On June 23, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported nine presentations of rolapitant data at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer, June 23 to 25, 2016, in Adelaide, Australia (Press release, TESARO, JUN 23, 2016, View Source [SID:1234513532]).

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"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. At this year’s MASCC/ISOO Annual Meeting, which is the premier global event for supportive care in cancer, we are pleased that data will be presented that demonstrate the activity of rolapitant in patients at high risk for CINV, including those who are receiving cisplatin- and carboplatin-based chemotherapy for gynecologic and lung cancers," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "With our Marketing Authorisation Application (MAA) for oral rolapitant under review by the European Medicines Agency (EMA) and our New Drug Application (NDA) for intravenous rolapitant under review by the U.S. FDA, we look forward to globalizing our mission of improving the lives of people bravely facing cancer."

Please visit TESARO at Booth #3 for information about VARUBI (rolapitant) and our pipeline.

Presentation Details:

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer
Abstract: MASCC-0318, Poster Presentation, Thursday, June 23, 2016

Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy
Abstract: MASCC-0322, Poster Presentation, Thursday, June 23, 2016

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged <65 versus ≥65 years
Abstract: MASCC-0432, Poster Presentation, Thursday, June 23, 2016

Single ascending dose pharmacokinetics of rolapitant administered intravenously at supratherapeutic doses in healthy volunteers
Abstract: MASCC-0489, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of cooperstown cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin [CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in healthy volunteers
Abstract: MASCC-0492, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of digoxin (P-gp) and sulfasalazine (BCRP) in healthy volunteers
Abstract: MASCC-0494, Poster Presentation, Thursday, June 23, 2016

A single-dose bioequivalence study of rolapitant following oral and intravenous administration in healthy volunteers
Abstract: MASCC-0485, Oral Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30 PM

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer
Abstract: MASCC-0321, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Abstract: MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full the U.S. prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is currently under review by the FDA, with a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An MAA for oral rolapitant is currently under review by the EMA. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

On June 22, 2016 IFM Therapeutics, a biopharmaceutical company developing a portfolio of first-in-class small molecules targeting the innate immune system, reported the closing of a $27 million Series A financing led by Atlas Venture and
Abingworth, with participation from Novartis. In conjunction with the funding Jean-François Formela and Vincent Miles, Partners at Atlas and Abingworth respectively, have joined IFM’s CEO, Gary D. Glick, on the board of directors, with Dr. Formela serving as chair of the board (Press release, IFM Therapeutics, JUN 22, 2016, View Source [SID1234520287]).

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IFM Therapeutics, incubated as a part of the Atlas Venture seed program, is developing modulators of novel targets that either enhance innate immune responses for treating cancer, or dampen certain immune responses that drive many inflammatory diseases. The company
will use the proceeds of the financing to advance and expand its early-stage portfolio and begin clinical development of its most advanced product candidate, a selective activator of a novel target, for treating solid tumors.

"While proteins in the innate immune system represent an attractive landscape of therapeutic targets, they have been notoriously difficult to drug," said Dr. Formela from Atlas. "During the brief period since its founding, IFM has made excellent progress on several of these targets, reflecting its exceptional team of experienced scientists and executives, possessing expertise in medicinal chemistry, a deep understanding of the relevant biology, and relationships with academic thought leaders in the areas of immunology and immune oncology."

"IFM’s programs have the potential to make a major difference in the lives of patients with serious, and sometimes fatal, diseases," said Abingworth’s Dr. Miles. "We look forward to helping the team build on their strong start to advance these programs into clinical development."

"This financing is an important validation of the IFM team and technology," said Dr. Glick, IFM’s Co-founder and CEO. "The company is fortunate to be working with a talented and experienced group of investors. Their expertise in building world-class biopharmaceutical
companies will be invaluable as we grow the company."

On June 22, 2016 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported results from the Company’s 7 year prospective placebo controlled double blind studies of treatment of 995 U.S. men with the Company’s lead drug fexapotide (Press release, Nymox, JUN 22, 2016, View Source;fvtc=4&fvtv=6907 [SID:1234513492]). Men who received fexapotide showed a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease.

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The men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were enrolled at over 70 top well-known U.S. urological investigational centers, and were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%. The new data analysis from the Nymox fexapotide study has now shown the statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population.

"These results are astonishingly good. Other drug treatments and controls tested in similar studies have been associated with a prostate cancer incidence 10 times higher than the results reported today by Nymox for fexapotide. This is truly good news. The data strongly indicate that in addition to benefit for BPH symptoms, fexapotide will also help to prevent cancer in these patients," said Dr. Ronald Tutrone, one of the Principal Investigators in the Nymox Fexapotide Prostate Cancer and BPH studies. Dr. Tutrone is Chief of the Division of Urology, Greater Baltimore Medical Center; Medical Director of Chesapeake Urology Research Associates and Chairman of the William E. Kalhert Endowment for Urological Research.

Fexapotide is a safe and painless single injection treatment given in the urologist’s office. The drug is in Phase 3 for BPH and Phase 2 for prostate cancer. It has been tested in over 1700 drug and placebo treatment administrations in the U.S. As a treatment for BPH, fexapotide shows long-term efficacy without the safety risk and side effect concerns or added cancer risk associated with currently approved BPH treatments. As a treatment for prostate cancer fexapotide was found to lead to highly statistically significant reduction in disease progression in a large 147 patient multi-year Phase 2 study of U.S. men with low grade cancer.

