Conference Day 1

9.00 am | Morning Networking Coffee

9:25 am Opening Address from Chair

9:45 am The Changing Therapeutic Landscape of Head and Neck Cancer & Future Directions


  • Addressing the changing therapeutic landscape of head and neck squamous cell carcinomas (HNSCC) that can arise in the oral cavity, oropharynx, hypopharynx, and larynx
  • Highlight developments in combination approaches (mainly involving the combination of radiotherapy, chemotherapy, immunotherapy including checkpoint inhibitors etc), outlining how these treatments are being used in the current era of widespread testing for the presence of human papillomavirus infection in patients with HNSCC
  • Overview of clinical trials that have led to the approval of the immunotherapeutic agents for HNSCC

10:15 am Panel Discussion: Strategic Importance of H&N as Proof-of-Concept Indication for Novel Immunotherapies


  • Defining head and neck as a go-to indication to enhance drug development decision making under the framework of maximizing resource investment, characterized by benefit-cost ratios (BCRs)
  • Explore the likelihood that a drug is successful in H&N cancer and reduce the risk of failure in phase II and III trials
  • Highlighting novel immunotherapies being tested in H&N cancers
  • Reviewing immunotherapies in combinations with checkpoint inhibitors (Keytruda, Opdivo) in H&N cancer as proof-of-concept

11.05 am | Networking Break

Boosting Immune Checkpoint Inhibitor Activity in Head and Neck Cancers

11:35 am Boosting Immune Checkpoint Inhibitor Activity in Head and Neck Cancers


  • Checkpoint inhibitors have shown clinically relevant activity in head and neck cancer
  • Telomerase is expressed in Head and Neck cancer and is a relevant target for an off-the-shelf cancer vaccine
  • A sub-optimal T cell repertoire might be optimized by the expansion of telomerase-specific T cells

12:05 pm A Soluble LAG-3 Protein (eftilagimod alpha) with an Anti-PD-1 Antibody (Pembrolizumab) Tested in Two phase II Studies in HNSCC


  • An MHC class II agonist (eftilagimod) used as an antigen-presenting cell (APC) activator combined with an immune checkpoint inhibitor (ICI): a unique combination in immuno-oncology
  • Results of the TACTI-002 (Two ACTive Immunotherapies) phase II trial in second-line PD-X naïve head and neck small cell carcinoma (HNSCC) patients
  • Presentation of the ongoing TACTI-003 randomized phase IIb trial in first-line HNSCC patients

12.35 pm | Networking Lunch Break

Linking the Innate & Adaptive Arms of the Immune System to Generate a Robust Durable Tumor Specific Response in Head & Neck Cancers

2:00 pm Targeting IL-2 to Tumor-specific T cells via Novel Biologic Platforms: Update on CUE-101 in R/M HNSCC and Beyond

  • Anish Suri Chief Scientific Officer & President, Cue Biopharma


  • To harness the fullest therapeutic potential of IL-2 immunotherapy, we have designed the CUE-100 series of Immuno-STATs (ISTs): rationally engineered Fc fusion proteins comprised of bivalent tumor-peptide-MHC (pMHC) complexes and four affinity-attenuated IL-2 molecules to preferentially engage and activate tumor-specific T cells directly in the patient
  • Our lead clinical candidate, CUE-101, incorporates an immunodominant peptide from the HPV E7 oncoprotein complexed with HLA-A*0201 to activate T cells targeting HPV+ epithelial cancers. In initial dose escalation, CUE-101 has been safely dosed up to 8 mg/kg in 2L+ recurrent/metastatic head and neck cancer with favorable pharmacodynamics and evidence of anti-tumor activity
  • These data provide proof-of-concept for the intended approach of selectively and safely delivering IL-2 to the tumor-specific immune cell compartment. The modularity of the IST platform enables rapid generation of additional clinical candidates by readily exchanging the tumor-antigen peptide. To that end, our next clinical candidate CUE-102 has been generated with a Wilms Tumor 1 (WT1) peptide for the treatment of patients with WT1-positive malignancies and is expected to enter the clinic in 2022. Preclinical studies show that CUE-102 selectively expands polyfunctional and cytotoxic WT1-specific CD8+ T cells in vitro and in vivo

2:30 pm ALX148 a Novel CD47 Myeloid Checkpoint Inhibitor in Patients with HNSCC


  • CD47 is an anti-phagocytic SIRPα ligand often overexpressed by cancer cells to evade immune response correlates with poor clinical prognosis. The disruption of the CD47-SIRPα anti-phagocytic signal via CD47 blockade has been shown to maximize phagocytic activity against tumor cells in combination with a pro-phagocytic signal. Targeting the CD47-SIRPα myeloid checkpoint interaction with cancer therapeutics has the potential to bridge both innate and adaptive immune responses to cancer and represents a novel approach to cancer-targeted treatment
  • Describe the clinical experience to date of ALX148 a novel CD47 myeloid checkpoint inhibitor in patients with HNSCC

3:00 pm Chair’s Closing Remarks

3.15 pm | End of Conference Day One