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CREATE Medicines and Amsterdam University Medical Center Initiate First In Vivo CAR Therapy Trial in Frontline Setting for Solid Tumors

On October 28, 2025 CREATE Medicines, Inc., formerly Myeloid Therapeutics, Inc. ("CREATE"), reported that Amsterdam University Medical Center ("Amsterdam UMC") has dosed the first patient in the SPaCE-MT clinical trial. The trial will evaluate the treatment of advanced gastroesophageal cancer with CREATE’s MT-302 with capecitabine, oxaliplatin (CAPOX) with or without nivolumab or trastuzumab, representing the first clinical evaluation of an in vivo CAR therapy combined with a standard frontline regimen for solid tumors.

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This trial marks a pivotal step in advancing in vivo immune programming to unlock truly scalable, off-the-shelf cell therapies. With this milestone, CREATE Medicines is one step closer to realizing its vision for the future of in vivo cell therapy through repeat-dose treatments that expand access and integrate seamlessly with existing standards of care.

"In vivo mRNA CARs represent a new class of programmable medicines, and SPaCE–MT brings this modality into frontline care. The early MT–302 data demonstrate safety and activity that support combination therapy – expanding options and meaningfully improving outcomes for patients," said Daniel Getts, Chief Executive Officer of CREATE Medicines.

Professor Hanneke van Laarhoven, leading scientist on the trial and Medical Oncologist and Head of the Department of Medical Oncology at Amsterdam UMC – Cancer Center in the Netherlands, recognizes that MT-302 has significant potential to enhance frontline therapy and improve outcomes for patients with advanced esophageal and gastric cancers. The research team is eager to discover new insights into how this therapy may positively influence outcomes for patients with various types of cancer.

In Vivo CAR Clinical Validation

In vivo CAR therapies have become one of the most closely watched frontiers in oncology, offering the potential to overcome the manufacturing complexity, cost, and scalability limitations of traditional ex vivo CAR-T approaches. CREATE has distinguished itself by generating one of the largest clinical datasets in the in vivo CAR field across multiple Phase 1 studies:

Proof-of-mechanism: Paired biopsies confirmed CAR+ immune cells infiltrating tumors, with immune remodeling and CD8 T-cell recruitment.
Safety data and repeat dosing: Over 200 monotherapy doses administered with a consistent, manageable safety profile and no cumulative toxicities observed to date.
Evidence of activity: CAR expression detected in circulating immune cells, stable disease in several patients, and a confirmed partial response lasting 16 months.
These results provide compelling human validation for CREATE’s mRNA-LNP platform and de-risk next-generation multi-cell programming initiatives.

"The initiation of this study underscores the need for innovative treatment strategies in gastroesophageal cancer, where outcomes still remain very poor," said Matt Maurer, Chief Medical Officer, CREATE Medicines. "By combining our in vivo CAR therapy with established chemotherapeutic and immunotherapy treatments, we aim to unlock the full potential of a coordinated immune attack against cancer."

About SPaCE-MT

SPaCE-MT (Safety and Preliminary Clinical Efficacy of MT-302 with CAPOX-based Regimens in Metastatic Esophagogastric Cancer, EUCT 2024-520213-45-00) is an open-label, Phase 1/2 investigator-initiated trial led by Professor Hanneke van Laarhoven at Amsterdam UMC. The study evaluates the safety, tolerability, and preliminary efficacy of MT-302 in combination with CAPOX with or without nivolumab or trastuzumab in patients with advanced gastroesophageal cancer.

About Gastroesophageal Cancer

With over 1.3 million new cases diagnosed globally each year, gastroesophageal cancers remain a leading cause of cancer-related mortality worldwide. While progress has been made with chemotherapy, targeted agents, and immune checkpoint inhibitors, outcomes for patients with advanced gastroesophageal cancer remain poor, and resistance to frontline therapies is common, underscoring the urgent need for novel treatment approaches.

About MT-302

MT-302 is a first-in-class, TROP2-FcA-LNP therapy that programs immune cells directly in vivo to attack tumors. TROP2 is overexpressed in most epithelial cancers, with limited expression in normal tissues. Unlike antibody-drug conjugates, MT-302 elicits a coordinated immune response by engaging innate and adaptive arms, including presentation of tumor neoantigens to T cells.

