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Chi-Med Initiates a Phase II Study of Sulfatinib in Second-line Biliary Tract Cancer in China

On January 16, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated a Phase II study of sulfatinib in second-line biliary tract cancer ("BTC") patients in China (Press release, Hutchison China MediTech, JAN 16, 2017, http://www.chi-med.com/chi-med-initiates-a-phase-ii-study-of-sulfatinib-in-second-line-biliary-tract-cancer-in-china/ [SID1234517412]). Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. The first drug dose was administered on January 9, 2017.

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This Phase II study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of sulfatinib as a monotherapy in treating advanced or metastatic BTC patients who failed one prior systemic therapy. The primary endpoint is progression free survival ("PFS") at 16 weeks, with secondary endpoints including objective response rate ("ORR"), disease control rate ("DCR"), duration of response, PFS, overall survival ("OS") and safety. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02966821.

Hope Biosciences Licenses nuc-Gemcitabine, A ‘Trojan Horse’ Anti-nucleolin-Gemcitabine Aptamer Drug Conjugate Against Cancer

On January 13, 2017 HOPE BIOSCIENCES reported that it has acquired the exclusive rights to develop and commercialize nuc-gemcitabine (APTA-12/HOPE-888) through a licensing agreement with AptaBio Therapeutics, a Korean pharmaceutical company (Press release, Hope Biosciences, JAN 13, 2017, View Source [SID1234609541]).

nuc-Gemcitabine consists of Antisoma’s AS1411*, a clinically-tested DNA aptamer against surface nucleolin found on many cancer cells, and dFdCMP, an activated form of gemcitabine. Unlike ADCs (antibody drug conjugates) or SMDCs (small molecule drug conjugates), which require ‘linker’ conjugation of the cytotoxic payload to the drug, nuc-gemcitabine is created by incorporating a single activated gemcitabine molecule in lieu of a thymidine molecule during the one-step solid phase synthesis of the DNA aptamer.

Clinical trials in over 80 cancer patients showed AS1411 to have modest anti-cancer activity and a favorable safety profile. nuc-Gemcitabine is 100-1,000x more potent compared to AS1411 or conventional gemcitabine (Gemzar) in pre-clinical studies. Composition of matter patent has been granted in major countries, including the United States.

"Nucleolin is constantly and abundantly expressed on the cell surface of tumor cells where it serves as a binding protein for a variety of ligands implicated in cancer growth and angiogenesis," said Dr. SungHwan Moon, President and Chief Scientific Officer of AptaBio. "High nucleolin expression is correlated with decreased survival. nuc-Gemcitabine binds to surface nucleolin with high specificity and affinity, leading to internalization of the aptamer-drug into tumor cells, where it mediates cell death. We have demonstrated significantly greater anti-cancer activity at low doses of nuc-gemcitabine containing the equivalent of 3 mg/kg gemcitabine versus 80-100 mg/kg of Gemzar in gemcitabine-resistant pancreatic cancer xenograft mouse models."

"HOPE-888 has demonstrated impressive anti-cancer activity in preclinical models. It could truly be a game changing treatment strategy for pancreatic cancer and other difficult-to-treat malignancies," said George Uy, CEO and Founder of HOPE. "Our goal is to file IND application in the next 12-18 months and bring it into the clinic soon thereafter. We intend to truly personalize nuc-gemcitabine therapy by screening patients for nucleolin-expression with a biomarker kit."

Aptevo Therapeutics Receives $20 Million Payment From Emergent BioSolutions

On January 13, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, reported that it has received a $20 million cash payment from Emergent BioSolutions pursuant to a promissory note granted as a result of the spin-off of Aptevo from Emergent, effective August 1, 2016 (Press release, Aptevo Therapeutics, JAN 13, 2017, View Source;p=irol-newsArticle&ID=2237367 [SID1234517410]).

With the additional $20 million cash payment announced today, Emergent has provided a total of $65 million in cash contributions to fund Aptevo’s operations as a newly-launched oncology and hematology-focused company with a broad pipeline of commercial, clinical and preclinical assets and a proprietary bispecific technology platform, ADAPTIR, focused on the development of immuno-oncology therapeutics.

"The achievement of this final payment from Emergent marks another important milestone in Aptevo’s progress," said Marvin L. White, President and Chief Executive Officer. "With the generous funding provided by Emergent, and a strong portfolio of revenue-generating commercial assets, Aptevo is solidly positioned to achieve our near-term goals. Specifically, these include: capturing increased market share for our newly-launched Hemophilia B therapeutic, IXINITY; generating additional data from our two clinical-stage programs, otlertuzumab and MOR209/ES414; and rapidly advancing new ADAPTIR immuno-oncology candidates into clinical development."

About Aptevo Therapeutics Inc.

Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Our core technology is the ADAPTIR (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology.

RedHill Biopharma Provides 2017 Semi-Annual Business Update

On January 12, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported update on key programs, potential milestones and estimated timelines (Press release, RedHill Biopharma, JAN 12, 2017, View Source [SID1234517389]).

