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

Myovant Sciences 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, Myovant Sciences, 2017, JUN 14, 2017, View Source [SID1234522034]).

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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.

On June 13, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that it has entered into a co-development partnership agreement with Altor BioScience Corp. (Altor) in which the companies will collaborate exclusively in the clinical development of a novel 161533 TriKE fusion protein for cancer therapies using Oxis’ trispecific killer engager (TriKE) technology (Press release, OXIS International, JUN 13, 2017, View Source [SID1234539560]).

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Altor, based in Miramar, Fla., is a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases. Altor is run by Hing C. Wong, Ph.D., Founder and Chief Executive Officer and Chaired by Dr. Patrick Soon-Shiong, a noted cancer researcher who owns NantWorks, a network of healthcare companies.

The TriKE technology was developed by researchers at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs immune cells to kill cancer cells while diminishing drug-related toxicity. Addition of Altor’s IL-15 superagonist technology to the 161533 TriKE molecule would further augment its ability to stimulate immune responses.

Under the partnership, Oxis and Altor will conduct a first-in-man Phase 1 FDA human clinical trial of the 161533 TriKE for the treatment of hematologic malignancies.

Anthony J. Cataldo, Chief Executive Officer of Oxis, believes that the partnership with Altor will greatly benefit Oxis and the University of Minnesota in their efforts to leverage the TriKE technology into approved cancer therapies. The TriKE platform technology has received considerable attention, including having recently won the "REACH" award from the NIH (National Institutes of Health) for technology most likely to achieve commercial success. A research study on 161533 TriKE molecule was also selected as "Editors’ Choice" by the journal Science Translational Medicine, which stated, "TriKEs were superior in restoring potent antigen-specific NK cell responses against AML targets and mediated robust and specific NK cell proliferation."

Mr. Cataldo further said, "Altor’s elegant design of a mutant IL -15 can further enhance the targeting and effective killing of myeloid malignancies by the 161533 TriKE."

Hing C. Wong, Ph.D., Founder and Chief Executive Officer of Altor, said: "The 161533 TriKE is an innovative second-generation immunotherapeutic fusion protein being developed by Oxis that targets human CD16 and human CD33. We are excited to have Altor’s proprietary IL-15 technology as an integral part of this molecule that is poised to rapidly enter into the clinic."

The clinical project will be managed by Jeffrey S. Miller, M.D., Deputy Director of the University of Minnesota Masonic Cancer Center and a member of the Oxis Scientific Advisory Board. Dr. Miller said, "The goal of a TriKE is to make NK cells antigen specific by creating an immune synapse between NK cells and tumor targets. Preclinical data suggest that use of an IL-15 linker not only boosts immune activation but it also delivers a proliferative signal to NK cells to sustain and further drive the immune response, a property that should overcome tumor induced immune suppression."