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Clinical data of Medigene’s dendritic cell (DC) vaccines in prostate cancer to be presented at AACR conference

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

Allergan Confirms Generic Abraxane® Patent Challenge

On March 17, 2016 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, reported that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Paclitaxel Protein-Bound Particles for Injectable Suspension, 100 mg/vial (Press release, Allergan, MAR 17, 2016, View Source;p=irol-newsArticle&ID=2149174 [SID:1234509619]).

Logo – View Source

Allergan’s ANDA product is a generic version of Celgene’s Abraxane, which is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Based on available information, Allergan believes it is a "first applicant" to file an ANDA for the generic version of Abraxane and, should it’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending January 31, 2016, Abraxane had total U.S. sales of approximately $683 million, according to IMS Health data.

Abraxane is a registered trademark of Abraxis BioScience, LLC.

Celldex Therapeutics to Present New Clinical and Preclinical Data at the AACR Annual Meeting 2016

On March 17, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that the Company and its collaborating investigators will present seven posters with new clinical and preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Celldex Therapeutics, MAR 17, 2016, View Source [SID:1234509616]).

Highlights include immune response data from the ongoing Phase 1/2 study of varlilumab and nivolumab in multiple solid tumors, the role of gpNMB as a relevant therapeutic target across multiple cancers and a late-breaking poster from the Phase 1 investigator-sponsored study of CDX-301 (Flt3L) in B-cell lymphomas.

The following Celldex-sponsored abstracts have been selected for poster presentations at AACR (Free AACR Whitepaper):

Title: Phase 1 results from the combination of an immune-activating anti-CD27 antibody (varlilumab) in combination with PD-1 blockade (nivolumab): activation across multiple immune pathways without untoward immune-related adverse events

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 13
Abstract: CT023

Title: Glycoprotein NMB (gpNMB) overexpression is prevalent in human cancers: pancreatic cancer, non-small cell lung cancer, head and neck cancer, and osteosarcoma

Date/Time: Wednesday, April 20, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 27
Abstract: 5032

Title: IHC and RT-PCR assays for detection of cancer antigen NY-ESO-1 in human tissues

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 21
Abstract: 1373

Title: Development and characterization of novel CD40 antibody agonists for cancer immunotherapy

Date/Time: Wednesday, April 20, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 22
Abstract: 4866

The following investigator-sponsored abstracts have been selected for poster presentations at AACR (Free AACR Whitepaper):

Title: In situ vaccination of low-grade lymphoma with intratumoral Flt3L and poly-ICLC with low-dose radiotherapy

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 10
Abstract: LB-081

Title: Targeting GPNMB with 89Zr-CR011 for PET imaging of triple negative breast cancer

Date/Time: Tuesday, April 19, 1:00 p.m. – 5:00 p.m. CDT
Location: Section 33
Abstract: 4209

Title: Targeting the melanosome: overcoming MAPK-inhibitor resistance in melanoma

Date/Time: Sunday, April 17, 1:00 p.m. – 5:00 p.m. CDT
Location: Section 16
Abstract: 296

Kura Oncology Reports Fourth Quarter and Full Year 2015 Operational and Financial Results

On March 17, 2016 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company, reported highlights and financial results for the fourth quarter and full year ended December 31, 2015 (Press release, Kura Oncology, MAR 17, 2016, View Source;p=RssLanding&cat=news&id=2149364 [SID:1234509615]).

"Over the past year, we have made significant progress toward positioning Kura Oncology to realize the promise of precision medicines for cancer," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We advanced our lead product candidate tipifarnib into three Phase 2 clinical trials, progressed our preclinical programs, and strengthened our balance sheet. We look forward to further applying our expertise in cancer pathways, genetics and companion diagnostics in 2016, as we seek to improve patient outcomes by identifying those most likely to benefit from treatment with our drug product candidates."

Development Program Updates and Company Highlights:

Tipifarnib in HRAS Mutant Solid Tumors

In May 2015, Kura initiated a Phase 2 clinical trial of tipifarnib in patients with advanced tumors that carry HRAS mutations. The primary objective of the study is to investigate the antitumor activity, in terms of objective response rate, of tipifarnib in patients with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated during the second half of 2016.
In November 2015, a Phase 2 clinical trial of tipifarnib was initiated in patients with advanced urothelial carcinoma tumors with HRAS mutations. The study is being conducted under the direction of Se Hoon Park, M.D., Ph.D., in the Division of Hematology-Oncology at the Samsung Medical Center in Seoul, South Korea. The primary objective of the study is objective response rate, and secondary objectives include evaluation of progression-free survival, duration of response, and safety.

Tipifarnib in Peripheral T-Cell Lymphoma

In September 2015, Kura initiated a Phase 2 clinical trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL consists of a group of rare and usually aggressive forms of non-Hodgkin’s lymphoma that develop from mature T-cells. These patients generally have a poor prognosis with a low response rate to available treatment options and commonly experience repeated treatment failures. The primary objective of the study is to evaluate the efficacy of tipifarnib in terms of objective response rate. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated in the second half of 2017.

