Positive Safety and Efficacy of NI-1801 in Platinum Resistant Ovarian Cancer Patients Presented in Proffered Paper Oral Presentation at ESMO 2025

On October 20, 2025 Light Chain Bioscience, a clinical-stage biotechnology company advancing the next generation of bispecific antibodies to treat cancer, reported positive results from a Phase 1/1b study of NI-1801 as a monotherapy and in combination with pembrolizumab in heavily pretreated Platinum Resistant Ovarian Cancer (PROC) patients. The results were reported in a Proffered Paper oral presentation at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin.

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NI-1801 is a first-in-class mesothelin x CD47 bispecific antibody that selectively targets the innate immune checkpoint CD47 on mesothelin-expressing cancer cells.

The Phase 1b study of NI-1801 in combination with pembrolizumab showed an overall survival (OS) rate at one year of 75.2% in 21 patients at the data cutoff (August 2025), with a median follow-up of 11 months (15 patients alive and 6 patients ongoing). The immature progression-free survival (PFS) rate was 32.7% at 9 months with a confirmed response rate by RECIST¹ criteria of 28.5% and a clinical benefit rate (CBR) of 48%. In the monotherapy Phase 1 study, NI-1801 showed an OS rate at one year of 35.3% in 21 patients, with a median follow-up of 19 months and 7 patients alive at the data cutoff.

NI-1801 was safe and well tolerated as monotherapy and in combination with pembrolizumab.

Platinum-resistant ovarian cancer patients treated in this study received ≥ 4 prior chemotherapy lines, representing the most fragile subpopulation of ovarian cancer patients.

With standard of care chemotherapy, previous studies reported a median OS ranging from 9 to 12 months, in a PROC patient population that received at least one chemotherapy line.²

Jose Saro, MD, Chief Medical Officer, Light Chain Bioscience, said: "We are delighted to report substantial clinical benefit of NI-1801 in this subpopulation of platinum-resistant ovarian cancer patients. The overall survival rate reported for NI-1801 in combination with pembrolizumab is particularly noteworthy in a chemotherapy-free regimen, and it is the first example of a combined immunotherapy approach to show effectiveness in this hard-to-treat ovarian cancer patient population. These findings indicate the potential of NI-1801 to positively impact the management of this devastating disease."

Professor Thibault de la Motte Rouge, MD, PhD, Research Director, Centre Eugène Marquis, France, and the investigator presenting the data at 2025 ESMO (Free ESMO Whitepaper) said: "Patients with platinum-resistant ovarian cancer face poor survival outcomes, and current treatment options remain limited, highlighting the urgent need for novel therapeutic approaches. To date, clinical results with immunotherapy in ovarian cancer have been largely disappointing, although the recent Phase III Keynote-B96 trial has shown a benefit with pembrolizumab in patients with early relapsing platinum-resistant disease. In this context, our study demonstrates that NI-1801, administered either as monotherapy or in combination with pembrolizumab, provides durable clinical benefit and meaningful survival improvement, with a favorable safety and tolerability profile. These findings support a therapeutic strategy that synergistically engages both innate and adaptive immune pathways – by targeting CD47 within the tumor microenvironment and blocking the PD-L1/PD-1 axis – as a promising chemotherapy-free approach to enhance immunotherapy efficacy and improve outcomes in this high unmet-need population."

Nicolas Fischer, CEO of Light Chain Bioscience, said: "These promising results confirm our long-held conviction that bispecific antibodies targeting CD47 have a fundamentally different therapeutic window than anti-CD47 monoclonal antibodies, which have faced major setbacks. These findings showed that, in a challenging subpopulation where immune exhaustion and tumor heterogeneity are pronounced, combining blockade of innate and adaptive immune pathways can overcome the ovarian tumors’ immunosuppressive barriers, improving the immunotherapy success rate, which is traditionally low for this tumor type."

