1stOncology™: Cancer Intelligence Service – Page 14918 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Can-Fite Reports Second Quarter 2018 Financial Results and Provides Clinical Update

On August 31, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported financial results for the three months ended June 30, 2018 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, AUG 31, 2018, View Source [SID1234529220]).

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!

Clinical Development Program and Corporate Highlights of the Second Quarter 2018 and Recent Weeks Include:

Business Development Activities Q

In August 2018, Can-Fite signed a License, Collaboration and Distribution agreement with CMS Medical Venture Investment Limited ("CMS Medical") for the development and commercialization of Can-Fite’s Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan). Under the terms of the agreement, CMS Medical made an upfront payment of $2,000,000 to Can-Fite and is required to pay to Can-Fite milestone payments of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.

This deal adds to the distribution agreements that the Company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis and psoriasis), Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in South Korea for rheumatoid arthritis), Chong Kun Dang (for distribution of Namodenoson in South Korea for treatment of liver cancer) and Gebro Pharma (for the distribution of Piclidenoson in Spain, Switzerland and Austria).

Intellectual Property

Can-Fite has been granted by the Australian and Chinese patent offices a patent for the utilization of A3 adenosine receptor ligands in the treatment of sexual dysfunction, in a patent (Australian, No. 2013301125ZL; Chinese No. 2013800472970) titled, "A3adenosine receptor ligands for use in treatment of a sexual dysfunction." The Company has been investigating compounds that target the A3 adenosine receptor (A3AR) and the Company’s CF602 drug candidate previously demonstrated a robust positive effect in the treatment of erectile dysfunction in preclinical studies.

Clinical Development Activities

Piclidenoson (CF101)

Psoriasis – In August 2018, Can-Fite enrolled and dosed the first patient in its Phase III Comfort trial for the treatment of moderate-to-severe plaque psoriasis, which makes up about 90 percent of cases. The study, is designed to evaluate the efficacy and safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla) and placebo, in 407 patients. The study will be conducted in 5 countries in Europe, Israel and Canada. The first patient has been dosed in Israel.

Study initiation prompts a milestone payment of 300,000 Euro that is due under the distribution agreement recently entered into with Gebro.

Rheumatoid Arthritis – The Company continues to enroll patients in its Phase III Acrobat trial that is evaluating Can-Fite’s lead drug candidate Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate (MTX). The trial will enroll approximately 500 patients in Europe, Canada and Israel.

Namodenoson (CF102)

Advanced Liver Cancer

In August 2017, Can-Fite completed enrollment of its global Phase II advanced liver cancer study of Namodenson. In June 2018, the Company reported that the accumulated safety data continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson. The Company continues to follow up on patients’ overall survival.

In July 2018, the Company announced that key opinion leaders from the University of Texas MD Anderson Cancer Center, Houston, TX, USA, published scientific findings recommending development of anti-liver cancer drugs based on a mechanism of action utilized by Namodenoson. The latter inhibits a specific molecular signaling pathway in the liver cancer cells, designated as the Wnt/β-catenin, and is responsible for the development and progression of hepato-cellular carcinoma (HCC).

NAFLD/NASH

The Company is continuing to enroll patients for its Phase II trial of Namodenoson for the treatment of 60 patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

"We continue to make progress with our drug candidates. We also signed a significant development and commercialization agreement with CMS Medical for both Piclidenoson and Namodenoson for the Chinese market with significant regulatory and sales’ milestone payments. We look forward to providing updates on our Phase II study of Namodenoson towards the end of year," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2018 were $0.9 million compared to $0.1 million in the first six months of 2017. The increase in revenue was mainly due to the recognition of a portion of the U.S. $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro.

Research and development expenses for the six months ended June 30, 2018 were $2.6 million compared with $2.4 million for the same period in 2017. Research and development expenses for the first six months of 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2018 and beyond.

General and administrative expenses were $1.8 million for the six months ended June 30, 2018, compared to $1.3 million for the same period in 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that the annual general and administrative expenses for 2018 will be higher compared to 2017.

