Allterum Therapeutics granted Orphan Drug Designation and Rare Pediatric Disease Designation for its monoclonal antibody therapy for pediatric leukemia
These two designations highlight the medical need and research behind this program and pave the way for an expected Phase I clinical trial in 2021.
HOUSTON, Oct. 6, 2020 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been granted both an Orphan Drug Designation and a Rare Pediatric Disease Designation by the FDA for its monoclonal antibody therapy under development for the treatment of pediatric acute lymphoblastic leukemia (ALL). These two designations highlight the medical need and research behind this program and pave the way for an expected Phase I clinical trial in 2021.
Orphan Drug Designation is granted by the FDA to promising new therapies which are being developed for rare indications in the United States. Similarly, Rare Pediatric Disease Designation is granted by the FDA to recognize programs which are specifically geared towards technologies for life-threatening diseases which primarily impact pediatric populations.
While many pediatric patients with ALL respond favorably to standard chemotherapeutics, a subset of patients experience relapsed or refractory disease. In particular, patients with relapsed T-cell ALL have no effective standard therapies available to them. Similarly, additional patients with a subtype of B-cell ALL may not be managed effectively with currently available therapies. Allterum's antibody therapy is designed to be effective in these patient populations.
The technology was invented at the National Cancer Institute by Dr. Scott Durum and his colleagues. Allterum has received $2.9 million in funding from CPRIT (Cancer Prevention & Research Institute of Texas) and is scaling up its antibody for GMP manufacture with Fujifilm Diosynth Biotechnologies. Allterum is partnering with the TACL (Therapeutic Alliance for Children's Leukemia) consortium for its Phase 1 program. The Chair and Vice-Chair of the TACL study are Dr. Eric Schafer (Baylor College of Medicine and Texas Children's Hospital) and Dr. Susan Rheingold (Children's Hospital of Philadelphia), respectively.
Allterum Therapeutics is currently completing remaining toxicology and scale-up manufacturing for its monoclonal antibody therapy. "Allterum remains on track to submit an Investigational New Drug (IND) application to the FDA in early 2021," said Dr. Atul Varadhachary, Fannin Managing Partner and President of Allterum. "We are eager to bring our antibody into clinical trials next year with the hope that we will see significant clinical benefit in children with relapsed ALL."
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About Allterum
Founded in 2018, Allterum Therapeutics, Inc., is a bio-pharmaceutical company developing 4A10, a monoclonal antibody therapy for the treatment of pediatric acute lymphoblastic leukemia. Allterum Therapeutics is a spin-out company, founded through Fannin Innovation Studio.
About Fannin Innovation Studio
Houston-based Fannin Innovation Studio is an early-stage life sciences development group focused exclusively on commercializing biotech and medtech technologies. Fannin creates and manages startups to develop internal and in-licensed programs. To further bridge the commercialization gap, Fannin's fellowship and internship programs provide aspiring entrepreneurs with hands-on development experience with its portfolio companies. For more information, visit http://www.FanninInnovation.com, come by the Studio at 3900 Essex Lane -- Suite 575 in Houston, or email us at [email protected].
For More Information:
Serena Miggins
Fannin Innovation Studio
[email protected]
713.966.5844
SOURCE Allterum Therapeutics, Inc.
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