On March 24, 2016 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will present three abstracts at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting based on pre-clinical research conducted with its lead anti-cancer product candidate, VAL-083 (dianhydrogalactitol), a "first-in-class" small-molecule chemotherapeutic agent (Press release, DelMar Pharmaceuticals, MAR 24, 2016, View Source [SID:1234509928]).

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The Company’s first two abstracts have been published and can be viewed on the AACR (Free AACR Whitepaper) Annual Meeting website.

DelMar will present abstract (#2157): "Enhanced in vitro activity of dianhydrogalactitol (VAL-083) in combination with platinum drugs: Impact of p53 and platinum-resistance," during the session entitled "New Drugs, Therapeutic Targets, and Treatment Approaches being held on Monday, April 18, 2016, from 1:00 p.m.-5:00 p.m. CDT. In this abstract, the Company will present new in vitro data in cell-lines representing difficult to treat subsets of non-small cell lung and ovarian cancer that may be targeted by VAL-083’s unique anti-cancer mechanism.

A second abstract (#2985): "Molecular mechanisms of dianhydrogalactitol (VAL-083) in cancer treatment," will be presented during the session entitled New Mechanisms of Anticancer Drug Action being held on Tuesday, April 19, 2016, from 8:00 a.m.-12:00 p.m. CDT. In this abstract, DelMar will present new data related to VAL-083’s mechanism of action, which may lead to opportunities to treat resistant cancer phenotypes and to beneficial combination therapy approaches in the treatment of cancer.

DelMar will also present an update on its ongoing "Phase I/II study of VAL-083 in patients with recurrent glioblastoma," as a late-breaking abstraction during the Phase II/III Clinical Trials in Progress session on Tuesday, April 19. Details of this abstract (#CT074) will be published during the session beginning at 8:00 a.m. CDT.

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas. DelMar recently announced that the FDA’s Office of Orphan Products had also granted an orphan designation to VAL-083 for the treatment of medulloblastoma.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar has been conducting a Phase I/II clinical trial in GBM patients whose tumors have progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggests a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083. Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar also reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

VAL-083 is well tolerated using a regimen of 40mg/m2 daily x 3 every 21 days. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed at doses above 40 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment.

Based on these data, DelMar initiated a Phase II expansion cohort utilizing the 40mg/m2 dosing regimen in June 2015 at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO). DelMar announced the completion of enrollment in a Phase II expansion cohort in September, 2015.

Further details can be found at View Source

On March 23, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and Memorial Sloan Kettering Cancer Center (MSK) reported the publication of new, seminal data validating FoundationOne Heme – the fully informative comprehensive genomic profiling assay for hematologic malignancies developed as part of their collaboration – further supporting its integration into oncology clinical practice (Press release, Foundation Medicine, MAR 23, 2016, View Source [SID:1234509929]). The data, available online as a first edition and soon to be published in an upcoming issue of the journal Blood, demonstrate that FoundationOne Heme has proven highly accurate in detecting the types of genomic alterations known to impact diagnosis, therapy selection and prognosis in hematologic cancers. Importantly, the publication demonstrates the molecular information gleaned from comprehensive genomic profiling can be utilized to accurately match patients with an appropriate therapeutic approach.

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"Foundation Medicine has an established track record of developing genomic profiling assays with the highest standards of analytical and clinical validation," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "Publication of our validation data in this highly regarded, peer-reviewed journal supports the clinical significance of the FoundationOne Heme assay, in particular, for its ability to identify specific therapeutic targets, to help refine underlying diagnosis, and to improve prognostic and risk stratification of hematologic cancers."

"The development of FoundationOne Heme represents a state-of-the-art genomics assay which can be used to profile patients with hematologic malignancies worldwide, which is a critical step in improving outcomes for all patients," stated Ross Levine, M.D., a physician-scientist and the Laurence Joseph Dineen chair in leukemia research at MSK. "Our team’s expertise in hematologic malignancies and in translating genomics to the clinic has allowed us to partner with Foundation Medicine to bring this innovative genomic test to the patients we treat."

Conventional diagnostic assays, including FISH and real-time PCR, are designed to identify a sub-set of genomic alterations, and in some cases, there are no assays that can reliably identify specific rearrangements. FoundationOne Heme, an integrated DNA/RNA platform using targeted hybrid-capture next-generation sequencing, is a proven and effective comprehensive genomic profile developed to detect all types of genomic alterations with therapeutic relevance, including single-nucleotide substitutions, insertions and deletions, copy number alterations and rearrangements, which are not fully evaluated using conventional diagnostic assays.

