HS-110

HS-110 (viagenpumatucel-L), an Off-the-Shelf Allogeneic Cell Therapy Designed to Stimulate Immune Responses Against Non-Small Cell Lung Cancer (NSCLC)

Tumors have evolved multiple mechanisms to avoid immune detection and induce tolerance that prevents the body’s own ability to combat cancer.  Based on the gp96 platform, HS-110 (viagenpumatucel-L) is an allogeneic “off-the-shelf” cellular vaccine derived from a lung adenocarcinoma cancer cell line and genetically modified to secrete a wide range of cancer-associated antigens bound to the immunostimulatory chaperone gp96. This approach is designed to stimulate and facilitate uptake of these antigens by professional antigen-presenting cells (APCs), which in turn activate a broad, T-cell mediated immune response against a patient’s cancer.

How it works

  • Intracellular gp96 is naturally bound to self-antigens (peptides) in the endoplasmic reticulum (ER)
  • Stress-events such as necrotic cell death can result in the release of self-antigens bound to gp96.
  • Extracellular gp96 can stimulate the innate immune toll-like receptors 2 and 4 on APCs to promote activation.
  • Uptake of gp96 antigen complexes via CD91 can lead to processing and presentation to T cells.
  • HS-110 is engineered with an immunoglobulin version of gp96-Ig to constitutively transport cancer testis antigens (CTAs) derived from a proprietary lung adenocarcinoma cell line to promote an anti-tumor response.

HS-110 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer

We have completed the enrollment of our Phase 2 trial evaluating the safety and efficacy of HS 110 in combination with either nivolumab (Opdivo®), a Bristol-Myers Squibb anti-PD 1 checkpoint inhibitor, or Merck’s anti-PD1 checkpoint inhibitor, pembrolizumab (KEYTRUDA®), for the treatment of patients with advanced NSCLC. Eligible patient populations included individuals in a second line or greater setting, or with pembrolizumab in a front-line maintenance setting. Eligible patient populations included individuals in a second line or greater setting, or with pembrolizumab in a front-line maintenance setting.

Positive interim results have been presented at leading medical conferences including American Society of Clinical Oncology (ASCO), American Association for Cancer Research (AACR) and Society for Immunotherapy of Cancer (SITC).1-4
Clinical Trials

HS-110 Manufacturing

HS-110 manufacturing is being conducted by our NightHawk ecosystem partner Scorpion Biological Services in compliance with cGMP guidelines. We utilize Scorpion's scalable 3D biomanufacturing process designed to increase yield, improve efficiency, and support late stage clinical and commercial applications. The cell line is manufactured in bulk, dispensed into individual doses, frozen in liquid nitrogen, irradiated to render cells replication incompetent, and release tested per FDA guidelines.

References

  1. Cohen et al. Interim Results of Viagenpumatucel-L (HS-110) Plus Nivolumab in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer in Two Treatment Settings. 2021
  2. Morgensztern et al. Tumor Antigen Expression and Survival of Patients with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Receiving Viagenpumatucel-L (HS-110) Plus Nivolumab. 2020
  3. Morgensztern et al. Viagenpumatucel-L (HS-110) in Combination with Nivolumab in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (NSCLC). 2019
  4. Treating Advanced Non-Small Cell Lung Cancer (NSCLC) Patients After Checkpoint Inhibitor Treatment Failure with a Novel Combination of Viagenpumatucel-L (HS-110) Plus Nivolumab. 2019