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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Cellular Biomedicine Group 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, Cellular Biomedicine Group, MAR 31, 2015, View Source [SID1234502879]).

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MUSC, Aeterna Zentaris sign discovery library transfer accord

On March 31, 2015 The Medical University of South Carolina (MUSC) and Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") reported that the Company has agreed to transfer its discovery library of roughly 100,000 unique compounds to the South Carolina Center for Therapeutic Discovery & Development (SCCTDD) housed at MUSC, pursuant to a just-concluded material transfer agreement (Press release, AEterna Zentaris, MAR 31, 2015, View Source [SID:1234512461]). This agreement represents the beginning of a long-term relationship between the two entities that will result in the continued use of the library for the discovery of drug development candidates for Aeterna Zentaris in the areas of oncology, neurology, endocrinology and women’s health. SCCTDD may make the library available to all investigators in the MUSC system without restriction on its use and will own any therapeutic compounds discovered outside Aeterna Zentaris’ areas of therapeutic interest.

"The ongoing research at MUSC is outstanding in basic, translational, and clinical sciences, focused on understanding disease processes. The transfer of this high quality collection of drug-like compounds will significantly increase our opportunities to find new medicines through sophisticated screening mechanisms," said Karen Lackey, MUSC Center for Drug Discovery director. "The SCCTDD’s mission is to discover and develop effective medicines in diseases that currently lack viable treatment options."

For a 10-year period beginning in 2018, SCCTDD has agreed to conduct screening and pre‑clinical activities with respect to the library with the goal of developing at least one drug candidate in the Company’s areas of therapeutic interest each year. Aeterna Zentaris receives the right of first refusal to license the drug candidates.

"This agreement with MUSC is another concrete step in our strategy of streamlining our internal drug discovery programs in order to focus our resources on our late-stage clinical programs, as well as on our commercial activities," said David Dodd, Aeterna Zentaris chairman, president and CEO. "This agreement will therefore make it possible to continue drug discovery activities without the costs and risks that they imply. More importantly, it is in line with our overall strategy of transitioning into a commercially operating specialty biopharmaceutical company. We look forward to working with the center and MUSC, with which we have already established a close collaboration for our ZoptEC Phase 3 trial in endometrial cancer."

Should Aeterna Zentaris decide to pursue a drug candidate submitted by SCCTDD, MUSC will license the compound candidate to the Company, and will receive a royalty on the net sales of all commercialized products developed from that drug compound. Conversely, if Aeterna Zentaris decides not to further develop the drug candidate submitted by SCCTDD, MUSC will pay the Company a royalty on net sales of all commercialized products developed from that drug candidate.

Aeterna Zentaris Signs Transfer Agreement of its Discovery Library with the Medical University of South Carolina

On March 31, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") reported that it has agreed to transfer its discovery library of roughly 100,000 unique compounds to the South Carolina Center for Therapeutic Discovery & Development (the Center) pursuant to a just concluded Material Transfer Agreement (Press release, AEterna Zentaris, MAR 31, 2015, View Source;q=651 [SID:1234506615]). This Agreement represents the beginning of a long-term relationship between the Company and the Center, which is part of The Medical University of South Carolina (MUSC), that will result in the continued use of the library for the discovery of drug development candidates for the Company in the areas of oncology, neurology, endocrinology and women’s health. The Center may make the library available to all investigators in the University of South Carolina system without restriction on its use and will own any therapeutic compounds discovered outside the Company’s areas of therapeutic interest.

The Center has agreed to conduct screening and pre-clinical activities with respect to the library with a view toward submitting to the Company at least one development candidate in its areas of therapeutic interest per year during a ten-year period beginning in 2018. The Company will receive the right of first refusal to license the development candidates.

Should the Company decide to further develop a development candidate submitted by the Center, MUSC will license the compound candidate to the Company, and be entitled to a royalty on the net sales of all commercialized products developed from the development candidate.

However, should the Company decide not to further develop the development candidate submitted by the Center, MUSC shall pay to the Company a royalty on net sales of all commercialized products developed from the development candidate.

