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ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

On October 23, 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 preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations 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), taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

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"Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference."

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

(Press release, ALX Oncology, OCT 23, 2025, View Source [SID1234656933])

Alligator Bioscience AB reports financial results for Q3 2025 and provides a business update

On October 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported its interim results for the third quarter of 2025 and provided a business update.

"This quarter represented several important steps forward for Alligator, both scientifically and strategically. The final 30-month OPTIMIZE-1 results confirm mitazalimab’s unprecedented long-term survival benefit in pancreatic cancer and strengthen our conviction in its transformative potential. In parallel, we secured strong shareholder support through the successful TO 13 warrant program. These achievements position us well as we prepare for a Phase 3 trial and continue discussions with potential partners to fully realize the potential of mitazalimab and our broader pipeline."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Final OPTIMIZE-1 data: Reported on 22 September, confirming durable clinical benefit and long-term survival beyond two years — an unprecedented outcome in metastatic pancreatic cancer.
Scientific validation: 24-month results presented at ESMO (Free ESMO Whitepaper) GI; following the quarter, Cell Reports Medicine publication identified biomarkers linked to response and survival, supporting Phase 3 design.
Investigator-initiated studies: CROCOBIL (France) and APHRODITE (Italy) will further explore mitazalimab in biliary tract cancer and oral potentially malignant disorders, respectively.
HLX22

Phase 3 trial with HLX22: Henlius dosed the first U.S. patient in a global trial in HER2-positive gastric cancer — a key milestone for the program, which remains linked to potential milestone and royalty revenues for Alligator.
Partnering and innovation

RUBY agreement: Evaluation and option deal with a company in infectious diseases highlights platform potential beyond oncology.
ATOR-4066 progress: Preclinical data published in Cancer Immunology Research and presented at CICON25 confirmed its immune-modulating activity.
Conference recognition: Two abstracts for mitazalimab and ATOR-4066 accepted at SITC (Free SITC Whitepaper) 2025, underlining scientific momentum.
Company

TO 13 completed: 91.7% exercised, raising SEK 28.1 million (gross) to strengthen near-term liquidity.
Loan renegotiation: Updated agreement with Fenja Capital increases flexibility.
Enhanced visibility: Alligator hosted an R&D Day in August and presented at BioStock’s Investing in Life Science event in September.
Upcoming rights issue announced 22 October: Rights issue of approx. SEK 120 million gross (65% secured) will provide 6–9 months of financial runway during 2026, enabling Phase 3 preparations for mitazalimab and advancing strategic partnering discussions.
FINANCIAL SUMMARY FOR Q3 2025 AND YEAR-TO-DATE 2025
The financial summaries for the quarterly periods ending 30 September 2025 and 30 September 2024 are presented below.

All amounts in MSEK,
unless specified July – September
2025 July – September
2024
Net sales 0.47 1.4
Operating profit/loss -17.3 -62.0
Profit/loss for the period -12.3 -66.5
Cash flow for the period -8.8 -29.5
Cash and cash equivalents 25.1 47.8
Earnings per share before and after dilution, SEK -0.34 -87.74
The financial summaries for the year-to-date periods ending 30 September 2025 and 30 September 2024 are presented below.

All amounts in MSEK,
unless specified January – September
2025 January – September
2024
Net sales 0.47 16.0
Operating profit/loss -83.3 -169.1
Profit/loss for the period -22.3 -178.5
Cash flow for the period -38.4 -18.3
Cash and cash equivalents 25.1 47.8
Earnings per share before and after dilution, SEK -1.01 -246.01
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, 23 October 2025, at 3 p.m. CEST/ 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

(Press release, Alligator Bioscience, OCT 23, 2025, View Source [SID1234656932])

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 23, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported preclinical data for HMPL-A251 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), held October 22–26, 2025, in Boston, USA. HMPL-A251 is a first-in-class PI3K/AKT/mTOR ("PAM")-HER2 Antibody-Targeted Therapy Conjugate ("ATTC") comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker.

HER2 is a well-established therapeutic target. HER2 overexpression is found in a variety of cancer types and often associated with poor prognosis. As a key downstream signaling pathway of HER2, the PAM pathway contributes significantly to the resistance against HER2-targeting treatments when altered. HMPL-A251 is innovatively designed to leverage the synergy between HER2 targeting and PAM pathway inhibition to address limitations of traditional toxin-based antibody-drug conjugates ("ADCs") and standalone PAM inhibitors.

In vitro, the PI3K/PIKK inhibitor payload exhibited high potency, selectivity, and broad anti-tumor activity across a panel of 130 tumor cell lines. By conjugating this potent payload with an anti-HER2 antibody via a hydrophilic linker, the ATTC compound HMPL-A251, upon binding to the HER2-positive target cells, undergoes rapid internalization, lysosomal trafficking, payload release, and inhibition of PAM and PIKK signaling, inducing tumor cell apoptosis. HMPL-A251 demonstrated HER2-dependent antitumor activity in vitro, potently inhibiting HER2-positive tumor cell growth regardless of PAM pathway alterations, with moderately reduced activity in HER2-low, PAM-altered cell lines. HMPL-A251 also demonstrated a bystander effect on HER2-null cells when co-cultured with HER2-positive cells.

