On October 22, 2025 Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, reported that it will present new data from its proprietary Targeted Protein Degradation (TPD) and Proximity Inducer Platform (A-PROX) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held at the Hynes Convention Center in Boston, MA, from October 22–26, 2025.

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!

Aurigene’s A-PROX platform integrates library screening, direct-to-biology chemistries, proprietary ternary complex assays, modelling algorithms, and structure-based design to accelerate the discovery and optimization of both protein degraders, molecular glues and proximity inducers.

Through this integrated approach, Aurigene has advanced a strong pre-clinical portfolio of next-generation degraders, including a SMARCA2-selective degrader, which recently received Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA); a pan-KRAS degrader; a SMARCA4-selective degrader; and a p300 degrader.

"Our A-PROX platform represents a significant step forward in the rational discovery of targeted protein degraders and molecular glues," said Dr. Murali Ramachandra, CEO of Aurigene Oncology Ltd. "We are excited to share our progress at the AACR (Free AACR Whitepaper)-NCI-EORTC conference and continue advancing differentiated therapies that have the potential to transform cancer treatment."

These programmes underscore Aurigene’s capability to deliver potent, paralogue-selective, and mutant-agnostic degraders, enabling the targeting of previously undruggable oncology pathways. Aurigene’s proprietary long-acting injectable (LAI) formulation has enabled infrequent intravenous dosing, just once every three weeks for most molecules, while maintaining excellent efficacy.

Poster Presentations

Title: Identification of an orally bio-available SMARCA2 selective degrader for treatment of SMARCA4 mutant cancers
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C025

This presentation describes the identification and characterization of an orally bioavailable SMARCA2 degrader with good potency and selectivity over SMARCA4. SMARCA2 and SMARCA4 regulate chromatin architecture by mobilizing and repositioning nucleosomes on DNA, which is critical for various genomic functions, including transcriptional regulation, DNA recombination and repair, and mitotic chromosome segregation. Loss-of-function mutations or silencing of SMARCA4 are frequently observed in multiple cancer types, where tumorigenesis becomes dependent on the residual SMARCA2 degrader with good potency and selectivity over SMARCA4. In this study, the lead SMARCA2 degrader demonstrated potent antitumor activity, driven by efficient SMARCA2 degradation, in multiple SMARCA4-deficient cell line-derived xenograft (CDX) models at well-tolerated dose levels. Additionally, with the use of Aurigene’s proprietary long-acting injectable (LAI) formulation, AUR110, a candidate with US-FDA clearance for first-in-human studies, has shown potent and comparable anti-tumor activity following once every three week intravenous dosing.

Aurigene will also be showcasing other pipeline programmes in poster presentations at the conference, including:

Title: Discovery and development of a highly differentiated, efficacious, first-in-class anti-SIRPα/β dual antibody with single agent phagocytosis activity
Presenting Author: Subhra Chakrabarty
Presentation Date/Time: Oct 24 12:30-4PM ET
Abstract Number: B077

Title: Discovery and preclinical characterization of novel macrocyclic KIF18A inhibitors for treatment of chromosomally instable tumors
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 23 12:30-4PM ET
Abstract Number: A030

Title: Development of a Differentiated, Best-in-Class oral Cbl-b inhibitor with Robust Immune Activation and Favourable Safety for Cancer Immunotherapy
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C059

(Press release, Aurigene Discovery Technologies, OCT 22, 2025, View Source [SID1234656910])

On October 22, 2025 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, production, and commercialization of novel cell therapies, reported that the Blood published the latest results of its independently developed fully human anti-GPRC5D CAR-T cell therapy, RD118, for the treatment of relapsed/refractory multiple myeloma (R/R MM). The study demonstrates that RD118 exhibited significant efficacy and a manageable safety profile in heavily pretreated R/R MM patients, offering new therapeutic hope for the patients with a poor prognosis.

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 study entitled ‘Fully Human anti-GPRC5D CAR T-Cell Therapy RD118 Induces Durable Remissions in Relapsed/Refractory Multiple Myeloma’ has been published in Blood. Full text available at: View Source This is an open-label, phase 1 dose-escalation and expansion study to evaluate the efficacy and safety of RD118 in the treatment of R/R MM, which was conducted at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (registered as NCT05759793 and NCT05219721).

