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NewLink Genetics Shares Its Immuno-Oncology Strategy 2016 Analyst and Investor Day

On October 25, 2016 NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, reported its strategy for becoming a leading immuno-oncology company at the company’s 2016 meeting for analysts and investors in New York City (Press release, NewLink Genetics, OCT 25, 2016, View Source [SID1234516005]).

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The program focused on the science and increasing validation of the IDO pathway as a target for oncology drug candidates and NewLink Genetics’ clinical programs. A link to a replay of the webcast and the slides can be accessed in the events tab of the investor and media relations section of the company’s website, View Source

"With data presentations from recent oncology medical meetings, there is a lot of excitement and promise in IDO as an important target. IDO pathway inhibitors are natural potential partners for combination treatments with other immuno-oncology checkpoint inhibitors and chemotherapies. We are excited to have two of the five IDO product candidates in clinical development now," said Charles J. Link, Jr., M.D., Chairman and Chief Executive Officer. "One is indoximod, which is our proprietary IDO pathway inhibitor, and the other is GDC-0919, which is partnered with Genentech, a member of the Roche Group."

Leaders in the field of immuno-oncology who presented at today’s meeting include: George C. Prendergast, PhD, President & CEO, Lankenau Institute for Medical Research (LIMR) and Editor in Chief, Cancer Research; David H. Munn, MD, Professor of Pediatric Hematology-Oncology, Medical College of Georgia Augusta University; Montaser Shaheen MD, Associate Professor, University of New Mexico Cancer Center; and Ashkan Emadi, MD, PhD, Associate Professor, University of Maryland.

Key takeaways include:

Validation of IDO as a Target. The IDO pathway can allow cancer to escape the immune system. Many cancers have developed the ability to employ IDO to evade immune attack. Clinical results are increasingly validating the IDO pathway as a target for cancer therapies. Just as scientists discovered the role of PD-1/PD-L1 expression and the usefulness of PD-1/PD-L1 blockade, there is an increasing body of research into the role of the IDO pathway and the potential for its inhibition.

NewLink’s Two IDO Pathway Inhibitor Clinical Candidates. NewLink Genetics is engaged in clinical trials for two IDO pathway inhibitor product candidates, with two distinct mechanisms of action.

• GDC-0919, a direct IDO enzyme inhibitor, is being developed in partnership with Genentech. GDC-0919 is currently in Phase 1b trials, in combination with atezolizumab in solid tumors. In October, 2014, NewLink and Genentech entered in to a license and collaboration agreement with an upfront payment of $150 million, more than $1 billion in potential milestones and substantial royalties.

• Indoximod, an IDO pathway inhibitor, is proprietary to NewLink Genetics. Indoximod is in the clinic addressing multiple cancers including melanoma, pancreatic, glioblastoma multiforme, breast, acute myeloid leukemia and non-small cell lung.

Indoximod Clinical Development. Our clinical development strategy for indoximod includes formulation optimization intended to improve the candidate’s commercial and clinical potential. The Company reported that it will evaluate the data and report on several clinical trials underway in 2017.

Future R&D. NewLink also discussed its program targeting the PTEN pathway in regulatory T cells (Treg cells) as a central driver of tumor immunosuppression. NewLink Genetics is an early leader in the field of PTEN research just as it was in identifying IDO as a potential pathway for immune suppression.
Nicholas N. Vahanian, MD, Co-founder, President & Chief Medical Officer added, "We have built a strong management team, comprised of scientific, clinical and business leaders, with proven expertise in drug discovery and clinical development."

Dr. Vahanian continued, "With the early clinical results in IDO inhibition from NewLink Genetics and our partner, Genentech, we are very well positioned to execute our strategy in taking these immuno-oncology clinical programs forward. Further, we have a strong balance sheet which supports the execution of our clinical plan."

