1stOncology™: Cancer Intelligence Service – Page 23 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Iksuda Presents Encouraging IKS014 Phase 1 Data at ESMO

On October 20, 2025 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported the presentation of new data from its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2)-directed ADC, in patients with advanced HER2+ solid tumours. The data was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Part I, the dose escalation portion, is being conducted in sites in Australia and is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) for IKS014 and provide initial safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic and immunogenicity characteristics. Part II dose expansion studies will assess IKS014 in HER2+ breast cancer in patients who have previously received Enhertu, HER2-low breast cancer, HER2+-gastric/ GEJ cancers and other HER2+ tumours and mutated HER2-NSCLC. Dose expansion studies will be conducted in sites in the US, Australia, New Zealand and Singapore.

At the data cut-off date (31 July 2025), a total of 62 patients were enrolled in the study, with 55 patients evaluable for efficacy as measured by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Anti-tumour activity was observed across all dose levels, with partial responses and unconfirmed partial responses observed in various tumour indications including breast, lung, oesophageal, ovarian, gastric, gallbladder and gastroesophageal junction cancers and in both HER2+ and HER2-low tumours.

Amongst 11 participants with breast cancer treated at doses >90mg/m2, seven responses were seen (objective response rate (ORR) 64%), including partial responses in all four patients with HER2+ disease. Three of these patients had previously received Enhertu. Additionally, amongst 10 patients with pre-treated, HER2+ oesophageal cancer that were enrolled across all dose levels, five achieved a response, including complete regression in one patient with non-measurable disease.

Treatment with IKS014 was generally well-tolerated at doses up to 120mg/m2 (~3.2 mg/kg), with anticipated adverse events including ocular surface AEs, pneumonitis and hypokalaemia, all of which were predominately Grade 1 and Grade 2.

An MTD was not reached per the study protocol. Dose selection for further evaluation in the expansion cohorts will be based on preliminary activity, safety, pharmacokinetic, pharmacodynamic profile and overall benefit-risk assessment from the dose escalation. The Phase 1 trial is expected to complete in H2 2026.

This data follows positive data from Phase 1 clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase 3 trials in China.1

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented: "We are hugely encouraged by these data, which illustrates the potential of IKS014 to improve outcomes and address the clinical unmet need across various HER-2 positive cancers, including treatment of those patients which are refractory to prior therapy options."

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, OCT 20, 2025, View Source [SID1234656850])

CatalYm Presents Long-Term Phase 1/2a Data Confirming Sustained Responses with Visugromab in CPI-Refractory Tumors at ESMO 2025

On October 20, 2025 CatalYm, a world leader in neutralizing GDF-15 in cancer and cachexia, reported updated long-term data from its ongoing GDFATHER-1/2a trial (NCT04725474) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. The data provide further evidence that Growth Differentiation Factor-15 (GDF-15) blockade by visugromab can reverse resistance to PD-(L)1 treatment in patients with advanced solid tumors and deliver durable responses in patients who have relapsed or progressed on prior checkpoint inhibitor treatment.

Visugromab is a humanized monoclonal antibody designed to neutralize the tumor-derived cytokine GDF-15, which plays a key role in immune suppression and resistance to therapy. The updated dataset highlights visugromab’s potential to reinvigorate immune responses in difficult-to-treat tumor types and patient populations with limited treatment alternatives.

"The durability of responses we are seeing with visugromab in this heavily pretreated, late-stage population is particularly remarkable," said Prof. Dr. Ignacio Melero, Co-Director of Immunology and Immunotherapy at CIMA, Universidad de Navarra, and Principal Investigator of the trial. "To observe ongoing responses extending beyond two and sometimes even three years in patients who had progressed on prior checkpoint inhibition is both encouraging and remarkable in this setting. These data underscore the potential of GDF-15 blockade to establish immune sensitivity in resistant tumors."

