Late last spring Advaxis (OTCBB:ADXS) was down to its last $115,000. The biotechnology company, working on a cure for cervical cancer and for head and neck cancer based upon injecting modified listeria bacteria to destroy it, was burning through cash at a rate of about $180,000 a month.
How nervous was CEO Thomas Moore at that point?
“It’s always a concern,” he says, “but we knew we would eventually get the funding.” Biotechnology, he adds, “is not for the faint hearted.”
Moore backed up his faith with cash, providing a bridge loan of $400,000 in August. He also raised an additional $200,000 at that time. It was enough to get Advaxis through to early-October, when it was able to provide details on two developments that will take it to the next level.
On October 9 the company reported that Phase I/II trials of its product, Lovaxin C, indicated that it is safe for humans. The 111-day trial on a small group of women with end stage cervical cancer indicated that the treatment stimulated their immune systems, as it is designed to do. It also established a dosage ceiling. At the first two dosage levels, relatively tolerable flu-like symptoms occurred, but at the third level symptoms were “more severe and dose limiting.”
On October 18 receipt of funding to carry on the research was announced. The company had reeled in $9.4 million from the sale of common stock and warrants to several institutional and accredited investors.
The deal was not contingent on the release of a report on the Phase I/II trial, says Moore, but the finding was indeed helpful in consummating the funding round.
“We knew that Lovaxin was safe by the summer,” he says. The company had released information to that effect, but the final report was not ready at that time.
Advaxis is now preparing to move ahead with three separate Phase II studies in which it hopes to establish that Lovaxin will destroy cancer cells — and keep them from returning. Most of the money from the recent funding round will go into these studies.
“An arm of the National Cancer Institute will conduct a test of Lovaxin with healthier cervical cancer patients with stronger immune systems,” says Moore. This group is doing the trial at its own expense.
In the second trial, Advaxis is testing its treatment on women with cervical dysplasia. This is a pre-cancerous change in cells that is now often treated by removing a part of the cervix, or even by a hysterectomy, especially if the dysplasia is advanced. Treatment with his company’s drug, Moore points out, could therefore be especially beneficial for women of childbearing age.
In the third trial Lovaxin will be tested on patients with head and neck cancers. It might seem strange that the same treatment could be effective on such disparate parts of the body, says Moore, but he explains that the same virus that causes most cases of cervical cancer also causes 30 percent of head and neck cancers.
Advaxis is designing and conducting the second and third trials itself. Moore says that the cervical dysplasia trial should begin in March, 2008. Subjects in the trial will be treated for six months, and results could be published in one year.
The head and neck trial will take considerably longer. It is designed to show whether Lovaxin can reduce the return of cancer cells following standard treatment — surgery to remove the tumor and then radiation. Recurrence rates now are about 25 percent, and Moore posits that Lovaxin can reduce that percentage to 10 percent. In animal tests, he says, Lovaxin has been so effective that no matter what researchers do, they cannot induce the cancer to return.
“But animals aren’t people,” he is quick to add.
In a quick tutorial Moore explains the science behind listeria injections. The theory that bacteria could possibly cure cancer, Moore says, has been around since the late-1800s, when a doctor in New York City noticed that tumors in patients with measles and similar diseases got smaller. “He began to inject them with these diseases,” he says.
The science behind Advaxis’ treatment was developed by Yvonne Paterson at the University of Pennsylvania. The theory is that the bacteria, which, says Moore, “is so modified that even its mother wouldn’t recognize it,” will put a patient’s immune system “on red alert.” The injected bacteria will then direct the aroused immune system to attack the cancer cells. It will forever be on the lookout for their re-emergence, and therefore just one course of treatment, theoretically, will both eradicate the cancer cells and will keep them from coming back.
Cancer treatment by therapeutic injection of bacteria is completely different from any other current treatment, says Moore.
Moore puts commercialization at five to seven years down the road, but is also designing trials with an eye toward getting speedier FDA approval should Lovaxin quickly prove itself to be a life-saving therapy. Meanwhile, the $9.4 million he has just spent months raising is likely to last only until the end of 2008 or the very beginning of 2009. More fund-raising will be necessary. It is possible that an infusion of cash could come through a partnership with a large pharmaceutical company. Moore has an eye out for that possibility, but says that, realistically, it is too early in the game for that to occur.
Meanwhile, the fresh cash gives him some breathing room. It also gives him at least a little time to spend on another venture, the sale of his, Tusculum, the former farm and summer residence of John Witherspoon, a signer of the Declaration of Independence. Moore and his wife, Avril, Princeton University classmates (Class of 1973), who have three grown children, restored the historic home, and have sold some 60 acres of the property for public open space preservation.
The house, along with the 23 remaining acres of land that surround it, is now on the market for $12 million, a record asking price in Princeton. Marketing is going well, says Moore, commenting that “it was in the Wall Street Journal.”
He knows that selling a house in that price range will take time, and does not sound stressed by the process. Moving a super-luxury home in this market is difficult, but not nearly as difficult as finding a cure for cancer.
