Allterum Therapeutics, a clinical-stage biotechnology company committed to developing innovative, best-in-class precision oncology and inflammation therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, 4A10, a monoclonal antibody targeting the interleukin-7 receptor alpha (IL-7Rα; CD127) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).
HOUSTON, Nov. 11, 2025 /PRNewswire-PRWeb/ -- Allterum Therapeutics, a clinical-stage biotechnology company committed to developing innovative, best-in-class precision oncology and inflammation therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, 4A10, a monoclonal antibody targeting the interleukin-7 receptor alpha (IL-7Rα; CD127) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).
This designation underscores the urgent medical need for new treatment options in pediatric and young adult patients with ALL, one of the most common and devastating childhood cancers. Fast Track status facilitates more frequent communication with the FDA, rolling review of a Biologics License Application (BLA), and eligibility for priority review—measures designed to expedite the availability of promising therapies for patients with serious and life-threatening diseases.
This important regulatory milestone follows FDA clearance of Allterum's Investigational New Drug (IND) application in October 2025 and builds on multiple non-dilutive grant awards totaling more than $20 million from the Cancer Prevention and Research Institute of Texas (CPRIT) and the National Cancer Institute (NCI) to support development of 4A10.
Together, these achievements reflect Allterum's momentum and its steadfast mission to bring new hope to children and young adults facing the devastating realities of leukemia.
Key Highlights
- 4A10 is a highly selective IgG1 monoclonal antibody directed at IL-7Rα (CD127), a receptor subunit implicated in T-ALL and pre-B-ALL oncogenesis and resistance mechanisms.
- Allterum previously received Orphan Drug Designation and Rare Pediatric Disease designation for 4A10 in ALL, underscoring its potential to address critical unmet needs in pediatric leukemia.
- The Fast Track designation builds on FDA clearance of Allterum's Investigational New Drug (IND) application, paving the way for a Phase 1 first-in-human clinical trial in relapsed or refractory ALL.
- Preclinical studies demonstrated potent anti-leukemic activity and a favorable safety profile, supporting advancement into the clinic.
- The Company also plans to explore 4A10's utility in other CD127-expressing hematologic and solid malignancies.
Leadership Commentary
"Children and young adults with relapsed ALL confront daunting odds and a profound lack of effective options," said Yan Moore, MD, Chief Executive Officer of Allterum. "The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and families as quickly as possible."
"Fast Track designation brings us another step closer to delivering 4A10 to patients who need it most," said Atul Varadhachary, MD, PhD, Allterum Executive Chair and Fannin Managing Partner. "This recognition validates the strength of our CD127 platform and the science behind 4A10, reinforcing our mission to change outcomes for children and adults with ALL and related cancers."
"Children with many relapsed leukemias have very few effective therapies," said Eric Schafer, MD, Associate Professor and Interim Director, Leukemia Program at Baylor College of Medicine and Texas Children's Hospital. "Innovative approaches like 4A10 that target IL-7Rα could represent a meaningful advance for these young patients and their families."
Dr. Schafer will serve as Chair of the 4A10 ALL study which will be conducted in partnership with the Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) consortium.
About 4A10
4A10 is a monoclonal antibody with a human Immunoglobulin G1 (IgG1) backbone that specifically binds to CD127 (Interleukin-7 receptor alpha; IL-7Rα). CD127 is a key component of both the IL-7 receptor and the Thymic Stromal Lymphopoietin Receptor (TSLPR), expressed on T-ALL and pre-B-ALL cells, respectively. Following binding, 4A10 inhibits IL-7-induced signaling and induces antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP), leading to targeted elimination of leukemic cells.
About Allterum Therapeutics
Allterum Therapeutics is a Houston-based, clinical-stage biotechnology company advancing a pipeline of innovative precision oncology and inflammation drugs. Through cutting-edge science and strategic collaborations, Allterum is dedicated to developing transformative therapies for children and adults with high unmet medical needs. For more information, visit www.allterum.com.
About Fannin
Established in 2014, Fannin is one of the most active early-stage life sciences product development groups in the U.S., advancing a dozen therapeutic and platform programs at various stages of development. With over $270 million invested across its programs—$78 million in grant funding and $192 million from investors—Fannin partners with innovators to translate scientific breakthroughs into clinical realities. Its nationally recognized talent development program has trained more than 350 alumni now active across the biopharma ecosystem. For more information, visit www.FanninInnovation.com.
Media Contact
Serena Miggins, Fannin, 1 7139665844, [email protected], www.fannininnovation.com
SOURCE Fannin
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