On June 11, 2015 Targovax AS ("Targovax" or the "Company") reported that it has entered into an agreement with the shareholders of Oncos Therapeutics Oy ("Oncos") to acquire the shares of Oncos with settlement in Targovax shares (the "Transaction") (Press release, Oncos Therapeutics, JUN 11, 2015, View Source [SID:1234512624]). The combined company with multiple assets in research and development will be a Nordic leader within immuno-oncology. The new company will have a strong senior management team and be financially backed by reputable institutional investors with sector specialist HealthCap as the largest shareholder. After the Transaction, the shareholders of Oncos will own 50 per cent of Targovax.

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To fund the combined company, Targovax contemplates to raise NOK 125-150 million through a private placement directed towards Norwegian and international investors (the "Private Placement") and has already received indications from leading institutional investors for a substantial amount, including but not limited to a NOK 26 million commitment from HealthCap, NOK 25 million from Datum Invest AS and NOK 5 million from the Norwegian Radium Hospital Research Foundation. In addition, the Private Placement is directed towards the 24 employees of Targovax and Oncos and their respective subsidiaries, and companies controlled by any such employees ("Eligible Employees").

Rationale for the Transaction
Targovax and Oncos—based in Oslo and Helsinki, respectively—are both clinical-stage biotechnology companies with broad pipelines addressing the immuno-oncology market, which currently is quite modest, but is expected to grow to USD 30-35 billion over the next decade.

By combining Targovax and Oncos, a larger and more visible Nordic immuno-oncology player with a more extensive portfolio will be created. Furthermore, the combination of two highly competent and complementary organizations will promote more efficient execution and accelerate the development of ongoing and future programs.

Clinical results to date confirm the safety and the mechanisms of action for both technology platforms. Safety data from Targovax and Oncos programs have been collected on approximately 250 and 290 patients, respectively. Both companies have completed Phase I and are now in Phase II development, or about to enter Phase II development, with broad pipelines, and both utilize an immuno-oncology approach that is highly suitable for combination therapies. Clinical programs in several indications will provide increased opportunities for newsflow over the next 18 months.

"The combination of Targovax and Oncos creates a major Nordic player within immuno-oncology. We will have a wide array of programs in the pipeline and multiple shots at goal. The companies’ complementary technologies will provide a unique platform for the development of cutting-edge immunotherapies, and we will have a higher chance of success, thus offering investors an even more compelling opportunity. I am excited to lead an organization of highly skilled professionals with deep industry experience", said Gunnar Gårdemyr, Chief Executive Officer of Targovax.

Senior Executives and Board of Directors
After the Transaction, the highly experienced senior management team will consist of the following members:

Gunnar Gårdemyr (Chief Executive Officer) has more than 30 years of international experience in the pharmaceutical and biotech industry from companies such as Nycomed and Takeda
Dr. Magnus Jäderberg (Chief Medical Officer) has more than 25 years of experience from R&D functions and was previously CMO at Bristol-Myers Squibb (Europe)
Øystein Soug (Chief Financial Officer) has prior experience as the Chief Financial Officer of Algeta and in positions with the Orkla Group
Jon Amund Eriksen (Chief Operating Officer) was the co-founder of Targovax and has 35 years of R&D experience in the pharmaceutical and biotech industry, of which 25 years were within immuno-oncology
After the Transaction, the proposed Board of Directors will consist of the following members:

Jónas Einarsson (Chairman of the Board of Directors), Chief Executive Officer of the Norwegian Radium Hospital Research Foundation
Johan Christenson (Board Member), Partner at HealthCap
Per Samuelsson (Board Member), Partner at HealthCap
Lars Lund-Roland (Board Member), CEO of Bringwell, with more than 25 years of experience from various executive positions within Merck
Bente-Lill Romøren (Board Member), Board Member of the Norwegian Radium Hospital Research Foundation and Chairman of Farmastat and Photocure
Robert Burns (Board Member), Chairman of Haemostatix, previously CEO of 4-Antibody, Affitech, and Celldex Therapeutics, all three being early companies in the immuno-oncology space

On June 11, 2015 BIND Therapeutics, a subsidiary of Navidea Biopharmaceuticals reported they have entered into a research collaboration to engineer Accurins with the Manocept targeting platform that enables selective, efficient binding to CD206 positive disease-associated macrophages (Press release, Navidea Biopharmaceuticals, JUN 11, 2015, View Source;p=RssLanding&cat=news&id=2058494 [SID:1234505428]). Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to develop Manocept-linked Accurins as a novel, potent approach to impact the tumor microenvironment which, in many forms of cancer, is a barrier to immune effector cells.

