Fannin Partners, LLC has received a $2 million Small Business Innovation Research (SBIR) Phase II grant from the National Cancer Institute (NCI) to advance spin-out Allterum Therapeutics' 4A10 monoclonal antibody for the treatment of acute lymphoblastic leukemia (ALL), the most frequently diagnosed cancer in children. The SBIR grant will help support a Phase I clinical trial to assess the safety and activity of 4A10 as monotherapy and will determine pharmacokinetics, pharmacodynamics, and tumor biomarkers associated with the therapy.
HOUSTON, May 8, 2023 /PRNewswire-PRWeb/ -- Fannin Partners, LLC has received a $2 million Small Business Innovation Research (SBIR) Phase II grant from the National Cancer Institute (NCI) to advance spin-out Allterum Therapeutics' 4A10 monoclonal antibody for the treatment of acute lymphoblastic leukemia (ALL), the most frequently diagnosed cancer in children. The SBIR grant will help support a Phase I clinical trial to assess the safety and activity of 4A10 as monotherapy and will determine pharmacokinetics, pharmacodynamics, and tumor biomarkers associated with the therapy.
Allterum's 4A10 antibody, which was invented at NCI by senior investigator Dr. Scott Durum and his collaborators, targets CD127 (the interleukin-7 receptor subunit alpha; IL-7R). The antibody will initially be focused on patients with relapsed/refractory ALL with the expectation of expansion into the first-line setting. 4A10 is also being evaluated for the treatment of patients with other CD127-expressing malignancies.
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. "We have completed our Pre-IND meeting and received FDA feedback that has been incorporated into our development program," commented Dr. Philip Breitfeld, Chief Medical Officer of Allterum. "We expect to initiate our clinical trial in 2024 and receive results in 12 months, to be followed by a Phase IIA trial in ALL patient subsets including those with T-ALL and Ph-like ALL."
"Allterum's monoclonal antibody is a much-needed therapeutic for patients with ALL who have exhausted known effective treatment options," said Dr. Eric Schafer, Associate Professor in the Department of Pediatrics, Section of Hematology/Oncology at Baylor College of Medicine and Texas Children's Hospital who will serve as the Chair of the TACL study. "Current chemotherapies come with significant toxicity, which limits their effective use. Allterum's targeted therapy is designed to be effective in these patient populations, with greatly reduced side effects."
Since ALL is an ultra-orphan indication with an unmet medical need, Allterum has qualified for programs to facilitate and expedite development of new drugs for rare diseases. The 4A10 antibody has received Orphan Drug Designation and Rare Pediatric Disease Designation from FDA, providing an accelerated path to approval, and potentially qualifying for a Pediatric Priority Review Voucher. In addition, Allterum's 4A10 antibody has the potential for label extension to include the front-line treatment of patients with T-cell ALL and high-risk B-cell ALL, other T-cell malignancies, and CD127-expressing subsets of other hematologic cancers.
Allterum has been spun out of Fannin, and early work was 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. This work included manufacturing scale-up and preclinical toxicology activities. The SBIR Phase II grant from NCI, together with additional fundraising, will advance the 4A10 antibody to an Investigational New Drug (IND) filing and the first-in-human clinical trial.
"We appreciate the additional validation by the NCI provided by the SBIR award and the funding that will support the further development of 4A10," said Dr. Atul Varadhachary, Managing Partner of Fannin and President and CEO of Allterum. "We are excited about the potential for this targeted treatment modality to address the needs of patients with ALL and possibly other CD127-expressing cancers."
Media Contact
Serena Miggins, Fannin Partners, LLC, 1 7139665844, [email protected]
SOURCE Fannin Partners, LLC
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