(Press release, Amsterdam UMC, OCT 28, 2025, View Source [SID1234657082])

Mercy BioAnalytics Publishes Validation Study in Gynecologic Oncology Demonstrating Unprecedented Performance of Blood Test for Early Detection of Ovarian Cancer

On October 28, 2025 Mercy BioAnalytics, Inc., a pioneer in blood-based detection of early-stage cancer, reported the publication of a validation study in the journal of Gynecologic Oncology highlighting the performance of a novel blood test for detection of preclinical early-stage ovarian cancer.

Led by Mercy researchers in partnership with the Medical Research Council Clinical Trials Unit (MRC CTU) at University College London (UCL), this landmark study represents the first demonstration of a blood test capable of detecting ovarian cancer up to three years prior to diagnosis in prospectively collected preclinical samples from the landmark UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Study Highlights

The blood test achieved 89% sensitivity and 98% specificity for detecting stage I/II high-grade serous carcinoma (HGSC) in average-risk, postmenopausal women, with significantly improved specificity and discrimination compared to CA125.
The blinded evaluation of samples that were prospectively collected prior to cancer diagnosis from the intended use population minimizes bias while demonstrating generalizability of performance.
These findings build upon Mercy’s previous published work validating their blood-based detection technology and establishes the Mercy Halo assay as a promising next-generation screening platform.
The results demonstrate that the test, which detects tumor-derived extracellular vesicles and particles, can identify ovarian cancer with high accuracy—even in preclinical, early-stage disease where intervention is most impactful. These findings suggest the technology has the potential to enable a practical, blood-based screening approach for average-risk women, addressing a critical unmet need in ovarian cancer care. The test’s high specificity minimizes the potential for false positives, while its high early-stage sensitivity enables the detection of ovarian malignancy even before symptoms arise.

"This study marks a watershed moment for noninvasive ovarian cancer screening," said Dawn Mattoon, Ph.D., Chief Executive Officer of Mercy. "Achieving nearly 90% sensitivity with 98% specificity in early-stage disease is unprecedented in this space. We are more confident than ever that our technology can transform how ovarian cancer is detected, offering women a real chance at earlier intervention and improved outcomes."

Ovarian cancer is one of the leading causes of cancer death among women and will kill nearly 13,000 women in the U.S. this year. More than 70% of ovarian cancer is diagnosed in women over 50 years of age, and nearly 80% of ovarian cancer is diagnosed at an advanced stage of disease, when survival is poor. When ovarian cancer is detected early, when disease is still localized, nearly 90% of women survive for ten years or more. Unfortunately, legacy diagnostic test methods have not shown adequate clinical performance to enable broad adoption for ovarian cancer screening.

"This study demonstrates that blood-based biomarkers can provide a highly specific and sensitive signal for early ovarian cancer," said Dr. Usha Menon, Professor of Women’s Cancer at UCL and senior author of the paper. "The blinded evaluation of preclinical samples from the no screening and ultrasound arms of UKCTOCS represents an important step forward in population screening. The next stage is to assess the robustness and reliability of these findings by assessing performance in the third arm of the UKCTOCS trial (the multi-modal screening arm)."

(Press release, Mercy BioAnalytics, OCT 28, 2025, View Source [SID1234657081])

Fosun Pharma Announces 2025Q3 Financial Results

On October 28, 2025 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; SSE: 600196, HKEX: 02196), a leading innovation-driven global healthcare company, reported its financial results for the first three quarters of 2025. In the first three quarters of 2025, Fosun Pharma achieved operating revenue of RMB29,393 million, net profit attributable to shareholders of RMB2,523 million. The revenue from Innovative Drugs grew steadily, exceeding RMB6,700 million in the first three quarters of 2025, up by 18.09% period-on-period, implying a continued optimization of revenue structure.

Meanwhile, Fosun Pharma continued to deepen lean operations, drive cost reduction and efficiency enhancement, and advance asset-light strategies to optimize assets and financial structure, actively strengthen supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2025, the net cash flow from operating activities of Fosun Pharma amounted to RMB3,382 million, up by 13.23% period-on-period, representing a sustained improvement in operational quality.

Revenue from Innovative Products Maintains Steady Growth

Fosun Pharma’s innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors, and immune-inflammatory disorders, while emphasizing core technology platforms including antibodies/ADCs, cell therapy, and small molecules, building a synergistic, open, and global innovative R&D system.

