equity 16,491 62,104 68,708

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)


Convenience translation into
U.S. dollars

Three months ended March 31,
2016 2016 2015
Unaudited
USD NIS NIS


Revenues 57 214 -

Research and development expenses 1,083 4,077 2,328
General and administrative expenses 628 2,364 2,476

Operating loss 1,654 6,227 4,804

Finance expenses 382 1,438 18
Finance income (499 ) (1,878 ) (3,316 )
Net loss 1,537 5,787 1,506

Other comprehensive loss (income):
Adjustments arising from translating financial statements of foreign operations (7 ) (26 ) 234
Total comprehensive loss 1,530 5,761 1,740

Net loss attributable to:
Equity holders of the Company 1,533 5,771 1,359
Non-controlling interests 4 16 147
1,537 5,787 1,506

Total comprehensive loss attributable to:
Equity holders of the Company 1,527 5,750 1,551
Non-controlling interests 3 11 189
1,530 5,761 1,740

Net loss per share attributable to equity holders of the Company :
Basic and diluted net loss per share 0.06 0.21 0.06