Genmab Announces Abstracts to be Presented at 23rd EHA Annual Congress

On May 17, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that one abstract on Genmab’s DuoBody-CD3xCD20 and six industry sponsored abstracts on daratumumab will be presented at the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2018 in Stockholm, Sweden, June 14-17 (Press release, Genmab, MAY 17, 2018, View Source [SID1234526767]). An abstract containing a pre-clinical evaluation of Genmab’s proprietary DuoBody-CD3xCD20 will be presented as a poster. The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation on ALCYONE (MMY3007), the Phase III trial of daratumumab plus bortezomib, melphalan and prednisone in newly diagnosed multiple myeloma that was the basis for the recent U.S. Food and Drug Administration approval. There will also be an oral presentation regarding the Phase II CENTAURUS (SMM2001) study of daratumumab in smoldering multiple myeloma. The abstracts have been published on the EHA (Free EHA Whitepaper) website, and may be accessed via www.ehaweb.org.

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"In addition to the multiple presentations of daratumumab clinical data in multiple myeloma or amyloidosis, we are very pleased that a pre-clinical evaluation of our proprietary DuoBody-CD3xCD20 product will be presented to the attendees at this year’s EHA (Free EHA Whitepaper) congress," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts

DuoBody-CD3xCD20
CD3 Bispecific Antibody Screen Identifies CD20 as the Most Efficient Target for Elimination of B Cell Malignancies; Pre-clinical Evaluation of DuoBody-CD3xCD20 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Daratumumab
Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 Years of age) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) — Oral presentation, Friday, June 15, 12:00 PM — 12:15 PM CEST

Effects of Daratumumab on the Composition and Activation Status of Immune-Cell Populations in CENTAURUS, a Phase 2 Randomized Study of Smoldering Multiple Myeloma (SMM) Patients — Oral presentation, Sunday, June 17, 8:30 AM — 8:45 AM CEST

Subcutaneous Daratumumab (DARA SC) + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA — Poster presentation, Saturday, June 16, 5:30 PM — 7:00 PM CEST

Daratumumab, Carfilzomib and Dexamethasone (D-Kd) in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma (MM): Subgroup Analysis of MMY1001 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Impact of Baseline Renal Function on Efficacy and Safety of Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplantation (ALCYONE) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Tarveda Therapeutics to Present Data from Phase 1 Study of PEN-221 at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting

On May 17, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that it will present Phase 1 results from a Phase 1/2a study of PEN-221 in patients with neuroendocrine tumors or small cell lung cancer at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring June 1-5, 2018 in Chicago IL (Press release, Tarveda Therapeutics, MAY 17, 2018, View Source [SID1234526784]).

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The data presented will describe the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221, a miniature drug conjugate containing a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2) that is conjugated to the potent payload DM1. SSTR2 is a cell surface target that is overexpressed in a variety of solid tumor cancers. PEN-221 is currently being evaluated in a Phase 2a trial in patients with gastrointestinal midgut neuroendocrine tumors, pancreatic neuroendocrine tumors, or small cell lung cancer.

"We are very pleased to have completed the Phase 1 portion of our Phase 1/2a clinical trial for PEN-221 on schedule and to present the data from the Phase 1 trial evaluating PEN-221 at ASCO (Free ASCO Whitepaper)," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "We are encouraged by the data from studies of PEN-221 to date and look forward to advancing the Phase 2a portion of the study for PEN-221 as well as our Phase 1 trial for PEN-866."

Details of the poster presentation are as follows:

Title: First in human phase 1/2a study of PEN-221 somatostatin analog (SSA)-DM1 conjugate for patients (PTS) with advanced neuroendocrine tumor (NET) or small cell lung cancer (SCLC): Phase 1 results.
Abstract Number: 4097
Date: June 3, 2018
Time: 8:00 – 11:30 AM CT
Location: Hall A

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

Triumvira Expands Management Team with Chief Medical Officer and VP, Finance

On May 17, 2018 Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, today formally reported the appointments of Sabine Chlosta, MD, PhD, as Chief Medical Officer, and Jon Irvin as Vice President, Finance (Press release, Triumvira Immunologics, MAY 17, 2018, View Source [SID1234526750]).

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"We are delighted to expand our executive management team with Dr. Chlosta and Mr. Irvin," said Paul Lammers, MD, MSc., President and CEO of Triumvira Immunologics. "We look forward to leveraging Sabine’s extensive experience in immuno-oncology and clinical trial oversight as we work to develop and commercialize innovative therapies that will empower a patient’s own immune system to tackle serious and life-threatening diseases."

"In addition, Jon’s finance expertise in the pharmaceutical and technology industries will be a strong asset to Triumvira as we build our company to bring new treatments to patients in need," Lammers added.

Prior to Triumvira, Sabine Chlosta consulted for Aurora BioPharma, a start-up company developing CAR-T cells in solid tumors and was previously a Senior Medical Director at Merck & Co. where she played a key role in the development of its PD-1 inhibitor Keytruda in Non-Hodgkin’s lymphoma and oversaw trials in other indications, as well. Earlier in her career, Dr. Chlosta was a medical director at Glycomimetics where she helped launch the company’s first trial in cancer. She began her industry career as a Fellow in Oncology Drug Development at Novartis overseeing clinical pharmacology trials with a small molecule and helped launch their CAR-T lymphoma program with Kymriah. Dr. Chlosta is a board-certified pediatric hematologist oncologist out of Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College.

