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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.

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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

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)

DelMar Pharmaceuticals Announces Third Quarter Fiscal Year 2018 Financial Results

On May 17, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the third quarter ended March 31, 2018 (Press release, DelMar Pharmaceuticals, MAY 17, 2018, View Source [SID1234526736]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 30, 2018 at 4:30 p.m. Eastern Time.

"This quarter has been a pivotal and important period for DelMar. I am pleased with our enhanced focus on leveraging VAL-083’s unique mechanism of action to advance both of our Phase 2 clinical programs including MGMT-unmethylated, second-line, bevacizumab (Avastin) naïve glioblastoma, and MGMT-unmethylated, first-line, temozolomide-naïve glioblastoma. MGMT methylation status has become increasingly important in the diagnosis and treatment of glioblastoma, and a routine part of clinical practice as it is a well-established biomarker that correlates with resistance to the standard-of-care chemotherapy, temozolomide, and with patient outcomes. We believe that using this biomarker will optimize patient selection for treatment in future trials with our lead drug candidate, VAL-083, thereby streamlining development and enhancing opportunities for success in our clinical development programs," commented Saiid Zarrabian, Interim President and Chief Executive Officer.

KEY HIGHLIGHTS

Continued enrolling patients in the Company’s Phase 2, open-label, second-line Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme (GBM) trial being conducted at the MD Anderson Cancer Center

·Increased patient enrollment rate of the Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM trial at Sun Yat-sen University Cancer Center

Presented a positive interim update from ongoing open-label Phase 2 clinical trials in MGMT-unmethylated GBM at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in April, 2018

·Presented promising pre-clinical results supporting the potential of VAL-083 in the treatment of cancer patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently available therapies at the Annual Meeting of AACR (Free AACR Whitepaper) held in April, 2018

·Presented promising pre-clinical data supporting the potential of VAL-083 as part of second- line combination treatment with Avastin for GBM at the biennial Canadian Neuro-Oncology meeting in May 2018

Ramped-up evaluation of improved development strategies for VAL-083’s ovarian program, including specific biomarkers for optimal VAL-083 efficacy and combination treatment with PARP inhibitors, utilizing our newly formed clinical advisory board

·Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the third quarter of calendar 2019

For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s 10-Q filed with the SEC on May 15, 2018, View Source

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss its financial results for the quarter ended March 31, 2018 and provide a corporate update on May 30, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1 877-876-9176 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE PERIOD ENDED MARCH 31, 2018

At March 31, 2018, the Company had combined cash and cash equivalents and clinical trial deposits on hand of approximately $9.4 million.

For the three months ended March 31, 2018, the Company reported a net loss of $2,933,057 or $0.13 per share, compared to a net loss of $1,868,460, or $0.18 per share, for the three months ended March 31, 2017. For the nine months ended March 31, 2018, the Company reported a net loss of $8,761,061 or $0.44 per share, compared to a net loss of $5,480,772, or $0.54 per share, for the nine months ended March 31, 2017.

The following represents selected financial information as of March 31, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis ("MD&A"), as filed.