On October 24, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported interim clinical data as of a July 29, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L and 2L metastatic colorectal cancer (mCRC), and petosemtamab monotherapy in 3L+ mCRC. These data will be presented in a plenary session oral presentation by Dr. Moh’d Khushman M.D., Washington University School of Medicine, St. Louis, MO, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Friday, October 24 at 10:20 a.m. ET.

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"Petosemtamab’s unique mechanism of action, including targeting both EGFR and LGR5, and potential to safely combine with FOLFOX/FOLFIRI, represents an important finding for patients with EGFR inhibitor-naïve metastatic colorectal cancer," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "These data demonstrate petosemtamab’s clinical activity beyond head and neck squamous cell carcinoma. We are encouraged that petosemtamab has the potential to become a transformational treatment and new standard of care for patients across a range of solid tumors."

"Metastatic colorectal cancer remains a formidable challenge with limited effective therapies. The promising early results with petosemtamab offer hope for advancing care and bringing new treatment possibilities to patients facing this difficult disease," added Dr. Khushman.

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics)

Presentation title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial
Observations in the presentation include:
As of a July 29, 2025 data cutoff date:

54 patients (pts) with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC received petosemtamab 1500 mg every two weeks, in combination with FOLFOX/FOLFIRI or as monotherapy
Pts treated in 1L or 2L had no prior anti-EGFR therapy
Pts treated in 2L received 1 prior chemotherapy regimen in the metastatic setting
Pts treated in 3L+ received at least 2 prior regimens in the metastatic setting, including a prior anti-EGFR therapy
Efficacy evaluable population consisted of patients with ≥1 dose of petosemtamab who had opportunity for ≥8 weeks follow up and ≥1 post baseline tumor assessment or discontinued petosemtamab early due to disease progression, symptomatic deterioration and/or death
1L petosemtamab with FOLFOX/FOLFIRI
14 pts were treated in 1L (10 FOLFOX and 4 FOLFIRI)
10 pts were efficacy evaluable, 8 left-sided; 10 (100%) remained on treatment
80% (8 of 10) response rate: 1 confirmed complete response, 7 partial responses (PRs) (4 unconfirmed of which 1 confirmed post data cutoff); 2 stable diseases (SDs)
88% (7 of 8) response rate in left-sided: 1 confirmed complete response, 6 PRs (3 unconfirmed, 1 unconfirmed response confirmed post data cutoff); 1 SD
One SD observed to be an unconfirmed PR post data cutoff leading to 100% (8/8) response rate left-sided and 90% (9/10) response rate overall in 1L
All unconfirmed PRs remained on treatment without disease progression
2L petosemtamab with FOLFOX/FOLFIRI
14 pts were treated in 2L (2 FOLFOX and 12 FOLFIRI)
13 were efficacy evaluable; 10 (77%) remained on treatment
62% response rate: 8 PRs (3 unconfirmed of which 1 confirmed post data cutoff); 4 SDs and 1 clinical deterioration prior to first scan
All unconfirmed PRs and SDs remained on treatment without disease progression
3L+ petosemtamab monotherapy:
26 pts were treated
20 were efficacy evaluable, 6 (30%) remained on treatment
10% confirmed response rate: 2 PRs; 9 SDs (5 remained on treatment)
Safety:
Petosemtamab safety profile in mCRC observed thus far, appears consistent with its established safety profile in recurrent/metastatic head and neck squamous cell carcinoma
No significant overlapping toxicities identified in combination with FOLFOX/FOLFIRI
No new safety signals identified
Infusion related reactions (IRRs) were managed with premedication and prolonged infusion on cycle 1 day 1; no discontinuations due to IRRs
Presentation:
Title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial
Session Title: Plenary Session 4: Clinical Trials Plenary Session
Date and Time: Friday, October 24, 10:20 a.m. ET
The same data will also be available in a poster:
Session Title: Poster Session B
Session Date and Time: Friday, October 24, 12:30-4:00 p.m. ET

As full presentations become available at the conference, they will contemporaneously be available on the Merus website.

(Press release, Merus, OCT 24, 2025, View Source [SID1234656991])

On October 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2025.

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Chugai reported increased revenue and operating profit year-on-year for the third quarter (Core-basis).

