Expanding Its Strategic Relationship with Wisconsin Alumni Research Foundation (WARF), Cellectar Biosciences Executes New License Agreement

On March 8, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported it has entered into a licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property rights covering the method of use (MOU) for the company’s lead PDC compound, CLR 131, in multiple myeloma (Press release, Cellectar Biosciences, MAR 8, 2017, View Source [SID1234518032]).

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"We are extremely pleased to further strengthen our relationship with Cellectar," said Carrie Thome, WARF director of investments. "WARF’s ability to use the many assets that exist in our portfolio to help advance an important new technology towards ultimate commercialization is a wonderful example of the power of the unique WARF model that combines world class technology transfer and investment management capabilities."

WARF has been, and continues to be, an investor in Cellectar and has been a joint owner, with Cellectar, of the MOU patent filing for CLR 131 for the treatment of multiple myeloma. While the company has always maintained the rights to develop and commercialize CLR 131 for multiple myeloma, the execution of this licensing agreement provides the company with exclusive rights to the development and commercialization of the compound in multiple myeloma. As a result of this agreement, the company has now consolidated its control of the multiple myeloma indication, while continuing to maintain complete control for all other therapeutic uses of CLR 131.

"WARF is one of Cellectar’s largest shareholders and remains a formidable partner. We believe this expansion of our relationship further solidifies our mutual commitment," said Jim Caruso, president and CEO of Cellectar. "Acquiring the remaining rights to the use of CLR 131 in multiple myeloma now provides us with complete control over the product’s development and commercialization in all therapeutic areas."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. In the first quarter of 2017, the company plans to initiate a Phase II clinical study to advance its multiple myeloma program, assess efficacy in a range of B-cell malignancies, and explore the clinical benefits of a second dose. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall survival, an improvement in progression-free survival (PFS), surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

About Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

The National Institute of Health’s SEER database reports the annual prevalence and incidence in the United States to be approximately 90,000 and 30,000, respectively.

Heat Biologics Announces Agreement to Acquire Pelican Therapeutics

On March 8, 2017 (GLOBE NEWSWIRE) — Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, reported that the company has entered into a definitive agreement with the holders of 75.5% of the outstanding capital stock of Pelican Therapeutics, Inc (Press release, Heat Biologics, MAR 8, 2017, View Source [SID1234518030]). ("Pelican") to acquire an 80% controlling interest in Pelican. Headquartered in Austin, Texas, Pelican is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a highly differentiated and potentially "best-in-class" T cell costimulatory receptor.

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Key highlights include:

Pelican was the recipient of a highly competitive $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT), which should enable the company to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial. The CPRIT grant is subject to customary CPRIT funding conditions and was awarded in 2016 following a rigorous scientific and clinical evaluation process.
Pelican’s T cell costimulator, PTX-25, in combination with other immunotherapies, including Heat’s ImPACT and ComPACT technologies, has the potential to enhance durability of responses due to its preferential specificity to ‘memory’ CD8+ T cells.
Preclinical studies demonstrate PTX-25 has superior "best-in-class" costimulatory activity for CD8+ cytotoxic T cells as compared to other costimulators.

"The acquisition of Pelican aligns with our strategic focus targeting exciting immuno-oncology combinations, strengthening Heat’s portfolio in the emerging T cell activation space," said Jeff Wolf, Heat’s Founder and Chief Executive Officer. "Pelican’s two product candidates are transformative assets for us as there are compelling data indicating that targeting TNFRSF25 may have significant advantages over competing costimulatory receptors currently under development. This is important because many of the leading global pharmaceutical companies are focused on T cell costimulators to enhance the effectiveness of their existing immuno-oncology therapies."

"Pelican’s PTX-25 has the potential to dramatically improve the durability of antigen-specific immune responses due to its preferential specificity for stimulating the production of ‘memory’ CD8+ T cells," added Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "We look forward to advancing these new product candidates with synergistic combinations including Heat’s existing T cell-activating platform technologies, ImPACT and ComPACT, vastly expanding our reach within oncology and possibly beyond."

The acquisition is contingent upon certain closing conditions, including agreements of the holders of 80% of the outstanding capital stock of Pelican, on a fully diluted basis, to participate in the acquisition and enter into a stockholders agreement with respect to their remaining Pelican shares. As consideration for the sale of 80% of the Pelican Stock, Heat will pay the Pelican stockholders that participate in the acquisition an upfront cash payment not to exceed $500,000 and will issue an aggregate of 1,323,021 shares of Heat common stock, representing 4.99% of the outstanding shares of Heat common stock. In addition, Heat will cause Pelican to pay certain clinical and commercialization milestone payments, royalty and sublicensing income payments, and Heat will loan Pelican amounts sufficient to pay Pelican’s transaction expenses. Cassel Salpeter & Co. served as financial advisor to the Heat special committee and Geller Biopharm served as financial advisor to the Pelican special committee and Pelican stockholders.

The acquisition is expected to close no later than April 30, 2017, subject to applicable regulatory approvals and other customary terms and conditions.

