On November 30, 2016 Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) reported that data on GRANIX (tbo-filgrastim) Injection, TREANDA (bendamustine HCl) Injection and TRISENOX (arsenic trioxide) Injection will be presented during poster sessions at the 2016 ASH (Free ASH Whitepaper) Annual Meeting to be held at the San Diego Convention Center in San Diego, CA on December 3-6, 2016 (Press release, Teva, NOV 30, 2016, View Source;p=RssLanding&cat=news&id=2226456 [SID1234516848]). Additional bendamustine abstracts were also accepted for publication in an online issue of Blood to be issued during the annual meeting.

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"We look forward to sharing real world data and outcomes research from our Oncology portfolio that provide deeper insights into our products," said Richard Nieman, M.D., Senior Vice President, Global Medical Affairs, Teva Pharmaceuticals. "The presentations at this year’s ASH (Free ASH Whitepaper) Meeting further highlight Teva’s commitment to providing innovative medicines that positively impact our healthcare system, treatment and management of disease, and the lives of people, particularly those affected by cancer."

Teva-sponsored data to be presented include:
GRANIX (tbo-filgrastim) Injection
P2504: Real-World Safety Experience for Short-Acting Recombinant Human Granulocyte Colony-Stimulating Factor.

This abstract will be presented during Granulocytes, Monocytes, and Macrophages on Sunday, December 4, 2016, 6:00 p.m. to 8:00 p.m. in Hall GH
P2407: Budget Impact Analysis of Treating Chemotherapy Patients with Health Care Provider-Administered Tbo-Filgrastim, Filgrastim-Sndz, and Filgrastim in the United States.
This abstract will be presented during Outcomes Research—Malignant Conditions on Saturday, December 3, 2016, 5:30 p.m. to 7:30 p.m. in Hall GH
P4786: Budget Impact Analysis of Treating Chemotherapy Patients with Patient-Administered Tbo-Filgrastim, Filgrastim-Sndz, and Filgrastim in the United States.
This abstract will be presented during Outcomes Research—Malignant Conditions on Monday, December 5, 2016, 6:00 p.m. to 8:00 p.m. in Hall GH
TREANDA (bendamustine HCl) Injection
P2406: Differences in Healthcare Utilization in Chronic Lymphocytic Leukemia (CLL) Patient Treated With Bendamustine plus Rituximab (BR) Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR).
This abstract will be presented during Outcomes Research—Malignant Conditions on Saturday, December 3, 2016, 5:30 p.m. to 7:30 p.m. in Hall GH
TRISENOX (arsenic trioxide) Injection
P4034: Long-Term Safety Experience with Arsenic Trioxide in Patients with Acute Promyelocytic Leukemia.
This abstract will be presented during Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation on Monday, December 5, 2016, 6:00 p.m. to 8:00 p.m. in Hall GH

GRANIX (tbo-filgrastim) Injection
Indication
GRANIX is a leukocyte growth factor indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Important Safety Information for GRANIX (tbo-filgrastim) Injection
Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX.
Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.
Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.
Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis.
Capillary leak syndrome (CLS): CLS can occur in patients receiving hG-CSFs and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.
Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.
Please see Full Prescribing Information for GRANIX (tbo-filgrastim) Injection
TREANDA (bendamustine HCl) Injection
Indications
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Important Safety Information for TREANDA (bendamustine HCl) Injection
Contraindication: TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.
Myelosuppression: TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. If myelosuppression occurs, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.
Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death have occurred. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections. Patients treated with TREANDA are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation prior to administration.
Anaphylaxis and Infusion Reactions: Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.
Tumor Lysis Syndrome: Tumor lysis syndrome associated with TREANDA treatment has occurred. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly.
Skin Reactions: Fatal and serious skin reactions have been reported with TREANDA treatment and include, toxic skin reactions, [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema and rash. Events occurred when TREANDA was given as a single agent and in combination with other anticancer agents or allopurinol. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue TREANDA.
Hepatotoxicity: Fatal and serious cases of liver injury have been reported with TREANDA. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients. Most cases were reported within the first three months of starting therapy. Monitor liver chemistry tests prior to and during bendamustine therapy.
Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma.
Extravasation Injury: TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA.
Embryo-fetal Toxicity: TREANDA can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using TREANDA.
Most Common Adverse Reactions:
The most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
The most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
The most common hematologic abnormalities for both indications (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
TO REPORT ADVERSE REACTIONS: Contact us at 1-800-896-5855 or [email protected]
Please see Full Prescribing Information for TREANDA (bendamustine HCl) Injection
TRISENOX (arsenic trioxide) Injection
Indication
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 USMedinfotevapharma.com
Please see Full Prescribing Information for TRISENOX (arsenic trioxide) Injection

On November 30, 2016 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported that interim data from its ongoing Phase 1 clinical study of bb2121, the company’s investigational anti-BCMA CAR T cell product candidate in patients with relapsed/refractory multiple myeloma, will be presented on Thursday, December 1, 2016 at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany (Press release, bluebird bio, NOV 30, 2016, View Source;p=RssLanding&cat=news&id=2226688 [SID1234516854]). bluebird bio is developing bb2121 in collaboration with Celgene Corporation.

