On October 21, 2025 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported that its Chief Scientific Officer, Philip Beer, will be presenting data on the identification of a CTPS1-dependent synthetic lethality in solid tumours at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) 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 from 22-26 October in Boston, MA.

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The presentation will focus on the use of the AACR (Free AACR Whitepaper) Project GENIE data, a publicly accessible cancer registry of real-world clinico-genomic data, to identify loss of CTPS2 as a novel biomarker to select solid tumours with a synthetic lethal dependency on CTPS1. Deletion of CTPS2 was subsequently identified as a frequent event in many cancer types, with the highest prevalence found in ovarian cancer. As tumours derived from epithelial tissues can utilise both CTPS1 and CTPS2 in the final step of the CTP synthesis cascade, loss of CTPS2 in solid tumours exposes a dependence which could be targeted with CTPS1 inhibition to prevent tumour cell proliferation.

As a result of these findings, dencatistat, an orally available and highly potent inhibitor of CTPS1, which is currently being evaluated in a phase 1a dose escalation study in patients with solid tumours, will be evaluated in safety expansion cohorts in patients with CTPS2 null cancers, with the first being ovarian cancer (NCT06297525). Selecting patients whose tumours have deleted CTPS2 represents a precision oncology approach that is expected to maximise the therapeutic potential of dencatistat.

Philip Beer, Chief Scientific Officer of Step Pharma, said:

"Our work analysing clinico-genomic data led us to identify patients with CTPS2 null solid tumours as a promising therapeutic application for dencatistat. About 15-20% of ovarian cancers harbour this deletion, and so through inhibition of CTPS1 with dencatistat, we can selectively target the de novo pyrimidine synthesis pathway in ovarian cancer and other solid tumours. I look forward to presenting at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) international conference and to initiating the first expansion cohort in the near future."

Session: AACR (Free AACR Whitepaper) Project GENIE: Powering Drug Discovery Through an International Consortium’

Presentation title: Using GENIE data to drive oncology target identification and drug development.

Date: Thursday 23 October 2025

Time: 17:55 EDT

(Press release, Step Pharma, OCT 21, 2025, View Source [SID1234656872])

On October 21, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported it will host a conference call and webcast on Friday, October 24 at 1:30 p.m. ET (10:30 a.m. PT) to discuss initial results from the ongoing Phase 1 dose-escalation study of XmAb819, an ENPP3 x CD3 T-cell engaging bispecific antibody, in development for patients with advanced clear cell renal cell carcinoma.

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The live webcast of the conference call may be accessed through this link and through "Events & Presentations" in the Investors section of the Company’s website, located at investors.xencor.com. A recording will be available for at least 30 days.

The results will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts, during Poster Session B on Friday, October 24 from 12:30 to 4:00 p.m. ET in a poster titled "Preliminary Phase 1 safety and antitumor activity of XmAb819, a first-in-class ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC)."

About XmAb819

XmAb819 is a first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3, an antigen highly expressed on kidney cancers. ENPP3 is a differentially expressed target, with high level expression in renal cell carcinoma (RCC) and low-level expression on normal tissues. With two tumor-antigen binding domains and one T-cell binding domain, Xencor’s XmAb 2+1 format enables antibodies to bind more avidly and selectively kill tumor cells with higher antigen density, potentially sparing normal cells. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC.

(Press release, Xencor, OCT 21, 2025, View Source [SID1234656874])

On October 21, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that a global licensing and collaboration agreement with Novartis, previously announced on September 2, 2025, has now closed. Closing of the transaction was subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

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Summary of License and Collaboration Agreement

Novartis received an exclusive worldwide license to research, develop, manufacture, and commercialize ARO-SNCA, a preclinical stage program that utilizes Arrowhead’s Targeted RNAi Molecule (TRiMTM) platform for subcutaneous administration and delivery to the CNS designed to target the gene that encodes the alpha-synuclein protein as a potential treatment for patients with Parkinson’s Disease, and other synucleinopathies. Novartis may also select additional collaboration targets outside of Arrowhead’s current pipeline to be developed using the TRiMTM platform.

For all licensed programs under the agreement, Arrowhead will conduct and complete preclinical research activities necessary to enable a clinical trial application (CTA) filing. Novartis will then assume sole control over development, manufacturing, medical affairs, and commercialization activities.

Summary Financial Terms

Arrowhead will receive a $200 million upfront payment from Novartis and is also eligible to receive development, regulatory, and sales milestone payments of up to $2 billion. Arrowhead is further eligible to receive tiered royalties on commercial sales up to the low double digits.

