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PharmaMar announces data presentations for both its molecules Yondelis® and lurbinectedin at ASCO 2018

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.

Intellia Therapeutics Announces WT1 as Its First Cell Therapy Target, Following Presentation of Early Data at the American Society of Gene and Cell Therapy 21st Annual Meeting

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.

"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

VBL Therapeutics Announces First Quarter 2018 Financial Results

On May 17, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, VBL Therapeutics, MAY 17, 2018, View Source [SID1234526744]).

"We continue to advance the OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation," said Yael Cohen M.D., VP Clinical Development of VBL Therapeutic. "We are in the process of amending the protocol to include an interim analysis for evidence of an early efficacy signal with a potential readout from this analysis in the fourth quarter of 2019."

"We are also advancing our MOSPD2 program for oncology and inflammatory indications and, at the recent American Academy of Cancer Research (AACR) (Free AACR Whitepaper) meeting, presented new proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics. "VBL is well capitalized, with approximately $50 million in cash, which will enable us to continue the development of VB-111 and our deep pipeline through 2020.’

First Quarter and Recent Corporate Highlights:

Continued to treat patients in the ongoing Phase 3 OVAL trial, studying VB-111 in platinum-resistant ovarian cancer. The OVAL study has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the U.S. and Israel.

— The Company is modifying the OVAL protocol to incorporate an efficacy interim readout, which is expected to occur in the fourth quarter of 2019.

The Company is conducting an in-depth analysis of the GLOBE study, including analysis of patient subgroups, in order to better understand the outcome of the study, the major difference between the Phase II and the GLOBE trial and the potential activity of VB-111 in rGBM.

Presented late breaking research on the Company’s MOSPD2 oncology program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting.

— The data provide proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells, with potential applicability to solid tumors and myeloid malignancies.

— The MOSPD2 program was also featured in a presentation at the 17th MIXiii-BIOMED 2018 Conference and Exhibition, May 15-17 in Tel Aviv, Israel.

— VBL is developing its VB-600 series of antibodies targeting MOSPD2 for oncology and inflammatory applications.

Awarded 8.9 million New Israeli Shekels (approximately US$2.5 million) non-dilutive grant by the Israel Innovation Authority (IIA).

— The funds will support the development of VB-111 as well as the Company’s Vascular Targeting System (VTS) platform for therapeutic gene therapy.

Appointed two senior pharmaceutical executives, Susan Kelley, M.D., and David Hastings, to its Board of Directors.
First Quarter Ended March 31, 2018 Financial Results:

Revenues: In 2017 the Company entered into an exclusive license agreement with NanoCarrier Co., Ltd. and received an up-front and a milestone payment of $17.0 million in aggregate, of which $0.2 million was recognized as of March 2018.

Cash Position: Cash, cash equivalents and short-term bank deposits at March 31, 2018, were $49.9 million. Working capital at March 31 was $44.3 million. The Company expects that the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements through 2020.

R&D Expenses: Research and development expenses for the quarter ended March 31, 2018, were approximately $5.8 million, compared to approximately $4.1 million in the comparable period in 2017. R&D expenses are shown net of IIA grants.

G&A Expenses: General and administrative expenses for the quarter ended March 31, 2018 were $1.4 million, compared to $1.1 million for the comparable period in 2017.

Comprehensive Loss: The Company reported a comprehensive loss for first quarter ended March 31, 2018 of $7.2 million, or ($0.24) per share, compared to a net loss of $5.0 million, or ($0.19) per share in first quarter ended March 31, 2017.
Conference Call:

NantHealth to Present at the Bank of America Merrill Lynch Health Care Conference 2018 on May 17

On May 17, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that its management will be presenting at the Bank of America Merrill Lynch 2018 Health Care Conference on Thursday, May 17, 2018, at 11:20 a.m. PT in Las Vegas (Press release, NantHealth, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349532 [SID1234526743]).

Sumitomo Dainippon Pharma announces the Clinical Data will be presented at ASCO 2018

On May 17, 2018 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director President and CEO: Hiroshi Nomura) reported that a total of 6 presentations including clinical study results and designs for investigational anti-cancer agents napabucasin (BBI608), DSP-7888 and TP-0903 will be made at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 1 to June 5, 2018 (Press release, Sumitomo Dainippon Pharma, MAY 17, 2018, View Source [SID1234526742]).

【About napabucasin】
Napabucasin is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. Napabucasin has been shown to inhibit STAT3 pathways, Nanog pathways and β-catenin pathways in pre-clinical studies.
3
【About DSP-7888】
DSP-7888 is a therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. DSP-7888 is a vaccine containing peptides that induces WT1-specific cytotoxic T lymphocytes (CTLs) and helper T cells. DSP-7888 is expected to become a treatment option for patients with various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1- specific CTLs that attack WT1-expressing cancer cells. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a CTL-inducing peptide alone may be achieved. DSP7888 is expected to be an option for a wide range of patients.

【About TP-0903】
TP-0903 is an AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to conventional agents and developing metastatic capacity in cancer cells.TP-0903 may have anti-cancer activities on various cancer types through blocking transition from epithelial to mesenchymal phenotype by inhibiting AXL. TP0903 has been shown to inhibit AXL signaling and reverse the mesenchymal to epithelial phenotype in pre-clinical studies.

These agents have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer or any other disorder.
Contact: Public & Investor Relations Group, Corporate Governance
Sumitomo Dainippon Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka); +81-3-5159-3300 (Tokyo)