Dr. Paul Averback, CEO of Nymox said, "The new results now add a third dimension to fexapotide utility: clinical prostate cancer prevention. The drug has now demonstrated statistically significant prospective long-term outcome data showing dramatic reduction in the incidence of newly diagnosed prostate cancer after minimal BPH treatment with fexapotide. Nymox announced in Q3 last year that it will seek regulatory approvals for fexapotide for BPH based on the long-term BPH safety and efficacy data announced Q3 last year. We believe that the exciting new prostate cancer prevention results reported today will add to the evidence in fexapotide’s favor towards our goal of widespread major benefit for middle-aged and elderly men."

Dr. Averback added, "We are extremely grateful to the thousands of people who have been part of these clinical trials. The Company also thankfully acknowledges our shareholders for their long-term commitment that supports these studies."

On June 22, 2016 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company reported dosing of the first patient in a Phase 1 clinical trial evaluating KPT-9274, an oral, first-in-class, dual-acting p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT) inhibitor, in patients with advanced solid malignancies (including sarcoma, colon and lung cancer) or non-Hodgkin’s lymphoma (NHL) whose disease has relapsed after standard therapy(s) (NCT02702492) (Press release, Karyopharm, JUN 22, 2016, View Source [SID1234517065]).

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This first-in-human, multi-center, open-label, dose-escalation trial is expected to enroll up to 175 patients. The primary endpoints of this study are to determine the recommended Phase 2 dose (RP2D) and the maximum tolerated dose (MTD) of KPT-9274 administered alone and with extended release niacin, and to evaluate safety and tolerability. The key secondary endpoint is to assess anti-tumor activity in patients predicted to be more sensitive to PAK4/NAMPT inhibition, including those with NAPRT-deficient tumors and tumors harboring IDH1 mutations.

"Our first-in-class, oral, small molecule PAK4 and NAMPT modulator, KPT-9274, has synergistic anti-tumor effects through several mechanisms including immune cell activation by inhibiting ß-catenin, reduction of NAD levels which tumor cells use as a key energy source, blockade of DNA damage repair mechanisms, and induction of tumor cell apoptosis," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We are encouraged by the preclinical profile of KPT-9274, highlighted at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) and 2016 American Association of Cancer Research annual meetings, which support the novel mechanism and demonstrated encouraging preclinical anti-tumor activity. To our knowledge, we are the only company with a compound in clinical development that directly targets both PAK4 and NAMPT. This important Phase 1 study will continue to build upon the body of scientific evidence supporting KPT-9274’s safety and efficacy, and we look forward to reporting top-line data next year."

This Phase 1 clinical study is supported by extensive preclinical data demonstrating KPT-9274’s anti-cancer activity against hematological and solid tumors while showing minimal toxicity to normal cells in vitro. Preclinical studies demonstrate that by blocking PAK4, KPT-9274 potently inhibits ß-catenin as well as certain Ras oncogene-dependent pathways. ß-catenin is believed to be a key mediator of immune suppression, including resistance to immune-activating therapies. In addition, both ß-catenin and Ras are key growth signaling pathways for many common tumors such as colon and lung cancers. NAMPT, which can be found in a complex with PAK4 within the cell, is a pleiotropic protein with intra- and extra-cellular functions as an enzyme, cytokine, growth factor and hormone, and is thought to play a role in cellular energy metabolism. Hematologic and solid tumor cells become dependent on both PAK4 and NAMPT pathways and are therefore susceptible to single-agent cytotoxicity by KPT-9274. In mouse and rat xenograft studies, orally administered KPT-9274 showed robust anti-cancer activity with favorable tolerability. Based on in vitro and in vivo activity, Karyopharm believes KPT-9274 holds significant potential for the treatment of a wide variety of both solid and hematological cancers.

About KPT-9274

KPT-9274 is a first-in-class, orally bioavailable, small molecule immunometabolic modulator that works through non-competitive dual inhibition of p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT). Co-inhibition of these targets is believed to lead to synergistic anti-tumor effects through suppression of ß-catenin by blocking PAK4, leading to both immune cell activation and inhibition of tumor growth, energy depletion through NAMPT inhibition, blockade of DNA repair, cell cycle arrest and ultimately apoptosis. KPT-9274 may therefore have both immune-activating and direct antitumor effects. In contrast, normal cells are less sensitive to inhibition by KPT-9274 due in part to their relative genomic stability and lower metabolic demands.

On June 21, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it will present new analyses of the Phase 3 NAPOLI-1 data in an oral presentation and poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer, June 29 – July 2, 2016 in Barcelona, Spain (Press release, Merrimack, JUN 21, 2016, View Source [SID:1234513483]). An oral presentation by Dr. Richard Hubner, Consultant Medical Oncologist, The Christie NHS Foundation Trust and investigator on the NAPOLI-1 trial, will compare the effects of ONIVYDE (also known as "nal-IRI") in combination with fluorouracil and leucovorin on quality of life in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy versus treatment with fluorouracil and leucovorin alone.

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Merrimack will also present an analysis of the NAPOLI-1 safety data across patient subgroups in a poster discussion session and a trials-in-progress poster on a Phase 2 study evaluating ONIVYDE containing regimens as first-line therapy for patients with metastatic pancreatic cancer.

Oral Presentation:

Effects of nal-IRI (MM-398) ± 5-fluorouracil on quality of life (QoL) in NAPOLI-1: A phase 3 study in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy (Abstract O-004)
Wednesday, June 29, 2016, 5:53 – 6:03 PM CEST
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Poster Sessions:

Safety across subgroups in NAPOLI-1: A phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract PD-023)
Session: Pancreatic Cancer
Poster Discussion Time: Thursday, June 30, 2016, 11:00 – 11:30 AM CEST
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma (mPAC): A randomized, open-label phase 2 study (Abstract P-287)
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall