InNexus Biotechnology Inc (CE) (IXSBF) 銘柄情報

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IXSBF SEC Suspension:

http://www.sec.gov/litigation/suspensions/2015/34-74398.pdf

Order:

http://www.sec.gov/litigation/suspensions/2015/34-74398-o.pdf

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InNexus Biotechnology Awarded Federal Grant

A9:00 AM ET 11/5/10 | BusinessWire
InNexus Biotechnology Inc. (TSX:IXS.V) (www.ixsbio.com), a leading drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today announced it has been awarded a cash grant by the U.S. government totaling $116,760 for projects related to the Company's development of DXL(TM) anti-cancer antibodies.

Jeff Morhet, InNexus CEO, said, ""The funds will be used to advance the preclinical and clinical development of InNexus' DXL(TM) product candidates (engineered antibodies) for diseases and disorders affecting the immune system, heart and breast, as well as the further development of the InNexus' Transmab(TM) program targeting inflammation disorders such as psoriasis. Our program was recognized by the federal government for its significant achievement and innovative approach in advancing the battle against cancer."

These grants were certified under the Qualifying Therapeutic Discovery Project (QTDP) program, which was created as part of the Patient Protection and Affordable Care Act of 2010. The QTDP program provides support for innovative projects that are determined by the U.S. Department of Health and Human Services to (i) have the potential to develop new treatments that address unmet medical needs or chronic and acute diseases; (ii) reduce long-term health care costs; (iii) represent a significant advance in finding a cure for cancer; (iv) advance U.S. competitiveness in the fields of life, biological, and medical sciences; or (v) create or sustain well-paying jobs, either directly or indirectly.

InNexus Resources

* AACR 2009 Scientific Poster on DXL625(TM)

* DXL(TM) Pipeline & Programs

* Stock Quick Check

* Scientific Advisory Board

* Leadership Team

About InNexus Biotechnology

InNexus is a leading drug development company commercializing the next generation of monoclonal antibodies based on its DXL(TM) and Transmab(TM) technology to improve the potency of existing antibodies and to develop novel antibodies based on the unique and patented methods and technologies of InNexus. InNexus has its own in-house developmental (GLP) and manufacturing (GMP) facilities, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus is listed on the TSX Venture Exchange (TSX.V:IXS).

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.

SOURCE: InNexus Biotechnology Inc.

InNexus Announces Discovery of Novel Protein for AMD Eye Disorder
- Will Bypass Needles with Topical Application A9:00 AM ET

6/29/10 | BusinessWire
InNexus Biotechnology Inc. (TSX:IXS.V)(www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today announced that it has developed IXS312(VEGF), an antibody fragment with activity against the growth factor VEGF for planned use in ocular treatments.

Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the US. Speaking on the announcement, Jeff Morhet, InNexus CEO said, "This is a rapidly growing market with limited options for patients. Some treatments cost greater than $15,000 annually. Our product has a novel approach, unique drug design and simplified manufacturing (cost competitive) process. We are in active discussions with several potential development partners to commercialize IXS312 and products based on our technologies."

"Vascular Endothelial Growth Factor (VEGF) is a chemical signal produced by cells that stimulate the growth of new blood vessels. Over-expression of VEGF can cause vascular disease in the retina of the eye and other parts of the body. InNexus' protein research team developed IXS312 to treat ocular diseases, without invasive application steps such as direct injection into the eye," said Dr. Thomas Kindt, InNexus CSO. "IXS312 is a small protein fragment intended for use as a topical therapy for AMD and diabetic retinal dysplasia. Our R&D program has made great progress. We originally modified the fragments to give them stability at body temperature, something very important for packaging and administration and then modified the IXS312 sequence to promote the passage of the product across cellular membrane layers. The recombinant IXS312 is expressed in good yield and was shown to be properly folded through its isolation and purification, binding its antigen target with high affinity. Development is ongoing."

Earlier this year InNexus announced it developed a novel antibody fragment product, IXSCD11a, directed at treatment of psoriasis and produced by recombinant technology identical to IXS312(VEGF).

