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.

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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.

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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

On May 17, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, advises that its Chief Medical Officer and Chief Scientific Officer, Dr. Frédéric Triebel, reported it will present interim results from the three initial patient cohorts of its ongoing TACTI-mel Phase I clinical trial in a global webcast and Q&A (Press release, Immutep, MAY 17, 2018, View Source [SID1234526798]). The webcast will also include an update on the Company’s clinical immuno-oncology combination program.

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Dr. Triebel will also present a subset of these interim results at the 3rd Annual Advances in Immuno-Oncology Congress, on 25 May 2018 in London, UK. The presentation, titled "Two ACTIve Immunotherapies in melanoma (TACTI-mel): results of a phase I trial with metastatic melanoma patients treated with a soluble LAG-3 receptor (LAG-3Ig or eftilagimod alpha) as an antigen presenting (APC) activator combined with pembrolizumab" will be released to the market to coincide with the event and made available on the Company’s website.

Immutep’s current lead product is eftilagimod alpha ("efti" or "IMP321"), a potential first-in-class major histocompatibility complex class II ("MHC II") agonist and antigen presenting cell ("APC") activator. Efti is a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti, unlike blocking antibodies, is unique as it uses LAG-3 itself as a tool to activate the immune system via MHC II molecules.

The TACTI-mel Phase I clinical trial is a multi-center, open-label clinical trial evaluating the combination of efti with pembrolizumab (KEYTRUDA) for unresectable or metastatic melanoma. As previously disclosed, interim results from the first three cohorts was expected in H1 2018. The trial remains ongoing, following its expansion by an additional cohort, with results from this additional cohort expected in H2 2018.

Investor Webcast Details

The webcast will be hosted by Dr. Triebel, Marc Voigt, CEO and Christian Mueller, Director of Clinical Development.

Date & Time:
Wednesday, May 30, 2018, 8:00am Australian Eastern Standard Time

Tuesday, May 29, 2018, 6:00pm US Eastern Daylight Time

Register: Interested investors can register via a link to the webcast on the Company’s website at Clinical Results of Ongoing Melanoma Study and Update on Eftilagimod Alpha Clinical Development Strategy or via the following link.

View Source

A replay of the webcast will also be available at www.immutep.com from the day after the event.

LOGO

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label, dosing escalating (1, 6 or 30 mg of eftilagimod alpha or "efti") study evaluating the combination of efti with pembrolizumab for 6 months, starting at treatment cycle 5 in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869). The initial study consists of three cohorts of six patients.

In February 2018, Immutep expanded the TACTI-mel study by an additional cohort of 6 patients at 30 mg of efti in combination with pembrolizumab starting at cycle 1 and with a treatment duration of 12 months. As announced on March 22, 2018, the first patient from this additional cohort has received their first dose.

On May 17, 2018 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director President and CEO: Hiroshi Nomura) reported that a total of 6 presentations including clinical study results and designs for investigational anti-cancer agents napabucasin (BBI608), DSP-7888 and TP-0903 will be made at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 1 to June 5, 2018 (Press release, Sumitomo Dainippon Pharma, MAY 17, 2018, View Source [SID1234526742]).

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【About napabucasin】
Napabucasin is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. Napabucasin has been shown to inhibit STAT3 pathways, Nanog pathways and β-catenin pathways in pre-clinical studies.
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【About DSP-7888】
DSP-7888 is a therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. DSP-7888 is a vaccine containing peptides that induces WT1-specific cytotoxic T lymphocytes (CTLs) and helper T cells. DSP-7888 is expected to become a treatment option for patients with various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1- specific CTLs that attack WT1-expressing cancer cells. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a CTL-inducing peptide alone may be achieved. DSP7888 is expected to be an option for a wide range of patients.

【About TP-0903】
TP-0903 is an AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to conventional agents and developing metastatic capacity in cancer cells.TP-0903 may have anti-cancer activities on various cancer types through blocking transition from epithelial to mesenchymal phenotype by inhibiting AXL. TP0903 has been shown to inhibit AXL signaling and reverse the mesenchymal to epithelial phenotype in pre-clinical studies.

These agents have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer or any other disorder.
Contact: Public & Investor Relations Group, Corporate Governance
Sumitomo Dainippon Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka); +81-3-5159-3300 (Tokyo)

On May 17, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported it has initiated ALX148 combination dosing with targeted antibody therapies in its Phase 1 clinical program in patients with advanced solid tumors and lymphoma (Press release, Alexo Therapeutics, MAY 17, 2018, View Source [SID1234526778]). The Company will present updated data on ALX148 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Poster Presentation Information
Title: A Phase 1 Study of ALX148, a CD47 Blocker, Alone and in Combination with Established Anti-Cancer Antibodies in Patients with Advanced Malignancy and Non-Hodgkin Lymphoma
Session Name: Developmental Therapeutics-Immunotherapy
Session Date: June 04, 2018
Presentation Time: 8:00am – 11:30am CT
Abstract Number: 3068

"The initiation of ALX148 combination cohorts marks the next important milestone in Alexo’s development," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of Alexo Therapeutics. "ALX148 is designed to enhance the efficacy of antibody-based therapies, while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic. ALX148 is generally well tolerated in patients with advanced tumors and exhibits favorable pharmacokinetics and CD47 target occupancy at doses evaluated. No maximum tolerated dose of ALX148 was reached. With broad therapeutic potential across many types of cancer, we are eager to now be evaluating ALX148 in combination with select anti-cancer therapeutic antibodies."

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the single-agent dose escalation phase is complete and the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. Clinical data will be presented at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218)