Impact of Immuno-Oncology (IO) Agents

In the past decade, immuno-oncology (IO) agents, particularly immune checkpoint inhibitors (ICIs) in solid tumor settings and chimeric antigen receptor (CAR) T-cells in hematological malignancies, have revolutionized the field of oncology. Patients who had limited therapeutic options are now experiencing long-term remissions and even cures. Ongoing investment in IO research and development (R&D) by academia and industry is expected to further enhance the clinical outlook for oncology patients, according to GlobalData, a leading data and analytics company.

Exploring the Diverse Immuno-Oncology (IO) Pipeline

GlobalData’s latest report, “Thematic Research: Immuno-Oncology,” (1^✔ ✔Trusted Source
Immuno-oncology (IO) – Thematic Intelligence

) delves into the expansive IO pipeline, identifying over 700 novel agents currently undergoing clinical development. Among the various IO classes, cell therapies take the lead, with more than 300 agents in clinical development, predominantly CAR-T cell therapies. Following cell therapies, checkpoint modulators have over 140 agents in clinical development.

Unlocking Potential: Cell Therapies and Immune Checkpoint Inhibitors (ICIs)

Avigayil Chalk, Senior Oncology & Hematology Analyst at GlobalData, highlights that significant investments are being made in classes of agents with demonstrated efficacy, namely, cell therapies and ICIs. However, pipeline ICIs face intense competition as they enter a crowded treatment landscape, with multiple ICIs already approved for a wide range of solid tumor indications. To gain market share, novel agents aim to target novel checkpoints that enhance response rates or enable retreatment of patients previously exposed to checkpoints.

Pipeline cell therapies entering the hematological malignancy space also encounter fierce competition, given the existing marketed therapies for B-cell malignancies. To compete effectively, cell therapies targeting novel or multiple receptors/antigens, with simplified manufacturing processes or allogeneic approaches, show promise. Additionally, the ongoing development of cell therapies, including CAR-Ts, CAR-Natural Killer cells (CAR-NK), and stimulated dendritic cells, focus on solid tumor indications. However, this high-risk, high-reward approach requires suitable targets and demonstrated efficacy.

Bispecific T-cell Engagers (BiTEs): An Exciting IO Class

Among the multi-specific antibodies in IO, bispecific T-cell engagers (BiTEs) hold significant potential. Over 100 BiTE agents are currently in clinical development, with four already marketed. Three BiTEs have gained regulatory approval for hematological malignancies, and one for uveal melanoma. Physicians express great enthusiasm for expanding the application of BiTEs in both hematological and solid tumor settings. BiTEs connect endogenous effector T-cells to tumor-expressed antigens, stimulating an anti-tumor immune response. Unlike CAR-T therapies, BiTEs offer simplified manufacturing processes, lower costs, and broader availability, making them an “off-the-shelf” product accessible to a larger patient population.

Advancements in Therapeutic Cancer Vaccines

Historically, therapeutic cancer vaccines have shown disappointing clinical efficacy. However, recent years have seen an increase in the number of agents in clinical development, particularly those based on mRNA technology. Educating the immune system to target rapidly evolving, genetically complex tumors that still present self-antigens remains a significant challenge. However, successful immune responses could lead to persisting antibodies and memory cells, providing long-term immunity and preventing disease relapse. Moderna’s mRNA-4157/V940, which demonstrated efficacy for this therapeutic class, generated excitement within the oncology field.

Addressing Unmet Needs in Oncology

Despite the remarkable progress in IO, significant unmet needs persist in oncology, with the majority of patients diagnosed with advanced disease failing to achieve long-term remission. The exciting and novel IO pipeline aims to address these unmet needs, improving the outlook for patients and offering hope for a brighter future in cancer treatment. Continued investment and research efforts in IO hold the potential to transform the field and provide better outcomes for oncology patients worldwide.