In the third quarter of 2025, several self-developed Innovative Drugs from Fosun Pharma achieved key milestones in major markets. Notably, 1 additional indication for the innovative small molecule CDK4/6 inhibitor Fovinaciclib Citrate Capsules (Chinese trade name:复妥宁), of which Fosun Pharma owns independent intellectual property rights, was approved in Chinese Mainland. The inhibitor is for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative breast cancer, bringing more diverse treatment options to breast cancer patients in China.

In September 2025, the self-developed denosumab injection (project no.: HLX14), in both 60 mg/mL and 120 mg/1.7 mL presentations, was approved for launch successively in the United States and the European Union, becoming the first domestically developed denosumab to be approved overseas, covering all original indications. This provides additional therapeutic options in multiple areas related to bone loss, including osteoporosis.

In the hematology tumors field, the drug registration application of Brexucabtagene Autoleucel Injection (project code: FKC889) of Fosun Kairos was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Strengthening Original Innovation Capability, Building a High-Value Pipeline Portfolio

Fosun Pharma committed to innovation-driven sustainable growth, emphasizing the rational allocation of R&D resources and efficiency enhancement. The Group has gradually built a high-value pipeline portfolio and deployed radiopharmaceuticals, RNA, gene therapy, AI drug R&D and other cutting-edge technologies in order to facilitate the R&D process. Meanwhile, Fosun Pharma continuously strengthens its fundamental innovation capabilities and advances the deep integration of scientific and industrial innovation.

In terms of R&D investment, in the first three quarters of 2025, Fosun Pharma’s R&D investment amounted to RMB3,998 million in total, up by 2.12% period-on-period. In particular, R&D expenses amounted to RMB2,730 million. In the third quarter of 2025, R&D expenses amounted to RMB1,013 million, up by 28.81% period-on-period. The investment primarily focused on cutting-edge technology platforms such as radiopharmaceuticals and cell therapy, as well as global multicenter clinical trials of high-value pipelines, including HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) and HLX43 (PD-L1-targeted antibody-drug conjugate).

Fosun Pharma’s self-developed innovative anti-PD-1 monoclonal antibody (mAb) Han Si Zhuang (serplulimab injection) is making steady progress across multiple clinical studies. Among them, the phase 3 clinical study of Han Si Zhuang in combination with chemotherapy for the neo-/adjuvant treatment of gastric cancer has met the primary endpoint, supporting an early new drug application submission. Han Si Zhuang has become the world’s first perioperative (pre-/post-surgical) treatment regimen for gastric cancer in which an immunotherapy monotherapy replaces postoperative adjuvant chemotherapy, marking a major breakthrough in this field. In October, the U.S. bridging study of serplulimab injection in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) has completed enrollment of all 200 patients, laying a solid foundation for the subsequent submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). As the world’s first anti-PD-1 mAb approved for 1L treatment of ES-SCLC, serplulimab has been approved in nearly 40 countries and regions including China, the U.K., Germany, Singapore and India, serving as a high-quality example of Chinese innovation drugs reaching global markets.

In October 2025, HLX43 (PD-L1-targetede antibody-drug conjugate) for injection was granted Orphan-Drug Designation (ODD) by the U.S. FDA for the treatment of thymic epithelial tumors (TETs). This designation will facilitate the subsequent R&D, registration, and commercialization of the product for the relevant indication in the United States. HLX43 is a potential best-in-class (BIC) broad-spectrum anti-tumor antibody-drug conjugate (ADC) that combines dual mechanisms of action—immune checkpoint blockade and payload-mediated cytotoxicity. As the world’s first PD-L1 ADC developed for TETs, HLX43 has demonstrated promising preliminary efficacy in the later-line treatment of patients with TC. It is positioned to address the unmet clinical need for ADC therapies in this rare and highly aggressive malignancy. Currently, Fosun Pharma’s subsidiary, Henlius, is advancing the clinical development of HLX43 at full speed, with over 400 patients enrolled globally.

In September 2025, Fosun Pharma established a radiotherapy business platform, Xingrui Jingxuan, which will deploy diagnosis-therapy integrated radiopharmaceuticals development in pan-tumor through both independent R&D and collaborative pathways, bringing more benefits to patients.