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"We are pleased that these early data from our ongoing Phase 1 study of bb2121 demonstrate objective anti-tumor responses in heavily pre-treated patients with multiple myeloma, with all patients in the 15.0 x 107 and 45.0 x 107 CAR+ T cell dose cohorts achieving responses, including among them, patients with stringent complete responses and elimination of minimal residual disease," said David Davidson, M.D., chief medical officer, bluebird bio. "We are also encouraged by the safety profile to date, particularly the lack of severe cytokine release syndrome or neurotoxicity. In light of these positive data, and thanks to the multiple participating clinical sites and centralized manufacturing infrastructure we and our partner Celgene have built for this program, we anticipate efficiently completing the dose escalation stage of the trial and initiating the expansion cohort."

Clinical remissions and limited toxicity in a first-in-human multicenter study of bb2121, a novel anti-BCMA CAR T cell therapy for relapsed/refractory multiple myeloma (Abstract #14, LBA)

Presenter: Yi Lin, M.D., Ph.D., Assistant Professor of Medicine and Oncology, Mayo Clinic Division of Hematology, Rochester, MN
Date: Thursday, December 1, 2016, 18:00 CET (12:00 pm ET)
Session: Plenary Session 7

The open-label Phase 1 CRB-401 study (NCT02658929) is investigating the administration of bb2121 anti-BCMA CAR T cells in patients with relapsed and/or refractory multiple myeloma. The primary endpoint of the study is incidence of adverse events (AEs) and abnormal laboratory test results, including dose-limiting toxicities (DLTs). The study also seeks to assess disease-specific response criteria including: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. The study also seeks to determine the recommended dose for further clinical trials. Patients on study were heavily pre-treated, with a median of six prior therapies (range: 5 – 13). As of the November 18th, 2016 data cut-off, 11 patients had been enrolled and dosed in four dose cohorts: 5.0 x 107, 15.0 x 107, 45.0 x 107 and 80 x 107 CAR+ T cells. All 11 dosed patients were evaluable for safety, and the first nine patients (5.0 x 107, 15.0 x 107, 45.0 x 107 dose cohorts) have undergone their first multiple myeloma tumor restaging and were evaluable for efficacy. This study is currently enrolling patients at seven sites in the U.S., with an anticipated total enrollment of 50 patients.

Patients received a conditioning regimen of cyclophosphamide and fludarabine, followed by an infusion of bb2121 anti-BCMA CAR T cells. The CAR T cells were produced from each patient’s own blood cells, which were modified using a lentiviral vector encoding the anti-BCMA CAR.

Results, as of November 18th, 2016 Data Cut-off:

Cohort 1 2 3
CAR+ T Cell dose 5.0 x 107 15.0 x 107 45.0 x 107
Overall Response
Rate in cohort

33% 100% 100%
Best Response PD
SD

PR

sCR (time to response: 2 months)
sCR* (time to response: 4 months)
VGPR*

*Both patients with
a minimal residual
disease (MRD)
assessment at
Month 1 were MRD
negative

PR
PR

PR

All patients in cohorts 2 and 3 with bone
marrow involvement at baseline had no
detectable multiple myeloma cells in their
bone marrow on Day 14 or beyond

Median Prior
Lines of Therapy

6 (range: 5-13); all patients had a prior autologous stem cell
transplant, as well as prior exposure to a proteasome inhibitor and
an immunomodulatory agent; 64 percent of patients had
previously received daratumumab or CD38 antibody

Safety
No dose-limiting toxicities and no Grade 3 or higher
neurotoxicities or Grade 3 or higher cytokine release syndrome
(CRS) have been observed. No patients received tocilizumab or
steroids.

On November 30, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported that two posters will be presented at the upcoming San Antonio Breast Cancer Symposium taking place December 6-10, 2016 in San Antonio, TX (Press release, Galena Biopharma, NOV 30, 2016, View Source [SID1234516851]).

