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Monday, December 3, 2018

Tabula Rasa HealthCare to acquire DoseMe


Tabula Rasa HealthCare announced it has executed a definitive agreement to acquire Brisbane, Australia based DoseMe. DoseMe is the developer of DoseMeRx, a precision dosing tool to help physicians and pharmacists accurately dose patients’ high-risk parenteral medications based on individual needs, resulting in improvements to mortality, risk, and patient outcomes. Already available in over 100 hospitals and infusion providers worldwide, DoseMeRx’s precision dosing capabilities will now be combined with TRHC’s proprietary medication risk mitigation, or MRM, technologies in order to enhance and accelerate medication safety solutions available in the hospital setting. TRHC expects the acquisition to close in Q1 of 2019, subject to customary closing conditions. TRHC expects to fund the acquisition through cash on hand and cash from operations, and from the use of its existing credit facility. Following the completion of the acquisition DoseMe will become part of TRHC’s CareVention technology and service division.
https://thefly.com/landingPageNews.php?id=2831141

Aduro Biotech presents BION-1301 data at ASH


Aduro Biotech announced preclinical data in two abstracts for its first-in-class anti-APRIL antibody BION-1301 supporting its potential use as a treatment for multiple myeloma, or MM, at the American Society of Hematology, or ASH. Data from the studies demonstrated that therapies blocking a proliferation inducing ligand, or APRIL, from binding to B cell maturation antigen, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI, may simultaneously target MM cells and APRIL-induced immunosuppression. Moreover, studies showed patient serum levels of APRIL were elevated at all stages of MM investigated, suggesting a role for APRIL in early development and pathogenesis. In addition, APRIL was found to induce production of key chemokines with osteolytic capacity. Blocking APRIL could modulate the tumor microenvironment more broadly, illustrating the potential of BION-1301 as a therapeutic agent for MM, particularly in combination therapies. Aduro is currently conducting a Phase 1/2 multi-center, open-label study designed to evaluate the safety and activity of BION-1301 in patients with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies, including immunomodulatory drugs, proteasome inhibitors, chemotherapies, or monoclonal antibodies.
https://thefly.com/landingPageNews.php?id=2831145

Anthem price target raised to $345 from $323 at Jefferies


Jefferies analyst David Windley raised his price target for Anthem to $345 and reiterates a Buy rating on the shares. The analyst says he’s more positive on Anthem’s long-term outlook following meetings with management at the company’s headquarters. Anthem has “numerous levers” to accelerate sales and improve margins, Windley tells investors in a research note. He sees “wide optionality” for management from the $3.2B in pharmacy benefit manager savings they plan to reinvest.
https://thefly.com/landingPageNews.php?id=2831149

Edwards Lifesciences receives clearance for HemoSphere platform


Edwards Lifesciences announced that the HemoSphere advanced hemodynamic monitoring platform has received U.S. FDA clearance for the Acumen suite of intelligent decision-support solutions.
https://thefly.com/landingPageNews.php?id=2831153

LabCorp downgraded to Hold at Craig-Hallum on headwinds ahead


Craig-Hallum analyst Kevin Ellich downgraded LabCorp (LH) to Hold from Buy as he believes volume and reimbursement headwinds will intensify in 2019 keeping a lid on the stock. While lower 23andMe volume is understandable due to lower than forecast Black Friday and Cyber Monday sales, the analyst is concerned about lower volume from hospitals, which might be attributable to hospitals keeping more testing in-house, especially with physician-owned practices. Given the lowered 2018 outlook and increased pressure in 2019, Ellich also reduced his estimates and lowered his price target on the shares to $152 from $193. Overall, the analyst argues that lost UnitedHealth (UNH) exclusivity starts snowball effect as “Winter is coming” for LabCorp with lowered FY18 guidance.
https://thefly.com/landingPageNews.php?id=2831183

Adverum publishes macular degeneration med data


Adverum Biotechnologies announced the publication of preclinical long-term expression and efficacy data in “Molecular Therapy”, the international journal for research on the development of molecular and cellular therapeutics to correct genetic and acquired diseases. A single intravitreal administration of ADVM-022 in non-human primates, or NHPs, provided stable and robust intraocular expression of aflibercept and resulted in high levels of aflibercept within the retina and choroid where wet age-related macular degeneration occurs. Robust aflibercept expression in retinal and choroidal tissues obtained at 16 months post-administration demonstrated that cells transduced with ADVM-022 may continue to generate aflibercept for an extended period of time. In a laser-induced choroidal neovascularization model in NHPs, a single intravitreal administration of ADVM-022 13 months before lasering prevented the occurrence of clinically relevant choroidal neovascularization lesions, similar to animals that received a bolus of intravitreal aflibercept at the time of lesioning. A single intravitreal administration of ADVM-022 may provide a safe and effective long-term treatment option for wet AMD.
https://thefly.com/landingPageNews.php?id=2831223

Enzo reports publication of study on breast cancer therapeutic candidate


Enzo Biochem reported the publication of a study in the Journal of Lipid Research by researchers at a collaborating institution that shows SK1-I, the company’s proprietary Sphingosine Kinase 1 inhibitor drug candidate, was effective in reversing resistance to the breast cancer drug tamoxifen in a tamoxifen-resistant human breast cancer cell line. As pointed out in the publication, endocrine therapy, such as tamoxifen, is a first line treatment for estrogen receptor-positive breast cancer patients. However, more than 50% of patients who initially respond to tamoxifen ultimately fail therapy due to the development of resistance. These results suggest that SK1-I may have potential in the treatment of tamoxifen-resistant breast cancers. Sphingosine Kinase 1 is a key enzyme in the Sphingosine pathway that has been implicated in tumor cell growth and pathological inflammation. The enzyme acts by phosphorylating the cellular lipid Sphingosine to Sphingosine 1-Phosphate, an important biological mediator of tumor cell proliferation and drug resistance in various cancers, and of immune function. SK1-I is a small molecule that specifically inhibits Sphingosine Kinase 1 and has shown anti-cancer activity in various models of hematological cancers, such as Acute Lymphoblastic Leukemia, and solid tumors, such as glioblastoma. As a result of Enzo’s research, a novel solid tumor indication for SK1-I has also recently been validated in multiple in vitro human tumor cell line models and is undergoing further development. In further support of this program, Enzo has established in-house GMP manufacturing of SK1-I and is planning to initiate in vivo tumor xenograft studies for the lead solid tumor indication using the GMP-manufactured compound in the near term. The company is also exploring various partnership approaches for the continued development of the compound. Apart from oncology, in the immunoregulation area, another of Enzo’s research collaborators has shown that SK1-I prevents the induction of Interferon Gamma, a major inflammatory biomarker, in a well-established Concanavalin A induced animal model of autoimmune hepatitis. The compound SK1-I and related compounds, as well as their use in oncology and other therapeutic areas, are covered by a family of issued U.S. patents co-owned by Enzo and Virginia Commonwealth University and exclusively licensed by VCU to Enzo. Foreign patent family members have also issued or been allowed. The basic patent terms of the U.S. patents in this patent family continue into 2029, before possible extensions. On May 22, 2018, the latest patent in this family, U.S. Patent No. 9,974,758, which is directed to methods for treating cancer using SK1-I, was issued.
https://thefly.com/landingPageNews.php?id=2831225