On August 19, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC) (Press release, Delcath Systems, AUG 19, 2025, View Source [SID1234655369]).

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The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will be conducted at more than 20 sites across the United States and Europe. Results from the trial’s primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, while overall survival (OS), a secondary endpoint, is expected in late 2028.

The company estimates that the total addressable market for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the United States. This market includes patients who present with significant liver disease burden, determined through radiological and clinical criteria. Delcath aims to provide a novel treatment option for this patient population with limited therapeutic alternatives.

"This milestone marks a significant advancement in our mission to address unmet needs in liver-dominant cancers," said Vojislav Vukovic, Chief Medical Officer of Delcath Systems, Inc. "Dosing the first patient in this Phase 2 trial is an exciting step toward exploring HEPZATO’s potential to provide a new treatment option for patients with metastatic colorectal cancer, building on its proven role in metastatic uveal melanoma."

On August 19, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors (Press release, ALX Oncology, AUG 19, 2025, View Source [SID1234655368]).

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"Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026."

The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial.

ALX2004: Optimized for Success Based on Rigorous Drug Design Process

Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload.

Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class

Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile.

On August 18, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on its recent activities (Press release, Lixte Biotechnology, AUG 18, 2025, View Source [SID1234655373]).

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"This has been a transformative period for our company," said Geordan Pursglove, who became LIXTE’s new Chairman and Chief Executive Officer in June. "Momentum has been energized on several fronts, including securing essential funding to support our ongoing clinical trials, and to pursue long-term growth opportunities to enhance shareholder value."

Added Bas van der Baan, President and Chief Scientific Officer, "We are especially proud of the recent publication in a leading medical journal, Nature, further validating the promise of our proprietary compound, LB-100, to treat ovarian and colorectal cancer. The recent formation of our medical advisory committee marks yet another strategic step toward our mission of developing and delivering effective solutions to patients battling cancer."

LIXTE’s clinical trials are underway for ovarian cancer at the M.D. Anderson Cancer Center and at Northwestern University, supported by GSK. The Company’s colorectal trial, supported by F. Hoffmann-La Roche, is being conducted at the Netherlands Cancer Institute.

Summary of Recent Corporate Activities:

● Completion of two financings: a private placement with accredited investors, raising aggregate gross proceeds to the Company of approximately $5 million, and a registered direct offering with accredited investors, raising aggregate gross proceeds to the Company of approximately $1.5 million. Proceeds will be used for general corporate purposes and working capital and allowed the Company to regain compliance for continued listing on the Nasdaq Capital Market.

● Management and Board changes: Geordan Pursglove was appointed Chairman and Chief Executive officer in June 2025, succeeding Bas van der Baan, who became President and Chief Scientific Officer. Jason Sawyer and Michael Holloway, MD, joined LIXTE’s Board as independent directors in July 2025, succeeding Stephen Forman, MD, and Yun Yen, MD, who were appointed to serve as members of a newly established Scientific Advisory Committee. Other committee members include Bas van der Baan and Board member René Bernards, PhD.

● Validation of LB-100: The medical journal Nature has published findings that validate LIXTE’s ongoing clinical trials with LB-100. A team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of patients treated with immune checkpoint blockade therapy. The study showed that patients having tumors with inactivating mutations in PPP2R1A – the major scaffold subunit of protein phosphatase 2A (PP2A) – had significantly better overall survival, compared with patients who did not have this mutation in their tumors. (View Source

● New Pre-Clinical trial: LIXTE has initiated a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LB-100. The study represents a new opportunity in cancer prevention.

On August 18, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC) (Press release, Natera, AUG 18, 2025, View Source [SID1234655365]). The trial is sponsored by Genentech, a member of the Roche Group.

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IMvigor011 utilizes the Signatera ctDNA test in patients with MIBC to detect molecular residual disease (MRD) in the bloodstream after surgery and predict who will benefit from adjuvant treatment with the cancer immunotherapy atezolizumab (Tecentriq). Approximately 760 patients were enrolled in the surveillance phase of the trial and underwent serial Signatera testing for up to 12 months post surgery. Patients were randomized to treatment with atezolizumab or placebo if they tested Signatera-positive and remained free of cancer recurrence on imaging with treatment administered every 4 weeks for 12 cycles or up to one year. Patients who consistently tested Signatera-negative were not randomized to treatment but continued to be followed up with radiographic imaging and ctDNA MRD testing.

Topline results from IMvigor011 demonstrated a statistically significant and clinically meaningful improvement in disease-free survival and overall survival for Signatera-positive patients treated with atezolizumab. Natera expects trial data to be presented at an upcoming medical conference.

"The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging," said Professor Thomas Powles, MBBS, MRCP, M.D., lead principal investigator of the study; Barts Cancer Institute QMUL. "We look forward to presenting the positive results later this year."

"Importantly, IMvigor011 could change how resectable bladder cancer is managed for the tens of thousands of patients diagnosed with MIBC each year," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera.

Natera will finalize its premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

In addition to the topline result released today, a preliminary analysis of Signatera-negative patients from IMvigor011 was presented at the European Association of Urology in April 2024. The data highlighted that post-operative patients who remain Signatera-negative on serial testing had excellent outcomes without adjuvant treatment. The analysis showed that 171 patients who remained Signatera-negative during the surveillance window had overall survival rates of 100% at 12 months and 98% at 18 months, and disease-free survival rates of 92% at 12 months and 88% at 18 months after surgery.

On August 18, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the Company’s management will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference (Press release, PharmaEssentia, AUG 18, 2025, View Source [SID1234655364]). The conference will take place September 8-10, 2025 in New York, NY.

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Senior members of the Company’s management team will be available for investor meetings September 8-9.