On August 20, 2025 Novocure (NASDAQ: NVCR) reported it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer (Press release, NovoCure, AUG 20, 2025, View Source [SID1234655415]).

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This submission is supported by the PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median overall survival for patients treated with TTFields and GnP compared to GnP alone. The PANOVA-3 data was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where the presentation was selected for inclusion in the "Best of ASCO (Free ASCO Whitepaper)" program. The data were simultaneously published in the Journal of Clinical Oncology.

"The submission of our application is a key step in our efforts to advance Tumor Treating Fields therapy as a treatment option for people living with pancreatic cancer," said Ashley Cordova, CEO, Novocure. "This milestone, achieved nine months after the positive topline readout of the PANOVA-3 trial, reflects the focus, drive and commitment of our team to bring this innovative treatment to patients as quickly as possible."

The PMA for pancreatic cancer was submitted as a PMA Panel-Track Supplement to Optune Lua, which is currently indicated for the treatment of patients with non-small cell lung cancer (NSCLC). The PMA supplement is expected to be converted to a separate, original PMA for the treatment of pancreatic cancer.

Novocure anticipates an approval decision in the second half of 2026.

About PANOVA-3

PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

Quality of life outcomes further reinforced the clinical benefit of TTFields therapy, with patients treated with TTFields therapy exhibiting a statistically significant extension in pain-free survival (secondary endpoint) and a significant preservation of quality of life in terms of global health status, pain, pancreatic pain, and digestive symptom domains.

TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On August 20, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that Shaun Bagai, Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Renovorx, AUG 20, 2025, View Source [SID1234655414]). The conference will be held at the Lotte New York Palace Hotel in New York City, September 8-10, 2025.

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Mr. Bagai will be conducting a virtual presentation, which will be available for the duration of the conference, and afterwards on the Company’s IR website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Mr. Bagai will discuss RenovoRx’s ongoing commercialization efforts and the organic revenue growth reflecting the strong clinical need and market demand for RenovoCath as a standalone targeted drug-delivery product among both new and existing customers.

Mr. Bagai’s presentation will also highlight the latest developments in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial, including the Data Monitoring Committee’s (DMC) recent recommendation to continue the trial following its review of the second pre-planned interim analysis which was triggered by the 52nd death. The TIGeR-PaC trial is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of locally advanced pancreatic cancer (LAPC).

Presentation Details:

Date: Monday, September 8, 2025
Time: 7:00 A.M. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Shaun Bagai, CEO
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact KCSA Strategic Communications at [email protected].

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

On August 20, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the enrollment and dosing of the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody developed by Akeso, in combination with chemotherapy for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma (Press release, Akeso Biopharma, AUG 20, 2025, View Source [SID1234655413]).

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The COMPASSION-33 study represents the third Phase III trial for cadonilimab in gastric cancer. The study aims to improve the radical resection rate in patients with advanced gastric cancer, reduce the risk of recurrence and metastasis, and enhance overall patient outcomes. This study broadens cadonilimab’s clinical application from unresectable advanced gastric cancer to also include resectable advanced gastric cancer, potentially expanding the number of gastric cancer patients that can benefit from its synergistic and simultaneous targeting of PD-1 and CTLA-4 checkpoints.

Cadonilimab, in combination with chemotherapy, has already been approved for the first-line treatment of advanced gastric cancer in China, showing efficacy for patients with tumors across all levels of PD-L1 expression, including those with high, low, and negative PD-L1 expression. Additionally, a Phase III registration trial is currently underway to evaluate the combination of cadonilimab with pulocimab (VEGFR-2) for treating immune therapy (IO)-resistant advanced gastric cancer. This study aims to provide a new, effective second-line treatment option for patients with IO resistance, further demonstrating cadonilimab’s potential to address critical unmet need in this difficult to treat cancer patient populations.

Currently, there are no approved perioperative immunotherapy regimens in the world, highlighting a significant unmet need. Preliminary data suggest that cadonilimab may offer superior efficacy and a more favorable safety profile compared to existing PD-1 therapies for the perioperative treatment of G/GEJ adenocarcinoma. As the world’s first approved and commercially available PD-1/CTLA-4 bispecific antibody, cadonilimab has already demonstrated superior efficacy compared to other treatment options in a Phase III trial for the first-line treatment of advanced G/GEJ adenocarcinoma. Cadonilimab’s ability to meaningfully improve survival outcomes and significantly reducing risk of death for patients across all levels of PD-1 expression is particularly meaningful. Whereas current approved PD-1 treatments have demonstrated very limited or no survival benefit for patients with G/GEJ tumors that have low or negative PD-L1 expression, cadonilimab has demonstrated clinically meaningful survival benefit even in this difficult to treat patient population. Moreover, in patients with higher levels of PD-L1 expression, cadonilimab has demonstrated superior overall survival benefits compared to other approved PD-1 treatments in the first-line treatment of advanced G/GEJ.