Details of the Proffered Paper Oral Presentation

Title (#1512O): NI-1801, a mesothelin x CD47 bispecific antibody: Safety and activity as single agent and in combination with pembrolizumab, in heavily pretreated (≥ 4 prior lines) mesothelin expressing platinum resistant epithelial ovarian cancer patients

Presenter: Professor Thibault de la Motte Rouge, MD, PhD, Research Director, Centre Eugène Marquis, Rennes, France

Lecture Date and Time: Monday 20 October – 10:55 – 11:05

About ovarian cancer

Ovarian cancer accounts for approximately 200,000 deaths worldwide annually.² It is a heterogeneous disease, showing major differences in terms of its incidence, tumor behavior, and outcomes across histological subtypes. Treatment options for platinum-resistant recurrence cases are limited, with no effective therapies that significantly prolong the prognosis.

About NI-1801

Light Chain Bioscience’s most advanced asset, NI-1801, is a first-in-class bispecific antibody selectively targeting the innate immune checkpoint CD47 on mesothelin-expressing cancer cells, as a potential treatment for ovarian and other mesothelin+ cancers. NI-1801 is being evaluated in a Phase 1 trial in patients with heavily pretreated platinum-resistant ovarian cancer (PROC). NI-1801 is also being evaluated in a Phase 2 randomized trial in PROC patients having received 1-3 prior chemotherapy lines.

(Press release, Light Chain Bioscience, OCT 20, 2025, View Source [SID1234656846])

Biparatopic HER2-targeting ADC JSKN003 Was Granted Another Breakthrough Therapy Designation for HER2-Positive Advanced Colorectal Cancer

On October 20, 2025 Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly reported that biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted another breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the indication of monotherapy for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan (Press release, Alphamab, OCT 20, 2025, View Source [SID1234656989]). Previously, JSKN003 had received breakthrough therapy designation from the CDE for platinum-resistant ovarian cancer (PROC) (not restricted by HER2 expression), as well as clinical trial approval from the U.S. Food and Drug Administration (FDA). It has also been granted Orphan Drug Designation by the U.S. FDA for gastric and gastroesophageal junction cancer. This latest designation in colorectal cancer further underscores its clinical value and global development potential across multiple refractory tumor types.

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Colorectal cancer is among the most common malignancies worldwide. According to data from the International Agency for Research on Cancer (IARC), there were approximately 1.93 million newly diagnosed cases and about 903,900 deaths attributed to CRC globally in 2022, ranking third in incidence and second in mortality among all cancers. In China, CRC has the second-highest incidence after lung cancer, with over 500,000 new cases annually and a continuing upward trend. There are currently no HER2-targeted therapies approved in China for CRC. For patients with HER2-positive advanced CRC who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan, the median progression-free survival (mPFS) of approved therapies is only 2.0 to 3.7 months, and the median overall survival (mOS) is approximately 7 to 10 months. There remains a significant unmet clinical need within this patient population.

Clinical studies demonstrated that JSKN003 monotherapy exhibited notable efficacy and a favorable safety profile in patients with HER2-positive advanced CRC, showing meaningful clinical advantages over existing therapeutic options. As of June 30, 2025, a total of 33 patients with HER2-positive advanced metastatic CRC, were enrolled and received JSKN003 monotherapy in a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in China (JSKN003-102, NCT05744427), with 42.4% of these patients having previously received 3 or more prior lines of antitumor therapy. Among 32 efficacy-evaluable patients , the overall response rate (ORR) was 68.8%, the disease control rate (DCR) was 96.9%. Additionally, among 31 BRAF V600E wild-type patients, the ORR was 71.0%, the DCR was 100%, and median duration of response (DoR) was 9.89 months, the median PFS achieved 11.04 months, with a 9-month PFS rate of 66.6%. In terms of safety, the median follow-up time was 9.26 months. 7 patients experienced Grade 3 or above treatment-related adverse events (TRAEs). There were no TRAEs led to discontinuation or death. Detailed data from the study were presented recently at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025). By comparison, in a similar patient population, trastuzumab deruxtecan (DS-8201) previously reported an ORR of 37.8 %, a PFS of 5.8 months, and Grade 3 or above adverse events in nearly 50 % of patients.

JSKN003 is currently being evaluated in multiple Phase II and Phase III clinical studies in China for the treatment of various solid tumors including breast cancer, ovarian cancer, and gastric cancer. This latest breakthrough therapy designation for JSKN003 is expected to further accelerate its development and review processes, with the aim of bringing benefits to more cancer patients sooner.

