On May 16, 2019 Biocure Technology Inc. (formerly Gravis Energy Corp.) (CSE: CURE OTCQB: BICTF) (the "Company" or "Biocure") reported that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis (Press release, Biocure Technology, MAY 16, 2019, View Source [SID1234628754]).

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 two Companies will work together in developing anti-CD19 CAR T-cell therapy products, conduct preclinical, clinical trials and commercialize anti-CD19 CAR T-cell therapy products overseas to treat leukemia and lymphoma patients. Some of the highlights of collaborative R&D work scopes in the Agreement include:

Manufacture of products for preclinical trial of Contract Product
Preclinical trial of Contract Product
Manufacture of 3 batch of test product for clinical trial application of Contract Product
Application for clinical trial of Contract Product
Manufacture of product for clinical trial of Contract Product
Clinical trial of the Contract Product
Establishment of manufacturing technology and SOP of Contract Product
Establishment of QC test method and SOP of Contract Product
Preparation of safety / efficacy data of Contract Product
Establishment and operation of GMP Facility of Contract Product
Biologics License Application (BLA) of Contract Product
Obtaining the product registration and (conditional) sales permit for Contract Product
Pharos and BPK (collectively "Parties") have agreed on the exclusive manufacturing and marketing rights of anti-CD19 CAR T-cell products for 15 years from the starting date of sales in the markets. The territories BPK shall have exclusive rights under this Agreement are all the countries except China.

Dr. Sang Mok Lee, a CEO and President of Biocure as well as BPK states, "I am pleased to have this agreement executed with Pharos to be clear about what both firms are supposed to do for the development of world market of CAR-T Cell products beyond Korea market. Biocure has finished successfully pre-clinical trial in Korea last September 2018 and now plans to start a clinical trial in the Q3 this year. Our next goal shall be developing overseas market by implementing clinical trials in those countries we are targeting to enter into. By this Agreement, Pharos and Biocure could have clear paths on what roles each firm should play in the development of world markets."

On May 16, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the outline of the ongoing Phase I study with the bispecific drug candidate ATOR-1015 will be showcased at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago on May 31- June 4, 2019 (Press release, Alligator Bioscience, MAY 16, 2019, View Source [SID1234538664]).

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 ATOR-1015 Phase I study is a first-in-human dose-escalation study in patients with advanced solid malignancies (NCT03782467). The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and to identify the maximum tolerated dose/recommended dose for subsequent Phase II studies. The first patient was dosed in March 2019 and the study results are expected to read out in the second half of 2020.

The study design includes accelerated dose titration with one patient cohorts, followed by a modified 3+3 design with at least three patients per dose level. At the maximum tolerated dose, or at a lower dose level, an expansion cohort is planned with up to 14 patients, for additional safety and efficacy evaluation.

Charlotte Russell, Chief Medical Officer at Alligator Bioscience will present the poster (#292b) entitled "A first-in-human, multicenter, open-label, phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of intravenously administered ATOR-1015" by Jeffrey Yachnin et al. on June 1 from 8-11 a.m. CDT in the session Developmental Immunotherapy and Tumor Immunobiology.

"While immune activation through CTLA-4 has shown impressive efficacy in multiple cancers, it is coupled with severe toxicity. We believe that ATOR-1015 will be at least as effective as the approved monospecific CTLA-4 antibody and with less side effects," said Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST (2:30 a.m. EDT) on May 16, 2019.

About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T cell depletion. It is wholly owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

On May 16, 2019 Probiodrug AG (Euronext Amsterdam: PBD), reported its first quarter business update for the period ending March 31, 2019 (Press release, Vivoryon Therapeutics, MAY 16, 2019, View Source [SID1234537747]).

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 first quarter 2019 report is available for download on the company website (View Source).

KEY HIGHLIGHTS
In March, Probiodrug and Alzheimer’s Disease Cooperative Study (ADCS) announced the awarding of a 15 million USD grant from the National Institutes of Health (NIH) for U.S. Phase 2b core program for its lead compound PQ912
In April, Probiodrug raised EUR 8.2 million from a consortium of strategic investors in a successful capital increase primarily intended to initiate the European Phase 2b clinical study of PQ912
Expenditure and corresponding liquidity position of EUR 2.5 million on March 31, 2019, in line with management expectations

CORPORATE REVIEW

Financial Review (According to IFRS)

In the first quarter of 2019, research and development expenses amounted to EUR 443k, reduced significantly compared to the first quarter of 2018 (EUR 1.026k). General and administrative expenses declined to EUR 410k (Q1 2018: EUR 513k). The Company did not generate any revenue in the reporting period, in line with corporate planning. Correspondingly, the net loss of the period was EUR 859k, compared to EUR 1,511k in the first quarter of 2018.