InNexus also announced today that it is currently in discussions with multiple parties to secure financing to continue the development of its lead product, DXL625, to the completion and filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) as communicated during InNexus' successful meeting with the FDA in March 2009. The filing of an IND for DXL625, estimated to take 18 months following funding, triggers a payment from one of InNexus' commercial partners.

InNexus Biotechnology Signs Collaboration Agreement with the National Cancer InstituteFont size: A | A | A9:02 AM ET 5/27/10 | BusinessWire
InNexus Biotechnology Inc. (TSX:IXS.V) (www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today announced the Company has entered into a Collaboration Agreement with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH) to research proprietary technologies developed by InNexus.

"I look forward to working with the scientists at the NCI to study our technologies. Antibodies are the chosen drug development platform for pharmaceutical companies and DXL has been shown to enhance antibody performance. We will initially work with the NCI to enhance immunotoxins currently under study at the NCI," said Dr. Thomas Kindt, Chief Scientific Officer of InNexus. The principal investigator for the NCI will be Dr. Ira Pastan, distinguished Chair and Chief of the Laboratory of Molecular Biology, Center for Cancer Research at the NCI. Dr. Pastan established the Laboratory of Molecular Biology in 1970.

"We believe our technologies for enhancing the function of antibodies have immediate applicability to research currently underway at the NCI. We're excited to collaborate with the NCI and develop genetically engineered immunotoxins to selectively kill cancer cells," said Jeff Morhet, CEO of InNexus. "Dr. Pastan and the world-class research team, resources and facilities at the NCI are a wonderful opportunity for the InNexus team to collaborate and showcase our science and ability to build and commercialize products."

InNexus Resources

-- AACR 2009 Scientific Poster on DXL625(TM)

-- DXL(TM) Pipeline & Programs

-- Stock Quick Check

-- Scientific Advisory Board

-- Leadership Team

About InNexus Biotechnology

InNexus Biotechnology Inc. is a public biotechnology company commercializing the next generation of monoclonal antibodies based on its DXL(TM) and Transmab(TM) technology to improve the potency of existing antibodies and to develop novel antibodies based on the unique and patented methods and technologies of InNexus. InNexus has its own in-house developmental (GLP) and manufacturing (GMP) facilities, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus Biotechnology Inc. is listed on the TSX Venture Exchange (TSX.V:IXS). Please visit www.ixsbio.com.

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.

SOURCE: InNexus Biotechnology Inc.

InNexus Biotechnology Inc.
Jeff Morhet, Chairman & Chief Executive Officer
Dr. Thomas Kindt, Chief Scientific Officer
1-480-862-7500
www.ixsbio.com

2:39 PM ET 3/23/10 | BusinessWire

InNexus Biotechnology Inc. (TSX:IXS.V) (http://www.ixsbio.com), commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today announces the Journal of Anti-Cancer Drugs is publishing the manuscript titled, "The autophilic anti-CD20 antibody DXL625 displays enhanced potency due to lipid raft-dependent induction of apoptosis" by Bingaman et al.

The manuscript showcases in detail how InNexus' lead product, DXL625 (anti-CD20) induces apoptosis (cell death) in cancer cells, having a mechanism not previously seen with commercially available antibody drugs including Rituxan(R). Comparison experiments were also conducted with Rituxan(R) to confirm this unique cell killing ability.

"DXL625 was found to be superior in (1) inhibiting growth of lymphoma cells and (2) directly inducing lymphoma cell death," said Dr. Thomas Kindt, InNexus' Chief Scientific Officer. "Treatment with DXL625, even in the absence of any secondary immune mechanisms, elicited significant levels of lymphoma cell apoptosis, while equivalent treatment with the commercially available alternative did not."

"Our manuscript provides wonderful insight into our DXL(TM) technology and is indeed a testament to the accomplishments of our scientific team and the value of their work toward the advancement of cancer research," said Jeff Morhet, Chief Executive Officer of InNexus. "We look forward to advancing DXL625 to Phase I clinical trials and look forward to the team's continued success through 2010 and beyond."

The manuscript is available now for download in the Published Ahead of Print section of the Journal's website.

