Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Burzynski Research Institute, 2018, MAY 22, 2018, View Source [SID1234526849]).

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On May 22, 2018 CoBioRes NV, an early stage biotech company that valorises promising academic research in the field of medicine by translating it into innovative therapeutic approaches, reported that it has received a € 1.7 million R&D grant from Flanders Innovation and Entrepreneurship (VLAIO) (Press release, Collaborative Biotech Research, MAY 22, 2018, View Source [SID1234526842]). This grant will allow CoBioRes to further develop and to select a lead Tetra-doxo candidate (doxorubicin prodrug) for treatment of Triple Negative Breast Cancer (TNBC) based on in vivo efficacy and toxicity testing. Furthermore, potential new biomarkers will be investigated.

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Approximately 12% of all breast cancers are triple negative. In TNBC the growth of the cancer is not supported by the hormones estrogen and progesterone, nor characterised by the presence of many HER2 receptors. Therefore, TNBC does not respond to hormonal therapy or therapies that target HER2 receptors, such as trastuzumab (Herceptin). There’s a clear need for new effective treatments in this large patient population.

"We are very pleased to receive this support from VLAIO. This will enable the company to obtain in vivo proof-of-concept of its Tetra-doxo prodrugs and to identify new biomarkers for patient selection. This will pave the way for initiation of further preclinical and clinical development," said dr. Nele Kindt, CEO at CoBioRes.

About Tetra-prodrugs technology
Use of traditional chemotherapeutic drugs is restricted by severe side effects and lack of tumour specificity. CoBioRes has designed a tumour-specific activation system by chemically linking a cap and a specific oligopeptide to a chemotherapeutic drug, rendering the modified drug inactive and blocking systemic toxic side effects of the drug. The chemotherapeutic prodrugs are activated by selective proteases available in the tumour microenvironment. This leads to a precise control of drug activation and release, circumventing distribution of native active drugs in other tissues. This finally leads to a combination of selective efficacy and reduced systemic toxicity, resulting in an improved therapeutic index.

On May 22, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported the upcoming presentation of clinical data from the First-In-Human C101 phase Ia/Ib study of its GM102 antibody during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 4 in Chicago, USA (Press release, GamaMabs Pharma, MAY 22, 2018, View Source [SID1234526865]).

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Data will be reported on 27 patients with advanced or recurrent AMHRII-positive epithelial ovarian (EOC), granulosa ovarian (GCT), cervical and endometrial cancers, treated with GM102 monotherapy in eight successive escalation cohorts at five major European cancer centers.

No safety signal was reported at all doses tested. Two clinical objective partial responses according to RECIST criteria were observed among four GCT patients. Peripheral blood pharmacodynamic changes observed under GM102 treatment suggested an immune cell recruitment to the tumor site. In paired tumor biopsies before and under GM102 treatment, enhanced CD16 and Granzyme B biomarker expression was observed in the tumor micro-environment, suggesting GM102-induced cellular cytotoxicity or phagocytosis.

Expansion cohorts in EOC and GCT at the recommended GM102 dose are currently ongoing, with first results anticipated early 2019.

GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and re-expressed in approximately 70% of gynecological tumors. GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and ADCC (Antibody Dependent Cell Cytotoxicity).

"These first results are really encouraging, especially for patients with granulosa ovarian cancers who do not have therapeutic alternatives at this stage," said Pr. Alexandra Leary, Gustave Roussy Institute (France), principal investigator of the study. "We are gathering experience with additional patients in the expansion part of the study; should these first results be confirmed, we will move forward with a larger phase 2 study in this indication with great enthusiasm, given the unmet medical need."

"We are happy to share such exciting data with the medical community, which confirm the unique immunological mode of action of GM102 and shows its translation into clinical activity," said Stéphane Degove, CEO at GamaMabs Pharma. "We are expanding our GM102 clinical development program beyond the field of gynecological cancers in other tumor types that also express AMHRII," he added.

Results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, during the Gynecologic Cancer session, on June 4, 2018, 1:15 PM-4:45 PM.
Abstract #5542; Poster ID 214461, ‘A first-in-human study of monoclonal antibody GM102 in patients with Anti-Mullerian-Hormone-Receptor II (AMHRII) positive gynecological cancers’ by A Leary and co-authors.
Following the presentation, the poster will be available on the Publication page of GamaMabs’ website1.

