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OncoMed Pharmaceuticals Completes Enrollment of Phase 2 ALPINE Clinical Trial of Tarextumab in Pancreatic Cancer

On August 31, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported that it has completed patient enrollment in its Phase 2 "ALPINE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of pancreatic cancer more than eight months ahead of schedule. The ALPINE study enrolled 177 patients with advanced pancreatic cancer who had not received prior treatment (Press release, OncoMed, AUG 31, 2015, View Source [SID:1234507362]). Enrollment in the randomized, double-blinded, multi-center clinical study began in July 2014.

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"We are encouraged to have accrued patients in this expanded trial over eight months ahead of our original projections and by the enthusiasm of the ALPINE investigators for the potential of tarextumab in combination with chemotherapy for the treatment of patients with pancreatic cancer," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "The ALPINE clinical study will be the first of our ongoing Phase 2 trials testing novel anti-cancer stem cell therapeutics to read out, and we expect to report data from this trial in the second half of 2016. The primary endpoint of the study is overall survival."

The Phase 2 ALPINE trial is designed to evaluate the efficacy of tarextumab in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The Phase 2 clinical trial will compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.

Eileen O’Reilly, M.D., Associate Director for Clinical Research, David M. Rubenstein Center for Pancreatic Cancer Research at Memorial Sloan Kettering Cancer Center in New York, and a Principal Investigator of the ALPINE study commented, "The Notch pathway is a key biological pathway in pancreatic cancer that is associated with poor survival outcomes for patients. The ALPINE trial will help us determine whether the novel antibody tarextumab, which targets the Notch pathway, can provide clinical benefit for patients with pancreatic cancer that need better treatments, and whether the companion Notch3 biomarker can help identify the patients who might derive greater benefit with tarextumab treatment."

The protocol for the randomized Phase 2 ALPINE trial was amended in February 2015 to designate overall survival as the primary endpoint (rather than progression-free survival), and the target enrollment increased from 124 to at least 160 patients. These changes occurred based on the anti-cancer stem cell mechanism of action of tarextumab and following the review of final data from the Phase 1b portion of the ALPINE trial in 40 patients with first-line metastatic pancreatic cancer, where 24 patients received the tarextumab-Abaxane-gemcitabine combination. Analyses of the Phase 1b subjects receiving the three drug combination revealed a median overall survival of 14.6 months in patients whose tumor samples had elevated levels of Notch3 gene expression and 11.6 months in all patients regardless of Notch3 biomarker status1. By comparison, the historical overall survival using the standard-of-care in this patient population is 8.5 months2. Results from OncoMed’s Phase 1b trial of tarextumab were presented at the 2015 Gastrointestinal Cancer Symposium.

About Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related deaths. According to the American Cancer Society, each year in the United States there are approximately 49,000 new cases of pancreatic cancer and 41,000 deaths. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year3.

About Tarextumab (anti-Notch2/3, OMP-59R5)

Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive-stage small cell lung cancer patients. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

Bristol-Myers Squibb and QIMR Berghofer Medical Research Institute Announce Worldwide Collaboration to Discover Novel Immuno-Oncology Antibodies

On August 30, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and QIMR Berghofer Medical Research Institute reported that they have signed a research collaboration and license agreement to discover novel therapeutic antibodies against an undisclosed immuno-oncology (I-O) target (Press release, Bristol-Myers Squibb, AUG 30, 2015, View Source [SID:1234507358]).

"Bristol-Myers Squibb continues to invest in strategic partnerships that accelerate the discovery and development of novel immunotherapies through innovative science and technologies," said Carl Decicco, Ph.D., Head of Discovery, R&D, Bristol-Myers Squibb. "We are excited to work with QIMR Berghofer Medical Research Institute, a partner that brings significant experience and expertise in cancer research."