About the Journal of Anti-Cancer Drugs

Anti-Cancer Drugs (on the web at http://journals.lww.com/anti-cancerdrugs) reports both clinical and experimental results related to anti-cancer drugs, and welcomes contributions on anti-cancer drug design, drug delivery, pharmacology, hormonal and biological modalities and chemotherapy evaluation. An internationally refereed journal devoted to the fast publication of innovative investigations on therapeutic agents against cancer, Anti-Cancer Drugs aims to stimulate and report research on both toxic and non-toxic anti-cancer agents. Consequently, the scope on the journal will cover both conventional cytotoxic chemotherapy and hormonal or biological response modalities such as interleukins and immunotherapy.

InNexus Biotechnology Inc. (TSX.V: IXS) (www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today announced the development of a new psoriasis product based on its proprietary dermal permeating Transmab(TM) technology.

Scientists at InNexus have designed and produced by recombinant technology, a novel antibody product directed at treatment of psoriasis, an autoimmune skin disease. The product, designated IXSCD11a, is being formulated for topical use either as a lotion or in patches to be applied to affected areas. IXSCD11a is an antibody fragment based on InNexus' Transmab technology that penetrates cell membranes and dermal barriers. IXSCD11a has shown significant increase in cell penetration compared to other products targeting psoriasis.

Dr. Thomas Kindt, InNexus' CSO, said, "The target bound by the antibody fragment is a cell surface molecule involved in inflammation, which is a factor in the development of psoriasis, as well as a number of other autoimmune conditions. It binds the CD11a receptor that is key to the immune cell-cell interactions that lead to inflammatory processes causative of the painful and disfiguring psoriatic lesions. A full-length antibody product previously marketed by another company with specificity for this receptor was used successfully for treatment of the most serious forms of psoriasis, but was withdrawn due to incidences of fatal brain infection caused by systemic immunosuppression. IXSCD11a was designed to circumvent this side effect because low molecular weight antibody fragments do not persist in circulation long enough to mediate systemic immune suppression. In contrast to full-length antibodies that persist in the bloodstream with half-lives of 18-24 days, antibody fragments like IXSCD11a are eliminated within three hours. Immune-suppressive activity of IXSCD11a is likely to be confined to the region of application and eliminated rapidly."

Jeff Morhet, CEO of InNexus, said, "2009 might have been a year for survival, but 2010 is a year for biotech companies to differentiate and show their value. It is our aim to develop safe and effective treatments for disease conditions that cause physical and mental suffering to millions of people. Our IXSCD11a product combines the proven efficacy of previous products with a desired and reassuring safety profile. This is exciting science."

According to the National Psoriasis Foundation (http://www.psoriasis.org), psoriasis affects 125 million people worldwide (2-3% of total population) and is present in all racial groups in varying rates. Psoriasis is the most prevalent autoimmune disease in the U.S., affecting 7.5 million people.

InNexus And XERIS Announce Research Collaboration
9:00 AM ET 12/10/09 | BusinessWire
InNexus Biotechnology Inc. (TSX.V:IXS) (www.ixsbio.com) and XERIS Pharmaceuticals, Inc. (www.xerispharma.com) announced today a research collaboration in which the companies will pursue development of a potential subcutaneous delivery of InNexus' Dynamic Cross Linking (DXL(TM)) antibodies using XERIS' proprietary formulation-injection technologies.

"We see a need for an improved delivery system for antibodies that enables self injection of these important therapeutic agents, by patients at home," said John Kinzell, CEO of XERIS. "Our delivery system addresses a number of major issues related to storing and administering antibodies and is suitable for and could add value in both chronic and acute therapies."

Jeff Morhet, CEO of InNexus said, "We continue to demonstrate applicability of our DXL technology to a variety of disease targets and we are excited to work with XERIS to identify DXL antibodies which are suitable for subcutaneous delivery to patients using XERIS formulation-injection technology. Antibodies are the leading choice of pharmaceutical companies for drug development and we will continue to position InNexus and our technology to take advantage or the industry's growth. This collaboration is novel and showcases two dynamic technologies."

InNexus also announced that it will be hosting a shareholder teleconference on December 10, 2009 at 4:15 PM Eastern Time to discuss outlook and plans for InNexus in the upcoming year. Participants can dial 1-877-551-8166 to participate in the call.

