1stOncology™: Cancer Intelligence Service – Page 6 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals

On July 1, 2025 Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, reported that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon (Press release, Genenta Science, JUL 1, 2025, View Source [SID1234654216]). Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not experienced disease progression following Temferon administration and has not required any second-line therapies. The other showed initial signs of disease progression that subsequently stabilized without additional therapeutic intervention. Both these cases suggest possible Temferon-mediated control of disease progression, which warrants further investigation in larger studies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

As of the April data cutoff, the survival rate at two years in the GBM trial for unmethylated MGMT (uMGMT) patients remained consistent at 29% with median overall survival holding steady at 17 months. In historical cohorts, uMGMT patients receiving standard of care have shown a two-year survival rate of approximately 14% and a median overall survival of 13 to 15 months.

In parallel, the TEM-GU Phase 1 study—designed to enroll 12 patients with genitourinary tumors—has begun recruitment. In this trial, Temferon is administered at a fixed dose of 4 million genetically modified cells per kilogram of body weight—a level previously shown to be safe and well tolerated in the TEM-GBM dose-ranging study. Genenta aims to demonstrate the safety and tolerability of Temferon in patients with Metastatic Renal Cell Carcinoma by year-end. The study is designed to evaluate Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors to assess the potential for immunologic synergy in this patient population. Further clinical updates will be shared once sufficient patient experience has been gained to support meaningful interpretation.

Temferon’s mechanism of action is based on the reprogramming of the tumor microenvironment, which promotes the activation and durability of adaptive immune responses. A scientific manuscript demonstrating Temferon’s potential to enhance and prolong the durability of CAR-T activity in preclinical murine models of solid tumors has been accepted for publication in Science Translational Medicine.

"For the first time, we show that hematopoietic stem cells can be engineered to durably give rise to myeloid cells that localize to the tumor and reprogram its immune environment. In glioblastoma, this strategy induced a pro-inflammatory shift in macrophages and the emergence of tumor-reactive T cells, offering a promising new avenue for immune engagement against one of the most resistant cancers," said prof. Luigi Naldini, co-founder of Genenta Science.
"We are encouraged by the consistent clinical signals emerging from our glioblastoma trial," said Pierluigi Paracchi, CEO of Genenta Science. "These findings reinforce our confidence in Temferon’s differentiated mechanism and support our commitment to advancing the platform."

Merck KGaA, Darmstadt, Germany Completes Acquisition of SpringWorks Therapeutics to Accelerate Sustainable Growth of its Healthcare Business

On July 1, 2025 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported that it has closed the acquisition of SpringWorks Therapeutics, Inc., for an enterprise value of $3.4 billion (approximately €3 billion)*, following regulatory clearances and the fulfillment of other customary closing conditions (Press release, Merck KGaA, JUL 1, 2025, View Source [SID1234654206]).

The definitive agreement between Merck KGaA, Darmstadt, Germany and SpringWorks, based in Stamford, Connecticut, was announced on 28 April, 2025. It represents one of the biggest M&A deals in the global biopharma sector so far in 2025. The business combination will immediately contribute to Merck KGaA, Darmstadt, Germany’s revenues and is expected to be accretive to the company’s earnings per share pre (EPS pre) by 2027.

"Today, we officially welcome SpringWorks to Merck KGaA, Darmstadt, Germany. The acquisition of SpringWorks illustrates our decisive portfolio approach to further position Merck KGaA, Darmstadt, Germany as a globally diversified science and technology powerhouse," said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. "This is the largest acquisition we have made for our Healthcare business sector in nearly 20 years, marking an exciting new chapter for Healthcare. Furthermore, we remain committed to identifying M&A opportunities across our three business sectors, with a focus on Life Science, prioritizing strategic fit, financial robustness, and long-term value creation."

"This acquisition is a significant step forward in bringing innovation to patients living with rare and often debilitating tumors—many of whom are young and facing a long, uncertain journey with limited treatment options," said Danny Bar-Zohar, CEO of Healthcare and member of the Executive Board at Merck KGaA, Darmstadt, Germany. "By combining our global reach with SpringWorks’ expertise, we are expanding access to life-changing therapies for patients around the world. At the same time, this move strengthens our foundation for further expansion in rare tumors and adjacent disease areas. I’d like to warmly welcome the SpringWorks team to Merck KGaA, Darmstadt, Germany."

SpringWorks’ portfolio features two highly innovative products for the treatment of rare tumors in areas of high unmet need where limited treatment options exist. U.S. Food and Drug Administration (FDA)-approved, OGSIVEO (nirogacestat) is a first-in-class therapy for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. In June 2025, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of nirogacestat.

GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. In May 2025, the CHMP adopted a positive opinion recommending the approval of mirdametinib.

SpringWorks’ portfolio complements Merck KGaA, Darmstadt Germany’s progress in building a rare tumor business with Merck KGaA, Darmstadt, Germany having worldwide commercialization rights for pimicotinib, an investigational therapy developed by Abbisko Therapeutics Co., Ltd. for patients with tenosynovial giant cell tumor (TGCT). Global regulatory filings for pimicotinib are underway. The joint portfolio will serve a broad range of patients with rare tumors who have high unmet medical needs.

Shares in SpringWorks will no longer be traded on the Nasdaq, with Merck KGaA, Darmstadt, Germany now being the sole owner of SpringWorks. SpringWorks shareholders are being paid US$ 47 per share in cash.

*Based on SpringWorks’ cash balance as of 31 December 2024

Novocure to Present Final Secondary Endpoint Data from the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) in Pancreatic Cancer at the ESMO Gastrointestinal Cancers Congress 2025

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.

"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.

Ensem Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of ETX-636, a Potential Best-In-Class Allosteric Pan-Mutant-Selective PI3Kα Inhibitor and Degrader

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]).

"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.

MAIA Biotechnology to Present Two Posters Featuring Cancer Telomere-Targeting Agents at FEBS 2025 Congress

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.

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.