Advancing Hope in the Fight Against Pediatric Cancers: Allterum Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for 4A10 in Acute Lymphoblastic Leukemia. Allterum Therapeutics, a clinical-stage biotechnology company dedicated to developing innovative and best-in-class precision oncology and inflammation therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for 4A10. This clearance paves the way for the initiation of a Phase 1 first-in-human clinical trial in patients with Acute Lymphoblastic Leukemia (ALL).
HOUSTON, Oct. 9, 2025 /PRNewswire-PRWeb/ -- Allterum Therapeutics, a clinical-stage biotechnology company dedicated to developing innovative and best-in-class precision oncology and inflammation therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for 4A10. This clearance paves the way for the initiation of a Phase 1 first-in-human clinical trial in patients with Acute Lymphoblastic Leukemia (ALL).
This milestone underscores Allterum's unwavering commitment to tackling some of the most devastating cancers affecting children and young adults. Pediatric cancers remain one of the greatest areas of unmet medical need, and Allterum is driven by a vision to deliver life-changing therapies where few options exist.
The upcoming clinical trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of 4A10 in patients with relapsed or refractory ALL. By advancing this therapy into the clinic, Allterum takes a bold step forward in its mission to transform outcomes for patients and families facing the harsh realities of pediatric cancer.
"FDA clearance of 4A10 marks a transformational step for Allterum as we transition into a clinical-stage company," said Yan Moore, MD, Chief Executive Officer of Allterum Therapeutics. "Our mission is deeply personal - we are determined to bring forward best-in-class precision medicines that not only advance science but also bring new hope to children and families who have been waiting far too long for better options."
"ALL is the most common pediatric cancer and patients who have failed available therapies have a poor prognosis and few options" said Atul Varadhachary, MD, PhD, Chairman of the Board of Directors at Allterum Therapeutics. "This IND clearance validates our strategy and moves us closer to providing therapies that can truly change the trajectory in this important disease."
"Children and young adults with relapsed ALL urgently need new therapeutic approaches," said Eric Schafer, MD, national pediatric leukemia thought leader and study chair. "We are eager to begin this first-in-human trial of 4A10 and explore its potential to address a critical gap in treatment for these vulnerable patients."
With this FDA clearance, Allterum strengthens its resolve to fight pediatric cancers with determination, innovation, and compassion — turning cutting-edge science into a future where children and families can look forward to brighter tomorrows.
About 4A10
4A10 is a monoclonal antibody with a human Immunoglobulin G Subclass 1 (IgG1) backbone that specifically binds to CD127 (Interleukin-7 receptor alpha subunit; IL-7Rα). CD127 is a key component of both the IL-7 receptor and the Thymic Stromal Lymphopoietin Receptor (TSLPR), which are expressed on T-ALL and pre-B-ALL cells, respectively.
Following binding to CD127, 4A10 inhibits IL-7–induced signaling and induces cell-mediated killing through Antibody-Dependent Cellular Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Preclinical studies demonstrated potent anti-leukemic activity, and a favorable safety profile, supporting advancement into first-in-human clinical trials.
About Allterum
Allterum Therapeutics is a Houston-based and now clinical-stage biotechnology company advancing a pipeline of innovative, best-in-class precision oncology and inflammation drugs. By leveraging cutting-edge science and strategic collaborations, Allterum is dedicated to accelerating the development of transformative therapies for children and adults with high unmet medical needs. For more information, visit www.allterum.com.
About Fannin
Established in 2014, Houston-based Fannin is among the most active early-stage product development groups in the life sciences with a dozen programs/platforms at different stages of development. Fannin advances its pipeline both internally and through Fannin-founded entities with a combination of investor and grant funding. In the last decade, Fannin has brought in more than 35 programs, of which a dozen are active, including three in the clinic. Fannin has had $270 million invested across our programs, with $78 million from grant funding and $192 million from investors. An additional critical element to our model is helping develop life sciences entrepreneurs locally through our talent development programs. Our talent development program, which includes part-time interns and full-time fellows/product development associates, has grown to become one of the largest of its kind. Fannin's 350+ alumni are active in pharma/biotech, medical device/medtech and VC firms across our ecosystem and nationally.
For more information, visit www.FanninInnovation.com, come by the office at 3900 Essex Lane -- Suite 575 in Houston, or email us at [email protected].
Media Contact
Serena Miggins, Fannin Partners, 1 713.966.5844, [email protected], www.fannininnovation.com
SOURCE Allterum Therapeutics, Inc.
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