Tipifarnib in Lower-Risk Myelodysplastic Syndromes

Kura plans to initiate a Phase 2 clinical trial to investigate the anti-tumor activity of tipifarnib in patients with lower risk myelodysplastic syndromes (MDS) in the second quarter of 2016. MDS are a group of hematopoietic stem cell malignancies with significant morbidity and mortality. MDS is characterized by ineffective blood cell production, or hematopoiesis, leading to low blood cell counts, or cytopenias, and high risk of progression to acute myeloid leukemia. Kura’s interest in MDS arose from the results of a prior Phase 2 clinical trial sponsored by Johnson & Johnson in patients with intermediate to high risk MDS and additional work by Kura to identify potential biomarkers that could be predictive of response to tipifarnib in MDS patients. Lower risk MDS has been prioritized because of the prevalence of this disease and the company’s belief that treatment of lower risk MDS remains a significant unmet need.

KO-947

Kura plans to submit an investigational new drug application for KO-947, a small molecule inhibitor of extracellular receptor kinase (ERK1/2), in the second quarter of 2016. KO-947 demonstrates potent and selective inhibition of ERK kinase and has shown promising activity in patient-derived xenograft models. Kura is advancing KO-947 as a potential treatment for patients who have tumors with dysregulated activity of the MAPK pathway, including patients with lung, colorectal, pancreatic, melanoma and other cancers.

Menin-MLL

Kura’s menin-MLL program is focused on the identification of product candidates with the potential to treat patients with MLL-rearranged as well as MLL-PTD leukemias, both of which have no current effective therapy. The company anticipates nominating a development candidate for the menin-MLL program during the second half of 2016.

Financial Highlights

$60 Million Private Placement and Reverse Merger

In March 2015, Kura announced that it had completed a private placement of its common stock to new institutional investors and existing investors that resulted in gross proceeds of approximately $60 million to the company, including approximately $7.5 million in bridge notes that converted into common stock at the closing. EcoR1 Capital was the lead investor in the financing, which included significant participation from Fidelity Management & Research Company, ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, and Nextech Invest, as well as a number of other well-known healthcare investors. In conjunction with the private placement, Kura completed a reverse merger with Zeta Acquisition Corp III, a public reporting company with no prior business operations. Following the effectiveness of its registration statement prepared in connection with the reverse merger, Kura was cleared for quotation on the OTC Market.

Public Offering and Listing on NASDAQ

In November 2015, Kura closed a public offering that raised gross proceeds of approximately $55 million, and the company’s shares were approved for quotation on NASDAQ under the symbol "KURA".

Upcoming Clinical and Preclinical Milestones for Kura Programs

Initiation of a Phase 2 clinical trial for tipifarnib in lower-risk MDS, anticipated in the second quarter of 2016
IND submission for ERK inhibitor, KO-947, anticipated in the second quarter of 2016
Initiation of Phase 1 clinical trial for KO-947, anticipated in the second half of 2016
Topline data from Phase 2 clinical trial for tipifarnib in HRAS mutant solid tumors, anticipated in the second half of 2016
Nomination of development candidate for menin-MLL program, anticipated in the second half of 2016

Financial Results for the Fourth Quarter and the Full Year

Cash, cash equivalents and short-term investments totaled $85.7 million as of December 31, 2015, compared with $41.2 million as of September 30, 2015. The difference is attributable to the net proceeds of approximately $50.3 million from Kura’s November 2015 public offering, less cash expenses for the quarter.

Operating expenses for the fourth quarter of 2015 were $6.8 million, compared to $3.9 million for the fourth quarter of 2014. Operating expenses for the full year 2015 were $23.9 million, compared to $3.9 million for the period from August 2014 (Inception) to December 31, 2014. Kura was incorporated in August 2014; therefore, there were minimal operations for the period from August 2014 (Inception) to December 31, 2014. Operating expenses for 2015 consisted of expenses related to the expansion of Kura’s research and development activities and its transition to a public company.

Research and development expenses for the fourth quarter of 2015 were $5.1 million, compared to $2.6 million for the fourth quarter of 2014. Research and development expenses for the full year 2015 were $17.8 million, compared to $2.7 million for the period from August 2014 (Inception) to December 31, 2014.

General and administrative expenses for the fourth quarter of 2015 were $1.7 million, compared to $1.2 million for the fourth quarter of 2014. General and administrative expenses for the full year 2015 were $6.1 million, compared to $1.3 million for the period from August 2014 (Inception) to December 31, 2014.

Net loss for the fourth quarter of 2015 was $6.5 million, compared to a net loss of $3.6 million for the fourth quarter of 2014. Net loss for the full year 2015 was $22.6 million, compared to a net loss of $3.7 million for period from August 2014 (Inception) to December 31, 2014.

Financial Guidance

Kura expects that its current cash, cash equivalents and short-term investments of $85.7 million as of December 31, 2015 will be sufficient to fund its current operations into 2018.

8-K – Current report

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