Allterum Therapeutics, Inc. (Allterum) has been approved to receive support from the National Cancer Institute (NCI) Experimental Therapeutics (NExT) Program. NCI is part of the National Institutes of Health. The approval will support key product development activities for Allterum's 4A10 monoclonal antibody targeting acute lymphoblastic leukemia (ALL). The milestone-driven NExT Program will support a pivotal GLP toxicology study and the initial GMP manufacturing of 4A10, enabling Allterum to submit an Investigational New Drug application and to launch its Phase I clinical trial in 2024.
HOUSTON, Jan. 24, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. (Allterum) has been approved to receive support from the National Cancer Institute (NCI) Experimental Therapeutics (NExT) Program. NCI is part of the National Institutes of Health. The approval will support key product development activities for Allterum's 4A10 monoclonal antibody targeting acute lymphoblastic leukemia (ALL). The milestone-driven NExT Program will support a pivotal GLP toxicology study and the initial GMP manufacturing of 4A10, enabling Allterum to submit an Investigational New Drug application and to launch its Phase I clinical trial in 2024.
The NExT Program was founded in 2009 to advance promising new drug discovery and development projects and bring cancer therapeutics into the clinic. The NExT Program is not a grant mechanism, rather it provides resources for projects focused on developing therapies for unmet needs in the area of oncology that are not typically addressed by the private sector.
"We appreciate the support provided by the NExT Program to advance our 4A10 program through our pivotal toxicology study and GMP manufacturing run," said Atul Varadhachary, MD, PhD, President and CEO of Allterum. "Acceptance by NExT after a rigorous evaluation process provides further scientific validation for Allterum's 4A10 program, and the NExT Program's support will play a vital role in bringing our novel therapeutic antibody into the clinic to improve outcomes for patients with ALL."
Leukemias are the most commonly diagnosed pediatric cancer in the U.S., and ALL is the most common leukemia in children. Although current therapies are effective for a majority of patients, the prognosis is poor for patients who have relapsed or are refractory to treatment. Allterum's initial trial will focus on patients who are relapsed or refractory to therapy with follow-up label expansion trials in ALL patients in a first-line setting as well as in patients with other CD127-expressing hematological and solid cancers.
"We have received Orphan Drug Designation and Rare Pediatric Disease Designation for ALL from FDA, which will provide an accelerated path to approval and potentially qualify us for a Pediatric Priority Review Voucher," said Philip Breitfeld, MD, Allterum's Chief Medical Officer. "This funding from NExT will play a vital role in advancing our development program for 4A10. We are eager to progress to Phase I/IIA clinical trials to evaluate our antibody for treating leukemia and potentially other malignancies."
The 4A10 antibody targets CD127 (the interleukin-7 receptor subunit alpha; IL-7R), a protein implicated in driving cancer growth and chemotherapy resistance in ALL and other CD127-expressing cancers. The antibody was invented by NCI senior investigator Scott Durum, PhD and his collaborators, and the technology was licensed to Allterum. Allterum is a spin-out of Fannin, a Houston-based life-science firm developing early-stage therapeutic and medical device technologies.
Early development activities for 4A10, including manufacturing scale-up and preliminary safety studies in non-human primates, were funded by a $2.9M grant from the Cancer Prevention and Research Institute of Texas (CPRIT), matched by a $1.8M Series Seed financing that was led by Fannin. Fannin has also received a $2M NCI SBIR Phase II grant to support the program which, together with Allterum's NExT support and a $12M Product Development Grant from CPRIT, will advance 4A10 to clinical testing in ALL in a trial designed to provide clinical proof-of-concept.
Allterum plans to conduct its ALL Phase I trial in partnership with the Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) consortium, which includes 31 leading pediatric cancer centers, along with key adult leukemia centers such as The University of Texas MD Anderson Cancer Center. The company expects to initiate clinical testing in 2024.
About Allterum
Allterum Therapeutics, Inc. is a Fannin-founded biopharmaceutical company targeting the IL-7 pathway for the treatment of patients with Acute Lymphoblastic Leukemia (ALL) and other cancers expressing CD127 (IL-7 receptor subunit alpha; IL-7R). The company's lead candidate, 4A10, is a monoclonal antibody targeting CD127 in-licensed from NCI. For more information, visit www.Allterum.com.
About Fannin
Established in 2015, 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 ~35 programs, of which a dozen are active including three in the clinic. We have had ~$225 million invested across our programs, $75M from grant funding and $150M 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. Our over 320 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, 1 713-966-5844, [email protected], www.fannininnovation.com
SOURCE Fannin
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