MSK and Foundation Medicine collaborated to develop FoundationOne Heme, which was commercially launched in 2013. The assay is performed using archived FFPE, blood or bone marrow samples with high accuracy in a clinically relevant timeframe in Foundation Medicine’s laboratory, which is certified by New York State and CLIA and is CAP accredited. FoundationOne Heme simultaneously detects all classes of genomic alterations in the DNA of 405 cancer-related genes and employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers. It is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.

Key Study Findings

Established analytic accuracy of detecting substitutions, insertions and deletions (indels) and copy number alterations (CNAs) by comparing the performance of the new assay with Foundation Medicine’s DNA-only assay that has previously undergone comprehensive validation across a large number of clinical samples. Compared to FoundationOne, FoundationOne Heme contains an additional 90 genes relevant to hematologic malignancies.

Samples that were previously profiled with a validated test in which 169 alterations were identified in 55 genes common to both assays. The concordance between the two sets of results was 99.4%.

Blinded comparisons were performed with CLIA-certified diagnostic assays, including Sequenom, RT-PCR, FISH and PCR fragment analysis, for 76 clinical specimens previously tested for 214 clinical relevant alterations in 11 genes that are known and routinely tested in clinical practice in AML, ALL and MDS.

Overall concordance was 99% (211/214).

In addition to the concordance analysis, genomic profiling of the 76 test samples identified 126 additional somatic alterations which are not covered by available hot spot assays in the given disease type, including clinically relevant genomic alterations in KRAS, TET2, EZH2, and DNMT3A.

In independent low frequency variants ( < 10% mutant allele frequency), 20 of 21 variants were confirmed from AmpliSeq assay and another hotspot clinical assay.

Combined DNA and RNA sequencing approach accurately detects a wide variety of genomic rearrangements and gene fusions with immediate clinical value in hematologic malignancies.

Sensitivity for fusion detection at 20% or greater tumor fraction was 100% (161/161) and 98% (84/86) at 10% tumor fraction.
Clinical experiences from 3,696 hematologic malignancies are summarized, with a high fraction of clinically relevant genomic alteration detected.

At least one driver alteration was identified in 95% tumor specimens, and 77% cases harbored at least one alteration linked to a commercially available targeted therapy or one that is in clinical development. In addition, 61% of cases harbored at least one alteration with known prognostic relevance in that tumor type.

Genomic rearrangements were detected from 37% of clinical hematologic malignancies; known and novel fusions in kinase drug targets are highlighted.

In 16 cases of high-risk, BCR-ABL-negative B-ALL malignancies, known and novel clinical relevant genomic alterations were detected by FoundationOne Heme, and gene fusions involving JAK2, CRLF2 and EPOR were detected in 9 of 16 cases.

On May 23, 2016 Arbor Pharmaceuticals, LLC (Arbor) and XenoPort, Inc. (XenoPort) (NASDAQ:XNPT) announced today that they have signed a definitive agreement under which Arbor will acquire XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million (Press release, Arbor Pharmaceuticals, MAR 23, 2016, View Source [SID1234523639]). The purchase price per share represents a 60 percent premium to the closing price of XenoPort shares on May 20, 2016.

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"We are pleased to be adding HORIZANT and the XenoPort pipeline to the growing portfolio of Arbor products," said Ed Schutter, President and Chief Executive Officer of Arbor. "We believe that XenoPort’s lead product HORIZANT offers patients and physicians a valuable treatment option for moderate-to-severe primary restless legs syndrome and postherpetic neuralgia. The XenoPort sales team has done an excellent job of growing HORIZANT, and we look forward to supporting them to continue this significant momentum."

Vincent J. Angotti, Chief Executive Officer of XenoPort, stated, "This transaction provides immediate and substantial value to our stockholders, and we believe that Arbor is well positioned to provide the proper resources for a more expanded commercialization effort of HORIZANT. We evaluated many potential options to maximize the value for stockholders and believe this transaction represents a great outcome for XenoPort stockholders."

Under the terms of the agreement, Arbor will commence a tender offer to purchase all of the outstanding shares of XenoPort for $7.03 per share. Following the closing of the tender offer, the agreement provides for the parties to effect, as promptly as practicable, a merger that would result in all shares not tendered in the tender offer being converted into the right to receive $7.03 per share in cash. The transaction, which has been unanimously approved by both the Arbor Board of Directors and the XenoPort Board of Directors, is expected to close in the third quarter of 2016.

