Validus Cellular Therapeutics Gains Momentum in Cellular Therapy

Validus Cellular Therapeutics, Inc. is pioneering the use of cellular therapy for the treatment of drug-resistant, chronic bacterial infections. Cellular therapy approaches have been successful for oncology patients, and researchers at Colorado State University and the Anschutz Medical Campus discovered stem cells can also be activated to fight infections.

Colorado BioScience Association President and CEO, Elyse Blazevich, asked Ethan Mann, Chief Executive Officer of Validus Cellular Therapeutics, Inc. and CBSA Board Vice Chair, CBSA’s Key Questions for Life Sciences Innovators.

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Ethan Mann, Chief Executive Officer of Validus Cellular Therapeutics

Q: Tell us about your company or organization.

A: I founded Validus in September 2019 along with Dr. Steven Dow and support from both Colorado State University and the University of Colorado. I was installed as the CEO of Validus while Dr. Dow maintained his role at CSU with his veterinary practice and research. While filling the role of Chief Technology Officer, I engaged CSU, through CSU Research Foundation (CSURF), to establish an exclusive license agreement for all fields of use for accessing the intellectual property (IP) developed by Dr. Dow on March 11, 2020. Validus’ lead candidate is a proprietary cell-based composition referred to as, VCT-101. It represents a major therapeutic advance rooted in immunological understanding and vetted by rigorous preclinical studies performed at CSU by my co-founder.

Q: Describe your team culture. How does your culture shape what your company or organization produces or offers?

A: Our team culture is built on transparency and well-described goals. Our small team firmly believes that goal alignment allows team members to have ownership in the success of tasks that they understand to be critical for company growth. I work to foster an environment of cohesion, comfort, and team-building culture for our organization.

Q: What are you working on right now?

A: I am focused on development of production and clinical strategies based on preclinical data to communicate our plans to the FDA through a pre-IND meeting later in 2022. We are raising a seed round from angel investors while assembling interested larger investors for our planned Series A syndicate. Validus has submitted several grants to NIH, NSF, and the State of Colorado to support early R&D and company formation efforts. We were awarded a $250,000 Early-Stage Capital & Retention Grant through the Colorado Office of Economic Development and International Trade (OEDIT) Advanced Industries Accelerator Grant Program in May of 2022.

Q: How will your work save or change lives?

A: Validus offers a completely innovative strategy to address infections. Activated stem cells will initially extend the effectiveness of existing or new small molecule chemical antibiotics through combinational use, but eventually further development of stem cells could allow for disruption of the classic antibiotic market. We believe prophylactic stem cell administrations will be a future use of our strategy given the dynamic nature of the strategy.

Q: Tell us about your team’s biggest breakthroughs.

A: VCT-101 therapeutic has exhibited dynamic capability to target bacteria directly while also stimulating the host’s innate immune system in preclinical in vivo evaluations. This represents the power of cell therapies accomplished without off-target toxicity so typical of small molecule chemical antibiotics.We have identified an efficient clinical management strategy that allows for establishment of initial safety endpoints treating patients with acute wound infections and then transitioning to the intended market, chronic orthopedic infections which will be the focus of subsequent phase 2 and 3 trials. Finally, development of VCT-101 to be used as a human therapeutic has required subtle adaptations to the format tested in preclinical studies at CSU. Validus has identified stem cell innovations to allow for economically efficient and scalable means for production of VCT-101. This will be critical for clinical use and future coverage and reimbursement conversations.

Q: CBSA champions a collaborative life sciences ecosystem because we are #strongertogether. How has being an active participant in our life sciences community supported your success?

A: CBSA and the life sciences community provided an easy opportunity for us to meet and discuss our mutual interest in development of stem cell based anti-infective technologies at Validus. Validus has continued to work with Gates Biomanufacturing Facility as well as other CBSA members, Essent Biologics and ACG Biologics, as leads in stem cell manufacturing capabilities. Validus engages numerous CBSA-associated investors to participate in both seed and series A raises.

Fitzsimons Innovation Community provides valuable support for manufacturing, clinical affairs, and R&D that is not available at other locations. Validus is looking forward to growing along with continued cell and gene therapy investments at CU Anschutz and Fitzsimons Innovation Community.

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