On May 17, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that clinical data from SL-801 and SL-701 trials have been selected for poster presentations at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 1-5, 2018, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, MAY 17, 2018, View Source [SID1234526753]). Abstracts are now available on the ASCO (Free ASCO Whitepaper) conference website.

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Details on the presentations are as follows:

Phase 2 Trial of SL-701 in Relapsed/Refractory Glioblastoma (GBM): Correlation of Immune Response with Longer-Term Survival

Abstract: 2058
Session: Central Nervous System Tumors
Presenter: David Peereboom, MD; Cleveland Clinic
Date: Saturday, June 2, 2018
Time: 1:15 – 4:45 PM CT
Interim Results from A Phase 1 Trial Of SL-801, A Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors

Abstract: 2560
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Presenter: Judy Wang, MD; Florida Cancer Specialists and Research Institute
Date: Monday, June 4, 2018
Time: 8:00 – 11:30 AM CT
About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.

On May 17, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a poster presentation of additional prostate cancer data (Abstract #229675) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held in Chicago, June 1-5, 2018 (Press release, Inovio, MAY 17, 2018, View Source [SID1234526752]). Previously reported data from a Phase 1b clinical trial demonstrated that Inovio’s cancer immunotherapy (INO-5150) slowed PSA rise in patients with biochemically recurrent prostate cancer. Additional analyses show clinically meaningful PSA stabilization post-administration of Inovio’s immunotherapy in patients with no documented disease progression during the study. Of note, this effect was also observed in the patients with the fastest PSA doubling at the time of study entry.

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The multi-center Phase 1b study enrolled 62 patients with biochemically relapsed prostate cancer following definitive local therapy. Under the trial design, eligible patients received INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA-5P device. Of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Additional analyses are underway to elucidate the correlation between immunologic efficacy and clinical benefit. For more information, please visit ClinicalTrials.gov (Identifier: NCT02514213).

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "The additional results from our Phase 1b INO-5150 study continue to support our rationale that Inovio’s T cell generating INO-5150 could be an important agent as an immunotherapy as it provides strong and durable immune responses in a particularly difficult-to-treat prostate cancer patient population. We remain diligent on establishing an outside partnership to further advance INO-5150 and I look forward to sharing additional observations from our prostate cancer development program later this year."

INO-5150 was generated using Inovio’s proprietary ASPIRE technology process to enable significant production of engineered PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

Independently, as part of the active, ongoing collaboration, two additional posters are being presented at the ASCO (Free ASCO Whitepaper) meeting that provide details on the ongoing trials of AstraZeneca/MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in abstract #TPS6093 and #5525.

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."

On May 17, 2018 During the Congress of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will be held form the 1st to the 5th of June in Chicago (USA), PharmaMar reported it will present the data obtained from various clinical studies of the molecules Yondelis , lurbinectedin (PM1183) and plitidepsin (Press release, PharmaMar, MAY 17, 2018, View Source [SID1234526748]).

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Two studies carried out with Yondelis (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on the results of aprospective phase III study comparing trabectedin versus best supportive care in patients with soft tissue sarcoma. And the design of the phase I/II safety and efficacy study
using the triple combination of trabectedin, ipilimumab and nivolumab for the first line treatment of soft tissue sarcoma. PharmaMar will also have data for lurbinectedin (PM1183), presenting the clinical
advances made in indications such as Ewing´s sarcoma, breast cancer and smallcell lung cancer, which is currently in a pivotal phase III clinical trial called ATLANTIS that should complete recruitment in Q3.

The studies that will be presented during the meeting are available at View Source Studies highlighted at ASCO (Free ASCO Whitepaper) 2018

Lurbinectedin

Lurbinectedin is a compound under clinical investigation which is an inhibitor of the RNA polymerase II enzyme which is essential for the transcription process. It’s inhibition suppresses tumor growth, and results in tumor death. The antitumor efficacy of PM1183 is being investigated in various types of solid tumors.

• Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma:
Final results from a phase 2 study. (Abstract #11519)
Poster Board: #264. Saturday, June 2. 15:00 to 16:15. Hall A
Discussed at the Poster Discussion Sessuon on Satuday, June 2, from 15:00
to 16:15 at S404
Lead author: Vivek Subbiah, MD. The University of Texas MD Anderson
Cancer Center

• Antitumor activity of PM1183 (lurbinectedin) in combination with capecitabine in metastatic breast cancer patients: results from a Phase I trial. (Abstract #1072)
Poster board: #153. Saturday, June 2. 8:00 a.m. to 11:30 a.m. Hall A.
Lead author: Ahmad Awada, MD, PhD. Medical oncology Clinic, Institut Jules
Bordet, Université Libre de Bruxelles

• Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. (Abstract #8570)
Poster board: #176. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Jose Manuel Trigo Perez, MD. Hospital Virgen de la Victoria,
Spain.

