Arrowhead Pharmaceuticals Reports Fiscal 2018 First Quarter Results

On February 9, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2018 first quarter ended December 31, 2017 (Press release, Arrowhead Research Corporation, FEB 9, 2018, View Source [SID1234523890]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 4788374.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 4788374.

Selected Fiscal 2018 First Quarter and Recent Events

Filed a Clinical Trial Application for ARO-AAT, a second generation subcutaneously administered clinical candidate for the treatment of alpha-1 antitrypsin deficiency liver disease

Filed a Clinical Trial Application for ARO-HBV, a third generation subcutaneously administered clinical candidate for the treatment of chronic hepatitis B virus infection

Presented new clinical data at HEP DART 2017 demonstrating up to 5.0 log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following RNAi therapy, ARC-520, in the 2001 open-label extension study

Made continued progress on a two-product cardiovascular collaboration with Amgen, in which one that was previously called ARO-LPA against the target lipoprotein(a) has been formally nominated as a potential clinical candidate and which is now referred to as AMG 890 by Amgen

Expanded Arrowhead’s cardiometabolic pipeline, which now includes ARO-APOC3, targeting apolipoprotein C-III, and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3); with CTA filings planned around the end of 2018

Achieved continued progress with the Company’s extra-hepatic platform and pipeline, including:

ARO-Lung1, Arrowhead’s first candidate against an undisclosed gene target in the lung, which achieved nearly 90% target knockdown following inhaled administration in rodents

ARO-HIF2, the Company’s candidate targeting renal cell carcinoma, which achieved 85% target gene knockdown in a rodent tumor model

Immune Design to Present at Upcoming Investor Conferences

On February 9, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that senior management will present at upcoming investor conferences (Press release, Immune Design, FEB 9, 2018, View Source [SID1234523900]).

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Leerink Partners 7th Annual Global Healthcare Conference
Thursday, February 15, 2018 at 9:30 a.m. Eastern Time in New York.

RBC Capital Markets 2018 Global Healthcare Conference
Wednesday, February 21, 2018 at 4:05 p.m. Eastern Time in New York.

Cowen & Company 38th Annual Health Care Conference
Monday, March 12, 2018 at 12:00 p.m. Eastern Time in Boston.

A live webcast of each presentation will be available online from the investor relations page of the company’s corporate website at View Source After the live webcast, an archive of each presentation will be available on the company website for 30 days.

Editas Medicine to Participate in Upcoming Investor Conferences

On February 8, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that it will participate in two upcoming investor conferences (Press release, Editas Medicine, FEB 8, 2018, View Source;p=RssLanding&cat=news&id=2331410 [SID1234523827]). Details are as follows:

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BIO CEO & Investor Conference
Date: Monday, February 12, 2018
Forum: Presentation
Time: 1:30 p.m. ET
Location: New York

SunTrust Robinson Humphrey 4th Annual Orphan Drug Day
Date: Tuesday, February 13, 2018
Forum: 1×1 Meetings
Location: New York

A live webcast of the presentation will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com. An archived replay will be available for approximately 30 days following the presentation.

Syros to Present at Leerink Partners 7th Annual Global Healthcare Conference

On February 8, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines that control the expression of genes, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the Leerink Partners 7th Annual Global Healthcare Conference (Press release, Syros Pharmaceuticals, FEB 8, 2018, View Source [SID1234523869]). Details are as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Leerink Partners 7th Annual Global Healthcare Conference
Date: Thursday, February 15
Presentation Time: 11:30 a.m. ET
Location: Lotte New York Palace Hotel, 455 Madison Ave, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.

GlycoMimetics Enters into Agreement with HOVON to Initiate Study Startup Activities for Planned Clinical Trial of GMI-1271 and Decitabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Unfit for Chemotherapy

On February 8, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it has entered into an agreement with the Haemato Oncology Foundation for Adults in the Netherlands (HOVON) group to initiate clinical trial startup activities (Press release, GlycoMimetics, FEB 8, 2018, View Source [SID1234523836]). In the planned clinical trial, HOVON researchers will evaluate GlycoMimetics’ drug candidate, GMI-1271, in adults with newly diagnosed acute myeloid leukemia (AML) but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome (MDS) with a high risk of leukemia. The HOVON Central Office has already approved a protocol concept, and this agreement enables HOVON to commit staff to the planned trial in order to finalize the protocol, start regulatory and ethics reviews, and begin development of the database. Separately, GlycoMimetics said it plans to announce the design details for its company-sponsored Phase 3 trial in relapsed/refractory AML patients as part of its fourth-quarter and year-end 2017 earnings call scheduled for March 6, 2018.

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"HOVON is one of the most prestigious collaborative clinical groups in Europe and is focused exclusively on improving clinical outcomes in patients with hematologic malignancies. HOVON’s interest in evaluating GMI-1271 in patients with previously untreated AML and MDS who are unable to tolerate intensive chemotherapy underscores the importance of the efficacy and safety data we’ve generated to date in clinical trials with GMI-1271," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice-President, Clinical Development and Chief Medical Officer. "We believe GMI-1271 has the potential for broad utility in the treatment of hematologic malignancies, and this trial expands the scope of development across the continuum of care in AML and complements our own planned Phase 3 registration trial in patients with relapsed/refractory disease."

Professor Gerwin Huls, Principal Investigator at HOVON and Professor of Haematology at University Medical Centre Groningen, said, "With Breakthrough Therapy designation awarded by the U.S. Food and Drug Administration in patients with relapsed/refractory AML, GMI-1271 is clearly a promising agent. We look forward to generating data in this ‘unfit’ AML population to see if GMI-1271 can improve patient outcomes over what is achieved with decitabine alone."

The HOVON trial will be the first to evaluate GMI-1271 together with decitabine in this underserved population of AML and MDS patients, who are not considered by their physicians to be candidates for intensive chemotherapy; these two populations represent a significant potential label expansion opportunity for GMI-1271. HOVON intends to enroll approximately 140 patients in the clinical trial, including a control arm. Key efficacy endpoints will include complete remission rate, disease-free survival, and overall survival. The trial is expected to start this year and will be conducted in five countries across Europe.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In the Phase 1/2 clinical trial that has now completed enrollment, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population was well tolerated with minimal adverse effects.