Advaxis (ADXS), 675 Route 1 South, North Brunswick 08902; 732-545-1590; fax, 732-545-1084. Tom Moore, CEO. Home page: www.advaxis.com.
New in Town
Pharmaceutical Regulatory Services, 111 Commons Way, Suite 111, Princeton; 609-945-3137; fax, 609-497-9695. Jurij Petrin, president and CEO. www.pharmregservices.com.
Pharmaceutical Regulatory Services, consultants in drug development, has opened an office in Montgomery Commons to house its pharmacovigilance department. The company registers drugs around the world and does clinical trials.
Jurij Petrin, the president and chief executive officer, started his career as an academic in internal medicine at the University of Ljubljana Medical School. He then moved to Bristol-Myers Squibb in Munich as medical director for central and eastern Europe before coming to Princeton to be the company’s executive director of international regulatory affairs. He ended his career at Bristol-Myers Squibb as vice president of intercontinental regulatory science, responsible for regulatory activities in the markets outside of the United States and Europe.
ZRG Inc., 3371 Route 1 South, Lawrence Commons, Suite 215, Lawrenceville 08648; 609-275-6600; fax, 609-275-6677. Steve Tosches, managing director. Home page: www.zrgroup.com.
ZRG Inc., an executive search firm headquartered in Westborough, Massachusetts, recently opened an office in Lawrence Commons. The firm also has an office in Ramsey, New York, and two in California. Steve Tosches, the managing director, was Princeton University’s head football coach for 13 years. He lives in Princeton, but had been working out of the Ramsey office. He has one other colleague in the office and will be adding another one or two in the near future.
ZRG, which reported 63.7 percent revenue growth in the first half of 2007, focuses on the broad umbrella of healthcare and life science companies. ZRG is retained by clients seeking executive-level talent, primarily at the director level and above. All of its contracts are exclusives, as opposed to contingency agreements, where several search firms simultaneously hunt for top talent for the same position with the same client.
The company changed its name to ZRG in January from Z Resource Group (the Z was the full “Zurich” until the late 1990s). “We felt that shortening it to just letters was easier from a marketing and communication standpoint,” says Tosches. “In the retained executive search world, many companies are referred to as just their letters.”
Tosches worked for 20 years in college athletics. He graduated from the University of Rhode Island and was inducted into its hall of fame in 1996. At his previous search firm, Tosches specialized in the healthcare, industrial, and scientific markets.
CytoMab BioSciences, 11 Deer Park Drive, Suite 102 A, Monmouth Junction 08852; 732-274-9450; fax, 732-274-9452. Faribourz Payvandi PhD, president. www.cytomabbiosciences.com.
Faribourz Payvandi founded CytoMab BioSciences two months ago with the goal of creating a diagnostic tool for use in the field of oncology. The company is also involved in research and development in oncology and inflammation. His plan is to collaborate with the University of Medicine and Dentistry New Jersey and Princeton University and to provide services for pharmaceuticals and biotechnology companies.
Payvandi earned a bachelor’s degree in biology from Northwest Missouri State University, a master’s degree from University of Nebraska-Lincoln, and a doctorate in immunology from the University of Medicine and Dentistry of New Jersey in 1997.
His work was in the fields of oncology and inflammation. From 1988 to 1994 he worked for Schering Plough and from 1997 to 1999 he worked Robert Wood Johnson Hospital as a postdoctoral fellow.
Before starting his own company he was with Celgene in Summit.
ComData, 34 Chambers, Princeton 08542; 609-921-0670; fax, 609-921-0672. John Stowe, director of national sales. Home page: www.comdata.com.
Comdata has moved from the Dow Jones complex in South Brunswick to smaller offices in downtown Princeton. The company processes credit card, gift card, and loyalty card transactions for merchants.
John Stowe, director of national sales, says that many employees, given the opportunity to work from home, had opted to do so. With its lease up and a need for less space, the company had the option of renting a smaller space where it was or moving. When Stowe heard that space was available in the Henderson building, he had no trouble making the decision.
“There are lots of places to go out for lunch,” he says, “and it’s closer to my home in Pennington.” It’s also closer to toy store Jazams, one of his young son’s favorite Princeton attraction.
Is his business competitive? “Oh yes,” says Stowe. “In fact, one of our biggest competitors, Heartland, is right across the street.” (Heartland Payment Systems has offices at 90 Nassau Street.)
Working from home is working out for his employees, but Stowe wants no part of it. “I have a two-year-old and one on the way,” he says. “I couldn’t do it, too many distractions. I don’t know how people work from home.”
Law Offices of Mark K. Smith, 3100 Princeton Pike, Building 1, Suite 1, Lawrenceville 08648; 609-896-2800; fax, 609-896-2808. www.marksmithlawfirm.com.
Mark K. Smith, who specializes in commercial, employment, and bankruptcy law, moved from 993 Lenox Drive into a 1,500-square-foot suite on Princeton Pike with his wife, Rosemarie Cataldo, a psychologist who treats both adults and children. She has been in building 4 of the same complex.
