World Ovarian Cancer Day 2025: Looking Back at Progress for Cell Therapy
In observance of World Ovarian Cancer Day, held annually on May 8, we took a look back at news in cell therapy for ovarian cancer indications.
According to the World Ovarian Cancer Coalition, at a global scale ovarian cancer is the 8th most common cancer for women and the 8th most common cause of death from cancer for women. Each year around the world, approximately 207,000 women with ovarian cancer die. Although treatment options exist, substantial unmet need remains, and many companies and academic institutions are currently pursuing new treatment approaches for the disease.
An important area of interest for new therapeutic development in ovarian cancer is cell therapy, such as chimeric antigen receptor T-cell (CAR-T) therapy and T-cell receptor-engineered T-cell (TCR-T) therapy. In honor of World Ovarian Cancer Day, observed annually on May 8 by the patient and clinician communities, CGTLive® is taking a look back at the progress that was made for cell therapy in ovarian cancer over the past year. Click the "READ MORE" buttons for more details and information about each item.
Gradalis' Personalized Immunotherapy Gemogenovatucel-T Receives FDA RMAT Designation
February 5, 2025 — Gradalis' Gemogenovatucel-T (also known as Vigil), an investigational personalized cellular immunotherapy currently being evaluated for the treatment of ovarian cancer, has received regenerative medicine advanced therapy (RMAT) designation from the FDA.
The product is being evaluated in the ongoing randomized, placebo-controlled phase 2b VITAL clinical trial (NCT02346747) in patients with newly diagnosed, advanced stage IIIb/IV ovarian cancer who are homologous recombination proficient (HRP), have a high clonal tumor mutation burden (cTMB-H), and who remain in complete response after debulking surgery and frontline platinum-based doublet chemotherapy. According to the clinicaltrials.gov page, which was most recently updated on January 9, 2025, VITAL is active, but no longer recruiting new patients. It was initiated in February 2015 and has an estimated completion date of December 2025. The total enrollment for the study is listed as 92 patients. According to Gradalis, results from the study showing a statistically significant and clinically meaningful improvement in overall survival (OS) in patients with HRP ovarian cancer and cTMB-H informed the FDA's decision to grant the RMAT designation, which applies specifically to that indication.
“The RMAT designation for Vigil highlights the transformative capacity of our unique immunotherapy to benefit women battling advanced ovarian cancer,” David Shanahan, BS, the chief executive officer of Gradalis, said in a statement. “This important recognition affirms that Vigil has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions. We continue to advance our Vigil development efforts as we work to bring this investigational therapy to patients as rapidly as possible.”
Anixa Biosciences Seeks Protocol Change to Enable Repeat Dosing in Trial for Ovarian Cancer CER-T
October 2, 2024 — Anixa Biosciences and its partner Moffitt Cancer Center have submitted a protocol amendment to the FDA for their ongoing phase 1 clinical trial (NCT05316129) evaluating Anixa's novel follicle stimulating hormone receptor (FSHR)-targeting chimeric endocrine receptor (CER) T-cell therapy for the treatment of ovarian cancer, aimed at enabling the use of second doses for patients who may benefit.
Anixa noted that it had previously obtained clearance of a single-patient investigational new drug (IND) application to redose a patient in the trial whose tumor showed cellular infiltration and necrosis in a biopsy, suggesting the CER-T therapy had produced biologic activity. In order to avoid the need to continuously submit single-patient IND applications on a case-by-case basis, the company’s protocol amendment will allow for patients in the trial to receive a second leukapheresis and dose of the CER-T, without the need for additional clearance.
"In initial phase 1 clinical trials, it is customary to begin with low, often subtherapeutic cell doses to verify safety, before increasing the dose levels,” principal investigator Robert Wenham, MD, MS, FACOG, FACS, the chair of the Gynecologic Oncology Department at Moffitt, said in a statement. “In our study, the patient approved for a second dose by the individual IND received the starting, lowest dose. While initially meeting the criteria for progression due to size of her predominate tumor, her cancer has since remained relatively stable and she has not received additional therapy since her first infusion. We are hoping a second, higher dose may improve her overall response and outcome. In general, we anticipate that higher cell doses will lead to efficacy, but for solid tumors, a second dose may be needed in a subset of patients to improve the rate and durability of responses."
First Patient Receives TCR-T Therapy in Multiplexed Study Screening Patients With Melanoma, Cervical Cancer and More
June 4, 2024 — Screening is underway for participants with solid tumors to receive T-Plex, a multiplexed TCR-T therapy, with 1 participant having received 1 Singleplex therapy so far in a phase 1 study (NCT05973487) with no acute toxicities.
Data from the TSCAN-003 screening study (NCT05812027) and initial data from the phase 1 study were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 - June 4, in Chicago, Illinois, by Dawn Pinchasik, MD, MS, vice president, clinical development, TScan Therapeutics.
The TSCAN-003 screening study has enrolled over 300 participants since September 2023. Over 75% of participants have melanoma, head and neck cancer, non-small lung cancer, or ovarian cancer. Cervical, uterine, anogenital, and soft tissue sarcoma cancers are also represented. The study screens patients for a match to one of the 4 TCR-Ts in the ImmunoBank. Of the enrolled participants so far, 71% had at least one HLA match in the ImmunoBank, and of these, 68 have passed the screening for target expression and LOH. Of the 68, 73% have at least 1 TCR-T match and 27% have more than 1 TCR-T match, qualifying for T-Plex therapy.
A2 Bio’s Trial for Solid Tumor Tmod CAR-T A2B694 Doses First Patient
May 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.
TAC01-CLDN18.2 integrates TAC, Triumvira’s proprietary chimeric receptor that is intended to activate and direct T-cells against tumor cells. TAC01-CLDN18.2 specifically expresses the CLDN18.2 TAC with the intention of targeting tumor cells that are CLDN18.2-positive. The TACTIC-3 trial is currently recruiting patients with gastric cancer, gastroesophageal cancer (GEJ), esophageal adenocarcinoma (AC), non–small cell lung cancer (NSCLC), cholangiocarcinoma, pancreatic ductal AC (PDAC), ovarian mucinous cancer, and colorectal cancer.
The phase 1 dose escalation portion of the study will follow a standard 3+3 design and aims to treat 9 to 24 patients in total. Four different dose levels will be evaluated: 1-3x105 cells/kg, 6-8x105 cells/kg, 1-3x106 cells/kg, and 6-8x106 cells/kg. Patients with gastric cancer, GEJ, esophageal AC, NSCLC, PDAC, cholangiocarcinoma, ovarian mucinous cancer, and colorectal cancer are eligible for this portion of the trial. These participants must have cancer that is negative for expression of HER2 and must have had at least 2 lines of prior therapy.
