On December 26, 2017 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The presentation will begin at 3:00 p.m. Pacific Time (6:00 p.m. Eastern Time) on Monday, January 8, 2018 at the Westin St. Francis (Press release, Allergan, DEC 26, 2017, View Source [SID1234523070]).

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at www.allergan.com/investors. The webcast can also be accessed through the following URL: View Source;.

An archived version will be available within 24 hours of the live presentation, and can be accessed at the same location for 90 days.

On December 25, 2017 Batu Biologics, an immuno-oncology Company dedicated to the development of its clinical stage tumor-angiogenesis targeting immunotherapy, ValloVax, reported the successful closure of a regulation 506(c) equity crowdfunding offering bringing in $1.3 Million in capital to the Company (Press release, Batu Biologics, DEC 25, 2017, View Source [SID1234522764]).

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The proceeds of this offering were initially earmarked for IND-enabling experiments, when the offering was launched on EquityNet in May of 2017. In early November of this year, Batu Biologics announced the clearance of the Investigational New Drug Application (#16296) for the ValloVax immune therapy. Based upon the successful completion of this milestone, the remaining proceeds from this offering will be used to upscale GMP manufacturing in preparation for the Company’s Phase I study and to position the Company to secure partnerships to demonstrate clinical proof of concept for the ValloVax program.

"We would like to graciously thank our shareholders and collaborators for the support of our vision in the development of the ValloVax immune therapy," stated Samuel C. Wagner, President and CEO of Batu Biologics. "2018 will be a landmark year for Batu Biologics with the goal of establishing safety and feasibility of ValloVax in a pilot clinical study in all solid tumors, and to further elucidate the mechanism of action of our novel placentally-derived immune therapy."

ValloVax targets angiogenesis, or blood vessel formation, which is a biological process that is commonly found in all solid tumors. Instead of targeting the tumor itself, which can be a difficult strategy due to cancer’s propensity to mutate, ValloVax trains the body to initiate a cellular and antibody response against several targets associated with tumor angiogenesis. To date, ValloVax has demonstrated strong inhibition of melanoma, lung cancer, colorectal cancer, breast cancer, and glioblastoma in animal models as a standalone therapy. However, by facilitating better drug delivery and lymphocyte penetration into the tumor, ValloVax may be an ideal candidate for combination therapies with some of the latest immuno-oncology drugs.

On December 22, 2017 Keryx Biopharmaceuticals, Inc, (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported it will webcast its corporate presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 10, 2018 at 11:30 a.m. PST (2:30 p.m. EST) (Press release, Keryx Biopharmaceuticals, DEC 22, 2017, View Source/phoenix.zhtml?c=122201&" target="_blank" title="View Source/phoenix.zhtml?c=122201&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2323964 [SID1234522776]). In addition, the company will webcast the question & answer session immediately following its presentation at 12:00 p.m. PST (3:00 p.m. EST).

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A live audio webcast of both the presentation and breakout session will be accessible from Keryx’s website at View Source within the Investor Relations section under "webcasts and presentations." Archived versions of the webcasts will be available for at least 15 days following the conclusion of each session.

On December 22, 2017 Rhizen Pharmaceuticals S.A., reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the active moiety of Tenalisib (RP6530), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of peripheral T-cell lymphoma (PTCL) (Press release, Rhizen Pharmaceuticals, DEC 22, 2017, View Source;%20PR/Rhizen_Press%20Release__22DEC2017_Tenalisib_RP6530_ODD.pdf [SID1234523401]).

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"We are pleased to receive US FDA orphan-drug designation for the active moiety of Tenalisib (RP6530), our Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, and we look forward to advancing the drug into further development for treatment of peripheral T-cell lymphoma (PTCL)," said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A.

About FDA Orphan-Drug Designation:

Orphan-Drug Designation is granted to a drug or biological product intended to treat a rare disease in the United States. A number of incentives are provided for an orphan-drug such as 7-year marketing exclusivity, tax credits for clinical development costs, exemption/waiver of application (filing) fees and assistance from the FDA Office of Orphan Products Development (OOPD) during the development process.

