On November 15, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced today it will present first-in-human data from its Phase 1 clinical trials of anti-RSPO3 (OMP-131R10) and anti-DLL4/VEGF bispecific antibody (OMP-305B83) at the upcoming 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held November 28 — December 2, 2016 in Munich, Germany. Abstracts for the presentations have been posted to www.ecco-org.eu/ENA.

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Data will be presented on Tuesday, November 29, 2016:

Poster #P039; Abstract #68: Initial results from a Phase 1a/b study of OMP-131R10, a first-in-class anti-RSPO3 antibody, in advanced solid tumors and previously treated metastatic colorectal cancer (CRC)
Session: Molecular targeted agents I
Presenting author: Johanna Bendell, M.D., Sarah Cannon Research Institute

Poster #P057; Abstract #87: A first-in-man Phase 1a study of the bispecific anti-DLL4/anti-VEGF antibody OMP-305B83 in patients with previously treated solid tumors
Session: Molecular targeted agents I
Presenting author: Kathleen Moore, M.D., University of Oklahoma Stephenson Cancer Center

The posters will be available on OncoMed’s website following the presentation at www.oncomed.com.

About Anti-RSPO3
OncoMed is currently enrolling patients in an ongoing Phase 1a/b clinical trial of anti-RSPO3 that was started in July 2015. The Phase 1a/b trial initially enrolled patients with advanced refractory solid tumors and includes an expansion arm for biomarker-selected patients to receive single-agent therapy. The Phase 1b portion, which began enrollment in January 2016, is testing anti-RSPO3 with FOLFIRI in patients with second-line metastatic colorectal cancer. Anti-RSPO3 is believed to be the first drug candidate in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

About Anti-DLL4/VEGF
OncoMed initiated a single-agent study of its anti-DLL4/VEGF bispecific in January 2015 in patients with advanced refractory solid tumors. Dose escalation is completed in the Phase 1a trial and enrollment in an expansion cohort is ongoing. The anti-DLL4/VEGF bispecific antibody is designed to combine the anti-cancer stem cell, dysangiogenic and immunotherapy mechanisms of anti-DLL4 with the anti-angiogenic activity of an anti-VEGF agent. The bispecific antibody was discovered using OncoMed’s proprietary MAbTrap antibody display technology, which enables the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity. The antibody is the first program based on OncoMed’s BiMAb bispecific platform technology to enter clinical testing.

On November 14, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three and nine months ended September 30, 2016

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CASI PHARMACEUTICALS REPORTS THIRD QUARTER 2016 FINANCIAL RESULTS.

As of September 30, 2016, CASI had cash and cash equivalents of approximately $24.1 million.

CASI reported a net loss for the third quarter of 2016 of ($1.7 million), or ($0.03) per share. This compares with a net loss of ($1.6 million), or ($0.05) per share, for the same period last year. For the first nine months of 2016, the reported net loss was ($6.8 million), or ($0.15) per share as compared to ($5.5 million), or ($0.17) per share for the first nine months of 2015.

Commenting on these results, Sara B. Capitelli, CASI’s Vice President, Finance, said, "Our third quarter 2016 financial results were in line with expectations. Research and development expenses increased during the 2016 period compared with the previous year primarily due to costs associated with our ENMD-2076 fibrolamellar carcinoma trial which began in late 2015. As we continue to execute our regulatory, clinical and business development plan, we expect operating expenses to increase for the remainder of 2016."

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "I am pleased with our third quarter financial results. In October, we completed the last closing ($7.8 million) of our previously announced financing, and also completed an additional $3.0 million financing. Participants in the financing included our existing shareholders represented on our Board of Directors. In addition to a positive financial outlook, we look forward to further advancing our proprietary clinical candidate ENMD-2076, as well as MARQIBO, ZEVALIN and EVOMELA in China, and securing additional in-license assets to expand our pipeline. Proceeds from the recent financings will help accelerate these activities."

On November 14, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the third quarter ended September 30, 2016 (Press release, Cyclacel, NOV 14, 2016, View Source [SID1234516611]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.

"SEAMLESS, a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have been conducting data validation operations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the fourth quarter of 2016 or in early 2017."

"The collection and processing of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population. We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP, Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study."

"During the quarter data presented at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer. MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors," continued Mr. Rombotis.

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
DNA damage response program

The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The sixth dose escalation level has been reached.

Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
KEY UPCOMING MILESTONES

SEAMLESS study

Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Initiate Phase 1 part 3, to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS)

Plan Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
THIRD QUARTER 2016 FINANCIAL RESULTS

Cash and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately $5.2 million was raised from the sale of common stock through the Company’s at-the-market facility with FBR Capital Markets. A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September 30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through the second quarter of 2018.

Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.

General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.

