On November 5, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported it will present data on its investigational PARP inhibitor pamiparib at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held November 15-18 in New Orleans, LA (Press release, BeiGene, NOV 5, 2018, View Source;p=RssLanding&cat=news&id=2375241 [SID1234530712]). Discovered by BeiGene, pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.

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Oral Presentation:

Title: Phase 1b/2 study to assess the clinical effects of pamiparib (BGB-290) in combination with radiation therapy (RT) and/or temozolomide (TMZ) in patients with newly diagnosed or recurrent/refractory glioblastoma (GBM)
Presentation #: ACTR-30
Session ID: Concurrent Session 2A: Adult Clinical Trials I/Trials in Development
Location: Grand Ballroom
Date: Friday, November 16
Time: 2:25-2:30 pm CT
Presenter: Kent Shih, M.D.
About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists in Beijing, pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.

On November 5, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that four abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, California, which takes place December 1-4, 2018 (Press release, Onconova, NOV 5, 2018, View Source [SID1234530731]).

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ORAL PRESENTATION:

Phase 2 Expansion Study of Oral Rigosertib Combined with Azacitidine (AZA) in Patients (Pts) with Higher-Risk (HR) Myelodysplastic Syndromes (MDS): Efficacy and Safety Results in HMA Treatment Naïve & Relapsed (Rel)/Refractory (Ref) Patients

Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Novel Therapeutics I

Date: Saturday, December 1, 2018

Session Time: 4:00 – 5:30 PM

Presentation Time: ORAL SESSION 4:15 PM PST

Room: Manchester Grand Hyatt San Diego, Grand Hall A

Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

POSTER PRESENTATIONS:

1) Truncation Products of Stromal Cell Derived Factor-1 (CXCL12) Quantified By Mass Spectrometry in Patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Treated with Rigosertib in a Phase I-II Study

Session Name: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I

Date: Saturday, December 1, 2018

Presentation Time: 6:15 – 8:15 PM

Location: San Diego Convention Center, Hall GH

Presenter: John Roboz, PhD, Icahn School of Medicine at Mount Sinai, New York, NY

2) Evaluation of Underlying Cause of Genitourinary (GU) Adverse Events (AEs) in Patients with Myelodysplastic Syndromes upon Oral Administration of Rigosertib: Safety and Pharmacokinetic Analysis of Rigosertib across Three Clinical Trials

Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II

Date: Sunday, December 2, 2018

Presentation Time: 6:00 – 8:00 PM

Location: San Diego Convention Center, Hall GH

Presenter: Manoj Maniar, PhD, Onconova Therapeutics, Inc., Newtown, PA

3) Amelioration of Rigosertib Treatment Related Genitourinary (GU) Adverse Events (AEs) in Patients with Myelodysplastic Syndromes: Implementation of Novel Dosing Regimen Derived through Pharmacokinetic Modeling in Phase 2 Study of Oral Rigosertib in Combination with Azacitidine

Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III

Date: Monday, December 3, 2018

Presentation Time: 6:00 – 8:00 PM

Location: San Diego Convention Center, Hall GH

Presenter: David Taft, PhD, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY

On November 5, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will present three abstracts at the upcoming Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) November 15-19 in Seattle (Press release, BioCryst Pharmaceuticals, NOV 5, 2018, View Source [SID1234530749]).

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Oral Administration of a Liquid Formulation of BCX7353 Rapidly Provides Sustained Concentrations and Kallikrein Inhibition; Poster P153, Friday, November 16, 3:30 p.m. PT

Relationship of Target Concentrations with Efficacy: Results from the APeX-1 Study of BCX7353; Poster P157, Friday, November 16, 4:10 p.m. PT

Pharmacokinetics and Pharmacodynamics of BCX7353, an Oral Plasma Kallikrein Inhibitor, in Healthy Japanese Subjects, Poster P158, Friday, November 16, 4:20 p.m. PT
"The Annual Scientific Meeting of the ACAAI provides a focused opportunity for us to meet with many of the clinical and academic leaders driving continued innovation to improve HAE therapy, and we are excited to, once again, have an important scientific presence at the meeting," said Dr. William Sheridan, chief medical officer of BioCryst.