Unlike toxin-based ADCs, which often face challenges with toxicity related to their cytotoxic payloads, ATTCs are designed to prioritize tumor-specific delivery of a pathway-modulating payload, enhancing safety for long‑term use and enabling potential frontline combinations with chemotherapy. In vivo, HMPL-A251 demonstrated superior anti-tumor efficacy and tolerability as compared to the naked antibody and payload administered together. A single intravenous dose of HMPL-A251 induced tumor regression across multiple models including HER2-positive and HER2-low models with or without PAM alteration. Efficacy correlated strongly with payload concentration and target inhibition in tumor tissue. Notably, when benchmarked against T-DXd (trastuzumab deruxtecan, a HER2‑directed ADC), HMPL-A251 achieved superior or comparable efficacy at equivalent doses in most tested models. Moreover, payload-based toxicities are expected to be low, as the plasma exposure of free payload was much lower than for HMPL-251, with a mass ratio of less than 1:500,000.

"We are excited to share the progress of HMPL-A251, the first candidate from our ATTC platform. It represents a potentially significant leap forward in addressing the limitations of toxin-based ADCs and narrow therapeutic window of systemic PAM inhibitors. By combining selective PI3K/PIKK inhibition with precise HER2 targeting, HMPL-A251 achieves potent antitumor effects while maintaining a favorable safety profile," said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "The compelling preclinical data presented underscore its potential to redefine treatment for a wide spectrum of cancers, and we are excited to advance HMPL-A251 as well as more ATTC drug candidates toward clinical trials."

HUTCHMED plans to initiate global clinical trials for HMPL-A251 around the end of 2025, followed by multiple global Investigational New Drug (IND) filings for more ATTC candidates in 2026.

About the ATTC platform
HUTCHMED’s Antibody-Targeted Therapy Conjugate platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based ADCs, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

(Press release, Hutchison China MediTech, OCT 23, 2025, View Source [SID1234656897])

Boston Scientific announces results for third quarter 2025

On October 22, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.065 billion during the third quarter of 2025, growing 20.3 percent on a reported basis, 19.4 percent on an operational1 basis and 15.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $755 million or $0.51 per share (EPS), compared to $469 million or $0.32 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.63 a year ago.

"We delivered another exceptional quarter of strong performance across businesses and regions thanks to the winning spirit of our global team," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As we shared at our recent Investor Day meeting, we are well-positioned for differentiated growth that is fueled by our category leadership strategy, relentless focus on innovation and commitment to scaling capabilities."

Third quarter financial results and recent developments:

Reported net sales of $5.065 billion, representing an increase of 20.3 percent on a reported basis, compared to the company’s guidance range of 17 to 19 percent; 19.4 percent on an operational basis; and 15.3 percent on an organic basis, compared to the company’s guidance range of 12 to 14 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.51 per share, compared to the company’s guidance range of $0.44 to $0.46 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.70 to $0.72 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 16.4 percent reported, 15.6 percent operational and 7.6 percent organic
Cardiovascular: 22.4 percent reported, 21.5 percent operational and 19.4 percent organic
Achieved the following net sales growth/(declines) in each region, compared to the prior year period:
United States (U.S.): 27.0 percent reported and operational
Europe, Middle East and Africa (EMEA): 2.6 percent reported and (2.0) percent operational
In the second quarter of 2025, management made the decision to discontinue worldwide sales of the ACURATE neo2 and ACURATE Prime Aortic Valve Systems, which had prior year global sales of approximately $50 million per quarter
Asia-Pacific (APAC): 17.1 percent reported and 16.9 percent operational
Latin America and Canada (LACA): 10.4 percent reported and 9.6 percent operational
Emerging Markets4: 11.8 percent reported and 11.5 percent operational
Announced Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan for expanded labeling of the FARAPULSE Pulsed Field Ablation (PFA) System to include treatment of drug refractory, symptomatic persistent atrial fibrillation (AF).
Commenced enrollment in the AGENT DCB STANCE trial to assess the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) in patients with previously untreated coronary lesions, compared to standard of care percutaneous coronary intervention (PCI) treatment with drug-eluting stents and/or balloon angioplasty.
Published in JAMA Neurology outcomes from the five-year INTREPID study demonstrating sustained benefits of deep brain stimulation in people with moderate to advanced Parkinson’s disease, including improved motor function and quality of life.
Completed asset acquisition with Elutia, Inc. to acquire the antibiotic-eluting EluPro BioEnvelope and the CanGaroo Envelope, designed to prevent certain post-operative complications for devices such as pacemakers and defibrillators.
Announced agreement to acquire Nalu Medical, Inc., developer of the Nalu Neuromodulation System, which is designed to use peripheral nerve stimulation to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin — subject to customary closing conditions.

(Press release, Boston Scientific, OCT 22, 2025, View Source [SID1234661705])

Q3 2025 update

On October 22, 2025 Ipsen reported third quarter 2025 results (Presentation, Ipsen, OCT 22, 2025, View Source [SID1234661390]).