Regarding revenue, domestic sales increased by 3.6%. In the oncology field, sales increased by 0.2%. While our mainstay product Avastin was affected by NHI drug price revisions and generics, this was offset by steady growth of new products Phesgo, Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 7.7%, driven by steady performance of mainstay products Vabysmo, Hemlibra, and Enspryng, along with successful market penetration of the new product PiaSky. Overseas sales increased by 7.7%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.9%, despite the increase in income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 0.6 percentage points year-on-year to 33.1%, mainly due to changes in the product mix. Research and development expenses increased by 0.7% due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses decreased by 4.3% mainly driven by various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥450.5 billion (+5.6%) with a Core operating profit margin (to revenue) of 49.4%.

Chugai made good progress in both in-house products and products in-licensed from Roche.

For in-house products, PiaSky was launched in Taiwan as the first subcutaneous formulation for paroxysmal nocturnal hemoglobinuria. Enspryng has obtained results from Phase III clinical trials for thyroid eye disease, and will be discussed with health authorities. For Chugai originated project, Orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly, met primary endpoints in multiple Phase III clinical trials for obesity and type 2 diabetes.

For products in-licensed from Roche, Tecentriq has obtained approval for an expanded indication for relapsed or refractory extranodal NK/T-cell lymphoma, nasal type. Avastin has been filed for an expanded indication for neurofibromatosis type II. Glofitamab has initiated Phase II clinical trials in Japan for both relapsed or refractory diffuse large B-cell lymphoma and relapsed or refractory mantle cell lymphoma. Additionally, afimkibart has initiated Phase III clinical trial for Crohn’s disease, and divarasib initiated Phase Ib/II clinical trial for non-small cell lung cancer (first-line treatment). Furthermore, Chugai has in-licensed CT-388, a long-acting GLP-1/GIP receptor agonist, from Roche.

[2025 third quarter results]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Core results
Revenue 911.6 868.5 +5.0%
　Sales 794.6 750.3 +5.9%
　Other revenue 117.1 118.2 -0.9%
Operating profit 450.5 426.6 +5.6%
Net income 320.0 301.3 +6.2%
IFRS results
Revenue 911.6 868.5 +5.0%
Operating profit 429.8 418.6 +2.7%
Net income 305.6 295.8 +3.3%
[Sales breakdown]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Sales 794.6 750.3 +5.9%
Domestic sales 343.7 331.7 +3.6%
　Oncology 180.7 180.3 +0.2%
　Specialty 163.0 151.3 +7.7%
Overseas sales 450.9 418.7 +7.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Tecentriq 46.0 47.4 -3.0%
Polivy 27.0 24.5 +10.2%
Phesgo 24.5 15.0 +63.3%
Alecensa 24.3 22.4 +8.5%
Avastin 19.6 25.6 -23.4%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Hemlibra 44.7 41.5 +7.7%
Actemra 36.7 34.8 +5.5%
Enspryng 20.9 17.8 +17.4%
Vabysmo 18.5 14.7 +25.9%
Evrysdi 12.0 11.3 +6.2%
[Progress in R&D activities from Jul 25th, 2025 to Oct 24th, 2025]

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, OCT 24, 2025, View Source [SID1234656975])

On October 24, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported data from a real-world analysis of Protein Tyrosine Kinase 7 (PTK7) at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). As part of a collaboration between Whitehawk and Tempus AI, the analysis evaluated real-world data from the Tempus AI database and the Clinical Proteomic Tumor Analysis Consortium to, for the first time, robustly characterize PTK7 expression.

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PTK7 is an oncofetal transmembrane pseudokinase that drives early embryonic development, has restricted expression in adult tissues and frequent overexpression in a wide range of cancers. There are no approved PTK7-directed ADCs.

This large-scale RNA analysis of >157,000 tumor samples, nearly half from metastatic lesions, confirms PTK7 as one of the most broadly and highly expressed targets across solid tumors, reinforcing its potential as a clinically meaningful pan-tumor ADC target, and further support development of HWK-007, Whitehawk’s PTK7-directed ADC candidate.