On November 14, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending September 30, 2016, the first quarter of the Company’s 2017 fiscal year (Press release, DelMar Pharmaceuticals, NOV 14, 2016, View Source [SID1234516612]). DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 15, 2016 at 4:30 pm EST.

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"Looking back, 2016 has been a transformational year for our Company," stated Jeffrey Bacha, DelMar’s Chairman and chief executive officer. Our goals this year included listing our company’s shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications."

RECENT CORPORATE HIGHLIGHTS

DelMar raised gross proceeds of approximately $7.2 million in a private placement and our common stock began trading on the Nasdaq Capital Markets under the symbol "DMPI";
DelMar confirmed that the Institutional Review Board ("IRB") at the University of Texas MD Anderson Cancer Center ("MD Anderson") approved our planned Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression;
DelMar reported promising data from our Phase I/II clinical trial of VAL-083 in refractory GBM at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting; supporting the potential for an improved survival benefit for bevacizumab-failed GBM patients treated with VAL-083 in comparison to current salvage chemotherapy;
DelMar announced the successful completion of an ‘End of Phase II’ meeting with the FDA and confirmed plans to advance VAL-083 into a pivotal Phase III clinical trial for GBM patients whose tumors have progressed following treatment with bevacizumab;
DelMar entered into a collaborative research agreement with Accurexa, Inc. to explore local delivery of VAL-083 as a potential combination therapy for the treatment of brain tumors;
DelMar continued to report promising research results supporting the potential of VAL-083 in new indications:
Presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers, including data suggesting the potential for treatment synergy of VAL-083 combined with Astra Zeneca’s PARP inhibitor, Lynparza (olaparib), at the 11th Biennial Ovarian Cancer Research Symposium;
Presented new research results demonstrating that VAL-083 exhibits a distinct mode of action compared to other chemotherapies used in the treatment of newly diagnosed GBM patients at the European Association of Neuro-Oncology annual meeting;
Presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer in comparison to platinum and tyrosine kinase inhibitor treatments at the AACR (Free AACR Whitepaper) New Horizons in Cancer Research meeting;
Presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR (Free AACR Whitepaper) – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
DelMar continued to strengthen its intellectual property portfolio. DelMar now holds six issued US patents and seven issued patents outside of the US representing thirteen patent families in various stages of prosecution, and over 100 patent filings in total.
"We were very pleased with the outcome of our End-of-Phase II meeting and the guidance provided by the FDA," said Mr. Bacha. "The DelMar clinical team and our advisors have been developing a Phase III study protocol that would provide strong statistical power, enroll fewer than 200 patients, and is designed to reach its final endpoint in two years or less. We plan to submit the protocol to the FDA in the coming weeks, and subject to the FDA’s continued guidance and availability of funding, anticipate initiating a registration-directed Phase III study as soon as practicable."

DelMar is also pleased to confirm the accomplishment of critical steps toward initiating new clinical trials designed to position VAL-083 as an alternative to temozolomide in newly diagnosed GBM for patients whose tumors exhibit a high expression of MGMT, the DNA repair enzyme linked to failure of standard front-line chemotherapy and poor patient outcomes:

The MD Anderson IRB has approved the protocol of the Company’s planned Phase II Study of VAL-083 in patients with MGMT-unmethylated, bevacizumab-naive recurrent glioblastoma. DelMar anticipates completing study initiation activities and commencing the dosing of patients in the coming weeks.
The Company is also completing the final remaining steps required for initiation of an international clinical trial in newly diagnosed GBM patients with high expression of MGMT.
"Importantly, these two new Phase II trials are largely supported through our collaborators, so their initiation will not materially impact our near-term cash expenditures," stated Mr. Bacha. "Our current working capital will support DelMar’s operations for at least the next twelve months and, while our planned Phase III clinical trial will require additional financing, we have the opportunity to expand our clinical research efforts in GBM and to continue advancing our research into new indications without an immediate need to raise additional funds."

EXPECTED NEAR-TERM MILESTONES

Commence treating patients at MD Anderson with VAL-083 in a Phase II clinical study of GBM patients with high expression of MGMT at first recurrence/progression;
Submit a Phase III protocol to the FDA proposing a pivotal, multi-center, randomized clinical trial of VAL-083 in GBM patients who have failed both standard chemo-radiation and bevacizumab;
Initiate a Phase II clinical trial in China in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
Expand DelMar’s clinical research with VAL-083 in new solid tumor indications, subject to financial resources;
Present our research results at international peer-reviewed scientific meetings;
Continue to pursue pre-clinical research that further differentiates VAL-083 from established chemotherapeutic regimens, and to identify opportunities for combination therapy;
Maximize the value of the VAL-083 pipeline through collaborations with industry leaders in attractive oncology markets; and
Continue to build our intellectual property portfolio.

