Amid troubles, ex-Rosetta CEO Berlin parachuted in as new Advaxis head

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Advaxis' former CEO, Daniel O'Connor, left abruptly last July and CBO Tony Lombardi stepped in as interim CEO for nearly 10 months. (skeeze)

Advaxis has hired a new CEO after the abrupt departure of Daniel O'Connor last summer, an exit that left the oncology biotech in CBO Tony Lombardo's stewardship for the better part of a year. Who's in the hot seat? Former Rosetta Genomics chief Kenneth Berlin. 

The Princeton, New Jersey-based biotech rang in more changes, and announced a new chief medical officer in the form of Andres Gutierrez, M.D., Ph.D., who was CMO at Oncolytics Biotech until just five days ago, as well as the departure of Lombardo and CFO Sara Bonstein. 

RELATED: Oncolytics Biotech’s CMO departs on cusp of phase 3 trial

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“After a comprehensive and methodical search, we are very pleased to announce that Ken Berlin has agreed to join Advaxis as president and CEO, and that Dr. Andres Gutierrez is joining our team as CMO. Both of these executives are eminently qualified for their new positions, and we expect to benefit greatly from their expertise. Under their leadership, we look to the future of the company with excitement and confidence,” stated David Sidransky, M.D., chairman of the board, in a statement. 

Advaxis started 2017 out strong, inking a licensing pact with Sellas that could reap up to $358 million in milestones and, with its partner, Amgen, getting the go-ahead for a trial of its neoantigen vaccine in multiple cancers. But things went downhill from there, starting with O'Connor's mysterious exit last July. 

In March, the FDA placed a hold on the phase 1/2 trial of its axalimogene filolisbac and AstraZeneca’s Imfinzi in patients with human papillomavirus-associated cancers. The agency made the move after a cervical cancer patient developed respiratory failure and died after receiving the combo treatment. The death is currently under investigation, while Advaxis' other programs have continued as normal. 

Advaxis is looking to tap Berlin's decades of experience at Rosetta, Veridex and Johnson & Johnson, while Gutierrez is tasked with overseeing all global clinical development and regulatory initiatives for the company's Lm-based antigen delivery technology. 

The new CEO's time at Rosetta was not, however, the most auspicious: Last year, the troubled company was bought by California-based Genoptix, formerly part of Novartis, for a mere $10 million, which works out at around 60 cents a share. Rosetta introduced a clutch of miRNA-based cancer diagnostic tests in the years following its IPO but never gained significant traction commercially. That led to liquidity problems and ultimately to the company’s position becoming untenable.  

It seems as if he's going from one troubled company to another, but Advaxis played up his experience: “Ken brings to Advaxis a truly valuable combination of executive leadership experience with large and small, development-stage and commercial companies with a particular expertise in oncology. He has a proven ability to raise capital, launch products, achieve rapid sales growth, build businesses and complete strategic M&A and licensing transactions," Sidransky said. 

“I am excited to be joining Advaxis at this important time in the company’s evolution with multiple clinical programs planned and underway, and look forward to contributing to the impressive progress made to date by the Advaxis team in advancing its innovative Lm-based antigen delivery technology across a number of important cancer indications,” Gutierrez said. “Advaxis has a promising future as we continue to accelerate the development of our pipeline and bring innovative new medicines to patients.” 

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