On October 13, 2015 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that it held its first R&D Day and provided an in-depth review of the Company’s broad portfolio of product candidates and technology platforms (Press release, MacroGenics, OCT 13, 2015, View Source [SID:1234507712]). Special guest speakers included Charles Drake, M.D., Ph.D., Professor of Oncology, Urology and Immunology, Johns Hopkins School of Medicine, and Holbrook Kohrt, M.D., Ph.D., Assistant Professor of Medicine (Oncology) at Stanford University Medical Center.

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"The team at MacroGenics continues to make significant advances in realizing our mission to create breakthrough biologics and life-changing medicines," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our growing and advancing pipeline now includes eight product candidates in clinical development across a wide range of indications in solid and hematological malignancies, as well as autoimmune disorders. Today’s R&D Day allowed us to provide an update on our Fc-optimized antibodies, margetuximab and enoblituzumab, our five DART molecules in the clinic, additional programs that we have not previously disclosed and the evolution of our multi-specific targeting platforms."

Program Updates and Highlights:

Margetuximab. MacroGenics today provided details about its ongoing SOPHIA Phase 3 clinical study of margetuximab, the company’s Fc-optimized, HER2-directed monoclonal antibody in patients with metastatic breast cancer. The Company also highlighted activity of margetuximab as single agent in patients with gastric cancer from its recently completed Phase 1 study, and a planned Phase 1b/2 study evaluating the combination of margetuximab with an anti-PD-1 antibody.

B7-H3 Franchise. MacroGenics highlighted its industry-leading franchise related to therapeutic targeting of B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is developing three product candidates that engage this target through complementary mechanisms of action and take advantage of this target’s broad expression pattern in multiple solid tumors.

Enoblituzumab (MGA271). The Company provided an overview of initial data from its ongoing Phase 1 monotherapy clinical study of enoblituzumab, an Fc-optimized monoclonal antibody. To date, enoblituzumab has been well tolerated in patients and has shown encouraging, initial single-agent activity, including tumor regression in multiple, heavily pre-treated patients. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company continues to enroll patients in additional monotherapy Phase 1 study cohorts as well as in two combination studies with either ipilimumab or pembrolizumab. Data from the ongoing monotherapy study will be presented in a late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7, 2015.

MGD009. MacroGenics disclosed that MGD009, a Dual-Affinity Re-Targeting (DART) molecule targeting B7-H3 and CD3, has entered into a Phase 1 study in patients and is being evaluated across multiple solid tumor types. MGD009 is designed to target tumors expressing B7-H3 as well as recruit and expand T cells at the tumor site. MacroGenics retains worldwide development and commercialization rights to MGD009.

B7-H3 Antibody-Drug Conjugate. MacroGenics also presented pre-clinical data on an antibody-drug conjugate (ADC) program targeting B7-H3. The Company is evaluating several toxin/linker combinations to induce direct killing of B7-H3-positive tumor cells.

DART Platform. MacroGenics provided an overview of the advantages and versatility of its DART platform for bispecific targeting. The Company also provided a summary of the five DART molecules currently in clinical development, including MGD006 (CD123 x CD3), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3), MGD010 (CD32B x CD79B) and MGD009 (B7-H3 x CD3). In addition, the Company disclosed for the first time two DART molecules that it expects to advance into clinical development in the first half of 2017. These two product candidates include the following:

MGD013. MacroGenics is developing MGD013 to provide co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and LAG-3, for treatment of diseases spanning a wide range of solid tumors and hematological malignancies. The Company presented pre-clinical data on an Fc-bearing DART molecule directed against these targets. In addition to MGD013, MacroGenics is generating and evaluating multiple other candidates that target a range of immune regulators using its DART and Trident platforms.
MGD014. MacroGenics presented pre-clinical data on MGD014, an Fc-bearing DART molecule that targets HIV-infected cells and CD3. MGD014 is being developed to eliminate latent HIV infection in patients treated with continuous anti-retroviral therapy (cART) alone or in combination with latency-reversing agents. MGD014 will be developed under a contract recently awarded by the National Institute of Allergy and Infectious Diseases for up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.

Trident Platform

MacroGenics presented its Trident tri-specific platform, extending the Company’s leadership position in multi-specific antibody-based targeting. Trident molecules have an antibody-like structure with three specificities that enable novel mechanisms of action by recognizing up to three separate antigens in different, customizable conformations.