Key findings include:

PTK7 is expressed in ~70% of solid tumors.
PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, after HER2 and HER3.
Highest median PTK7 mRNA expression1 observed in endometrial (7.4), ovarian (7.2), head and neck (7.1), non-small cell lung cancer (NSCLC) (6.9) and breast (6.7) tumors.
Stable expression across disease stages and metastatic status, underscoring relevance in both early- and late-stage disease.
Expression levels comparable to or exceeding clinically validated and emerging ADC targets:
Lung cancer: Comparable to HER2, HER3, Trop-2 and cMET.
Ovarian cancer: Comparable to HER2 and FRα; markedly higher than CDH6, B7-H4 and CLDN6.
Endometrial cancer: Comparable to Trop-2; markedly higher than FRα, B7-H4 and HER2.
"These results emphasize the translational potential of PTK7 as a broadly expressed and stable target across solid tumors," said Grace Dy, MD, Chief, Thoracic Oncology, Professor of Oncology, Department of Medicine, Roswell Park Comprehensive Cancer Center. "By demonstrating consistent expression across histologies, disease stages and sample types, this analysis builds on the foundational rationale for developing next-generation ADCs that have the potential to reach a wide range of patients."

Whitehawk is advancing HWK-007, a PTK7-targeting ADC that leverages an advanced ADC technology platform which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The Company plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration for HWK-007 by year-end, with initial clinical evaluation planned in NSCLC, ovarian and endometrial cancers.

"These findings reinforce PTK7’s promise as one of the most compelling and underexplored ADC targets in oncology," said Dave Lennon, PhD, President and Chief Executive Officer, Whitehawk Therapeutics. "As the third most abundant tumor marker across all cancer patients – present in approximately 70% of solid tumors – the opportunity for HWK-007 has never been clearer. We believe we are well positioned to develop a differentiated ADC that could have a meaningful impact for the nearly 750,0002 patients in the US with PTK7-expressing cancers."

The analysis was conducted as part of a previously announced collaboration between Whitehawk and Tempus AI. The abstract is available as a freely available supplement in the AACR (Free AACR Whitepaper) journal Molecular Cancer Therapeutics.

(Press release, Whitehawk Therapeutics, OCT 24, 2025, View Source [SID1234656992])

On October 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura and Kyowa Kirin announced the launch of the KOMET-017 trials on September 29, 2025.

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KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.

(Press release, Kura Oncology, OCT 24, 2025, View Source [SID1234656976])

On October 24, 2025 ChemDiv reported the extension of its discovery and early development partnership with Mondego Bio to advance the company’s best-in-class immuno-oncology program targeting PTPN2. The announcement follows Mondego Bio’s successful Series A financing led by Biovance Capital with participation from OrbiMed Advisors and Torrey Pines Investment, underscoring strong momentum behind Mondego’s strategy.
ChemDiv previously supported the accelerated discovery of a drug candidate by Eilean Therapeutics LLC in the U.S., which preceded the establishment of

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Mondego Bio in Portugal in 2025. Leveraging rational drug design across reversible, covalent, and allosteric inhibitors, the collaboration established a differentiated selectivity profile that delivers high oral bioavailability, robust in vivo efficacy, and strong safety and tolerability—hallmarks of potentially best-in-class cancer therapeutics.

Medicinal chemistry and scale-up were led by ChemDiv’s group in Germany, while pharmacology and translational biology were supported by ChemDiv facilities in the U.S. and Portugal. Together, these efforts advanced Mondego’s pre-IND program, supported by its European venture capital–backed launch.

Looking ahead, ChemDiv will continue to provide:

Medicinal chemistry and discovery biology for backup series,
CMC process research and large-scale manufacturing of the lead candidate for non-GLP and GLP animal studies,
Computational and wet-lab pharmacology to accelerate clinical readiness.
These efforts build on ChemDiv’s deep expertise in designing selective kinase and phosphatase inhibitors, leveraging its extensive kinase and phosphatase chemical libraries, and applying parallel lead optimization supported by AI/ML-enabled rational design, ADME/DMPK, and translational capabilities.

"We’re moving fast with Mondego to translate PTPN2 biology into medicines," said Ilya Baimetov, COO and Head of Digital Platforms at ChemDiv.
"By combining our advanced rational design, medchem horsepower, and focused tool libraries with Mondego’s cutting-edge immuno-oncology platform, we are advancing the next generation of phosphatase inhibitors with best-in-class potential."

(Press release, ChemDiv, OCT 24, 2025, View Source [SID1234656993])