On January 15, 2018 LIDDS AB (publ) reported that it has decided on a direct share issue to Nyenburgh Holding, a Dutch Life Science Fund that invests in selected European biotech- and pharma companies (Press release, Lidds, JAN 15, 2018, View Source [SID1234555919]). The raised capital will facilitate a faster acceleration of LIDDS’ development projects, especially in the immune-oncology field where NanoZolid based immuno-active compounds have shown very promising preclinical effects.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The direct issue of 890 419 shares will add approx. 13,5 MSEK. Nyenburgh Holding will be the fourth biggest shareholder in LIDDS and contribute with financial strength, an excellent network and expertize within the sector. The share price of 15,12 SEK is based on volume weighted average of the share price with a 5 % discount. The share issue decision is based on the shareholders authorization on LIDDS Annual Meeting on May 11, 2017.

– The directed share issue to Nyenburgh Holding is an important validation of the NanoZolid technology. It further adds resources to reach key milestones in our development projects and give LIDDS the financial strength to conduct an effective business development process, says Monica Wallter, CEO of LIDDS.

– We are excited to make this investment in LIDDS as we see ample opportunities for LIDDS to employ this innovative technology. We believe innovation of the current healthcare system is not only coming from New Chemical Entities and biologicals but also from efficient and effective drug delivery technology. LIDDS is a logical add-on to our current portfolio" says Dave van Mastwijk from Dutch healthcare investor Nyenburgh Holding.

LIDDS total number of shares after the direct issue will be 21 871 188 and the share capital will amount to 1 159 172,96 when the new shares are registered with the Swedish Companies Registration Office, Bolagsverket. The dilution of shares is 4,1 %

LIDDS will with the raised capital accelerate the exciting development projects in immuno- oncology with the aim to build alliances, collaborations and license agreements.

The directed share issue to Nyenburgh Holding is further strengthening LIDDS owner structure and it confirms the international interest for LIDDS and the NanoZolid-technology.

On January 15, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that irinotecan liposome injection (Onivyde), cabozantinib (Cabometyx), lanreotide (Somatuline Autogel / Depot), and telotristat ethyl (Xermelo) are the subject of 11 posters, along with 2 others focusing on patients living with neuroendocrine tumors, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO-GI), January 18-20, 2018 in San Francisco (CA, USA) (Press release, Ipsen, JAN 15, 2018, View Source [SID1234523186]). In addition, cabozantinib (Cabometyx) will be featured in one oral abstract session:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Abstract Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Friday, January 19: 2:15 PM-3:45 PM

Abstract 207:
Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: results from the randomized phase 3 CELESTIAL trial.

First Author: Ghassan Abou-Alfa, MD

"Ipsen has a strong presence in oncology at ASCO (Free ASCO Whitepaper)-GI 2018 with 13 posters dealing with clinical outcomes in pancreatic cancer, advanced hepatocellular carcinoma, neuroendocrine tumors and carcinoid syndrome. We and Exelixis, our partner, are excited to announce that the results of the pivotal Phase 3 CELESTIAL Trial of Cabozantinib in Previously Treated Advanced Hepatocellular Carcinoma will be shared for the first time with the medical community as a late breaking presentation, on January 19th," said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen.

2 poster sessions (poster session B and poster session C) with 7 abstracts/posters featuring nal-IRI / liposomal irinotecan (ONIVYDE) :

Poster Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Poster Display Session, Friday, January 19: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM

BOARD F20 – (Abstract 335)
Deposition characteristics and resulting DNA damage patterns of liposomal irinotecan (nal-IRI) in pancreatic cancer xenografts.

First Author: Shannon Leonard

BOARD H16 – (Abstract 379)
Subgroup analysis by baseline pain intensity (BPI) and analgesic use (BAU) in NAPOLI-1: A phase III study of liposomal irinotecan (nal IRI)±5-fluorouracil/ leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy.

First Author: Teresa Macarulla, MD, PhD

BOARD J2 – (Abstract 388)
Dose modifications of liposomal irinotecan (nal-IRI) + 5-fluorouracil/leucovorin (5-FU/LV) in NAPOLI-1: Impact on efficacy.

First Author: Andrea Wang-Gillam, MD, PhD

BOARD K3 – (Abstract 410)
Subgroup analysis by baseline (BL) weight-associated parameters: A phase III study of liposomal irinotecan (nal IRI)±5 fluorouracil/leucovorin (5 FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based (gem) therapy.

First Author: Teresa Macarulla, MD, PhD

BOARD M6 – (Abstract 459)
Nomogram for predicting overall survival (OS) in patients (pts) treated with liposomal irinotecan (nal-IRI) ± 5-fluorouracil/leucovorin (5-FU/LV) in metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy in NAPOLI-1.
First Author: Andrea Wang-Gillam, MD, PhD

BOARD M7 – (Abstract 460)
Subgroup analysis by measurable metastatic lesion (ML) number and selected lesion locations (LL) at baseline (BL) in NAPOLI 1: A phase III study of liposomal irinotecan (nal-IRI)±5 fluorouracil/leucovorin (5 FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy.
First Author: Jens Siveke, Prof. Dr. med.