InNexus Resources

-- AACR 2008 Scientific Poster on DXL625(TM)

-- DXL(TM) Pipeline & Programs

-- Stock Quick Check

-- Scientific Advisory Board

-- Leadership Team

About InNexus Biotechnology

InNexus Biotechnology Inc. is a public biotechnology company commercializing the next generation of monoclonal antibodies based on its DXL(TM) technology, which improves the potency and safety of existing antibody products, thus expanding their usefulness, enabling new disease applications and opening new markets. DXL(TM) antibodies utilize unique, novel and patented methods and technologies of InNexus. Headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic, InNexus has its own development facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus Biotechnology Inc. is listed on the TSX Venture Exchange (TSX.V:IXS). To learn more about InNexus, please visit www.ixsbio.com.

XERIS is an early-stage, specialty biopharmaceutical company developing patient-friendly injectables to treat endocrine and metabolic diseases. The company's formulation-injection technologies allow the subcutaneous delivery of highly concentrated, semi-solid formulations of all drug classes, including small molecules, peptides, proteins, antibodies, and nucleotide-based therapeutics. XERIS' proprietary delivery system offers distinct advantages over existing needle and "needle-free" delivery approaches, including ease of use, less discomfort, room-temperature stability and broad dosing flexibility. To learn more about XERIS, please visit www.xerispharma.com

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.

SOURCE: InNexus Biotechnology Inc.

View dataInNexus Biotechnology Inc.
Jeff Morhet, Chairman & Chief Executive Officer
1-480-862-7500
http://www.ixsbio.com
or
XERIS Pharmaceuticals, Inc.
John Kinzell, President & CEO
1-415-250-8763
http://www.xerispharma.com

InNexus Biotechnology Inc. Jeff Morhet, Chairman & Chief Executive Officer 1-480-862-7500 http://www.ixsbio.com or XERIS Pharmaceuticals, Inc. John Kinzell, President & CEO 1-415-250-8763 http://www.xerispharma.com

InNexus Bio Issues a Shareholder Update



AM ET 12/2/09 | BusinessWire
InNexus Biotechnology Inc. (TSX Venture:IXS)(www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL(TM)) technology, today issued a shareholder update on several key initiatives for the 2009 calendar year.

Dear Shareholders and Friends,

Despite the challenging economy of 2008/2009 and the cautious investment environment particularly affecting small publicly traded biotech companies, InNexus has successfully advanced the development of its lead pre-clinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. Review of this product at a Pre-IND meeting with the Food & Drug Administration (FDA) resulted in a highly positive outcome as the FDA, in support of our regulatory and manufacturing plans, provided a rare manufacturing exception that will allow for the onsite manufacture of DXL625 at our facilities on the campus of the Mayo Clinic in Scottsdale, Arizona for use in Phase I human clinical trials. The FDA also provided recommendations for a more cost efficient and expeditious design for final preclinical studies to set the stage for clinical testing within humans in Phase I. We have targeted late 2010 for completion of the preclinical studies and submission of the IND to the FDA. Following the submission and approval of our IND, we will begin our first human trials. This is an exciting milestone for the company and can greatly increase the value of a therapeutic antibody product. Ongoing development of DXL625, however, remains dependent on continued flow of investment funds into the program and InNexus is in active negotiations with potential partners to share costs and accelerate the development of DXL625.

We continue to rely on investments from lead investors, as well as the senior leadership of InNexus, to fund operations and R&D efforts. To maximize productive use of these investments and ensure successful operations into 2010 and beyond, we have taken aggressive steps to streamline our operating costs by reducing staff, implementing across the board salary cuts, subleasing available surplus space in our facilities and deferring senior leadership salaries. We are considering other cost saving measures to further reduce our operating costs and insure the focus of our business and development activities.

To further advance our scientific and financial efforts, we have added two new members to the InNexus team. Earlier this year, we were privileged to add the eminent oncologist Dr. Daniel Von Hoff to our world-class Scientific Advisory Board and he has already made significant contributions to our programs. More recently, we have reinforced our leadership team with the addition of David Petulla as our Chief Financial Officer. InNexus' previous CFO, Wade Brooksby, due to ongoing health concerns, left his demanding role on the leadership team but remains actively involved with our team and Board of Directors.