On November 5, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for PD-0325901, an investigational, oral, small molecule selective inhibitor of MEK1 and MEK2, for the treatment neurofibromatosis type 1 (Press release, SpringWorks Therapeutics, NOV 5, 2018, View Source [SID1234538852]).

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Neurofibromatosis type 1, or NF1, is a rare genetic disorder that is caused by mutations in the NF1 gene, and that affects both children and adults. NF1 mutations can result in a loss of activity in the protein neurofibromin, which can lead to MAPK pathway overactivation, uncontrolled cellular growth, and tumor formation.1 NF1 is a heterogeneous condition that frequently causes plexiform neurofibromas, which are painful, disfiguring tumors of the peripheral nervous system. It is estimated that there are approximately 100,000 patients in the United States living with NF1. 2

"There is an urgent need for an effective treatment for patients with NF1. We are pleased that the FDA has granted Orphan Drug designation for our MEK inhibitor, recognizing its potential to improve the outlook for patients and families facing NF1," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to working closely with the FDA as we prepare to initiate a Phase 2b study of PD-0325901 in patients with NF1-associated plexiform neurofibromas, a severe form of NF1 that causes tumors to grow on nerves throughout the body, which can cause severe pain, disfigurement, loss of range of motion, and shortened lifespan."

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to drugs and biologic products that are intended for treatment of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug status is intended to facilitate drug development for rare diseases and may provide certain benefits and incentives to drug developers, including seven years of market exclusivity if the drug is approved, FDA assistance in clinical trial design, and tax credits for qualified clinical trial costs. 3

SpringWorks expects to initiate a Phase 2b single-arm, open-label study of PD-0325901 in patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-associated PN) in the first half of 2019.

About Neurofibromatosis Type 1
Neurofibromatosis type 1, or NF1, is a rare genetic disorder that is caused by mutations in the NF1 gene, and that affects both children and adults. Throughout their lifetime, about 30 to 50 percent of NF1 patients progress to a more severe form of the disease that results in the development of plexiform neurofibromas (PN), which are progressive peripheral nerve sheath tumors that cause severe pain, morbidity, and can significantly shorten lifespan.4-6 The clinical course of NF1-associated PN is heterogeneous with varying manifestations and severity across patients.

It is estimated that NF1 affects 1 in 3,000 individuals worldwide, and that there are approximately 100,000 patients in the United States living with this disease.2 Most patients with NF1-associated PN are treated with surgical removal of the tumors, sometimes requiring amputation; however, surgery has variable success rates and a high rate of recurrence has been observed because of the aggressive nature of these tumors.7 There are no therapies currently approved for the treatment of NF1-associated PN.

About PD-0325901
PD-0325901 is an investigational, oral, small molecule, selective inhibitor of MEK1 and MEK2, proteins that play key roles in the MAPK pathway. The MAPK pathway is critical for cell survival and proliferation, and overactivation of this pathway has been shown to help enable tumor growth. By blocking activity of the MAPK pathway, PD-0325901 may help arrest uncontrolled cellular growth associated with many types of tumors.

PD-0325901 has been tested in several Phase 1 and Phase 2 clinical trials, and approximately 260 subjects have been exposed to treatment. SpringWorks is evaluating PD-0325901 as a monotherapy for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-associated PN). In addition, given the critical role that the MAPK pathway plays in the growth and proliferation of a large number of tumor types, SpringWorks is also pursuing PD-0325901 in combination with other rational anticancer agents across a range of solid tumors.

On November 2, 2018 Celgene Corporation (NASDAQ:CELG) reported to present at two upcoming investor events where Celgene management will provide an overview of the Company (Press release, Celgene, NOV 2, 2018, View Source [SID1234530609]). The events will be webcast live and will be available in the Investor Relations section of the Company’s website at www.celgene.com.

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Wednesday, November 14, 2018, Celgene will present at the Credit Suisse 27th Annual Healthcare Conference at 9:45 am MST/ 11:45 am ET

Sunday, December 2, 2018, Celgene will host an Analyst & Investor Event at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting at 8:00 pm PT/ 11:00 pm ET