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 20, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.

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"We are pleased the agency has accepted the resubmission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit."

During the past few months, Replimune has been working to address agency feedback. Additional information, data and analyses were included in the resubmission which will be part of the BLA review. The FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, OCT 20, 2025, View Source [SID1234656821])

On October 20, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported the latest results from the ongoing Phase I/II CLINCH study of ATG-022 (CLDN18.2 ADC), were presented in a Poster Presentation at ESMO (Free ESMO Whitepaper) 2025.

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Details of the Poster Presentation:
Title: Phase I/II study of CLDN18.2 ADC ATG-022 in patients with advanced gastric/gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P

ATG-022 and CLINCH Study Overview

ATG-022 is a CLDN18.2-targeted ADC with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high/low/ultra-low CLDN18.2 expression.
The ongoing Phase I/II CLINCH study consists of dose escalation and dose expansion phases. In dose escalation, patients with advanced solid tumors regardless of CLDN18.2 expression receive ATG-022 (0.3-3.0 mg/kg Q3W) to evaluate safety, tolerability, and pharmacokinetics; CLDN18.2-positive (≥IHC 1+, 1%) patients are treated at 1.8 or 2.4 mg/kg in dose expansion to evaluate the efficacy and safety.
Key Results Presented

Efficacy:
Among GC/GEJC patients with moderate/high CLDN18.2 expression (IHC 2+ >20%), the 2.4 mg/kg dose cohort observed 1 CR, 11 PRs and 15 SDs, resulting in 40% ORR (12/30) and 90% DCR (27/30). The median PFS was 6.97 months and the 12-month OS rate was 66.2%. In the 1.8 mg/kg dose cohort, there were 1 CR, 9 PRs, and 11 SDs, giving a 40% ORR (10/25) and 84% DCR (21/25).
Among GC/GEJC patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤20%), patients treated at the efficacious dose of 1.8-2.4 mg/kg achieved 1 CR and 5 PRs, resulting in 33.3% ORR (6/18) and 50%DCR (9/18). The CR patient has demonstrated durable response and has been on the study for 22+ months.
Safety:
At 2.4 mg/kg in the dose expansion, 45.8% of patients had ≥1 TEAEs, 60.4% of patients had grade ≥3 TEAEs.
In the dose-expansion phase, the 1.8 mg/kg cohort demonstrated excellent safety and tolerability, with only 13.6% of patients reporting serious TEAEs and 18.2% reporting Grade ≥3 TEAEs. The favorable safety profile of this dose level support its potential use in first-line combination regimens with chemotherapy and immune checkpoint inhibitors.
Conclusions and Outlook

ATG-022 demonstrated a manageable safety profile and encouraging antitumor effects in GC/GEJC adenocarcinoma patients with a broad range of CLDN18.2 expressions, thus supporting further clinical investigation in patients with variable CLDN18.2 expressions.
Preliminary efficacy has also been observed in other non-GI tumor types which will be reported at upcoming conferences.
The 2.4 mg/kg cohort showed a favorable safety profile, while the 1.8 mg/kg cohort demonstrated even better safety and tolerability. These findings provide strong support for advancing ATG-022 in combination with immune checkpoint inhibitors and chemotherapy in first-line treatment settings, paving the way to significantly expand its clinical reach and commercial potential.

(Press release, Antengene, OCT 20, 2025, View Source [SID1234656837])

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])