On October 12, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported the Company’s oncology drug candidate, CF102, has been granted Orphan Drug Designation by the European Medicines Agency (EMA) for the indication of hepatocellular carcinoma (HCC), the most common form of liver cancer (Filing, 6-K, Can-Fite BioPharma, OCT 12, 2015, View Source [SID:1234507701]).

CF102 will benefit from protocol assistance and a 10-year market exclusivity following market authorization in the 28 European Union (EU) Member states, as well as 3 additional European Economic Area (EEA) countries.

"The EMA’s Orphan Drug designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of our liver cancer drug towards market approval. As we actively recruit patients in our Phase II study of CF102 in Europe, we are pleased the EMA will support CF102 through protocol assistance and post-authorization market exclusivity," stated Can-Fite CEO Dr. Pnina Fishman.

In the U.S., CF102 has already received Fast Track Designation as a second line for the treatment of HCC of patients who have previously received Nexavar (sorafenib) and Orphan Drug Designation for the treatment of HCC. Israel’s Ministry of Health has also approved CF102 for Compassionate Use for HCC.

Can-Fite is conducting a Phase II study with CF102 in patients with advanced HCC in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer, were €773 million in 2014.

About CF102

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

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!

On October 12, 2015 Double Bond Pharmaceutical AB reported that it has entered into an agreement for the acquisition of the global rights for Temodex, a locally acting formulation of the established antineoplastic drug temozolomide, from the Research Institute of Physical and Chemical Problems (RI PCP) in Belarus, excluding the Eurasian Economic Union (Russia, Belarus, Kazakhstan, the Republic of Armenia, the Kyrgyz Republic), and Ukraine (Press release, Double Bond Pharmaceutical, OCT 12, 2015, View Source;a-locally-acting-brain-tumor-therapy-based-on-temozo,c9845990 [SID:1234508038]).

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!

Temozolomide is currently approved in Europa and USA as a first-line treatment for glioblastoma multiforme and as a second-line treatment for astrocytoma. Temodex, which is a locally acting form of temozolomide, was developed by the RI PCP and has successfully been studied clinically. Temodex was registered as a first-line treatment of glioblastoma multiforme in Belarus 2014. Glioblastoma multiforme, also known as glioblastoma and grade IV astrocytoma, is the most common and most aggressive malignant form of primary brain tumor.

"We are very pleased to further reinforce our commitment to oncology products and to add a new superior drug delivery candidate to our innovative portfolio. This acquisition is transformational for our company since DBP is taking a giant step forward from a preclinical-stage company to a clinical- and marketing-stage pharmaceutical company. It is a game changer for our commitment to build a leading independent pharmaceutical company that delivers value to our shareholders," says Igor Lokot, CEO of DBP. "Our vision is to develop therapies that improve the current standards of care and meets the urgent need for innovative and efficient drugs for patients suffering from glioblastoma."

DBP will be responsible for the development and regulatory and commercialization activities for Temodex worldwide excluding Eurasian Economic Union and Ukraine. Under the terms of the agreement, the RI PCP is eligible to receive one-digit tiered royalties on net sales.

About Temozolomide
Temozolomide is an oral chemotherapy drug which is considered to be a prodrug and also an imidazotetrazine derivative of the alkylating agent dacarbazine. Temozolomide is used as a treatment of several brain cancer forms, e.g., as a second-line treatment for astrocytoma and as a first-line treatment for glioblastoma multiforme. The therapeutic benefit of temozolomide is due to its ability to alkylate/methylate DNA. This alkylation/methylation destroys the DNA and triggers the death of the tumor cells. Temozolomide was developed by Malcolm Stevens and his team at Aston University in Birmingham in UK and has been available in the US since year 1999, and in other countries since year 2000.

About Temodex
Temodex, which is a locally acting form of temozolomide, was developed by the RI PCP in Minsk in Belarus and has successfully been clinically assessed. Temodex is registered as a first line treatment of glioblastoma multiforme in Belarus since 2014.

On October 12, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported the Company’s oncology drug candidate, CF102, has been granted Orphan Drug Designation by the European Medicines Agency (EMA) for the indication of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, OCT 12, 2015, View Source [SID1234529377]).

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!

CF102 will benefit from protocol assistance and a 10-year market exclusivity following market authorization in the 28 European Union (EU) Member states, as well as 3 additional European Economic Area (EEA) countries.

"The EMA’s Orphan Drug designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of our liver cancer drug towards market approval. As we actively recruit patients in our Phase II study of CF102 in Europe, we are pleased the EMA will support CF102 through protocol assistance and post-authorization market exclusivity," stated Can-Fite CEO Dr. Pnina Fishman.

In the U.S., CF102 has already received Fast Track Designation as a second line for the treatment of HCC of patients who have previously received Nexavar (sorafenib) and Orphan Drug Designation for the treatment of HCC. Israel’s Ministry of Health has also approved CF102 for Compassionate Use for HCC.

Can-Fite is conducting a Phase II study with CF102 in patients with advanced HCC in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer, were €773 million in 2014.

About CF102

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

On October 11, 2015 Eli Lilly and Company (NYSE:LLY) and Innovent Biologics, Inc. (Innovent) reported an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company (Press release, Eli Lilly, OCT 11, 2015, View Source [SID:1234507692]).

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!

Below are details of the expanded agreement:

The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed.

Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.

"We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "We are pleased to be expanding our collaboration with Innovent to further the development of potential therapies for those fighting cancer in China and around the world."

Michael Yu, Ph.D., co-founder, president and CEO of Innovent, stated, "We are honored that Lilly is so quickly expanding our relationship and that Lilly is trusting Innovent to develop and manufacture their newly created bispecific antibodies for China. We are excited to be at the forefront of immuno-oncology drug development and to benefit from Lilly’s deep experience in bispecific antibodies."

On October 9, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present new data on its myRisk Hereditary Cancer molecular diagnostic test at the 18th Annual Meeting of the Collaborative Group of the Americas – Inherited Colorectal Cancer (CGA-ICC) being held Oct. 11 to 12, 2015 in Baltimore, Md (Press release, Myriad Genetics, OCT 9, 2015, View Source [SID:1234507681]).

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!

"Myriad is committed to improving the care of patients and families with inherited colorectal cancer syndromes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "These syndromes are under-diagnosed and our new data using the myRisk Hereditary Cancer gene panel test highlight how next generation sequencing technology can identify more patients at elevated risk of hereditary colon cancer. This information empowers patients and their physicians to take steps that may reduce the risk of a cancer developing. Our recent studies focus on expanding our understanding of the gene mutations associated with colorectal cancer syndromes, and we believe that these data provide further evidence that testing guidelines need to be revised to ensure that patients continue to have access to advances in sequencing technology that may be life-saving."

A list of the Myriad presentations at CGA-ICC (#CGA2015) follows:

Podium Presentations

Title: Pan-cancer gene panel results for patients with > 5 adenomas.
Date: Monday, Oct. 12, 2015, 9:00 a.m. ET.

Title: Ohio Colorectal Cancer Prevention Initiative: Germline mutation spectrum in 250 colorectal cancer patients diagnosed under age 50.
Date: Monday, Oct. 12, 2015: 9:10 a.m. ET.

Poster Presentation

Title: Clinical Presentations of Patients and Families Identified with Pathogenic Variants in CDH1.
Date: Monday, Oct. 12, 2015: 7:30 a.m. ET.

For more information about the meeting, please visit the CGA website at: View Source

About Myriad myRisk Hereditary Cancer Testing

The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source