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through enzyme, cell, and whole blood-based studies. Besides inhibiting growth of immortalized cancerous cell lines and primary patient leukemic/lymphoma cells, RP6530 plays a significant role in modulation of tumor microenvironment at clinically achievable concentrations. In preclinical studies, RP6530 reprograms macrophages from an immunosuppressive M2-like phenotype (pro-tumor) to an inflammatory M1-like state (anti-tumor), which can potentially enhance the activity of checkpoint inhibitors or overcome resistance to these drugs. Tenalisib obtained US FDA Fast Track and Orphan-Drug Designations for treatment of peripheral T-cell lymphoma (PTCL).

On December 22, 2017 MolecularMD Corporation, a diagnostics company that enables the development and commercialization of precision medicines in oncology, reported that the FDA authorization of the MRDx BCR-ABL Test as a companion diagnostic (Press release, Molecular MD, DEC 22, 2017, http://molecularmd.com/news-post/molecularmd-obtains-fda-authorization-mrdx-bcr-abl-test-companion-diagnostic-treatment-free-remission-ph-cml-cp-patients-treated-tasigna/ [SID1234525535]). The MRDx Test is indicated as an aid in identifying Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia (CML) patients in the chronic phase being treated with Tasigna* (nilotinib) capsules who may be candidates for treatment discontinuation and for monitoring of treatment-free remission (TFR).

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TFR is the ability for eligible patients to sustain major molecular response (MMR) or deep molecular response (DMR) after discontinuing Tasigna, an FDA-approved BCR-ABL tyrosine kinase inhibitor (TKI)1. These patients no longer take daily oral therapy but continue to be actively managed through frequently-scheduled monitoring of molecular response with the MRDx BCR-ABL Test.

The TFR data in the Tasigna label approved by the FDA includes the use of the MolecularMD MRDx BCR-ABL Test in the ENESTfreedom and ENESTop clinical studies. These trials evaluated the potential to maintain deep molecular response (DMR) after stopping Tasigna therapy among eligible patients 18 years of age or older with Ph+ CML-CP. The trials demonstrated that nearly half of the Ph+ CML-CP patients who discontinued Tasigna remained in TFR nearly two years after stopping treatment. Among patients who did lose molecular response during the TFR phase of the trials, nearly all regained MMR when Tasigna therapy was promptly reinitiated1.

Now that the inclusion of TFR data has been approved for Tasigna under priority review within first-line and second-line settings, discontinuation of daily oral therapy with Tasigna is a new option for physicians and their patients. "This is a major advancement in CML treatment practice. The Tasigna label update represents a new milestone, which may significantly impact thousands of patients," reflected Dan Snyder, CEO of MolecularMD. "The FDA authorized MRDx BCR-ABL Test ensures that physicians have the information needed to identify patients that meet the stringent eligibility criteria to attempt TFR and provides the robust sensitivity and accuracy necessary for monitoring minimal residual disease with confidence."

Experts from The National Comprehensive Cancer Network (NCCN) have published treatment guidelines for physicians who treat CML2. These treatment guidelines suggest the best practice for cancer care, including criteria to select patients suitable for a TFR attempt. The duration of a molecular response is viewed as one of several critical aspects to patient management1. MolecularMD’s MRDx Test is the only test authorized by the FDA for monitoring deep molecular response for TFR patients as a result of the analytical and clinical validation data demonstrated in the ENESTfreedom and ENESTop clinical studies1.

MolecularMD is the exclusive manufacturer of the MRDx BCR-ABL Test and intends to provide the companion diagnostic kit to reference laboratories that support their clinicians practicing TFR. MolecularMD has also received CE Marking for the MRDx Test, making it broadly accessible to clinicians and CML patients.

*Tasigna is a registered trademark of Novartis AG.

References:

Tasigna (nilotinib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; December 2017.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). CML. Version 1.2018