(Press release, Arrowhead Pharmaceuticals, OCT 21, 2025, View Source [SID1234656875])

On October 20, 2025 Sairopa, a clinical-stage biotechnology company developing innovative cancer immunotherapies, reported new clinical data on ADU-1604, its differentiated CTLA-4 blocking antibody, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025 in Berlin, Germany.

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The company presented a scientific poster showcasing significant clinical advances with ADU-1604 in melanoma patients who had previously failed PD-1 inhibitor therapy (n=27). The poster presentation featured the full results from the SRP-21C101 Phase 1 combined dose escalation and dose expansion clinical trial. Clinical efficacy was observed in 4/27 patients indicative of efficacy similar to other CTLA-4 inhibitors. Importantly, ADU-1604 showed a significantly milder safety profile as compared to existing CTLA-4 inhibitors, as evidenced by the reduced severity of immune-related adverse events.

"We are excited to share the clinical results from ADU-1604 in PD1 relapse/refractory melanoma with the international oncology community at ESMO (Free ESMO Whitepaper) Congress," said Laura Lassouw-Polman, Chief Operating Officer at Sairopa. "ADU-1604’s milder safety profile as compared to other CTLA-4 blocking agents will support its future use as combination agent, with PD-1 blocking agents and/or other agents. We are grateful to all patients, their families and investigators that supported our study."

(Press release, Sairopa, OCT 20, 2025, View Source [SID1234656822])

On October 20, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, reported that new clinical data from HCB101, its differentiated, engineered SIRPα-Fc fusion protein, and the preclinical results from HCB301, its next-generation tri-specific checkpoint immunotherapy, will be presented at five major international oncology congresses in the fourth quarter of 2025.

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The upcoming presentations will showcase progress from HCB101, including both the HCB101-101 monotherapy (NCT05892718) and the HCB101-201 combination (NCT06771622) studies, as well as the preclinical data from HCB301, underscoring the company’s innovation in advancing next-generation innate immune checkpoint therapies.

Federation of Asian Clinical Oncology (FACO), October 24-25, 2025
– Two poster presentations on HCB101 monotherapy and HCB101 in combination with standard of care in advanced cancers
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), November 5-9, 2025
– Two late-breaking poster presentations from HCB101-101 and HCB101-201, highlighting safety, pharmacology, and emerging efficacy signals
– One poster presentation from HCB301, revealing the first-time the preclinical data from HanchorBio’s novel tri-specific fusion protein targeting CD47-SIRPα, PD-1, and TGFb pathways
ESMO Asia Congress, December 5-7, 2025
– One abstract updating the results from HCB101-101, demonstrating safety and activity across solid tumors and hematologic malignancies
American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 6-9, 2025
– Poster presentation of the first-in-human Phase 1 study of HCB101 in relapsed/refractory non-Hodgkin lymphoma
ESMO Immuno-Oncology Congress (ESMO-IO), December 10-12, 2025
– One abstract integrating the HCB101 monotherapy and combination data across multiple solid tumor indications
"Presenting across five major oncology meetings in one quarter underscores both the breadth and pace of HCB101’s clinical progress," said Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio. "HCB101 continues to validate our differentiated approach to CD47-SIRPα blockade, while the first preclinical data from HCB301 showcase the innovation of our FBDB platform in advancing next-generation, multi-checkpoint therapies. Together, they highlight HanchorBio’s commitment to delivering transformative treatments for patients with difficult-to-treat cancers and advancing the next generation of immunotherapies."

About HCB101: A Differentiated CD47-SIRPα Blockade
HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s proprietary FBDB platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.

Key Differentiators of HCB101:

Enhanced safety: Demonstrates a cytopenia-sparing profile, with no dose-limiting toxicities observed up to 24 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window.
Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer.
Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC and second-line HNSCC, substantially exceeding historical benchmarks.
About HCB301: a Tri-Specific Checkpoint Immunotherapy
HCB301 is HanchorBio’s next-generation immunotherapy designed to integrate three synergistic mechanisms into a single molecule: CD47-SIRPα blockade to activate macrophage-mediated phagocytosis, PD-1 inhibition to restore exhausted T cells, and TGF-b pathway suppression to improve tumor micro-environment. Developed using the proprietary FBDB platform, HCB301 represents a next-generation approach to multi-checkpoint immunotherapy. Preclinical studies demonstrated enhanced immune activation and potent antitumor activities, and the first results will be presented at SITC (Free SITC Whitepaper) 2025.

(Press release, Hanchor Bio, OCT 20, 2025, View Source [SID1234656838])