"QIMR Berghofer is committed to translational research, so it is gratifying when high quality research at the Institute results in the strategic collaboration announced today," said Professor Frank Gannon, QIMR Berghofer Director and CEO. "Bristol-Myers Squibb is the ideal partner to progress these assets to the clinic, with their world-leading expertise in immuno-oncology and a proven track record developing multiple cancer therapies on the market. We look forward to a fruitful, long-term collaboration, delivering new therapies for cancer patients."

QIMR Berghofer Medical Research Institute is a world leading translational research institute focused on cancer, infectious diseases, mental health and a range of complex disorders. Bristol-Myers Squibb will be solely responsible for clinical development and commercialization of antibodies discovered through the collaboration. Financial terms were not disclosed.

Telesta Receives FDA BLA Filing Notification Letter and Priority Review Designation for MCNA(1)

On August 28 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration (FDA). This formal letter communicates that the FDA has completed its initial review of Telesta’s Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing (Press release, Telesta Therapeutics, AUG 28, 2015, View Source [SID:1234507865]). In the same letter, the FDA communicated that it has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.

Commenting on the FDA letter, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year. While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the United States."

About MCNA

MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, ImmunoGen, AUG 27, 2015, View Source [SID:1234507356])

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

On August 27, 2015 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 six months ended June 30, 2015 and updates on its drug development programs (Filing, 6-K, Can-Fite BioPharma, AUG 27, 2015, View Source [SID:1234507355]).

Clinical Development Program and Corporate Highlights Include:

● CF101 – Favorable Psoriasis Data, New U.S. Patent, Proposed Generic Name, and Next Advanced Clinical Studies in Rheumatoid Arthritis & Psoriasis

During the second quarter of 2015, Can-Fite reported positive data from further analysis of its completed Phase II/III study that suggests CF101 as a potential systemic therapy for patients with moderate-severe psoriasis, this despite the study not meeting its primary endpoint, as previously announced during the first quarter of 2015. Based on these findings, the Company is preparing the protocol for its next advanced psoriasis trial. During the second quarter of 2015, Can-Fite also completed the design of a Phase III clinical study for the treatment of rheumatoid arthritis and plans to submit the protocol to Institutional Review Boards (IRBs) for approval in the fourth quarter of 2015. The Company is discussing the protocol and the registration plan with its EU notified body. Further, the U.S. Patent and Trademark Office granted Can-Fite a patent covering the manufacturing process for CF101 in the U.S., and the World Health Organization accepted "piclidenoson" as the proposed generic name for CF101, both are important steps prior to bringing a new drug to market.

● CF102 – Ongoing Phase II Liver Cancer Trial & Application for Orphan Drug Status in Europe

Can-Fite is continuing to enroll and dose patients in its global Phase II liver cancer study. Approximately 78 patients are expected to be enrolled in the trial in the U.S., Europe, and Israel by the end of the first half of 2016. Can-Fite previously received Orphan Drug Designation in the U.S. for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

● CF602 – New Pre-clinical Data Supports Upcoming IND Submission for Sexual Dysfunction Drug

As Can-Fite prepares to file an investigational new drug (IND) application with the U.S. Food and Drug Administration prior to a Phase I clinical study of CF602 in the treatment of sexual dysfunction, the Company announced new data showing efficacy in a diabetic rat preclinical study. The animals were treated twice daily with CF602 for a period of 1 and 5 days. Treated animals showed a significant response rate resulting in a 188% and 250% increase in penial intra-cavernosal pressure, respectively compared to placebo.

