Editas Medicine to Present New Data Demonstrating Progress Towards Creating Genome Editing Medicines at the American Society of Gene & Cell Therapy Annual Meeting

On April 30, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that 10 scientific abstracts, including three from research collaborations, have been accepted for presentation at the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Editas Medicine, APR 30, 2018, View Source;p=RssLanding&cat=news&id=2345605 [SID1234525852]). The meeting will take place May 16-19 in Chicago. The Company is presenting data on its pipeline and platform technologies to support ongoing development programs.

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Key Editas Medicine presentations at ASGCT (Free ASGCT Whitepaper) will include data demonstrating:

EDIT-101, the Company’s experimental medicine for the treatment of Leber Congenital Amaurosis type 10, administered to non-human primates via subretinal injection was well-tolerated;
Therapeutically relevant editing levels in non-human primates regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9;
Specificity of EDIT-101 with no verified off-targets in the human genome as assessed by a two-staged approach using orthogonal methods;
In vitro validation of an exon deletion editing strategy with the potential to treat Usher Syndrome type 2a (USH2A)-associated retinal disease;
In vivo proof-of-concept in animal models for developing a CRISPR-based medicine for the treatment of ocular herpetic keratitis caused by latent herpes simplex virus-1 (HSV-1); and
Fetal hemoglobin induction by editing of novel therapeutic sites identified through saturation genomic CRISPR screening of the beta-globin locus as a potential treatment for sickle cell anemia.
In addition, Editas Medicine’s Chief Scientific Officer will speak at the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, a pre-meeting program, on May 15.

"We are making significant scientific advances in our programs to unlock the potential of CRISPR genome editing for making medicines," said Charles Albright, Ph.D., Chief Scientific Officer, Editas Medicine. "At ASGCT (Free ASGCT Whitepaper), we will showcase our recent scientific advances as we make progress towards the clinic and towards our goal of making medicines for people living with serious diseases."

The complete list of Editas Medicine presentations is below. Abstracts can be accessed on the ASGCT (Free ASGCT Whitepaper) website at View Source

Oral Presentation:
Evaluation of Tolerability and Immunogenicity of EDIT-101 Following Subretinal Injection in Non-human Primate
Date/Time: May 18, 4:00 – 4:15 p.m.
Location: Salon A-5
Session: Preclinical Pharmacology and Toxicology Studies and Assessment of Gene Therapy in Large Animal Models

Editas Medicine Poster Presentations:

Treatment of Herpetic Keratitis with CRISPR/Cas9 Gene Editing in a Rabbit Disease Model
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases) I

Potent HbF Induction Following ssODN-Mediated Repair of Cas9-Induced DSB at the HBG Promoter in CD34+ HSPC
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Saturated Mutagenesis Surrounding Beta-globin Locus Identifies Novel Therapeutic Targets for Fetal Globin Induction and Treatment of Sickle Cell Anemia
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Improving Efficacy of CAR T cells Through CRISPR/Cas9 Mediated Knockout of TGFbR2
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Cancer – Targeted Gene & Cell Therapy I

Efficient Targeted Integration in Human T cells with CRISPR-Cas9 for the Treatment of X-Linked Hyper-IgM Syndrome
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases II

Gene Editing Specificity Assessment for EDIT-101, an LCA10 Therapeutic Candidate
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Pharmacology/Toxicology Studies or Assay Development

Research Collaboration Poster Presentations (Editas Medicine Author):

Development of an Assay to Detect Pre-existing Anti-Cas9 Antibodies and an Estimate of the Prevalence of Anti-Staphylococcus- and Streptococcus-Cas9 Antibodies in the US Population
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Gene Targeting & Gene Correction II

Preclinical Modeling Highlights the Therapeutic Potential of the Adoptive Transplant of Gene Corrected T cells in X-Linked Hyper-IgM Syndrome
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases

Evaluation of Therapeutic Potential of Human USH2A Gene Lacking Exon 13 (USH2A-∆Ex13) for Restoring Ciliogenesis
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases)

Eagle Pharmaceuticals, Inc. to Present at 43rd Annual Deutsche Bank Health Care Conference

On April 30, 2018 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the 43rd Annual Deutsche Bank Health Care Conference as follows (Press release, Eagle Pharmaceuticals, APR 30, 2018, View Source [SID1234525851]):

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Date: Wednesday, May 9, 2018

Time: 8:40 a.m. EDT

Location: The InterContinental Boston Hotel

The presentation will be webcast live at the aforementioned time, and archived for 90 days thereafter, via the company’s website at www.eagleus.com, under the Investors Section and is also available at View Source

Atossa Genetics Receives Approval from the Swedish Medical Products Agency for Phase 2 Topical Endoxifen Study

On April 30, 2018 Atossa Genetics Inc. (Nasdaq:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD. Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer (Press release, Atossa Genetics, APR 30, 2018, View Source [SID1234525850]).