Financial income, net for the six months ended June 30, 2018 aggregated $0.6 million compared to financial income, net of $0.2 million for the same period in 2017. The increase in financial income, net was mainly due to fair value revaluation of our long-term investment.

Can-Fite’s loss for the six months ended June 30, 2018 was U.S. $3.0 million compared with a loss of U.S. $3.5 million for the same period in 2017. The difference in loss for the first half of 2018 was primarily attributable to an increase in revenues and an increase in financial income, net.

As of June 30, 2018, Can-Fite had cash and cash equivalents of U.S. $5.8 million as compared to U.S. $3.5 million at December 31, 2017. The increase in cash during the six months ended June 30, 2018 is due to U.S. $4.4 million received from a registered direct offering in March 2018, net of issuance expenses, and the $2.2 million upfront payment received from Gebro.

The Company’s consolidated financial results for the six months ended June 30, 2018 are presented in accordance with International Financial Reporting Standards.

OncoSec to Present at H.C. Wainwright 20th Annual Global Investment Conference

On August 31, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, will present a corporate overview at the H.C. Wainwright 20th Annual Global Investment Conference on Thursday, September 6, 2018 at 11:15 a.m. ET in New York City (Press release, OncoSec Medical, AUG 31, 2018, View Source [SID1234529219]).

A live audio webcast of the presentation will be available on the Investors section of OncoSec’s website at ir.oncosec.com, where it will be archived for approximately 30 days.

BeiGene Announces Acceptance of New Drug Application for Anti-PD-1 Antibody Tislelizumab in Hodgkin’s Lymphoma in China

On August 31, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA) has accepted the new drug application (NDA) for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) (Press release, BeiGene, AUG 31, 2018, View Source [SID1234529218]).

"The acceptance of our first NDA for tislelizumab represents an important milestone for BeiGene and for Chinese patients with Hodgkin’s lymphoma. Patients who relapse or don’t respond to standard treatment with chemotherapy or radiation often have poor prognoses. We are encouraged by the potential for tislelizumab to provide a new treatment option for these patients," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The NDA is supported by a clinical and non-clinical data package, including the results from a pivotal Phase 2 study of tislelizumab in Chinese patients with R/R cHL. A recent independent review of data from all 70 enrolled patients in an intent-to-treat analysis showed that with a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months at the data cutoff, overall response rate (ORR) was 85.7 percent, including 61.4 percent complete response (CR). Frequency and severity of adverse events were generally consistent with previously reported Phase 1 safety and tolerability data for tislelizumab, or, in the case of certain immune-related events such as hypothyroidism and fever, consistent with previous reports of other PD-1 antibodies for the treatment of cHL. Full results of the study are planned to be presented at an upcoming medical conference.

"We are excited by the response rates, including high complete response rates we have seen in our pivotal study in R/R cHL, and look forward to working closely with the NMPA to make tislelizumab available to patients in China as quickly as possible," said Wendy Yan, Global Head of Regulatory Affairs at BeiGene.

In addition to the pivotal Phase 2 clinical trial in R/R cHL, tislelizumab is also being studied in global Phase 3 trials in a number of malignancies, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas, and an additional pivotal Phase 2 trial in China in urothelial cancer.

About Classical Hodgkin’s Lymphoma
Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin’s lymphoma, the most common form representing about 95 percent of the patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

Selecta Biosciences Announces Presentation at the 20th Asia Pacific League of Associations for Rheumatology Congress (APLAR)

On August 31, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that Chief Scientific Officer Takashi Kei Kishimoto, Ph.D. will present on the poster entitled Ongoing Phase 2 Clinical Trial of SEL-212 Shows Sustained Reduction of Serum Uric Acid by Mitigating Formation of Anti-Uricase Antibodies at the 20thAsia Pacific League of Associations for Rheumatology Congress (APLAR), taking place 6-9 September 2018 at the Kaohsiung Exhibition Centre, Taiwan (Press release, Selecta Biosciences, AUG 31, 2018, View Source [SID1234529216]).

