On November 4, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and a phase II protocol evaluating ILKN421H in combination with pembrolizumab for first line and post-IO treatment of patients with advanced NSCLC.

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ILKN421H is a novel LNP-formulated mRNA therapy encoding a non-alpha HSA–IL-2v fusion protein for the treatment of cancer. Administered intravenously every three weeks, ILKN421H achieves efficient and preferential mRNA expression in lymphoid organs with an extended half-life of IL-2v approximately 20 hours. Its non-alpha IL-2v design selectively expands stem-like CD8 T and NK cells, while the mRNA platform overcomes cytokine-sink limitations seen with protein-based IL-2 therapies—offering the potential for greater efficacy with reduced systemic toxicity.

In a first-in-human, open-label Phase I study (NCT05978102), ILKN421H demonstrated antitumor activity and a favorable safety profile, with no cases of vascular-leak syndrome or hypotension. In this trial evaluating ILKN421H as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, ILKN421H was well tolerated, with no dose-limiting toxicities and no maximum tolerated dose reached among the 45 enrolled patients. Combination therapy with pembrolizumab, in first-line NSCLC, achieved a confirmed objective response rate (ORR) of 80% (n=16/20) regardless of PD-L1 expression, with median progression-free survival (PFS) not yet reached and projected to exceed 12 months. The summary of this Phase I study was selected as an oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting, and the results will be presented on November 8, 2025.

"Next-generation IL-2 agents have been a major focus of the immuno-oncology field for the past decade," said Haining Huang, Chief Executive Officer of iLeukon Therapeutics. "ILKN421H expands cytotoxic lymphocytes—CD8 T cells and NK cells—by up to five- and twenty-five-folds respectively, the first IL-2 based treatment that achieved this level of immune promotion safely. We believe ILKN421H can enhance the efficacy of checkpoint inhibitors, such as pembrolizumab, and may also support future modalities including TIL and in vivo CAR-T therapies. With FDA clearance to proceed to phase II, we look forward to advancing ILKN421H globally to meet the significant unmet needs and to improve the outcomes for patients with NSCLC and potentially other types of cancers in the future."

(Press release, iLeukon Therapeutics, NOV 4, 2025, View Source [SID1234659397])

On November 4, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates, reported it will be presenting at the following upcoming scientific conferences:

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21st Annual Industry/Academia Precision Oncology & Radmed Symposium
November 5th, 2025 – La Jolla, California

Title: DR5 Agonist Clinical Data in Chondrosarcoma, Colorectal Cancer and Ewings Sarcoma
Format: Presentation
Presenters: Josep Garcia, PhD, Executive Vice President, Chief Clinical Development Officer, Inhibrx; Katelyn Willis, PhD, Director, Biotherapeutics, Inhibrx
Date: Wednesday, November 5th, 2025
Time: 4:45 PM Eastern Standard Time
Location: The Alexandria at Torrey Pines, La Jolla, California

Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting
November 12th – 15th, 2025 – Boca Raton, Florida

Title: The Tetravalent Death Receptor 5 (DR5) Agonist ozekibart (INBRX-109) in Conventional Chondrosarcoma: Results from the Randomized, Registrational, Phase 2 ChonDRAgon Study
Lead Author: Robin L. Jones, MD – Medical Oncology, The Royal Marsden and Institute of Cancer Research
Format: Presentation
Date: Friday, November 14th, 2025
Time: 8:30 AM – 10:00 AM Eastern Standard Time
Location: The Boca Raton, Boca Raton, Florida

Society for NeuroOncology (SNO) 2025 Annual Meeting
November 19th – 23rd, 2025 – Honolulu, Hawaii

Title: The Tetravalent Death Receptor 5 (DR5) agonist ozekibart (INBRX-109) exhibits anti-tumor activity in GBM models as a monotherapy and in combination with TMZ
Format: Poster Presentation
Date: Saturday, November 22nd, 2025
Time: 4:45 pm – 6:00 PM Eastern Standard Time
Location: Hawaii Convention Center, Honolulu, Hawaii; Kamehameha Exhibit Hall II & III

The presentation and poster will be accessible through a link on the investors’ section of Inhibrx’s website at View Source upon commencement of each event.

