Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said.

Iggenix deploys its single-cell genomics platform to capture and analyze rare human B cells that express allergen-binding antibodies. Then the company engineers them with immune-modulating activities derived from the IgG antibody class to suppress allergic reactions. Founded in the summer of 2019, Iggenix is based on work by Stephen Quake of Stanford University, allergist Kari Nadeau, and Derek Croote, who was a PhD student in Quake’s lab. Research by Croote led to a December 2018 paper in Science.

“I’ve been involved with [Quake] over the years, helping him start companies, and was asked to join as the startup CEO,” Hironaka said. The financing, led by Khosla Ventures with participation from Parker Ventures, will be used to refine, expand and de-risk the platform while assembling a pipeline of potential lead candidates. The firm also needs to find a replacement for Hironaka. “At this stage of my career, I’m not looking for full-time work,” he said, though the Iggenix project carries more personal meaning for him than others, since his older daughter is anaphylactic to peanuts. “Having seen her have to apply an Epipen [epinephrine, Mylan NV] – we have to find a better way,” he said.

Bruce Hironaka, CEO, Iggenix

Near the start of the year, Brisbane, Calif.-based Aimmune Therapeutics Inc.’s Palforzia became the first approved treatment for patients with peanut allergy. The oral biologic immunotherapy is designed to mitigate allergic reactions, including anaphylaxis, that come with accidental exposure. Palforzia (previously AR-101) was tested in more than 1,200 patients, many of them children. The U.S. clearance “is important, and it’s a positive step, but we believe that is not going to be the end-all, be-all,” Hironaka said. “There’s significant opportunity still for the approach that we’re pursuing,” and Iggenix is working “as fast as we can.”

The company has several non-food allergies among a dozen or so allergies under investigation. For advancing biologics, regulatory “paths out there are well-trodden,” Hironaka said, and “most of our allergies of interest are going to be eligible for breakthrough status and fast-track status.”

COVID-19 impact

For Iggenix as for others, the COVID-19 pandemic has caused hang-ups. “We’re wondering whether [dealing with the virus is] going to impact how the FDA thinks about drug development post-COVID-19,” which could mean speedier routes in the offing for candidates other than antivirals. Timelines for Iggenix may be determined partly by “whether we see some fundamental changes in how people do preclinical work,” he said. “We specifically have talked to a smaller antibody company that’s involved in COVID-19 with big pharma, and have tried to learn some lessons from them.”

Iggenix may be “a couple of years away from the clinic,” though efforts to move more briskly will continue, Hironaka said. Iggenix felt COVID-19’s impact early on. “As we tried to slowly start ramping up headcount [earlier this year], we ran into the shelter-in-place [edict]. We had a two-and-a-half month hiatus from wet lab work. I hate to admit it, but one of our planning scenarios is that we get shut down again.” The firm has been talking with contract research organizations that may be able to help if that were to happen.

As COVID-19 rages, Aimmune has been struggling in the marketplace with Palforzia, too. The company reported zero net sales in the second quarter. Wainwright analyst Andrew Fein said the timing of the product’s approval – which included a risk evaluation and mitigation strategies provision – “sailed the program directly into the headwinds of the pandemic. Allergists have faced a reported two- to three-month patient backlog, with patient volume down approximately 65%, which we believe specifically impacts patients and prospective new patients for Palforzia being able to visit a certified health care setting to receive their first dose for up-dosing administration in-person,” he wrote in a report last week.

Approval for Palforzia could happen in Europe during the fourth quarter of this year. Meanwhile, CEO Jayson Dallas told investors during a conference call last Thursday that sales reps are navigating the pandemic as best they can. “At this point, the vast majority of our account managers are able to engage with allergists, to some degree, face-to-face across the country,” he said. “Many of them are in some sort of hybrid model, where they're doing a mixture of face-to-face as well as virtual engagements using technology. The most challenging, in terms of our ability to have face-to-face meetings, continues to be the Southwest,” especially cities such as Los Angeles and, to a degree, Arizona. “That, I suspect, will continue to be the case,” he said.

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