Immusoft

ICYMI: Immusoft presented new data from the ongoing Phase 1/2 study of ISP-001 in MPS I at #ASGCT2026. We had a great turnout at the poster session. Thanks to all those who stopped by to learn more about our approach to engineer B cell therapies and the latest data on ISP-001. The results continue to demonstrate favorable safety and tolerability, along with early signs of functional improvement and reductions in pain, supporting continued development in adults and planned expansion into pediatric populations. Thank you to R. Scott McIvor, Sean Ainsworth, Alissa R. Kerner, PhD, and our founder, Matthew Scholz, for representing Immusoft at ASGCT.

Today, on International MPS Awareness Day, we join the mucopolysaccharidosis (MPS) community in raising awareness for people and families affected by these rare, life-threatening diseases. At Immusoft, our mission is rooted in advancing engineered B cell therapies designed to bring meaningful functional improvement for people living with rare diseases like MPS I. We remain committed to helping advance new possibilities for the patients and families living with MPS I who urgently need more treatment options. Join the community and get involved in this year’s initiative from the @MPS Society, “Boogie for a Cause,” designed to help spread awareness and hope for the MPS community: https://lnkd.in/eX_5yCzV #MPSAwarenessDay

Immusoft will present new data from the world’s first engineered B cell therapy in a human clinical trial at the American Society of Gene & Cell Therapy Annual Meeting. Data from our ongoing Phase 1/2 study of ISP-001 in MPS I continue to demonstrate favorable safety and tolerability, including early clinical results demonstrating signs of functional improvement and reductions in pain. These findings support the continued development of ISP-001 in adult patients and planned expansion into pediatric populations, where there remains a significant unmet need.   We thank CIRM for their continued support in advancing this program.   Learn more: https://bit.ly/4d9no91 #ASGCT2026

We’re looking forward to joining the life science community at the Life Science Innovation Northwest 2026 conference. Our CEO, Sean Ainsworth, will be presenting on Immusoft’s engineered B cell therapy platform and our lead program, ISP-001, which is being developed to deliver long-term, continuous protein expression for patients with MPS I. Catch his presentation to learn more and hear about early clinical results demonstrating signs of functional improvement and reductions in pain. Learn more about the conference and see the agenda: https://bit.ly/4muKYkw #LifeScienceWashington #LifeScienceInnovationNW

Our CMO, Dr. Robert Sikorski MD, PhD, has been invited to speak at tomorrow’s public workshop hosted by the FDA and Alliance for Regenerative Medicine. The workshop is titled “Advancing Pediatric Cell and Gene Therapy Clinical Trials.” At the meeting, he’ll present a clinical case review of the world’s first engineered B cell therapy administered to a patient, highlighting encouraging early pharmacodynamic and functional improvements for ISP-001, our lead candidate for mucopolysaccharidosis type I (MPS I). Read the announcement to learn more: https://lnkd.in/gxzhXAjG

We’re pleased to announce that we’ve been awarded a $15M grant from the California Institute for Regenerative Medicine (CIRM)! This funding will support further development of ISP-001 for MPS I, a rare, life-threatening disease with no cure. In our ongoing Phase 1/2 trial, ISP-001 has demonstrated a favorable safety and tolerability profile along with early signs of functional improvement and reduced pain. Read to learn more: https://lnkd.in/gU4pB9zZ

Tomorrow, our Chairman and CEO, Sean Ainsworth, will present at the LSX Investival Showcase. Be sure to catch his presentation to learn about our recent progress, including receiving FDA Fast Track Designation for our lead engineered B cell therapy, ISP-001 for MPS I, and learn about our continued efforts to advance engineered B cells for sustained therapeutic protein delivery. #InvestivalUSA

Thank you Jennifer Smith-Parker for highlighting Immusoft’s work in MPS II for the article “From Awareness to Acceleration: Rare Disease Drug Development Enters a Pivotal Era” in honor of Rare Disease Month. This month, and every month, we continue to work diligently to develop life-changing therapies for patients with these devastating genetic diseases. #raredisease #celltherapy #MPSII #rarediseasemonth https://lnkd.in/gkTDYQNk

In a huge win for patients, and especially the pediatric and rare disease communities, the Rare Pediatric Disease Priority Review Voucher (PRV) program has been re-authorized! We are incredibly thankful to the bipartisan support this received in Congress and to the patient advocacy groups who worked tirelessly to get this passed. #raredisease #FDA #PRV #GiveKidsAChance https://lnkd.in/eCH4FicT

The good news keeps on coming! We’re delighted to share that Immusoft has received FDA Rare Pediatric Disease Designation for ISP-002, our investigational engineered B cell therapy for mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. This designation continues our clinical momentum from our lead program (in MPS I), further validating our platform and the serious, unmet medical need for pediatric patients with MPS II. We are grateful for the early support from the California Institute for Regenerative Medicine (CIRM) whose funding helped advance the development of our engineered B cell platform. #RareDisease #MPSII #HunterSyndrome #CellTherapy #Biotechnology #CIRM https://lnkd.in/etqJweGj