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This Smart News Release features multimedia. View the full release here: View Source

"This collaboration represents a potentially significant advance in the evolution of our platform as we develop Accurins with novel targeting ligands," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "The modular nature of our platform offers multiple therapeutic possibilities, and our collaboration with Macrophage Therapeutics may enable the development of Accurins that target activated macrophages, which in cancer, help create an immunosuppressive microenvironment. We believe the clinically validated Manocept platform, with its unique ability to seek out activated macrophages, fits into our vision to engineer Accurins that have a profound impact on the treatment of diseases, including our current focus in cancer."

Disease-associated macrophages generally play a pro-tumoral role and are immunosuppressive, preventing the immune system from mounting an attack on tumor cells. Based on the expression of CD206 mannose receptors on disease-associated macrophages, BIND and Macrophage plan to conduct joint research to develop a CD206 targeted Accurin nanoparticle that is capable of concentrating various therapeutic payloads to the tumor microenvironment.

"We are pleased to work with BIND Therapeutics to explore the therapeutic potential of our two complementary technology platforms," said Michael M. Goldberg, M.D., CEO of Macrophage Therapeutics and Director of Navidea. "The Manocept platform is the basis for the FDA-approved CD206 targeted sentinel lymph node detection agent, Lymphoseek (technetium Tc 99m tilmanocept) injection. Coupled with BIND’s specifically engineered Accurins that concentrate therapeutic payloads to extracellular and intracellular compartments, with a tunable controlled-release profile, we are optimistic that we can create a wide range of therapeutic applications."

"It is well-established that macrophages play an important role in many disease states but it has proven difficult to selectively target and alter macrophages that play a key role in disease progression," said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND Therapeutics. "By coupling Accurins with Macrophage’s well-credentialed CD206 targeting ligand, we may be able to treat macrophage-mediated diseases through increased uptake, and concentration, of targeted therapeutic payloads in the tumor microenvironment. BIND’s Medicinal Nanoengineering platform is able to combine multiple molecular components into a targeted, long-circulating Accurin. An Accurin nanoparticle that binds to CD206 positive macrophages could be a valuable asset in the armament against multiple cancers and disease states."

"The collaboration furthers our vision to develop therapeutic applications of the Manocept platform through strategic partnerships," said Rick Gonzalez, president and CEO of Navidea. "In collaborating with BIND, we will be able to leverage their accomplished R&D team who has strong track record for advancing targeted nanoparticles from concept into the clinic."

About Accurins

Accurins, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of Accurins allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

Accurins can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables Accurins to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

About Manocept CD206 Targeting Platform for Therapeutics Development

Manocept CD206 Targeting Platform is a proprietary mannose-containing, receptor-directed technology platform designed to engineer novel, synthetic receptor targeted imaging agents and therapeutics for cancer and other diseases. Manocept’s unique structural and molecular properties enable the design of novel immuno-constructs that selectively target and bind to CD206 (mannose receptor) and other C-type Lectins found on activated, disease-associated macrophages and tumor associated macrophages (TAMs). The Manocept CD206 Targeting Platform provides a novel and valuable approach to the design of drug molecules targeting CD206 disease-associated macrophages for therapeutic purposes.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On June 11, 2015 TG Therapeutics reported that clinical data for TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s once-daily PI3K delta inhibitor, will be presented at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), being held from June 11 – June 14, 2015 in Vienna, Austria as well as at the 13th International Congress on Malignant Lymphoma (ICML), being held from June 17 – June 20, 2015 in Lugano, Switzerland (Press release, TG Therapeutics, JUN 11, 2015, View Source [SID:1234505398]).

