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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.

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"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

RedHill Biopharma Acquires Phase II First-in-Class Oral Small Molecule SK2 Inhibitor From Apogee Biotech

On March 31, 2015 RedHill Biopharma reported that they have entered into an exclusive worldwide license agreement under which RedHill has acquired the rights to the Phase II drug candidate ABC294640 and additional intellectual property rights (Press release, RedHill Biopharma, MAR 31, 2015, View Source [SID:1234502885]). ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications.

Under the terms of the agreement, RedHill has acquired the exclusive worldwide development and commercialization rights to ABC294640 and additional intellectual property for all indications. RedHill will pay Apogee an upfront payment of $1.5 million, as well as an additional $4 million in potential milestone payments, and potential tiered royalties starting in the low double-digits.

ABC294640 inhibits SK2, a lipid kinase that catalyzes formation of the lipid signaling molecule sphingosine 1-phosphate (S1P). S1P promotes cancer growth, and proliferation and pathological inflammation, including TNFα signaling and other inflammatory cytokine production. Specifically, by inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of S1P which regulates fundamental biological processes such as cell proliferation, migration, immune cell trafficking and angiogenesis, and are also involved in immune-modulation and suppression of innate immune responses from T cells. Preliminary evidence suggests that because of its specificity for targeting SK2, rather than SK1, ABC294640 may have a better therapeutic ratio than nonspecific sphingosine kinase inhibitors or those targeting only SK1.

Apogee received cumulative funding exceeding $14 million to support the development of ABC294640, primarily through grants and contracts from U.S. federal and state government agencies such as the NIH Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program, including funding from the National Cancer Institute (NCI), the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the Department of Defense (DoD), the FDA Office of Orphan Products Development and the Pennsylvania Department of Health.

With this funding Apogee has completed numerous successful pre-clinical studies with ABC294640 in GI-inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation Phase I clinical study demonstrated the drug’s safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors.

A Phase Ib/II clinical study with ABC294640 for refractory/relapsed diffuse large B cell lymphoma (DLBCL) is planned to commence in the second quarter of 2015 and will be funded by a $1.5 million grant awarded by the National Cancer Institute under the NIH SBIR/STTR program to Apogee in conjunction with the Louisiana State University Health Science Center. The study will include approximately 30 patients and is intended to assess the tolerability of ABC294640 within the DLBCL population, as well as provide a preliminary evaluation of efficacy. A second Phase II clinical study of ABC294640 for the treatment of multiple myeloma is planned, subject to funding by a pending grant from the National Cancer Institute. A third Phase II clinical study is being planned by RedHill in order to evaluate ABC294640 as a radio-protectant and radiation enhancer in cancer patients undergoing radiotherapy.

Furthermore, multiple pre-clinical studies funded by the NIH (BARDA) and the DoD have demonstrated activity of ABC294640 against gastrointestinal injury from accidental acute radiation exposure. Therefore, a possible additional indication of protection against accidental radiation exposure may qualify as a medical countermeasure under the Animal Rule, under which no human efficacy studies would be required for FDA approval.

"With a unique mechanism of action, ABC294640 is a novel potential treatment for multiple inflammatory and oncology diseases with strong unmet medical needs. In particular, the drug may be a unique and important treatment for prevention of severe toxicity and inflammation induced in many cancer patients by radiotherapy, while at the same time potentially enhancing the effectiveness of the radiotherapy treatment," said Dr. Terry Plasse, Medical Director at RedHill. "We are looking forward to further advancing this promising program into clinical studies, and plan a Phase II study to evaluate the ability of ABC294640 to decrease radiotherapy-induced toxicity."

Adi Frish, Senior VP Business Development and Licensing at RedHill added: "With the acquisition of ABC294640 we adhere to RedHill’s multiple-shots-on-goal strategy. The acquisition of this potential blockbuster further expands our late clinical-stage pipeline, reflecting RedHill’s solid commitment to patients suffering from inflammatory and gastrointestinal diseases, including cancer, who are in need of new treatment options. Thanks to the thorough development work conducted by Apogee, ABC294640 is supported by extensive pre-clinical, clinical and CMC package, as well as strong intellectual property protection, and we believe in its potential to become a leading treatment for multiple inflammatory, gastrointestinal and oncology indications. We are excited to continue advancing this important novel drug candidate, and would like to thank our new partners at Apogee for entrusting us with the development and commercialization of ABC294640."

Dr. Charles Smith, President and CEO at Apogee stated: "We are very pleased to be collaborating with RedHill to advance the clinical development of ABC294640 for the potential benefit of cancer patients. We view RedHill as an outstanding partner for this effort, and are particularly impressed by their demonstrated commitment to tackling the difficult problem of improving therapeutic outcomes and the quality of life for cancer patients. Additionally, RedHill’s expertise with gastrointestinal inflammatory diseases provides a very strong foundation for clinical testing of this drug candidate, and we are looking forward to a successful outcome of this collaboration."

In addition to the three ongoing Phase III studies in GI indications (RHB-105 for H. pylori infection, BEKINDA (RHB-102) for gastroenteritis, and RHB-104 for Crohn’s disease), RedHill’s pipeline now includes three proprietary, Phase II-stage, orally-administered, first-in-class small molecule drug candidates intended to treat gastrointestinal and other solid tumor cancers, as well as other potential indications: Mesupron, a urokinase-type plasminogen activator (uPA) inhibitor, RP101 (under an option-to-acquire), a heat shock protein 27 (Hsp27) inhibitor, and the newly-acquired SK2 inhibitor, ABC294640.

About ABC294640

ABC294640 is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting a number of potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. ABC294640 has completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors.