On July 1, 2025 Novocure (NASDAQ: NVCR) reported that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer (Press release, NovoCure, JUL 1, 2025, View Source [SID1234654205]). These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain.

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"In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient’s overall quality of life, a promising outcome we observed in this trial," said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d’Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d’Hebron Institute of Oncology (VHIO). "The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer."

The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.

"The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients’ quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025."

Results from PANOVA-3

The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

The additional secondary endpoint data to be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use.

The quality of life outcomes were measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms.

There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023.

The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003.

Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006.

These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027.

All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP.

In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046.

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

The company will also present two posters of preclinical data from its pancreatic cancer development program.

Data Presentation Details

Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC)

Presenting Author: Teresa Macarulla, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Spain

Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room

Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields)

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

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.

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

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S.i and the fifth most frequent cause in Europe.ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S.iv and the global incidence is more than 500,000.v Pancreatic cancer has a five-year relative survival rate of just 13%.vi

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed when the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.

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 July 1, 2025 Ensem Therapeutics, Inc. (ENSEM), a clinical stage, oncology-focused biopharmaceutical company, reported the first patient has been dosed in its phase 1/2 study of ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader (Press release, ENSEM Therapeutics, JUL 1, 2025, View Source [SID1234654204]).

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"Dosing the initial patient in our first-in-human study of ETX-636 represents a critical milestone," said Ron Peck, M.D., Chief Medical Officer of ENSEM. "Mutant PI3Kα is a key and frequent oncogenic driver across a broad spectrum of cancers, including up to 40 percent of hormone receptor-positive (HR+) /HER2-negative advanced breast cancers. While the first generation PI3Kα inhibitors validate PI3Kα as a therapeutic target in patients, the toxicities associated with inhibiting non-mutant PI3Kα underscore the importance of developing better therapies. ETX-636 inhibits and degrades mutant PI3Kα within tumors through a novel allosteric approach and spares wildtype PI3Kα in normal tissues, affording a potentially superior tolerability profile while exerting a robust anti-tumor effect."

Shengfang Jin, Ph.D., Chief Executive Officer of ENSEM, added, "ENSEM is dedicated to bringing novel precision oncology therapies to patients. We are excited to demonstrate ETX-636’s clinical potential, building on its superior and differentiated preclinical profile compared to other compounds in its class. Dosing this first patient marks the second novel ENSEM oral inhibitor to enter the clinic. ENSEM also eagerly anticipates INDs for additional pipeline programs in 2026."

This first-in-human, Phase 1/2 study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PI3Kα mutation (NCT06993844). The first patient was dosed at START San Antonio (Amita Patnaik, M.D.), under an IND cleared by the FDA in April 2025. ETX-636 will be administered alone and in combination with fulvestrant, a selective estrogen receptor degrader approved for the treatment of advanced hormone receptor HR+/HER2- breast cancer.

About ETX-636
ETX-636 was designed to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα. This allosteric binding site has been shown to selectively inhibit all activating mutant forms of PI3Kα, including hotspot kinase and helical domain PI3Kα mutants, while sparing wildtype PI3Kα. The high selectivity of ETX-636 for mutant PI3Kα greatly reduces the risk for hyperglycemia and other wildtype PI3Kα-related adverse events compared to non-mutant selective PI3Kα inhibitors. In addition to its potent inhibitory effect on mutant PI3Kα catalytic activity, ETX-636 also leads to proteasome-dependent degradation of mutant PI3Kα, while sparing wildtype protein (a feature not seen with other pan-mutant allosteric inhibitors). This dual mechanism of action results in deep and durable pathway inhibition and induces concordant tumor regression in kinase and helical domain PI3Kα-mutant breast cancer xenograft models as monotherapy and in combination with fulvestrant with or without a CDK4/6 inhibitor. In preclinical toxicology studies, ETX-636 did not disrupt glucose homeostasis at predicted human efficacious doses.

On July 1, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported two upcoming poster presentations at the 49th Federation of European Biochemical Societies (FEBS) 2025 Congress, hosted by the Turkish Biochemical Society, to be held July 5-9, 2025, in Istanbul, Turkey (Press release, MAIA Biotechnology, JUL 1, 2025, View Source [SID1234654203]). The poster presentations highlight MAIA’s lead telomere-targeting agent and next-generation treatments. The first presentation will be delivered by MAIA Scientific Advisory Board member, Z. Gunnur Dikmen, M.D., Ph.D., Hacettepe University, Faculty of Medicine, Department of Biochemistry in Ankara, Turkey.

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Poster Presentation 1

Abstract title: "Telomere-targeting therapeutics RiboTHIO and THIO synergize with radiotherapy and immune checkpoint blockade to suppress lung tumor growth"

Abstract number:

62164

Abstract notation:

LB-R-32-12

Session title:

Cancer Therapy

Session date and time:

July 7, 2025, from 12:30pm to 2:30pm TRT

Presenter:

Z. Günnur Dikmen, M.D., Ph.D.

Abstract access:

Available at FEBS Open Bio Journal after the Congress

Poster Presentation 2

Abstract title: "The effects of telomerase mediated telomere-targeting novel drug candidate compounds on oxidative DNA damage and DNA repair on A549 cells"

Abstract number:

60494

Abstract notation:

P-32-095

Session title:

Cancer Therapy
Session date and time:

July 7, 2025, from 12:30pm to 2:30pm TRT
Presenter:

Gamze Tuna

Abstract access:

Available at FEBS Open Bio Journal after the Congress

"We appreciate the opportunity to participate at the FEBS Congress where the outstanding merits of our first-in-class cancer telomere targeting agents will be featured before a gathering of the top European academic researchers and scientists." said MAIA Chairman and CEO Vlad Vitoc, M.D. "These scientific findings further illustrate the potential of our current and next-generation treatments to synergize with therapies used in several cancer indications."

The most recent data from MAIA’s THIO-101 pivotal Phase 2 clinical trial of ateganosine as a treatment for non-small cell lung cancer (NSCLC) showed median overall survival (OS) of 17.8 months1 in a heavily pre-treated population.

On July 1, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported new data that will be presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) in Barcelona, Spain (Press release, Natera, JUL 1, 2025, View Source [SID1234654202]). These presentations reinforce the strong clinical and economic utility of Signatera monitoring across colon and rectal cancers (CRC), as well as new clinical validation data on its tissue-free MRD assay.

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Signatera in CRC surveillance

Data on >3,000 CRC patients will be shared in an oral presentation, concluding that adding Signatera ctDNA* monitoring to the current standard of care in surveillance can better identify patients who are candidates for metastasis-directed therapy (MDT). Results indicated that Signatera-positive patients were up to 20x more likely to receive curative-intent MDT than Signatera-negative patients. By comparison, CEA positivity led to only a 2x increase, with no added value in stage IV.

Signatera Genome in rectal cancer

An analysis will be presented from the MD Anderson INTERCEPT study (n=31) that used serial Signatera Genome testing in patients with locally advanced rectal cancer after neoadjuvant therapy. Results demonstrated 100% specificity/PPV, with surveillance sensitivity of 100% in the surgical cohort and 88% (7/8) overall.

Economic utility of Signatera-guided therapy in adjuvant CRC

A budget impact model from BUPA, a multinational health insurance provider with over 60 million customers, will outline a 43% expected reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard of care in stage II-III CRC.

"We’re excited to present these new findings that continue to support the utility of Natera’s products across GI cancers," said Adham Jurdi, M.D., senior medical director of oncology at Natera. "These data highlight our commitment to improving outcomes and driving innovation in MRD detection."

Full list of data featuring Natera’s technology at ESMO (Free ESMO Whitepaper) GI:

July 4, 16:40-16:50 CET | FPN: 20 | Signatera (Oral Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care (SoC) colorectal cancer (CRC) surveillance

July 4, 16:50-17:00 CET | FPN: 30 | Signatera (Oral Presentation)
Presenter: Hideaki Bando, M.D.
Association of ctDNA Clearance with Disease-Free Survival and Safety and Quality of Life from ctDNA-Directed Therapy: Findings from the ALTAIR Study

July 4, 15:30-16:30 CET | FPN: 102P | Signatera (Poster Presentation)
Presenter: Christos Mikropoulos, MBBS, MSc, M.D. (Res), MRCP, FRCR
Direct cost of healthcare analysis of Signatera ctDNA testing in the adjuvant setting for a hypothetical cohort of stage II and stage III colorectal cancer (CRC) patients: a UK private payer perspective

July 4, 15:30-16:30 CET | FPN: 243P | Signatera Genome (Poster Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical performance of Signatera Genome assay in a sub-cohort of locally advanced rectal cancer (LARC) patients (pts) in the MD Anderson INTERCEPT program

July 4, 15:30-16:30 CET | FPN: 93P | Tissue-free MRD (Poster Presentation)
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA

July 4, 15:30-16:30 CET | FPN: 89P | Early Cancer Detection (Poster Presentation)
Presenter: John P.Y. Shen, M.D.
Development of methylation-based biomarkers to predict metastases, treatment effect, and microsatellite status in colorectal cancer

On July 1, 2025 HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, reported the signing of a major out-licensing agreement with Shanghai Henlius Biotech, Inc. (hereafter "Henlius") (Press release, Hanchor Bio, JUL 1, 2025, View Source [SID1234654201]). The deal grants Henlius exclusive development and commercialization rights to HCB101 across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA).

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Under the terms of the agreement, HanchorBio will receive an upfront payment of USD 10 million, with additional payments tied to development and regulatory milestones of up to USD 192 million. Henlius will also pay tiered royalties and assume full responsibility for development, manufacturing, and commercialization in the licensed territories. HanchorBio retains all rights outside the licensed regions.

HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB) platform. It is designed to selectively block the CD47 "don’t eat me" signal and activate macrophage-mediated anti-tumor immunity. Compared to earlier CD47-targeted agents, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated in over 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics. Its binding affinity to CD47 is 100-fold higher than that of wild-type SIRPα-Fc fusions, and its signal-blocking potency exceeds 1,000-fold that of earlier versions.

In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile, high CD47 receptor occupancy (saturating RO levels across multiple doses), and early signs of anti-tumor activity. Two patients achieved confirmed partial responses (PRs): one with head and neck squamous cell carcinoma and another with marginal zone lymphoma confirmed by both PET imaging and CT, as reported at ASCO (Free ASCO Whitepaper) 2025. Both tumors continued to shrink with ongoing weekly dosing. Additionally, six patients achieved stable disease at low to mid dose levels, including one ovarian cancer patient who maintained disease control for over 40 weeks.

Following regulatory clearance from the U.S. FDA, Mainland China’s NMPA, and Taiwan’s TFDA, HCB101 has advanced into multi-regional Phase 2 trials in patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers.

"This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio’s scientific strength and global partnering strategy," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "It also marks a critical milestone for HanchorBio’s biopharmaceutical innovation as we pursue our mission to deliver globally accessible, next-generation cancer immunotherapies, and as Taiwan continues to gain global recognition."