On October 12, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has been awarded a 5-year contract by the National Institute for Public Health and the Environment (RIVM) in the Netherlands for implementation of the cobas HPV Test as the first-line, primary screening test in the national cervical cancer screening program (Press release, Hoffmann-La Roche , OCT 12, 2015, View Source [SID:1234507693]). The decision concludes an extensive public tender process in which diagnostic providers were assessed on their ability to meet performance, quality and pricing criteria. The new national HPV based screening program is expected to start in the second half of 2016.

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The Netherlands is expected to be the first country in the world with an organized cervical screening program to fully transition from the Pap test to primary HPV screening. Using HPV as the primary test is based on the overwhelming scientific evidence that it offers significant improvement over more traditional Pap cytology screening due to its ability to detect more pre-cancerous disease.
"The movement towards a national HPV screening program will lead to a more efficient and effective use of resources and, most importantly, fewer women will develop cervical cancer." said Dr. R.L.M. Bekkers, Gynecologist/Gynecologic Oncologist, Radboud University Medical Centre. Nijmegen. "Selecting the appropriate HPV test is a crucial first step for the success of this program."
The new Dutch cervical screening program with HPV includes a longer interval between routine screening visits as well as an option for women to self-collect their screening samples. To meet the needs of these program requirements, only HPV tests that utilize DNA PCR-based technology were considered for the tender.

"The cobas HPV Test was selected by the RIVM because it is supported by all the necessary evidence and data", said Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. "We believe countries around the world will be looking toward the Netherlands as a potential model for how to best implement HPV primary screening to prevent cervical cancer. We are excited to have been chosen as their partner."

About the cobas HPV Test and cobas 4800 System from Roche Molecular Systems
Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample. In April 2014, the FDA approved the cobas HPV Test as a first-line primary screening test for cervical cancer in women 25 and older. It is now the only assay approved for the following indications: ASC-US reflex, co-testing, and primary screening.

The test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas 4800 CT/NG Test (chlamydia/gonorrhea), cobas Cdiff Test, cobas MRSA/SA Test, cobas HSV1 and 2 Test, and the cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test and cobas KRAS Mutation Test.

On October 12, 2015 Varian Medical Systems (NYSE: VAR) reported it has received CE Mark for its latest ProBeam proton therapy system (Press release, InfiMed, OCT 12, 2015, View Source [SID:1234507695]). The CE Mark allows Varian to begin installation of the newest version of its ProBeam system in the European Union.

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Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient. Especially in pediatric patients, the risk of developing a new, radiation-induced cancer later in life may be reduced.

Varian’s ProBeam system with Dynamic Peak scanning gives clinicians the ability to deliver the dose precisely in order to minimize dose to healthy tissue. It is uniquely capable of high-speed intensity modulated proton therapy (IMPT), the most precise form of proton therapy available, enabling modulation of the dose on a spot-by-spot, layer by layer basis throughout the treatment area. Irradiations from multiple angles are combined in an optimal manner to improve control of dose distributions. Scanning beam technology also eliminates the time-consuming need to manually insert separate shaping accessories for each beam angle in order to match the beam to the shape of the tumor.

High resolution images are available in the Varian newsroom at the following URL: View Source

On October 12, 2015 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported the presentation of additional data from a Phase 2 trial of its PSMA-targeted imaging agent candidate, 1404, at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany (Press release, Progenics Pharmaceuticals, OCT 12, 2015, View Source [SID:1234507698]). 1404 is a prostate specific membrane antigen (PSMA) targeted small molecule labeled with technetium-99m designed to "visualize" prostate cancer.

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Results from the Phase 2 trial in high-risk patients undergoing radical prostatectomy were presented by Professor Karolien Goffin, M.D., Ph.D., University Hospitals Leuven, and included previously reported sensitivity and accuracy data for 1404 and data related to the uptake of 1404 in the lobes of the prostate gland. New data presented at the meeting demonstrate that 1404 uptake in the prostate gland is significantly higher in prostate cancer patients with upgraded Gleason scores at radical prostatectomy from those who are downgraded at radical prostatectomy.

"The data presented demonstrate the potential of 1404 to better assess the stage and extent of a patient’s prostate cancer versus biopsy, as confirmed by comparison with histopathology, the truth standard, obtained from radical prostatectomy," stated Dr. Goffin.

In the Phase 2 study, 31% (25/81) of evaluable patients had their biopsy Gleason score upgraded to >7 or downgraded to ≤7 by histopathologic assessment of the prostatectomy specimen. Of patients upgraded to a Gleason score >7, 79% (11/14) demonstrated high lesion uptake of 1404 with a mean tumor to background ratio (TBR) of 47:1. Of patients downgraded to Gleason score ≤7, 91% (10/11) had significantly (p<0.001) lower lesion uptake of 1404 with a mean TBR of 16:1.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease, and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

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.

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