Kiadis Pharma announces Financial Results for the six months ended June 30, 2018 and Company update

On August 31, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, reported its unaudited interim Financial Results for the six months ended June 30, 2018, which have been prepared in accordance with IAS 34 as adopted by the European Union (Press release, Kiadis, AUG 31, 2018, View Source [SID1234529210]).

Arthur Lahr, CEO of Kiadis Pharma, commented: "We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101."

Operating highlights – ATIR101 (including post reporting period)

European marketing authorization application for ATIR101:
Responses to the Day 120 List of Questions submitted in March 2018;
Day 180 List of Issues received in May 2018 and responses submitted in August 2018;
On track to obtain CHMP opinion from the European Medicines Agency in the fourth quarter of 2018.
Phase 3 trial CR-AIR-009, comparing ATIR101 against the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol:
Progress in line with internal plans: 14 clinical sites are currently open for recruitment, 16 patients have been enrolled;
Protocol amendment submitted to regulatory authorities: number of patients increased to 250 to further increase power [80% power to detect 16% Graft-versus-host-disease-free and Relapse-Free Survival (GRFS) difference]; interim analysis to occur after 2/3 of GRFS events to increase chance of positive read out, now expected in the second half of 2020; conditioning regimens harmonized between the two treatment arms to reduce heterogeneity.
Phase 2 trial CR-AIR-008 (‘008’): The last patient received a single dose of ATIR101 in January 2018.
Pooled analysis: Further analysis of 1-year Phase 2 pooled data [Intention-To-Treat (ITT), 37 patients] from studies CR-AIR-007 and single dose CR-AIR-008 shows GRFS 53% [95% confidence interval (CI), 39%-72%]; Overall Survival (OS) 58% (95% CI, 44%-77%), in line with Phase 2 CR-AIR-007 trial. For the PTCy/Baltimore protocol, single site data from Johns Hopkins (McCurdy et al. 2017) and Atlanta (Solh et al, 2016) show a disease-risk index (DRI) normalized 1-year GRFS value of 40% and 30%, respectively.
Operating highlights – Organization (including post reporting period)

Robbert van Heekeren resigned as Chief Financial Officer and as member of the Management Board.
Scott A. Holmes appointed as new Chief Financial Officer.
Organization strengthened across all functions, comprises 73 employees, up from 51 a year ago. Key new appointments include head of Medical US (former Iovance/ Dendreon), head of Medical EU (former Genzyme/ AstraZeneca), head of market access EU (former Genzyme/ Novo Nordisk), head of pharmacovigilance (former Astellas), head of facilities (former Merck/ Douwe Egberts).
Otto Schwarz, former Chief Operating Officer of Actelion and Mr. Subhanu Saxena, former Chief Executive Officer of Cipla and former member of the senior executive team of Novartis, were appointed as Supervisory Board members of the Company at the Annual General Meeting of shareholders in June 2018. Mr. Stuart Chapman resigned from the Supervisory Board following the shareholders’ meeting.
Financial highlights (including post reporting period)

In the first six months of 2018, the Company did not generate any revenues. Total operating expenses increased by EUR2.9 million from EUR8.2 million in the first six months of 2017 to EUR11.1 million in the same period of 2018. This increase was primarily caused by a further expansion of the workforce in all areas of the organization, the move to a larger building which includes a commercial manufacturing facility, laboratories and office space, and consultancy expenses for business development and market access.
In the first six months of 2018, net financial result came in at EUR3.0 million compared to EUR0.4 million for the same period of 2017. Higher finance costs were mainly the result of higher interest expenses on loans and borrowings, and a net foreign exchange loss in the first six months of 2018 compared to a net foreign exchange gain in 2017.
The net loss for the six months ended June 30, 2018 came at a level of EUR14.1 million compared to a loss of EUR8.5 million for the six months ended June 30, 2017. Operating expenses and net result for the first six months of 2018 were in line with management expectations.
The Company ended the first six months of 2018 with EUR41.7 million in cash and cash equivalents. In March 2018, the Company issued 2.6 million shares and raised EUR23.4 million in gross proceeds.
On July 31, 2018, the Company received a new debt facility from Kreos Capital V (UK) Ltd providing the Company with up to EUR20 million of additional financing.