Welcome to another edition of our Sponsor Atlas series, which focuses on startups and young pharmaceutical and biotechnology companies that are in early stages or stealth mode. In the next edition of Sponsor Atlas: Discovering Biotech Startups, we’re looking at Intrepida Bio, Inc., and exploring the current affairs and future orientation of this emerging San Diego - based stealth biotech startup. To accomplish this, we will give a business overview of their current operations, summarize their outsourcing needs, map out their development goals and decision-makers, and highlight their current strategies for capturing innovation. If you haven’t already read our other blogs on new biotech startups, be sure to check them out here.
Intrepida Bio is a preclinical biotechnology company that develops medicines intended to modulate the immune system to fight cancer and potentially other diseases. This startup designs proprietary monoclonal antibodies that block novel targets and receptors as well as prevent their ability to create a sustainable environment for tumor growth, enabling patients to get innovative treatments to cure cancer and beyond.
Intrepida Bio does not have any registered trademarks, but they do have a nicely developed website packed full of information about their executive team, pipeline, core technology, past news articles, and current research efforts. The business was registered in Delaware as a C-Corp on 3/16/2016 and has a registered agent address. Intrepida’s principal place of business, as noted on the business entity search, is located at 9920 Pacific Heights Blvd., Ste 150, San Diego, CA 92121. Current estimates show the company has an annual revenue of under $500,000 and currently employs a staff of approximately 2-5.
Their research team is dedicated to the discovery and development of medicines that modulate the innate immune system to fight cancer and other diseases. In October 2019, an initial $9.5 million equity investment from Sofinnova Investments and Canaan funded the investigational new drug (IND) application-enabling studies of Intrepida’s lead oncology program. Co-founders Dr. Joel F. Martin, President and CEO, and Dr. Olivier Laurent, CSO, together with Biouniversa s.r.l., established Intrepida with worldwide rights to develop a therapeutic technology platform based on the unique targets BAG3 and its receptor IFITM-2. Biouniversa’s Dr. Maria Caterina Turco, who studied the protein, BAG3, found that it is overexpressed by some cancer tumors—especially pancreatic tumors. 
The information on the outsourcing needs of Intrepida Bio are few and far between, but their recent venture funding is a good sign they have a lot of capital to play around with for outsourcing more R&D and clinical manufacturing work. Intrepida Bio will be progressing through the usual steps while working on their IND enabling studies. Until recently the company has done a very good job of staying under the radar, especially with their large amount of funding and investor backing. Intrepida Bio will use the venture capital to further their research and manufacturing activities, so we can definitely expect to see an increased need for outsourcing work in the near future. As mentioned above the $9.5M funding will bankroll IND-enabling studies focused on specific antibodies that target BAG3 and its receptor IFITM-2, which normally play a role in the immune response against viruses but is hijacked by tumors to create an optimal environment that promotes their growth and prevents attacks from the immune system.
We think business development teams in the realms of antibody R&D and commercial upscale, preclinical programs with animal model development for pancreatic cancer, bioanalytical CROs, and large molecule CMOs should definitely have Intrepida Bio on their radar for the next few years.
Intrepida is dedicated to the discovery and development of medicines that modulate the innate immune system to fight cancer and other diseases. The company is the first to design proprietary monoclonal antibodies that block the novel targets BAG3 and its receptor IFITM-2 to prevent their ability to create a favorable environment for tumor growth. The University of Salerno spun the technology out into Biouniversa, which developed and validated it under the leadership of Dr. Maria Caterina Turco, a professor at the university. Dr. Turco’s team showed in both in-vitro and animal studies that the anti-BAG3 antibodies slowed tumor growth, cut down on metastases and boosted survival. The studies included those carried out in pancreatic cells from mice and humans.
Pancreatic cancer cells use BAG3 – IFITM-2 signaling to create an environment that promotes tumor growth. BAG3 does this by binding to a receptor, IFITM-2, on macrophages. Once that happens, the macrophages, which are normally protective immune cells, are hijacked into producing signaling molecules that boost tumor growth, block immune response, and induce a tumor-protective, fibrotic microenvironment. This BAG3 expression is particularly strong in pancreatic ductal adenocarcinoma (PDAC), where it was recently detected in every single patient tested in a study, and high levels of BAG3 were associated with an overall poor prognosis. Intrepida’s anti-BAG3 antibodies therefore are designed to block this pathway, eliminating a tumor’s pro-growth environment while encouraging the immune system to attack the tumor. By blocking BAG3, these antibodies broadly affect an array of mechanisms that support and protect the tumor.
“There are the old-school, nasty, cytotoxic, cell-killing drugs, but there is not much in the way of targeted therapies for pancreatic cancer—at least, not anything that’s worked,” Dr. Martin of Intredpida said. A BAG3-targeting treatment could be a huge breakthrough in a cancer that is often a death sentence, but Dr. Martin also warned that there is a long way to go to show that their antibodies are effective in humans. Intrepida expects to advance its first clinical candidate, IB001, into clinical trials in 2021.
Intrepida Bio will continue on the path to developing cures for cancer via drugs that alter the body’s first line of defense, the immune system. They are developing products derived from the breakthrough research of Dr. Maria Caterina Turco at the University of Salerno. Dr. Turco discovered a biological pathway that tumors use to subvert the immune system by producing an environment that encourages tumor growth. By treating these tumors with a monoclonal antibody that blocks this negative cycle, Dr. Turco, her team, and academic collaborators restored a healthy anti-tumor environment that kept cancer growth at bay. Over at Biouniversa the investigators determined that when the protein leaves the cancer cell, it acts as a signaling molecule, binding to a receptor on macrophages and, in essence, hijacking those immune cells into supporters and protectors of the tumor. Dr. Turco, who is now also chairwoman of Intrepida’s scientific advisory board, developed the actual anti-BAG3 antibody designed to disrupt that feedback loop. 
“Usually, as we dug into assets over the course of the year, we started out excited but got less excited. This was the opposite. The further we dug into the data, the more enthusiastic we became, in part because of multiple layers of validation to this technology,” said Dr. Martin. The research team has a few ideas of where else this technology can go, but they’re keeping them under wraps for now until it’s put them through the paces. Intrepida Bio has several drugs in development that target the BAG3 – IFITM2 pathway. 
“We’re already engaged in additional studies on efficacy and things like dose response, as well as CMC work necessary to make commercial antibodies,” Dr. Martin said. 
If you would like a simple solution for keeping an eye on drug sponsor companies, like Intrepida Bio, without relying on a database and generic lists of leads each week, we at Zymewire are here to help. Reach out today, and stay tuned for the next installment of the Sponsor Atlas: Discovering Biotech Startups. If you enjoy these articles, please feel free to give them a share through the social links below!