Micha Ben Chorin, RedHill’s CFO, said: "We are heading into 2017 with important potential catalysts in the coming months and with several ongoing Phase III and Phase II programs for gastrointestinal indications. Following the recently announced U.S. co-promotion agreement for Donnatal1, RedHill is advancing its strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with commercial presence in the U.S. This transition is planned to support potential future commercialization of RedHill’s Phase III-stage gastrointestinal drugs, if approved by the FDA. We are backed by strong institutional investors and maintain a debt-free balance sheet with approximately $70 million in cash, allowing us to continue to diligently execute our plans."

RHB-105 – H. pylori bacterial infection (confirmatory Phase III)

The confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to enroll 440 patients in up to 55 U.S. sites, is planned to be initiated by April 2017 following completion of an ongoing supportive pharmacokinetic (PK) program.
RHB-104 – Crohn’s disease (Phase III)

254 of the planned total of 410 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study in the U.S. and additional countries with RHB-104 for Crohn’s disease (the MAP US study).
A second independent data and safety monitoring board (DSMB) meeting of the MAP US study is expected in the second quarter of 2017, with an interim efficacy analysis and an option for early stop for success for overwhelming efficacy.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)

291 of the planned total of 320 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study). Top-line results are expected by mid-2017.
83 of the planned total of 120 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results are expected in mid-2017.
YELIVA – Phase I/II studies for multiple oncology and inflammatory indications

RedHill is currently pursuing several Phase I/II clinical studies with YELIVA in the U.S., targeting oncology indications, with support from National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities, including ongoing studies for advanced hepatocellular carcinoma (Medical University of South Carolina), refractory or relapsed multiple myeloma (Duke University Medical Center ) and refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma (Louisiana State University Health Sciences Center).
Additional Phase I/II studies with YELIVA are in various stages of preparation, including a Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy, planned to be initiated in the first half of 2017.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)

As part of RedHill’s strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered earlier this month into an exclusive co-promotion agreement with a subsidiary2 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion rights for Donnatal, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)3. RedHill expects to initiate promotion of Donnatal in the coming months.
RIZAPORT (RHB-103) – acute migraines (approved for marketing in Germany)

Re-submission of the RIZAPORT NDA to the FDA is expected in the first half of 2017. RIZAPORT was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and a second commercialization agreement was signed with Pharmatronic Co. for South Korea. RedHill continues discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.
About Donnatal:

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets and immediate release Donnatal Elixir, a fast acting liquid.

Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for important safety information about Donnatal: View Source

Kitov Enters Immuno-Oncology Field Through Acquisition of TyrNovo

On January 12, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported the expansion of its pipeline through the acquisition of a majority stake in TyrNovo Ltd., a privately held developer of novel small molecules in the immuno-oncology therapeutic field (Press release, Kitov Pharmaceuticals , JAN 12, 2017, View Source [SID1234517379]).

The expansion into developing immuno-oncology drugs comes as Kitov plans to file its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its flagship combination drug, KIT-302, which is intended to treat osteoarthritis pain and hypertension simultaneously, in Q1 2017, with commercial launch anticipated for the first half of 2018. Kitov plans to harness its development and regulatory capabilities in proceeding towards submitting an investigational new drug (IND) application with the U.S. FDA and initiate clinical trials for its newly acquired drug, NT219.

The market for immuno-oncology treatments is believed to become worth $14 billion by 2019 and to grow to $34 billion by 2024, driven by long-term and durable tumor responses to immuno-oncology drugs, according to Global Data.

Kitov will initially acquire an approximately 56% equity stake in TyrNovo from its majority shareholder, for consideration of $2 million in cash and $1.8 million equivalent ordinary shares of Kitov based on the closing price of Kitov’s shares on the TASE on January 11, 2017. Following the closing of this initial acquisition, which is expected to take place on January 13, 2017, Kitov anticipates that it may acquire additional equity stakes in TyrNovo from all or part of TyrNovo’s additional minority shareholders for consideration consisting of ordinary shares of Kitov in such amounts as to be agreed with the shareholders.

"The TyrNovo acquisition represents a major milestone in Kitov’s strategic vision of establishing a diverse pipeline that we believe will secure long term value creation for its shareholders. We are excited about NT219 and its prospects in the oncology field. NT219 can be developed as a platform combination drug for overcoming multi-drug resistance often observed in various tumors. It has the potential to be developed as a combination therapy with several approved oncology drugs for multiple types of tumors," stated Dr. Paul Waymack, Kitov’s Chairman and Chief Medical Officer.

"The Kitov regulatory team has a proven track record in the development and approval of drugs for oncology as well as other indications required to develop NT219 towards submission of an IND and initiation of clinical trials," Waymack added.

TyrNovo is led by its CEO, Dr. Hadas Reuveni, a co-inventor of the TyrNovo technology, who received her Ph.D., Summa Cum Laude, for anti-cancer drug discovery from the Hebrew University of Jerusalem and has nearly two decades of R&D experience in Biotechnology. Dr. Reuveni commented, "I am excited to join Kitov and its team to expedite the development of NT219, which addresses a true unmet medical need for numerous oncology indications. Cancer drug resistance is the major reason for failure in anti-cancer drug treatment. Preventing resistance to the drugs is critical for improving effective cancer treatment."

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3). While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers by preventing the tumors from developing multi-drug resistance and ameliorating multi-drug resistance after resistance is acquired. NT219, in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, through the prevention of acquired resistance and regression of resistant tumors.