On June 15 2017 Q BioMed Inc. (QBIO), reported their entry into a final license agreement with The Oklahoma Medical Research Foundation (OMRF) and the Rajiv Gandhi Centre for Biotechnology (RGCB) (Press release, Q BioMed, JUN 15, 2017, View Source/index.php/news-and-media/news-2017/35-q-biomed-inc-finalizes-license-agreement-with-oklahoma-medical-research-foundation-and-the-rajiv-gandhi-centre-for-biotechnology-for-novel-liver-cancer-treatment-3" target="_blank" title="View Source/index.php/news-and-media/news-2017/35-q-biomed-inc-finalizes-license-agreement-with-oklahoma-medical-research-foundation-and-the-rajiv-gandhi-centre-for-biotechnology-for-novel-liver-cancer-treatment-3" rel="nofollow">View Source [SID1234533226]). Under the agreement QBioMed has the global exclusive rights to develop and market a novel chemotherapeutic drug to treat liver cancer.

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The compound was isolated and characterized from the leaves of Solanum nigrum Linn, or black nightshade, a plant widely used in traditional medicine.

In animal models, the compound, called uttrocide B, was shown to be 10 times more cytotoxic to HepG2 liver cancer cells than the only drug currently on the market for the condition.

"Our ultimate goal is to use uttrocide B as a chemotherapeutic against liver cancer, which has very few therapeutic options," said Q BioMed, Inc., CEO Denis Corin.

RGCB researchers identified the therapeutic effect of the compound and then entered into collaboration with OMRF to further develop and commercialize it. In animal models, uttrocide B was shown to be more potent than the currently available drug for the disease and caused no noticeable side effects.

"We are excited at the prospect of developing a drug that could address a significant unmet medical need and benefit patients", said Dr. M.R.Pillai, Director of RGCB.

Liver cancer is the second most common cause of cancer deaths worldwide, according to the Centers for Disease Control and Prevention, and claims approximately 750,000 lives each year. The American Cancer Society estimates that 39,000 people in the U.S. will be diagnosed with primary liver cancer in 2017 and that 27,000 will die from the disease this year.

"This is truly an unmet need in liver cancer," said OMRF Vice President of Technology Ventures, Manu Nair. "To find a plant-based treatment for a condition like liver cancer can open the door to a wide variety of other natural products for treating human disease."

Please visit View Source for more information and sign up to receive regular updates. Follow us on Twitter @QBioMed.

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 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

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 14, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reporte that Norman Michael Greenberg, Ph.D., Senior Vice President and Chief Scientific Officer, will participate in a panel discussion on immuno-oncology being held during the 2017 BIO International Conference on Thursday, June 22, 2017, from 10:15 a.m. – 11:15 a.m. PT in San Diego, CA (Press release, Atreca, JUN 14, 2017, View Source [SID1234522950]).

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The panel, titled "Immune-Oncology Drugs: Ready for First Line Therapy?", will take place in Room 7A in the San Diego Convention Center.