Launching Share Incentive Scheme, Successfully Issuing First Medium-to-Long Term Sci-Tech Innovation Bond in Private Pharmaceutical Industry

In addition, in the first three quarters of 2025, Fosun Pharma completed its A-share and H-share repurchase plans on schedule and proposed adoption of the 2025 A share option incentive scheme and the H share restricted share unit (RSU) scheme, further strengthening its long-term incentive mechanism. In August 2025, the Group successfully issued RMB 1 billion of medium-to-long-term Sci-Tech Innovation Bonds with a maturity of two years, becoming the first private pharmaceutical company to issue such bonds after the joint announcement of the People’s Bank of China and the China Securities Regulatory Commission in May 2025 regarding support for Sci-Tech Innovation Bonds. The bonds carry a coupon rate of 2.70% and will provide strong funding support for Fosun Pharma as it deploys in key scientific innovation areas, accelerating the transformation and commercialization of innovative products.

Looking forward, Fosun Pharma will continue to adhere to innovation-driven development, optimize R&D resource allocation, accelerate the clinical progress and commercialization of high-potential pipeline, and remain committed to delivering higher-quality and more accessible healthcare products and services to patients worldwide.

(Press release, Fosun Pharma, OCT 28, 2025, View Source [SID1234657080])

Harbour BioMed Launches First Fully Human Generative AI HCAb Model to Accelerate Next-Generation Biologics Discovery

On October 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported the launch of its first fully human Generative AI HCAb (Heavy Chain-Only Antibody) Model powered by its Hu-mAtrIx AI platform, built upon the Harbour Mice platform. This platform establishes a closed-loop process integrating AI design, intelligent screening, and wet-lab validation.

The announcement was made at the company’s Global R&D Day 2025 event in Shanghai. During the event, the Global AI + Pharmaceutical Ecosystem Alliance was also officially launched. The alliance brings together leading expertise, cutting-edge technologies, and resources from various sectors, aiming to systematically reshape the entire drug R&D process through artificial intelligence technologies, accelerating the development of innovative therapies for the benefit of patients worldwide.

AI-Driven Precision for Faster and More Accurate Target Identification

The newly released AI HCAb Model establishes a closed-loop workflow that integrates AI-driven sequence generation, design and screening, and wet-lab validation. This end-to-end process transforms antibody discovery from blind screening to AI-driven intelligent selection, dramatically improving efficiency and accuracy in antibody discovery.

HCAb, known for its simple structure and low molecular weight, holds strong potential for advanced applications like bispecific/multi-specific antibodies, ADCs, CAR-T, and mRNA therapies. However, conventional human VH domains struggle to maintain stability without VL pairing.

Harbour BioMed’s Harbour Mice platform — the world’s first transgenic mouse platform that produces fully human functional HCAb — laid the foundation for overcoming this challenge. The key AI design lies in accurately identifying functional, autonomous HCAbs from vast datasets, given the high structural and sequential similarity between HCAb VH sequences and those of conventional (H2L2) antibodies. Harbour BioMed’s HCAb generation model is trained on 9 million NGS-derived HCAb sequences and extensive public data. Using a fine-tuned protein large language model, it enables de novo generation of high-potential HCAb sequences, with secondary optimization for target specificity.

These AI-generated sequences then undergo a multi-stage intelligent screening process, which includes:

AI Classification Model to filter non-HCAb sequences
Multimodal AI Developability Prediction Model (achieving SOTA performance) to assess key developability parameters such as stability, solubility, and aggregation tendency
Only candidates that pass rigorous screening proceed to synthesis and wet-lab validation.

AI HCAb Model Delivers Higher Binders Diversity and Binding Success Rate

The AI HCAb Model demonstrated a tenfold increase in candidate generation and significantly improved success rates. Data show that among 107 de novo generated binder sequences produced by AI HCAb model, 78.5% successfully hit the target, while 20 molecules were further validated in wet-lab assays, demonstrating high activity, purity, yield, and specificity.

These AI-designed binders demonstrated outstanding developability profiles, with an average yield exceeding 700 mg/L. Multiple candidate sequences showed nanomolar-level binding affinity while maintaining binding activity against relevant targets in both humans and cynomolgus monkeys.

Accelerating the Development of Next-Generation Therapies

Harbour BioMed’s AI platform is designed as a self-evolving innovation flywheel driven by continuous learning and feedback: AI design – automated validation – AI re-learning.