A total of eighteen patients received RD118 infusion in this study, including 17 with R/R MM and 1 with a history of primary plasma cell leukemia (pPCL) who had relapsed after achieving complete remission. Among the 18 patients, the median age was 59.5 years, and the median line of prior therapies was 5. High-risk features included double-hit cytogenetics (50%), triple-class refractoriness (50%), penta-class refractoriness (22.2%), and prior anti-BCMA CAR-T therapy (38.9%). Following lymphodepletion with fludarabine and cyclophosphamide, patients received a single infusion of RD118 at one of three dose levels (1.0, 2.0, or 3.0×106 cells/kg) during the dose-escalation phase or 2.0×106 cells/kg in the expansion cohort. At a median follow-up of 17.0 months, results show that:

Efficacy: The overall response rate (ORR) was 94.4%, with 72.2% of patients achieving complete response or stringent complete responses (CR/sCR). Among the seven patients who had received prior BCMA-directed CAR T-cell therapy, the ORR was 85.7%, with 5 patients (71.4%) achieving CR/sCR. All three patients with extramedullary disease and the patient with pPCL achieved sCR and remained in remission at last follow-up. The median progression-free survival (PFS) was 18.2 months, with 12-month PFS and overall survival (OS) rates of 82.1% and 93.3%, respectively.

Safety: Cytokine release syndrome (CRS) occurred in 88.9% of patients, primarily grade 1-2. Only one patient developed grade 3 or higher CRS, which rapidly recovered with intensive management. One patient developed grade 3 immune effector cell–associated neurotoxicity (ICANS) which resolved within 72 hours. No cerebellar toxicities or treatment-related deaths were reported

Conclusion ：Fully human anti-GPRC5D CAR-T therapy RD118 demonstrated a 94.4% ORR and a median PFS of 18.2 months with a manageable safety profile in heavily over pretreated R/R MM, including patients who relapsed after prior anti-BCMA CAR-T therapy.

Professor Mi Jianqing from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, commented: "Multiple myeloma remains an incurable malignant plasma cell disorder. While anti-BCMA CAR-T therapy has greatly transformed the treatment for relapsed/refractory patients, challenges such as antigen escape often leads to relapse, highlighting the need for novel targets to overcome these limitations. GPRC5D has attracted significant attention due to its high expression, specificity, and independence from BCMA. The current study results have validated its potential: among patients previously treated with anti-BCMA CAR-T therapy, RD118 achieved an 85.7% overall response rate, with 71.4% of patients reaching complete response, demonstrating that GPRC5D is a highly promising novel therapeutic target."

Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, commented: "The innovative design of RD118 is the foundation of its outstanding clinical performance. RD118 is a novel GPRC5D-directed CAR-T that incorporates a fully human nanobody (VHH) as its antigen-binding domain. This design provides distinct advantages over conventional scFv, it is expected to lower immunogenicity, and potentially enhanced persistence, offering a new approach to overcome the safety limitations of existing comparable therapies. Meanwhile, the construct also includes a 4-1BB and a CD3ζsignal domains, which support expansion and sustained anti-tumor activity. Together, these features position RD118 as a highly competitive next-generation CAR-T product."

Ms. Jinhua Zhang, Founder, Chairwoman and CEO of IASO Bio, remarked: "We are delighted that the remarkable research results of IASO Bio’s independently developed anti-GPRC5D CAR-T product, RD118, for the treatment of R/R MM have been published in the prestigious international journal Blood. This achievement marks another significant milestone for the product following the IND approval from China’s NMPA in June 2024. The treatment landscape for multiple myeloma requires continuous innovation, and GPRC5D, alongside BCMA, are represents a crucial therapeutic target in this field. Developed based on our fully human antibody platform, RD118 is designed to provide a new treatment option for patients. It offers renewed hope particularly for those who have relapsed after prior anti-BCMA CAR-T therapy. This publication will further motivate us to advance the clinical development of RD118, with the goal of delivering this innovative therapy to more patients worldwide."

About RD118

RD118 is an autologous T-cell immunotherapy product targeting G protein-coupled receptor class C group 5 member D (GPRC5D). It can identify and eliminate malignant tumor cells expressing GPRC5D. GPRC5D is highly expressed on multiple myeloma cells. However, in normal tissues, its expression is limited to plasma cells and hair follicle cells. Such a feature has made GPRC5D a promising safe and effective target for the treatment of multiple myeloma.

The antigen recognition domain of RD118 is developed from IASO Bio’s proprietary fully human single-domain antibody library. It has advantages of high affinity, high specificity, and low immunogenicity. The intracellular domain is a fusion of 4-1BB (CD137) and CD3ζ signaling domains. RD118 has been subjected to extensive development and optimization in terms of antibody screening and structure design. The candidate molecule has demonstrated excellent in vitro cytotoxic activity and in vivo tumor suppression ability. Additionally, it has good expansion capability and persistence in vivo, indicating high development potential.

