On May 17, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the signing of a license agreement granting Cumulus Oncology exclusive worldwide rights to develop and commercialize VER250840, a novel, oral, selective, preclinical Chk1 Kinase Inhibitor discovered using Ligand’s Vernalis Design Platform (VDP) (Press release, Ligand, MAY 17, 2019, View Source [SID1234536461]). Under the terms of the agreement, Ligand will receive an upfront license fee, and is eligible to receive over $76 million of milestone payments and tiered royalties in the mid-to-high single digit range, depending on revenue. In addition, Ligand is eligible to receive an additional fee, payable in cash or Cumulus equity, upon Cumulus achieving specified financing-related events.

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"We are pleased to be partnered with Cumulus to continue to advance the development of this important kinase target," said John Higgins, Chief Executive Officer of Ligand. "Since Ligand’s acquisition of Vernalis in October of last year, the business in Cambridge has been successfully integrated and is significantly contributing to the advancement of Ligand’s Shots-on-Goal business model. VDP consists of a team of accomplished scientists servicing the needs of partners to design molecules addressing highly-challenging targets, and we expect additional partnered programs to result from their efforts over the coming months and years."

About VER250840

VER250840 is a novel oral, selective Chk1 kinase inhibitor discovered using the Vernalis Design Platform (VDP). Chk1 is an important target within the DNA Damage Response (DDR) network and has been shown to play a key role in maintaining genomic integrity of cancer cells. Inhibition of Chk1 blocks cell cycle arrest and DNA repair, forcing cancer cells to undergo cell division with substantial DNA damage that results in their death. In both in vitro and in vivo preclinical studies, VER250840 has demonstrated an ability to target Chk1 in a range of different tumor types, as a single agent and in combination with several different cytotoxic agents. The clinical utility of DDR inhibitors for the treatment of cancer has recently been validated by the approval of inhibitors of Poly (ADP-ribose) polymerase (PARP). The opportunity to select patients most likely to respond to Chk1 inhibitors exists.

About the Vernalis Design Platform (VDP)

Vernalis (R&D) Limited is a Ligand subsidiary based in Cambridge, UK, and is a world leader in structure-guided drug discovery. The Vernalis Design Platform (VDP) integrates protein structure determination and engineering, fragment screening and molecular modeling, with medicinal chemistry, to enable success in novel drug discovery programs against highly-challenging targets. A key element to the success of VDP is establishing a robust platform for drug discovery for each target to validate hit identification using multiple proprietary assay and biophysical systems. Vernalis has collaborations across many therapeutic areas, including oncology, CNS, anti-infectives and inflammation, with global partners and a heritage of successful internal drug discovery in oncology and anti-infectives.

On May 17, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported the Phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, demonstrated no survival benefit for patients receiving Depatux-M at an interim analysis (Press release, AbbVie, MAY 17, 2019, View Source [SID1234536457]). An Independent Data Monitoring Committee (IDMC) recommended the study be stopped due to lack of survival benefit for patients receiving Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. No new safety findings were observed. Enrollment in all ongoing Depatux-M studies has been halted.

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"Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options. While we are disappointed that Depatux-M did not demonstrate a survival benefit in the INTELLANCE-1 study, we remain committed to discovering and developing therapies to address some of the most debilitating cancers," said Michael Severino, M.D., vice chairman and president, AbbVie.

The INTELLANCE-1 trial was conducted in collaboration with the RTOG Foundation, an independent, non-profit cancer research organization. Results from INTELLANCE-1 will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal.

"The highly collaborative partnership between RTOG Foundation’s scientific and physician leaders, under the leadership of Andrew Lassman, M.D., the study principal investigator, and the AbbVie team facilitated the early completion of this important international clinical trial. The RTOG Foundation’s outstanding glioblastoma experts will continue to vigorously investigate new approaches to this very challenging malignancy," said Walter J. Curran Jr., M.D., F.A.C.R., F.A.S.C.O., RTOG Foundation Board Chair and Executive Director of the Winship Cancer Institute of Emory University.

About the Phase 3 INTELLANCE-1 Trial and Depatuxizumab Mafodotin (Depatux-M; ABT-414)
The randomized, placebo-controlled Phase 3 study was designed to evaluate the efficacy and safety of Depatux-M versus placebo when administered with concurrent radiation and temozolomide and with adjuvant temozolomide in subjects with newly diagnosed EGFR-amplified GBM.1 The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients. Depatux-M is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit View Source

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]).

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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]).

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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]).

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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]