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Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025

On October 20, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.

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The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001).

This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.1,2

These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade ≥3 toxicity related to immunotherapy.

Dr. Katarzyna Kozak, said: "The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial’s primary endpoint in resectable soft tissue sarcoma. These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti’s unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas. We hope these findings can help pave a path to a new therapeutic option for the substantial unmet medical need in this challenging indication."

Marc Voigt, CEO of Immutep, noted: "We sincerely thank the principal investigators leading this study, as well as the patients and their families for taking part in this important trial. There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy."

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3

The EFTISARC-NEO study has been primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

The presentation slides can be found on the Posters & Publications page of Immutep’s website.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, OCT 20, 2025, View Source [SID1234656867])

Successful IMvigor011 Trial Achieves 41% Improvement in Overall Survival for Bladder Cancer Patients

On October 20, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

IMvigor011 prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive based on serial testing up to 7 times in the first year post-cystectomy.

Study highlights:

761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo.

Signatera-positive patients treated with atezolizumab experienced a >2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo (HR: 0.64; P=0.005). Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS (median of 32.8 months vs. 21.1 months; HR: 0.59; P=0.01).

Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk (DFS of 95.4% at 1 year and 88.4% at 2 years). OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity.
"IMvigor011 has delivered practice-changing evidence in bladder cancer," said Professor Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology, chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Patients who tested Signatera-positive clearly benefitted from atezolizumab, while those who remained Signatera-negative had excellent outcomes without additional treatment. This is the most impactful data to date for personalized MRD testing, reinforcing Signatera’s predictive abilities to transform care."

"This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimizing overtreatment and allowing therapy to be precisely guided by Signatera results," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumor types."

Data from IMvigor011 will support Natera’s premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

(Press release, Natera, OCT 20, 2025, View Source [SID1234656851])

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.

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])