Before Smith opened his practice in 2004, he was a partner at Pellettieri, Rabstein and Altman, where he had practiced since 1994. At that firm he served as general counsel to Nelligan Sports Marketing from 2002 to 2004. Another Pellettieri attorney, Mel Narol, had also worked with Nelligan.
Narol died at about the time that Smith’s third child was on the way, and with the loss of that close relationship, says Smith, “the joy was no longer there.” So he left and started his own firm.
Nelligan is his largest client.
Born in Lakehurst, Smith received a bachelor of arts from Rutgers College in 1984 and a J.D. degree from Rutgers University-Camden in 1988.
Edward Hunter, Attorney, 3490 Route 1, Suite 15A, Princeton Service Center, Princeton 08540; 609-419-0077; fax, 609-419-0909.
Edward Hunter moved his law practice from building 15-A to building 11 at 3490 Route 1. His practice includes criminal and municipal courts, real estate, matrimonial law, and estates.
Nicholas C. Maida CPA, 379 Princeton-Hightstown Road, Building 3, Cranbury 08512; 609-443-4409. Joseph C. Maida CPA, president. Home page: www.ncmcpa.com.
Nicholas C. Maida has moved from 379 Princeton-Hightstown Road in Cranbury to a newer, more accessible space, with better signage, in East Windsor. The firm reports that sales are up, and it will probably be adding one more person after the first of the year. It also has an office in Ewing.
Atlantic Business Products, 4390 Route 1 South, Princeton 08540; 609-249-7917; fax, 609-919-9783. Rob Bain, vice president of sales. Home page: www.tomorrowsoffice.com.
As the result of a mass defection from a competitor, Atlantic Business Products has greatly expanded its presence in New Jersey. The company sells and services Savin/Ricoh copiers and provides both hardware and software for scanning and archiving records for easy retrieval.
Rob Bain, vice president of major accounts for Atlantic, says that he and approximately 40 others recently left another company, which he declines to name, to join Atlantic. He says that Atlantic is the only company that is authorized to sell Savin/Ricoh products throughout New Jersey.
In addition to the office on Route 1, Atlantic has just opened offices in Bloomfield and in Freehold. The 50-year-old company, with headquarters in Manhattan, has also opened three new offices in New York.
Its clients, says Bain, include businesses in all sectors, schools, and government entities. “We have accounts with from one to 4,000 machines,” he says. While Bain and many of his new New Jersey colleagues have been with Atlantic for only a short time, he says that most of the new employees have decades of experience in the industry.
Opportunities for All, 1733 South Broad Street, Hamilton; 609-394-7000; fax, 609-394-7002. Vernon Long, executive director. Home page: www.opp4all.com.
Opportunities for All, a for-profit employment agency specializing in placement for the disabled and non-disabled, has moved from 3490 Route 1 to larger quarters in what was the Holy Angels Catholic school and its rectory to accommodate growth. The organization now has 26 staff members and is providing more re-entry services, including training in culinary and carpentry skills.
Bristol-Myers Squibb Company (BMY), Route 206 and Province Line Road, Box 4000, Princeton 08543; 609-252-4000. Elliott Sigal MD, chief scientific officer, president, R&D. www.bms.com.
Jeremy Levin has joined Bristol-Myers Squibb as senior vice president of external science, technology, and licensing. He had been global head of business development and strategic alliances at the Novartis Institutes of Biomedical Research since 2003. Before that he was head of Physiome Sciences, then a Princeton company that was developing a computer model of the heart that simulated its biochemical interactions.
He also worked at Cadus Pharmaceutical and was managing director of Perseus Capital. Levin’s degrees are all from the University of Cambridge — a bachelor of arts in zoology, a master of arts and doctorate in cell biology and chromatin structure, and a doctor of medicine.
Heidelberg USA Inc., 21 Commerce Drive, Cranbury 08512; 609-395-9600; fax, 609-395-0021. Tom Watson, regional manager. www.us.heidelberg.com.
Heidelberg USA Inc. closed its main equipment warehouse at 1250 South River Road in Cranbury on June 30 to achieve cost efficiencies, according to Jonathan Ross, regional operations manager. Instead it is using a warehouse in Kennesaw, Georgia. The company still maintains a regional sales and service office on Commerce Drive, where it has been since 1991.
The Heidelberg Group, headquartered in Heidelberg, Germany, manufactures sheetfed press systems as well as prepress and postpress components, software, and other items for printing applications. It has roughly 18,000 employees in 170 countries . Founded in 1926 it claims to be the largest distributor of graphic arts equipment in this country.
Dr. Abraham George, 57, on October 18. A cardiologist and doctor of internal medicine, he had been chief of staff at Capital Health System in 2001 and 2002, and was a member of its board of directors. He was featured in U.S. 1 on June 19, 2002, in a column by Richard K. Rein, one of his many patients.
Eartha Garvin, 55, on October 17. She was unit secretary at St. Lawrence Rehabilitation Center for 35 years before retiring in August.
Leonard Hunt, 70, on October 15. Founder of L.R. Hunt and Associates of Skillman, he was involved in building more than 400 homes in the Princeton area and was on the board of Trenton Habitat for Humanity.