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argenx to Present Data at Upcoming 61st American Society of Hematology (ASH) Annual Meeting

On November 6, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported three presentations at the the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held from December 7-10, 2019 in Orlando, FL (Press release, argenx, NOV 6, 2019, View Source [SID1234550437]). The presentations will include preclinical translational data highlighting the multiple modes of action of cusatuzumab to target leukemic stem cells, potential synergies of cusatuzumab in combination with a BCL-2 antagonist, and previously announced data from the Company’s completed Phase 2 trial of efgartigimod for primary immune thrombocytopenia (ITP).

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Details for the oral presentations are as follows:

Title: Targeting CD70 with Cusatuzumab Eliminates Acute Myeloid Leukemia Stem Cells in Humans

Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targets and Combinations

Date and Time: Saturday, December 7, 3:15 p.m. ET

Location: Orange County Convention Center, Chapin Theater, W320

Presenter: Dr. Adrian Ochsenbein, M.D., University of Bern

Title: Phase 2 Study of Efgartigimod, a Novel FcRn Antagonist, in Adult Patients with Primary Immune Thrombocytopenia

Oral Session: 311. Disorders of Platelet Number or Function: Advances in ITP Therapy

Date and Time: Monday, December 9, 6:15 p.m. ET

Location: Orange County Convention Center, W307

Presenter: Dr. Adrian Newland, M.D., The Royal London Hospital

Details for the poster presentation are as follows:

Title: The Combination of the BCL-2 Antagonist Venetoclax with the CD70-Targeting Antibody Cusatuzumab Synergistically Eliminates Primary Human Leukemia Stem Cells

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Date & Time: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Dr. Carsten Riether, Ph.D., University of Bern

Alpine Immune Sciences Announces Oral Presentation of ALPN-101 at the 61st American Society of Hematology Annual Meeting and Exposition

On November 6, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported an abstract has been accepted for an oral presentation highlighting the company’s lead autoimmune/inflammatory program ALPN-101 at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 7-10, 2019 in Orlando, FL (Press release, Alpine Immune Sciences, NOV 6, 2019, View Source [SID1234550436]).

The Company will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS costimulatory pathways with strong preclinical and translational rationale in GvHD.

Last year, preclinical data on ALPN-101 was included in an oral presentation at the 60th ASH (Free ASH Whitepaper) Annual Meeting, highlighting the novel role ICOS ligand (ICOS-L) plays in acute GvHD and extending what is currently understood about the CD28/B7 protein family in disease pathogenesis. Since then, Alpine has been conducting a first-in-human, randomized, placebo-controlled single- and multiple-ascending dose Phase I study in adult healthy volunteers. "This year’s presentation will discuss the translational and therapeutic potential of ALPN-101 based on our learnings to date," indicated Stanford Peng, M.D. Ph.D., President and Head of Research and Development at Alpine.

61st ASH (Free ASH Whitepaper) Annual Meeting Oral Presentation

Title: An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (aGvHD)
Presenter: Dr. Jan Hillson, Senior Vice President, Clinical Development, Alpine
Session Name: 802. Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action (9:30 – 11:15 AM ET)
Oral Presentation Date and Time: Sunday, December 8, 2019: 11:00 AM ET
Location: OCCC, W414AB
About Graft Versus Host Disease (GvHD)

Graft versus host disease (GvHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as different and attack them. Acute GvHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver and gastrointestinal tract. Despite extensive studies of many different therapies in GvHD, corticosteroids remain its primary treatment.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 and/or ICOS pathways alone.

Alligator Bioscience: ATOR-1017 Induces Long-Lasting Immunity – New Preclinical Data to be presented at SITC 34th Annual Meeting

On November 6, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the company will present new preclinical data showing that their drug candidate ATOR-1017 can induce a long-lasting immunological memory which is of great importance in a potential future patient setting (Press release, Alligator Bioscience, NOV 6, 2019, View Source [SID1234550435]). The results will be presented at the ongoing Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting. The ATOR-1017 drug candidate is in development for the treatment of metastasized cancer.

