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Stemline Therapeutics Announces Four SL-401 Presentations at Upcoming ASH Meeting

On December 8, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported that SL-401, a novel targeted therapeutic directed to CD123, will be featured in four presentations at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 9-12, 2017 in Atlanta, GA (Press release, Stemline Therapeutics, DEC 8, 2017, View Source [SID1234522473]).

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Details on the presentations are listed below. Presentations will be available on the Stemline website, Scientific Presentations tab, after their delivery, as well as at our Stemline corporate booth (#3122) at ASH (Free ASH Whitepaper) 2017.

SL-401: BPDCN (Clinical)

Title: Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 1298
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Date/Time: Saturday, December 9, 2017 5:30 PM–7:30 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401: AML in CR with MRD (Clinical)

Title: Results from Ongoing Phase 2 Trial of SL-401 As Consolidation Therapy in Patients with Acute Myeloid Leukemia (AML) in Remission with High Relapse Risk Including Minimal Residual Disease (MRD)
Presenter: Andrew Lane, MD, PhD; Dana-Farber Cancer Institute
Abstract: 2583
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Date/Time: Sunday, December 10, 2017 6:00 PM–8:00 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401: Myeloproliferative neoplasms (Clinical)

Title: Results from Ongoing Phase 2 Trial of SL-401 in Patients with Myeloproliferative Neoplasms Including Chronic Myelomonocytic Leukemia and Primary Myelofibrosis
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 2908
Session: 634. Myeloproliferative Syndromes: Clinical: Poster II
Date/Time: Sunday, December 10, 2017 6:00 PM–8:00 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401 + Azacitidine: High risk MDS and elderly AML (Preclinical) – Oral Presentation

Title: Resistance to SL-401 in AML and BPDCN Is Associated with Loss of the Diphthamide Synthesis Pathway Enzyme DPH1 and Is Reversible By Azacitidine
Presenter: Andrew A. Lane, Dana-Farber Cancer Institute
Abstract: 797
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Novel Therapeutics and Mechanisms of Resistance in Myeloid Disease
Date/Time: Monday, December 11, 2017 5:30 PM
Location: Georgia World Congress Center, Building B, Level 2, B207-B208

About BPDCN
Please visit the BPDCN awareness booth (#3143) at ASH (Free ASH Whitepaper) 2017 and www.bpdcninfo.com.

Rigel to Present One-Year Efficacy and Safety Results for Fostamatinib in ITP at the 2017 American Society of Hematology Annual Meeting

On December 8, 2017 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that the one-year efficacy and safety results from its FIT Phase 3 clinical program of fostamatinib for chronic or persistent immune thrombocytopenia (ITP) will be featured in an oral presentation at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held in Atlanta, GA from December 9 to December 12, 2017 (Press release, Rigel, DEC 8, 2017, View Source;p=RssLanding&cat=news&id=2321827 [SID1234522471]).

During the presentation, James B. Bussel, M.D., professor emeritus of pediatrics at Weill Cornell Medicine and the principal study investigator on the FIT Phase 3 program who has served as a member of an advisory/scientific board for Rigel Pharmaceuticals, will share an overview of the FIT clinical program.

Oral Presentation Details:
TITLE: Long-Term Maintenance of Platelet Responses in Adult Patients with Persistent/Chronic Immune Thrombocytopenia Treated with Fostamatinib: 1-Year Efficacy and Safety Results
Session Name: 311. Disorders of Platelet Number or Function: ITP: clinical aspects
Session Date: Saturday, December 9, 2017
Session Time: 7:30 AM – 9:00 AM EST
Presentation Time: 8:15 AM EST
Location: Georgia World Congress Center, Bldg B, Lvl 3, B304-B305 (Atlanta, GA)

About Fostamatinib in ITP
Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, is an investigational drug for adult patients with chronic or persistent immune thrombocytopenia (ITP). The New Drug Application (NDA) for fostamatinib for adult patients with chronic or persistent ITP, which was previously granted Orphan Drug designation, is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2018. The conditionally approved proprietary name for fostamatinib (as confirmed by the FDA) is TAVALISSETM.

The NDA is supported by data from the FIT Phase 3 clinical program, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). Together with an initial proof of concept study, the NDA included 163 ITP patients. Across all indications, fostamatinib has been evaluated in over 4,600 subjects. Data from all studies, including preclinical evaluation and drug manufacturing data, were included in the NDA submission.

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

AntriaBio Announces Exclusive License Agreement for a Phase 2 Orphan Disease Therapy with XOMA Corporation and Name Change to Rezolute, Inc.

On December 07, 2017 Rezolute, Inc. ("Rezolute" or the "Company") (OTCQB:ANTB), a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies for metabolic and orphan diseases, and XOMA Corporation ("XOMA") (NASDAQ:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported that they have executed a license agreement that provides Rezolute with the exclusive global rights to develop and commercialize RZ358 (formerly XOMA 358) for Congenital Hyperinsulinism (CHI), an ultra-orphan indication.