On November 11, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported new data for its preclinical CGEN-15029 program demonstrating the potential for the development of new cancer immunotherapy treatments for solid tumors, including the potential for drug combination with current immune checkpoint blockers (Filing, 6-K, Compugen, NOV 14, 2016, View Source [SID1234516652]). CGEN-15029 is the internal designation for PVRIG, a novel immune checkpoint identified by Compugen utilizing its in silico predictive discovery infrastructure. The Company plans to file an IND in 2017 for COM701, its lead antibody targeting PVRIG.

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Today’s presentation, titled "Computational identification, functional characterization and antibody blockade of a new immune checkpoint in the TIGIT family of interacting molecules" was made by John Hunter, Ph.D., Site Head and Vice President, Antibody R&D, Compugen USA, Inc. The presentation included the discovery by Compugen of PVRIG and its expression pattern in the context of cancer, demonstrating that PVRIG is expressed in infiltrating immune cells in solid tumors, specifically on cells with potent anti-tumor activity, such as effector T-cells and natural killer cells. Also disclosed was the identification of PVRL2 as PVRIG’s ligand, and the functional characterization and anti-tumor in vitro and in vivo efficacy of blocking antibodies developed by Compugen targeting the interaction of PVRIG with PVRL2. Binding of PVRIG to PVRL2 is of particular therapeutic interest, as it links PVRIG to the axis of a second immune checkpoint, TIGIT, which is recently gaining traction in the field of immuno-oncology.

In his presentation, Dr. Hunter presented additional data demonstrating that antibodies developed by Compugen, which block the interaction between PVRIG and PVRL2, enhance activation of the immune system by activating both primary CD4+ T-cells and tumor-derived CD8+ T-cells.

Consistent with the placement of PVRIG in the TIGIT axis, antibody blockade of both TIGIT and PVRIG had an additive effect on human T-cell stimulation, indicating the potential of the two to generate enhanced immune response against the cancer. Moreover, antibodies targeting the mouse PVRIG developed by the Company were assessed in vivo for effects on tumor growth inhibition in mouse models, commonly used to study immune checkpoint inhibitors. In these studies, antibodies that block the mouse PVRIG/PVRL2 interaction, similar to those generated against the human target, were shown to inhibit tumor growth when used in combination with PD1 pathway blockade. These results were further reinforced when tumor growth was tested in knock-out (KO) mice. Tumor growth was significantly reduced in KO mice, where the PVRIG gene was removed. Consistent with the antibody combination data, this effect was even further enhanced in the KO mice when they were treated with anti-PDL1 blocking antibodies.

Collectively, the experimental data strongly suggest that PVRIG, which was initially predicted computationally by the Company to serve as a novel immune checkpoint target, presents a new opportunity for the development of cancer immunotherapy treatments, including the potential for drug combination with current immune checkpoint blockers.

In June 2016, the Company selected COM701, a high affinity antagonist antibody against PVRIG, as the lead therapeutic candidate for the program. COM701, which is currently in preclinical development by the Company, demonstrates potent and reproducible enhancement of T-cell activation, consistent with the desired mechanism-of-action required to generate anti-tumor immune responses.

Anat Cohen-Dayag, Ph.D., CEO and President of Compugen, explained, "While antibody blockade of the CTLA4 and PD1 pathways has emerged as an effective treatment modality for certain types of cancer, the majority of patients do not derive long-term benefits, suggesting a need for additional approaches such as new immune checkpoints targeting new pathways and providing new mechanisms to activate the immune response against the tumor. Employing our unique predictive infrastructure to define new immune checkpoint targets, we identified PVRIG, among other novel immune checkpoint target candidates in our target pipeline."

Dr. Cohen-Dayag continued, "We are very pleased to see the rapidly increasing amount of preclinical data demonstrating the potential utility of COM701, an antibody targeting PVRIG, as a new cancer immunotherapy treatment. These results highlight, once more, the power and uniqueness of our computational predictive approach – from computer prediction of novel drug targets to preclinical validation. This capability, along with our significantly enhanced development infrastructure, allows us now to pursue and advance a number of novel immuno-oncology programs with potentially different mechanisms-of-action, thus providing us with a diversified early-stage internal target pipeline, in addition to the two programs that are the subject of an ongoing pharma collaboration."

About PVRIG
PVRIG (designated internally as CGEN-15029) is one of the novel B7/CD28-like immune checkpoint target candidates discovered by Compugen utilizing its predictive discovery infrastructure. The CGEN-15029 target was predicted in silico and experimentally confirmed to be a receptor-like immune checkpoint protein expressed on immune cells. In June 2016, COM701, a high affinity antagonist antibody against CGEN-15029, was selected as the lead therapeutic candidate for the program.