On November 28, 2017 SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported that the Company will participate in the following upcoming investor conferences (Press release, Scynexis, NOV 28, 2017, View Source [SID1234522275]):

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The Global Mizuho Investor Conference (MIC) NY at the Lotte New York Palace Hotel on Monday, December 4, 2017.
The Guggenheim Securities 5th Annual Boston Healthcare Conference at the InterContinental Boston on Wednesday, December 13, 2017.

On November 27, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported the synergistic effect of combining Inovio’s TERT (telomerase reverse transcriptase) cancer immunotherapy in combination with a checkpoint inhibitor in preclinical tumor model (Press release, Inovio, NOV 27, 2017, View Source [SID1234522244]). The combination therapies resulted in robust anti-tumor effects and showed significant improvement in survival compared to either therapy alone. Preclinical TERT study results were detailed in a paper published in the most recent edition of Molecular Therapy entitled, "Synergy of Immune Checkpoint Blockade with a Novel Synthetic Consensus DNA Vaccine Targeting TERT," by Inovio and its collaborators at the Wistar Institute.

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Dr. J. Joseph Kim, President and CEO, said, "The synergistic anti-tumor effect observed in this published preclinical study provides Inovio with added confidence in the company’s recently initiated efficacy studies combining checkpoint inhibitors and INO-5401, Inovio’s cancer immunotherapy which includes three of Inovio’s top SynCon cancer antigens – hTERT, WT1, and PSMA, which are over-expressed in multiple tumor types. MedImmune, Regeneron and Genentech have all turned to Inovio’s DNA-based immunotherapy products to evaluate increased response rates in combination with their checkpoint inhibitors. We look forward in sharing combination data from these efficacy trials when they become available."

Inovio is currently evaluating its human TERT (hTERT) immunotherapy, INO-1400, as a mono-therapy, in nine different solid tumors including breast, lung and pancreatic cancers. A recent poster presentation at the SITC (Free SITC Whitepaper) annual conference demonstrated that INO-1400 generated hTERT-specific T cell immune responses in patients. Furthermore, hTERT along with WT1 and PSMA antigens also comprise the new multi-antigen immunotherapy INO-5401, which is being evaluated in two separate phase 1/2 efficacy trials in combinations PD-L1 (with Genentech) and PD-1 (with Regeneron) checkpoint inhibitors in metastatic bladder cancer and in newly diagnosed Glioblastoma multiforme (GBM), respectively.

INO-5401 is being tested in combination with PD-1/PD-L1 inhibitors to bring about better anti-tumor effects in metastatic bladder and GBM. Nearly 430,000 new cases of urinary bladder cancer are diagnosed each year worldwide; it accounts for about 165,000 deaths worldwide annually. Advanced unresectable or metastatic UC remains a high unmet medical need as survival remains poor for most patients. The approval of several checkpoint inhibitors for advanced unresectable or metastatic UC has improved response and survival rates for some patients, however, the majority (~80%) of patients do not experience meaningful clinical responses to checkpoint inhibitor monotherapy. GBM is the most aggressive brain cancer and its prognosis is extremely poor. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent. Clinical responses to checkpoint inhibitors in GBM patients have been poor overall (ORR<10%). Both of these INO-5401 combination studies are designed to test the synergistic anti-tumor effects of the combination therapies.

Significant early checkpoint combination effects were seen in a clinical study of another Inovio T-cell generating product, INO-3112 (licensed to MedImmune and now called MEDI0457). In a phase 1 study of MEDI0457 in 22 HPV-positive patients with squamous cell carcinoma of the head and neck, Inovio has previously demonstrated that this cancer immunotherapy generated robust antigen-specific CD8+ killer T cell responses measured in both tumor tissue and peripheral blood. One patient who initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study. The patient subsequently received nivolumab, a PD-1 checkpoint inhibitor and sustained complete response after only four doses of nivolumab. This patient continues on therapy with no evidence of disease, 16 months after initiation of nivolumab. Medimmune is currently conducting a separate phase 1/2 efficacy trial combining its PD-L1 inhibitor (durvalumab) with MEDI0457 in 50 metastatic HPV-associated head and neck cancer patients to evaluate the clinical efficacy of the combination treatment. Head and neck cancer caused by HPV is the fastest growing cancer in men today, and the checkpoint inhibitor therapies alone have only been positive in limited percentage (ORR<20%) of treated patients.

This published paper highlights the potential benefits of DNA immunotherapy/immune checkpoint blockade combinations using PD-1 or CTLA4 checkpoint inhibitors in patients that respond poorly to immune checkpoint blockade alone, and allow for better rational design of combination therapies. Furthermore, these results suggest that this synergistic anti-tumor effect is due to the effect of immune checkpoint blockade on expanding effector T cells generated from the TERT therapy in the tumor microenvironment rather than boosting vaccine responses in the periphery.