Furthermore, the results show that treatment with ATOR-1017 activates the immune system in the tumor area but not systemically. These preclinical data support a tumor-directed activity of ATOR-1017. The aim is to focus the immune attack towards the tumor in order to increase efficacy and minimize side effects for the patient. ATOR-1017 is currently about to initiate Phase I clinical study and dosing of the first patient is expected shortly.

"These preclinical data support the potential of ATOR-1017 to generate a strong and long-lasting immune response or even to induce immunity to cancer. This is our fourth asset to enter the clinic and with its unique tumor-directed profile, we continue to build a clinical pipeline of the next generation cancer immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

The upcoming Phase I study will be a first-in-human, dose escalation study in patients with advanced cancer. It will be conducted at three sites in Sweden and will enroll up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

Karin Enell Smith, Senior Scientist at Alligator Bioscience will present a poster with the title "ATOR-1017, a 4-1BB antibody developed for tumor-directed immunotherapy of cancer" on Saturday November 9 at the SITC (Free SITC Whitepaper) 34th Annual Meeting held in National Harbor, Maryland, US. The poster presentation will be available on the Alligator web site View Source on the day of the presentation.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on November 6, 2019.

About ATOR-1017
ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity to detect and kill tumor cells, making 4-1BB a particularly attractive target for cancer immunotherapy. ATOR-1017 has a unique profile related to the fact that its immunostimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation, while minimizing side effects for the patient.

Agios Announces Proposed Offering of Common Stock

On November 6, 2019 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) reported that it is offering to sell, subject to market and other conditions, up to 7.5 million shares of its common stock in an underwritten public offering (Press release, Agios Pharmaceuticals, NOV 6, 2019, View Source [SID1234550434]). Agios also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the public offering. All of the shares in the offering are to be sold by Agios. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The shares are being offered by Agios pursuant to an automatically effective shelf registration statement that has been filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov.

Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Agios to Present Broad Set of Clinical and Translational Data for Oncology and Rare Genetic Disease Programs at the 2019 ASH Annual Meeting

On November 6, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that 15 abstracts featuring clinical and translational data from its oncology and rare genetic diseases programs will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 7-10, 2019 in Orlando (Press release, Agios Pharmaceuticals, NOV 6, 2019, View Source [SID1234550433]).

The accepted abstracts are listed below and are available online on the ASH (Free ASH Whitepaper) conference website: View Source

Oral Presentations

Abstract #541: Complex Polyclonal Resistance Mechanisms to Ivosidenib Monotherapy in IDH1-Mutant Relapsed or Refractory Acute Myeloid Leukemia Revealed By Single Cell Sequencing Analyses
Date & Time: Monday, December 9, 2019 at 7:00 a.m. ET
Oral Abstract Session: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Single-Cell and Clonal Approaches to Treatment Resistance in AML
Location: Orange County Convention Center, Valencia A (W415A)
Presenter: Hongfang Wang, Ph.D., Agios Pharmaceuticals

Abstract #545: Molecular Mechanisms Mediating Relapse Following Ivosidenib Monotherapy in Patients with IDH1-Mutant Relapsed or Refractory Acute Myeloid Leukemia
Date & Time: Monday, December 9, 2019 at 8:00 a.m. ET
Oral Abstract Session: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Single-Cell and Clonal Approaches to Treatment Resistance in AML
Location: Orange County Convention Center, Valencia A (W415A)
Presenter: Sung Choe, Ph.D., Agios Pharmaceuticals

Abstract #643: Enasidenib Plus Azacitidine Significantly Improves Complete Remission and Overall Response Compared with Azacitidine Alone in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) with Isocitrate Dehydrogenase 2 (IDH2) Mutations: Interim Phase II Results from an Ongoing, Randomized Study
Date & Time: Monday, December 9, 2019 at 10:30 a.m. ET
Oral Abstract Session: 613. Acute Myeloid Leukemia: Clinical Studies: Non-Intensive Therapy
Location: Orange County Convention Center, Valencia A (W415A)
Presenter: Courtney DiNardo, M.D., University of Texas MD Anderson Cancer Center

