On March 17, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, reported that the academic group of Prof. Gunnar Kvalheim at the Department of Cellular Therapy at the Oslo University Hospital, Norway, will present preliminary clinical phase I/II data on dendritic cell (DC) vaccines for the treatment of prostate cancer utilising Medigene’s DC vaccine technology at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, LA, USA from 16 – 20 April 2016 (Press release, MediGene, MAR 17, 2016, View Source [SID:1234509841]).

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The poster entitled "Clinical results of a Phase I/II trial of adjuvant therapeutic vaccination in high risk resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and survivin" will be presented during the poster session on Adoptive Cell Therapy, Immune Checkpoints, and Vaccines on Monday, 18 April, providing data from an ongoing investigator-initiated trial (IIT) conducted at the Oslo University Hospital.

More detailed information can be found in the abstract under the following link: View Source;sKey=ac456e79-efd5-416e-a7de-67382c67723a&cKey=2ab5cd11-b3d8-40a8-8087-b0c57f2e8034&mKey=1d10d749-4b6a-4ab3-bcd4-f80fb1922267

Presentation Time: Monday, April 18, 2016, 1:00 PM – 5:00 PM
Location: Section 21
Poster Board Number: 27

The Oslo University Hospital has an agreement with Medigene for use of Medigene`s new generation DC vaccines for their ongoing academic clinical studies.

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. Currently, Medigene evaluates its DC vaccines in a company-sponsored phase I/II clinical trial in acute myeloid leukaemia (AML). Further studies utilising Medigene’s DC vaccine technology include two ongoing clinical investigator-initiated trials (IITs): a clinical phase I/II trial for treating acute myeloid leukaemia (AML) at Ludwig Maximilians University Hospital Grosshadern, Munich, and a clinical phase II trial of a treatment for prostate cancer at Oslo University Hospital. Moreover, compassionate use patients are treated with DC vaccines at the Department of Cellular Therapy at Oslo University Hospital.

Dendritic cells (DCs) are the most potent antigen presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognise and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumour cells. The team of Medigene Immunotherapies GmbH’s scientists has developed new, fast and efficient methods for generating dendritic cells ex-vivo, which have relevant characteristics to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumour-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.

Further audio-visual education about Medigene’s DC-Vaccines at:
View Source

On March 17, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will present data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting next month in New Orleans, Louisiana (Press release, Dynavax Technologies, MAR 17, 2016, View Source [SID:1234509605]). The details for the poster presentations are as follows:

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Date and Time: Monday, April 18, 2016, 1:00 p.m. – 5:00 p.m. EDT

Abstract Title: SD-101, a novel intratumoral class C CpG-ODN, given with low-dose radiation in patients with untreated low-grade B-cell lymphoma: interim results of a phase I trial

Session Title: Phase I Clinical Trials 1

Abstract Control Number: 7361

Permanent Abstract Number: CT047

Location: Convention Center, Halls G-J, Poster Section 13

Poster Board Number: 3

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 18, 2016.

Date and Time: Monday, April 18, 2016, 1:00 p.m. – 5:00 p.m. EDT

Abstract Title: Intratumoral treatment with a highly interferogenic TLR9 agonist reverts tumor escape from PD-1 blockade

Session Title: Immune Checkpoints 1

Abstract Control Number: 4045

Permanent Abstract Number: 2322

Location: Convention Center, Halls G-J, Poster Section 26

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 18, 2016.

Date and Time: Wednesday April 20, 2016, 8:00 a.m. – 12:00 p.m. EDT

Abstract Title: Radiation potentiates systemic anti-tumor immunity unleashed by a novel TLR9 agonist (SD-101)

Session Title: Immune Modulation from Non-Immunotherapy and Antibodies: Clinical

Abstract Number: 4985

Location: Convention Center, Halls G-J, Poster Section 26

Poster Board Number: 9

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 20, 2016.

About SD-101

SD-101, the subject of AACR (Free AACR Whitepaper) abstracts CT047, 2322 and 4985, is Dynavax’s proprietary, second-generation, CpG-C class oligodeoxynucleotide TLR 9 agonist. SD-101 activates multiple anti-tumor mechanisms of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and induce high levels of Type I interferons and maturation of plasmacytoid dendritic cells and B cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its preliminary safety and activity.