About Pelican Therapeutics, Inc.
Pelican Therapeutics, Inc. is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a differentiated and potentially "best-in-class" T cell costimulatory receptor. TNFRSF25 has shown great promise due to its preferential specificity for stimulating the production of "memory" CD8+ T cells, the strongest predictive biomarker of clinical benefit from cancer immunotherapy. T cell costimulatory therapy, when combined with checkpoint inhibitors and other treatments, could significantly improve clinical responses for a broader range of patients. Pelican has conducted extensive preclinical studies and completed humanization of its lead monoclonal antibody, PTX-25.

About the Cancer Prevention and Research Institute of Texas (CPRIT)
Beginning operations in 2009, CPRIT has to-date awarded $1.78 billion in grants to Texas researchers, institutions and organizations. CPRIT provides funding through its academic research, prevention, and product development research programs. Programs made possible with CPRIT funding have reached all 254 counties of the state, brought more than 123 distinguished researchers to Texas, advanced scientific and clinical knowledge, and provided more than three million life-saving education, training, prevention and early detection services to Texans. Learn more at www.cprit.texas.gov.

Cyclenium Pharma announces a Research Collaboration with The Hospital for Sick Children to Identify Novel Macrocyclic Modulators for Pharmacological Targets in Multiple Therapeutic Areas

On March 07, 2017 Cyclenium Pharma Inc., an emerging pharmaceutical company specializing in the discovery and development of novel drug candidates based on proprietary macrocyclic chemistry and The Hospital for Sick Children (SickKids), one of the world’s premier biomedical research and treatment centres, reported they have entered into a research agreement designed to discover novel modulators for multiple new and existing biological targets of pharmacological interest across a variety of disease areas, including cardiovascular, immunology and oncology (Press release, Cyclenium, MAR 7, 2017, View Source [SID1234635927]). This collaboration will provide SickKids researchers with immediate access to Cyclenium’s proprietary QUEST Library of next generation macrocyclic molecules and associated chemical hit and lead optimization capabilities. The initial objective of these exploratory efforts is to identify compounds capable of interacting with specific therapeutic targets being studied at SickKids, thereby providing tools to improve the understanding of their involvement in the pathophysiology of specific diseases, with the ultimate goal of discovering novel therapeutic or diagnostic agents.

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"We are delighted that a distinguished institution like SickKids is interested in the power and capabilities of our small molecule macrocyclic technology to contribute to their cutting-edge research efforts," stated Helmut Thomas, Ph.D., President, Chief Scientific Officer & Chief Executive Officer of Cyclenium. "The combination of their internationally renowned investigators and translational expertise with our CMRT Technology and past development success in the macrocycle space provides unique opportunities for the ground-breaking discovery and development of new therapies and diagnostics."

The library will be made available to researchers through the SickKids Proteomics, Analytics, Robotics & Chemical Biology Centre (SPARC BioCentre). The SPARC BioCentre is a high-throughput drug screening facility at SickKids. One of the first studies to be initiated involves targets implicated for the treatment of cancer and immune disorders.

For Cyclenium, this is the latest in an extensive series of international discovery collaborations established with prominent companies and research institutions to explore the exciting potential of its unique macrocycle chemistry technology, including Astellas Pharma, Haplogen GmbH, Fundación MEDINA, German Cancer Research Center (DKFZ), McGill University/Goodman Cancer Research Centre, Institute for Research in Immunology and Cancer (IRIC)/Université de Montréal, and Southern Research Institute.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, AstraZeneca, 2016, MAR 7, 2017, View Source [SID1234518031])

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Daiichi Sankyo Announces New Oxycodone Extended Release Tablets "Daiichi Sankyo" for Sustained Cancer Pain Treatment

On March 8, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has launched new generic oxycodone extended release formulations to treat sustained cancer pain: Oxycodone Extended Release 5 mg, 10 mg, 20 mg and 40 mg "Daiichi Sankyo" (date of approval: August 15, 2016; date of listing in the NHI reimbursement price list in Japan: December 9, 2016) (Press release, Daiichi Sankyo, MAR 7, 2017, View Source [SID1234518076]).

This oxycodone extended release tablet is an opioid analgesic providing the degree of analgesia prescribed for various cancers with moderate to severe pain, and the first tablet generic for an oxycodone extended release formulation. Our domestic subsidiary, Daiichi Sankyo Propharma Co., Ltd. (manufacturing and marketing) manufactures from drug substance to formulation using our GWATab technology*.

Daiichi Sankyo expects this drug to be able to contribute to all patients and medical staff by offering a new therapeutic option.

Product summary
Product name
Therapeutic Category
Original brand name
Oxycodone Extended Release tablets 5mg "Daiichi Sankyo"
Oxycodone Extended Release tablets 10mg "Daiichi Sankyo"
Oxycodone Extended Release tablets 20mg "Daiichi Sankyo"
Oxycodone Extended Release tablets 40mg "Daiichi Sankyo"
Sustained cancer pain treatment
OxyContinⓇTablets 5mg
OxyContinⓇTablets 10mg
OxyContinⓇTablets 20mg
OxyContinⓇTablets 40mg

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*GWATab (Gelling WAter soluble polymer matrix Tablet) technology is proprietary technology that combines a drug substance with a water-soluble polymer, releasing medication along a wide range of the gastrointestinal tract after dosing, for sustained drug efficacy.