On November 27, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported that all planned patients have been enrolled in the Company’s ongoing Phase I/II study with dendritic cell (DC) vaccines in acute myeloid leukaemia (AML) (Press release, MediGene, NOV 27, 2017, https://www.medigene.com/investors-media/press-releases/detail/article/patient-recruitment-completed-for-phase-iii-dc-vaccine-trial-in-aml/ [SID1234522264]). The completion of the study, as previously announced, is expected in 2019 after a treatment period of two years for all patients.

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Medigene’s Phase I/II trial (NCT02405338) includes 20 AML patients who show complete remission after standard chemotherapy, but who are not eligible for stem cell transplantation that would reduce the risk of a relapse. All patients will be vaccinated with Medigene’s DC vaccines for two years. The primary objective is to assess safety and feasibility of the active immunotherapy with Medigene’s dendritic cells. Secondary objectives of the study are induction of immune responses, overall survival (OS), progression free survival (PFS), control of minimal residual disease (MRD) and time to progression (TTP).

Dr. Kai Pinkernell, SVP Clinical Affairs and Chief Medical Officer of Medigene AG, comments: "With this study we aim to improve the outcome of the patients and show that vaccination with dendritic cells can help to control AML, a leukemia with normally high relapse rates. We are glad to announce the complete enrollment of our phase I/II trial as projected, which puts us on track for a study end in 2019. We intend to provide preliminary data on certain aspects of the trial at scientific conferences once a large part of the patients has been treated for more than a year."

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced of Medigene’s highly innovative and complementary immunotherapy platforms. Currently Medigene evaluates its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

Dendritic cells (DCs) are the most potent antigen-presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of Medigene Immunotherapies scientists has developed new, fast and effective methods for generating dendritic cells ex-vivo, which are able to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or for use in combination therapies.

About acute myeloid leukaemia (AML): Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences are registered annually.
AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a drop in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.
AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately, the majority of patients suffer a relapse. Only about 15 – 20% of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

Varian Medical Systems has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Varian Medical Systems, 2017, NOV 27, 2017, View Source [SID1234522258]).

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On November 27, 2017 Can-Fite BioPharma Ltd. (NYSE MKT:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the nine months ended September 30, 2017 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, NOV 27, 2017, View Source [SID1234522245]).

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Clinical Development Program and Corporate Highlights Include:

Namodenoson (CF102): Advances Phase II Trials and Receives Milestone Payment

First Patient Enrolled in Phase II Trial for Treatment of NAFLD/NASH
Patient enrollment has commenced in Can-Fite’s Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The 12-week trial is enrolling approximately 60 patients and is estimated to cost less than $1 million. There is currently no U.S. FDA approved drug for the indication of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

Milestone Payment Received for Distribution of Namodenoson in Korea for the Treatment of Liver Cancer
During the third quarter of 2017, Can-Fite received a milestone payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD), which licensed the exclusive right to distribute Namodenoson for the treatment of liver cancer in Korea upon receipt of regulatory approvals. The payment is part of a deal worth up to $3,000,000 in upfront and milestone payments plus 23% royalties.

Patient Enrollment Completed in Phase II Liver Cancer Trial of Namodenoson
Can-Fite completed enrollment during the third quarter of 2017 and randomized all 78 patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Patients with advanced HCC, Child Pugh B, were enrolled in the U.S., Europe and Israel. The primary endpoint of the Phase II study is overall survival. Can-Fite is following the survival data closely and plans to perform the survival analysis at the earliest possible opportunity. The HCC market is expected to generate $1.4 billion in sales in 2019.

Data Presented on Namodenoson at NASH Summit Europe and The Liver Meeting
Dr. Pnina Fishman, Can-Fite’s CEO, joined global thought-leaders in the treatment of NASH at the NASH Summit Europe in October, in Frankfurt, Germany, where she delivered a presentation titled, "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson (CF102): From Preclinical to Human Studies."

Can-Fite also presented two scientific posters at the American Association for the Study of Liver Diseases (AASLD) annual conference, The Liver Meeting in Washington, D.C. in October. The posters were titled "Namodenoson (CF102) Prevents Liver Fibrosis in the CCL4 Model" and "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson (CF102) in a Non-Alcoholic Steatohepatitis model."

Piclidenoson (CF101): Commences Patient Enrollment and Dosing in ACRobat Phase III Trial in Rheumatoid Arthritis

Patient enrollment and dosing has commenced in Can-Fite’s Phase III ACRobat trial that is evaluating Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The trial is enrolling approximately 500 patients in Europe, Canada and Israel. The estimated cost of the entire 24-week Phase III study is approximately $5 million. An estimated 90% of rheumatoid arthritis patients receive MTX at some point in their disease. However, studies show that up to 50% of patients stop taking MTX due to reasons including drug intolerance, minor and major side effects, and lack of efficacy, creating a significant need for a new, safe and effective treatment option in the rheumatoid arthritis treatment market which is forecast to reach $34.6 billion by 2020.

