TAMPA, Fla. (WFLA) – A Tampa company developing a skin cancer vaccine has recently appointed a new CEO who plans to take the company public within the next few months.

Dr. James Bianco, an oncologist by trade, is the new CEO of Morphogenesis, a company based in Tampa. He was appointed CEO of the company on July 1, 2022, after living in Seattle for nearly 30 years.

Bianco did most of his training in New York City, and was recruited to the Fred Hutcherson Cancer Research Center, where he ran the bone marrow transplant program at the hospital.

There, he was convinced to start a company in 1992 to help more patients with transplants.

“And that was a big milestone for me because I loved clinical medicine. I mean the whole thing, especially transplant because those patients are so courageous with what they have to get to,” he said.

In his time with the company until 2016, Bianco acquired five different medications, focused on blood-related cancers like leukemia.

“We utilized a pathway that the FDA has, called accelerated approval pathway, in other words, you can do a single trial for patients that have an unmet medical need. And that was kind of one of my sweet spots, again, wanted to stay close to what patients could really benefit from,” he said.

News Channel 8’s Daisy Ruth last spoke with Morphogenesis then-CEO Patricia Lawman in April 2021, after Morphogenesis had completed its first in-human skin trial vaccine for cutaneous melanoma at Moffitt Cancer Center. The company had then moved into studying patients with earlier stages of skin cancers.

The vaccine contains a bacterial protein that has the unique ability to attach itself to cancer cells, allowing the immune system to target those dangerous cells and destroy them.

“So basically we’re taking all of the smarts of the immune system, of the body, and bringing it to bear on a person’s tumor. So what we do is basically put a bacterial gene – it’s not a bacteria, it’s not a live bacteria – it’s a single gene that we put into a patient’s tumor cells. This is expressed as a protein on the surface of the tumor cells, like a beacon, if you will, and it brings in the immune system,” Lawman said. “And once the immune system sees our bacterial beacon it can then expose all of the patient’s tumor antigens that are in that person’s tumor.” 

Bianco said he found the technology interesting.

“The science was really kind of cutting edge in what they were doing. But I think the one thing that was missing was that one link to understanding that kind of care path that cancer patients have to deal with,” he said.

He met Lawman during the COVID-19 pandemic, largely over Zoom.

Bianco explained Morphogenesis had one patient for its single trial in Merkel cell carcinoma, a skin cancer, who went back to “checkpoint inhibitor” technology within the vaccination, and has been in complete remission.

The trial was supposed to enroll 20 patients over two and a half years.

“When you see a single patient, you know, biology’s different, if the drug could do that, that would be very exciting. So at that time, they had a second patient that had come in, and that patient did extremely well again. I mean, patients who were treated with this new class of drugs, called checkpoint inhibitors… And about half of those patients with Merkle will have a good response,” Bianco said. “But the other half don’t. And when they don’t have a response, about 60% of them will die before they even get in to a clinical trial.”

He said that was an unmet medical need.

 “If you can give your drug and then re-challenge them with a very effective drug that didn’t work for them before, but now it works, and you put them in remission, and you keep their disease from progressing. And we’re talking in the first patient, 18-19 months now,” Bianco said.

Bianco is positive that more therapies and vaccines will be available to skin cancer patients.

“We’re working with the FDA to be able to try and do that with a single-step. That’s this accelerated approval path. The FDA recognizes that if there are no alterative therapies that may work and your product may offer a benefit,” he said. “Then they will let that drug be approved on relatively a small amount of data in a relatively fast period of time. And then subsequently, you’ll have to do a larger study, but it makes it immediately available to patients.”

Bianco said he refocused the team, in order to take the company public, re-establishing Morphogenesis’ relationship with Moffit Cancer Center.

“And really this concept, if this drug is working in that population, would you work with us on convincing the FDA that this may be a direction to go forward with?” Bianco said.

Bianco said the company now has five patients who have all responded the same way to the same treatment.

“And by the same thing, I mean, that you’re able to re-challenge them with a class of drugs that are very important that they failed, and after your therapy, they’ve had major responses to that re-introduction to that drug. And those are ongoing, anywhere from 5 months out to like I said, 18, 19 months,” he continued.

Bianco called the technology “evolutionary.”

“What this technology does, it takes advantage of what we were all born with over eons, this is evolutionary, it makes your tumor cell look like a bacteria,” he said. “So it’s a DNA that you inject into the tumor and then the tumor cell produces a bacterial protein on the surface, on the outside. Well we’re all pre-wired, with an immune system that can recognize bacteria, viruses, fungi, any pathogen, because over evolution, the way that protein looks is essentially imprinted in to your immune system.” 

Bianco compared the process to the COVID-19 vaccination, with the body’s immune system “chewing up” what is abnormal to it.

“You can think of this just like COVID. You’re injecting in to somebody the proteins that the virus expresses that your immune system gets to see. So before you get the virus, we’re educating your immune system, what the virus is going to look like, if it ever comes in,” Bianco said. 

Morphogenesis is no longer pursuing its cervical cancer vaccine, something revealed to News Channel 8 last February.

“The concept was, ‘Could you give this gene therapy, by just putting it on the skin?’ In this case, it was going to be the epithelial [on] this cervix and then allow the gene therapy to essentially infect wherever the cancer is and make it look like a bacterium and initiate an immune response,” said Bianco.

He’s confident the company will be able to come of terms on a single trial for its skin cancer vaccine.

“And they hear these stories, and they know that if they’re successful, they go home and they made a big impact, not just in the patient’s lives, but you read the families’ stories in not just how heart wrenching it is for them, of if they get a little glimmer of hope, everyone brightens up,” he said. 

If the Initial Public Offering (IPO) window doesn’t open for Morphogenesis, Bianco is confident a “reverse merger” process will be beneficial, meaning other public companies with failed technology, whose investigators have left, but who still have money to spend, will seek out Morphogenesis.

“We have to be public certainly in the next 6-8 months at the latest,” Bianco said.