BreakBio Corp. Receives IND Approval from the FDA for BreakVax

Miami, FL, October 20, 2023 - BreakBio Corp., a biotech company dedicated to advancing innovative solutions in vaccine development for the treatment of cancer, is pleased to announce that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its investigational new personalized immunotherapy drug, BreakVax, on October 20, 2023.

This represents a significant milestone in the company's commitment to addressing unmet medical needs and improving global health outcomes. This IND approval marks the culmination of extensive research and development by BreakBio Corp.'s dedicated team of oncologists, bioinformaticians, immunologists, and personalized cancer vaccine specialists.

BreakVax is a cutting-edge personalized peptide immunotherapy designed by mass spec, ML and manufactured per patient. Leveraging breakthrough technology and scientific expertise, BreakVax aims to provide a safe and effective treatment for solid cancers.

"We are thrilled to receive IND approval for BreakVax, as it underscores our unwavering dedication to advancing immunotherapies that have the potential to transform solid cancer treatments," said Roy de Souza, CEO of BreakBio Corp. "This milestone brings us one step closer to fulfilling our mission of improving survival rates, and aiming for cures for all solid cancers."

BreakBio Corp. remains committed to advancing BreakVax through the next stages of development, including our First In Human clinical trial in first indication (colorectal cancer) in 2024, with the ultimate goal of achieving the FDA’s Breakthrough Designation and making this personalized immunotherapy available to cancer patients who need it.

For more information about BreakBio Corp. and its groundbreaking initiatives in immunotherapy development, please visit

About BreakBio Corp.:

BreakBio Corp. designs and manufactures unique, personalized peptide immunotherapy, leveraging mass spec, ML and its proprietary AI model, and combines it with approved cancer drugs, to reach for a breakthrough in solid cancers. BreakBio Corp.’s proprietary, patent-pending treatment designs personalized immunotherapy that targets all solid cancers, starting with metastatic colorectal cancer.

Media Contact:
Kim Nancarrow
BreakBio Corp.