On December 22, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported acceptance of two abstracts for poster presentations at international oncology conferences in February 2017 (Press release, Provectus Pharmaceuticals, DEC 22, 2016, https://www.pvct.com/pressrelease.html?article=20161222.1 [SID1234517165]). Both abstracts describe data from the Company’s phase 1 study of PV-10 in tumors of the liver (View Source).

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The first abstract, titled "Percutaneous Rose Bengal as an Ablative Immunotherapy for Hepatic Metastases," to be presented at Clinical Interventional Oncology (CIO) on February 4-5, 2017, in Hollywood, Florida, focuses on outcome in patients with colorectal cancer that has metastasized to the liver.

The second abstract, titled "Intralesional Rose Bengal as an Ablative Immunotherapy for Hepatic Tumors," to be presented at the 26th Conference of the Asian Pacific Association for the Study of the Liver (APASL) on February 15-19, 2017, in Shanghai, China, focuses on outcome in patients with hepatocellular carcinoma.

Eric Wachter, Ph.D., Chief Technology Officer of Provectus, observed, "We are pleased to be able to update the oncology community on our investigation of PV-10 in tumors of the liver. Our phase 1 ‘basket study’ allows us to collect data on a range of tumor types affecting the liver. CIO is an attractive venue to focus on results with tumors metastatic to the liver, which remains an important clinical challenge in the west. Similarly, the high incidence of hepatocellular carcinoma (primary liver cancer) in Asia makes Shanghai a tremendous opportunity to provide an update on HCC."

Provectus believes the posters will be available online following each conference.

About CIO

As North America’s fastest growing meeting in the IO arena, CIO features a concentrated two-day program renowned for its originality, practicality, patient-care focus, and dynamic learning format. CIO focuses on highlighting the most viable and sought-after treatments in clinical interventional oncology, previewing new developments, and providing practical pearls in this rapidly growing practice area. For more information, visit: View Source

About APASL

Since its inception in 1978 in Singapore, APASL (Asian Pacific Association for the Study of the Liver) has become one of the leading associations based on investigation and treatment of liver diseases in the world and the largest scientific body that upholds the standards and profession, research and create improved treatment methods for millions of liver patients particularly in the entire Asia Pacific Region. APASL’s main objectives are to promote the latest scientific advancement and education of hepatology science, exchange of information and the development of consensus, encourage the practice of medicine in liver diseases and also coordinate scientific studies between various scientists and clinicians throughout the region. For more information, visit: View Source

On December 21, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that, following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin), pertuzumab (Perjeta) and ado-trastuzumab emtansine (T-DM1, Kadcyla) (Press release, Merrimack, DEC 21, 2016, View Source [SID1234517147]).

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The decision to stop the trial was made following the DSMB’s opinion that continuing would be unlikely to demonstrate benefit over the comparator treatments. Subsequent to this recommendation, a futility assessment was performed that confirmed the DSMB’s opinion. Both the treatment and control arms were found to have shorter than expected median progression free survival.

Importantly, there were no new or unexpected safety concerns. Patients currently enrolled in the trial may choose to continue on their assigned treatment based upon discussion with their study physician.

"Late line HER2-positive breast cancer is very difficult to treat, especially in this new and previously unstudied group of patients who appear to experience rapid cancer progression following treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine," said Istvan Molnar, MD, Vice President of Clinical Development at Merrimack Pharmaceuticals. "While we are disappointed with this outcome, we would like to thank the study Steering Committee, the investigators and, most importantly, the patients who participated in the HERMIONE trial. We will report our learnings from this study at a later date."

In light of this development, Merrimack now expects to provide further details about MM-302, as well as the results of its full pipeline review, in January.

On December 21, 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 and liver diseases, cancer, and sexual dysfunction, reported it has received its first payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) (Filing, 6-K, Can-Fite BioPharma, DEC 21, 2016, View Source [SID1234517146]). Can-Fite recently announced entering a distribution agreement with CKD for the exclusive right to distribute Namodenoson (CF102) for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus royalties on net sales of 23%.

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"We are pleased to receive this upfront payment of $500,000 from CKD and look towards future potential milestone payments as we advance Namodenoson through completion of our current Phase II trial as a second line treatment for hepatocellular carcinoma and into Phase III," stated Can-Fite CEO Dr. Pnina Fishman.

Per the terms of the distribution agreement, Can-Fite will deliver finished product to CKD and CKD has a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of Namodenoson as a second-line treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

About Namodenoson (CF102)

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased 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, Namodenoson has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing Namodenoson has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.

On December 21, 2016 Circle Pharma, Inc. reported a Series A financing round in which it has issued over $4.5M of shares of Series A Preferred Stock (Press release, Circle Pharma, DEC 21, 2016, View Source [SID1234635669]). The financing was led by Mission Bay Capital, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors joining the round. In connection with the financing, Walter H. Moos, Ph.D., representing ShangPharma, has joined the Circle Board of Directors.

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"We are delighted with the participation of such high caliber investors in our first equity round," said David J. Earp, J.D., Ph.D., Circle’s president and CEO. "With our seed funding, we established Circle’s computational design platform, advanced our synthetic chemistry capabilities in collaboration with ChemPartner, and engaged in a target-based collaboration with Pfizer. The Series A funds will be used to support Circle’s therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. We are also now building a physical library of cell- permeable macrocycles to augment our computational design tools, and this library will later be available to our collaboration partners. We are particularly excited to welcome Walter Moos to our Board of Directors. Dr. Moos brings a wealth of life sciences R&D experience, having served most recently as the president of SRI Biosciences and previously in senior executive roles at MitoKor, Chiron and Warner-Lambert/Parke-Davis. His teams have advanced numerous pharmaceutical products from discovery to commercialization, and we are fortunate to have him join Circle."

"I am very much looking forward to taking an active role on Circle’s board," said Walter Moos. "The combination of innovative technology and the great team at Circle could help unlock high value targets that have long been considered out of reach of drug developers."

Dr. Moos has served on about 20 business and scientific boards, including Amunix, Oncologic (Aduro), Onyx (Amgen), Rigel and the Biotechnology Industry Organization (BIO).

About Macrocyclic Peptides

Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle’s ability to design potent macrocycles with intrinsic cell permeability could unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches.

On December 21, 2016 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that it has completed the acquisition of Ganymed Pharmaceuticals AG ("Ganymed"), a biopharmaceutical company located in Mainz, Germany, and Ganymed has become a wholly owned subsidiary of Astellas as of CET December 20, 2016 (Press release, Astellas, DEC 21, 2016, View Source [SID1234517149]).

Under the agreement executed between Astellas and Ganymed’s shareholders, Astellas paid EUR 422 million to acquire 100% of the equity in Ganymed. In addition, Ganymed’s shareholders will become eligible to receive up to EUR 860 million in further contingent payments based on progress in the development of IMAB362, Ganymed’s most advanced clinical program.

Through the acquisition, Astellas will expand its oncology pipeline with antibody program in the late-stage to build upon its leading oncology franchise as a platform for sustainable growth.

Astellas is still reviewing the impact of the completion of the acquisition on its financial results for the fiscal year ending March 31, 2017.

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