HAMBURG, Germany — Only a half-year after its founding, Mologen Holding AG, of Berlin, reported several partnerships with pharmaceutical companies.

Virbac, a French veterinary vaccine producer, will obtain two exclusive licenses for the use of Mologen's proprietary MIDGE DNA vaccine technology. In addition, Mologen has agreed on research collaborations with German and international companies to establish its proprietary MIDGE-technology in clinical studies targeting infectious diseases and cancer.

Mologen, a young German start-up founded in May, is a company concentrating on the development of DNA vaccines for the prevention and treatment of infectious diseases and cancer, in humans and animals.

"In the pharmaceutical industry there is great interest in DNA vaccines," Burghardt Wittig, founder and CEO of Mologen, told BioWorld International. "One of their biggest advantages is their potential to stimulate long-lasting immunity, both cell and antibody-mediated. Besides, they possess heat-stability and they can be constructed as multivalent vaccines."

One of the greatest challenges, however, is delivery and safety. DNA vaccines derived from classic plasmid constructs tend to be large molecules, consisting of the gene to be expressed flanked by several genes necessary for the propagation process — bacterial and mammalian promoters, origins of replication, antibiotic resistance genes, etc.

"Large DNA molecules are difficult to deliver, however," Wittig explained. "Besides, the additional genes pose safety risks. They can lead to a strong immune response to bacterial proteins or they might be inserted into genomic DNA."

Mologen's MIDGE (Minimalistic Defined Gene Expression) vectors do not carry these disadvantageous sequence elements, but only the genetic message that must to be introduced into the patient. "Hence, our vectors are not only cleaner and safer, but very small and compact as well," Wittig said. "Their size is about 1/100th or 1/1000th the size of a classic viral vector so they are easy to deliver." Vectors can be modified chemically by adding peptides or small molecules.

"That way, we are able to facilitate a selective uptake by specific tissue or cells," Wittig said. "And, as we have a technology to bind our vectors to gold covalently, we can obtain a much deeper penetration of tissue using a gene gun." Normally, DNA gets lost in the upper cell layers, although the gold particles themselves travel much deeper into tissue. "However, our vectors are adaptable to any ballistic, liposome or electroporation transfer protocol for naked DNA," he said. "We have a strong patent portfolio for the design of these vectors and their transfer directly into the nuclei of cells. Core patents are on our so-called ballistomagnetic transfer, a combination of the gene gun technique with magnetic particles."

Mologen's MIDGE technology can be used to develop vaccines as well as vectors for gene therapy. Currently, the clinical value of the technology is investigated in Phase I clinical trials in patients with kidney cell cancer. Isolated tumor cells of the patients are treated with gene vectors to transfer genes that provoke an immune response against the tumor cells when they are transferred back into the body of the patient.

"We use a gene gun to transfer gold projectiles into the cells, on which the genes are bound very strongly," Wittig said. "With our technique, we are able to transfect up to 10 to the order of 7 cells at the same time. Magnetic particles allow us to separate the cells from unwanted byproducts. This 'ballistomagnetic' separation process simplifies the purification of the treated cells." Other proprietary inventions are a nozzle for the gene gun and procedure protocols that enable the use of the gene gun technology for clinical purposes. Wittig added he was well aware that therapies using autologous cells could be a first step only. Mologen was already developing strategies for a tumor vaccine mass market, he said.

"All in all, we sell the shovels for the coming gold rush in genetic vaccination," Wittig said. "We want to be present in the whole vaccine and vector business in the future. Our vector is safer and much more effective than anything else that has been developed so far."

Six months earlier than intended, Mologen has started a clinical trial of vaccines against a feline epidemic. Virbac, of Carros, France, this month obtained two licenses to develop vaccines against an infectious peritonitis in cats and against feline leukemia. Virbac is one of the biggest producers of animal vaccines and is known for its intense vaccine research.

"With these clinical trials and alliances, we are well ahead of our schedule," Wittig said. "We are especially proud that our human health products are in the same research and development stage as our small animal products. In our strategic planning, we had anticipated that we would find partners willing to invest in [collaborations] for human clinical trials only in a couple of years. And, despite our accelerated and extended research activities, we could keep the costs within the scope of our planning."

Financial details of the alliances and the names of the partners for the human clinical trials were not disclosed. *

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