On September 25, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the successful manufacture of its first clinical cell product using lentiviral vector supplied by Miltenyi Bioindustry, a dedicated CDMO division of Miltenyi Biotec (Press release, Verismo Therapeutics, SEP 25, 2025, View Source [SID1234656248]). The batch was produced for STAR-101, a Phase 1 clinical trial evaluating Verismo’s lead pipeline SynKIR-110 targeting mesothelin. This marks a major milestone in the clinical trial and lays the groundwork for later-stage development of SynKIR-110 for the treatment of solid tumors.

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This collaboration ensures a reliable supply chain and is an important step in preparation for Phase 2 and beyond, including use in commercial applications. Miltenyi Bioindustry is a leader in translating gene-edited cell therapy products into the clinic, including design, construction, and production of lentiviral vectors, from research through GMP manufacturing.

"Our collaboration with Miltenyi Bioindustry plays a key role as we scale our programs," said Dr. Bryan Kim, CEO of Verismo Therapeutics. "This partnership reflects Verismo’s commitment to ensuring manufacturing continuity and Phase 2 clinical readiness."

Stefan Miltenyi, founder and CEO at Miltenyi Biotec, added: "We’re proud to continue supporting Verismo’s efforts with our viral vector platform. Their work in next-generation CAR T therapies reflects the innovation we strive to enable."

On September 25, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the first half year 2025 ended June 30, 2025 (Press release, Celyad, SEP 25, 2025, View Source [SID1234656232]).

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First Half 2025 financial review

As of June 30, 2025, the Company’s Treasury position amounted to €0.8 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2025 and 2026, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the fourth quarter of 2025.

Key financial figures for first half 2025, compared with the first half of 2024 and full year 2024, are summarized below:

Selected key financial figures (€ millions) Half Year 30 June 2025 Half Year 30 June 2024 Full Year 31 December 2024
Revenue – – 0.2
Research and development expenses (2.1) (1.5) (3.2)
General and administrative expenses (1.7) (1.7) (3.2)
Other income/(expenses) 0.1 0.2 0.4
Operating loss (3.7) (3.1) (5.9)
Loss for the period/year (3.7) (3.0) (5.9)
Net cash used in operations (3.3) (2.8) (5.7)
Cash and cash equivalents 0.8 6.2 4.2

Research and Development (R&D) expenses were €2.1 million in June 2025 as compared to €1.5 million during the same period in 2024, an increase of €0.6 million. The increase in the Company’s R&D expenses was primarily driven by the increase of the IP costs related to the licensing activities as well as the increase of the expenses linked to the redevelopment of the catheter.

General and Administrative (G&A) expenses remained stable with €1.7 million in June 2025 as in June 2024.

Net loss for the first half of 2025, was €3.7 million, or €(0.09) per share, compared to a net loss of €3.0 million, or €(0.07) per share, for the same period in 2024.

Net cash used in operations was €3.3 million for the first half of 2025 compared to €2.8 million for the first half of 2024. The increase of €0.5 million was primarily driven by the global increase of IP activities and catheter development costs.

As of June 30, 2025, the Company had cash and cash equivalents of €0.8 million. No capital increase occurred in the first half of 2025. The total number of basic shares outstanding was 41.4 million like in December 31, 2024.

The interim financial report for first half 2025 of the Company can be found on our website: View Source

On September 25, 2025 TAE Life Sciences (TLS), a global leader in advancing next-generation boron neutron capture therapy (BNCT), and the University of Wisconsin–Madison (UW) reported to have signed a memorandum of understanding (MOU) announcing the intention to launch the first accelerator-based BNCT center in the United States (Press release, TAE Life Sciences, SEP 25, 2025, View Source [SID1234656249]). As part of this collaboration, UW would install the Alphabeam compact accelerator-based BNCT system developed by TAE Life Sciences. This significant milestone has the potential to pave the way for the adoption of BNCT in the United States.

