Deverra Therapeutics Granted FDA Fast Track Designation for DVX101 (Dilanubicel) for the Treatment of Acute Myeloid Leukemia

Designation Validates Preliminary Data and Supports Accelerated Drug Development

SEATTLE, WA / ACCESSWIRE / April 24, 2024 / Deverra Therapeutics, Inc., a clinical-stage biotechnology company developing allogeneic universal donor cell therapy treatments to fight cancer and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track (FT) designation to dilanubicel, the Company's lead candidate for the treatment of newly diagnosed acute myeloid leukemia (AML) to improve response with first-line therapy.

Dilanubicel was recently granted Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation and has now also been granted FT designation based on the potential of DVX101 (dilanubicel) to address the significant unmet medical need in the treatment of patients with newly diagnosed AML, where the 5-year overall survival rate remains less than 30%. FT is a program offered by the FDA that is designed to streamline the development, review, and approval of new drugs or therapies intended to treat or prevent serious conditions that have the potential to fulfill an unmet medical need.

"We are thrilled to receive FT, ODD, and RMAT designations to foster expedited development and approval for our lead clinical asset, dilanubicel, for the treatment of AML," said Dr. Colleen Delaney, MD, MSc, Chief Science Officer and EVP of Research and Development at Deverra Therapeutics. "I am excited about this added level of commitment and partnership provided by the FDA in granting us this additional designation approval, and we look forward to working closely with the FDA to improve patient outcomes."

About DVX101 (Dilanubicel) for AML

DVX101 (dilanubicel), an ex vivo expanded hematopoietic stem and progenitor cell product generated from pooled donor umbilical cord blood derived CD34+ cells, is being developed as an off-the-shelf, universal (no donor-recipient matching is required), cryopreserved product for the treatment of newly diagnosed AML. Preliminary clinical efficacy studies demonstrated a statistically significant improvement in complete remission (CR) rates in subjects with newly diagnosed AML who received dilanubicel with standard-of-care induction/consolidation chemotherapy compared to the control arm (chemotherapy alone). It also showed that dilanubicel was well tolerated and did not increase toxicity compared to the control arm; there were 184 infusions in 101 subjects.

For patients with newly diagnosed AML, achieving CR after initial induction and consolidation chemotherapy is critical to survival, has been correlated with improved event-free and overall survival, and is necessary to gain access to definitive therapies such as allogeneic stem cell transplant.

About Acute Myeloid Leukemia (AML)

AML is an extremely aggressive hematological (blood) cancer that, if left untreated, progresses rapidly and is life-threatening, with fatal consequences generally within a few months from diagnosis. Even with appropriate treatment, AML is associated with a high rate of morbidity and mortality and a high rate of post-remission disease recurrence, making it a serious health concern. The incidence of AML increases with age, typically affecting people 60 years old and older, but it can affect people of all ages. With current therapies, the 5-year relative survival rate for people 20 and older with AML is less than 30 percent.

About Deverra Therapeutics, Inc.

Deverra Therapeutics, Inc. is a clinical stage biotechnology company developing allogeneic, off-the-shelf universal donor cellular immunotherapies for on-demand treatment of patients with cancer and infectious diseases. Deverra Therapeutics has exclusive license to the proprietary Notch-mediated stem cell expansion and directed differentiation platform from the Fred Hutchinson Cancer Center based on more than 20 years of federally funded research and multiple clinical trials. Deverra Therapeutics' innovative and well-established platform can be used to generate a range of unmodified and modified (engineered) progenitor and immune cells to boost the patient's blood and immune system to eliminate cancer and virally infected cells. Deverra Therapeutics currently has three clinical trials, with one pending (dilanubicel) for upfront therapy for newly diagnosed Acute Myeloid Leukemia (AML) patients, and two out-licensed (DVX201-COV-01 & DVX201-AML-01) to Coeptis Therapeutics that are utilizing an unmodified NK cell therapy in COVID-19 and in AML and Myelodysplastic Syndrome (MDS). For more information on the Company, please visit www.deverratx.com.

Contacts:

Colleen Delaney, MD, MSc
Scientific Founder, CSO and EVP of R&D
Deverra Therapeutics, Inc.
[email protected]

Media and Investor Contact:

Alpha IR Group
Jackie Marcus or Josh Carroll
[email protected]
Source: Deverra Therapeutics Inc.

SOURCE: Deverra Therapeutics