On March 17, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP) ("Adaptimmune" or the "Company"), a leader in the use of T-cell therapy to treat cancer, reported financial results for the six-month period ended December 31, 2015 (Press release, Adaptimmune, MAR 17, 2016, View Source;p=RssLanding&cat=news&id=2149178 [SID:1234509609]).

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Adaptimmune previously announced its decision to change its fiscal year end to align fiscal reporting more closely with comparable companies in the industry which use calendar years and to provide more efficient reporting for U.S. investors. As a result of the change, the Company is required to and has filed with the Securities and Exchange Commission ("SEC") today a transition report on Form 20-F (the "Transition Report") for the transition period of July 1, 2015 to December 31, 2015.

As of December 31, 2015, Adaptimmune had a total liquidity position1 of $247.6 million (£167.9 million). The Company is reiterating its cash burn guidance and expects its liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million.

"The six months ended December 31, 2015 marked an important period of execution throughout our organization," commented James Noble, Adaptimmune’s Chief Executive Officer. "We initiated a study in non-small cell lung cancer with our affinity-enhanced T-cell therapy targeting NY-ESO. We also made strong progress in moving our proprietary pipeline forward, including initiating a study in non-small cell lung cancer with our wholly-owned affinity-enhanced T-cell therapy targeting MAGE-A10. Further, we received RAC approval for our wholly-owned T-cell therapeutic candidate targeting AFP and anticipate filing an IND for this therapy during the first half of 2016."

Mr. Noble continued, "Since the start of 2016, we have already reached two key milestones. Firstly, we and GlaxoSmithKline ("GSK") expanded the terms of our strategic collaboration to enable us to accelerate the development of this candidate therapy into pivotal trials and conduct a range of combination studies. Secondly, we were recently awarded breakthrough therapy designation for our NY-ESO therapy in synovial sarcoma."

Recent Corporate and Clinical Highlights:

Expanded terms of strategic collaboration agreement with GSK to accelerate Adaptimmune’s lead clinical cancer program, an affinity-enhanced T-cell therapy targeting NY-ESO, with goal of initiating pivotal trials around year end 2016;

Received breakthrough therapy designation from U.S. Food and Drug Administration for affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma;

Initiated Phase I/II trial evaluating affinity enhanced T-cell therapy targeting NY-ESO in patients with non-small cell lung cancer ("NSCLC");

Initiated Phase I/II trial evaluating the Company’s wholly-owned affinity enhanced T-cell therapy targeting MAGE-A10 in patients with NSCLC;

Received Recombinant Advisory Committee ("RAC") approval for Adaptimmune’s wholly-owned T-cell therapeutic candidate targeting AFP

Completed preclinical assessment of wholly-owned affinity-enhanced T-cell therapy targeting AFP; the Company expects to file an Investigational New Drug ("IND") application for Phase I/II studies in hepatocellular cancer in 1H2016; and

Announced strategic alliance with Universal Cells to develop allogeneic T-cell therapies.

Financial Results for the six-month period ended December 31, 2015

Cash / liquidity position: As of December 31, 2015, Adaptimmune had a total liquidity position of $247.6 million (£167.9 million). This consists of $193.2 million (£131.0 million) of cash and cash equivalents and $54.3 million (£36.8 million) of short-term deposits.
Cash burn: The net decrease in cash and cash equivalents was $21.6 million (£14.6 million) for the six months ended December 31, 2015, which includes the impact of unrealized foreign exchange gains of $10.0 million (£6.8 million) and $10.3 million (£7.0 million) of milestone payments received under the Company’s collaboration with GSK.

Revenue: For the six months ended December 31, 2015, revenue was $8.1 million (£5.5 million) compared to $3.6 (£2.4 million) for the six months ended December 31, 2014 (unaudited). The increase in revenue was due to an increase in services performed and achievement of development deliverables under the Company’s collaboration with GSK.