David Dodd, Chairman and CEO at Aeterna Zentaris stated, "This agreement with MUSC is another concrete step in our strategy of streamlining our internal drug discovery programs in order to focus our resources on our late-stage clinical programs, as well as on our commercial activities. This agreement will therefore make it possible to continue drug discovery activities without the costs and risks that they imply. More importantly, it is in line with our overall strategy of transitioning into a commercially operating specialty biopharmaceutical company. We look forward to working with the Center and MUSC, with which we have already established a close collaboration for our ZoptEC Phase 3 trial in endometrial cancer."

Karen Lackey, Director of the MUSC Center for Drug Discovery, added, "The ongoing research at MUSC is outstanding in basic, translational, and clinical sciences, focused on understanding disease processes. The transfer of this high quality collection of drug-like compounds will significantly increase our opportunities to find new medicines through sophisticated screening mechanisms. The Center’s mission is to discover and develop effective medicines in diseases that currently lack viable treatment options."

Lead compound

Cancer, pancreatic; Cancer, solid, general
It is in a Phase I clinical trial in all solid tumors with expansion to pancreatic cancer (Company Pipeline, Apogee Biotechnology, MAR 31, 2015, View Source [SID:1234502922]).

Peregrine Pharmaceuticals Announces Promising Bavituximab Phase I Data Published in the Peer-Reviewed Journal Cancer Medicine in Advanced Metastatic Breast Cancer

On March 31, 2015 Peregrine Pharmaceuticals reported the peer-reviewed publication of clinical data from a Phase I investigator-sponsored trial evaluating the company’s lead investigational immunotherapy bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (Press release, Peregrine Pharmaceuticals, MAR 31, 2015, View Source [SID:1234502894]). The manuscript details the results of the Phase I trial showing that the combination produced an objective tumor response in 85% of patients, including 15% of these patients achieving a complete response, measured in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

"The publication of these data marks an important milestone in the development of this novel therapeutic in a difficult to treat patient population," said Alison Stopeck, M.D., the principal investigator on the trial and Professor, Department of Medicine and Associate Director for Translational Research at the Stony Brook Cancer Center in Stony Brook, New York. "The regimen was very well tolerated and the clinical responses were encouraging. The data also suggest bavituximab may uniquely affect the coagulation system in a beneficial way for cancer patients. It is my belief that the combination of bavituximab with weekly paclitaxel is a feasible regimen that is associated with a promising response rate in patients with metastatic breast cancer and warrants further clinical exploration."

In the online released manuscript, researchers at the University of Arizona Medical Center led by Alison Stopeck, M.D. enrolled 14 patients with metastatic breast cancer (MBC) and while all were evaluable for toxicity, 13 were evaluable for response and progression free survival (PFS). These patients with HER2-negative MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks of each four-week cycle and bavituximab (3 mg/kg) administered weekly beginning on day 15 after two weekly doses of paclitaxel. Results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including two patients (15%) that achieved a complete response (CR), 9 patients with partial responses (PR) and 2 patients with progressive disease (PD). Median PFS for the combination of bavituximab with weekly paclitaxel was 7.3 months. In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated with the majority of grade 1 or 2 adverse events being paclitaxel related. Approximately half of these patients were classified as "triple negative," a traditionally difficult-to-treat patient population. In addition, treatment with bavituximab reduced circulating PS-expressing microparticles (exosomes) which are immunosuppressive.

"These compelling results in a very difficult to treat patient population provide the foundation to move with confidence into a later stage trial," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "These data build upon our historical clinical experience in the area of breast cancer and when combined with recent preclinical data demonstrating bavituximab’s ability to promote antitumor immune activity, increase our understanding of the immune-stimulatory aspects of bavituximab."

These results appear in the March issue of the peer-reviewed journal, Cancer Medicine, in a manuscript titled: "A Phase I Clinical Trial of Bavituximab and Paclitaxel in Patients with HER-2 Negative Metastatic Breast Cancer."

The online article is available at: View Source