On September 8, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, SEP 8, 2025, View Source [SID1234655841]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt"). The fifth cohort is expected to commence following a routine 30-day safety verification that no adverse effects have been observed in the fourth cohort.

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To date several treated patients remain alive beyond disease-specific median survival benchmarks. Notably, one patient from the 1st cohort remains alive 28 months post-treatment. These observations are preliminary and from a small number of patients and dose levels.

The fourth cohort in the trial received 3×10⁶ CAR-positive cells per kilogram of body weight—approximately a 30-fold increase versus the first cohort (1×10⁵ cells/kg). No dose-limiting toxicities (DLTs) have been observed to date in the fourth cohort. Pending safety review, the fifth cohort is planned at approximately 1×10⁷ cells/kg.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. This first-in-human trial is enrolling adult women with recurrent ovarian cancer who have progressed following at least two prior therapies and is designed to evaluate safety, identify the maximum tolerated dose, and explore preliminary signals of activity.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With the completion of the fourth cohort, we are gaining important insights into the potential of our CAR-T therapy for ovarian cancer at higher dose levels. While this study is primarily designed to assess safety, we are encouraged by the early indications of potential efficacy, and look forward to initiating the next dose cohort following the standard safety review."

Anixa’s CAR-T technology was invented by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. The ongoing clinical trial is being conducted at Moffitt under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program. Anixa holds an exclusive worldwide license to the FSHR-targeting CAR-T technology from The Wistar Institute.

On September 8, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported it will present initial data at their 10-Year Anniversary R&D Day from two expansion cohorts in their Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2A) inhibitor, in combination with Gilead’s Trodelvy (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with late-line methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC) (Press release, Ideaya Biosciences, SEP 8, 2025, View Source [SID1234655840]). MTAP-deletion is estimated to occur in approximately 25-30% of UC and 15-20% of non-small cell lung cancer (NSCLC) patients. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for patients with MTAP-deletion solid tumors.

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Data in the presentation were as of a cut-off date of August 29, 2025, and included a total of 19 patients with late-line MTAP-deletion UC who received the combination of IDE397 and Trodelvy. Of the 19 patients, 16 (Cohort 1: n=9; Cohort 2: n=7) were evaluable for efficacy having received at least one post-baseline tumor assessment per RECIST v1.1. Of the patients evaluated in the combination trial, 68% (13/19) had progressed after two or more prior therapies, with 84% (16/19) having received an immune-oncology therapy and 32% (6/19) having received enfortumab vedotin (EV).

"We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer. These results set the stage for further testing of the combination in non-small cell lung cancer, where we have just dosed the first patient in our clinical trial," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.

Summary of key findings

Dose Level 1 (DL1)

Dose Level 2 (DL2)

IDE397 (15mg) + Trodelvy (10mg/kg)

IDE397 (30mg) + Trodelvy (7.5mg/kg)

Evaluable patients (n)

n=9

n=7

ORR (cPR+uPR)

33% (3cPR)

57% (3cPR +1uPR)

DCR%

100% (9/9)

71% (5/7)

To date, median progression free survival (PFS) and duration of response (DOR) has not been reached.
33% ORR at DL1 (3/9); 3 confirmed partial responses (cPR), including one patient with a confirmed response after the cut-off date, and 57% ORR at DL2 (3 cPR and 1 unconfirmed partial response (uPR)). The preliminary combination data is trending favorably versus historical Trodelvy monotherapy efficacy reported in metastatic UC, including 11% ORR in patients post-EV therapy (Sternschuss et al., 2025) and 23% ORR in predominantly EV-naïve patients (Powles et al., 2025).
Manageable safety profile consistent with known adverse events of both drugs as single agents, with no treatment related serious adverse events observed at the IDE397 30mg and Trodelvy 7.5 mg/kg expansion dose. The most common Grade 3 or greater treatment-related adverse events seen in DL1 were anemia and neutropenia, and in DL2 were anemia, asthenia, and diarrhea.
Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

The use of Trodelvy in MTAP-deletion UC and NSCLC is investigational, and the safety and efficacy of this use have not been established. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

On September 8, 2025 Sirtex Medical ("Sirtex"), a leading manufacturer of minimally invasive interventional oncology solutions, reported that it has received an expanded CE Mark approval for SIR-Spheres Y-90 resin microspheres for the treatment of patients with liver cancer (Press release, Sirtex Medical, SEP 8, 2025, View Source [SID1234655839]). With this expansion, eligibility now covers both primary and secondary liver metastases, increasing patient access to a well-established, targeted therapy.

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"This milestone is about more than regulatory approval—it’s about giving hope and options back to patients facing some of the toughest cancer diagnoses," said Matt Schmidt, CEO of Sirtex Medical. "By expanding access to SIR-Spheres, we’re ensuring that more people can benefit from a well-tolerated therapy when they need it most."

Radioembolization—also known as selective internal radiation therapy (SIRT)—delivers yttrium-90 directly to tumors via the hepatic artery, allowing for high-dose, targeted radiation aiming to minimize impact to surrounding healthy tissue.

"Y-90 radioembolization has long demonstrated clinical value in managing complex liver tumors," said Prof. Dr. med. Jens Ricke, Director of the Clinic and Polyclinic of Radiology at the University Hospital Ludwig-Maximilians in Munich, Germany. "With this expanded CE Mark, more patients will have access to a therapy that can extend life, improve quality of life, and offer hope when other treatments may no longer be effective."

The CE Mark expansion follows an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres across diverse liver metastases. Together with the FDA’s recent approval of SIR-Spheres Y-90 resin microspheres for the treatment of unresectable HCC in the United States, this milestone underscores the growing global recognition of SIR-Spheres as a versatile, differentiated therapy and reinforces the Sirtex commitment to advancing liver-directed interventional oncology.

On September 8, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of spevatamig in combination with chemotherapy for the treatment of biliary tract carcinoma (BTC) (Press release, Phanes Therapeutics, SEP 8, 2025, View Source [SID1234655838]).

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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase I/II clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase I (CTR20241655) and Phase II (CTR20252758) clinical trials of spevatamig in China are currently recruiting patients.

On September 8, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of spevatamig in combination with chemotherapy for the treatment of biliary tract carcinoma (BTC) (Press release, Phanes Therapeutics, SEP 8, 2025, View Source [SID1234655838]).

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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase I/II clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase I (CTR20241655) and Phase II (CTR20252758) clinical trials of spevatamig in China are currently recruiting patients.