About JSKN003

JSKN003 is Alphamab Oncology’s first bispecific ADC, developed based on HER2-targeting bsAb KN026, and utilizing the proprietary glycan-specific conjugation platform. It binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, exerting anti-tumor effects. Compared to similar ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window.

Clinical data in heavily pretreated advanced solid tumors have shown high-security profile, with promising efficacy of JSKN003, particularly in platinum-resistant ovarian cancer (PROC), HER2-high/low breast cancer (BC), HER2-positive colorectal cancer (CRC)/ gastric cancer (GC) and other HER2-expressing tumors. JSKN003 was granted breakthrough therapy designation by CDE for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and HER2-positive advanced colorectal cancer that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for GC and gastroesophageal junction cancer (GEJ). Three Phase III trials in HER2-low expressing BC, PROC, and HER2-positive BC and multiple Phase II studies are underway.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK). JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003.

Immatics Highlights Compelling Anti-Tumor Activity of Anzu-cel PRAME Cell Therapy in Metastatic Uveal Melanoma at the ESMO 2025 Presidential Symposium

On October 20, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported the presentation of updated data from 16 patients with metastatic uveal melanoma treated with anzu-cel PRAME cell therapy.

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The uveal melanoma data from the ongoing Phase 1b trial will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 during the Presidential Symposium III by Sapna Patel, M.D., Professor of Medicine, University of Colorado Cancer Center. The slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website.

"Patients with metastatic uveal melanoma face a poor prognosis and represent a population in need of better outcomes, given the limited options currently available," said Sapna Patel, M.D. "I believe the results with anzu-cel presented today signal a much-needed breakthrough for patients with metastatic uveal melanoma. These findings highlight the potential of anzu-cel to redefine the treatment paradigm for uveal melanoma and bring new hope to patients who urgently need more effective options."

"Our goal is to leverage every opportunity to bring innovative PRAME therapies to patients with limited treatment options," said Cedrik Britten, M.D., Chief Medical Officer at Immatics. "The continued strong clinical data presented today reinforce our conviction in maximizing the potential of our PRAME cell therapy, anzu-cel, and expanding its development into metastatic uveal melanoma, a rare cancer with very high unmet medical need. We are excited to further execute on our PRAME franchise and bring meaningful progress to patients in need."

Presidential Symposium III Presentation Summary – Anzu-cel Phase 1b Trial

Patient Population: Difficult-to-treat patient population with metastatic uveal melanoma

As of September 24, 2025, 16 patients with metastatic uveal melanoma were administered a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR T cells) as part of the anzu-cel Phase 1b dose expansion. Patients received a median infused TCR T-cell dose of ~4 billion (range 1.62 – 8.43 billion TCR T cells) and had a median of 2 lines of prior systemic treatments. Patients had a median target lesion sum of a diameter of 103 mm (ranging from 31 to 210 mm), and 81% of patients had liver and extrahepatic metastasis.

Anti-tumor Activity and Durability: Continued strong anti-tumor activity and durability of anzu-cel PRAME cell therapy

Updated data of a one-time infusion of anzu-cel PRAME cell therapy demonstrated promising benefit in a difficult-to-treat population with limited effective treatment options:

Confirmed objective response rate (cORR) of 67% (10/151)
Disease control rate (DCR) of 88% (14/16)
Median duration of response (mDOR) of 11 months (min 4.4, max 31.6 months)
Median progression-free survival (mPFS) of 8.5 months (min 1.4, max 32.9) at a mFU of 10.4 months. The PFS rate was 69% at six months and 39% at 12 months
Median overall survival (mOS) not reached (min 4.3+, max 34.2+ months) at a mFU of 14.3 months. The OS rate was 71% at 12 months

Anti-tumor activity was observed in liver and extrahepatic metastases, including lung, lymph node, abdomen/peritoneum and others. 14/16 patients had target lesions in the liver and treatment with anzu-cel led to a median shrinkage in liver target lesion size of 49.6%.

Notably, 11 out of the 16 patients received a TCR bispecific (ten gp-100-targeting, one PRAME-targeting) as prior systemic treatment line, and thereof, six achieved a confirmed partial response, one a partial response and three stable disease. These results demonstrate anti-tumor activity of anzu-cel in patients who received prior TCR-based therapies.

