On November 13, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer reported that data from NLG2101, a global randomized Phase 2 trial testing indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast cancer, will be presented at the San Antonio Breast Cancer Symposium being held December 8-12, 2015 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, NewLink Genetics, NOV 13, 2015, View Source [SID:1234508239]).

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Details for the presentation follow:

Abstract Title: A phase 2 randomized trial of the IDO pathway inhibitor indoximod in combination with taxane based chemotherapy for metastatic breast cancer: preliminary data
Abstract Number: P2-11-09
Time: 7:30-9:00 a.m.
Date: Thursday, December 10
Location: Halls A-B
Session Title: Treatment: Immunotherapy (Clinical)
Session Type: Poster

On November 13, 2015 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported financial results for the quarter ended September 30, 2015 and provided business highlights (Press release, Cellular Biomedicine Group, NOV 13, 2015, View Source [SID:1234508232]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dr. William Wei Cao, Chief Executive Officer, commented, "We achieved pivotal milestones in the third quarter that redefined CBMG’s business and strategically positioned the Company as an emerging, bifurcated and world-class immuno-oncology and cell therapy contender with international aspirations through the advancement of key infrastructure and clinical milestones. We are encouraged by the positive clinical development of our therapeutic platforms in the third quarter. The Chinese PLA General Hospital ("PLAGH") CAR-T Phase I clinical trial for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors in Non-Small Cell Lung Cancer ("NSCLC") and cholangiocarcinoma, and the Phase IIa CD20 Non-Hodgkin’s Lymphoma ("NHL") clinical trial have inspired us to accelerate their development to treat these terminal conditions. We are planning to launch multi-site CAR-T and Dendristim vaccine (previously called GVax) clinical trials in China and are evaluating options to further develop this prospective treatment in the U.S. In addition, we continued to strengthen our scientific team with the appointments of Alan List, M.D., as Chair of the Scientific Advisory Board and Yihong Yao, Ph.D., as Chief Scientific Officer."

"In terms of infrastructure, in addition to our Shanghai and Wuxi sites, we opened a new GMP facility in Beijing, and now operate three GMP facilities in China housing nine independent production lines to address increasing manufacturing demands."

"We believe we are one of the few emerging and versatile biotech companies with a growing revenue-generating T cell technical service. We have proven our ability to make acquisitions and expand globally recognized therapies addressing large and critical markets. We believe we are in an enviable position for the future in carrying out our mission to deliver evolutionary science and serving large patient populations," concluded Dr. William Wei Cao, Chief Executive Officer of Cellular Biomedicine Group.

Third Quarter 2015 Financial Performance

Cash Position: Cash and cash equivalents as of September 30, 2015 were $20.1 million compared to $14.8 million as of December 31, 2014

Net Cash Used in Operating Activities: Net cash used in operating activities for the third quarter of 2015 was $2.9 million, compared to $3.4 million for the same period in 2014

Revenue: Revenues in the third quarter of 2015 were $0.6 million compared to nil for the same period in 2014. All of the revenue has resulted from our acquisition of Agreen Biotech Ltd. that provides T cell technical services, and we are continuing to expand our network of hospitals to grow our revenue.

G&A Expenses: General and administrative expenses for the third quarter of 2015 were $3.5 million compared to $1.9 million for the same period in 2014. Increased expenses in 2015 were primarily attributed to the hiring of senior technical leaders, expanded GMP facility expenses, and amortization of the IP expenses associated with previous acquisitions.

R&D Expenses: Research and development expenses for the third quarter of 2015 were $2.2 million, compared to $0.8 million for the same period in 2014. Approximately two thirds of the increase resulted from the addition of scientific talent to our immunotherapy research and development team, while the remaining increase stems from increased clinical trial expenditures in CAR-T, Tcm, and automated production techniques.

Net Loss: Net loss allocable to common stock holders was $5.1 million, compared to $2.8 million for the same period in 2014. Changes in net loss are primarily attributable to an increase in share-based compensation and clinical trial expenses.

During and since the third quarter of 2015, Cellular Biomedicine Group achieved the following milestones and significant events:

Business Highlights

Appointed Alan List, M.D. as Chair of the Scientific Advisory Board
Appointed former MedImmune/AstraZeneca Director, Yihong Yao, Ph.D., B.S., as Chief Scientific Officer
Opened new GMP facility in Beijing
Evaluating options for U.S. clinical trials on NSCLC and Dendristim vaccine immune-cell therapy

Technology Achievements

Received two new certifications from the China Food and Drug Administration (the "CFDA") for its proprietary cell and tissue preservation media kits respectively, in accordance with the CFDA’s new regulations announced on June 1, 2015
Expanded our intellectual property portfolio from 70 to 77 patents in various stages of approval
Announced preliminary Phase I clinical results of CAR-T EGFR-HER1 ("CBM-EGFR.1") for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors, with overall disease control rate (DCR) of 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)
Upcoming Public Events

Management is scheduled to participate in the following upcoming industry and investor conferences:

November 18-19, Jefferies 2015 Global Healthcare Conference, London, UK
December 1-2, Piper Jaffray Annual Healthcare Conference, New York, NY

On November 13, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported data on the promising potential of VAL-083 (dianhydrogalactitol) as a solution for major unmet needs in the treatment of a variety of cancers (Press release, DelMar Pharmaceuticals, NOV 13, 2015, View Source [SID:1234508231]).