(Press release, IASO Biotherapeutics, OCT 22, 2025, View Source [SID1234656909])

On October 22, 2025 ACM Biolabs, a clinical-stage biotechnology company developing next-generation nanoparticle-based immunotherapies, reported encouraging early clinical findings from its ongoing Phase 1 study of ACM-CpG, a TLR9 agonist formulated with ACM’s proprietary polymersome platform through a strategic collaboration with the National Cancer Centre Singapore (NCCS).

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!

Preclinical experiments show that the ACM nanoparticle formulation fundamentally alters CpG’s mechanism of action, enabling myeloid modulation through comprehensive TLR9 engagement in immunologically "cold" tumors. The ongoing Phase 1 trial (NCT06587295)[i] is enrolling patients with advanced solid tumors at NCCS to assess the safety, tolerability, and pharmacodynamic effects of ACM-CpG.

Early clinical data indicate that these preclinical findings are translating into humans. In patients with advanced solid tumors, intramuscular administration of ACM-CpG – at weekly or biweekly doses as low as 0.25mg CpG – has demonstrated robust systemic immune activation as evidenced through immune biomarker data. The therapy shows a highly favorable safety and tolerability profile and to date, no dose-limiting toxicities have been observed.

"TLR9 has long been recognized as a validated immunologic target, but its therapeutic potential has been limited by delivery and safety limitations," said Dr. Madhavan Nallani, CEO of ACM Biolabs. "Our intramuscular nanoparticle delivery enables systemic immune activation with an excellent safety profile, creating opportunities not only for combination approaches but also for targeted monotherapy in patient populations with few treatment options. Over time, this platform can also support additional routes of administration allowing us to tailor treatment strategies to diverse tumor settings and address significant unmet medical needs."

"The safety profile and clear pharmacodynamic activity we have observed so far are very encouraging, with two out of the three patients enrolled at the 0.25mg dose level having ongoing disease control for eight months with monotherapy alone." said Dr. Amit Jain, Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore. "We look forward to exploring ways to optimize its delivery and maximize its therapeutic potential for patients with advanced cancers."

The collaboration is supported in part by funding from Singapore’s Industry Alignment Fund – Pre-Positioning (IAF-PP), which fosters strategic collaborations between industry and research institutes. This study is evaluating ACM-CpG in patients with advanced head and neck, lung, bladder, and kidney cancers and is designed to establish proof of mechanism to support global clinical development.

(Press release, ACM Biolabs, OCT 22, 2025, View Source [SID1234656908])

On October 22, 2025 SkylineDx reported that results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, have been published in the October 2025 issue of JAMA Surgery, the most cited surgery journal in the world. The study demonstrates that the Merlin CP-GEP Test stratified T1-T3 melanomas with clearly distinct risk levels for sentinel node metastasis: patients with a High-Risk result had a three-fold higher rate of sentinel node metastasis compared to those with a Low-Risk result (23.8% vs. 7.1%) overall.

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 MERLIN_001 trial enrolled 1,761 patients across leading U.S. academic cancer centers including the Mayo Clinic, University of Louisville, University of Michigan, Huntsman Cancer Institute, University of Kentucky, Emory University, Duke University, Memorial Sloan Kettering Cancer Center, and Moffitt Cancer Center.

"This study represents a major step forward in evaluating personalized melanoma care," said Vernon Sondak, MD, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center in Tampa, Florida. "Studying the Merlin CP-GEP Test’s ability to distinguish patients’ risk of sentinel node metastasis with a rigor and precision no other test or nomogram can match. Our results show that the test adds a level of accuracy above current clinical factors alone, even when factors like mitotic rate and histologic subtype are taken into account, and this kind of knowledge ultimately allows patients and surgeons to make better decisions about when sentinel node biopsy should be part of the management of clinically localized melanoma. In appropriately selected patients, this test can add value for shared decision-making."