Can-Fite is also advancing Piclidenoson towards a Phase III trial in the treatment of psoriasis which is expected to commence in 2018. The upcoming trial will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla sales are estimated to be $2.35 billion by 2020.

Expands Intellectual Property

Can-Fite was issued a new patent from the Korean Intellectual Property Office for Piclidenoson titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) For Treatment of Psoriasis."

A new patent application was filed by Can-Fite to protect the use of its drugs and other ligands which target the A3 adenosine receptor (A3AR) in the treatment of cytokine release syndrome (CRS), a potentially life-threatening complication of CAR-T cell therapy. CAR-T is viewed by the medical community as a very promising cancer immunotherapy, however, CRS, which is caused by an overactive immune response to the treatment, has been identified as a potentially severe and life-threatening side effect of CAR-T. Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation in CRS, and as such, Can-Fite believes that A3AR targeting may serve as an important treatment option for patients in reducing the risk of CRS without limiting the utility of the underlying cancer immunotherapy.

Can-Fite’s Former Subsidiary OphthaliX Successfully Completes Merger with Wize Pharma

Can-Fite’s former majority-owned subsidiary, OphthaliX Inc. (since renamed Wize Pharma, Inc.) recently completed a merger with Wize Pharma Ltd. As a result of the merger, Can-Fite’s ownership of OphthaliX, immediately post-merger, became approximately 8% of the outstanding shares of common stock. In addition, immediately prior to the merger, OphthaliX sold on an "as is" basis to Can-Fite all the ordinary shares of Eyefite Ltd., a former wholly owned subsidiary of OphthaliX, in exchange for the irrevocable cancellation and waiver of all indebtedness owed by OphthaliX and Eyefite to Can-Fite, including approximately $5 million of deferred payments and, as part of the purchase of Eyefite, Can-Fite also assumed certain accrued milestone payments in the amount of $175,000 under a license agreement previously entered into with the U.S. National Institutes of Health (NIH). In addition, as a result of the merger, an exclusive license of Piclidenoson (CF101) for the treatment of ophthalmic diseases previously granted by Can-Fite to OphthaliX and a related services agreement was terminated.

"We are pleased to be on target with commencing patient enrollment in our Phase III rheumatoid arthritis and Phase II in NAFLD/NASH studies. Namodenoson is gaining increasing recognition in the medical community, as evidenced by our recent scientific presentations, for its liver protective properties in both NASH and liver cancer. In 2018, we look forward to initiating our Phase III study of Piclidenoson in psoriasis, as well as potentially announcing top line data on our Phase II liver cancer study of Namodenoson," Dr. Fishman stated.

Financial Results

Revenues for the nine months ended September 30, 2017 were NIS 2.61 million (U.S. $0.74 million) compared to NIS 0.64 million (U.S. $0.18 million) in the first nine months of 2016. The increase in revenue was mainly due to payment received of NIS 1.8 million (U.S. $0.5 million) in August 2017 under the distribution agreement with CKD.

Research and development expenses for the nine months ended September 30, 2017 were NIS 12.7 million (U.S. $3.6 million) compared with NIS 15.45 million (U.S. $4.38 million) for the same period in 2016. Research and development expenses for the nine months ended September 30, 2017 comprised primarily of expenses associated with the Phase II study for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The decrease is primarily due to a reduction in preclinical studies of CF602 conducted during the nine months ended September 30, 2017.

General and administrative expenses were NIS 7.48 million (U.S. $2.12 million) for the nine months ended September 30, 2017, compared to NIS 7.88 million (U.S. $2.23 million) for the same period in 2016. The decrease in general and administrative expenses was mainly due to a decrease in investor relations expenses.

Financial income, net for the nine months ended September 30, 2017 aggregated NIS 3.91 million (U.S. $1.11 million) compared to financial income, net of NIS 3.12 million (U.S. $0.88 million) for the same period in 2016. The increase in financial income, net in the nine months ended September 30, 2017 was mainly from a larger decrease in the fair value of warrants that are accounted for as financial liability as compared to the same period in 2016, offset by exchange rate differences as compared to the same period in 2016 and from issuance expenses.

Can-Fite’s net loss for the nine months ended September 30, 2017 was NIS 13.75 million (U.S. $3.90 million) compared with a net loss of NIS 19.56 million (U.S. $5.54 million) for the same period in 2016. The decrease in net loss for the nine months ended September 30, 2017 was primarily attributable to a decrease in research and development expenses.

As of September 30, 2017, Can-Fite had cash and cash equivalents of NIS 18.02 million (U.S. $5.11 million) as compared to NIS 31.2 million (U.S. $8.84 million) at December 31, 2016. The decrease in cash during the nine months ended September 30, 2017 is due to use of cash to fund operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on September 30, 2017 (U.S. $1 = NIS 3.529).

The Company’s consolidated financial results for the nine months ended September 30, 2017 are presented in accordance with International Financial Reporting Standards.