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"Poor outcomes due to drug-resistance remain a significant unmet clinical challenge for many cancer patients. New agents are needed to address treatment-resistant cancers," stated Jeffrey Bacha, DelMar’s president and CEO. "Historical clinical data from the U.S. National Cancer Institute (NCI), along with our own preclinical and clinical trial data, all support the activity of VAL-083 against a range of tumor types via a novel mechanism of action that we believe could provide improved treatment options for patients."

DelMar’s presentation summarizes the Company’s data on the promising potential of VAL-083 across a range of indications. A poster entitled, "The unique mechanism of action of dianhydrogalactitol (VAL-083) may provide a new treatment option for chemo-resistant cancers," was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) New Horizons in Cancer Research Conference: Bringing Cancer Discoveries to Patients in Shanghai, China.

DelMar’s presentation highlights the Company’s recent research supporting the importance of VAL-083 as a chemotherapeutic agent in the treatment of cancer where resistance to alkylation-based chemotherapy remains an unmet medical need in the modern treatment of cancer and is summarized in the poster presentation as follows:

VAL-083 activity is independent of O6-methylguanine-DNA methyltransferase (MGMT) expression and overcomes temozolomide (TMZ)-resistance in GBM cell lines;

VAL-083 overcomes cisplatin-resistance in ovarian cancer and NSCLC cell lines;

VAL-083 overcomes tyrosine kinase inhibitor (TKI)-resistance in non-small cell lung cancer (NSCLC) cell lines, including H1975 with T790M mutation in EGFR;

VAL-083 displays synergy and super-additivity with both cisplatin and oxaliplatin in NSCLC cell lines, including TKI-resistant cells in vitro and in vivo;

VAL-083 activity is independent of p53 status than in comparison to platinum-based chemotherapy; and
VAL-083 is active against pediatric brain tumors in vitro including high grade gliomas (HGG), GBM cancer stem cells and p53 mutated SHH medulloblastoma.

"The data presented today support expanded clinical use of VAL-083 under its current lung-cancer approval in China and also serve as the basis for global development of VAL-083 in important cancer indications such as GBM, NSCLC and ovarian cancer," added Mr. Bacha. "These data represent important steps toward realizing our vision of leveraging historical clinical data with new research into the mechanism of VAL-083 to address modern unmet medical needs in the treatment of cancer."

The poster on VAL-083’s promise as new treatment option for chemo-resistant cancers may be found on DelMar’s website under View Source

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 a bifunctional alkylating agent which primarily mediates cytotoxic guanine interstrand N7 DNA cross-links, separating it from other widely used DNA alkylating chemotherapeutics such as temozolomide (TMZ), nitrosoureas and platinum-based agents. Additionally, VAL-083 readily crosses the blood-brain barrier and has been demonstrated to accumulate preferentially in tumor tissue. 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 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 recently completed enrollment in Phase II clinical studies with VAL-083 for refractory glioblastoma multiforme (GBM) in the United States. Patients have been enrolled 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).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

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 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.

On November 13, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in the use of T-cell therapy to treat cancer, reported financial results for the first quarter, which ended September 30, 2015 (Press release, Adaptimmune, NOV 13, 2015, View Source [SID:1234508229]).

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"The first quarter of our fiscal year was one of great progress for Adaptimmune as we made good headway toward our goal of delivering important T-cell therapy products to patients suffering from solid and hematologic cancers," commented James Noble, Adaptimmune’s Chief Executive Officer. "We continued the disciplined execution of our clinical programs, and are close to initiating studies with our affinity enhanced T-cell therapies targeting MAGE-A10 and NY-ESO in patients with non-small cell lung cancer, the most common and deadly form of lung cancer. Beyond NY-ESO and MAGE-A10, we have a deep and robust pipeline. The next of Adaptimmune’s affinity enhanced T-cell therapies to enter clinical studies will target alpha-fetoprotein (AFP) in patients with hepatocellular cancer. We recently received important news that the NIH’s Recombinant DNA Advisory Committee (RAC) had completed its review of our AFP protocol, and we anticipate filing our Investigational New Drug application (IND) in the first half of
2016. We expect to file multiple new INDs each year from 2017 onwards."

