LA JOLLA – Vironexis Biotherapeutics, a biotech firm developing single-dose gene therapies for blood-based cancers, launched out of stealth this month with $26 million in seed funding and more than 10 candidate products for cancer treatment.
Drive Capital and Future Ventures led the funding round, which also included participation from Moonshots Capital and Capital Factory. According to Vironexis, the financing was secured in October 2022.
CEO
Vironexis Biotherapeutics
In addition to the financing, Vironexis has also received approval for an Investigational New Drug from the FDA for its VNX-101 gene therapy candidate, which is intended to treat CD19+ acute lymphoblastic leukemia. FDA also approved Fast Track Designation and Rare Pediatric Disease Designation for the candidate.
Vironexis intends to begin enrolling patients in a Phase 1/2 trial for VNX-101 in the last quarter of 2024. The company claims it will be the world’s first clinical trial of an adeno-associated virus cancer immunotherapy. AAV gene therapy utilizes single-stranded inactive viruses to deliver healthy DNA to targeted cells.
“To be able to progress something ourselves to the point of IND and just being on the cusp of a clinical trial, building value for the company, hitting milestones, and then coming out of stealth demonstrating a fairly mature company, … kind of puts us in a really nice, attractive position,” said Allen Reha, Vironexis’ chief development officer.
Body Becomes ‘Drug Manufacturing Plant’
Vironexis’ gene therapies rely on the company’s proprietary TransJoin technology, which the company says helps prompt a patient’s body to send T cells toward tumor cells to stop their growth and eventually kill them.
Vironexis licensed the gene engineering technology underlying TransJoin from Nationwide Children’s Hospital. Dr. Timothy Cripe, chief of the hospital’s Division of Pediatric Hematology, Oncology, Bone and Marrow Transplant, first published research on TransJoin in 2022 in the journal Science Advances.
“The simplest way I could put it is we’re turning the body into a drug manufacturing plant,” Cripe said. “We’re using the genes of the gene therapy to instruct, mainly, cells of the liver to create a new protein that it’s never made before, and to secrete that into the bloodstream to treat the leukemia.
Co-founder
Vironexis Biotherapeutics
“It’s important to note, I think, we’re not modifying the cellular genome,” Cripe added.
“We’re not correcting or editing the genes that are in there. We’re adding a new one into the nucleus. It doesn’t, except in rare instances, get integrated into the normal chromosomes of a cell, it’s separate from that, so it’s like an added instruction.”
Cripe co-founded Vironexis with CEO Samit Varma, as well as Brian Kaspar, the former chief scientific officer of AveXis, Inc., which developed the spinal muscular atrophy gene therapeutic Zolgensma. Novartis Gene Therapies acquired AveXis in 2018 for $8.7 billion.
“The experience that this team has – from the CEO to (Kaspar), to Allen, to others – is just second to none,” Cripe said. “And it’s hard to find experience in gene therapy and in oncology, because they’re two different disciplines.”
‘Progress to Milestones’ as ‘Lean’ Co.
Vironexis is currently seeking pre-IND approval from the FDA for its next gene therapeutic candidate, VNX-202, which would potentially treat metastatic HER2+ cancers such as breast cancer.
A Phase 1/2 trial for VNX-202 is tentatively planned for 2025, according to the company.
“Our goal is to be lean, progress to the milestones,” Reha said. “As we meet success, as we achieve milestones, we get value, gain value for the company, and then we build after that in those tranches.”
Vironexis’ product candidates also include TransJoin-based treatments for types of multiple myeloma, B-cell lymphoma, neuroblastoma, gastric cancer, pancreatic cancer, osteosarcoma and nasopharyngeal cancer and a vaccine for nasopharyngeal cancer. The company said it also plans to partner with other medical researchers to continue developing a treatment for systemic lupus erythematosus.
“Our focus on execution has yielded an expansive pipeline and a clinic-ready lead program in just three years,” Varma said. “We’re working as quickly as possible to transform the future of cancer treatments for patients.”
Prior to co-founding Vironexis, Varma founded the fast-casual restaurant chain Pizza Studio, which allows customers to create their own pizza with the help of an employee. The Los Angeles-based franchise has locations in California, Utah, New York, Arizona and Kansas.
Varma is also a former partner at Anthem Ventures, where he started in 2003, and a former executive with the audio technology equipment company Audyssey Labs.
Vironexis Biotherapeutics
FOUNDED: 2021
CEO: Samit Varma
HEADQUARTERS: La Jolla
BUSINESS: biotech focused on developing gene therapies for blood cancers
FUNDING: $26M (seed)
WEBSITE: vironexis.com
NOTABLE: Prior to co-founding Vironexis, CEO Varma founded fast-casual restaurant chain Pizza Studio.
