The AKT Awakening: Immunity Pharma’s Novel Approach to ALS and Neurodegenerative Disease

If there’s one thing I took away from speaking with Eran Ovadia, CEO of Immunity Pharma, it’s that success in biotech isn’t necessarily a field of eureka moments, it’s an accumulation of small wins, each one a hard-earned validation. “Every day, or every few days, I find a new proof point,” he told me. “Some new signal that we’re going in the right direction. That’s what keeps me going.”

And he’s been going for quite some time. A longtime entrepreneur with a background in health and science, Eran founded Immunity Pharma around a promising scientific discovery: a peptide that showed an unusual effect—it helped protect animals from radiation damage, even when administered post-exposure. “It wasn’t preventative. The primary damage had already happened,” he explained. “And it still worked, most of animals recovered. That’s when I knew we might have a true drug.”

The peptide was first developed by Professor Irun Cohen at the Weizmann Institute, who originally named it stressin,a nod to its effects on cellular stress. Eran quickly saw potential with much wider applications. He joined forces with Cohen and began exploring how the compound might be used to treat neurodegenerative diseases, which are often tied to cellular stress pathways.

After reviewing several disease candidates, the team chose to pursue the science in treating ALS, securing early preclinical funding from the Israeli ALS Association, IsrALS. Initial animal studies showed encouraging results, prompting the formal founding of Immunity Pharma. “We had a few options in parallel,” Eran said. “But the signal in ALS was strong, so we focused on it.”

IPL344 is now part of a family of peptides developed to activate the same stress-response mechanism. While ALS is the initial focus, the potential applications are extensive. “Today it is a platform,” Eran said. “We believe it could support a pipeline of therapies targeting other age-related diseases.”

Why ALS?

Amyotrophic lateral sclerosis (ALS) is a rare but devastating neurological disorder which causes progressive degeneration of motor neurons, leading to muscle weakness, difficulty speaking and swallowing, and eventually, respiratory failure. ALS is a highly challenging disease with a grim prognosis—the majority of ALS patients survive only two to five years after diagnosis, although life expectancy can vary greatly.

For a company like Immunity Pharma, ALS presented both a scientific challenge and an opportunity. “An advantage of focusing on ALS is that it’s one of the most aggressive diseases related to cellular stress,” Eran told me. “If it works there, we’ll know. And if it doesn’t, we’ll know that too. We won’t waste time and resources on futile dreams.”

That commitment to clarity shaped everything about Immunity’s lead candidate, IPL344. Most approved ALS therapies address symptoms or target a single process, such as oxidative stress or inflammation. IPL344 is designed to address six disease-driving mechanisms simultaneously, a distinction Eran believes is key.

The drug is a novel peptide designed to reactivate the AKT pathway, a crucial cellular signaling mechanism that supports neuron survival, reduces oxidative stress, and maintains metabolic stability. In ALS, this cellular pathway is often downregulated, and many drugs that attempt to stimulate it via cell membrane receptors fail because those receptors are themselves impaired.

Immunity Pharma’s approach is different. IPL344 bypasses the usual membrane receptor mediated pathways, instead entering the cell and activating a stress response that reawakens the AKT pathway from within. It’s a workaround, or as Eran put it, “a back door into the pro- survival system of the cell.”

That mechanism matters because ALS is a multi-pathology disease. “You’re not dealing with one problem,” Eran said. “You’re dealing with apoptosis, oxidative stress, misfolded proteins, disrupted metabolism, DNA damage, even immune dysfunction.” IPL344 addresses most of these, he believes, by unlocking AKT and, with it, the cell’s self-repair machinery.

Early results seem to back him up. In a Phase 1/2a open-label study, IPL344 was administered intravenously once daily, and preliminary data suggest about a 60% slower rate of disease progression in people living with ALS who received it, a rare, perhaps even unique, result. Additionally, the treatment was well tolerated and easily administered at home.

“We treated ten patients,” Eran said, “and we saw disease slow down in nine of them. Some were small, most of them significant, but there was a clear effect in multipledisease parameters.”

So, with these initial encouraging results, what are the next steps for the company?

“We’re now preparing for a large, pivotal trial that we expect to lead to drug approval,” Eran told me. But that next step is no small feat. “The science is there. The mechanism is solid. The clinical signs are encouraging. But bridging to the next phase takes enormous resources.”

Eran stressed that the company couldn’t have gotten to where it is today without the close partnership of scientists Prof. Irun Cohen, Dr. Ilana Cohen, and Dr. Oren Becker who cofounded the company with Eran, and the angels Rony Pfeifer, Gideon Stein and Yigal Tamir who joined him soon after, creating a small professional community around this endeavor. This core group has since expanded with dedicated clinical, scientific, professional, and business partners who have a shared vision and align with the business goals, maintaining long-term involvement in the company.

The Funding Journey

Like many early-stage biotech CEOs, Eran needs to spend a lot of his time and effort on fundraising. After good success with private investors, Immunity is now looking to include institutional partners to bring IPL344 to the finish line. That leap, from private to institutional backing, is particularly tough in Israel. “In the U.S., institutional investors are used to this stage. Here, it’s much harder to bring them in unless you are already past the finish line.”

If there’s a message here for other health tech founders, it might be this: storytelling matters. “Since I started the company, I’ve rewritten our presentation 200 times,” Eran said. While the science evolved gradually, the way he communicates it must constantly adapt to shifting business and scientific narratives. “You need to keep refining how you communicate the value of what you’re doing, maintaining a consistent core while demonstrating clear progress. That’s how you bridge the trust gap.”

Despite those hurdles, Eran stays focused. “This is a marathon, and we’re in the last ten kilometers,” he said. What helps him endure? A combination of incremental wins and belief in the mission of helping stop the progress of dreaded neurodegenerative diseases.   

As Immunity Pharma prepares for the next stage, Eran is clear-eyed about what lies ahead. “In five years, I hope we will have a drug on the market. I hope we’ve expanded the platform to treat other neurodegenerative diseases. But most of all, I hope we’ve helped people.”

It’s that final point—the patients—that keeps coming back in our conversation. “I know this drug helped the people who took it. I saw it,” he said. “Now we need to prove it, at scale. That’s the mission.”

Immunity Pharma began collaborating with ADRES.bio in 2012, advancing the company’s groundbreaking work to develop a treatment for ALS. Early in the partnership, ADRES.bio supported the production of the first manufacturing batches, enabling compassionate use treatment for a patient whose life was extended by 18 months. Over the years, the two teams have worked closely to navigate the complex regulatory path toward approval, sharing in the progress and discoveries that continue to reveal the therapeutic potential of Immunity Pharma’s product.