Closing of the tender offer and merger is subject to certain customary conditions, including the tender of more than 50 percent of all outstanding shares of XenoPort. The transaction is also subject to review by the U.S. Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and other customary closing conditions.

Centerview Partners is serving as exclusive financial advisor to XenoPort, and Weil, Gotshal & Manges LLP is serving as legal advisor to XenoPort. Deutsche Bank has provided sole committed debt financing to Arbor in support of the transaction. Alston & Bird, LLP and Simpson, Thacher & Bartlett LLP acted as legal advisors to Arbor.

On March 23, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that the company will host a Research Reception at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Advaxis, MAR 23, 2016, View Source [SID:1234509834]). The Research Reception, for which registration is required, will be held at 6:30 PM CT on April 18, 2016 at the Sheraton New Orleans Hotel in New Orleans, Louisiana.

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The Advaxis Research Reception will feature two presentations:

Lm Immunotherapy: Impact within the Tumor Microenvironment
A review of the late-breaking poster presentation (Abstract #LB-095) on the immunogenicity of Advaxis’ lead immunotherapy candidate, axalimogene filolisbac, as preoperative treatment prior to robotic-assisted surgery in patients with HPV-associated head and neck cancer.
Rosemarie Krupar, MD, Baylor College of Medicine

Immunogenicity of ADXS-HER2 in Canine Osteosarcoma
Nicola Mason, PhD, BVetMed, Assistant Professor of Medicine, University of Pennsylvania

Effects of Advaxis’ Lm Immunotherapy on the STING Pathway
Robert Petit, PhD, Chief Scientific Officer, Advaxis

Cancer Neoepitope Immunotherapy: An Update on ADXS-NEO
Robert Petit, PhD, Chief Scientific Officer, Advaxis

Attendees will also have the opportunity to view the late breaking Phase 2 poster featured at AACR (Free AACR Whitepaper) and ask questions of the lead author. Space is limited and registration, which is required, can be completed online at: www.regonline.com/advaxisreception2016.

On March 23, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported results for the fourth quarter and year ended December 31, 2015 (Press release, Navidea Biopharmaceuticals, MAR 23, 2016, View Source;p=RssLanding&cat=news&id=2150371 [SID:1234509838]). Navidea reported total revenue for 2015 of $13.2 million including Lymphoseek (technetium Tc 99m tilmanocept) injection sales revenue of $10.3 million compared to total revenue of $6.3 million for 2014, which included Lymphoseek sales revenue of $4.2 million.

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"2015 was marked by a strong turnaround in our commercial business, more than doubling total brand sales to approximately $20 million and recognizing revenue to Navidea of more than $10 million, meeting guidance for the first time under the leadership of our new management team," said Rick Gonzalez, Navidea President and Chief Executive Officer. "Importantly, we have advanced several innovative programs in our pipeline and have begun clinical testing for new large market opportunities, leveraging our Manocept immune-cell targeting platform. These achievements were accomplished while managing our operations within very restrictive capital constraints. Looking forward to 2016, we will continue our efforts to aggressively streamline operations and manage expenses while working towards our goals of doubling sales for the second year in a row, achieving operational cash flow break-even, and advancing our development pipeline, which is essential to sustaining our long-term growth."

Financial Results

Revenues for the year ended December 31, 2015 were $13.2 million compared to $6.3 million for 2014. Navidea’s revenues for 2015 consisted of $10.3 million in sales of Lymphoseek, $1.1 million related to licensing milestones and $1.9 million from various federal grants and other revenue, compared to $4.2 million, $300,000 and $1.7 million, respectively, for 2014. The Company also recorded $1.2 million related to royalties on the gamma detection device business we sold in 2011 (which is reported net of tax as income from discontinued operations).

Operating expenses for the year ended December 31, 2015 were $30.0 million compared to $32.3 million for 2014. Research and development expenses were $12.8 million during 2015 compared to $16.8 million during 2014. The net decrease from 2014 to 2015 was primarily a result of reductions in NAV4694 and NAV5001 product development costs coupled with reduced headcount and related support costs, offset by increased Lymphoseek EU-related manufacturing and regulatory activities, support for our therapeutics initiatives, and Manocept diagnostic product development costs. Selling, general and administrative expenses were $17.3 million for 2015 compared to $15.5 million for 2014. The net increase is due to increased costs related to the establishment and operation of our internal sales team coupled with one-time costs related to the first quarter 2015 reduction in force and increased professional services, license fees related to Lymphoseek, and other support costs which were partially offset by decreased launch-related marketing costs.