● Update on Licensing and Distribution Agreements in Canada and Japan

During the second quarter of 2015, Can-Fite received an upfront payment of CDN$1.7 million when it entered into a distribution agreement with Canada-based Cipher Pharmaceuticals. More recently, on August 27, 2015, Can-Fite entered into an agreement with Japan-based Seikagaku Corporation terminating its license agreement. Seikagaku informed Can-Fite that it is strategically focused on expanding its core research and development activities in the field of glyco-science. Under the license agreement, Seikagaku was granted a license for the use, development and marketing of CF101 in Japan with respect to inflammatory indications, except for ophthalmic disease indications. The termination agreement provides, among other things, that all licenses and rights granted to Seikagaku terminate and all clinical and non-clinical studies conducted by Seikagaku shall be transferred free of charge to Can-Fite. Over the life of the license, Can-Fite received an aggregate of approximately $8 million from Seikagaku. Can-Fite recently participated in an Israeli life sciences delegation to Japan with Israel’s Office of the Chief Scientist and signed Non-Disclosure Agreements with selected Japanese companies interested in licensing CF101 and CF102. The Company’s agreement with Korea-based Kwang Dong remains in place.

● Definitive Agreement to Acquire Improved Vision System by Can-Fite Subsidiary OphthaliX

During the second quarter of 2015, OphthaliX, Can-Fite’s subsidiary, which develops ophthalmic indications of CF101, signed a definitive agreement to acquire Israel-based Improved Vision Systems, LTD. (I.V.S.). The strategic acquisition aims to combine medical devices and pharmaceutical products to address multi-billion dollar markets in treating ophthalmic diseases.

● Ongoing Phase II Study in Glaucoma by Can-Fite Subsidiary OphthaliX

OphthaliX continues to enroll patients in a Phase II clinical study of CF101 for glaucoma and data release is expected during the first half of 2016.

"We look forward to starting advanced stage trials in the coming quarters for CF101 for both the treatment of rheumatoid arthritis and psoriasis, addressing multi-billion dollar markets. Prior Phase II trials for both of these indications have produced valuable data that have helped us optimize the design of the pivotal studies, which move us closer towards applying for marketing approval," stated Can-Fite CEO Dr. Pnina Fishman. "With CF102 in Phase II for liver cancer and our anticipated IND filing for CF602 in sexual dysfunction in Q3 2016, we believe we are well positioned with four distinct clinical programs. During the first half of 2015 we have forged a strategic partnership in Canada and are excited about new opportunities in the Japanese market."

Research and development expenses for the six months ended June 30, 2015 were NIS 5.75 million (U.S. $1.53 million) compared with NIS 8.64 million (U.S. $2.29 million) for the same period in 2014. Research and developments expenses for the first half of 2015 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The decrease is primarily due to the completion of the psoriasis Phase II/III study during the first quarter of 2015 and a decrease in the scope of the non-clinical expenses during the first six months of 2015 compared to the same period in 2014.

General and administrative expenses were NIS 4.67 million (U.S. $1.24 million) for the six months ended June 30, 2015 compared to NIS 5.43 million (U.S. $1.44 million) for the same period in 2014. The decrease is primarily due to a reduction in salary and professional services expenses.

Financial income, net for the six months ended June 30, 2015 was NIS 1.88 million (U.S. $0.49 million) compared to NIS 1.71 million (U.S. $0.45 million) for the same period in 2014. The increase in financial income, net in the first half of 2015 was mainly due to a decrease in the fair value of warrants that are accounted as financial liability.

Can-Fite’s loss for the six months ended June 30, 2015 was NIS 8.27 million (U.S. $2.19 million) compared with a loss of NIS 12.36 million (U.S. $3.28 million) for the same period in 2014. The decrease in net loss for the first half of 2015 was attributable mainly to a decrease in operating expenses.

As of June 30, 2015, Can-Fite had cash and cash equivalents of NIS 29.20 million (U.S. $7.74 million) as compared to NIS 36.09 million (U.S. $9.57 million) at December 31, 2014. The decrease in cash during the six months ended June 30, 2015 is due to operating expenses offset by NIS 5.14 million (U.S. $1.36 million) received from Cipher Pharmaceuticals as upfront payment for entering into the distribution agreement with Cipher.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on June 30, 2015 (U.S. $ 1 = NIS 3.769).

The Company’s consolidated financial statements for the six months ended June 30, 2015 are presented in accordance with International Financial Reporting Standards.