Research and development ("R&D") expenses: R&D expenses were $24.3 million (£16.5 million) for the six months ended December 31, 2015 compared to $8.4 (£5.7 million) for the six months ended December 31, 2014 (unaudited), primarily due to increased period-over-period costs associated with: ongoing clinical trials of the Company’s affinity-enhanced T-cell therapy targeting NY-ESO-1; preparation for, and initiation costs associated with, NSCLC studies with the Company’s affinity-enhanced T-cell therapies targeting NY-ESO-1 and MAGE-A10, and personnel expenses for an increased number of employees engaged in R&D.
General and administrative ("G&A") expenses: G&A expenses were $10.8 million (£7.3 million) for the six months ended December 31, 2015 compared to $3.1 (£2.1 million) for the six months ended December 31, 2014 (unaudited). The increase was primarily due to increased personnel costs, increased property costs and other costs associated with being a public company.

Net loss: Net loss attributable to holders of the Company’s ordinary shares was $10.9 million (£7.4 million) for the six months ended December 31, 2015. This equates to $(0.03) or £(0.02) per ordinary share, or $(0.15) per American Depositary Share. This loss is stated after recognizing $12.9 million (£8.8 million) of finance income, which primarily represents unrealized foreign exchange gains.

The Company will not be holding a conference call to discuss these results and instead will provide a full update during its 2016 Analyst Day to be held on April 22, 2016.

Financial Guidance
Adaptimmune is reiterating its cash burn guidance. For the full year 2016, the Company expects its cash burn to be between $80 and $100 million and expects its liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million. This guidance excludes any cash burn associated with potential new business development activities.

The Company prepared the Transition Report under International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board. The Company’s next fiscal year end will be December 31, 2016. Starting with the first quarter of 2016, the Company will file with the SEC quarterly reports on Form 10-Q and annual reports on Form 10-K prepared under U.S. Generally Accepted Accounting Principles ("GAAP").

On March 17, 2019 Kymab reported that Dr David Chiswell OBE has been appointed as Chief Executive Officer with effect from April 2016 (Press release, Kymab, MAR 17, 2016, View Source [SID1234537012]). Dr Chiswell has acted as interim CEO since early 2015, having been appointed Chairman in September 2013. Dr Tim Rink will take the role of Lead Director with effect from April.

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Dr Chiswell has an enviable record in the industry, having worked at Amersham, founded Cambridge Antibody Technology in 1990, been Chair of the UK’s BioIndustry Association, and served seven other biotech companies as Chairman or Director.

"I am delighted with Dave’s appointment as CEO; Dave has an outstanding track record and experience in antibody development and building Biotech companies," said Dr Rink. "He was instrumental in the development of the world’s best selling antibody, Abbvie’s HUMIRA (Adalimumab), which was launched in 2003 and has annual sales in excess of $14 billion."

"I have spent one of the most satisfying years of my career as interim CEO working closely with the excellent team at Kymab," said Dr Chiswell. "I believe Kymab has all the tools needed to enable it to become a truly successful major Biotech company. Our Kymouse platform has already generated an enviable product pipeline of human monoclonal antibodies which we will continue to expand.

"We attracted high quality investors Woodford and Malin alongside the Wellcome Trust and the Bill & Melinda Gates Foundation in our US$90 million Series B fund raise, one of the largest pre-clinical rounds in UK biotech. We have established major partnerships such as Novo Nordisk and the US cancer hospital MD Anderson.

"I am very pleased to be taking the helm on a permanent basis at a time when we are commencing our clinical trial programmes."

Dr Chiswell has over 30 years’ experience in the biotechnology industry having co-founded Cambridge Antibody Technology (CAT) in 1990, serving as CEO from 1996 to 2002. CAT listed on the London Stock exchange in April 1997 and Nasdaq in June 2001, and was subsequently sold to AstraZenca where it forms an important part of their biopharmaceutical franchise.

Since leaving CAT in 2002, he has focused on the development of early-stage biotechnology companies, having previously served as a director of Arakis, non-executive chairman of Sosei, Arrow Therapeutics and Daniolabs, and as CEO of Nabriva Therapeutics (2009 to 2012). Dr Chiswell currently serves as chairman of Albireo Pharma and is a director of Nabriva Therapeutics.

He is a past chairman of the UK BioIndustry association (BIA) and in 2006 he was awarded the Most Excellent Order of the British Empire (OBE) by Her Majesty the Queen for services to the biotechnology industry.