On May 22, 2018 Lupagen, Inc. (www.lupagen.com), a medical device company developing first-in-class cell and gene therapy delivery technologies for CAR-T, gene editing and immunotherapy products, reported the intent to explore the development of a bedside, point-of-care delivered CAR-T therapy with Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments (Press release, Lupagen, MAY 22, 2018, View Source;humanigen-to-explore-point-of-care-car-t-therapy-300652016.html [SID1234573190]).

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Lupagen and Humanigen are planning work to investigate the potential of a bedside CAR-T therapy created from Humanigen’s Ifabotuzumab, a first-in-class, monoclonal antibody targeting the EphA3 receptor tyrosine kinase.

"We are excited to support Humanigen’s strategic objectives to deliver safer, more effective and more routine CAR-T treatments, including one with the novel EphA3 target," said Nipon Das, M.D., chief executive officer and co-founder of Lupagen. "A bedside, closed-loop, point-of-care patient-connected system allows patient cells to be harvested, reprogrammed or modified, then reinfused at the bedside. The potential positive impact on CAR-T and other ex-vivo autologous cell and gene therapies is enormous through lower treatment costs, increased patient access and enhanced safety and control of these powerful new therapies."

On May 22, 2018 DelMar Pharmaceuticals, Inc. (the "Company")(NASDAQ: DMPI) reported that the board of directors (the "Board") has appointed Saiid Zarrabian as the full-time President and Chief Executive Officer of the Company, effective immediately (Press release, DelMar Pharmaceuticals, MAY 22, 2018, View Source [SID1234526845]). Mr. Zarrabian had previously served as the Company’s interim President and Chief Executive Officer since November 2017 and prior to that as an independent board member since July 2017.

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"Saiid has made significant contributions to DelMar, initially as an independent board member and, most recently, as DelMar’s interim President and CEO. We are pleased that he has agreed to further commit to the Company by taking on the full-time President and CEO role, effective immediately. His contributions have included a renewed focus on our two Phase 2 open label trials for MGMT-unmethylated glioblastoma multiforme, and enhanced fiscal responsibility while advancing our clinical programs in a timely and cost-effective fashion. The Board and I look forward to working with him to build on this momentum," stated Dr. Erich Mohr, Chairman of the Board.

"I am excited to transition from my interim role at DelMar and to continue the clinical advancement of VAL-083, which has been validated in over 40 prior clinical trials indicating VAL-083’s potential to combat multiple devastating diseases for patients with limited alternatives. Although VAL-083 may have applicability to many other solid tumor indications with potentially significant future commercial opportunities, we intend to use a disciplined and stepped approach to investing our resources in pursuing such opportunities. Over the next year, we expect to achieve a number of clinical milestones for VAL-083, including data from the ongoing Phase 2 second-line recurrent GBM study at MD Anderson, as well as data from the international Phase 2 study in newly diagnosed GBM patients. We plan to use our current capital efficiently and to continue to drive the enrollment of our clinical studies in an effort to maximize value for our shareholders," said Mr. Zarrabian.

Mr. Zarrabian is a successful veteran of the biotechnology industry. He previously served as chairman of the board of directors at La Jolla Pharmaceutical Company during the company’s transition from being an OTC listed company to a Nasdaq traded company. He also served as president of the Protein Production Division of Intrexon Corporation, a synthetic biology company. Prior to that, he served as chief executive officer and a member of the board of directors of Cyntellect, Inc., a stem cell processing and visualization instrumentation company until it was acquired in 2012. He served as president and chief operating officer of Senomyx, Inc., a company focused on discovery and commercialization of new flavor ingredients, and as chief operating officer of Pharmacopeia, Inc., a former publicly-traded provider of combinatorial chemistry discovery services and compounds, where he also served as president and chief operating officer of its MSI Division. In addition, Mr. Zarrabian has served on numerous private and public company boards, including at Immune Therapeutics, Inc., Exemplar Pharma, LLC, Ambit Biosciences Corporation, eMolecules, Inc. and Penwest Pharmaceuticals Co. Currently, he is serving as an advisor to Redline Capital Partners, S.A., a Luxemburg-based investment firm.