Helaina prepares to launch human lactoferrin in CPG products following $45 million Series B fundraise

The funding, led by Avidity Partners, will help Helaina commercialize effera, which supports iron homeostasis and metabolism, a balanced immune response and a healthy microbiome, CEO Laura Katz told FoodNavigator-USA.

“This money allows us to get into the market – to grow and expand and to really reach the customers we hope to reach. And, with scaling any business, there is a lot of infrastructure that needs to be built in the back, including supply chains, logistics operations – all the actual meat behind being an operational company,” Katz said.

She explained, “until this quarter, we have been doing R&D and scaling our platform,” which allows Helaina to replicate human bioactive proteins, like those found in human breast milk and colostrum.

“We have done all the background work. We have done regular clinical works and, of course regulatory work,” and “now we have the resources to focus on commercialization,” she said.

Initial focus on women’s health, active nutrition and healthy aging​

The company initially will focus on expanding production to support the women’s health, active nutrition and healthy aging markets through partnerships with multiple CPG companies, including Kroma Wellness, The Feed, Levelle Nutrition and Healthgevity, as well as nutritional ingredient distributor Mitsubishi International Food Ingredients, Inc.

Katz explained that each of these partners are strategically aligned with Helaina and share the same values, which include prioritizing scientific rigor to improve human nutrition.

She also noted that Helaina will work with them to communicate the value of effera, which will be called out as a branded ingredient on the front of pack and in the in the Nutrition Facts label.

“We work extensively with our customers on claims support to enable them with the right tools that they need to communicate the value of what we are selling to them. It is a one-of-a-kind product. Nobody has ever put effera into a product. But more broadly, nobody has ever put a human protein into food,” even though people have consumed breast milk and the proteins in it for a millennia, Katz said.

Human lactoferrin vs bovine lactoferrin​

She explained what makes effera special is it is the first lactoferrin made via precision fermentation modeled on human lactoferrin. Other lactoferrin on the market comes from cows in extremely limited amounts or is a replica of bovine lactoferrin made via precision fermentation.

Katz explains human lactoferrin and bovine lactoferrin behave differently in people, as revealed in a double-blind, controlled, well-powered clinical study conducted by Helaina.

“What we saw in the clinical study was pretty staggering to me. We saw that folks who consumed the cow’s milk version of the protein produced antibodies against the protein. So, basically, their body is recognizing that the protein is foreign, because we are not cows, and it tries to quickly get it out of the system. We also saw different digestion patterns between effera and cow’s lactoferrin,” she said.

Ramping up production of effera will also help Helaina double production of lactoferrin in the next five to seven years and meet demand for the ingredient, which currently far outpaces availability, she said.

“Part of the fundraise will allow us to now catch up with the demand curve that we have been experiencing,” she added.

She further explained that demand for lactoferrin is driven by its “overarching immune properties” for people at all stages of life, Katz said.

“Lactoferrin binds and transports iron in the body. That sounds like a really simple principle and not very interesting. But, it actually is incredibly interesting for women, a third of whom under the age of 50 in the US are iron deficient,” but who struggle with iron supplementation, which is not efficiently absorbed in the gut and cause stomachaches, Katz explained.

Because lactoferrin binds to iron and moves it to where it is needed in the body, it also supports immunity by limiting access of iron to viruses, which need it to replicate and infect the body, she added.

Next steps: More partnerships and ingredients​

Looking forward, Katz said she is eager to expand distribution of effera, but she also wants to focus on companies that share her values, and which prioritize science and are data driven.

The company also will continue to explore production of other human bioactives, most likely from human breast milk, via its platform.

Finally, Katz noted, the company is eager to partner with other companies to develop further ingredients that may be unique or of interest to them.

“We have the tools and the technology to do that relatively quickly,” she said.