Alume Biosciences, a privately held biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, announced that it has completed a Series A funding in the amount of $5.5 million dollars. Practicing physicians and biotechnology angel investors participated in the Series A round, including co-founder Chrysa Mineo (formerly of Receptos and Neurocrine Biosciences) and Dan Bradbury (co-founder and Executive Chairman of Equillium, Inc. and former CEO of Amylin).
The financing is expected to fully fund a Phase 1/2 study of lead candidate ALM-488, an intravenously administered peptide-dye conjugate for fluorescence highlighting of nerves during surgery. Alume has received a “Study May Proceed” letter from the US FDA related to its IND application for the use of ALM-488 in head and neck surgery. The IND was approved by the FDA Division of Medical Imaging and Radiation Medicine (DMIRM), which is responsible for drug products used in the image-based diagnosis and monitoring of diseases. The dose-escalation study plans to enroll up to 36 patients undergoing head and neck surgery. Specific study cohorts will also examine ALM-488 dose timing ahead of surgery to determine effect on fluorescence nerve labeling. The primary objective of the trial is safety, and secondary objectives include determining the pharmacokinetics (PK) of ALM-488, observing efficacy as defined by dose at which optimal fluorescence signal is observed, and evaluation of the effect of dose timing relative to surgery on optimal fluorescence imaging characteristics. The study will proceed at three sites including the University California San Diego (UCSD), Stanford Medical Center and Harvard-Massachusetts Eye & Ear. Alume anticipates trial initiation in Q2 2020.
Following the Phase 1/2 trial, and assuming positive safety and efficacy data, Alume plans to expand clinical applications including high priority indications such as spinal surgery and prostate surgery. The company plans to also explore the potential for use in combination with other fluorescent agents for tumor margin delineation during surgery and potentially future Artificial Intelligence (AI) enhancements to the surgical suite, assisting physicians to optimize surgical outcomes for patients. Alume is also investigating the possible utilization of nerve illumination agents for cardiac ablation and renal denervation as well as the application of its technology to deliver nerve-targeted pharmaceuticals for therapeutic use.
ALM-488 is a proprietary peptide-dye conjugate utilizing fluorescent excitation wavelength centered around 488nm. ALM-488 binds to the extracellular matrix of nerves, allowing real time nerve illumination during surgery. ALM-488 is expected to have broad surgical application due to unique characteristics of binding that are independent of myelin. This allows ALM-488 to highlight multiple types of nerves including motor, sensory, autonomic and degenerated nerves important during reconstructive procedures. Human autonomic nerves in the neurovascular bundle around the prostate gland, important for continence and erectile function and known to be poorly myelinated, label well with ALM-488 in preclinical tests. Surgeries where nerves are potentially at risk include procedures in the skull base, head and neck, spine, and nerve sparing prostatectomy. In vivo preclinical studies also indicate that ALM-488 has adequate pharmacokinetic characteristics to support clinical utility for the labelling of ureters in urology, gynecology and lower abdominal surgical indications.