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Aeterna Zentaris Enters into Licensing and Assignment Agreement with Strongbridge for Macrilen™ (macimorelin) in the U.S. and Canada

On January 17, 2018 Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) reported that it has, through a wholly-owned subsidiary, entered into a license and assignment agreement with a wholly-owned subsidiary of Strongbridge Biopharma plc (NASDAQ:SBBP) to carry out development, manufacturing, registration and commercialization of Macrilen (macimorelin) in the United States and Canada (Press release, AEterna Zentaris, JAN 17, 2018, View Source [SID1234523233]).

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"We are very excited to partner with Strongbridge on the commercialization of Macrilen (macimorelin) in the U.S. and Canada," said Michael Ward, Chief Executive Officer of Aeterna Zentaris. "We look forward to exploring the various alternatives to monetizing our rights to Macimorelin outside the United States and Canada."

Aeterna Zentaris will receive an upfront cash payment of US$24,000,000 from Strongbridge, and, for as long as Macrilen (macimorelin) is patent-protected, Aeterna Zentaris will be entitled to a 15% royalty on net sales up to US$75,000,000 and an 18% royalty on net sales above US$75,000,000. Following the end of patent protection in United States or Canada for Macrilen (macimorelin), Aeterna Zentaris will be entitled to a 5% royalty on net sales in that country. In addition, Aeterna Zentaris will also receive one-time payments from Strongbridge following the first achievement of the following commercial milestone events:

US$4,000,000 on achieving US$25,000,000 annual net sales,
US$10,000,000 on achieving US$50,000,000 annual net sales,
US$20,000,000 on achieving US$100,000,000 annual net sales,
US$40,000,000 on achieving US$200,000,000 annual net sales, and
US$100,000,000 on achieving US$500,000,000 annual net sales.
Upon approval by the U.S. Food and Drug Administration ("FDA") of a pediatric indication for Macrilen (macimorelin), Aeterna Zentaris will receive a one-time milestone payment of US$5,000,000 from Strongbridge.

Strongbridge will fund 70% of the costs of a worldwide pediatric development program to be run by Aeterna Zentaris with customary oversight from a joint steering committee. The joint steering committee will be comprised of four persons, two of whom will be appointed by each of Strongbridge and Aeterna Zentaris.

The decision to license Macrilen (macimorelin) in the U.S. and Canada was made following a detailed review process undertaken by a committee of independent directors of Aeterna Zentaris. The committee of independent directors of Aeterna Zentaris was advised by Stifel, Nicolaus & Company, Incorporated. Aeterna Zentaris is continuing to explore various alternatives to monetizing its rights to Macimorelin in other countries around the globe, including whether to find other license partners in these jurisdictions or to use its internal resources to commercialize Macimorelin in one or more of these countries.

The Agreement will be filed on SEDAR at www.sedar.com. The foregoing description of the terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement.

Macrilen (macimorelin) is an orally-active ghrelin agonist that stimulates the secretion of growth hormone. Macrilen (macimorelin) has been granted orphan drug designation by the FDA for the evaluation of growth hormone deficiency. On December 20, 2017, the FDA granted Aeterna Zentaris marketing approval for Macrilen (macimorelin) to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD").

AGHD reportedly affects approximately 60,000 adults across the U.S. and Canada. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.

Trillium Therapeutics Enhances Senior Management Team to Support Further Clinical Development of TTI-621

On January 17, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the following key additions to its leadership team (Press release, Trillium Therapeutics, JAN 17, 2018, View Source [SID1234523296]):

Blythe Thomson, MD, Executive Medical Director
Jane E. Cole, RN, Senior Director, Clinical Operations
Brian E. Jahns, PharmD, Senior Vice President, Commercial and Business Development

The company also announced that Eric Sievers, MD, has transitioned from Chief Medical Officer to Senior Clinical Advisor. In this new role, Dr. Sievers will maintain a close association with the company’s clinical programs and advisors, and continue to assist Trillium with clinical strategy and communications. The company is now initiating the process of identifying Dr. Sievers’ successor.

"These additions to our management team further bolsters our planned pipeline development activities," said Dr. Niclas Stiernholm, President and CEO of Trillium Therapeutics. "Our new team members bring diverse and deep drug development expertise, and will have a major impact on the advancement of our TTI-621 program and corporate growth. Under Dr. Sievers’ guidance, our TTI-621 program has been well positioned for advancement in 2018. We look forward to continued benefit from Dr. Sievers’ expertise in his new role."

Dr. Thomson, a board certified pediatric hematologist/oncologist, has held multiple academic and industry appointments, most recently at Ariad Pharmaceuticals, Epizyme Inc. and Medpace. She brings a great depth of experience in all phases of clinical development of therapies for solid tumors and hematologic malignancies, and will oversee Trillium’s development programs, ensuring they are optimized for adaptability and efficiency. Dr. Thomson completed her medical training at Ohio State University and the Fred Hutchinson Cancer Research Center, University of Washington, and currently serves as an attending physician at Floating Hospital for Children, Tufts University School of Medicine.

Ms. Cole brings to Trillium over 25 years of experience, leadership and capability in the global execution of drug development programs. A registered nurse who pursued a career in drug development, Ms. Cole has led numerous development teams in executing Phase I through Phase IV clinical trials globally. She has previously held clinical operation roles in multinational pharma companies, including Hoffman-La Roche, as well as in smaller biotechnology and contract research organizations. In her current role she will oversee the company’s clinical operations team as well as its relationships with clinical research organizations. Ms. Cole joins Trillium from Chiltern International, where she was Project Director, Global Executive Lead.