In addition to internally developing DXL(TM) products for various applications, we are also actively identifying collaborators to co-develop and license our proprietary technologies. Following the successful FDA meeting earlier this year for DXL625, we commenced a focused business development effort. While time consuming and difficult, our effort during 2009 has resulted in the signing of research and development collaborative agreements with multiple large international pharmaceutical companies for the evaluation and development of DXL(TM) based antibodies. With these new partners and ongoing programs, we hope to formally announce and provide greater detail of our collaborative efforts during 2010. We will continue efforts to build industry collaborations by advancing these relationships and actively engaging additional pharmaceutical partners for potential collaborations and licensing agreements.

In the coming year, we also expect to further advance our lead product, DXL625 (CD20) as well as developing additional antibodies for oncology and other disease conditions, showcasing the potential for DXL(TM) based products and our offering to the pharmaceutical industry.

We believe our partnering activities will provide significant value to the company and its shareholders. The InNexus leadership team is confident that the company has intellectual resources and a business strategy to not only survive but also truly thrive in this economically difficult environment.

Thank you for your continued support of our efforts and best wishes, Jeff Morhet InNexus Biotechnology Chairman and CEO

InNexus Resources

-- AACR 2008 Scientific Poster on DXL625(TM)

-- DXL(TM) Pipeline & Programs

-- Stock Quick Check

-- Scientific Advisory Board

-- Leadership Team

About InNexus Biotechnology

InNexus Biotechnology Inc. is a public biotechnology company commercializing the next generation of monoclonal antibodies based on its DXL(TM) technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL(TM) antibodies utilize unique, novel and patented methods and technologies of InNexus. InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus Biotechnology Inc. is listed on the TSX Venture Exchange (TSX.V:IXS). To learn more about InNexus, please visit www.ixsbio.com.

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.

SOURCE: InNexus Biotechnology Inc.

InNexus Biotechnology Inc.
Jeff Morhet, Chairman & Chief Executive Officer
1-480-862-7500
www.ixsbio.com

InNexus Announces Business Development Initiative

for DXL625, Royalty Pharma Comments

SCOTTSDALE, ARIZONA, August 5, 2009 – InNexus Biotechnology Inc. (TSX.V:IXS, www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL™) technology, announced today that the Company will embark on a business development initiative for DXL625™ (CD20), the Company’s lead preclinical candidate for the prospective treatment of Non-Hodgkin’s Lymphoma and/or Chronic Lymphocytic Leukemia.

“We have worked hard to establish DXL625 as a superior therapeutic over Rituxan®,” said Jeff Morhet, Chairman and CEO. “We have also optimized our manufacturing process for production of clinical Phase I materials at our facility on the Mayo Clinic campus in Scottsdale, Arizona, and established safety with the successful completion of our toxicology studies last year. We are pleased to continue working toward a 2010 Investigational New Drug Application (IND) submission to the FDA.”

Royalty Pharma – the industry leader in acquiring revenue-producing intellectual property, with royalty interests in such blockbuster biopharmaceutical products as Abbott’s Humira®, J&J/Centocor’s Remicade®, Pfizer’s Lyrica®, Amgen’s Neupogen® and Neulasta®, Genentech’s Rituxan®, Gilead’s Emtriva®, Truvada® and Atripla®, and Celgene’s Thalomid® – holds a royalty interest in the DXL625 product candidate.

Pablo Legorreta, Chief Executive Officer of Royalty Pharma stated, “The recently announced successful meeting with the FDA and the agency’s expressed support for InNexus’ proposed clinical pathway for DXL625 is very encouraging. We remain supportive of InNexus’ continued development of DXL625. We are excited to have this product candidate as a part of our portfolio of royalty interests on leading biopharmaceutical products.”