Poster Presentations

Abstract #2175: Comorbidities and Complications in Adults with Pyruvate Kinase Deficiency
Poster Session Date & Time: Saturday, December 7, 2019 from 5:30-7:30 p.m. ET
Poster Session: 904. Outcomes Research – Non-Malignant Conditions: Poster II

Abstract #1570: Hematologic Malignancies Exhibit Selective Vulnerability to Inhibition of De Novo Pyrimidine Biosynthesis By AG-636, a Novel Inhibitor of Dihydroorotate Dehydrogenase in Phase 1 Clinical Trials
Poster Session Date & Time: Saturday, December 7, 2019 from 5:30-7:30 p.m. ET
Poster Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster I

Abstract #1286: AG-636 for the Treatment of Adults with Advanced Lymphoma: Initiation of a Phase 1 Clinical Study
Poster Session Date & Time: Saturday, December 7, 2019 from 5:30-7:30 p.m. ET
Poster Session: 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Poster I

Abstract #2223: An Ongoing Global, Longitudinal, Observational Study of Patients with Pyruvate Kinase Deficiency: The PEAK Registry
Poster Session Date & Time: Sunday, December 8, 2019 from 6:00-8:00 p.m. ET
Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II

Abstract #2249: Mitapivat (AG-348), an Oral PK-R Activator, in Adults with Non-Transfusion Dependent Thalassemia: A Phase 2, Open-Label, Multicenter Study in Progress
Poster Session Date & Time: Sunday, December 8, 2019 from 6:00-8:00 p.m. ET
Poster Session: 112. Thalassemia and Globin Gene Regulation: Poster II

Abstract #3447: Development of Patient-Reported Outcome Measures (Symptoms and Impacts) in Adults with Pyruvate Kinase Deficiency
Poster Session Date & Time: Sunday, December 8, 2019 from 6:00-8:00 p.m. ET
Poster Session: 904. Outcomes Research – Non-Malignant Conditions: Poster II

Abstract #2593: AGILE: A Phase 3, Multicenter, Double‐Blind, Randomized, Placebo‐Controlled Study of Ivosidenib in Combination with Azacitidine in Adult Patients with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
Poster Session Date & Time: Sunday, December 8, 2019 from 6:00-8:00 p.m. ET
Poster Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II

Abstract #2706: High Rate of IDH1 Mutation Clearance and Measurable Residual Disease Negativity in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib (AG-120) and Azacitidine
Poster Session Date & Time: Sunday, December 8, 2019 from 6:00-8:00 p.m. ET
Poster Session: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster II

Abstract #3512: Long-Term Safety and Efficacy of Mitapivat (AG-348), a Pyruvate Kinase Activator, in Patients with Pyruvate Kinase Deficiency: The DRIVE PK Study
Poster Session Date & Time: Monday, December 9, 2019 from 6:00-8:00 p.m. ET
Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III

Abstract #3526: Mitapivat (AG-348) in Adults with Pyruvate Kinase Deficiency Who Are Regularly Transfused: A Phase 3, Open-Label, Multicenter, Study (ACTIVATE-T) in Progress
Poster Session Date & Time: Monday, December 9, 2019 from 6:00-8:00 p.m. ET
Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III

Abstract #3513: Prevalence of Pyruvate Kinase Deficiency: A Systematic Literature Review
Poster Session Date & Time: Monday, December 9, 2019 from 6:00-8:00 p.m. ET
Poster Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III

Abstract #4254: Ivosidenib (AG-120) in Patients with IDH1-Mutant Relapsed/Refractory Myelodysplastic Syndrome: Updated Enrollment of a Phase 1 Dose Escalation and Expansion Study
Poster Session Date & Time: Monday, December 9, 2019 from 6:00-8:00 p.m. ET
Poster Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III

Event and Webcast Information
Agios will host an investor event on December 9, 2019 at 8:00 p.m. ET in Orlando to review the data from the company’s oncology and rare genetic diseases programs. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.