Safety: Favorable tolerability in uveal melanoma, generally consistent with full anzu-cel tolerability profile

The most frequent treatment-emergent adverse events (TEAs) were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grade 1 or 2, which is consistent with the mechanism of action (Grade 1: 37.5%, Grade 2: 43.8%, Grade 3: 18.8%, Grade 4: 0%). No patients experienced long-term CRS, and most CRS was resolved by day 14. No anzu-cel-related Grade 5 events were observed.

Tolerability in the uveal melanoma subset was generally consistent with the full anzu-cel tolerability profile in the Phase 1b.

Development Path for Anzu-cel in Metastatic Uveal Melanoma

Based on the promising clinical data in patients with metastatic uveal melanoma, Immatics has initiated a Phase 2 cohort with approximately 30 uveal melanoma patients planned. The cohort is being conducted at select centers in the U.S. and Germany with deep expertise in uveal melanoma. Given the high prevalence of PRAME expression in uveal melanoma, prospective PRAME testing is no longer required for inclusion in the clinical trial.

The consistent tolerability, anti-tumor activity and pharmacokinetic profile of anzu-cel across both uveal and cutaneous melanoma provide a strong rationale for pursuing a parallel late-stage development strategy to serve both patient populations.

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

About Anzu-cel (IMA203) PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, "SUPRAME," in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1b clinical trial in patients with PRAME cancers is ongoing with a focus on uveal melanoma.

(Press release, Immatics, OCT 20, 2025, View Source [SID1234656815])

GRAIL and University of Oxford to Present Long-Term Data From the SYMPLIFY Study Evaluating the Galleri® Multi-Cancer Early Detection Test in Symptomatic Individuals at the Early Detection of Cancer Conference (EDCC)

On October 20, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford, reported that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.

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SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study.

"The conversion of false positive results to cancer diagnosis in this updated analysis of the SYMPLIFY study highlights the importance of proactive follow-up on positive MCED results, as one third of the apparent false positive results were actually cancers the standard-of-care diagnostic process couldn’t immediately identify," said Brian D. Nicholson, MRCGP, DPhil, Associate Professor at the Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom and co-lead investigator of the study. "Additionally, the results underscore the value of Galleri’s Cancer Signal Origin prediction, which aligned with the eventual diagnosis in almost all of the cases initially considered to be false positives. We are pleased to present these data at EDCC and have submitted this analysis for full publication."

Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer

Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. Many of these people report common, non-specific symptoms such as bloating, unexplained weight loss or abdominal pain, which can be attributed to various conditions as well as cancer2.

The primary analysis of the SYMPLIFY study, previously published in The Lancet Oncology, supported the feasibility of using the Galleri test to assist clinicians with decisions regarding referral from primary care. In that analysis, which followed participants until diagnostic resolution or up to nine months, Galleri’s positive predictive value (PPV) was 75.5%. When a cancer signal was detected, the test accurately predicted the Cancer Signal Origin (CSO) in 84.8% of cases.

Updated results demonstrate importance of continued follow-up after a cancer signal is detected

Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales. The analysis showed that 35.4% (28 of 79 participants) were later diagnosed with cancer within 24 months of enrollment. This reduction in false positives from 79 to 51 resulted in an increase of PPV to 84.2%. In aggregate, 27 of these 28 participants had a correct CSO prediction which could have led to a faster or more efficient diagnosis. In more than half of these cases, the cancer type diagnosed was not congruent with the original diagnostic clinic to which the patient was referred by the general practitioner based on the clinical presentation:

16 of the 28 (57.1%) were diagnosed with cancer within nine months of enrollment.
Eight of the 16 (50%) were diagnosed with cancers that were correctly predicted by the Galleri test’s CSO finding, but were incongruent with the diagnostic pathway chosen by the general practitioner based on the participants’ presenting symptoms.
12 of the 28 (42.9%) were diagnosed 10-24 months after enrollment.
Seven of the 12 (58.3%) were diagnosed outside the original referral pathway; in those cases, the CSO also was correct, matching the site that was ultimately diagnosed.
"The SYMPLIFY study, focused on patients presenting with symptoms, adds to the breadth of our clinical experience in asymptomatic populations. This robust data demonstrates the potential benefit of the Galleri test as a diagnostic tool for individuals presenting with symptoms of cancer, particularly where those symptoms are non-specific. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test’s CSO capability," said Sir Harpal Kumar, President, International Business & BioPharma at GRAIL. "Furthermore, the 24-month follow-up data being presented at EDCC underscore the importance of continued follow-up to help identify cancers that may initially be missed in diagnostic evaluation. These latest results add to the body of evidence that Galleri could support clinical decision-making in primary care for referral to urgent diagnostic investigations of cancer and drive more efficient use of diagnostic capacity."