Caris Life Sciences and Threshold Pharmaceuticals Collaborate to Utilize Caris’ ADAPT Biotargeting System in the Development Program for Evofosfamide

On October 25, 2016 Caris Life Sciences, a leading biotechnology company focused on fulfilling the promise of precision medicine, and Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company specializing in the development of novel pharmaceutical products for the treatment of cancer, reported that they have entered into a development and commercialization agreement to utilize Caris’ patented and proprietary ADAPT Biotargeting System to develop a tissue-based clinical diagnostic assay for pancreatic cancer patients to predict the likelihood of response to evofosfamide, Threshold’s lead drug candidate for the potential treatment of patients with cancer (Press release, Caris Life Sciences, OCT 25, 2016, View Source [SID1234515999]). Under the terms of the agreement, Caris is eligible to receive several million dollars in clinical development milestones and undisclosed downstream royalty payments. Through Caris’ proprietary ADAPT Biotargeting System, Threshold may gain access to a diagnostic tool that will enable physicians to determine which patients would be most likely to benefit from treatment with evofosfamide.

"We are pleased to work with Threshold Pharmaceuticals to support the development of their novel potential therapy, which has shown promising results in this difficult-to-treat disease," said Bart Howe, Executive Vice President of Business Development and Corporate Strategy at Caris. "Our innovative and revolutionary ADAPT Biotargeting System is uniquely positioned to support the pharmaceutical clinical development process by identifying complex molecular signatures that can predict a patient’s likelihood of response to a particular therapy."

"Since it is well understood that patients exposed to the same chemotherapy often respond differently, we look forward to working with Caris and their innovative ADAPT Biotargeting System to help physicians identify those patients most likely to benefit from evofosfamide," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "We remain optimistic about the potential role of evofosfamide for the treatment of cancer, and we continue to pursue discussions with Japanese regulatory authorities regarding potential registration pathways for evofosfamide and other development opportunities with evofosfamide."

Caris and Threshold will work together, leveraging tumor samples and outcomes data from the previously completed Phase 3 MAESTRO study in patients with advanced pancreatic cancer, to develop a novel, multiplexed diagnostic assay designed to classify a patient’s likely clinical outcome from the use of evofosfamide.

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a DNA cross-linking agent that is preferentially activated under hypoxic tumor conditions, a feature of many solid tumors. In December 2015, Threshold announced that a Phase 3 study (MAESTRO) of evofosfamide had not met its primary endpoint. However, data from the MAESTRO study demonstrated meaningful improvement in overall survival in a subgroup of 116 patients from Japan, in which the risk of death was reduced by 48 percent for patients receiving evofosfamide compared to patients in the control arm.

Caris’ ADAPT Biotargeting System is a proprietary platform that uses libraries of synthetically manufactured molecules trained to bind to biological targets of interest in order to characterize complex biological systems. Currently being utilized in discovery research, advanced diagnostics and drug development programs across multiple diseases, the ADAPT Biotargeting System also has potential utility in drug delivery, disease monitoring and direct therapeutic applications.

Propanc Completes Pivotal 28 Day Toxicokinetic Study for Lead Product PRP

On October 25, 2016 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported it completed a 28 day toxicokinetic study to support determination of a safe starting dose in patients as the Company progresses towards clinical trials in 2017 for its lead product, PRP (Press release, Propanc, OCT 25, 2016, View Source [SID1234515998]). PRP is a solution for intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen. All animals involved in the study appeared to be doing well, no issues were reported and plasma levels were not impaired over time.

Data from the GLP (Good Laboratory Practice) compliant, 28 day repeat dose toxicokinetic study will form the basis of a clinical trial application in the UK. The purpose of the study was to evaluate the toxicokinetic parameters of PRP following repeated, daily intravenous tail vein administration in rats and to evaluate distribution and bioavailability of the test articles over an extended period. Furthermore, the pharmacological properties and bioavailability of the treatment before and after repeat exposure were also evaluated.

Studies of this type are an important part of the development process for new therapeutic agents prior to clinical testing in humans and was discussed in detail at a recent scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, earlier this year. Data generated from this study will define conditions for a planned 4-week regulatory GLP compliant toxicology study commencing mid-November 2016 with results expected early 2017.