InNexus Resources

AACR 2008 Scientific Poster on DXL625™
DXL™ Pipeline & Programs
Stock Quick Check
Scientific Advisory Board
Leadership Team



About InNexus Biotechnology

InNexus Biotechnology Inc. is a public biotechnology company commercializing the next generation of monoclonal antibodies based on its DXL™ technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL™ antibodies utilize unique, novel and patented methods and technologies of InNexus. InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus Biotechnology Inc. is listed on the TSX Venture Exchange (TSX.V:IXS). To learn more about InNexus, please visit www.ixsbio.com.

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.




Contact

Jeff Morhet, Chairman & Chief Executive Officer

InNexus Biotechnology Inc.

1-480-862-7500

www.ixsbio.com

well beaten down indeed - atleast volume has picked up a bit

Decent news for this company this morning, been well beaten down, now Spanish company comes for collaboration


InNexus and Genhelix to Combine Antibody Development and Manufacturing Resources
INNEXUS BIOTECHNO INC IXS
7/10/2009 9:10:00 AM
LEON, Spain & BRITISH COLUMBIA, Canada, Jul 10, 2009 (BUSINESS WIRE) --
InNexus Biotechnology Inc. (TSX Venture: IXS) (OTCBB: IXSBF) and Genhelix Biopharmaceutical Company announced today the signing of a Letter of Intent to set the stage for a planned strategic collaboration to focus on developing novel antibodies engineered with InNexus' DXL(TM) technology.
The research and licensing agreement between the collaborators is expected to be completed later this year. InNexus will conduct preclinical development for a DXL(TM) therapeutic against an undisclosed target, with Genhelix providing GMP production and commercial manufacturing. DXL(TM) antibodies are biologics engineered with the novel ability to link with one another (self-binding) upon reaching their target, exhibiting marked enhancements for ADCC and CDC functions over the source antibody.
News of the planned alliance follows InNexus' recently announced successful meeting with the FDA, where the agency expressed clear support for the company's product development plans following a comprehensive review of the proposed clinical pathway for its lead preclinical candidate, DXL625 (CD20) for the prospective treatment of non-Hodgkin's lymphoma and/or chronic lymphocytic leukemia. The agency also provided a Manufacturing Exception Approval allowing InNexus to manufacture all clinical material needed for DXL625's Phase l human trial, in its facilities located on the campus of Mayo Clinic in Scottsdale, Arizona.
Speaking on the announcement, David Marcos Martinez, Chief Executive Officer of Genhelix, said, "The antibody industry is growing at an unprecedented rate. Today, it is estimated to have over $30 billion in worldwide sales, and antibodies are expected to be the pharmaceutical industry's leading choice for the development of new therapeutic compounds. We are excited to be working with Mr. Morhet, his team and the partnership, as both organizations have enormous potential."
Jeff Morhet, Chief Executive Officer of InNexus, said, "Our organizations are poised to strategically collaborate as partners focused on the development of new products, while maintaining our respective business competencies. This collaboration provides significant opportunities for both companies, and represents a creative approach to partnering that brings resources and capabilities together while the partners stay focused."
About Genhelix Biopharmaceutical Company
Genhelix is an independent biotechnology-based company devoted to the manufacturing of biopharmaceutical products through the application of mammalian cell culture technology under contract manufacturing agreements. The mission of the company is to produce high-value active compounds in the fields of anti-cancer, cardiovascular or immunology therapies. Applied technologies are based on monoclonal antibody manufacturing. Genhelix currently has agreements with leading biotechnological companies from Europe, America and Japan. To learn more about Genhelix, please visit www.genhelix.com.
About InNexus Biotechnology Inc.
InNexus is a public biotechnology company commercializing the next generation of monoclonal antibodies based on its DXL(TM) technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL(TM) antibodies utilize unique, novel and patented methods and technologies of InNexus. InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus Biotechnology Inc. is listed on the TSX Venture Exchange (TSX Venture: IXS) and the NASD OTCBB (OTCBB: IXSBF). To learn more about InNexus, please visit www.ixsbio.com.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.
SOURCE: InNexus Biotechnology Inc.
Genhelix Biopharmaceutical Company David Marcos Martinez, Chief Executive Officer +34 987 219 558 www.genhelix.com or InNexus Biotechnology Inc. Jeff Morhet, Chairman & Chief Executive Officer +01 480-862-7500 www.ixsbio.com
Copyright Business Wire 2009