Top News in Oncology Cell Therapy for World Cancer Day 2024

World Cancer Day, observed annually on February 4 by the patient and clinician communities, is organized by the Union for International Cancer Control and intended to improve awareness, education, and action towards ending preventable deaths from cancer.¹ The CGTLive^™ team regularly follows along the clinical development of targeted and novel engineered approaches to the treatment of patients with various medical disorders, and cancer is one of the key therapeutic areas of interest in the field of cell therapy.

The news items below appeared among the top pieces our team produced during 2024 so far, whether because of their clinical impact, their inventive mechanisms, or otherwise. Whatever the reason for the attention these stories got, their place here helps provide an understanding of the themes in oncology cell therapy this year so far.

Here, we'll highlight some of the most-read content on CGTLive's oncology page for 2024. Click the buttons to read further into these stories.

1. FDA Requests Black Box Warning Be Added for All Currently Approved CAR-T Therapies

January 23, 2024 — The FDA has requested that black box warnings related to secondary cancer risks be added to all 6 of the chimeric antigen receptor T-cell (CAR-T) therapy products currently approved by the agency for use in the United States. The FDA issued separate letters to each of the relevant companies for the therapies on January 19, 2024. These CAR-T products target either the antigen CD19 or B-cell maturation antigen (BCMA).

"[W]e consider the serious risk of T-cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.”

– Nicole Verdun, MD, the director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research

2. Prioritizing Cell and Gene Therapy Research for Pancreatic Cancer

January 2, 2024 — According to the American Cancer Society, approximately 64,000 people in the United States are diagnosed with pancreatic cancer each year. Additionally, an estimated 51,000 people in the US die of this disease each year, and Johns Hopkins Medicine reports that the 5-year survival rate is 5%-10%.

3. Senti Bio’s CAR-NK Therapy SENTI-202 Cleared for US Trial in Hematological Malignancies

January 4, 2024 — Senti Biosciences (Senti Bio)’s SENTI-202, an investigational allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapy candidate intended to treat acute myeloid leukemia (AML) and myelodysplastic syndrome, has received clearance of an investigational new drug application (IND) from the FDA.

“Our team has dedicated immense time and resources to developing our Gene Circuit technology from an initial synthetic biology hypothesis to what is now a tangible product for cancer patients. We look forward to initiating Senti’s first clinical trial and continuing our strong momentum into next year.”

– Timothy Lu, MD, PhD, the chief executive officer and co-founder of Senti Bio

4. Triumvira Immunologics’ TAC T-cell Therapy TAC01-CLDN18.2 to be Evaluated in Phase 1/2 Clinical Trail for Solid Tumors

January 19, 2024 — Triumvira Immunologics’ TAC01-CLDN18.2, an investigational autologous T-cell antigen coupler (TAC) CLDN18.2-targeted T-cell product, is set to be evaluated in the first-in-human phase 1/2 TACTIC-3 (NCT05862324) clinical trial for patients with various types of solid tumors. Triumvira recently presented a poster detailing the design of the dose escalation and dose expansion clinical trial at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GI) Symposium, held January 18-20, in San Francisco, California.

"Our abstract presentations at the ASCO Gastrointestinal Cancers Symposium underscores our dedication to pioneering advancements in autologous T-cell therapy and unveils promising clinical data from our ongoing phase 1/2 studies, shedding light on the safety and efficacy of autologous TAC01-HER2 and TAC01-CLDN18.2 in the challenging landscape of solid tumors."

– Paul Lammers, MD, MSc, the CEO of Triumvira Immunologics

5. Satri-Cel Shows Some Disease Control in Gastric/Gastroesophageal and Pancreatic Cancer

January 19, 2024 — Satricabtagene autoleucel (satri-cel; CT041; CARsgen) CAR T-cell therapy has shown some efficacy in patients with heavily pretreated CLDN18.2-positive advanced gastric/gastroesophageal (GC/GEJ) or pancreatic cancer (PC) treated in cohort A of the phase 1b ELIMYN18.2 clinical trial (NCT04404595). Updated data from the trial were presented in a poster by Gregory P. Botta, MD, PhD, associate professor of medicine, University of California San Diego, at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GI) Symposium, held January 18-20, in San Francisco, California.

“Claudin 18.2 (CLDN18.2) is a tight junction protein normally expressed in gastric mucosa and several types of cancer. CLDN18.2 is considered a potential therapeutics target. Autologous CLDN18.2 CAR T cell satri-cel was developed to treat solid tumors."

– Botta and colleagues

REFERENCE
1. World Cancer Day: a leading international awareness day. World Cancer Day. Website. Accessed February 4, 2024. https://www.worldcancerday.org/about-us