NeuroVive Pharmaceutical AB Publishes 2018 Annual Report

On March 25, 2019 NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) reported that the English version of the Annual report for 2018 is now available on the company’s website www.neurovive.com (Press release, NeuroVive Pharmaceutical, MAR 25, 2019, View Source [SID1234534616]).

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 information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 10:00 a.m. CET on 25 March 2019.

PHIO PHARMACEUTICALS TO PRESENT POSTER ON THE USE OF SELF-DELIVERING RNAI IN IMMUNO-ONCOLOGY AT THE AACR ANNUAL MEETING 2019

On March 25, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that the Company will present a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, which will be held from March 29–April 1, 2019 at the Georgia World Congress Center in Atlanta, Georgia (Press release, Phio Pharmaceuticals, MAR 25, 2019, View Source [SID1234534601]).

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 details of the presentation are as follows:

Poster #: 1963
Poster Title: Feasibility and efficacy using self-delivering RNAi against TGFB1 to reduce TME immunosuppression
Session: Secreted Changes in the Tumor Microenvironment: Exosomes and Chemokines
Date and Time: Monday, April 1, 2019, 1:00 p.m.–5:00 p.m. Eastern Time
Location: Hall B, Poster Section 6

The poster will be presented by Dr. Winnie Tam, Director of Pharmacology, and will also be available under the "Investors–Events and Presentations" section of the Company’s website, www.phiopharma.com, approximately one hour following the presentation.

Glycotope Expands Phase Ib Trial of Combination of Proprietary Anti-Tumor Antibodies to Include Marketed Anti-Tumor Antibodies

On March 25, 2019 Glycotope GmbH (Glycotope or the Company), a clinical-stage oncology/immuno-oncology company built on world-leading glycobiology expertise, reported it has enrolled the first patient in an expansion of its ongoing Phase Ib international GATTO study investigating the combination of Glycotope’s anti-TA-MUC1 antibody (Gatipotuzumab) and anti-EGFR antibody (Tomuzotuximab) (Press release, Glycotope, MAR 25, 2019, View Source [SID1234534576]).

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 phase Ib trial expansion will evaluate the feasibility, safety and efficacy of the combination of Gatipotuzumab with either Tomuzotuximab or a marketed anti EGFR antibody in patients with solid tumors such as metastatic colorectal, lung, breast and head and neck cancers with measurable disease after failure of standard treatment options.

GATTO is an international, multicenter phase Ib trial enrolling patients in Germany, Italy and Spain. The combination of Gatipotuzumab with Tomuzotuximab or a marketed anti EGFR antibodies is based on a strong preclinical rationale and preliminary clinical evidence from the first 20 patients enrolled in the study.

"We are pleased to have enrolled the first patient in this innovative and interesting trial expansion which will enable us to build on the preliminary clinical evidence from the first 20 patients enrolled in the study. We are excited to learn more about Gatipotuzumab’s efficacy when combined with anti EGFR antibodies," said Dr. Alfredo Zurlo, MD, external Medical Head of Glycotope GmbH. "The trial aims to confirm in selected cancer patients the preclinical synergy observed in combining anti-EGFR and anti TA-MUC1 targeting."

"The GATTO trial extension further highlights the potential and wide applicability of gatipotuzumab" said Henner Kollenberg, Managing Director of Glycotope GmbH. "We believe the versatility of our technology platform combined with our world-leading glycobiology expertise and clinical experience in oncology and primarily immuno-oncology leaves us well placed to further strengthen our position in the field."

The GATTO study has been registered with the European Medical Agency under the EudraCT number 2017-001609-33

About Gatipotuzumab

Gatipotuzumab (previously known as PankoMab-GEX) is an anti-tumor antibody developed through Glycotope’s proprietary glyco-epitope targeting and glycooptimization technologies. Gatipotuzumab enables tumor-specific binding to a carbohydrate-induced conformational epitope, the TA-MUC1 (tumor-associated MUC1), which is present across a variety of high prevalence carcinomas. It has thus potential in the treatment of several cancer types and as a platform for the development of multiple further oncology and immuno-oncology products including antibody drug conjugates (ADC) and bi-specifics activating the immune system.

About Tomuzotuximab

Tomuzotuximab (previously known as CetuGEX) is an immune-enhanced monoclonal antibody (mAb) against the epidermal growth factor receptor (EGFR) with optimized and fully human glycosylation. Tomuzotuximab works via several anti-tumor mechanisms of action: a strong antibody dependent cellular toxicity (ADCC), proliferation inhibition via receptor blockage and induction of apoptosis. Thanks to the optimization of a series of sugar determinants, in pre-clinical studies Tomuzotuximab has shown to be more active in eliciting anti-tumor ADCC compared to cetuximab. This enhanced potency may increase the number of patients with EGFR expressing tumors who benefit from treatment.

Curis to Release Fourth Quarter and Year-End 2018 Financial Results and Host Conference Call on March 26, 2019

On March 25, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter and full-year 2018 financial results on Tuesday, March 26, 2019, after the close of the US markets (Press release, Curis, MAR 25, 2019, https://www.prnewswire.com/news-releases/curis-to-release-fourth-quarter-and-year-end-2018-financial-results-and-host-conference-call-on-march-26-2019-300817490.html [SID1234534602]). Management will host a conference call on the same day at 4:30 p.m. ET.

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!

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the investors section of the Curis website at www.curis.com. A replay will also be available on the Curis website shortly after completion of the call.

Aptose Announces FDA Allowance of Investigational New Drug Application for CG-806

On March 25, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the U.S. Food and Drug Administration (FDA) completed their review of the Company’s Investigational New Drug (IND) submission for CG-806 (Press release, Aptose Biosciences, MAR 25, 2019, View Source [SID1234534580]). Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK, and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL).

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!

Aptose will conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and NHL who have failed or are intolerant to standard therapies. The Phase 1 trial is expected to initiate in the 2nd quarter of 2019. Pending collection and careful review of the initial safety data and predictive pharmacokinetic data in humans from this trial, Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a separate Phase 1 trial.

"We are pleased that the FDA has allowed Aptose to perform clinical trials with CG-806, our first-in-class pan-FLT3/pan-BTK inhibitor," said William Rice, Ph.D., Chairman, President & CEO. "CG-806 has demonstrated a favorable safety profile and compelling durable tumor elimination in animal models of cancer, and we look forward to advancing it into human clinical testing."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.