Nordic Nanovector Patent Issues in USA

On January 15, 2014 Nordic Nanovector reported that the U.S. Patent and Trademark Office has issued patent no. 8628749 entitled "RADIOIMMUNOCONJUGATES AND USES THEREOF" (Press release Nordic Nanovector, JAN 15, 2014, View Source [SID:1234500625]). The issued claims cover Nordic Nanovector’s proprietary radioimmunotherapy technology including the company’s lead product candidate Betalutin. The expiry date for the patent is 2031.

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"The issuance of this patent supports our investment in Betalutin, which is currently being developed as a treatment for patients with relapsed B-cell Non-Hodgkin lymphoma," said Jan A. Alfheim, Chief Executive Officer.

"We plan to pursue additional patents to expand the global patent protection of our proprietary technology in order to derive maximum commercial value for our shareholders. We will continue to work diligently toward growing our increasing portfolio of patents while developing and commercializing our radioimmunotherapy product candidates"

NantBioScience Announces Strategic Collaboration with Celgene Corporation Advancing Bold Research Initiative in the Interest of Cancer Patients

On January 13, 2014 NantBioScience, subsidiary of NantWorks, LLC, a company focused on the discovery and development of innovative treatments for diseases with high unmet medical needs,reported a strategic collaboration with Celgene to advance bold research programs to benefit cancer patients in need of new therapeutic solutions (Press release, NantBioScience, JAN 13, 2014, View Source [SID:1234514808]). As part of the transaction, Celgene will pay $75 million in funding to NantBioScience as an upfront option fee and equity investment.

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Building on the nab (nanoparticle albumin-bound) technology platform, NantBioScience will create a pipeline of nab-based molecules. As part of the collaboration, Celgene will license two nab product candidates to NantBioScience, both of which had previously received Investigational New Drug (IND) approval. The first product candidate (NTB-011) is a nanoparticle albumin-bound formulation of a novel colchicine dimer with cytotoxic and vascular disrupting properties. The second product candidate (NTB-010) is a nanoparticle albumin-bound formulation of the geldanomycin analogue, 17-AAG, a potent HSP90 inhibitor, which is planned to be studied in patients with a variety of hematological and solid tumors. Phase I clinical trials for these product candidates are being planned for initiation in 2014 – 2015.

The objective of NantBioScience is to innovate drug development by testing molecularly targeted drugs, based on the molecular profile of the patient’s tumor, independent of the cancer’s anatomical type. With capabilities of next generation sequencing and targeted proteomics, each cancer may now be viewed as a series of rare diseases. These comprehensive "omic" analytic tools and "big data" generated from supercomputing have been previously untapped on the scale now available in the field of drug development. NantBioScience and NantWorks are uniquely positioned to develop molecularly designed drugs in this era of genomics and proteomics, by identifying patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive "omic" analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects.

"We intend to make obsolete the standard method of clinical trial design of ‘trial and error’ and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. We also intend to make obsolete the common understanding that cancer treatments, developed under the age old dogma of ‘maximum tolerated dose,’ may work but only by wreaking terrible side effects, bringing patients to the brink of death," said NantWorks founder, Dr. Patrick Soon-Shiong. "Celgene has been a strong steward for Abraxane which is now approved for metastatic breast, lung and pancreatic cancer. This new partnership will enable us to aggressively advance our drug pipeline and put us one step closer to developing – and then delivering – molecular designed cancer treatments for patients to receive the right care at the right time."

"We have invested over $100 Million in the pursuit of this platform to date and are very excited to have Celgene as our partner in this pursuit," he said.

"Celgene is excited to team up again with Dr. Patrick Soon-Shiong, the creator of Abraxane and the founder of the nab technology platform. We are committed to his vision of molecularly driven personalized medicine and to collaborating with NantBioScience at the forefront of this era where genomic- and proteomic- based solutions may provide the path to a cure for cancers," said Bob Hugin, Chairman and Chief Executive Officer of Celgene Corporation.

In addition to the two nab product candidates, NantBioScience has a broad R&D program to discover new compounds that are specifically targeted at tumor signaling pathways in patients with specific genetic mutations. A novel inhibitor of oncogenic KRAS is showing promise in early development studies and will advance into a program of IND enabling studies in 2014. Normally a proto-oncogene, KRAS, when mutated to an oncogene, is transformed into the driver of tumorigenesis in pancreatic cancer amongst many other cancers and molecular profiles.

NantBioScience’s pursuit of targeted therapies includes the discovery and development of drugs that remediate the activities of the often mutated tumor suppressor, p53. Because the loss of p53 functionality is a driver for the development of over 50% of all cancers and because p53 is responsible for maintaining the integrity of the cellular genome, pharmaceuticals targeting cells harboring p53 mutations are highly coveted. NantBioScience plans to initiate IND-enabling studies on its lead p53 remediating compound, for which NantBioScience is targeting a first-in-man study in 2015.