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As part of this proposal, UW and TAE Life Sciences will collaborate on research and development of Alphabeam and novel boron-10 drugs through pre-clinical and clinical studies on several cancer indications with high unmet need, including brain and head and neck cancers. Available in Japan, and currently being evaluated in clinical trials in several other countries, BNCT is a cutting-edge cancer treatment that selectively targets cancer cells while minimizing harm to healthy tissue. TAE Life Sciences, with its compact accelerator-based neutron source and novel targeted boron-10 drug development, is the only company to have a comprehensive BNCT solution that replaces earlier challenges with nuclear reactor-based BNCT and has the potential to establish accelerator-based BNCT as a mainstay cancer treatment in the United States. This announcement further builds upon the success TAE Life Sciences has had deploying its technology globally. To date, the company has installed its neutron beam system in China’s Xiamen Humanity Hospital, which is currently running human clinical trials, and its Alphabeam will soon be installed at Italy’s National Center of Oncological Hadrontherapy (CNAO).

"Our collaboration with the esteemed University of Wisconsin–Madison underscores the growing momentum and recognition of BNCT as a transformative cancer therapy," stated Robert Hill, Chief Executive Officer of TAE Life Sciences. "By working closely with UW and the University of Wisconsin Carbone Cancer Center, a leading cancer center renowned for its commitment to innovation, we aim to revolutionize the landscape for cancer treatment, and make even the most challenging cancers treatable with minimal side effects."

Alphabeam is a patented neutron source developed for clinical BNCT that offers a breakthrough approach to cancer treatment. This combinational therapy utilizes targeted boron-10 drugs and low-energy neutrons to destroy tumors with no damage to healthy tissues. With this system, patients can undergo a short, minimally invasive treatment in just one or two sessions, providing a streamlined alternative to traditional cancer therapies.

"Today marks a significant milestone in the field of oncology in the United States," said Dr. Zachary Morris, Chair and Paul Harari Professor of Human Oncology at the University of Wisconsin School of Medicine and Public Health. "Our collaboration with TAE Life Sciences brings together our expertise in clinical radiation medicine, translational research, and theranostics with the accelerator-based BNCT system, enabling us to harness the full potential of this advanced cancer treatment. Together, we aim to accelerate the development and clinical implementation of this therapy, ultimately providing patients with what we hope will be a markedly improved cancer treatment option that is currently not available anywhere else in North America."

The Alphabeam BNCT system and novel boron-10 drugs are for research purposes and not available for sale.

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On September 25, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported an upcoming poster presentation highlighting the potential of CID-078 as a novel therapeutic option in pediatric cancers at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer, taking place from September 25-28 in Boston, MA (Press release, Circle Pharma, SEP 25, 2025, View Source [SID1234656234]). CID-078 is a first-in-class, orally bioavailable macrocyclic cyclin A/B RxL inhibitor that is currently being evaluated in a Phase 1 clinical trial for patients with advanced solid tumors.

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The presentation, based on a collaboration between Circle Pharma and Children’s Cancer Institute (Sydney, Australia), will focus on the novel mechanism of action of CID-078 for cancers driven by high E2F activity including those with alterations in the tumor suppressor genes RB1 or CDKN2A/B, as well as the prevalence of these biomarkers across a diverse range of pediatric cancer types. In addition, the presentation will outline new preclinical data on the correlation between CID-078 sensitivity and RB1 and E2F biomarker status in a database of pediatric tumor samples from The ZERO Childhood Cancer Precision Medicine Program.

"We believe CID-078 may represent a promising new therapeutic option for pediatric cancers with certain defined molecular drivers," said Michael C. Cox, PharmD, MHSc, BCOP, senior vice president and head of early development at Circle Pharma. "These findings may inform strategies for real-time patient identification and stratification in potential future pediatric studies of CID-078. Presenting these data generated in collaboration with Children’s Cancer Institute during Childhood Cancer Awareness Month reinforces our commitment to advancing the development of our therapies for patients who urgently need new options."

Details of the presentation are as follows:

Title: Investigating the Cyclin A/B RxL Inhibitor CID-078 in Pediatric Cancers with RB1 Loss and High E2F1

Abstract Number: B021

Session: Poster Session B

Date & Time: Friday, September 26, 5:00-7:00 p.m. ET

Presenting Author: Chelsea Mayoh, Children’s Cancer Institute, Lowy Cancer Centre, UNSW Sydney, Kensington, Australia

About CID-078, Circle Pharma’s Oral Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual activity blocking protein-protein interactions between both cyclins A and B and key substrates that bind to them via conserved RxL motifs. CID-078 selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation, including alterations in the tumor suppressor RB1. In pre-clinical studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and MYT1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center Phase 1 clinical trial (NCT06577987) is currently enrolling patients with advanced solid tumors harboring RB1 alterations.

