A biotech firm, on the brink of ruin, resurrects itself via man — and microbe

Princeton, New Jersey – Three years ago, a small biotech New Jersey was called Advaxis the brink of ruin.

Your AXAL cancer drug was in the midst of clinical trials, but the company was out of money and trade as a penny stock.

Today, Advaxis is on the rise. In recent weeks, the company has won two major awards – the cancer drug has been fast track for approval for the treatment of cervical cancer by the Administration Food and Drug US and the company has entered into a valuable partnership with Amgen for another technology to destroy tumors.

The article continues after the announcement

The rapid resurrection of Advaxis is the work of man and microbe – CEO Daniel O’Connor, who was hired by the company floors, and a kind of bacteria called listeria which is best known for causing food poisoning

a sinking ship

When O’Connor took over as CEO of Advaxis in August 2013, the company was in debt with various service providers and can not pay the payroll of his half-dozen employees, he said. But O’Connor had introduced drug embattled ImClone cancer, Erbitux, the market in 2006, following a insider trading scandal who sent the CEO and Martha Stewart to jail. He believed he could carry out a change of Advaxis similar trend.

“Advaxis was similar to ImClone as it had a lot of problems that need to be addressed,” O’Connor said. “But I thought the underlying technology was sound and should have the opportunity to move on.”

This technology uses a form of Listeria monocytogenes engineered to boost the patient’s immune system to attack cancer. For your first treatment, AXAL, which is coaxing blunt force – the system attacks the cervical cancer by recognizing a common tumor marker in cells infected by HPV. His second technology, currently under development, is called MINA, My immunotherapy neo-epitopes. How listeria coaxes the immune system to attack will be specific to the genetic makeup of each patient’s cancer system.

AXAL is now in Phase 3. The Amgen agreement mine is broken down as follows: a purchase of $ 25 million of Advaxis securities, $ 40 million in cash and $ 475 million in payments by potential landmarks. Amgen the day the deal was announced, shares of Advaxis a jump of 31 percent.

But, as in most drug development, it has not been an easy road.

Using the immune system to fight cancer

AXAL and mine are technologies that allow the immune system to recognize cancer cells are not normal and should be destroyed.

Tumors have figured out how to evade the body’s immune system, allowing them to grow and spread under what might be called an invisible layer. AXAL working with the presentation of that layer.

Listeria infections generate an immune response powerful on their own. In AXAL treatment weakened listeria are loaded with DNA coding for a specific protein found in almost all patients with HPV-associated cancer. Infection with listeria engineering these cells helps T First to recognize and kill tumors, where they could not have before.

for mine based technology listeria is adjusted to identify hundreds of tumor-specific mutations, or neo-epitopes from a tumor biopsy of each patient and a blood sample, by sequencing DNA to distinguish normal cells cancer cells. DNA corresponding to the neo-epitopes is used for a specific treatment by the patient bioengineering allow T cells to recognize mutations that patient and attack tumors.

because mine will be adapted to each patient tumor mutations, the company will have some technological hurdles to overcome.

“The technology to identify neo-antigens that provide a potent immune response is in place, but it takes months to do,” said Jill O’Donnell-Tormey, executive director of the Institute of Cancer Research in New York. “Reducing the time and so it is scalable is where this field needs to move.”

The dangers of listeria

support MINE Amgen is a vote of confidence, said Dr. Elliott Levy, vice president of global development at Amgen. The computer Advaxis said to have reduced to six weeks, the amount of time required to produce a batch of drugs adapted precisely to the tumor of a patient. Mine will not be ready for human trials until next year, however, and Advaxis has had to overcome problems with AXAL.

O’Connor and Advaxis scientific director, Robert Pettit, had to spend hours explaining the merits of listeria as a vector that destroys cancer investors. its less pathogenic listeria is touted as a system of better management viruses because the bacteria could get past a part of the immune response that often paralyzes the virus, and head straight to the part of the immune response that is directed to eliminate tumors.

After a small phase 2 study in India with 109 patients, the survival rate of cervical general cervical cancer 12 months patients taking AXAL was 32 percent, while another test group given AXAL plus cisplatin chemotherapy drug showed no additional survival over AXAL alone.

The Advaxis C-suite grossed $ 26.5 million and paid the debts of the company. The team set to work planning Phase 3 trials for AXAL in HPV-driven cancers.

However, in October 2015, the FDA forced to stop Advaxis four trials of AXAL after a patient with cervical cancer in terminal phase died of their disease he found that listeria was in his bloodstream.

The stock plummeted.

Advaxis presented a new plan for the FDA, which included antibiotics to patients after treatment. Two months later, the FDA lifted the clinical hold.

Advaxis is recruiting for the Phase 3.

The promise of mines

Levy said Amgen was inspired to make a bet from the start mining technology Advaxis, as it has the potential to complement drugs in a one size fits all immunotherapy as Keytruda Merck and Opdivo of Bristol-Myers Squibb. And Advaxis platform listeria is similar to the recently approved melanoma of Amgen Imlygic, which also uses a pathogen engineering drug – if the herpes virus – to generate an immune response against cancer. However, these drugs do not work for all patients, highlighting the need for faster and more personalized methods, Levy said.

“Cancer patients can not wait forever for treatment,” he said.

O’Connor has built the company a backup, but knows Advaxis still has a long way to go to prove the value of their technology.

“Patients depend on us to move forward,” he said. “This counteracts fear.”

This story has been updated with more information about MINA technology.

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