This iterative process enables generative AI to create diverse new molecules, while high-throughput automation rapidly characterizes and feeds back experimental data to continuously enhance model intelligence and R&D efficiency.

With this foundation, the AI HCAb Model is expected to accelerate applications of fully human HCAbs across next-generation therapeutic areas — including multi-specific antibodies, XDCs, in vivo CAR-T, and inhaled or oral large-molecule drugs — helping redefine the landscape of biologics discovery.

Building the Future AI + Pharmaceutical Ecosystem

At the event, Harbour BioMed also announced the official establishment of the Global AI + Pharmaceutical Ecosystem Alliance, which brings together leading experts, technology partners, and investors to reshape the entire drug discovery pipeline through AI innovation.

The alliance has gained strong support from government bodies, industry associations, and investors including Fortera Capital, Insilico Medicine, Molecular Mind, Evinova, INNOVEL, Fenglin Group, Taimei Technology, EClinCloud, Deep Intelligent Pharma, and Harbour BioMed.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, said: "The Global AI + Pharmaceutical Ecosystem Alliance aims to create an open, collaborative, and win–win ecosystem. Through shared value and collective innovation, we seek to address the toughest challenges in drug discovery and bring transformative therapies to patients faster and more effectively."

(Press release, Harbour BioMed, OCT 28, 2025, View Source [SID1234657079])

Pinetree Therapeutics Raises $47 Million in Oversubscribed Series B to Advance Next-Generation Protein Degraders in Oncology

On October 28, 2025 Pinetree Therapeutics, a preclinical-stage biotechnology company pioneering targeted protein degraders for drug-resistant cancers, reported the successful closing of an oversubscribed $47 million Series B financing. The proceeds will advance its lead preclinical oncology programs to Phase I clinical studies and accelerate development of Pinetree’s AbReptor platform. Participating investors include existing investors DSC Investment, WIDWIN Investment, STIC Ventures, Samho Green Investment, Atinum Investment, S&S Investment, SJ Investment Partners, Smilegate Investment, and Gauss Capital Management, as well as new investors Korea Investment Partners and SV Investment.

Founded in 2019, Pinetree is an industry leader in the targeted protein degradation (TPD) field, developing a novel class of modular bispecific and multispecific protein degraders designed to selectively eliminate disease-driving membrane-bound and extracellular proteins. The AbReptor platform has demonstrated compelling preclinical efficacy and safety in degrading receptor tyrosine kinases (RTKs) that drive tumor growth and resistance, including targets refractory to existing tyrosine kinase inhibitors (TKIs) and immune checkpoint therapies.

"The AbReptor platform has repeatedly demonstrated durable activity across a broad range of RTK targets, including models resistant to standard-of-care therapies, and has unlocked the potential to develop a novel class of degrading antibody drug conjugates (ADCs), which aim to overcome the limitations of traditional ADCs, including tolerability and limited durability. Our platform also offers new therapeutic approaches for targeting inflammatory cytokines in disease tissues, representing a potential alternative to current immunology and inflammation therapies," said Ho-Juhn Song, Ph.D., Founder and CEO of Pinetree Therapeutics. "We are thrilled by the strong support from our investors and look forward to using these proceeds to advance differentiated therapies that address significant unmet clinical needs."

The Series B financing will support IND-enabling studies and Phase I clinical trials for Pinetree’s lead programs, expand its multispecific degrader portfolio, and enable strategic collaborations to unlock new target classes. "We are excited to continue our partnership with Pinetree as they advance a highly differentiated platform with the potential to meaningfully impact patients with RTK-driven tumors," said Yohan Kim, Executive Director of DSC Investment. "We see significant promise in Pinetree’s approach to overcoming resistance and improving tolerability, particularly for patients with limited treatment options."

This financing follows a July 2024 collaboration with AstraZeneca, which included an exclusive global license option for Pinetree’s preclinical EGFR degrader candidate, valued at over $500 million in potential milestones and royalties, reflecting growing interest in AbReptor therapeutics. Pinetree continues to expand its pipeline and strategic partnerships to deliver novel TPD programs that aim to transform treatment for patients with hard-to-treat cancers and other diseases.

(Press release, PineTree Therapeutics, OCT 28, 2025, View Source [SID1234657078])