On December 22, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other technologies for targeting and treating cancer, reported that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue (Press release, Progenics Pharmaceuticals, DEC 22, 2016, View Source [SID1234517186]).

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"The growing acceptance of active surveillance among men with lower-grade prostate cancer presents a significant opportunity for 1404 to enable clinicians and patients to accurately and non-invasively visualize and manage their disease," said Mark Baker, Chief Executive Officer of Progenics. "We are pleased that the DMC has determined that the trial should continue. The decision to undergo more invasive treatments, such as radical prostatectomy, is a difficult one for both patients and their families given the severity of potential side effects, and we look forward to the completion of this study as we work to introduce new and effective surveillance options."

This Phase 3 study enrolls patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.

Approximately 190 of a planned 450 patients have been enrolled in the trial to date.

A modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy. In these patients, histopathology of tissues obtained from biopsies of those patients (rather than from radical prostatectomies) will be used as the truth standard in determining the specificity and sensitivity of 1404 imaging. The modification of the protocol was proposed in response to a lower percentage of patients enrolled in the trial having clinically insignificant disease, which is likely due to the emerging trend for more men with low-grade disease to use active surveillance for the management of their prostate cancer rather than undergo radical prostatectomy. The Company plans to monitor enrollment of patients based on the prevalence of clinical significant disease before determining whether any adjustment is needed to the sample size of the study.

Mr. Baker continued, "Our modification to the protocol reflects emerging trends among men with low grade disease to increasingly favor the use of active surveillance versus more aggressive measures, consistent with treatment guidelines. We believe that this shift underscores the potential for agents such as 1404 to address the growing active surveillance market. In addition, we expect that the protocol modification will allow for a better balance in the enrollment of subjects with clinically significant disease versus those with indolent disease, with the goal of evaluating the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and the sensitivity of 1404 imaging to identify patients with clinically significant disease."

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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