About the SYMPLIFY Study
SYMPLIFY is a prospective multicentre observational study and represents the first large-scale evaluation of an MCED test in symptomatic patients who were referred from the primary care setting due to clinical suspicion of cancer. The study enrolled 6,238 patients, aged 18 years and older, in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible cancer. Of the total enrolled patients, there were 5,461 evaluable patients who achieved diagnostic resolution. GRAIL’s MCED test was performed in batches, blinded to clinical outcome, and results were compared with the diagnosis obtained by standard of care pathways to assess the test’s performance.

The University of Oxford sponsored the SYMPLIFY study and was responsible for data collection, analysis and interpretation. The study was funded by GRAIL with support from National Health Service (NHS) England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.

(Press release, Grail, OCT 20, 2025, View Source [SID1234656831])

Fulgent Shares Preliminary Data from Poster Presentation at ESMO 2025 Conference

On October 20, 2025 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This preliminary data will be presented on October 20, 2025, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held October 17th to the 21st in Berlin, Germany.

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"We believe this preliminary data reinforces our mission to build a holistic platform that delivers comprehensive solutions across the cancer care continuum — from early detection, diagnostics, and monitoring to drug discovery and development," said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. "We are encouraged by the steady advancement of FID-007 in oncology indications to date, while our precision diagnostics business continues to provide strong momentum as the primary driver of revenue for Fulgent."

Poster title: "A Randomized Phase 2 Study of FID-007 Plus Cetuximab in Patients with Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma"

Observations in the Poster include:

As of a September 25, 2025 preliminary data cutoff date:

39 patients with R/M HNSCC have been randomized, of which 36 have received at least one dose of study treatment (FID-007 at 75 mg/m2 or 125 mg/m2 IV on Days 1, 8, 15 Q4W and cetuximab 500 mg/m2 IV biweekly).
FID-007 combined with cetuximab demonstrated meaningful anticancer efficacy at both dose levels for the 1L – 2L treatment of R/M HNSCC. Of the 35 patients evaluable for efficacy, the objective response rate (ORR) for the 75 mg/m2 arm and the 125 mg/m2 arm were 44% and 59% respectively, and 51% overall when both arms are combined. The median progression-free survival (PFS) for the 75 mg/m2 arm and the 125 mg/m2 arm were 9.2 months and 7.8 months, respectively. The overall PFS was 7.8 months, compared to the historical 2.3 months of the standard-of-care therapies.
FID-007 exhibited a favorable safety and tolerability profile, with a 6% overall treatment-related serious adverse event (SAE) rate in the 36 patients evaluated for safety. Overall grade 3 and worse treatment-related adverse events were observed in ≥ 5% of patients and consisted of lymphocyte count decreased (19%), neutrophil count decreased (17%), anemia (8%), dermatitis acneiform (8%), white blood cell count decreased (8%), rash (6%), hypomagnesaemia (6%) and pneumonia (3%). Grade 1-2 peripheral neuropathy was reported in 31% of the patients. No grade 3 and above peripheral neuropathy has been reported to date.
An optimal dose of FID-007 will be determined after data maturation to support further development of this combination therapy.
The poster will be available on the Investor Relations section of the company’s website at: View Source

About FID-007

FID-007 is designed to improve the pharmacokinetics of paclitaxel (PTX), increase its water solubility, reduce formulation-related toxicity, and enhance therapeutic efficacy by encapsulating PTX with a clinically safe polyethyloxazoline (PEOX) polymer excipient. Importantly, the smaller size of FID-007 nanoparticles compared to solvent-based PTX micelles in plasma enables efficient penetration and reduced clearance within the tumor due to the enhanced permeability and retention effect, thus resulting in higher accumulation of FID-007 in the tumor tissue.

(Press release, Fulgent Genetics, OCT 20, 2025, View Source [SID1234656847])