On September 12, 2017 BioInvent International AB (OMXS: BINV) reported that the Japanese patent office has decided that the company’s first patent application relating to the immune-oncology antibody BI-1206 now can proceed to grant (Press release, BioInvent, SEP 12, 2017, View Source [SID1234520495]). The patent will be granted once all remaining administrative actions, such as payment of fees, have been completed by BioInvent. This patent is important since it covers the use of the company’s drug candidate BI-1206, and similarCD32b antibodies, in combination with a CD19 or CD20 antibody, such as rituximab, in the treatment of cancer or inflammatory diseases in certain groups of patients.

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This will be the third patent granted in this patent family, after the patents granted in Australia and by the European Patent Office. There are also corresponding patent applications pending in other countries.

On September 11, 2017 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading "off-the-shelf" T-cell immunotherapy company developing novel treatments for patients with cancer and autoimmune diseases, reported receipt of positive regulatory feedback from Health Canada for ATA129, the Company’s most advanced T-cell immunotherapy in development for the treatment of cancer patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV-PTLD) following a hematopoietic cell transplant (HCT) or solid organ transplant (SOT).

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Based on feedback from a meeting with Health Canada’s Biologics and Genetic Therapies Directorate (BGTD), Atara plans to request advance consideration under the Notice of Compliance with Conditions (NOC/c) policy for ATA129 in the treatment of patients with rituximab-refractory EBV-PTLD after HCT. A Notice of Compliance issued under the NOC/c policy is an authorization to market a drug in Canada with the condition that the sponsor undertake additional studies to verify the clinical benefit, and is analogous to a conditional marketing authorization in the EU.

Consistent with Atara’s previously communicated regulatory plan in Europe, the Canadian filing is expected to be based on results from the Phase 1 and 2 clinical studies conducted at Memorial Sloan Kettering Cancer Center (MSK) and supported by available data from the Company’s planned MATCH and ALLELE Phase 3 studies, which are anticipated to be ongoing at the time of the NDS filing.

"Health Canada represents the second major regulatory body to provide feedback supporting the submission of ATA129 for an expedited approval pathway based on the compelling results of the prior Phase 1 and 2 studies," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "We look forward to working closely with Health Canada and other global health authorities to make ATA129 available to patients as expeditiously as possible."

Following completion of the Phase 3 studies, Atara also expects to file a ATA129 supplemental NDS for the treatment of cancer patients with rituximab-refractory EBV-PTLD after SOT, as well as request to remove the conditions of the NOC/c for the HCT indication.

About EBV-PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD), represents a life-threatening condition. Median overall survival in EBV-PTLD patients after HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV-PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One and two-year survival in high-risk EBV-PTLD patients after SOT is 36% and 0%, respectively.

About ATA129
Atara’s most advanced T-cell immunotherapy in development, ATA129, is a potential treatment for cancer patients with rituximab-refractory EBV-PTLD as well as other EBV positive hematologic and solid tumors including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted ATA129 Breakthrough Therapy Designation for EBV-PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, ATA129 was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. In addition, ATA129 also has orphan status in the U.S. and EU. Phase 3 studies of ATA129 in EBV-PTLD after HCT (MATCH study) or solid organ transplant (ALLELE study) are expected to start in 2017, and a Phase 1/2 study in NPC is planned for 2018. ATA129 is also available to eligible patients with EBV-positive tumors through an ongoing multicenter expanded access protocol (EAP) clinical study. Atara expects to submit ATA129 for conditional marketing authorization in EBV-PTLD following HCT in the EU in 2018.

About Atara Biotherapeutics, Inc.

On September 12, 2017 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of TRISENOX (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate 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, SEP 12, 2017, View Source [SID1234520484]).

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Currently, TRISENOX is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (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.
"With over 15 years of clinical experience, TRISENOX is an important treatment option for APL patients," said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. "Teva is committed to providing solutions that advance cancer care. We are very pleased that the FDA has accepted the sNDA for priority review as it brings us one step closer to expanding the label for TRISENOX to include use in combination with ATRA for patients with newly diagnosed low to intermediate risk APL."

The FDA has accepted the sNDA for priority review with regulatory action expected in the first quarter of 2018. FDA grants priority review to applications for drugs or biologics intended to treat serious conditions and address unmet medical needs. The sNDA filing includes data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide.

Please see full accompanying Prescribing Information and safety information including Boxed Warning regarding: APL differentiation syndrome, cardiac conduction abnormalities, and electrolyte monitoring.
TRISENOX (arsenic trioxide) Injection

Indications
TRISENOX is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (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.

Important Safety Information for TRISENOX (arsenic trioxide) Injection
WARNING: APL DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES, AND ELECTROLYTE MONITORING
APL Differentiation Syndrome: Patients with APL treated with TRISENOX have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This syndrome can be fatal. High-dose steroids have been administered at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), immediately initiate high-dose steroids (dexamethasone 10 mg intravenously BID), irrespective of the leukocyte count, and continue for at least 3 days or longer until signs and symptoms have abated. The majority of patients do not require termination of TRISENOX therapy during treatment of the APL differentiation syndrome.
Cardiac Conduction Abnormalities: Before initiating therapy, perform a 12-lead ECG, assess serum electrolytes and creatinine, correct preexisting electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. 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, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient (also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.

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

APL Differentiation Syndrome: Nine of 40 patients with APL treated with TRISENOX, at a dose of 0.15 mg/kg, experienced the APL differentiation syndrome.

Cardiac Conduction Abnormalities: Torsade de Pointes, Complete Heart Block, and QT Prolongation: Sixteen of 40 patients (40%) had at least one ECG tracing with a QTc interval greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned towards baseline by the end of 8 weeks after TRISENOX infusion. Monitor ECG weekly and more frequently for clinically unstable patients. For QTc greater than 500 msec, complete corrective measures and reassess the QTc with serial ECGs prior to initiating TRISENOX. During TRISENOX therapy, maintain potassium concentrations above 4 mEq/L and magnesium concentrations above 1.8 mg/dL. Reassess patients who reach an absolute QT interval value > 500 msec and immediately correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending TRISENOX therapy should be considered. The risk may be increased when TRISENOX is coadministered with medications that can lead to electrolyte abnormalities (such as diuretics or amphotericin B).

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. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during and after treatment with TRISENOX.

Lactation: TRISENOX is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, discontinue breastfeeding during treatment with TRISENOX.

Laboratory Tests: Electrolyte and glucose levels, as well as hepatic, renal, hematologic, and coagulation profiles should be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.

Drug Interactions: Avoid the concomitant use of TRISENOX with medications that can prolong the QT/QTc interval or those that can lead to electrolyte abnormalities. Concomitant use of drugs that can prolong the QT/QTc interval with TRISENOX may increase the risk of serious QT/QTc interval prolongation. Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation. Monitor ECGs and electrolytes more frequently in patients who are unable to avoid concomitant use of these medications and TRISENOX.

Pediatric Use: In a pediatric study, the toxicity profile observed in 13 pediatric patients with APL between the ages of 4 and 20 receiving TRISENOX was similar to that observed in adult patients. Additional drug-related toxicities reported included: gastrointestinal disorders, metabolic and nutrition disorders, respiratory disorders, cardiac failure congestive, neuralgia, and enuresis. One case each of pulmonary edema and caecitis were considered serious reactions. No children less than 4 years of age were enrolled in the trial due to the rarity of APL in this age group.
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: Most patients experienced some drug related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. These adverse effects have not been observed to be permanent or irreversible nor do they usually require interruption of therapy.

TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or [email protected]
Please see Full Prescribing Information for TRISENOX (arsenic trioxide) Injection