NantBioScience’s pipeline also contains novel potent multi-kinase inhibitors. These compounds are entering into a program of IND-enabling studies, with first-in-man studies planned for 2016. NantBioScience’s kinase inhibitor program is further buoyed by its library of >4,000 multi-kinase inhibitors which are currently under investigation for a variety of indications and molecular profiles.

As part of the collaboration, Celgene will receive an option to license a certain number of product candidates developed by NantBioScience, including the two nab product candidates to be licensed to NantBioScience. The options may be exercised by Celgene through completion of Phase I clinical studies.

The transaction is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and is expected to close in the first quarter of 2014.

arGEN-X receives two preclinical milestone payments under collaboration with Shire

On January 13, 2014, arGEN-X reported the initiation of a new pilot research agreement with Boehringer Ingelheim (Press release arGEN-X, JAN 13, 2014, View Source [SID:1234500576]). No further details are being disclosed at this stage.

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FORMA Therapeutics Announces Advancement Of Collaboration With Boehringer Ingelheim For Modulating Protein-protein Interactions In The Treatment Of Cancer

On January 9, 2014 FORMA Therapeutics reported the achievement of several discovery milestones in their alliance with Boehringer Ingelheim (BI) for the discovery of novel drug candidates against protein-protein interactions (PPI) for the treatment of cancer (Press release, Forma Therapeutics, JAN 9, 2014, View Source [SID:1234509339]).

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"Targeting PPIs is highly attractive for therapeutic intervention because they play a vital role in virtually all cellular processes. FORMA’s discovery engine has garnered critical insights into PPIs, which now instruct and guide our drug discovery initiatives."

"Our recent successes within the BI partnership, an agreement originally announced in January 2012, demonstrate FORMA’s ability to execute and deliver on challenging goals," said Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. "Targeting PPIs is highly attractive for therapeutic intervention because they play a vital role in virtually all cellular processes. FORMA’s discovery engine has garnered critical insights into PPIs, which now instruct and guide our drug discovery initiatives."

As part of the PPI alliance, BI has formally internalized novel compounds for an oncology-relevant PPI program from FORMA. Further, FORMA will continue to conduct screening within the alliance, has expanded chemistry resourcing to prosecute validated scaffolds, and will continue to further interrogate additional targets named within the agreement. FORMA will receive undisclosed payments as part of these recent scientific advancements.

Kenneth W. Bair, Ph.D., Chief Scientific Officer and Head of Research and Development, FORMA Therapeutics noted, "The combination of our cell-based screening technology (MAPPIT) and biochemical assay platforms provides a rapid way to screen for PPI inhibitors in two parallel formats, each offering distinct advantages. Further, integrating data from FORMA’s X-ray crystallography efforts across product pipeline targets with CS-Map technology interrogation of the surfaces for all human proteins in the Protein Data Bank (PDB) (~16,000) enabled the design and synthesis of shape-directed compound libraries biased toward shapes of druggable pockets on protein surfaces. The conformational flexibility of these novel molecules has proven essential to identify potential chemical starting material for PPIs of interest."

Avillion Group Partners with Pfizer to Co-develop BOSULIF® (bosutinib) as First-Line Treatment for Patients with Chronic Myelogenous Leukemia

On January 9, 2014 the Avillion Group reported that it has entered into an exclusive collaborative development agreement with Pfizer Inc. to conduct a global Phase 3 clinical trial of Pfizer’s BOSULIF (bosutinib) (Press release, Avillion, JAN 9, 2014, View Source [SID:1234502188]).

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The trial, which will be conducted across multiple sites in the United States, Asia and Europe, will evaluate BOSULIF, administered at a starting dose level of 400 mg daily, as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Under the terms of the agreement, Avillion will provide the funding for and will conduct the trial to generate the clinical data necessary to potentially support a registration dossier for marketing authorization of BOSULIF by regulatory authorities for an indication as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer upon regulatory approval of the drug. Pfizer will retain all rights to commercialize BOSULIF globally.

"We are delighted to announce Avillion’s agreement with Pfizer, a global leader in the biopharmaceutical industry, and we look forward to working with them with the goal of advancing the development of BOSULIF and expanding its availability to a broader range of CML patients," said Lewis Cameron, CEO of Avillion. "Avillion offers pharmaceutical and biotech companies a compelling option to partner late-stage drug development projects. We have an experienced team focused on global drug development and regulatory approval, with the capability to optimise contract research organization (CRO) management."

"Chronic myelogenous leukemia remains a difficult disease to treat despite recent advances," said Garry Nicholson, president and general manager, Pfizer Oncology. "Today, the distinct tolerability profile of BOSULIF offers physicians an important therapeutic choice for their patients with Ph+ CML, as has already been shown in patients who are resistant or intolerant to prior therapy. Through our collaboration with Avillion, we plan to expand the development of BOSULIF by exploring its potential benefit as a first-line therapy for patients with CML."

BOSULIF is an oral, once-daily, TKI which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. BOSULIF is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, BOSULIF was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.