On September 25, 2025 Pfizer Inc. (NYSE: PFE) reported it will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21 in Berlin, Germany (Press release, Pfizer, SEP 25, 2025, View Source [SID1234656250]). Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer’s core scientific modalities and key tumor areas.

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"At ESMO (Free ESMO Whitepaper), Pfizer is demonstrating how earlier interventions with our innovative medicines have the potential to deliver greater impact to even more patients," said Jeff Legos, Chief Oncology Officer, Pfizer. "The survival benefits we’re seeing across certain cancer types reinforce our commitment to accelerating innovative medicines that bring new hope to patients everywhere, while pipeline data highlight the next wave of potential breakthroughs that could transform care for even more people living with cancer."

Pfizer will share highlights from its leading Oncology portfolio at ESMO (Free ESMO Whitepaper), including:

In a Presidential Symposium, unprecedented survival results from the Phase 3 EV-303 trial (KEYNOTE-905) evaluating PADCEV (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), plus KEYTRUDA (pembrolizumab)* in patients with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based chemotherapy, showing potential to redefine standard of care in these patients (Presentation #LBA2)
Final overall survival results from the Phase 3 EMBARK trial evaluating XTANDI (enzalutamide)** in combination with leuprolide and as monotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, highlighting the benefit of XTANDI in this earlier line of treatment (Presentation #LBA87)
Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib)*** in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), reinforcing this combination as a potential key treatment option for these patients (Presentation #1849MO)
Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here.

Presentation Title

Details

Genitourinary Cancer

Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study [Merck/MSD-led]

Vulsteke et. al

Presidential Symposium (Presentation #LBA2)

Saturday, October 18, 2025, 4:30 PM CEST

Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression [Remegen-led]

Sheng et. al

Presidential Symposium (Presentation #LBA7)

Sunday, October 19, 2025, 4:30 PM CEST

Overall survival with enzalutamide in biochemically recurrent prostate cancer

Freedland et. al

Oral Presentation (Presentation #LBA87)

Sunday, October 19, 2025, 10:55 AM CEST

Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303)****

Nguyen et. al

Oral Presentation (Presentation #LBA86)

Sunday, October 19, 2025, 10:15 AM CEST

Thoracic Cancer

Updated overall survival analysis from the phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

Johnson et. al

Mini Oral Presentation (Presentation #1849MO)

Sunday, October 19, 2025, 8:30 AM CEST

Enfortumab vedotin plus pembrolizumab (EV + P) as first-line (1L) treatment in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): results from a cohort of the EV-202 trial [Astellas led]

Swiecicki et. al

Mini Oral Presentation (Presentation #1329MO)

Sunday, October 19, 2025, 4:30 PM CEST

Breast Cancer

Health-Related Quality of Life (HRQoL) from the PATINA Trial (AFT-38): Impact of Adding Palbociclib to HER2 and Endocrine Therapy (ET) after Induction in HR+/HER2+ Metastatic Breast Cancer (MBC)

Ines Vaz-Luis et. al

Mini Oral Presentation (Presentation #485MO)

Monday, October 20, 2025, 10:15 AM CEST

Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)−advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial*****

Campone et. al

Mini Oral Presentation (Presentation #489MO)

Monday, October 20, 2025, 10:15 AM CEST

Gastrointestinal Cancer

Circulating tumor (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER******

Kopetz et. al

Mini Oral Presentation (Presentation #729O)

Monday, October 20, 2025, 08:30 AM CEST

Cancer-Related Conditions

Efficacy and safety of ponsegromab in patients with cancer-associated cachexia: Results from the open-label extension of a randomized, placebo-controlled, Phase 2 study

Oral Presentation (Presentation #LBA102)

Friday, October 17, 2025, 4:00 PM CEST