BLG News Fall 2006

News from the Baylor Licensing Group
Volume 6, No. 1 Fall 2006

In this issue, we provide updates on companies developing products based on inventions licensed to them by BLG. To give you an idea of the variety of things we license, we have also listed examples of 60 products currently on the market developed from Baylor inventions.

Topics in this issue:
Agennix Inc – Persistence is Key
Products from Baylor College of Medicine
InfraScan Announces Initiation of a Clinical Trial in Brain Hematoma Detection
TyRx Received 510K Clearance on First Product, Files 510K for Second Product
Opexa Initiates Phase IIb Clinical Trial of Lead Product

Agennix Inc – Persistence is Key

Agennix Inc. (www.agennix.com) is a private biotechnology company started by Baylor in 1993. Agennix is developing talactoferrin, a recombinant form of human lactoferrin for the treatment of cancer and wound healing.

In the late-1980s, Drs. Orla Conneely and Bert O’Malley in the Department of Molecular and Cellular Biology at Baylor anticipated the value of producing human lactoferrin for the commercial market. They cloned and developed a method of expressing human lactoferrin in Aspergillus using novel vector constructs. They continued to refine their expression system and by 1994, they were able to produce very high levels of lactoferrin. The first patent was filed in 1989 and the patent family, managed by Agennix, now consists of more than 90 issued and pending patents in the United States and worldwide.

After obtaining the patent rights under a license from Baylor in 1993, Agennix started down the long path of product development. The hurdles they have faced have been typical of many new companies. One of the most significant hurdles is fundraising; a total of $86 million dollars have been raised so far by Agennix over many financing rounds. Another has been choosing the right commercial focus; Agennix has had to reinvent itself with respect to what their product would be. Other challenges include costly patent litigation, finding partners for GMP manufacturing and clinical trials and meeting requirements of the FDA for biologics.

Despite facing challenges, Agennix is moving forward with its product development efforts. In October Agennix received news of two regulatory successes. First, the Food and Drug Administration granted Fast Track designation to their talactoferrin clinical development programs for non-small cell lung cancer (NSCLC) and diabetic foot ulcers. Fast Track is designed to facilitate the development and FDA review of drugs that treat serious diseases and address unmet medical needs. Agennix submitted applications to the FDA for Fast Track designation based on positive Phase II results with oral talactoferrin solution in NSCLC and with topical talactoferrin gel in diabetic foot ulcers.

Second, the FDA granted orphan drug designation to the oral formulation of talactoferrin for the treatment of renal cell carcinoma, an indication currently in Phase II clinical development. The U.S. Orphan Drug Act provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans.

Agennix has demonstrated that persistence is required to be a successful start up company. Agennix aims to file its first BLA application in the second half of 2008, over 15 years after the company was formed and more than 20 years from when the project to produce lactoferrin at Baylor was first initiated.

Products from Baylor College of Medicine

As of fiscal year 2006, there were 60 products on the market that depended on technology developed at Baylor and licensed by BLG. Six of these products were launched by Baylor’s commercial partners in fiscal year 2006. Examples of products on the market from Baylor include:

Antibodies used as research reagents
A genetic diagnostic for Charcot-Marie Tooth disease
An oligonucleotide synthesis method using porous wafers (ABACUS^TM)
Database software based on the BRAIN database
A DNA profiling method using short tandem repeats
A blood centrifugation device for rapid replacement with reduced hemolysis of red blood cells during surgery
A cloning system for expression studies (ECHO^TM)

Companies selling these products are paying royalties to Baylor and those royalties are distributed by BLG according to the Baylor Policy on Patents and Other Intellectual Property.

Other Company News:

InfraScan Announces Initiation of a Clinical Trial in Brain Hematoma Detection

InfraScan Inc., a medical device firm specializing in brain injury diagnostic products, recently announced initiation of its clinical trial for hematoma detection using the Infrascanner^TM handheld brain hematoma detector. The trials are taking place at Baylor and at the Hospital of the University of Pennsylvania. InfraScan is planning to use the data from the clinical trial to file a 510K application with the FDA in early 2007. Infrascanner^TM is a portable imaging device using near infrared (NIR) technology for the detection of hematoma, or trauma induced bleeding in the brain.

Infrascanner^TM device is based on technology developed by Drs. Claudia Robertson and Shankar Gopinath in the Department of Neurosurgery at Baylor in collaboration with Dr. Britton Chance at University of Pennsylvania. This technology was licensed to InfraScan by the joint owner of the technology in 2005. This handheld scanner will speed up triage of patients with head injuries allowing for faster treatment for those who need it.

TyRx Received 510K Clearance on First Product, Files 510K for Second Product

TyRx Pharma Inc. received FDA clearance in July for their Antimicrobial Surgical Mesh, which is coated with a bioresorbable polymer coating impregnated with the antimicrobial compounds rifampin and minocycline. The surgical mesh is used in repair of soft tissues and the coating prevents microbial colonization of the repair site. In October, TyRx filed a 510K application with the FDA for a mesh pouch coated with the same bioresorbable polymer containing the antimicrobial agents. The pouch is designed to enclose pacemakers or ICD pulse generators to be implanted into the body.

The concept and the methods used to incorporate the antimicrobials were developed by Dr. Rabih Darouiche in the Department of Physical Medicine and Rehabilitation with collaborators at the M. D. Anderson Cancer Center. In our last newsletter we announced the completion of the license agreement with TyRx. Combining Baylor‘s antimicrobial coating methods with the bioresorbable polymer has allowed TyRx to move products into the market that improved patient outcome through lowering the risk of infection of these devices.

Opexa Initiates Phase IIb Clinical Trial of Lead Product

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development of cell therapies, has initiated a 150-patient Phase IIb clinical trial of Tovaxin^TM in multiple sclerosis. Tovaxin^TM consists of attenuated autoreactive T cells that are non-replicating but viable. They elicit an immune response directed against T cells within the patient that are self-reactive with myelin reducing the number of these autoreactive T cells in MS patients.

Specific sequences key to identifying the T cells and methods to create the attenuated autoreactive T cells were developed by Dr. Jingwu Zhang Zang in the Department of Neurology. These inventions were licensed to Opexa Therapeutics by BLG in 2001. Tovaxin has demonstrated a very good safety profile and should gain wide acceptance from MS patients and their physicians.

BLG Contact Information

For any questions related to inventions, patents and licenses, please contact BLG.

Baylor Licensing Group
One Baylor Plaza
BCMD-600D, MSC 210
Houston, TX 77030b

Phone:       713-798-6821
E-Mail:       blg@bcm.edu
Web site:    http://www.bcm.edu/blg/