RZ358 is a first-in-class fully human monoclonal antibody that counteracts the effects of elevated insulin via allosteric modulation of the insulin receptor, making it well-suited as a therapy for severe, persistent hypoglycemia caused by hyperinsulinemic conditions such as CHI. XOMA demonstrated clinical proof-of-concept through Phase 2a studies and Rezolute plans to advance clinical development in 2018. The compound has received designated orphan status in the US and European Union.

"We are excited about the addition of RZ358 to our growing product pipeline and for the opportunity to take a Phase 2 program forward with the hope of being able to offer a significantly better treatment option for a disease that is the most frequent cause of severe, persistent hypoglycemia in newborn babies and children," said Nevan Elam, Chairman and Chief Executive Officer of Rezolute. "XOMA has generated compelling safety data and proof-of-concept for RZ358 and we look forward to advancing its development."

Under the terms of the agreement, Rezolute will assume the global development, regulatory filings, manufacturing and commercialization for RZ358. In turn, XOMA will receive a total of $18 million in the form of cash and shares of Rezolute common stock and will be eligible to receive up to an aggregate of $222 million in clinical, regulatory and sales milestones. In addition, XOMA is entitled to receive royalties ranging from the high single digits to the mid-teens based upon annual net sales of RZ358. Finally, under the terms of the agreement, Rezolute will pay XOMA low single digit royalties on sales of the company’s other products.

"Having established proof-of-concept for XOMA 358 earlier this year, we now look forward to Rezolute continuing the clinical development of the program," stated Jim Neal, Chief Executive Officer of XOMA. "Our license agreement with Rezolute places this important drug asset in the hands of a very capable endocrine-focused team, provides XOMA with the potential to receive future milestones and royalties, and is an important milestone in the continued transformation of our programs to fully-funded status. We welcome Rezolute to our broad portfolio of partners, including Novartis, Five Prime and NanoTherapeutics, who continue the development of our product candidates."

CHI is a rare genetic disorder that affects one in 50,000 newborns. Ordinarily, beta cells in the pancreas secrete just enough insulin to keep blood sugar in the normal range. With CHI, the secretion of insulin is not properly regulated as the beta cells secrete too much insulin resulting in excessive low blood sugar (severe hypoglycemia). In infants and young children, these episodes are characterized by lethargy, irritability and difficulty feeding. Repeated episodes of hypoglycemia increase the risk of serious complications such as breathing difficulties, seizures, developmental delays and intellectual disability, vision loss, brain damage, coma and possibly death. CHI is the most common cause of persistent hypoglycemia in children and about 60 percent of infants with CHI experience a hypoglycemic episode within the first month of life. Other affected children develop hypoglycemia by early childhood. A significant number of patients cannot be adequately treated with or do not tolerate existing medical therapies. Surgical removal of all or part of the pancreas is a cornerstone of management for many patients, but is invasive and diabetes-inducing.

The Company’s new name reflects its transition as a developer of potentially paradigm-shifting therapies for treating metabolic diseases and orphan indications with high unmet medical needs. Under this strategy, the Company also exclusively licensed ActiveSite Pharmaceuticals’ oral plasma kallikrein inhibitor (PKI) portfolio in August and is developing RZ402 for Diabetic Macular Edema and RZ602 for Hereditary Angioedema, an orphan indication.

"The name change conveys our dedication to identifying and developing therapies that are transformative and target well-known genetic pathways and mechanisms," stated Mr. Elam. With the recent licensing agreements executed with XOMA Corporation for a monoclonal antibody to treat CHI, an ultra-orphan indication, and ActiveSite Pharmaceuticals for our oral PKI portfolio, we have evolved into a company advancing a robust pipeline of innovative solutions for patients and providers."

10-Q – Quarterly report [Sections 13 or 15(d)]

Enzo Biochem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Enzo Biochem, 2017, DEC 7, 2017, View Source [SID1234522436]).

Alexion and Halozyme Enter License Agreement for ENHANZE Technology

On December 7, 2017 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for their portfolio of products (Press release, Halozyme, DEC 7, 2017, View Source [SID1234522425]). The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.

"Alexion’s goal is to provide continued innovation and more treatment options that can significantly improve the lives of patients with rare diseases," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are excited to partner with Halozyme and look forward to utilizing its ENHANZE technology, which enables rapid injection of subcutaneous treatments and potentially increases bioavailablity, in our development programs."

"We are delighted to support Alexion’s innovative development initiatives focused on improving the lives of patients with rare diseases," said Dr. Helen Torley, president and CEO of Halozyme. "ENHANZE has become the industry standard for converting intravenous therapies to a subcutaneous delivery, helping partners and health care providers reduce the treatment burden and administration time for patients."

Under the terms of the agreement, Halozyme will receive an initial $40 million with the potential to earn additional payments of up to $160 million for each target developed, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous injection (just under the skin). This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Alexion is Halozyme’s eighth global collaboration and license partner for the ENHANZE technology, and the third partnership formed in 2017. These partnerships cover nearly 50 therapeutic targets and include three commercialized products.