• ATLANTIS: Global, randomized phase III study of lurbinectedin (L) with doxorubicin (DOX) vs. CAV or topotecan (T)in small-cell lung
cancer after platinum therapy. (Abstract #TPS8587)
Poster board: #189b. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Anna F. Farago, MD, PhD. Massachusetts General Hospital

• Phase I trial of lurbinectedin (PM1183) in Japanese patients with advanced tumors: results of the dose escalation part. (Abstract
#2551)
Poster board: #377. Monday, June 4. 8:00 a.m. to 11:30. Hall A
Lead author: Shunji Takahashi, MD. Cancer Institute Hospital of JFCR
Yondelis (trabectedin)
Trabectedin is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair.

• Whole exome sequencing (WES) od metastatic leiomyosarcoma (LMS) and liposarcoma (LPS) and correlation of genomic aberrations
with clinical outcomes in the phase III randomized trial of trabectedin (T) vs. dacarbazine (D). (Abstract #11513)
Poster board: #258. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Gurpreet Kapoor. Scientific Operations, LabConnect LLC.

• Multi-institutional European phase I/II trial of trabectedin plus radiotherapy in metastatic soft tissue sarcoma (STS) patients. A Collaborative Spanish (GEIS), Italian (ISG) and French (FSG)
Sarcoma Groups study. (Abstract #11544)
Poster board: #289. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Javier Martin Broto MD, PhD. Hospital Universitario Virgen del Rocio, Instituto de Investigación Biomédica, Universidad de Sevilla, Spain.

• Impact of pathological stratification of advanced well differentiated/dedifferentiated (WD/DD) liposarcoma (LPS) on theresponse to trabectedin (T). (Abstract #11566)
Poster board: #311. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Roberta Sanfilippo, MD. Departamento de Oncología Médica, Fondazione IRCCS Istituto Nazionale dei Tumori

• Phase 1/2 study of safety/efficacy using trabectedin, ipilimumab and nivolumab triple therapy as first line of treatment of advanced soft tissue sarcoma. (Abstract #TPS11591)
Poster board: #333b. Saturday, June 2. 15:00 to 16:15. Hall A

Lead author: Erlinda Maria Gordon, MD. Sarcoma Oncology Center
• Results of a prospective randomized phase III T-SAR trial comparing trabectedin (T) vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS): A French Sarcoma
Group (FSG) trial. (Abstract #11508)
Oral sesión. Monday, June 4. 8:00 a.m. to 11:00. S100a
Lead author: Axel Le Cesne, MD. Gustave Roussy Cancer Campus Plitidepsin

• Overall survival (OS) results of randomized phase III study (ADMYRE trial) of plitidepsin and dexamethasone (DXM) vs. DXM alone in patients with relapsed/refractory multiple myeloma (RRMM): Evaluation of the crossover impact. (Abstract #8018)
Poster board: #27. Monday, June 4. 8:00 to 11:30. Hall A
Discussed ta the poster discussion session on Monday, June 4, 15:00 to
16:15 at E450
Lead autor: Javier Gómez, PharmaMar

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

On May 17, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology, and its research collaborator, Ospedale San Raffaele (OSR), presented at the 21st Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) the first update on their joint discovery and development efforts of Wilms’ Tumor 1 (WT1)-specific transgenic T cells (Press release, Intellia Therapeutics, MAY 17, 2018, View Source [SID1234526747]). In conjunction with this presentation, Intellia reported that its first cell therapy target is WT1 for the treatment of acute myeloid leukemia and other potential hematological malignancies, as well as for solid tumors.

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"As Intellia expands its wholly owned T cell therapy ex vivo efforts, we are pleased to present our first set of data in this cell therapy area," said Intellia President and Chief Executive Officer John Leonard, M.D. "WT1 is over-expressed in many tumor types, including both leukemias and solid tumors, and is an ideal target for immuno-oncological therapies seeking to treat these malignancies. This early data being presented is part of Intellia’s broader strategy to develop next-generation solutions for immuno-oncology and autoimmune disorders, with novel, modular platforms based on genome editing."

Intellia and OSR are collaborating to develop best-in-class CRISPR-edited T cells directed to WT1, a tumor-associated antigen expressed across a wide range of different tumor types and a known driver of leukocyte blasts in hematological cancers. At this year’s ASGCT (Free ASGCT Whitepaper) Annual Meeting, OSR researchers, led by Chiara Bonini, M.D., Ph.D., shared findings showing the generation, characterization and advancement of WT1-specific, transgenic T cells against multiple WT1 epitopes presented on HLA-A*02:01 and other Class I alleles. Initial data demonstrating both recognition and killing of acute myeloid leukemia cells also was presented.

OSR researchers and Intellia presented the poster, entitled "Hunting WT1-Specific T Cell Receptors for TCR Gene Editing for Acute Myeloid Leukemia." The abstract is available on the ASGCT (Free ASGCT Whitepaper) website here.

"Our collaboration with Intellia represents our shared belief that the characteristics of T cell receptors as a targeting moiety may be an excellent approach to broadening the field of oncology cell therapy, opening the door to many more potential antigen targets in liquid and solid tumors," added Bonini, full professor at Università Vita-Salute San Raffaele; deputy director, Division of Immunology, Transplantation and Infectious Diseases; and head, Experimental Hematology Unit, Ospedale San Raffaele, Italy.

This ex vivo research effort is part of an integrated strategy to develop CRISPR-edited T cell therapies to address hard-to-treat cancers and overcome certain limitations of current-generation cell therapies, includin