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On June 16, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and "The Company"), a biopharmaceutical company focused on the development of unique new cancer therapies designed to save and improve lives, reported the presentation of a poster at The Society for Neuro-Oncology’s 4th Pediatric Neuro-Oncology Basic and Translational Research Conference (Press release, DelMar Pharmaceuticals, JUN 16, 2017, View Source [SID1234519624]). The forum takes place at the Wyndham New Yorker Hotel in New York City on June 15-16, 2017 .

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The Company’s presentation entitled "Dianhydrogalactitol (VAL-083) overcomes p53-mediated chemo-resistance and displays synergy with topoisomerase inhibitors" was presented the evening of Thursday, June 15.

The authors highlight the current absence of a viable standard-of-care for patients with pediatric high-grade gliomas (pHGG). This is because the only approved agent for this indication, temozolomide (TMZ), is rendered inactive due to pediatric brain tumors having a high expression of a TMZ-inactivating enzyme called MGMT* and a low expression of the TMZ-activating MMR** pathway proteins.

In prior clinical trials, DelMar Pharmaceuticals’ lead product candidate VAL-083 demonstrated activity against this dire pediatric cancer. The poster emphasizes the fact that VAL-083 maintains functionality regardless of the MGMT or MMR status of pHGG, and is also not affected by the p53 status of the cancer cells. In vitro, VAL-083 has been shown to cause a robust and irreversible S/G2 arrest of the cancer cells, potentially then leading to cancer cell apoptosis. The poster provides the rationale for a detailed clinical investigation of VAL-083 in pediatric high-grade gliomas both as a single agent or in combination with currently available therapies such as TMZ or topoisomerase inhibitors.

*MGMT= 06-methylguanine-DNA methyltransferase
**MMR= mismatch repair

"DelMar Pharmaceuticals is excited to share the promising horizon that VAL-083 results have shown in the treatment of pediatric brain tumor," said Jeffrey Bacha, chairman & CEO of DelMar. "We are conscious of the difference VAL-083 could make in the lives of patients and their families, and we are driven by the determination of improving patient outcomes. We are confident that our research efforts will make an impactful contribution to the community and this area of science."

About VAL-083

Dianhydrogalactitol (VAL-083) is a "first-in-class", DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes.

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details regarding these studies can be found at View Source

DelMar’s recent outcomes in Phase 1-2 clinical trials suggested that VAL-083 may offer a clinically meaningful survival benefit for patients with recurrent GBM following treatment with both TMZ and bevacizumab. A well-tolerated dosing regimen of 40mg/m2/day on days 1, 2, and 3 of a 21-day cycle was selected for study in subsequent GBM clinical trials.

DelMar has embarked human clinical trials for VAL-083 across every line of GBM therapy. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962). ii) A pivotal, controlled Phase 3 study in temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy (clinicaltrials.gov identifier: NCT03149575). iii) A single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. (clinicaltrials.gov identifier: NCT03050736). The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.

About Glioblastoma Multiforme (GBM)

Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%.

Generex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On June 15, 2017 Xspray Pharma AB reported that its lead product candidate, HyNap-Dasa, demonstrated the ability to eliminate the clinically relevant pH dependent of dasatinib in a Phase I clinical trial (Press release, Xspray, JUN 15, 2017, View Source [SID1234523282]).

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Xspray Pharma AB is a clinical stage product development company that utilizes its innovative HyNap technology to develop improved and generic versions of marketed anti-cancer products. Xspray’s lead product candidate, HyNap-Dasa, is being developed as an improved version of a leading dasatinib product indicated for treatment of CML. HyNap-Dasa has the potential to reach the US market in 2020.

One of the drugs being marketed for treatment of CML – SPRYCEL – reported global sales in 2016 exceeding 1.8 billion USD of which US sales were close to 1 billion USD. As disclosed in SPRYCEL labelling, one of the challenges is that the uptake is dependent on the patient’s gastric acidity. Reduced gastric acidity (increased pH) dramatically decreases dasatinib´s solubility and absorption. Previous studies with acid reducing agents (ARAs) have shown that dasatinib’s absorption measured as area under the curve (AUC), decreased by 61% and 43% using leading ARAs famotidine and omeprazole, respectively. SPRYCEL is a trademark of Bristol-Meyers Squibb Company. Xspray Pharma AB is not affiliated with, sponsored by, or endorsed by Bristol-Meyers Squibb Company.