"Triumvira is poised for growth and success in T cell therapy, and I am thrilled to be part of the team to take our innovative TAC technology into the clinic," said Dr. Chlosta.

Jon Irvin was the Chief Financial Officer and Vice President of Finance at Mirna Therapeutics, a publicly traded biotechnology company, before joining Triumvira. He also served in executive financial positions for Voxpath Networks, Inc., a telecommunications and intellectual property company, Reddwerks Corporation, a software company, Esoterix, Inc., a medical laboratory company, Topaz Technologies, a pharmaceutical software company, and BioNumerik Pharmaceuticals, Inc., a pharmaceutical company. Mr. Irvin previously worked with Ernst & Young’s life science practice in Palo Alto, California.

Irvin commented, "It’s exciting to be a part of this growing team as we develop our novel platform to treat patients’ unmet medical needs."

BioClin Therapeutics, Inc.Announces Poster Presentation of
B-701at the 2018 American Society of Clinical Oncology
(ASCO) Annual Meeting

On May 17, 2018 BioClin Therapeutics, Inc., a clinical stage drug development company reported that data will be presented from its ongoing Phase 1b/2 study of B-701, a first-in-class anti-fibroblast growth factor receptor 3 (FGFR3) monoclonal antibody, plus docetaxel for metastatic bladder cancer at a poster session at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting being held June 1-5, 2018 in Chicago, IL (Press release, BioClin Therapeutics, MAY 17, 2018, View Source [SID1234526785]).

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The details of the poster presentation are as follows:

[Abstract 4534]
FIERCE-21: Phase 1b/2 study of Docetaxel + B-701, a Selective Inhibitor of FGFR3, in Relapsed or Refractory (R/R) Metastatic Urothelial Carcinoma (mUCC).

Joaquim Bellmunt, M.D., Ph.D., Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster Session Date/Time: Saturday, June 3, 2018, 8:00 – 11:30 a.m., CDT, Hall A

Sensei Biotherapeutics Appoints John Celebi as President and Chief
Executive Officer

On May 16, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of John Celebi, M.B.A., as President and Chief Executive Officer (Press release, Sensei Biotherapeutics, MAY 16, 2018, View Source [SID1234526734]). He also joins the company’s board of directors. Mr. Celebi brings more than two decades of leadership experience with innovative and growing biotechnology companies, most recently in the field of cancer immunotherapies.

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The appointment of Mr. Celebi as President and Chief Executive Officer occurs at a time when Sensei is emerging with a focused immuno-oncology strategy, promising clinical data from the Phase I trial of its lead drug candidate SNS-301, and the proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies. SNS-301 and the SPIRIT platform originated at Panacea Pharmaceuticals which has become Sensei Biotherapeutics. Sensei’s growing team of 14 employees is focused on its growth strategy in
immuno-oncology, operating out of its new 30,000 square foot laboratory and office space.

"I am delighted to join Sensei at this exciting time when we have the opportunity to apply our SPIRIT platform to develop immuno-oncology therapies with an innovative mechanism for detecting and eliminating cancer. We are encouraged by the clinical data that is emerging for our lead drug candidate, SNS-301, which we are advancing to lead the way in our strategy to build a precision pipeline of immuno-oncology therapies through companion diagnostics," said Mr. Celebi. "Sensei is well positioned to leverage our unique technology to develop novel
therapies with the potential to achieve our mission to have a positive and profound impact for
cancer patients."

"We welcome John’s strong experience and strategic business acumen to help build our vision and future for Sensei," said Hossein Ghanbari, PhD, Chief Scientific Officer and Board Chair of Sensei Biotherapeutics, and the company’s original co-founder and Chief Executive Officer.

"John’s oncology background and accomplished track record in biotech will serve Sensei exceptionally well as we move forward with our innovative immuno-oncology platform and advance new medicines for patients." Mr. Celebi has a distinguished track record for growing innovative entrepreneurial biotechnology companies, including in the field of oncology. Previously, Mr. Celebi served as the Chief Operating Officer of X4 Pharmaceuticals where he established and oversaw the company’s oncology business strategy. He also served as Chief Business Officer of Igenica Biotherapeutics, Inc., an immunotherapy company formed by The Column Group, 5AM Ventures, Orbimed and Third Rock Ventures, where he established key academic and industry relationships, including with MedImmune. He has extensive transactional and alliance management experience. Previously, he served as Vice President of Business Development, New Product Planning and Alliance Management at ArQule, Inc., where he played a central role
in the formation of alliances with Roche, Daiichi-Sankyo, and Kyowa Hakko Kirin. Mr. Celebi was one of the early employees at Tularik, Inc., where he conducted drug discovery and basic research for an anti-viral drug program. Mr. Celebi received an M.B.A. from Carnegie Mellon University and a B.S. in Biophysics from the University of California, San Diego.