In addition, the Company is on target to file a second orphan medicinal product designation (OMPD) application for ovarian cancer with the European Medicines Agency (EMA) this month. Furthermore, similar orphan drug designation applications will be filed for pancreatic and ovarian cancers with the U. S. Food and Drug Administration (FDA) later this year. As well as satisfying the criteria for OMPD status for ovarian cancer in Europe, management believes that PRP will satisfy the criteria for orphan drug designation for both indications in the United States, where prognosis for patients diagnosed with these diseases are poor and few treatment options are available.

"We are making excellent progress completing these pivotal studies for PRP," said James Nathanielsz, Propanc’s Chief Executive Officer. "Preclinical efficacy is well established and the safety studies are pivotal because it provides the rationale for a safe starting dose for patient trials. In addition, we are finalizing our OMPD application for ovarian cancer which we will submit to the EMA very soon. This is the second indication where we are seeking this status in Europe, the first being pancreatic cancer. We will then target the US for both indications. We believe these are important milestones for the future development of PRP."

Actinium Pharmaceuticals Initiates Pursuit of Scientific Advice for Iomab-B from the European Medicines Agency

On October 25, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that the Company has initiated the European Medicines Agency (EMA) Scientific Advice process for Iomab-B (Press release, Actinium Pharmaceuticals, OCT 25, 2016, View Source [SID1234515997]). The EMA provides scientific advice to companies regarding the appropriate studies for the development of a medicine. The goal of scientific advice is to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefits of patients.

The Scientific Advice process allows Actinium to dialogue with regulators from the EMA to determine the appropriate development program for Iomab-B in Europe. The EMA created this program to increase the probability of positive outcomes and to reduce the risk of objections during the evaluation of a market-authorization application. Iomab-B, Actinium’s lead drug candidate, has been granted orphan designation in the European Union (EU) by the EMA. Iomab-B is intended to be used, upon marketing authorization, in preparing patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT). Iomab-B is currently in a 150 patient multicenter, pivotal Phase 3 trial that is being conducted in the United States.

Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals said, "We are very excited about the potential of Iomab-B in Europe to address an urgent unmet medical need. We believe Iomab-B is a potentially revolutionary therapy for relapsed or refractory AML patients who are over the age of 55 that could benefit from a bone marrow transplant. This remains a patient population that is drastically underserved on a global scale. Today’s initiation for scientific advice, together with our SME status and orphan designation for Iomab-B in the EU, is invaluable as we explore the regulatory pathway for Iomab-B in the EU. We will continue to drive the development of Iomab-B in the U.S. and beyond as we endeavor to bring Iomab-B to all patients that could potentially benefit from this drug candidate."

About Iomab-B

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

Can-Fite Signs Distribution Deal for Liver Cancer Drug CF102 in South Korea

On October 25, 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 signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) for the exclusive right to distribute 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 a percentage rate of royalties on net sales in the low twenties (Press release, Can-Fite BioPharma, OCT 25, 2016, View Source [SID1234515991]).

The distribution agreement further provides that Can-Fite will deliver finished product to CKD and grants CKD a right of first refusal to distribute CF102 for other indications for which Can-Fite develops CF102.

"This agreement marks our first distribution deal for CF102 as we near completion of patient enrollment in our Phase II trial of CF102 as a second line treatment for hepatocellular carcinoma. The pressing need for an effective drug in this difficult to treat cancer makes CF102, in our opinion, a strong potential candidate as we look towards Phase II results and ahead to Phase III in the U.S. where CF102 has Fast Track Designation in this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We look forward to working with CKD to advance CF102 in South Korea."

Approximately, 51,000 people had liver cancer in Korea, with approximately 11,000 deaths in 2012 according to a study published in Cancer Research and Treatment: Official Journal of Korean Cancer Association in 2015.

Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of CF102 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 CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

This agreement with CKD marks Can-Fite’s second distribution and licensing deal in South Korea, where the Company’s Piclidenoson (CF101) has already been out-licensed to Kwang Dong Pharmaceutical Co. for the treatment of rheumatoid arthritis.

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 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, CF102 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 CF102 has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for CF102 in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.