On August 20, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, reported it has selected PSI, a leading global contract research organization (CRO), to operationalize and manage its planned (Z)-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer (mBC) (Press release, Atossa Therapeutics, AUG 20, 2025, View Source [SID1234655412]). The study was designed following guidance from the U.S. Food and Drug Administration (FDA) and is intended to directly inform a subsequent Phase 3 trial.

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The global Phase 2, multi-center dose-ranging study is designed to evaluate (Z)-endoxifen monotherapy for safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. Patient enrollment is expected to follow the Investigational New Drug (IND) filing in Q4 2025, with topline data anticipated in 2026.

"This is a defining milestone for Atossa," said Dr. Steven Quay, Chairman and Chief Executive Officer of Atossa. "With PSI as our partner, we are advancing (Z)-endoxifen into its final steps before Phase 3. Unlike existing endocrine therapies, (Z)-endoxifen has demonstrated clinical activity even in tumors resistant to aromatase inhibitors and fulvestrant. If successful, this program could reshape the standard of care in breast cancer treatment, including in the metastatic setting, and deliver hope to patients who currently face limited options."

PSI is widely recognized for excellence in global oncology trial execution with the ability to move swiftly from Phase 2 into Phase 3 trials. In 2024, 93 percent of PSI-managed studies enrolled on time or ahead of schedule, leveraging its proprietary machine-learning feasibility platform, VISIONAL. Atossa selected PSI, following a highly competitive process, for its proven ability to:

Deliver regulatory-grade data through rigorous quality and compliance systems.

Consistently achieve on-time enrollment across diverse geographies.

Seamlessly scale programs into Phase 3 and pivotal studies, often reducing operational risk and accelerating timelines.
"We are excited to partner with Atossa on this pivotal study of (Z)-endoxifen. Based on our assessment, the program is designed to transition seamlessly into Phase 3, and we are allocating significant global resources to accelerate its execution. We believe this is a high-priority program with the potential to reshape the standard of care in metastatic breast cancer." — said Nick Sinackevich, PSI’s President.

Market Opportunity

Each year, approximately 5.6 percent of newly diagnosed invasive breast cancers in women in the U.S., or about 13,000 women annually, are diagnosed at the metastatic stage. In total, there are an estimated 170,000 women living with metastatic breast cancer in the United States. Current therapies often fail due to resistance to existing therapies, leaving patients with limited options. Atossa believes (Z)-endoxifen has the potential to become a first-in-class therapy in this multi-billion-dollar market.

Pipeline Momentum

In addition to the upcoming metastatic dose-ranging trial, Atossa is advancing additional Phase 2 studies in the ER+/HER2- neoadjuvant breast cancer setting (i.e., before definitive surgery), including studies of monotherapy of (Z)-endoxifen in early stage breast cancer; combination therapy with abemaciclib in women with early stage breast cancer at high risk of recurrence; and monotherapy in women with a biopsy-proven diagnosis of ductal carcinoma in situ (DCIS). Multiple clinical readouts are anticipated in the coming months.

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/ Degrader (SERM/D) with dual mechanisms of action:

Estrogen receptor inhibition and degradation, including in tumors resistant to other endocrine therapies.

Direct inhibition of protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels.
Preclinical and clinical studies suggest (Z)-endoxifen may deliver superior bone-protective effects relative to tamoxifen, while maintaining a favorable safety profile. Across more than 700 subjects dosed up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, underscoring its potential for broad dose exploration. Clinical studies with tamoxifen demonstrate an inverse correlation between endoxifen blood concentration and hot flash severity score following adjustment for age, BMI, and menopausal status, suggesting it may deliver a better tolerance profile.

Atossa’s proprietary oral, enteric-coated formulation is designed to preserve the active (Z)-isomer and promote optimal bioavailability, overcoming limitations of prior formulations.

On August 20, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that members of company management will participate in the following investor events (Press release, Tyra Biosciences, AUG 20, 2025, View Source [SID1234655411]):

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Virtual H.C. Wainwright "HCW@Home" series
Format: Fireside chat
Presentation Date/Time: Thursday, August 21, 2025, at 11 AM ET

H.C. Wainwright 27th Annual Global Investment Conference
Format: Fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, September 10, 2025, at 9 AM ET
Location: New York, NY

A live webcast of the events can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.