On January 16, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq:HCM) reported that it has initiated a Phase II study of a combination therapy using fruquintinib and Iressa in the first-line setting for patients with advanced or metastatic non-small cell lung cancer ("NSCLC") in China (Press release, Hutchison China MediTech, JAN 16, 2017, http://www.chi-med.com/chi-med-initiates-a-phase-ii-combination-study-of-fruquintinib-with-iressa-gefitinib-in-first-line-non-small-cell-lung-cancer/ [SID1234517415]). Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR"). The first drug dose was administered on January 9, 2017. Schedule your 30 min Free 1stOncology Demo! This Phase II combination therapy study is a multi-center, single-arm, open-label study. The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor ("EGFR") activating mutations. Treatment will be continued until disease progression or intolerable toxicity occurs. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02976116.
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About NSCLC and Tyrosine Kinase Inhibitors ("TKIs") to address EGFR-driven NSCLC
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factors ("VEGF"), which are protein ligandsthat stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play a pivotal role in tumor-related angiogenesis. Inhibition of the VEGF/VEGFR pathway represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Every year, it is estimated that approximately 1.7 million new patients around the world are diagnosed with NSCLC, according to Frost & Sullivan. Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths (American Cancer Society), and more than breast, prostate and colorectal cancers combined.
NSCLC patients with EGFR activating mutations, which are an estimated 10-15% of NSCLC patients in the United States and Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR-TKIs. However, tumors almost always develop resistance to treatment leading to disease progression. Combining therapies that inhibit different signaling pathways has the potential to be more effective than inhibition of a single pathway and to overcome tumor resistance.
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose without known off-target toxicities. It is currently under the joint development in China by Chi-Med and its partner Eli Lilly and Company. Two late-stage, pivotal Phase III registration studies are ongoing in colorectal cancer (FRESCO) and lung cancer (FALUCA). In addition, fruquintinib is also in clinical development for gastric cancer.
Colorectal: The FRESCO trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal trial in patients with locally advanced or metastatic colorectal cancer who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. Enrollment was completed in May 2016. 416 patients were randomized at a 2:1 ratio to receive either: 5 mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. The primary endpoint is overall survival ("OS"), with secondary endpoints including progression free survival ("PFS"), objective response rate, disease control rate and duration of response. Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819.
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Enrollment began in December 2015. Patients are randomized at a 2:1 ratio to receive either: 5 mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC . The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and duration of response. Chi-Med plans to enroll approximately 520 patients in about 45 centers across China. Additional details about FALUCA study may be found at clinicaltrials.gov, using identifier NCT02691299.
Gastric: Chi-Med completed a Phase Ib dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02415023.
About Iressa, an EGFR-TKI
Iressa (gefitinib) is a targeted monotherapy developed by AstraZeneca for the treatment of patients with advanced or metastatic EGFR activating mutation positive NSCLC. Iressa acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumors. Iressa is approved in 91 countries worldwide.
Year: 2017
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. Schedule your 30 min Free 1stOncology Demo! 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.
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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]).
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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]).
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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]).
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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