Mr. Noble continued, "We have also presented important new data on our clinical candidates at the 2015 SITC (Free SITC Whitepaper) conference, including an update to our NY-ESO synovial sarcoma data. In the primary efficacy analysis, the data show an overall response rate (ORR) of 50 percent in patients with metastatic or relapsed inoperable synovial sarcoma. Additionally, the response rate was 60 percent in patients receiving the target dose of cells, 90 percent of whom are still alive. These data are compelling, and we have already started two further cohorts with the aim of accelerating this program toward pivotal studies."

Recent Corporate and Clinical Highlights:

 Received protocol approval by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) for Adaptimmune’s next affinity enhanced T-cell therapy targeting AFP; the Company intends to file an
IND in hepatocellular cancer in the first half of 2016;

 Presented encouraging new data from trial of NY-ESO affinity enhanced T-cell therapy in patients with synovial sarcoma. In the primary efficacy analysis, 50 percent of patients receiving Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO responded and 75 percent remain alive and on long term-follow up. For patients receiving the target dose of cells, 60 percent of patients responded, and 90 percent remain alive and on long term-follow up;

 Expanded trial of NY-ESO affinity enhanced T-cell therapy in patients with synovial sarcoma to include two additional cohorts, and received two GSK milestone payments during the quarter, totaling £5 million.

 Accelerated site initiation efforts to achieve trial initiation of affinity enhanced T-cell therapies targeting MAGE-A10 and the NY-ESO-1 cancer antigen in patients with NSCLC shortly; and

 Broke ground on construction in Philadelphia, PA for new fully integrated laboratory and CMC / manufacturing facility, and in Oxfordshire, U.K. for new research and development facility.

First Quarter 2015-16 Financial Results

 Cash / liquidity position: As of September 30, 2015, Adaptimmune had $271.2 million (£179.4 million) in cash, cash equivalents, and short-term deposits, compared to £180.8 million as of June 30, 2015. This consists of $216.5 million (£143.2 million) of cash and cash equivalents and $54.7 million (£36.2 million) of short-term deposits. We also have $3.0 million (£2.0 million) of restricted cash providing security for letters of credit in respect of lease agreements entered into in September 2015.

 Cash burn: The net decrease in cash and cash equivalents before unrealized foreign exchange was $10.1 million (£6.7 million). Net operating cash outflows were $0.3 million (£0.2 million) after including $7.6 million (£5 million) of milestone payments received under our GSK Collaboration and License Agreement and $1.8 million (£1.2 million) in U.K. research and development tax credits.

 Revenue: For the quarter ended September 30, 2015, revenue was $3.9 million (£2.6 million) compared to $1.4 million (£0.9 million) for the same quarter of 2014. The increase in 2015 was primarily due to an increase in the services provided under our GSK Collaboration and License Agreement.

 Research and development (R&D) expense: Research and development expenses were $9.9 million (£6.5 million) for the quarter ended September 30, 2015 compared to $3.6 million (£2.4 million) for the same quarter of 2014, primarily due to increased period-over-period costs associated with ongoing NY-ESO-1 TCR clinical trials, preparation for NSCLC studies with the Company’s NY-ESO-1 and MAGE-A10 T-cell therapies, evaluation and validation of additional targets including AFP, personnel expenses including non-cash stockbased compensation for an increased number of employees engaged in research and development, and costs related to the Company’s growing operations.

 General and administrative (G&A) expense: General and administrative expenses were $4.9 million (£3.2 million) for the quarter ended September 30, 2015 compared to $1.7 million (£1.1 million) for the same quarter of 2014. The increase is primarily due to increased personnel costs, including non-cash stock-based compensation, increased property costs and other costs associated with being a public company.

 Net loss: Net loss attributable to common stockholders was $1.4 million (£0.9 million). This equates to (0.3)cents or (0.2)p per ordinary share, or (1.9)cents or (1.3)p per American Depositary Share, for the quarter ended September 30, 2015. This loss is stated after recognizing $8.2 million (£5.4 million) of finance income, which primarily represents unrealized foreign exchange gains.

Financial Guidance

Adaptimmune is reiterating its cash burn guidance. For the six months ending December 31, 2015, the Company expects its cash burn to be between $20 and $30 million, excluding cash burn associated with new business development activities. For the full year 2016, the Company expects its cash burn to be between $80 and $100 million, excluding cash burn associated with new business development activities, and expects its liquidity position at December 31, 2016, including cash, cash equivalents, and short term deposits, to be at least $150 million. The mix of cash and cash equivalents and short-term deposits is not provided as guidance.

Adaptimmune is transitioning from a June 30 fiscal year end to a December 31 fiscal year end to align more closely with sector comparators, and will be changing its accounting standard from International Financial Reporting Standards (IFRS) to U.S. Generally Accepted Accounting Principles (GAAP) starting in January 2016.