In the completed Phase I clinical trial in 16 healthy subjects, HyNap-Dasa given with or without the acid reducing agents omeprazole demonstrated bioequivalence by showing less than 2% difference in absorption measured as AUC.

Highlights from the clinical data include:

Absorption of dasatinib from HyNap-Dasa was equal before and after omeprazole treatment measured as area under the curve, AUC (AUC-ratio was 0.98 and C.I. 87 – 120%).
Dasatinib´s maximum concentration (Cmax) was equal before and after omeprazole treatment (Cmax-ratio was 0.98 and C.I. 81 – 128%).
The PK profile of HyNap-Dasa was shown not to be influenced by omeprazole treatment.

"We are extremely pleased with the clinical results obtained and believe that these data will support our further development of HyNap-Dasa as a product with clinically relevant benefits compared to available dasatinib products," stated Per Andersson, Chief Executive Officer. Mr. Andersson continued, "The results of this clinical trial also confirmed that our HyNap technology may not only address the food effect as shown in the previous clinical study with HyNap-Nilo (nilotinib) but also the important pH dependent absorption frequently encountered for orally administered PKI drugs in targeted cancer therapy."

Mikael von Euler, clinical advisor to Xspray, who has held leading clinical positions for 4 of today’s marketed PKIs at 3 different big pharma companies said: "I am impressed with the results of this study showing the ability of the HyNap technology to eliminate the clinically important drug-drug interaction between PKIs and omeprazole. There are currently 34 PKI anti-cancer products on the market, and more than 300 in clinical development. I believe HyNap formulations of PKIs have the potential to improve both present and upcoming products´ profiles improving safety and enhancing patients’ quality of life during this type of therapy."

On June 15, 2017 Generon Corporation, a leading biotechnology company in China, reported the initiation of a clinical trial for A-337, a CD3-activating bi-specific antibody targeting EpCAM, in Australia (Press release, Generon (Shanghai), JUN 15, 2017, View Source [SID1234531381]). This is a "Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of A-337 in patients with advanced solid tumors". EpCAM is up-regulated and over-expressed in most solid tumors.

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A-337 is the first immune oncology product generated by Generon’s immunotherapy antibody (ITabTM) platform to enter clinical development. ITabTM generates human CD3-activating bi-specific antibodies targeting tumor associated antigens (TAA), such as EpCAM. Bi-specific antibodies generated from this platform have demonstrated more than 1,000-fold potencies compared to conventional monoclonal antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity and favorable pharmacokinetics, in addition to improved safety profiles compared to competitors’ products. Generon has developed a robust manufacturing process to produce ITabTM antibodies in mammalian cells.

Dr. David Lacey, the Chairman of Generon’s Scientific Advisory Board, stated, "A-337 represents a next-generation CD3-activating bi-specific antibody targeting EpCAM-expressing solid tumors. The multivalency of the EpCAM portion of the molecule may enable activity across a wide range of tumor EpCAM expressions, including tumors expressing lower levels. This potential advance presents an important option for patients who have failed previous lines of therapy".

The management executives of E-fan Pharmaceuticals congratulated Generon’s team for their passion, efficiency and outstanding achievement for the project. Dr. Xiao Qiang Yan, Chairman and CEO of Generon, commented, "A-337 is our first immunotherapeutic antibody entering clinical development. This is another important milestone in "innovating for life". A-337 has demonstrated compelling advantages in pre-clinical safety studies over other CD3-activating bi-specific antibodies targeting EpCAM. We are committed to bringing innovative immunotherapy antibodies to treat cancer patients, providing them with more effective treatment options".

About ITabTM

Generon’s ITabTM (immunotherapy antibody) platform generates bi-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to specific tumor associated antigens (TAAs) in a mono-valent or bi-valent format. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cell, and the release of mediators lysing the tumor cell. These bi-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. ITabTM antibodies are manufactured in CHO cells in serum-free conditions