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The Company and its study investigators will present data from the following clinical studies:

TGR-1202 as a single agent in relapsed/refractory B-cell malignancies
TGR-1202 in combination with TG-1101 ("1303 combination") in CLL and NHL
TGR-1202 + TG-1101 + ibrutinib in B-cell malignancies
TG-1101 in combination with ibrutinib in patients with relapsed/refractory CLL

Additional information on the presentations can be found below:

20th Congress of EHA (Free EHA Whitepaper) (Vienna):

Date/Time: Friday, June 12, 2015, 17:15 – 18:45 CEST
Abstract Number: P327 (Poster)
Presentation Title: UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL
Presenter: Matthew Lunning, DO, University of Nebraska, Omaha, NE

Date/Time: Saturday, June 13, 2015, 11:45 – 12:00 CEST
Abstract Number: S432 (Oral Presentation)
Presentation Title: TGR-1202, A NOVEL ONCE DAILY PI3K-DELTA INHIBITOR, DEMONSTRATES CLINICAL ACTIVITY WITH A FAVORABLE SAFETY PROFILE, LACKING HEPATOTOXICITY, IN PATIENTS WITH CLL AND B-CELL LYMPHOMA
Presenter: Owen A. O’Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY

ICML Meeting (Lugano):

Date/Time: Wednesday, June 17, 2015, 17:45 CEST
Abstract Number: 038 (Oral Presentation)
Presentation Title: TGR-1202, A NOVEL ONCE DAILY PI3K δ INHIBITOR, DEMONSTRATES CLINICAL ACTIVITY WITH A FAVORABLE SAFETY PROFILE, LACKING HEPATOTOXICITY IN PATIENTS WITH CLL AND B-CELL LYMPHOMA
Presenter: Owen A. O’Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY

Date/Time: Thursday, June 18, 2015, 17:15 CEST
Abstract Number: 105 (Oral Presentation)
Presentation Title: UBLITUXIMAB (TG-1101), A NOVEL GLYCOENGINEERED ANTI-CD20 MAB, IN COMBINATION WITH IBRUTINIB ACHIEVES 95% ORR IN PATIENTS WITH HIGHRISK RELAPSED/REFRACTORY CLL
Presenter: John Burke, MD, Rocky Mountain Cancer Center/US Oncology, Aurora, CO

Date/Time: Thursday, June 18, 2015, 17:25 CEST
Abstract Number: 106 (Oral Presentation)
Presentation Title: THE CHEMOTHERAPY-FREE TRIPLET OF UBLITUXIMAB, TGR-1202, AND IBRUTINIB IS SAFE AND HIGHLY ACTIVE IN RELAPSED B-CELL MALIGNANCIES
Presenter: Loretta Nastoupil, MD, MD Anderson Cancer Center, Houston, TX

Date/Time: Thursday, June 18, 2015
Abstract Number: 284 (Poster)
Presentation Title: UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL
Presenter: Matthew Lunning, DO, University of Nebraska, Omaha, NE

On June 11, 2015 Merrimack reported the initiation of clinical imaging assessing the use of a potential marker for delivery of MM-398 (irinotecan liposome injection), also known as "nal-IRI," to metastatic breast cancer (Press release, Merrimack, JUN 11, 2015, View Source [SID:1234505397]). This study is an expansion of a Phase 1 pilot study which assessed the feasibility of using ferumoxytol*, an iron oxide nanoparticle, to act as a marker for MM-398 tumor response prediction. The study will now enroll patients who have metastatic breast cancer which is either hormone receptor-positive, triple-negative, or where active brain metastases are present.

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"We were encouraged by the results of the initial pilot phase of the study, particularly the data that suggest a relationship between high levels of ferumoxytol uptake and shrinkage of tumor lesions after MM-398 treatment," said Dr. Jasgit Sachdev, MD, Virginia G Piper Cancer Center. "We are excited to continue to evaluate the activity of MM-398 and the predictive value of this imaging approach in additional patients with metastatic breast cancer."