All results are in line with management expectations.

Probiodrug held EUR 2.5 million in cash and cash equivalents as of March 31, 2019.

OPERATIONAL REVIEW

NIH grant awarded for lead compound PQ912 – a first-in-class highly specific and potent Glutaminyl Cyclase (QC) inhibitor

The Company announced on March 20, 2019, that Probiodrug and the Alzheimer’s Disease Cooperative Study (ADCS) will receive 15 million USD from the National Institutes of Health (NIH) for part funding of a US Phase 2b clinical trial to evaluate the efficacy and safety of Probiodrug’s PQ912 in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD).

POST PERIOD HIGHLIGHTS

Probiodrug AG mandated ODDO SEYDLER BANK AG as Designated Sponsor

Probiodrug announced on April 4, 2019, that shares in Probiodrug AG, which have been trading in the Open Market of the Frankfurt Stock Exchange, are now also listed on XETRA. Probiodrug AG has mandated ODDO SEYDLER BANK AG as its Designated Sponsor to ensure continuous liquidity in share trading on XETRA.

Raise of EUR 8.2 million from investors in successful private placement of new shares

Probiodrug announced on April 9, 2019, the successful execution of a capital increase by issuing 4,093,367 new shares against cash contributions. Of those new shares, 3.1 million were sold to a consortium of investors led by Mr. Claus Christiansen founder and chairman of the board of Nordic Bioscience, Denmark, who has a strategic interest in the Company and intends to support the Probiodrug’s further development on a long-term basis . The Company will use the proceeds to initiate the European Phase 2b clinical study of lead compound PQ912 in Alzheimer’s Disease and to advance Probiodrug’s new program for immune checkpoint inhibition.

Invitation to Probiodrug’s Ordinary General Meeting of Shareholders on May 29, 2019

On April 18, 2019 Probiodrug invited its shareholders to its ordinary general meeting of shareholders to be held on Wednesday, May 29, 2019 at 10:00 am (CEST), at the registered office, Weinbergweg 22, 06120 Halle (Saale), Germany. The relevant documents can be found at: www.probiodrug.de/investors/ordinary-general-meeting-of-shareholders-2019/.

For more information, please contact:

Probiodrug
Dr. Ulrich Dauer, CEO
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

On May 16, 2019 Wellspring Biosciences, Inc., a wholly owned subsidiary of Araxes Pharma, LLC, reported that the U.S. Food and Drug Administration has cleared an investigational new drug (IND) application for ARS-3248, a small molecule KRAS G12C inhibitor (Press release, Wellspring Biosciences, MAY 16, 2019, View Source [SID1234537540]). ARS-3248 was discovered as part of an exclusive drug discovery and development agreement with Janssen Biotech, Inc, which will conduct the Phase 1 trial and have sole responsibility for clinical development.

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!

"Although KRAS was considered an undruggable target when we initiated this program in 2012, Wellspring scientists have shown considerable progress in being the first to demonstrate that direct and covalent inhibitors can specifically induce tumor regression in mouse tumor models harboring the mutation," said Yi Liu, Ph.D., Chief Scientific Officer of Wellspring Biosciences. "ARS-3248 represents the culmination of a significant and highly productive collaboration between scientists at Wellspring and Janssen, building upon the learnings of previous tool compounds. As we continue to advance this optimized clinical candidate that holds the potential to provide meaningful benefit to patients, we look forward to supporting Janssen as they evaluate the potential of ARS-3248 in patients with KRAS G12C-positive cancers."

About ARS-3248

ARS-3248 is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 12 percent of non-small cell lung cancer patients, as well as subsets of patients in other tumor types, such as those with colorectal and pancreatic cancers. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. ARS-3248 will be evaluated in a Phase 1 trial of patients with molecularly identified KRAS G12C-positive advanced solid tumors.

On May 16, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new preclinical data for CG-806, its oral, first-in-class pan-FLT3/pan-BTK inhibitor, will be presented in a poster presentation at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 13-16, 2019 in Amsterdam, the Netherlands (Press release, Aptose Biosciences, MAY 16, 2019, View Source [SID1234536456]).

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!

CG-806 Poster Presentation Details:

CG-806, PRECLINICAL IN VIVO EFFICACY AND SAFETY PROFILE AS A PAN-FLT3/PAN-BTK INHIBITOR
Date & Time: Friday, June 14, 2019, 5:30 p.m. – 7:00 p.m. CEST
Session Title: Acute Myeloid Leukemia – Biology & Translational Research
Abstract Number: PF203
Location: Poster area, RAI Amsterdam: Europaplein 24, 1078 GZ Amsterdam, The Netherlands

The accepted abstract is available online on the EHA (Free EHA Whitepaper) conference website (click here).

About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor in Phase 1 clinical development 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 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.