August 7, 2020

‘We’re changing the concept of cancer being a death sentence into a chronic, manageable disease.’

Clinical Trial for ‘promising’ gene-therapy treatment for cancer is unveiled in LA; Trial leaders recruiting participants.

By Susan Belknapp, California Business Journal.

Is it finally possible that an effective, minimally invasive, cost-efficient treatment for cancer is on the horizon? Morphogenesis Inc. has been developing the cancer treatment since the 1990s. This past January, the company’s human clinical trials opened, enabling the expansion of its human clinical trials for treatment for two types of skin cancer: Merkel cell and cutaneous squamous cell carcinoma.

The procedure, previously referred to as a “vaccine” is being developed under the name ImmuneFx.

CEO Patricia Lawman, Ph.D

CEO Patricia Lawman, Ph.D

“We referred to it as a vaccine in the past, but it is more of an immuno-modulator,” says CEO Patricia Lawman, Ph.D. “We inject a bacterial gene into tumor cells and then it expresses a protein on the surface, which initiates an immune response to the tumor’s antigens. This allows the body to fight the tumor cells itself without harming healthy cells and tissue.”

The Phase I clinical trial is being held at USC Norris Comprehensive Cancer Center under the direction of Dr. Jacob Thomas and it is seeking subjects with advanced Merkel cell or cutaneous squamous cell carcinoma for participation.

The trial launched just before California issued the stay-inside orders due to COVID-19, yet the team continues to perform clinical operations and the study.

The clinical trial features 20 adult patients of any sex, ethnicity and race with histologically confirmed Merkel cell carcinoma or cutaneous squamous cell carcinoma with accessible lesions.

“We’re looking for patients with slightly advanced disease,” says Ashraf Dehlawi, director of regulatory affairs for Morphogenesis. “One of the more common approaches for squamous cell is surgical. This is more involved when surgical removal is not an option.”

Study literature defines eligibility as patients with “at least one injectable lesion, that can be accurately localized, stabilized by palpation, and is superficial enough to enable intralesional injection, whose tumors have progressed despite standard therapies, or are intolerant to or refused standard therapies.” There can be reasons there has been a delay in treatment. Sometimes surgery is avoided when patients are concerned about getting a chunk taken out of their nose or cheek.”

ImmuneFx is an injection that is performed in an outpatient setting, without hospitalization or other prophylactic measures. According to Dehlawi, the longest part of the clinical trial is the administrative paperwork yet the actual injection is only seconds. The drug is administered directly into the lesion.

“It’s a very safe, simple process,” Dehlawi says. “Part of what we’re studying is single to multiple injections and understanding the safety profile with the goal of discovering if it will require 6- or 12-month boosting like other immuno-modulatory type technologies.”

Dr. Michael Lawman

Dr. Michael Lawman

Lawman and her team, which includes her husband and company president Dr. Michael Lawman, originally developed the technology in the 1990s yet didn’t get to test it in laboratory models until 2004.

“It takes a lot of time to build the company and get financing,” she says. “And then – rather than go directly into humans – we went into companion animals. We tested it on dogs and cats with lymphoma and then we went into treating horses with melanoma and then treating cats and dogs with all different types of cancers. We treated more than 400 animals before we started treating humans.”

During their research, they found that the therapies could be delivered in different ways for varying types of cancer and with every way delivered, it has proven to be “very safe and effective,” Dehlawi says.

“We did the veterinary approach for a while but it’s difficult to have animal and human trials going on at the same time because the valuation is so different, so our board decided a couple of years ago to halt the veterinary operations and only focus on humans.”

Because the treatment was proven to work on many different cancers in animals, the skin cancer tests on humans are only the beginning. “We’re starting out with skin cancers because they’re easy to access and inject and then we’re moving onto head and neck, gastric and colon,” Lawman says. “Just about any other cancer will be available to us. It’s just a matter of time and money.”

Lawman says that everything to do with the development of such a potentially revolutionary treatment is expensive … “except for the actual product itself,” she quickly adds. “We have invested in our company and have the opportunity to manufacture the product ourselves. This will be beneficial to our investors because we’ll be able to keep the cost of the treatment down.”

The clinical trials won’t just help take ImmuneFx to the next level on its journey to wide clinical release but it also helps “de-risk” the investment by proving its safety and efficacy.

“With these clinical trial milestones, the value will continue to go up,” Lawman says. “We’re talking about a broad-spectrum product with a cost less than the treatments being developed and used now and, because there are very, very few side effects, the supportive costs of treatment will be negligible as well.”

Ashraf Dehlawi, director of regulatory affairs for Morphogenesis

Ashraf Dehlawi, director of regulatory affairs for Morphogenesis

Other benefits include its adaptability – it can be used as a standalone treatment or complementary to the current standard of care – so patients don’t have to forego chemotherapy or radiation, if that is what their oncologists recommend. However, because it triggers the body to only attack the cancer cells and lesions, it offers a higher quality of life than most cancer patients experience with the toxic side effects of chemo and/or radiation.

“A lot of times chemo and radiation cause other cancers,” Lawman says. “Years later people who have ‘beat’ cancer have a recurrence because of the chemo and radiation they received. This can be used in conjunction with other treatments, and then even then go on to something else after this therapy. It will not interfere with other types of treatment.

“Anyone who works in this space has come to terms with the concept that if we’re going to succeed against cancer, it’s always going to be a multi-pronged approach,” Dehlawi says. “We’re switching whole concept of cancer being a death sentence into a chronic, manageable disease.”

Copyright © 2020 California Business Journal. All Rights Reserved.



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