(Press release, Inhibrx, NOV 4, 2025, View Source [SID1234659396])

On November 4, 2025 Grit Biotherapeutics Co., Ltd. ("Grit Bio"), a leading clinical-stage biopharmaceutical company pioneering next-generation immunotherapies, reported that its groundbreaking GT801 in vivo CAR-T program has been selected for an oral presentation at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 6–9, 2025, in Orlando, Florida, USA.

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The abstract, titled "Precision In Vivo CAR-T Generation via CLAMP-Enabled mRNA Delivery: Toward Scalable and Translatable Cell Therapy," was accepted in the CAR-T Cell Therapies: Basic and Translational session. The presentation will be delivered by Professor Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, on Saturday, December 6, 9:30–9:45 AM (local time) at the OCCC – Sunburst Room (W340).

GT801 is an innovative anti-CD19 in vivo CAR-T candidate developed using T-cell-targeted lipid nanoparticles (T-LNPs) encapsulating optimized mRNA. Grit Bio leveraged the proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology to achieve site-specific antibody conjugation and precise ligand density control. This approach allows selective T-cell targeting, minimal off-target uptake, and robust, durable CAR expression following systemic administration.

In preclinical studies, GT801 demonstrated:

>95% B-cell clearance in humanized PBMC mouse models at doses as low as 0.01 mg/kg;

>80% CAR expression across tissue-resident T cells with <1% off-target delivery to myeloid and hepatic cells;

>30-fold in vivo expansion of CAR-T cells with minimal cytokine release (IL-6, TNF-α), supporting the safety and feasibility of repeat dosing.
Preliminary clinical data further validate efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability, highlighting GT801’s strong potential as a scalable, off-the-shelf immunotherapy candidate.

"The invitation to present at ASH (Free ASH Whitepaper) 2025 highlights international recognition of Grit Bio’s leadership in advancing in vivo CAR-T innovation," said Dr. Yarong Liu, Chairman and CEO of Grit Biotherapeutics. "Our GT801 platform represents a paradigm shift in cell therapy—transforming complex ex vivo manufacturing into a simple, repeatable, and scalable in vivo process. We are eager to share our latest clinical data and explore global partnerships that accelerate the translation of this breakthrough technology to patients worldwide."

(Press release, Grit Bio, NOV 4, 2025, View Source [SID1234659395])

On November 4, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the first presentation of patient-reported outcomes data from the Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1 inhibitor, as well as encore pivotal efficacy and safety data from the ARROS-1 trial, during two poster presentations at the 2025 IASLC ASCO (Free ASCO Whitepaper) North America Conference on Lung Cancer being held December 5-7, 2025 in Chicago.

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Details of the poster presentations are as follows:

Title: Patient-Reported Outcomes and Health-Related Quality of Life of TKI Pre-Treated and TKI-naïve Patients with Advanced ROS1-Positive NSCLC Treated with Zidesamtinib: Examination of ARROS-1 Phase 2 Trial Data
Abstract Number: PP01.41
Presenting Author: Melissa Laurie, Pharm.D., M.S., M.B.A.1
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

Title: Zidesamtinib in Patients With Advanced Metastatic ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Tyrosine Kinase Inhibitors (TKI): Pivotal Efficacy and Safety Data From the Phase 1/2 ARROS-1 Trial
Abstract Number: PP01.32
Presenting Author: Stephen V. Liu, M.D.2
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

1 Nuvalent, Inc., Cambridge, MA, USA; 2Georgetown University, Washington, DC, USA

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC. Nuvalent completed its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC in the third quarter of 2025 and continues to engage with the U.S. Food and Drug Administration (FDA) on potential opportunities for line-agnostic expansion.

(Press release, Nuvalent, NOV 4, 2025, View Source [SID1234659394])

On November 4, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that Compugen management will participate in a fireside chat at the upcoming Stifel 2025 Healthcare Conference in New York City. The fireside chat will take place on Tuesday November 11, 2025, at 3:20-3:50 PM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, NOV 4, 2025, View Source [SID1234659393])