HistoIndex and Galecto to Collaborate on Galecto's Phase 2a MYLOX-1 Clinical Trial to Advance Myelofibrosis Assessment with AI-based Stain-free Digital Pathology

SINGAPORE,Oct. 20,2021 -- HistoIndex,a global leading artificial intelligence digital pathology (AI-DP) provider,has announced a collaboration with Galecto,Inc.,a biotechnology company focused on the development of novel treatments for fibrosis and cancer.

This collaboration expands HistoIndex's portfolio of fibrosis assessment outside of Nonalcoholic Steatohepatitis (NASH) and other liver diseases. The proprietary stain-free imaging technology,incorporated by Second Harmonic Generation (SHG) along with AI-based algorithms,will be utilized to analyze and quantify collagen-associated parameters as part of Galecto's Phase 2a trial for its oral LOXL2 inhibitor GB2064 in myelofibrosis.

With conventional histopathology being a primary method of myelofibrosis evaluation,issues such as the current scoring system's continued sole focus on reticulin fibers,semi-quantitative evaluation and interobserver variability due to the subjective scoring of stained slides continue to impede the reproducibility of traditional pathology[1]. Journal publications have discussed these limitations along with the need for the additional assessment of collagen fibers,which are associated with advanced myelofibrosis with a poorer prognosis[2],and the adoption of quantitative digital imaging as a potentially suitable resolution for the accurate prognostication and targeted therapy for patients at a higher risk of progression[3]. HistoIndex's stain-free AI-DP seeks to assist and advance myelofibrosis evaluation in this clinical trial by measuring morphological and architectural changes – following the GB2064 treatment – of collagen fibers in unstained tissues,especially minute changes that are unobservable under the human eye. These consequently eliminate interobserver variability and subjective readouts due to staining complications[4].

Says Dr. Hans Schambye,CEO of Galecto,"We are pleased to commence this collaboration with HistoIndex,where we can work together with an AI stain-free approach to better understand the disease behavior and how our drug candidate could work. We are encouraged by the potential of the SHG-enabled collagen parameters and look forward to learning how these parameters can translate unstained bone marrow tissue to histological significance to aid in the investigation of the efficacy of GB2064."

Says Dr. Gideon Ho,CEO of HistoIndex,"We are elated to partner with Galecto. With Galecto's in-depth knowledge on mechanisms that drive fibrosis activity and our strengths in quantifying post-treatment fibrosis changes that are both significant and minute,we aim to empower clinical trials with a reliable and reproducible decision support tool. This will bring patients,particularly individuals with progressive myelofibrosis,closer towards a targeted therapy."

About HistoIndex

Founded in Singapore,HistoIndex is a leading MedTech/Healthcare company that specializes in its proprietary integrated stain-free AI digital pathology platform. Enabled by Second Harmonic Generation (SHG) and Two-Photon Excitation (TPE) along with automated imaging analysis algorithms,the integrated platform accurately quantifies histological features and fine measurements that are critical for the evaluation of therapeutic efficacy in clinical trials. The stain-free AI platform is currently involved in multiple FDA clinical trials for Nonalcoholic Steatohepatitis (NASH). In addition,it has benefitted more than 150 research and academic institutes,CROs and biopharma companies around the world in drug discovery and development efforts for fibrotic diseases and cancers.

References

1. Problems and pitfalls in grading of bone marrow fibrosis,collagen deposition and osteosclerosis - a consensus-based study.

Kvasnicka HM,Beham-Schmid C,Bob R,Dirnhofer S,Hussein K,Kreipe H,Kremer M,Schmitt-Graeff A,Schwarz S,Thiele J,Werner M,Stein H. Histopathology. 2016 May;68(6):905-15. doi: 10.1111/his.12871.

2. Bone marrow fibrosis: pathophysiology and clinical significance of increased bone marrow stromal fibres.

Kuter DJ,Bain B,Mufti G,Bagg A,Hasserjian RP. Br J Haematol. 2007 Nov;139(3):351-62. doi: 10.1111/j.1365-2141.2007.06807.x.

3. Important Pathologic Considerations for Establishing the Diagnosis of Myelofibrosis

Mohamed E.Salama MD. Hematology/Oncology Clinics of North America Volume 35,Issue 2,April 2021,Pages 267-278,ISSN 0889-8588,ISBN 9780323795883. doi:10.1016/j.hoc.2020.11.002.

4. Stain-Free Detection and Quantification of Bone Marrow Fibrosis Using Two-Photon Excitation and Second Harmonic Generation Microscopy

Leslie R. Rowe,Ali Etman,Jessica Kohan,Josef Prchal,Gideon Ho,Dean Tai,Dong Quan Liu,Mohamed E. Salama. Poster Presentation,USCAP 104th Annual Meeting,2015. Techniques. Mod Pathol 28,510–528 (2015). doi:10.1038/modpathol.2015.30 (Abstract No. 2101).