Poster Session C – Cancers of the Colon, Rectum, and Anus

Poster Session Display, Saturday, January 20: 7:00 AM-7:55 AM and 11:30 AM-1:00 PM

BOARD G24 – (Abstract 711)
Influence of liposomal irinotecan (nal-IRI) and non-liposomal irinotecan, alone and in combination, on tumor growth and angiogenesis in colorectal cancer (CRC) models.
First Author: Annette Larsen, DVM, PhD

Cabozantinib (Cabometyx) is featured in 2 sessions:

Oral Abstract Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Friday, January 19: 2:15 PM-3:45 PM

Abstract 207:
Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: results from the randomized phase 3 CELESTIAL trial.

First Author: Ghassan Abou-Alfa, MD

Poster Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Poster Session Display, Friday, January 19: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM

BOARD A4 – (Abstract 207)
Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: results from the randomized phase 3 CELESTIAL trial.

First Author: Ghassan Abou-Alfa, MD

Lanreotide (Somatuline Autogel / Depot) is featured in 1 poster session:

Poster Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Poster Session Display, Friday, January 19: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM

BOARD G8 – (Abstract 347)
Lanreotide for the prolonged control of carcinoid syndrome (CS) in somatostatin analog (SSA)-naïve or experienced patients.

First Author: Edward Wolin, MD

Neuroendocrine tumors clinical research is featured in 1 poster session:

Poster Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Poster Session Display, Friday, January 19: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM

BOARD G20 – (Abstract 359)
Living with neuroendocrine tumors: Assessing quality of life (QoL) through a mobile application.
First Author: Jared Adams, MD, PhD

BOARD E8 – (Abstract 299)
Physical, emotional, and informational challenges of patients living with neuroendocrine tumors in the United States: Understanding their unmet needs.
First Author: Grace Goldstein

Telotristat ethyl (Xermelo) is featured in 1 poster session

Poster Session B – Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Poster session, Friday, January 19: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM

BOARD J9 – (Abstract 395)
Time to sustained improvement in bowel movement frequency with telotristat ethyl: Analysis of the phase III TELECAST study.
First Author: Joseph Dillon

Nota bene: Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications.

On January 15, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression (Press release, Teva, JAN 15, 2018, View Source;p=RssLanding&cat=news&id=2326522 [SID1234523123]). The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Today’s approval to expand the indication of TRISENOX is a testament to Teva’s commitment to providing solutions to advance cancer care," said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. "This label expansion represents an important benefit as TRISENOX is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia."

The new indication reinforces the current practice guidelines by the National Comprehensive Cancer Network (NCCN).

Please see the Full Prescribing Information for TRISENOX and the Important Safety Information below including Boxed Warning regarding: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES.

TRISENOX (arsenic trioxide) Injection IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES

Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain or peripheral edema, hypotension, and renal, hepatic, or multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Temporary discontinuation of TRISENOX may be required.

Cardiac Conduction Abnormalities: Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block, and a torsade de pointes-type ventricular arrhythmia, which can be fatal. Before initiating therapy, assess the QTc interval, correct pre-existing electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer TRISENOX to patients with ventricular arrhythmia or prolonged QTcF.

Contraindications: TRISENOX is contraindicated in patients who are hypersensitive to arsenic.

Differentiation Syndrome: In clinical trials, 16-23% of patients treated with TRISENOX for APL developed differentiation syndrome. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, and it has occurred as early as day 1 of induction to as late as the second month induction therapy. When TRISENOX is used in combination with tretinoin, prednisone prophylaxis is advised.

Cardiac Conduction Abnormalities: In the clinical trials of patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin, 11% experienced QTc prolongation > 450 msec for men and > 460 msec for women throughout the treatment cycles. In the clinical trial of patients with relapsed or refractory APL treated with TRISENOX monotherapy, 40% had at least one ECG tracing with a QTc interval greater than 500 msec. A prolonged QTc was observed between 1 and 5 weeks after start of TRISENOX infusion, and it usually resolved by 8 weeks after TRISENOX infusion. There are no data on the effect of TRISENOX on the QTc interval during the infusion of the drug.

The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. The risk may be increased when TRISENOX is co-administered with medications that can lead to electrolyte abnormalities (such as diuretics or amphotericin B).

Hepatotoxicity: In the clinical trials, 44% of patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin experienced elevated aspartate aminotransferase (AST), alkaline phosphatase, and/or serum bilirubin. These abnormalities resolved with temporary discontinuation of TRISENOX and/or tretinoin. During treatment with TRISENOX, monitor liver chemistries at least 2-3 times per week through recovery from toxicities. Withhold treatment with TRISENOX and/or tretinoin if elevations in AST), alkaline phosphatase, and/or serum bilirubin occur to greater than 5 times the upper limit of normal.

