On September 26, 2025 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, reported its subsidiary, ME Therapeutics Inc., has secured a U.S. patent for its lead G-CSF antibody candidate, as it continues to advance its broader drug development and discovery programs for cancer (Press release, ME Therapeutics, SEP 26, 2025, View Source [SID1234656276]).

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"We are pleased with the business and scientific progress we have made across our pipeline as we work towards bringing novel immuno-oncology drugs to patients worldwide who today have limited treatment options," said Salim Dhanji, CEO of ME Therapeutics. "This quarter we reached several key milestones for our lead G-CSF antibody candidate that keep us on our pathway to the clinic, including securing a U.S. patent and moving forward cell line development in preparation for Good Manufacturing Practices (GMP). We also continued to progress our therapeutic mRNA and in vivo CAR programs through preclinical testing and discovery research."

U.S. patent received

ME Therapeutics has received US Patent No. 12,421,308 from the United States Patent and Trademark Office (USPTO) for its G-CSF antibody candidate. The patent protects the amino acid sequence of the antibody candidate and its therapeutic use for cancer treatment in the United States. The antibody candidate, also known as H1B11-12, is a humanized biological drug formulated to target and block G-CSF, a glycoprotein cytokine known to drive immune suppression in the tumour microenvironment.

The U.S. patent marks the second international patent ME Therapeutics has received for the G-CSF antibody candidate. In 2023, ME Therapeutics also received a patent from the China National Intellectual Property Administration.

Other highlights:

Antibody candidate cell line development: To support clinical trial regulatory meetings, ME Therapeutics is progressing cell line development to meet Good Manufacturing Practices (GMP) standards. Work at the contract research organization has identified candidate cell lines demonstrating robust antibody production and stability. Next steps will involve continued testing of the antibody characteristics prior to choosing a lead clone for the development of a GMP master cell bank.
Therapeutic mRNA candidates preclinical testing: The Company’s therapeutic mRNA program is advancing through preclinical testing, with the lead therapeutic mRNA candidate tested in vivo. To date, results show the lead therapeutic mRNA candidate leads to immune cell recruitment into the tumour microenvironment (TME). ME Therapeutics now intends to initiate a study to test the lead candidate in a mouse colon cancer model, both alone and in combination with an immune checkpoint inhibitor. Meanwhile, their second therapeutic mRNA candidate has demonstrated strong T cell activation in vitro. This candidate will continue to be advanced through further in vitro testing.
In vivo CAR program discovery: ME Therapeutics is also progressing its in vivo CAR program through the discovery stage. This next-generation approach delivers genetic instructions directly into a patient’s body to reprogram cells within the TME. The Company has confirmed in vitro activity of its tumour-targeted CARs and plans to conduct further in vitro testing before exploring in vivo
Expanded research team: ME Therapeutics continues to grow its research and development capabilities with the addition of two new associate research scientists. This positions the company to move its lead antibody candidate towards clinical trials as well as accelerate progress for its broader drug development and discovery programs.

On September 26, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported that it will host a conference call and live webcast at 8:30 am ET on September 29, 2025, to discuss recently announced updated overall survival and safety data in first-line pancreatic cancer patients treated with atebimetinib + mGnP (N=34) with 9 months median follow up (Press release, Immuneering, SEP 26, 2025, View Source [SID1234656274]).

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"These exciting results were first announced in our press release on September 24, 2025, will be highlighted in a poster presentation at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025 on Sunday, and will be discussed during our conference call on Monday. We are committed to ensuring the community has multiple opportunities to engage with and understand these important results," said Ben Zeskind, Ph.D., CEO of Immuneering.

Individuals interested in listening to the live conference call may do so through this webcast link or by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 9502940. A webcast replay will be available from the "Investors" section of the Company’s website.

On September 26, 2025 Novartis reported it will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin (October 17-21, 2025) (Press release, Novartis, SEP 26, 2025, View Source [SID1234656245]).

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"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper) include:

Medicine Abstract title Abstract Number/
Presentation Details
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition) #LBA6
Presidential Symposium 2 (Proffered Paper session)
October 19, 2025
16:30 – 18:15 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Associations between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore Study #2390P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Final analysis of patients treated with [177Lu]Lu-PSMA-617 in early access program in metastatic castration-resistant prostate cancer (mCRPC) in France #2389P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
[225Ac]-PSMA-617 PSMAcTION trial-in-progress: a phase 2/3 randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy #2516TiP
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes #LBA14
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST
Kisqali (ribociclib) Impact of neoadjuvant chemotherapy (NACT) response on clinical outcomes with ribociclib (RIB) in HR+/HER2− EBC: a subgroup analysis from the phase 3 NATALEE trial #366P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) A NATALEE data–based machine learning (ML) model to predict distant recurrence (DR) and treatment (tx) effect in real-world (RW) patients (pts) with HR+/HER2– early breast cancer (EBC) without CDK4/6 inhibitor (CDK4/6i) tx #372P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Real-world characteristics, treatments and outcomes of NATALEE and monarchE-eligible HR+/HER2- early breast cancer patients in the hospital district of Helsinki and Uusimaa (HUS), Finland #360P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Risk of Recurrence (ROR) After Neoadjuvant Ribociclib Plus ET in Clinically High-Risk ER+/HER2− BC: Preliminary Analysis of the SOLTI-RIBOLARIS Trial #296O
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST

On September 25, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML) (Press release, Kyowa Hakko Kirin, SEP 25, 2025, View Source [SID1234656275]). Although newly diagnosed patients with NPM1-m AML have high response rates to approved standard of care, relapses are common and survival outcomes are poor. There is currently no approved therapy to specifically target NPM1-m AML. Ziftomenib is currently under priority review by the Food and Drug Administration (FDA) for treatment of R/R NPM1-m AML.

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"Relapsed or refractory NPM1-mutated AML remains very challenging to treat, particularly after venetoclax-based therapy or transplant," said Eunice Wang, M.D., Chief of Leukemia Service, Professor of Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY. "The manuscript describes deep responses, signals of clinical activity across relevant subgroups and a generally manageable tolerability profile, which is important in treatment of late line AML patients where accumulated toxicity can limit treatment options. The benefit-risk profile of ziftomenib is highly encouraging and, if replicated in additional treatment settings, has potential to be transformative for a large population of patients with menin pathway-driven AML."

"Publication in ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology is an important advancement for adult patients with NPM1-m AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "In addition to evidence of monotherapy activity, the safety and tolerability profile of ziftomenib from this trial is encouraging, marked by the absence of clinically meaningful QTc prolongation as well as low rates of both myelosuppression and treatment discontinuation. No clinically meaningful drug-drug interactions were observed, including with commonly used supportive-care medications, which may simplify co-administration in a polypharmacy setting. We continue to conduct studies in earlier line settings and in combination with multiple therapeutic agents in close collaboration with investigators, study teams and our partner Kyowa Kirin."

Summary of the published data
The publication, entitled "Ziftomenib in Relapsed or Refractory NPM1-Mutated AML", includes positive data from 92 adult patients with R/R NPM1-m AML in the phase 2 portion of the clinical trial as of the primary data cutoff date of October 28, 2024.

The KOMET-001 phase 2 trial met its primary endpoint with a complete remission with full or partial hematologic recovery (CR/CRh) rate of 22% (95% CI, 14 to 32; P=0.0058), which was significantly higher than the 12% historical standard-of-care response rate for patients with R/R NPM1-m AML. One additional response of CRh occurred after the primary analysis data cutoff resulting in a cumulative CR/CRh rate of 23% (95% CI, 15 to 33). 61% of evaluable CR/CRh responders were negative for measurable residual disease (MRD). Overall response rate (ORR) was 33% (95% CI, 23 to 43), with a median duration of overall response of 4.6 months (95% CI, 2.8 to 7.4).

Median overall survival (OS) was 6.6 months (95% CI, 3.6 to 8.6). Among ORR responders, median OS was 18.4 months (95% CI, 8.6 to not estimable) vs. 3.5 months (95% CI, 2.7 to 4.2) among non-responders. Two responders received subsequent allogeneic stem cell transplant and both resumed ziftomenib maintenance after transplant. At the time of data cutoff, nine patients (two after transplantation) remained on ziftomenib treatment. Prespecified subgroup analyses showed comparable CR/CRh rates regardless of lines of therapy, prior venetoclax exposure, or presence of co-mutations, including FLT3m or IDH1/2m.

Ziftomenib was well tolerated with a safety profile consistent with previously disclosed data. The most common grade ≥3 treatment-emergent adverse events were febrile neutropenia (26%), anemia (20%), and thrombocytopenia (20%). Differentiation syndrome occurred in 25% of patients (15% grade 3; no grade 4-5) and was manageable with protocol-defined mitigation. Three patients (3%) discontinued treatment because of ziftomenib-related adverse events.

These findings formed part of the data set used for the New Drug Application for ziftomenib as a potential treatment for patients with R/R NPM1-m AML. The FDA target action date is November 30, 2025. There is currently no FDA-approved treatment for patients with R/R NPM1-m AML.

"The publication of the investigational ziftomenib data adds important scientific context for clinicians and patients," said Takeyoshi Yamashita, Ph. D., Executive Vice President and Chief Medical Officer, Kyowa Kirin. "Together with Kura Oncology, we are committed to rigorous, globally coordinated evidence generation to support the benefit-risk profile of menin inhibition across the treatment landscape. Our shared goal is to advance development rapidly and generate the evidence needed to deliver ziftomenib to appropriate patients in need."

The publication is now available on the Journal of Clinical Oncology website and in the Scientific Manuscripts section on Kura’s website.

Ziftomenib is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.

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