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]).

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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.

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.

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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.

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).

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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.

On March 25, 2019 NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell based therapeutics company, reported that Patrick Soon-Shiong, MD, the company’s Chairman & CEO, on March 21, 2019, exercised 17,589,250 warrants with an exercise price of $1.9984 and 1,851,000 options with an exercise price of $2.1983, representing an aggregate cash exercise price of $39.2 million (Press release, NantKwest, MAR 25, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-chairman-ceo-dr-patrick-soon-shiong-exercises-39?field_nir_news_date_value[min]=2019 [SID1234534603]).

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In commenting on the exercise of the warrants and options, Dr. Soon-Shiong said the following: "Since the launch of NantKwest in 2015, the company has made remarkable progress in the development of a true, ‘off-the-shelf’ and ‘ready-to-use’ Natural Killer (NK) cell therapy that could be shipped on an ‘as needed basis,’ just about anywhere in the world. We have successfully established a truly off-the-shelf, cryopreserved product and are now ready to embark on pivotal trials. This advanced manufacturing capability combined with our ability to develop NK cells with high killing activity provides us with a distinct advantage as the leading company developing an immediately available NK cell therapy for patients with cancer."

Dr. Soon-Shiong continued, "My commitment and confidence in the future success of NantKwest has never been stronger. I firmly believe that the natural killer cell represents the missing link in our war against cancer. I believe that only by orchestrating the activity of the natural killer cell, the innate immune system, as well as the killer T cell, the adaptive immune system, could we achieve long lasting responses to immunotherapy. NantKwest represents this next generation of cell therapy with the potential to achieve activation of the memory T and NK cell, the holy grail of immunotherapy. Contributing an additional $39.2 million to the financial resources of NantKwest will enable the rapid opening of multiple clinical trial sites for the Phase 2 trial of off-the-shelf activated natural killer cells (haNK cells), combined with an IL-15 cytokine (N-803) which may proliferate NK and T cells, to treat refractory patients suffering from a deadly disease, Merkel Cell Carcinoma. In addition, preclinical data of the world’s first targeted off-the-shelf haNK cells (t-haNK) are highly encouraging and we are planning the first in human trials of both PD-L1 t-haNK and CD-19 t-haNK (targeted-haNKs) this year."

Dr. Soon-Shiong provided an update on the haNK and t-haNK programs at his keynote address to the scientific community at "The Innate Killer Summit" in San Diego on March 20, 2019.

On March 25, 2019 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has initiated development of a bio-analytical assay intended to quantify the active ingredients of the company’s lead product candidate, PRP, in preparation for human trials, planned for later this year (Press release, Propanc, MAR 25, 2019, View Source [SID1234534581]). The work will be conducted by a specialist Contract Research Organization with extensive knowledge in the development of functional assays for different bio-therapeutics. PRP is a solution of two proenzymes, trypsinogen and chymotrypsinogen, administered by I.V. injection.

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"We are keen to undertake this important work, as the quantification of PRP in human serum will provide invaluable information that links the biodistribution of the two proenzymes, as it exerts its potent anti-cancer and anti-tumor effects, to the efficacy and safety of our therapy on patients at different dosing levels," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer. "Initially we will carry out a feasibility study to quantify the two proenzymes trypsinogen and chymotrypsinogen, but in addition, the enzymes which become activated at the tumor site, trypsin and chymotrypsin. It is the activated enzymes which exert their effects on the cancer cells, by turning off important protein markers responsible for tumorigenicity and malignancy, so that the cancer cells die naturally. Measuring all four analytes will provide an important link to the action of PRP and its effects on cancer patients."

Development of the bio-analytical assay will be an important step towards the clinical development of PRP, as Propanc considers the possible sites to conduct a First-In-Human study in advanced cancer patients, possibly in Europe, specifically the UK, or at a prominent cancer hospital in Australia, with significant experience in early stage clinical development. Attractive R&D tax incentive benefits could be gained by undertaking the trial in Australia, as well as utilizing world-class facilities dedicated to treating and caring for people with cancer. Propanc will investigate selected clinical trial sites more thoroughly as it commences preparation of a clinical trial application for PRP.