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A poster will be presented on the trial design for the planned, Phase 2 investigator-sponsored clinical trial with NeuVax (nelipepimut-S) in patients with Ductal Carcinoma in Situ (DCIS). The trial is being run in collaboration with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center Phase I and II Chemoprevention Consortium. The trial was suspended in July 2016, but is now open for enrollment and is expected to initiate by the end of the year. Details of the poster presentation are as follows:

Title: VADIS trial: Phase 2 trial of the nelipepimut-S peptide vaccine in women with DCIS of the breast
Session Title: Ongoing Clinical Trials: Ongoing Trials — Immunotherapy
Date: Friday, December 9, 2016
Time: 5:00 p.m. to 7:00 p.m. local time
Location: Hall 1
Poster #: 1646
Abstract #: OT3-01-04 – the abstract can be found on the conference website here
A poster will be presented on the breast cancer patients in the Company’s GALE-301 (E39) and GALE-302 (E39’) Phase 1b clinical trial targeting Folate Binding Protein. Details of the poster presentation are as follows:

Title: Determining the optimal vaccination strategy using a combination of the folate binding protein (FBP) peptide vaccine (E39+GM-CSF) and an attenuated version (E39′) to maximize the immunologic response in breast cancer patients
Session Title: Poster Session 6: Treatment: Immunotherapy (Clinical)
Date: Saturday, December 10, 2016
Time: 7:30 a.m. to 9:00 a.m. local time
Location: Hall 1
Abstract #: P6-10-04 – the abstract can be found on the conference website here
About NeuVax (nelipepimut-S)

NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About Ductal Carcinoma in Situ

Ductal Carcinoma in Situ (DUK-tul KAR-sih-NOH-muh in SY-too), or DCIS, is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2015 there were over 60,000 diagnoses of ductal carcinoma in situ.

About GALE-301 and GALE-302

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers (ClinicalTrials.gov Identifier: NCT02019524).

About Breast Cancer1

New cases of breast cancer occur at an annual rate of 125 per 100,000 women in the U.S., with an estimated 246,660 new cases and 40,450 deaths in 2016. Approximately 89.7% of breast cancer patients are expected to survive five years after diagnosis. Approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 3,053,450 women living with breast cancer in the United States.

1National Cancer Institute Surveillance, Epidemiology, and End Results Program

On November 29, 2016 MedImmune, the global biologics research and development arm of AstraZeneca, and Abpro, an integrated life sciences company at the forefront of synthetic biology, reported they have entered into a collaborative agreement to advance the development of a preclinical, novel bispecific antibody targeting angiopoietin-2 and vascular endothelial growth factor (Ang2-VEGF) (Press release, abpro therapeutics, NOV 29, 2016, View Source [SID1234525610]). The agreement is structured as a spin out, benefiting from both companies’ scientific expertise and Abpro’s day-to-day leadership as it oversees the new company, AbMed.

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Several potential therapeutic areas will be explored where inhibition of the Ang2 and VEGF pathways with this unique bispecific antibody may provide clinical benefit.

Scientists at MedImmune leveraged the company’s significant experience with bispecific antibody development, engineering a novel bispecific antibody that demonstrated potent activity in animal models, which may be useful in targeting disease indications with high unmet needs. Abpro will bring strong scientific, technical and clinical expertise to the new company moving forward, and its core technology platform, DiversImmune, will be used to further refine the antibody.

Under the terms of the agreement, AbMed, which will operate as a subsidiary of Abpro, will receive majority global development and commercialization rights to the program, and MedImmune will receive development, regulatory and sales milestones and royalties, as well as hold a minority equity stake in AbMed.

"This agreement arises out of MedImmune’s culture of entrepreneurship and innovation – both in science and in business," said Jane Osbourn, Vice President of R&D, MedImmune. "We believe partners like Abpro can help us maximize our extensive pre-clinical portfolio to advance therapies for patients."

Ian Chan, CEO and Co-founder of Abpro said: "Abpro’s collaborative agreement with MedImmune creates an opportunity to work with one of the world’s leading biopharmaceutical companies to advance novel therapeutics into the clinic. This collaboration further validates our platform’s ability to develop therapeutic antibodies against traditionally difficult targets, with compelling prospects for potential clinical utility."

On November 29, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported that the company will be presenting at the EORTC-AACR-NCI Symposium being held November 29-December 1 at the Internationales Congress Center München in Munich, Germany (Press release, Argos Therapeutics, NOV 29, 2016, View Source [SID1234516822]).

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Irina Tcherepanova, Ph.D., senior director of research and development for Argos, will give a poster presentation entitled "Development of an RNA loaded Dendritic Cell (DC) immunotherapy starting from tissue obtained via needle biopsy". The poster will be exhibited in the meeting exhibition hall throughout the day on November 30th.

The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association of Cancer Research (AACR) (Free AACR Whitepaper), and brings together academics, scientists, and industry representatives from around the world to review the latest innovations in drug development, target selection and the impact of new discoveries in molecular biology.

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About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection as an individualized immunotherapy.