No more nosocomial infection

Novel approach to fighting hospital-acquired infections teams sanofi-aventis and U.S biotech Alopexx

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PARIS—sanofi-aventis and Alopexx Pharmaceuticals announcedin December that the two companies will begin a collaborative relationship toadvance the development of a first-in-class human monoclonal antibody for theprevention and treatment of S. aureus, S.epidermidis, E. coli, Y. pestis (thebacterium that causes plague) and other serious infections. Currently inpreclinical development, the new agreement includes an option for licensing theantibody at a later date.


Hospital-acquired, or nosocomial, infections continue to bea persistent problem in medical facilities around the globe. In 2005 alone,nearly 3 million cases of hospital-acquired infections were recorded in theUnited States. It is estimated that that number will continue to increasewithout powerful new weapons in the battle against organisms such asstaphylococcus, E. coli, MRSA and others that are attributed to increasingnumbers of both nosocomial and non-hospital-related infections.


Alopexx's new therapy is not an antibiotic. The therapy,known in testing as F598, is an antibody that has the potential to serve as analternative to antibiotics in the fight against MRSA (methicillin-resistantS.aureus) and other infections. Unlike antibiotics, monoclonal antibodies arenot expected to lead to the development of bacterial resistance to the therapy.


"F598 is a novel approach to treating these infections,"says Dr. Daniel Vlock, CEO of Cambridge, Mass-based Alopexx. "It is a humanmonoclonal antibody that attaches to the surface of bacteria. F598 can target anumber of bacteria, such as those known as MRSA, staph, E. coli and theplague."


Vlock adds, "We know the medical community world-wide needsan alternative approach to solve the growing problem of these nosocomialinfections. So many of the infections are becoming drug-resistant. This iswhere our approach can gain ground."


sanofi-aventis sees the global potential in Alopexx'stherapy, says Jack Cox, senior director of public affairs and media relationsfor sanofi-aventis in the United States.


"The emergence of antibiotic resistant infections is andremains an unmet medical need," Cox says. "The antibody Alopexx is developing,F 598, has the potential to be a first-in-class human antibody for preventionand treatment of nosocomial infections. This deal is totally in line with ourobjective of remaining a key player in the anti-infective arena and with ourstrategy of complementing our R&D pipeline with external opportunities."


The target of the antibody is a carbohydrate on thebacterial capsule known as PNAG. PNAG has been found to be a critical factor inthe virulence and immune response to staphylococcal infections. S. aureusstrains that cannot produce PNAG have a significantly reduced ability to causeinfections. The antibody is directed against PNAG and works by inducing killingby the patient's own white blood cells.


Under this agreement, Alopexx will bring the product intoPhase I clinical trials during 2010, with an option for an exclusive worldwidelicense for sanofi-aventis to develop and then commercialize the productthrough additional licensing. Alopexx will receive an upfront payment andresearch funding from sanofi-aventis and is eligible for development,regulatory and commercial milestone payments that could total $375 million, aswell as additional royalty payments for sales of products commercialized underthe license and collaboration.


Alopexx's Vlock said the time was right to find a big pharmaceuticalpartner to advance the work of his company.


"We've been in discussions with a number of possiblepartners," Vlock says. "It became increasingly obvious to us thatsanofi-aventis would make a good partner at this time. sanofi is in the midstof a major effort to reach out to biotech companies such as ours; it made agood fit for both of us. A large pharmaceutical partner at a particular pointin a company's development is a good idea and an important milestone. We needthat collaboration with a large partner going forward and to take our nextstep."


sanofi's Cox agrees that the time is right for an aggressivenew approach to fighting infections, as the number of nosocomial infectionstrends higher each year.


"It is estimated that there were approximately 2.9 millioncases of hospital-acquired infections in the 2005," Cox said. "Of thatnumber, 1.2 million were due to gram-positive organisms, such asstaphylococcus. That number is expected to increase to 1.9 million this year.Over the same time period, infections resistant to multiple anti-bacterials areexpected to almost double from over 600,000 to close to 1.2 million."


Alopexx Pharmaceuticals was co-founded by Dr. Gerald Pier aprofessor of medicine at Brigham and Women's Hospital and Harvard MedicalSchool, and Vlock. The company seeks to develop and explore the use of noveltherapies for the treatment and prevention of MRSA and other seriousinfections.


Sanofi Pasteur expands global dengue vaccine program inLatin America


MEXICO CITY, Mexico—Sanofi Pasteur, the vaccines division ofthe sanofi-

aventis Group, announced in December the expansion of itsdengue vaccine clinical program in Latin America with a new multicenter studyin children and adolescent in

Mexico, Colombia, Honduras and Puerto Rico. The newmulticenter study complements an earlier study in Mexico and an ongoing studyin Peru.


According to Sanofi Pasteur, the studies are aimed atadvancing the development of a novel vaccine for the prevention of dengueinfections in Latin America. Currently, there is no specific treatmentavailable against dengue fever, which is the most widespread tropical diseaseafter malaria.


Sanofi Pasteur started the development of a dengue vaccinein the 1990s. Clinical studies with its most advanced tetravalent candidatevaccine started in the 2000s. Sanofi Pasteur's dengue vaccine candidate hasbeen evaluated in Phase I and II clinical trials in adults and children fromnon-endemic (U.S.) and endemic countries (Mexico, Philippines). Overall, abalanced immune response against all four serotypes was observed after threedoses of the vaccine. The vaccine appears to be well tolerated with a similarsafety profile after each dose. 


Sanofi Pasteur's dengue vaccine research program includesongoing clinical studies with adults and children in Mexico, Colombia,Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore and Thailand.


"Fighting dengue is of the utmost public health importance;we must remain on epidemiological alert as dengue continues to circulate inLatin America," says Dr. Jorge Mendez, investigator at the children's hospitalFederico Gomez in Mexico and co-investigator for the evaluation of a denguevaccine in Mexico. "Clinical studies in Mexico are critical steps to advancethe development of a vaccine for the prevention of dengue. We are happy thatMexico contributes to scientific research that would benefit the entireregion."


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