Long-term liver abnormalities can occur in APL patients treated with TRISENOX in combination with tretinoin. In a published series, mild liver dysfunction and hepatic steatosis were seen in 15% and 43%, respectively, of patients at a median of 7 years (range 0-14 years) after treatment with arsenic trioxide in combination with tretinoin.

Carcinogenesis: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen. Monitor patients for the development of second primary malignancies.

Embryo-Fetal Toxicity: TRISENOX can cause fetal harm when administered to a pregnant woman. One patient who became pregnant while receiving arsenic trioxide had a miscarriage. Conduct pregnancy tests prior to starting treatment and advise pregnant women of the potential risk to a fetus. Advise patients of reproductive potential to use effective contraception during treatment with TRISENOX and after treatment for 6 months in females and 3 months in males. TRISENOX may also impair fertility in males.

Lactation: TRISENOX is excreted in human milk. Because of the potential for serious adverse reactions in the breastfed child, discontinue breastfeeding during treatment with TRISENOX and for two weeks after the final dose.

Patients with Renal Impairment: Exposure of arsenic trioxide may be higher in patients with severe renal impairment. Patients with severe renal impairment (creatinine clearance less than 30 mL/min) should be monitored for toxicity when these patients are treated with TRISENOX, and a dose reduction may be warranted. The use of TRISENOX in patients on dialysis has not been studied.

Patients with Hepatic Impairment: Since limited data are available across all hepatic impairment groups, caution is advised in the use of TRISENOX in patients with hepatic impairment. Monitor patients with severe hepatic impairment (Child-Pugh Class C) who are treated with TRISENOX for toxicity.

Most Common Adverse Reactions: The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia, and dizziness.

TO REPORT SIDE EFFECTS: Contact us at 1-888-483-8279 or [email protected]

Indications

TRISENOX is indicated:

In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

On January 15, 2018 LeadArtis´scientists, in collaboration with other prime research institutions, reported a new tactic to generate multispecific T-cell recruiting antibodies to eradicate cancers (Press release, LeadArtis, JAN 15, 2018, View Source [SID1234523122]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The redirection of T cell activity using bispecific antibodies is one of the most promising cancer immunotherapy approaches currently in development, but it is limited by cytokine storm-related toxicities, as well as the pharmacokinetics and tumor-penetrating capabilities of current bispecific antibody formats. We have engineered the ATTACK (Asymmetric Tandem Trimerbody for T cell Activation and Cancer Killing), a novel T cell-recruiting bispecific antibody which combines three Tumor Associated Antigen (TAA) binding single-domain antibodies with a single CD3-binding domain in an intermediate molecular weight package. The two specificities are oriented in opposite directions in order to simultaneously engage cancer cells and T cell effectors, and thereby promote immunological synapse formation. The ATTACK molecules are expressed as homogenous, non-aggregating, soluble proteins by mammalian cells and demonstrated an enhanced binding to the TAA but not CD3. The ATTACKs demonstrated extremely potent, dose-dependent cytotoxicity when retargeting human T cells towards TAA-expressing cells. These results suggest that the ATTACK is an ideal format for the development of the next-generation of T cell-redirecting bispecific antibodies.

The paper is online. Please visit (View Source), download and share with your colleagues

On January 12, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that it has updated the VARUBI (rolapitant) injectable emulsion package insert in collaboration with the U.S. Food and Drug Administration (FDA) (Press release, TESARO, JAN 12, 2018, View Source [SID1234523148]). VARUBI injectable emulsion is a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with chemotherapy in adults. The changes to the labeling include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Following its introduction in late November 2017, TESARO estimates that at least 7,000 doses of VARUBI injectable emulsion have been administered to patients receiving emetogenic chemotherapy in the United States. Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of VARUBI injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Patient safety is a paramount priority for TESARO. In its commitment to ensuring patients and healthcare professionals are aware of the label update, TESARO has issued a Dear Healthcare Professional (DHCP) letter. This letter, as well as the updated full prescribing information, has been posted on the VARUBI website (www.varubirx.com). Additionally, members of the TESARO field force will be calling on healthcare professionals to communicate this important new safety information.

Healthcare providers and patients are encouraged to report adverse events in patients taking VARUBI injectable emulsion to TESARO at 1-844-4-TESARO (1-844-483-7276). TESARO’s medical information department may be reached at 1-844-4-TESARO (1-844-483-7276) to address any questions from healthcare providers about the information contained in this release, or the safe and effective use of VARUBI injectable emulsion.

VARUBI Indication and Important Safety Information

VARUBI, in combination with other antiemetic agents, is indicated 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 taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes.

VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration. Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication).

In clinical trials, the most common adverse reactions reported were neutropenia, hiccups, decreased appetite and dizziness. IV administration of VARUBI was also associated with infusion-related symptoms (e.g., sensation of warmth, abdominal pain, dizziness, and paresthesia).

Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (e.g., rifampin), as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI.

VARUBI given as an oral dose is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (e.g., methotrexate, topotecan, or irinotecan) and P-gp substrates (e.g., digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations.

Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR.

VARUBI is available by prescription only. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.