BLG News Spring 2008
News from the Baylor Licensing Group
Volume 8, No. 1 Spring 2008
In this issue we cover recent news from seven of our licensees. They have been working to advance Baylor College of Medicine technology through their fundraising, product development and promotional activities.
Baylor Licensing Group's primary responsibility is to execute licenses to transfer research discoveries and inventions into the marketplace to benefit the public. For a laboratory discovery to move from "the bench to the bedside," a commercial partner must be found to develop the technology and shepherd it through the difficult and costly process of obtaining regulatory approvals. Without this commercial involvement and investment, many of the best, most exciting laboratory discoveries will never make it to the clinic. BLG provides the link between the Baylor's academic community and the commercial sector. BLG executes between 40-50 new licenses on Baylor innovations each year. The seven licenses profiled in this newsletter are examples of the more than 500 active licenses currently managed by BLG.
In this issue:
Agennix
American Diabetes Association
Engene
Ligocyte
Opexa
TyRx
VGX
Agennix, Inc.
Agennix, a Baylor company started in 1993, has continued to make notable progress in its efforts to develop its key product talactoferrin. Talactoferrin is based on a recombinant form of human lactoferrin developed by Drs. Orla Conneely and Bert O'Malley in the Department of Molecular and Cellular Biology.
Agennix recently achieved three major milestones. First, the company received approval from the FDA and the EMEA for its Phase III trial design for use of talactoferrin in combination with chemotherapy, as first-line treatment in patients with non-small cell lung cancer (NSCLC). The FDA approval included approval of a Special Protocol Assessment; the EMEA approval was through the European Scientific Advice process.
Second, Agennix concluded a successful Phase II trial of talactoferrin as monotherapy in patients with NSCLC that had progressed after chemotherapy. The study met the primary endpoint of increased overall survival. A second Phase II trial with talactoferrin as first-line therapy in combination with chemotherapy also yielded positive results. Agennix has received Fast Track designation from the FDA for both of these NSCLC indications, and is preparing to initiate Phase III trials in both indications.
Last, in late April Agennix announced the start of a randomized, double-blind, placebo-controlled Phase 2 study of talactoferrin in patients with severe sepsis. The study is being funded by a $3 million NIH grant, and will be conducted at approximately 25 leading U.S. centers.
BLG submitted a narrative on Agennix and its talactoferrin therapy to the Association of University Technology Managers 2008 Better World Report; Technology Transfer Works: 100 innovations from Academic Research to Real-World Application. The Better World Report is an AUTM publication that demonstrates how academic research activities contribute to the betterment of society through invention and innovation. A copy of the story on Agennix can be found on our web site.
American Diabetes Association
A set of educational materials called C.H.A.S.E. (Choosing Health and Sensible Exercise) was licensed to the American Diabetes Association by Baylor. The materials are used as a comprehensive program of health education and physical activity to promote healthy lifestyles and prevent type 2 diabetes in young people ages 8-17. C.H.A.S.E. was developed by Ms. Jennifer Markesino-Roberts and Dr. Valery Pavlik in the Department of Family and Community Medicine.
The C.H.A.S.E. program has been implemented in two elementary schools in Galena Park. Recently, U.S. Senator John Cornyn of Texas observed students at MacArthur Elementary school participating in activities and games as part of the program. Houston Public Radio reported on the event and photos can be found on the senator's web site.
enGene, Inc.
In 2001 Baylor licensed to enGene, Inc. patents covering gene delivery to the intestine. This technology was developed in the early 1990s by Dr. Susan Henning in the Department of Pediatrics and Dr. Fred Ledley in the Department of Molecular and Cellular Biology. enGene is using this technology to modify intestinal K cells to produce and secrete insulin to treat diabetes. enGene’s animal studies have shown promising results.
enGene recently raised $6.4 million in a Series A financing last month to support further development of their diabetes program. The funds will allow them to meet key developmental milestones to enable a larger Series B financing.
LigoCyte Pharmaceuticals, Inc.
We reported in our Spring 2007 newsletter that LigoCyte initiated a Phase I trial for its virus-like particle (VLP) -based norovirus vaccine. This trial is ongoing and is expected to conclude later this year. The vaccine under development at Ligocyte utilizes an intranasal route of administration, which should result in a strong mucosal immune response.
The norovirus vaccine is based on licensed patents covering Norwalk proteins, antibodies and VLPs. This technology was developed at Baylor by Dr. Mary Estes in the Department of Molecular Virology and Microbiology and Dr. David Graham in the Department of Medicine.
In March LigoCyte finalized a Series C financing of $28 million involving a syndicate of leading life science venture capital firms, which indicates a very strong vote of confidence in the company’s developmental programs. The ability to garner this level of financing was based on recent advances by LigoCyte in both influenza and norovirus vaccines; in particular the norovirus trial. The funds will be used to advance both vaccines through the clinic.
The norovirus VLP technology provides an illustration of the fact that the road to commercial and clinical development is often challenging. Dr. Estes first disclosed this technology to BLG in 1989. It was originally licensed to a major pharmaceutical company with a program focused on development of a vaccine against viral gastroenteritis. The pharmaceutical company decided to exit the market for these vaccines and returned rights to the technology to Baylor. BLG then executed a license agreement with Ligocyte to develop the norovirus vaccine. It is rare that a technology will get a second chance like this. Many times a company won’t be attracted to a technology that another company has decided against developing.
Opexa Therapeutics, Inc.
Opexa Therapeutics was formed in 2001 to commercialize technology developed at Baylor. Opexa's technology platform is based on autologous T-cell and stem cell therapies developed by Dr. Jingwu Zang, formerly of the Department of Neurology. The company's lead product, Tovaxin®, a T-cell therapy for Multiple Sclerosis is in Phase IIb trials. The company recently raised $6.8 million in a public offering which will fund the Phase IIb trial to completion. A mid-study analysis of the trial was conducted this spring and the independent Data Safety Monitoring Board recommended that the trial be continued as scheduled, suggesting the trial is yielding anticipated results.
BLG also submitted a story on the history of Opexa and Tovaxin® to the AUTM 2008 Better World Report and it was accepted for publication. Opexa's Better World Report story can be viewed on our web site.
TyRx Pharma, Inc.
In our Fall 2006 newsletter, we included an announcement by TyRx Pharma that they had received 510K clearance for their first product, a bioresorbable soft tissue surgical mesh coated with antimicrobial technology licensed from Baylor and The University of Texas M.D. Anderson Cancer Center.
In January 2008 TyRx announced it had also received FDA clearance on its second product, an antibacterial envelope for a cardiac rhythm medical device. The envelope is made of the same bioresorbable mesh and uses similar licensed antimicrobial coatings. This press release can be found on our web site.
In addition, TyRx has raised $25 million which will be used to develop and launch other anti-infective, implantable medical devices.
VGX Animal Health, Inc.
VGX Animal Health was formed in February 2007 by VGX Pharmaceuticals upon its acquisition of ADViSYS, a Baylor start-up company. VGX Animal Health received approval in Australia in January 2008 for its porcine Growth Hormone Releasing Hormone DNA technology, LifeTideTM SW 5. LifeTideTM SW 5 is an injectable DNA plasmid expressing GHRH which is administered to sows of breeding age. Studies have shown that LifeTideTM SW 5 can increase the number and survival of piglets born per sow, enhancing food production.
The GHRH therapy was developed in the laboratories of Dr. Robert J. Schwartz, formerly in the Department of Molecular and Cellular Biology, and Dr. Ruxandra Draghia-Akli formerly in the Department of Molecular and Cellular Biology and the Center for Cell and Gene Therapy.