Key Findings

Across the study population, the Merlin CP-GEP Test stratified melanomas into two distinct risk groups: High-Risk patients had greater than a three-fold likelihood of SLN metastasis (23.8%) compared to Low-Risk patients (7.1%). Overall, 37.0% of patients were Low-Risk while 63.0% were High-Risk. Importantly, the test was successful in 97.7% of submitted samples.
In patients aged 65 and older, where comorbidities can be more prevalent, the test identified 57.9% as High-Risk, with a positive SLNB rate of 20.3%, versus a 6.6% positive SLNB rate for Low-Risk cases.
In head and neck melanomas, where SLNB can be technically difficult and can carry higher morbidity, the Merlin CP-GEP test identified High-Risk cases with a 26.7% SLN rate and Low-Risk cases with a 4.9% SLN (five-fold risk increase in the High-Risk vs. the Low-Risk groups).
Across all ages and primary sites, cases with clinical Stage IB melanoma were classified as Low-Risk 49.3% of the time, with a 6.5% positive SLNB rate, compared with an 18.3% rate for High-Risk cases.
The MERLIN_001 trial results published in JAMA Surgery can be found here: View Source

About the Merlin CP-GEP Test

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assigns them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

(Press release, SkylineDx, OCT 22, 2025, View Source [SID1234656907])

On October 22, 2025 Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering a new class of small molecule precision cancer therapies, reported new preclinical data on its two lead programs: the novel KIF18A inhibitor, ATX-295, and the first-in-class DHX9 inhibitor, ATX-559. The company will share the data, which highlight the potential to target key tumor vulnerabilities for selective cancer cell death, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (the "Triple Meeting"), being held October 22-26, 2025, in Boston, Massachusetts.

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 data presented for our KIF18A and DHX9 programs continue to validate the success of our biomarker-driven strategy against challenging, genetically diverse cancers," said Serena Silver, Ph.D., Chief Scientific Officer of Accent Therapeutics. "By precisely targeting the vulnerabilities created by genomic instability, we are excited about the potential of ATX-295 and ATX-559 to address significant unmet needs for patients."

In the presentation entitled "Addressing Novel Oncology Targets for Tumors with Genomic Instability," (Concurrent Session 9, October 25th at 4:45 PM ET) Dr. Silver will discuss the promise of ATX-295 and ATX-559 as precision cancer therapeutics that exploit the genomic instability of cancer cells to effect cancer-selective growth inhibition in vitro and in vivo. She will highlight the potential for KIF18A inhibition by ATX-295 in cancers with high levels of chromosomal instability (CIN) such as ovarian and triple negative breast cancer, and for DHX9 inhibition by ATX-559 in multiple tumor types with high levels of replication stress including dMMR/MSI-H and BRCA alterations.

Additional Poster Presentations
ATX-295 (KIF18A Inhibitor)

Title: Activity of the Novel KIF18A Inhibitor, ATX-295, is Enriched in Whole Genome Doubled Ovarian and TNBC Preclinical Models
Summary: Inhibition of KIF18A by ATX-295 is a compelling strategy for chromosomally unstable cancers, supported by new data identifying whole genome doubling (WGD) as a strong predictive biomarker for tumors such as ovarian cancer and TNBC. This biomarker-driven approach was validated in preclinical models where ATX-295 induced dose-dependent tumor regression in WGD-positive models.
Session Details: October 24th, Session B, 12:30-4:00 PM ET
ATX-559 (DHX9 Inhibitor)

Title: ATX-559, a First-in-Class, Clinical-Stage DHX9 Inhibitor, as a Targeted Therapeutic for Molecularly Defined Tumors with Genomic Instability and Replicative Stress
Summary: Preclinical data show the first-in-class oral DHX9 inhibitor, ATX-559, increases replicative stress and DNA damage, leading to selective cell death in cancers with genomic instability. This activity led to robust, dose-dependent tumor regression in preclinical models with BRCA alterations and microsatellite instability-high (MSI-H).
Session Details: October 24th, Session B, 12:30-4:00 PM ET
About ATX-295
ATX-295 is a potential best-in-class inhibitor for KIF18A, a mitotic kinesin motor protein essential for cell division in select tumors with chromosomal instability. A subset of tumors with an abnormal number of chromosomes (aneuploid), such as those found in ovarian and triple-negative breast cancer (TNBC), are reliant on KIF18A. Treatment with a KIF18A inhibitor leads to rapid cell death in these chromosomally unstable cancer cells while leaving healthy cells with normal numbers of chromosomes unaffected. Accent retains full worldwide rights to the KIF18A program, including ATX-295, which is being evaluated in a Phase 1/2 clinical trial (NCT06799065).

About ATX-559
ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a DNA/RNA helicase that plays a critical role in tumors with high levels of replication stress. Such tumors include those with BRCA loss of function (breast, ovarian), mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancers (colorectal, endometrial, gastric), and others representing large patient populations with significant unmet medical need. DHX9 is a compelling oncology target as its inhibition exploits key tumor vulnerabilities related to replication, transcription, and the maintenance of genomic stability, resulting in cancer-specific cell death. Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial (NCT06625515), and the DHX9 program.

(Press release, Accent Therapeutics, OCT 22, 2025, View Source [SID1234656906])