Key trial results

Out of 199 patients enrolled, 77 patients with either non-squamous NSCLC (n=22), urothelial cancer (n=27) or hepatocellular carcinoma (n=28) received visugromab in combination with nivolumab, all with progression on prior anti-PD-(L)1 therapy.
Confirmed objective response rates (RECIST 1.1) were 18.2% (4/22) in non-squamous NSCLC, 18.5% (5/27) in urothelial cancer, and 14.3% (4/28) in hepatocellular carcinoma, including 5 complete responses and multiple deep partial responses across cohorts.
Median duration of response reached 32.2 months in non-squamous NSCLC, 28.8 months in urothelial cancer, and 19.4 months in hepatocellular carcinoma. At data cut-off, 53.8% (7 of 13) of responses were ongoing across all three cohorts.
In 76.9% (10/13) of responders, the duration of response on visugromab plus nivolumab exceeded that of their prior checkpoint inhibitor treatment; 61.5% of responders also achieved a deeper response than previously recorded.
The combination was well tolerated, with treatment-related adverse events (TRAEs) reported in 58.4% of patients. Most TRAEs were Grade 1 or 2 and manageable. Grade ≥3 TRAEs occurred in 13% of patients and included expected immune-related events.
In cachectic patients, treatment was associated with clinically meaningful weight gain, indicating potential quality-of-life benefit.
"Our long-term follow-up data suggest that GDF-15 blockade with visugromab may offer meaningful and sustained benefit to patients who progress or do not respond to immunotherapy," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "The duration and depth of responses we continue to observe support further development of visugromab in earlier treatment lines, where maintaining immune sensitivity is critical."

"The growing body of clinical data for visugromab confirms our conviction that GDF-15 neutralization provides a novel strategy to overcome immune resistance and support immune reactivation," said Scott Clarke, Chief Executive Officer at CatalYm. "With several Phase 2b trials now underway, we are focused on translating this approach into improved outcomes across different patient populations and tumor types."

GDFATHER-1/2a (NCT04725474) is a multicenter, open-label Phase 1/2a trial evaluating visugromab in combination with an anti-PD-1 inhibitor in patients with advanced solid tumors. Phase 1 dose escalation comprised one cycle of monotherapy followed by combination treatment, while Phase 2a focused on expansion cohorts e.g. in non-squamous NSCLC, urothelial cancer, and hepatocellular carcinoma that had progressed on prior anti-PD-(L)1 therapy. Patients received visugromab at the recommended Phase 2 dose plus nivolumab every two weeks. Key endpoints included objective response rate, duration of response, and translational markers of immune activation.

(Press release, Catalym, OCT 20, 2025, View Source [SID1234656849])

SunRock Biopharma and Chime Biologics Announce Strategic Collaboration to Advance Development of Anti-CCR9 Antibody SRB5

On October 20, 2025 SunRock Biopharma, a biotechnology company focused on developing next-generation therapeutic antibodies, and Chime Biologics, a global leading contract development and manufacturing organization (CDMO), reported a strategic collaboration for the development of SRB5, a novel anti-CCR9 monoclonal antibody targeting inflammatory bowel disease (IBD), with potential expansion into other immune-mediated inflammatory indications.

SRB5 is a humanized monoclonal antibody with enhanced ADCC properties, designed to selectively deplete CCR9+ cells involved in chronic intestinal inflammation. It is the latest advancement in SunRock’s anti-CCR9 platform and represents a significant advance in a selective therapeutic approach for treating diseases such as Crohn’s disease and ulcerative colitis. Through this partnership, SunRock will benefit from Chime Biologics’ global-standard GMP manufacturing platform to scale production and accelerate preclinical and regulatory milestones.

"We are proud to collaborate with SunRock Biopharma on this promising anti-CCR9 antibody (SRB5) for inflammatory bowel disease, a condition that significantly impacts patients worldwide. This partnership reflects our commitment to applying our global-standard quality and comprehensive experiences in manufacturing biologics to accelerate the development of innovative therapies. We look forward to contributing to the long-term mission of SunRock Biopharma to develop innovative antibodies against highly invasive tumors with an urgent clinical need in oncology," said Dr. Jimmy Wei, President of Chime Biologics.

Dr. Laureano Simón, CEO of SunRock Biopharma, added "This collaboration with Chime Biologics reinforces our strategy of working with world-class partners across every stage of development. Chime’s technical expertise and industrial quality standards will help us scale SRB5 under optimal conditions. SRB5 has a distinctive biological profile that could transform the therapeutic landscape in IBD and potentially in highly aggressive CCR9-expressing tumors. This agreement is a critical step toward clinical validation."

(Press release, SunRock Biopharma, OCT 20, 2025, View Source [SID1234656848])

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.

"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])

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.

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])