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The Phase 2 study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. Atossa plans to open the study for enrollment this quarter.

The primary endpoint is individual change in MBD, which will be measured after three and six months of entering the study, and the secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups on different doses of topical Endoxifen) with 30 participants per group. The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study.

"Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention. He is heading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen. We are honored to be working with Dr. Hall and his colleagues on our Phase 2 study of MBD as their unique experience and qualifications are simply unmatched anywhere in the world," said Dr. Steven C. Quay, CEO and President of Atossa.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen. Preliminary results from the topical arm of the study indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Topical Endoxifen Opportunities

Atossa is developing its proprietary topical Endoxifen to reduce MBD, which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 30 U.S. states require that findings of MBD be directly communicated to the patient. Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most physicians and their patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of, oral tamoxifen.

Atossa is also developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement, which affects 25% of men between the ages of 50-69. Atossa has commenced a Phase 1 study in men using topical Endoxifen, which it plans to fully-enroll this quarter.

Oral Endoxifen Opportunity

Approximately one million breast cancer survivors take oral tamoxifen annually; however, up to half of them do not properly metabolize tamoxifen and do not have desired levels of Endoxifen (meaning they are "refractory"). Low Endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Providing oral Endoxifen directly to the patient without having to be metabolized by the liver may help to address this problem.

Based on the number of women at high-risk of developing breast cancer and the number of patients who have survived breast cancer but are refractory to tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could each potentially exceed $1 billion in annual sales.

The Medical Products Agency

The Medical Products Agency is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics.

The Swedish Medical Products Agency is one of the leading regulatory authorities in the EU. During the last five years, the Swedish MPA has been among the top three agencies in Europe, counting the number of approval processes managed for central (i.e. European) approvals of medicines. The Swedish MPA also has strong representation in more than 110 working groups and committees in the scope of the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) for regulation of medical products in Europe.

The Medical Products Agency is a government body under the aegis of the Swedish Ministry of Health and Social Affairs. Its operations are largely financed through fees. Approximately 750 people work at the agency; most are pharmacists and doctors.

Breast Cancer Statistics

The American Cancer Society (ACS) estimates that approximately 268,000 women will be diagnosed with breast cancer in the United States this year and that approximately 41,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that in 2018 2,550 new cases of invasive breast cancer will be diagnosed in men; and 480 men will die from breast cancer.

About Stockholm South General Hospital

Stockholm South General Hospital is one of the largest hospitals in Sweden, offering care to more than two million Stockholmers. It is one of four hospitals collaborating with Karolinska on the KARMA project. For more information, please visit View Source

About Karolinska Institutet

Karolinska Institutet, located in Stockholm, Sweden, is one of the world’s foremost medical universities. Its vision is to make a significant contribution to the improvement of human health; its mission is to conduct research and education and to interact with the community. As a university, KI is Sweden’s single largest center of medical academic research and offers the country’s widest range of medical courses and programs. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology or Medicine. For more information, please visit www.ki.se/en and www.KARMAstudy.org.

Array BioPharma To Report Financial Results For The Third Quarter Of Fiscal 2018 On May 9, 2018

On April 30, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that it will report financial results for the third quarter of fiscal 2018 and hold a conference call to discuss those results on Wednesday, May 9, 2018 (Press release, Array BioPharma, APR 30, 2018, View Source;p=RssLanding&cat=news&id=2345678 [SID1234525849]). Ron Squarer, Chief Executive Officer, will lead the call.

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Date: Wednesday, May 9, 2018

Time: 9:00 a.m. Eastern Time

Toll-Free: (844) 464-3927

Toll: (765) 507-2598

Pass Code: 6465079

Webcast, including Replay and Conference Call Slides:
View Source

Arbutus Announces Conference Call to Provide a Corporate Update and First Quarter 2018 Financial Results

On April 30, 2018 Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that it will hold a conference call on Thursday, May 3, 2018 at 1:30 PM Pacific Time (4:30 PM Eastern Time) to discuss first quarter 2018 financial results and provide a corporate update (Press release, Arbutus Biopharma, APR 30, 2018, View Source [SID1234525848]).

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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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To access the conference call, a live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 4169558.