On May 17, 2018 SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS) reported that data from the Company’s ongoing Phase 1/2 study of galinpepimut-S (GPS) in combination with Bristol Myers Squibb’s nivolumab in patients with Wilms Tumor 1 + ovarian cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1 – 5, 2018 in Chicago, Illinois (Press release, Sellas Life Sciences, MAY 17, 2018, View Source [SID1234526776]). Additionally, following the positive outcome in triple negative breast cancer patients (TNBC) from the Phase 2b trial for NeuVax, SELLAS will be conducting clinical and regulatory advisory board meetings at ASCO (Free ASCO Whitepaper) based on the independent Data Safety Monitoring Board recommendation to expeditiously seek regulatory guidance by the FDA for the development of NeuVax in TNBC.

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!

Clinical and immunological data from the ongoing Phase 1/2 GPS plus nivolumab trial evaluating GPS in patients with recurrent WT1+ ovarian cancer in second or greater clinical remission after salvage chemotherapy will be presented. Details for the presentation are as follows:

Title: A phase I study of concomitant galinpepimut-s (GPS) in combination with nivolumab (nivo) in patients (pts) with WT1+ ovarian cancer (OC) in second or third remission.
Presenter: Roisin E. O’Cearbhaill, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: 5553
Poster Session: Gynecologic Cancer
Date and Time: June 4, 2018, 1:15PM – 4:45PM CT
Location: McCormick Place, Hall A

On May 17, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the European Commission (EC) has approved Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC) (Press release, Ipsen, MAY 17, 2018, View Source [SID1234650566]). This approval allows for the marketing of Cabometyx (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland.

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 EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care", said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen. "Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications."

Giuseppe Procopio, M.D., Head of the Genitourinary Unit at Fondazione Istituto Nazionale Tumori Milan, stated: "The value of treatment with Cabometyx has been corroborated by the data generated in clinical trials, and since 2016 physicians have also witnessed the potential of it when treating patients following VEGF-targeted therapy. For both of these reasons, physicians will be pleased to soon have access to this new first-line treatment option for intermediate- or poor- risk advanced RCC patients."
Today’s decision is based on the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in treatment-naive aRCC patients with intermediate- or poor-risk. Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-naïve aRCC patients with intermediate- or poor-risk.
The detailed recommendations for the use of this product are described in the Summary of Product Characteristics (SmPC), available here (View Source).
About the CABOSUN study
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with intermediate- or poor-risk aRCC per IMDC (International Metastatic RCC Carcinoma Database Consortium) criteria as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016, and published in the Journal of Clinical Oncology (Choueiri, JCO, 2018).i
On June 19 2017 Exelixis announced that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. The incidence of adverse events (any grade) and the incidence of grade 3 or 4 adverse events between cabozantinib and sunitinib were comparable.
CABOSUN is a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with aRCC determined to be intermediate- or poor-risk per IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on followed by two weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate- or poor-risk per IMDC criteria (Heng, JCO, 2009).ii Prior systemic treatment for RCC was not permitted.
About advanced Renal Cell Carcinoma
With the incidence predicted to rise 22% by 2020, renal cell carcinoma (RCC) threatens to become one of the fastest growing cancers in the world.iii Targeted therapies including tyrosine kinase inhibitors (TKIs) of the VEGF receptor (VEGFR) introduced a decade ago, significantly transformed the treatment landscape of aRCC.iv
The American Cancer Society’s 2017 statistics cite kidney cancer as one of the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.v Clear cell RCC is the most common type of kidney cancer in adults.vi If detected in its early stages, the five-year survival rate for RCC is high. For patients with advanced- or late-stage metastatic RCC, however, the five-year survival rate is only 12% with no identified cure for the disease.vii Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.viii
The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL, and VEGF.ix–x These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness, and metastasis.xi, xii, xiii, xiv MET and AXL may provide escape pathways that drive resistance to VEGFR inhibitors. xii – xv
About CABOMETYX (cabozantinib)
Cabometyx is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.
In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 9, 2016, the European Commission approved Cabometyx tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. Cabometyx is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On December 19, 2017, Exelixis received approval from the FDA for Cabometyx for the expanded indication of treatment of advanced RCC.
On May 17, 2018, Ipsen announced that the European Commission approved Cabometyx for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinomain the European Union, Norway and Iceland.

On May 17, 2018 Oncolytics Biotech Inc. (TSX:ONC) (OTCQX:ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported an investigator sponsored study (IST) supported by Merck Inc (Press release, Oncolytics Biotech, MAY 17, 2018, View Source [SID1234534183]). (Merck), Northwestern University (Northwestern) and Oncolytics. This study is an extension of the previously reported phase 1 study (REO 024) that will investigate pelareorep in combination with Merck’s anti-PD1 checkpoint inhibitor Keytruda, to treat second line pancreatic cancer patients. The study, run by the principal investigator of REO 024, Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

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!

"This study using Merck’s Keytruda is our second I-O combination in human trials after our multiple myeloma study in combination with Celgene’s Imnovid and Revlimid," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We’re very happy with Merck’s increased involvement in our pancreatic studies and believe combining pelareorep with Keytruda poses an exciting opportunity to lay additional groundwork towards our ultimate goal – to expand the use of check point inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor, or turning cold tumors hot."

"REO 024, a phase 1b study combining pelareorep and Keytruda in second line pancreatic patients, was designed to evaluate safety and tolerability of the combination," said Dr. Mahalingam, Associate Professor of Medicine (Hematology and Oncology), Northwestern University Feinberg School of Medicine. "The results from that study demonstrated that the combination is safe, but also that there was early evidence of clinical activity, including one patient that had a partial response lasting 17.4 months and two with stable disease of 126 days and 277 days. This new phase two study will enroll patients with advanced pancreatic cancer failing front line chemotherapy and will primarily evaluate overall response rate of the combination therapy. The study will also provide important biomarker data determined by analysis of pre- and post-treatment biopsies and blood-based immune markers."

