Merck to Present at the Evercore ISI HealthCONx Conference 2019

On December 2, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Michael Nally, chief marketing officer for Merck is scheduled to present during a fireside chat at the Evercore ISI HealthCONx Conference in Boston on Dec. 4, 2019 at 2:00 p.m. EST (Press release, Merck & Co, DEC 2, 2019, View Source [SID1234551822]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

Amphivena Appoints Dr. Curtis L. Ruegg as President and Chief Executive Officer

On December 2, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported that Curtis L. Ruegg, Ph.D. will join the company as its new President and Chief Executive Officer and will also sit on the company’s Board of Directors (Press release, Amphivena Therapeutics, DEC 2, 2019, View Source [SID1234551838]). The company’s Founder and current President and Chief Executive Officer, Jeanmarie Guenot, Ph.D., will transition into an Advisory role.

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Dr. Ruegg joins Amphivena from Parvus Therapeutics, where he was President and Chief Executive Officer. With more than 25 years of biopharmaceutical experience, he brings strong drug development expertise to Amphivena. Prior to Parvus, Dr. Ruegg filled various leadership roles at Revance, CoTherix, Intermune, AP Cells and Dendreon.

"I am excited to join Amphivena at this critical inflection point," said Dr. Ruegg. "Its lead investigational candidate, AMV564, has advanced in clinical development in both hematologic cancers and in solid tumors, with initial clinical trial data reading out as early as 2020. The momentum created by the team to date is significant and I look forward to helping to build Amphivena into a leading immuno-oncology company."

Executive Chairman Peter Van Vlasselaer, Ph.D., said, "Since the company’s inception, Jeanmarie has guided its leadership team to establish a preeminent position in the T cell engagement space, most recently by expanding the application of AMV564 beyond hematologic cancers to solid tumors. We thank her for her dedication to the company and look forward to her continued involvement with the company in her Advisory role. We welcome Curtis and look forward to his contributions as the company matures. I am enthusiastic about our prospects as we further cement Amphivena’s leadership in the T cell engager and immuno-oncology arenas."

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. The company announced in October initiation of a Phase 1 trial to evaluate the effect of AMV564 on these immune suppressive cells and the potential therapeutic benefit of relieving this important source of T cell suppression in patients with solid tumors. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is also currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) and at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

Cellectar Announces Oral Presentation at the 61st Annual American Society of Hematology Conference

On December 2, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported an oral presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting being held December 7-10, 2019 in Orlando, Florida (Press release, Cellectar Biosciences, DEC 2, 2019, View Source [SID1234551916]).

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Presentation details:

Present Title: Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Presenting Author: Dr. Sikander Ailawadhi
Session: 653. Myeloma: Therapy, excluding Transplantation: New Approaches in the Treatment of Relapsed/Refractory Plasma Cell Discrasias
Date/Time: Saturday, December 7, 2019 / 9:30 am – 11:00 am
Location: Orange County Convention Center, Hall E1

A copy of the poster can be accessed on the Posters and Publications section of the Cellectar website on the day of the poster presentation.

Sierra Oncology Announces Investor Event to Discuss Momelotinib Data Being Reported at ASH

On December 2, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that it will host an Analyst & Investor Event on Sunday, December 8th at 7:00 am ET to discuss newly reported clinical data for momelotinib that will be presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida (Press release, Sierra Oncology, DEC 2, 2019, View Source [SID1234551823]).

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The event will be led by Dr. Nick Glover, President and CEO of Sierra Oncology, and will include a presentation by renowned myelofibrosis expert, Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center. Dr. Mesa and members of Sierra Oncology’s senior management team will be available to answer questions at the conclusion of the event.

New analyses of RBC transfusion data from SIMPLIFY-1, a double-blind Phase 3 trial of Sierra’s investigational drug momelotinib head-to-head versus ruxolitinib in JAK inhibitor naïve patients, will be presented in a poster by Dr. Mesa on Saturday, December 7th at the ASH (Free ASH Whitepaper) Annual Meeting. These analyses demonstrate that patients who received momelotinib had significantly decreased transfusion requirements compared to those treated with ruxolitinib, including a nearly 10-fold higher odds of receiving no transfusions during the 24-week study period.

Analyst and Investor Event and Webcast Information
Date and Time: Sunday, December 8th at 7:00 – 8:00 am ET
Location: Bayhill 33 Meeting Room, Hyatt Regency, 9801 International Dr., Orlando

Event registration and webcast information are available through the Sierra Oncology website at www.sierraoncology.com. The event will be webcast live, and an archive of the presentation will be accessible after the event through the Sierra Oncology website.

ASH 2019 Momelotinib Poster Presentation Information:
Title: Dynamic and Time-To-Event Analyses Demonstrate Marked Reduction in Transfusion Requirements for Janus Kinase Inhibitor–Naïve Myelofibrosis Patients Treated with Momelotinib Compared Head to Head with Ruxolitinib
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster I
Date: Saturday, December 7th, 2019
Presentation Time: 5:30 pm – 7:30 pm ET
Location: Orange County Convention Center, Hall B

The poster will be available on Saturday, December 7th, 2019 on the company’s website at www.sierraoncology.com

Epizyme Announces FDA Advisory Committee Meeting to Review Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

On December 2, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) is scheduled to review data supporting the company’s New Drug Application (NDA) requesting accelerated approval for tazemetostat, an oral, first-in-class EZH2 inhibitor, at a meeting on Dec. 18, 2019 at 1:00 p.m. ET (Press release, Epizyme, DEC 2, 2019, View Source [SID1234551839]). The proposed indication to be discussed at this upcoming ODAC meeting is for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

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ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of a product is made solely by the FDA.

Epizyme announced on July 25, 2019 that the FDA had accepted for filing the NDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery with Priority Review and a Prescription Drug User-Fee Act (PDUFA) action date of Jan. 23, 2020. Epizyme’s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat.