By Mary Welch
Avax Technologies Inc. raised $10.1 million in a private placement to fund Phase III trials of M-Vax, its autologous cancer vaccine for melanoma, and additional studies of O-Vax for ovarian cancer.
¿It went very quickly,¿ said Jeffrey Jonas, president and CEO of Kansas City, Mo.-based Avax. ¿We had investors come in, look at the company and spend major dollars at a premium to market price. It¿s a happy event.¿
The private placement involved the issuance of 101,300 shares of Series C convertible preferred stock with a conversion price of $3.25, representing a premium over the average closing bid price for Avax¿s common stock for the five trading days prior to Feb. 11, which was the date of pricing.
Purchasers also received warrants to buy 311,692 shares of common stock with an exercise price of $4, and 311,692 shares with an exercise price of $4.50. The warrants are exercisable over a five-year period.
Investors included Essex Woodlands Health Ventures Fund IV LP, of Chicago, and the Petrus Fund LP, an affiliate of Perot Investments, of Dallas. As part of the financing, James Currie, of Essex Woodlands, joined Avax¿s board of directors.
¿We have a five-year plan for the company, including anticipated milestones, and this [$10 million] was what was required to get us the next hurdles¿ involved in bringing the drugs to market, Jonas said. ¿It was our chosen strategy, and will get us through 2000. It is part of our objective to go from a developmental company into one poised for commercialization. Of course, we will continue to look at domestic as well as international opportunities for marketing our vaccines.¿
Avax began its Phase III trial of M-Vax for Stage III melanoma in October 1997. The study, later delayed in order to answer some questions the FDA had about manufacturing, was re-started last July. So far, the company has 15 sites and plans to enroll 400 patients at 25 sites. (See Bio World Today, Oct. 31, 1997, p. 1, and July 28, 1998, p. 1.)
Jonas estimates enrollment will take between 12 months and 24 months, with a new drug application (NDA) filing expected in 2000 or 2001. Two pre-planned interim analyses will be conducted.
Last August, Avax completed a Phase I/II immunological study of O-Vax, its experimental vaccine of haptenized autologous ovarian cancer cells. The results, which Jonas dubbed ¿promising,¿ will be presented later this year. The company is also gearing up for a larger, multi-site Phase I/II trial of O-Vax.
The financing will also fund Phase I/II trials of a topoisomerase inhibitor and anti-estrogen technologies, which should start this year.
¿The technology used to create the vaccine for melanoma is readily transportable to other cancers, which was how we were able to develop one for ovarian cancer so quickly,¿ Jonas said. ¿We expect the vaccine can be used for other cancers as well.¿
Incorporated in 1990 as Nehoc Inc., the company changed its name to Avax in 1996. In 1995, the company bought from Thomas Jefferson University, in Philadelphia, the exclusive worldwide rights to develop, manufacture and sell a patented autologous cell vaccine, which works by conjugating the patient¿s tumor cells to a small molecule known as a hapten (dinitro phenyl) and then injecting them back into the patient along with an agent that boosts immune response (cyclophosphamide, commonly used in chemotherapy).
Haptenized molecules, recognized by the immune system, sometimes elicit an immune response against the unmodified cancer molecule as well.
Avax¿s stock (NASDAQ: AVXT) closed Wednesday at $3.625, up $0.062. n