Navidea’s loss from operations for the year ended December 31, 2015 was $18.6 million compared to $27.6 million for the same period in 2014. For the year ended December 31, 2015, Navidea reported a loss attributable to common stockholders of $27.6 million, or $0.18 per share, compared to a loss attributable to common stockholders of $35.7 million, or $0.24 per share, for the same period in 2014.

Fourth Quarter Financial Results: Revenues for the fourth quarter of 2015 were $4.3 million compared to $2.2 million for the same period in 2014 representing an increase of 95% period over period. Navidea’s revenues for the fourth quarter of 2015 consisted of $3.5 million in sales of Lymphoseek, $250,000 related to licensing milestones and $541,000 from various federal grants and other revenue, compared to $1.5 million, $0 and $738,000, respectively, for the same period in 2014.

Fourth quarter 2015 operating expenses were $6.4 million compared to $6.4 million for the fourth quarter of 2014. Research and development expenses were $2.6 million during the fourth quarter of 2015 compared to $2.3 million during fourth quarter of 2014. The net increase from 2014 to 2015 was primarily a result of increased Lymphoseek EU-related manufacturing and regulatory activities and therapeutics product development costs, offset by decreased NAV4694 product development costs coupled with reduced headcount and related support costs. Selling, general and administrative expenses were $3.8 million for the fourth quarter of 2015 compared to $4.1 million for the same period in 2014 for reasons consistent with the annual variances discussed above.

Navidea’s loss from operations for the fourth quarter of 2015 was $2.6 million compared to $4.5 million for the fourth quarter of 2014. For the fourth quarter of 2015, Navidea reported a loss attributable to common stockholders of $2.5 million, or $0.02 per share, compared to a loss attributable to common stockholders of $6.9 million, or $0.05 per share, for the fourth quarter of 2014.

"Over the last year and a half, we have made dramatic progress streamlining operations and cutting expenses. Based on our current projections and plans, we expect total operating expenses for 2016 to be roughly 25% lower than 2015 levels, while moving Lymphoseek forward commercially and continuing the development of our Manocept platform," said Brent Larson, Chief Financial Officer. "These measures, coupled with growing revenue, continue to bring us closer to our goal of cash flow break-even in the second half of 2016, which will further support the long term sustainability of the business. In addition, the recently reaffirmed Platinum line of credit will also provide flexibility in the near-term to ensure we have ample capital to support interim needs, but we expect the draws will not exceed $5 million during 2016, leaving us over $20 million of available credit in reserve."

2016 Financial Guidance

Navidea expects Total Revenues for 2016 to range from $23 million to $25 million including Lymphoseek product sales revenue, license revenue, grant and other revenue.

Navidea expects its 2016 total operating expenses, excluding costs related to its Macrophage Therapeutics subsidiary, to be in the range of $21.5 million to $23.5 million.
Milestones & Highlights

Select milestones and highlights that the Company achieved in 2015 and year to date in 2016 include:

Achieved 2015 Lymphoseek revenue guidance with $10.3 million in sales to NAVB, more than doubling year-over-year revenue;

Reduced total operating expenses and, in combination with record total revenues of $13.2 million, reduced the overall corporate cash burn by 35% over the prior year;

Recorded income from discontinued operations related to royalty payments from the Neoprobe/Devicor GDS business of $1.2 million;

Received notice of award for $3.8 million in non-dilutive NIH grants to advance Lymphoseek pipeline expansion programs through Phase 1/2;

Advanced our immunodiagnostics development pipeline, initially into rheumatoid arthritis, addressing a far greater number of patients than our current Lymphoseek label;

Reported investigator initiated clinical study results demonstrating that Lymphoseek reduces sentinel lymph node biopsy imaging time, facilitates patient throughput and workflow efficiencies and enhanced patient experience;

Presented promising data demonstrating that a Manocept-doxorubicin immunotherapeutic conjugate induced apoptosis in Kaposi’s Sarcoma and tumor associated macrophages;

Initiated patient enrollment in Lymphoseek expansion trials for pediatric cancer and cervical cancer;

Published 4 articles in noteworthy medical journals and presented data on Lymphoseek and Manocept compounds at 13 scientific and medical meetings; and,

Strengthened the Board of Directors by appointing two new shareholder-nominated candidates, Dr. Mark Greene and Dr. Anthony Fiorino.