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Allterum Therapeutics, Inc.

October 18, 2023
Franciscan C
Allterum Therapeutics 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 Alpha subunit; IL7R). The company's lead candidate, 4A10, is a chimeric monoclonal antibody targeting CD127 in-licensed from NCI. CD127 plays an important role in the establishment and maintenance of ALL and in chemotherapy resistance. CD127 is also expressed in subsets of several other cancers including lymphomas, AML, and several solid tumors. The IL-7 pathway is well validated with twenty approved small molecule anti-cancer drugs against targets along the pathway, yet Allterum's 4A10 is the first targeted cytotoxic drug to target CD127 for cancer. 4A10 has demonstrated robust pre-clinical activity in ALL, including in-vivo PDX efficacy, and activity in high-risk subsets such as Ph-like ALL. 4A10 binds both the wild type and mutated forms of CD127 and has a dual mechanism of action, including inhibition of IL-7 signaling and antibody-dependent cell-mediated cytotoxicity (ADCC) through its IgG1 Fc domain. The 4A10 manufacturing process has been scaled up, including a 200-liter demonstration run and development of a stable drug formulation. 4A10 is expected to be well tolerated based on CD127's limited CD127 expression in normal tissues, and pilot non-human primate (NHP) toxicology data with 4A10. 4A10 will enter clinic in 1H2024 with an initial focus on ALL with planned label extension to other CD127-expressing cancers. Allterum has received pre-IND guidance from the FDA and the feedback has been incorporated into the trial design. The Allterum has received both Orphan Drug and Pediatric Rare designations from FDA for ALL, and the company will apply for Breakthrough Therapy designation. The Allterum 4A10 technology has strong commercial potential because: (i) it is addressing a clear unmet medical need with a promising new agent; (ii) the target (CD127) is validated and supported by robust pre-clinical evidence of efficacy; (iii) the ultra-orphan initial patient population provides a well-defined path to regulatory approval; (iv) key early development risks (CMC, safety, regulatory) have been mitigated; (v) the technology is commercially attractive with label expansion opportunities and pharma interest; and (vi) the senior management team has a demonstrated track record of success.
Atul Varadhachary - Allterum Therapeutics, Inc.