Dogwood Therapeutics has secured exclusive worldwide rights to develop SP16, a novel cancer pain treatment, through an all-stock licensing agreement with Serpin Pharma announced September 29, 2025. The first-in-class LRP1 agonist targets chemotherapy-induced peripheral neuropathy (CIPN), with a Phase 1b study fully funded by the National Cancer Institute set to begin patient enrollment in the first half of 2026.
Novel Mechanism Addresses Unmet Medical Need
SP16 represents the active portion of alpha-1-antitrypsin (A1AT) responsible for both anti-inflammatory and tissue repair activities. In preclinical research, the intravenous formulation has demonstrated anti-inflammatory and analgesic benefits, as well as neural restorative and repair activity that could address the multiple symptoms and functional complications of CIPN.
"The National Cancer Institute's funding of the SP16 IV Phase 1b program obviates the need to use our existing capital in the near-term to advance SP16 into clinical development," said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. The NCI funding reflects both the uniqueness of this therapeutic approach and the extraordinary unmet medical need associated with this debilitating cancer-related condition.
Potential Synergy with Existing Pipeline
The SP16 acquisition strategically complements Dogwood's lead development candidate, Halneuron®, a NaV1.7 specific sodium channel inhibitor currently in Phase 2b development for chemotherapy-induced neuropathic pain (CINP). Halneuron® has demonstrated statistically significant and clinically meaningful pain reductions in general cancer pain and CINP in previous studies and has received FDA fast-track designation.
"SP16 IV may have intrinsic potential to deliver adjunctive improvement of non-pain symptoms if utilized with Halneuron®," said Lawrence Steinman, MD, Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University and Scientific Advisory Board Member of Serpin Pharma.
Over eighty patients have been recruited to date in the ongoing Phase 2b CINP study for Halneuron®, with interim data from 90-100 patients projected for December 2025.
Strategic Transaction Details
Under the exclusive licensing agreement, Serpin Pharma and its affiliates will receive 382,034 shares of Dogwood common stock and 179.1878 shares of non-voting convertible preferred stock, collectively representing 7.31% of the company's common stock on a fully diluted basis. The conversion of preferred stock to common stock requires stockholder approval in compliance with Nasdaq rules.
"Expanding a biotech company's quality shots on goal is always valued, but doing so with two development candidates that stand on their own merit, with additional potential to be mechanistically synergistic, adds additional value to this exciting worldwide SP16 license," said Mike Gendreau, M.D., Ph.D., Dogwood Therapeutics Chief Medical Officer.
Clinical Development Timeline
The Phase 1b CIPN study for SP16 IV will evaluate the treatment's potential to address multiple CIPN symptoms and explore its capacity to repair or restore nerve function damaged by chemotherapy. Patient enrollment is projected to begin in the first half of 2026, with the study design and endpoints to be determined as the program advances under NCI funding.
Dogwood intends to explore SP16's potential both as a standalone treatment for CIPN symptoms and in combination with Halneuron® to address the comprehensive spectrum of cancer-related pain and neuropathy.