The data from the initial pilot study (n=31 lesions comprising 9 patients) showed a relationship between ferumoxytol levels in individual tumor lesions, as measured using magnetic resonance imaging, and corresponding change in individual tumor lesion size following treatment with MM-398. Results observed in several patients with metastatic breast cancer in the pilot study warranted further expansion of the study to additional patients in this population. Adverse events from MM-398 therapy were consistent with previous studies. Reported grade 3 and above adverse events related to MM-398 treatment included diarrhea, hypokalemia, abdominal pain, anemia, nausea and neutropenia.

"We look forward to expanding this study and aim to use it to support our biomarker hypothesis and further our strategy to use diagnostic imaging to identify the patients who are most likely to derive benefit from treatment with MM-398," said Bart Hendriks, Ph.D., Director of Imaging Diagnostics at Merrimack.

As part of this expansion, 30 patients with metastatic breast cancer will be imaged with ferumoxytol followed by treatment with MM-398. Ten patients will be enrolled in each of three cohorts as follows: ER and/or PR-positive metastatic breast cancer, triple-negative metastatic breast cancer or metastatic breast cancer with active brain metastases. Eligible patients for the trial must have received less than four prior lines of chemotherapy for the treatment of metastatic disease. The primary objectives of this study are to investigate the feasibility of ferumoxytol quantitation in tumor lesions and to characterize the relationship between ferumoxytol uptake in the tumor and tumor response to MM-398 in patients with advanced metastatic breast cancer. Merrimack plans to conduct the trial at multiple sites in the United States. The Virginia G Piper Cancer Center in Scottsdale, Arizona is now open to screen patients. For more information, please visit clinicaltrials.gov (Identifier: NCT01770353).

About MM-398

MM-398 (irinotecan liposome injection), is an encapsulation of irinotecan in a long-circulating liposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. Merrimack and Baxter International’s biopharmaceutical business (NYSE: BAX) have an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan.

On June 11, 2015, Cellectar Biosciences reported that, after review of the company’s investigational new drug (IND) application, the U.S. Food and Drug Administration (FDA) has determined that Cellectar’s tumor margin illumination agent, CLR1502, will be evaluated as a combination product and assigned to the Center for Devices and Radiological Health (CDRH) (Filing, 8-K, Cellectar Biosciences, JUN 11, 2015, View Source [SID:1234505396]). As a result of this classification, the FDA has advised Cellectar that it will need to submit a new investigational application for the combination product prior to initiating its planned proof-of-concept trial in breast cancer surgery.

"Our tumor illumination agent shares similar spectral qualities with indocyanine green (ICG), a fluorescent dye commonly used in medical diagnostics, and can therefore use several commercially available fluorescent imaging devices. Current labeling for such devices is limited to FDA approved applications such as cardiac, circulatory, hepatic and ophthalmic conditions," said Dr. Simon Pedder, president and chief executive officer of Cellectar Biosciences. "Because of the groundbreaking nature of our overall technology and the potential for an agent like CLR1502 to dramatically expand the utility of such imaging devices, we appreciate the agency’s perspective and current interest in evaluating CLR1502 in combination with a light source technology. As previously disclosed, in the course of our discussions FDA regarding the CLR1502 registration program, the FDA has stressed that a combination product designation is not binding, can be revised later in our development program, and that we are not necessarily precluded from filing a standalone NDA in the future."

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About CLR1502

CLR1502 is a small-molecule, broad-spectrum, cancer-targeted, non-radioactive optical imaging agent developed by Cellectar to be the first of its kind for broad spectrum intraoperative tumor margin illumination and non-invasive tumor imaging. CLR1502 is comprised of a proprietary phospholipid ether (PLE) analog, acting as a cancer-targeted delivery and retention vehicle attached to a fluorophore to enable real-time visualization of malignant tissue under near-infrared light.

CLR1502 is being developed for intraoperative imaging of cancer that will aid in the identification of malignant tissue during diagnostic, staging, debulking and curative cancer surgeries. In particular, the potential of CLR1502 in tumor margin illumination during oncologic resections raises the possibility that this operative aid may improve surgical outcomes.