On March 10, 2016 Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, reported financial results for the year ending December 31, 2015 (Filing, Annual, Cellectar Biosciences, 2015, MAR 17, 2016, View Source [SID:1234509612]).
Summary of Recent Key Accomplishments:

· Positive initial data in phase 1 study of CLR 131 in multiple myeloma

· Research collaboration with Pierre Fabre involving PDC Delivery Platform

· $2.3 million NCI Fast Track SBIR Grant for study of CLR 125

· New IP protection for PDC Delivery Platform with CTX patent application

Summary of Financial Results:

Research and development expenses for 2015 were $5.2 million, a reduction of $0.8 million from the prior year. This reflects the company’s continued focus on research and development efforts and implementation of operating improvements that have resulted in reductions to its cost structure. General and administrative expenses for the year totaled $3.4 million, which is an improvement from 2014 of $0.3 million. The company also incurred $0.2 million of restructuring charges in fiscal 2015, which is consistent with 2014.

Operating loss was $8.8 million for 2015, compared to $9.9 million in 2014. Other income was $3.3 million for fiscal 2015, as compared to $1.8 million in 2014. These amounts are almost exclusively non-cash in nature, and are due to changes in the valuation of certain warrants that are classified as liabilities on Cellectar’s balance sheet. As a result, the company’s net loss for the year ended December 31, 2015 was $5.5 million, or ($7.03) per share, compared to a 2014 net loss of $8.1 million, or ($17.53) per share.

As of December 31, 2015, the company had $3.9 million in cash and cash equivalents on hand, compared to $9.4 million in cash and cash equivalents at December 31, 2014. While Cellectar anticipates its available cash and cash equivalents should fund its planned operations into the second quarter of 2016, management believes capital will be required to complete its planned clinical and preclinical development.

"The last two quarters of 2015 through the first quarter of 2016 continue to represent a significant shift in corporate objectives, culture and branding for Cellectar Biosciences," said Jim Caruso, president and CEO of Cellectar Biosciences. "Significant progress has been achieved and we remain confident in our corporate strategy, operating plan execution and our PDC Delivery Platform technology. We are pleased with the resulting program advancements and look forward to providing further details about our objectives for continued success on today’s call."

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

December 31,
2015 December 31,
2014
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 3,857,791 $ 9,422,627
Restricted cash 55,000 55,000
Prepaid expenses and other current assets 267,783 220,611
Total current assets 4,180,574 9,698,238
FIXED ASSETS, NET 1,728,471 2,033,944
GOODWILL 1,675,462 1,675,462
OTHER ASSETS 11,872 11,872
TOTAL ASSETS $ 7,596,379 $ 13,419,516

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current maturities of notes payable $ 243,590 $ 119,923
Accounts payable and accrued liabilities 675,924 933,988
Derivative liability 4,781,082 5,176,915
Capital lease obligations, current portion 2,449 2,180
Total current liabilities 5,703,045 6,233,006
LONG-TERM LIABILITIES:
Notes payable, less current maturities 86,632 330,077
Deferred rent 148,924 147,774
Capital lease obligations, less current portion 7,975 11,126
Total long-term liabilities 243,531 488,977
Total liabilities 5,946,576 6,721,983
TOTAL STOCKHOLDERS’ EQUITY: 1,649,803 6,697,533
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 7,596,379 $ 13,419,516

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Year Ended December 31,
2015 2014

COSTS AND EXPENSES:
Research and development $ 5,158,874 $ 5,964,453
General and administrative 3,395,360 3,704,676
Restructuring costs 203,631 221,816
Total costs and expenses 8,757,865 9,890,945

LOSS FROM OPERATIONS (8,757,865 ) (9,890,945 )

OTHER INCOME (EXPENSE):
Gain on revaluation of derivative warrants 3,667,826 2,285,157
Loss on issuance of derivative warrants (404,150 ) —
Interest expense, net (841 ) (446,314 )
Total other income, net 3,262,835 1,838,843
NET LOSS $ (5,495,030 ) $ (8,052,102 )
BASIC AND DILUTED NET LOSS PER COMMON SHARE $ (7.03 ) $ (17.53 )
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS
PER COMMON SHARE 781,975 459,266

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