Dr. Jahns has a wealth of experience in commercial activities, including long-term planning, strategic marketing, and working in an international matrix environment with partners in the United States, Canada and Europe. Drawing on his experiences as a pharmacist and an academic, and 18 years at Hoffmann-La Roche, he has been involved in the success of products such as Rituxan, Avastin, Zelboraf and Herceptin. Dr. Jahns will focus on developing partnership opportunities between Trillium and potential collaborators, and providing input on the company’s commercialization activities.

RXi Pharmaceuticals to Present at Immuno-Oncology Frontiers World Conference

On January 17, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company developing a new class of RNAi-based therapeutics reported that it will give an oral presentation highlighting the company’s proprietary therapeutic platform at the Immuno-Oncology Frontiers World conference (Press release, RXi Pharmaceuticals, JAN 17, 2018, View Source [SID1234523194]). This exclusive Immuno-oncology (I-O) partnering event provides direct access to decision makers and KOL’s working towards the next oncology blockbuster. Also, this is the only I-O event co-located with the leading Cell and Gene Therapy global meeting; providing access to the most commercially advanced technical expertise specifically for cellular immunotherapies. The conference will take place January 22-25, 2018 at the Hyatt Regency in Miami, Florida.

Title: Targeting Immune Checkpoints Using Self-Delivering RNAi (sd-rxRNA) Technology
Session: Stream 2- Emerging Science: Reprogramming the Tumor Microenvironment – Conquering Immune Suppressive Molecular Pathways
Date and Time: Tuesday, January 23, 2018, at 11:50 am ET
Presenter: James Cardia, Ph.D., Director of Business Development and Intellectual Property

The presentation will be available on the Company’s website approximately 1 hour after the presentation at www.rxipharma.com.

Logo – View Source

About RXi’s self-delivering RNAi (sd-rxRNA) technology platform

sd-rxRNA, RXi’s proprietary self-delivering RNAi platform, is a single chemically modified compound with delivery and therapeutic properties built directly into the compound itself. The compound is asymmetrical with a phosphorothioate backbone and contains chemical modifications that provide for efficient cellular uptake and gene silencing. These compounds are potent, stable and specific, and demonstrated to be safe and active in a clinical setting.

RXi’s novel sd-rxRNA technology differs from natural and most synthetic RNA interference (RNAi) molecules in that they are chemically modified to allow for efficient internalization of the compounds by cells and silencing of the targeted genes. Importantly, unlike other naked siRNA compounds, delivery of sd-rxRNAs are not limited to a specific cell type. For local delivery and ex vivo cell-based therapeutic applications, our compounds do not require delivery vehicles. This is a major advantage since delivery vehicles can have related toxicity that affects cell viability. sd-rxRNA has demonstrated nearly 100 percent transfection efficiency with high cell viability in numerous cell types.

Oncoceutics and Frontida BioPharm Announce Product Development and Commercialization Partnership

On January 16, 2018 Oncoceutics Inc. and Frontida BioPharm, Inc. reported that the two companies have entered into a product development and commercialization agreement to further develop and scale-up the finished product manufacturing process for ONC201, Oncoceutics’ lead molecule (Press release, Oncoceutics, JAN 16, 2018, https://oncoceutics.com/oncoceutics-frontida-biopharm-announce-product-development-commercialization-partnership/ [SID1234558375]). ONC201 is an antagonist of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) and is the first molecule designed to target this receptor specifically for oncology. The drug is currently in Phase II clinical trials for select advanced cancers, including multiple trials in high-grade gliomas, where patients treated with the compound have shown complete regressions of tumor lesions.

As a part of this agreement Frontida will manufacture ONC201 drug product in their GMP certified facilities for clinical trials and future commercial purpose. Frontida has also made an equity investment in Oncoceutics.

"Our partnership with Oncoceutics gives Frontida an important and strategic opportunity to contribute our development and manufacturing expertise toward the commercialization of a promising oncology therapy," said Ron Connolly, Chief Operations Officer of Frontida. "Oncoceutics’ lead molecule ONC201 has yielded compelling clinical outcomes, and our team is excited to have the opportunity to contribute to its advancement to commercialization."

"We are pleased to enter into this agreement with Frontida that provides Oncoceutics with the scale of ONC201 drug product manufacturing necessary for future commercialization," said Martin Stogniew Ph.D., Chief Development Officer of Oncoceutics. "The fact that Frontida has become a manufacturer and investor makes them a partner in Oncoceutics development programs, not simply a service provider."

Linnaeus Therapeutics Scientific Cofounders Publish Preclinical Melanoma Data in eLife Journal

On January 16, 2018 Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics, reported that preclinical data from studies conducted at the University of Pennsylvania by its scientific founders was published in the journal eLife (Press release, Linnaeus Therapeutics, JAN 16, 2018, View Source [SID1234539506]).

The paper, entitled "Activation of G protein-coupled estrogen receptor signaling inhibits melanoma and improves response to immune checkpoint blockade" was authored by Natale, et al.

For decades, research has associated female sex and a history of previous pregnancy with better outcomes after a melanoma diagnosis, but the mechanism for this protective effect has remained a mystery. This publication provides a potential explanation for this melanoma-protective effect. The mechanism is related to a cellular protein called the G protein-coupled estrogen receptor (GPER). When GPER was activated and combined with anti–PD-1 inhibitor drugs in mouse cancer models, the therapy dramatically extended survival in all animals and completely eliminated the tumor in up to 50 percent of the mice.

"The validation of our science by the acceptance of this paper in eLife underscores the importance of the G protein estrogen receptor ("GPER") as a therapeutic target," said Patrick Mooney, M.D., Chief Executive Officer of Linnaeus. "This data clearly demonstrates that using LNS8801 to target GPER should have therapeutic effects in various cancers, and we are excited to move this toward human studies in the future."