Final study design and other details will be announced upon enrollment of the first patient, expected in the third quarter 2018.

On May 17, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported positive results from a Phase 2 clinical trial assessing BL-8040 as a single agent for hematopoietic stem cell mobilization in an allogeneic transplantation setting (Press release, BioLineRx, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349638 [SID1234526759]). The full top-line results of the study will be presented at the 23rd Congress of European Hematology Association (EHA) (Free EHA Whitepaper), to take place June 14-17, 2018 in Stockholm, Sweden.

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!

Mobilization of hematopoietic stem and progenitor cells (HSPCs) for the purpose of donor (allogeneic) transplantation after high-dose chemotherapy is currently performed using a 4-5 day treatment cycle with G-CSF and a 1-2 day apheresis procedure. Single-agent treatment with BL-8040, a novel, high-affinity CXCR4 antagonist with rapid HSPC mobilizing kinetics, showed similar efficacy in only one administration. In addition, BL-8040 showed non-inferiority in recipient engraftment, with all transplanted recipients successfully engrafting with BL-8040-mobilized grafts.

This proof-of-concept Phase 2 study, consisting of 24 donor/recipient pairs, assesses the ability of BL-8040 monotherapy to mobilize HSPCs for transplantation in a single administration. In the first part of the trial, HLA-identical donors were treated with a single dose of 1 mg/kg of BL-8040 for evaluating safety and tolerability. The second part of the study, which is still ongoing, includes both HLA-identical and haploidentical pairs, and donors were treated with 1.25 mg/kg of BL-8040. HSPCs were collected by leukapheresis after a single BL-8040 injection. The primary endpoint was collection of ≥2×106 CD34 cells/kg of recipient weight in up to 2 leukapheresis sessions.

Of the 21 evaluable donors that have been enrolled in the study to date, 11 out of 13 donors (85%) treated at the 1 mg/kg dose and 8/8 donors (100%) treated at the 1.25 mg/kg dose of BL-8040 reached the primary goal of ≥2×106 CD34 cells/kg of recipient weight in up to 2 leukapheresis sessions. BL-8040 was safe and well tolerated, with adverse events consisting of injection site reactions and transient systemic reactions, all of which were resolved. No related serious adverse events were observed. All 19 transplanted recipients were successfully engrafted with BL-8040-mobilized grafts, 13 of which have reached the secondary endpoint of 100 days post-transplant. Preliminary graft-versus-host disease (GVHD) data are in line with current standard-of-care incidence rates. The full effect of BL-8040 on acute and chronic GVHD, as well as on relapse rates, await longer follow-up periods and will be reported at a later stage once available.

"Hematopoietic stem cell transplant is vital for the treatment of various hematological malignancies," stated Dr. Geoffrey Uy, from the Section of Blood and Marrow Transplantation and Leukemia in the Division of Oncology at the Washington University School of Medicine, and the principal investigator of the study. "Currently, hematopoietic stem cells are mobilized from the bone marrow to the peripheral blood using repeated administrations of G-CSF, followed by leukapheresis, with the whole process lasting almost a week. It is therefore encouraging to see these top-line results, supporting the application of BL-8040 as a single agent for rapid mobilization of hematopoietic stem cells after only one injection."

"We are very pleased with the results of this proof-of-concept Phase 2 clinical trial, showing that a single administration of BL-8040, followed by apheresis, results in rapid and effective HSPC mobilization and leads to prompt hematopoietic recovery after allogeneic transplantation," stated Philip A. Serlin, Chief Executive Officer of BioLineRx. "These robust results in an allogeneic setting continue to strongly support BL-8040’s mechanism of action, and demonstrate the ability of BL-8040 as a fast and effective mobilizing agent, thereby giving us further confidence in our ongoing Phase 3 study in stem cell mobilization for autologous transplants. We look forward to the results of the lead-in period from the Phase 3 trial, which are expected in the next few months. In parallel, we are further evaluating the allogeneic transplant landscape in order to decide on the best development pathway forward for this complementary indication."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Stem Cell Mobilization

High-dose chemotherapy followed by stem cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after chemotherapy. This type of treatment often replaces the use of traditional bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.

On May 17, 2018 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported that clinical and preclinical abstracts for PTG-300, the Company’s injectable hepcidin mimetic in development for treatment of anemia and iron overload in rare blood disorders, have been accepted for oral presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Protagonist, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349672 [SID1234526777]). The Annual Congress of EHA (Free EHA Whitepaper), a flagship meeting with 11,000 participants that encompasses the entire spectrum of hematological diseases, takes place in Stockholm, Sweden, June 14-17, 2018.

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!

Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

The details of the oral presentations are as follows:

Presentation Title: Hepcidin mimetic PTG-300 for treatment of ineffective erythropoiesis and chronic anemia in hemoglobinopathy diseases
Date and Time: Saturday, June 16 from 11:45 AM to 12:00 PM CEST
Session: Thalassemias
Location: Stockholm International Fairs Convention Center, Room K2

Presentation Title: Hepcidin Mimetic PTG-300 induces dose-related and sustained reductions in serum iron and transferrin saturation in healthy subjects
Date and Time: Saturday, June 16 from 5:00 PM to 5:15 PM CEST
Session: Iron metabolism, deficiency and overload
Location: Stockholm International Fairs Convention Center, Room A13