On November 4, 2025 Flatiron Health reported its presence at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition happening from December 6-9, 2025, in Orlando, Florida. Flatiron’s real-world data and research capabilities are featured across multiple presentations, including 12 research acceptances spanning hematologic malignancies—from CAR T cell therapy delivery and outcomes to measurable residual disease (MRD) testing patterns and treatment equity across blood cancers.

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Flatiron’s presence at ASH (Free ASH Whitepaper) 2025 closely follows their announcement of six new hematology Panoramic datasets, including five B-cell lymphomas and multiple myeloma, which draw from over 505,000 relevant longitudinal patient records in Flatiron’s network. The datasets represent a six-fold increase in cohort sizes when compared to the company’s previously available datasets and lay the evidence foundation that will guide better treatment decisions, accelerate new development, and ultimately improve outcomes for patients with blood cancers.

"The rapid advancements in the treatment of hematologic malignancies have required an incredibly thoughtful approach to research, one that captures the clinical nuance of disease subtypes, rare patient cohorts, novel endpoints, and evolving biomarkers at scale," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Our presence at ASH (Free ASH Whitepaper) unlocks answers to questions that are shaping hematology care right now and our six newly launched hematology Panoramic datasets represent a clinical breakthrough, enabling researchers to study the real-world complexity of blood cancer care—from MRD testing patterns to CAR T therapy utilization—with a level of depth and rigor that was previously impossible."

Research highlights include:

Research examining real-world CAR T cell therapy delivery patterns across US oncology practices, including analysis of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and healthcare burden—addressing critical gaps in understanding how this transformative therapy is implemented across care settings.
Multiple studies evaluating measurable residual disease testing patterns and their association with clinical outcomes in Philadelphia-negative B-cell acute lymphoblastic leukemia and multiple myeloma, providing insights into the real-world impact of this precision monitoring approach.
EHR-derived datasets from Germany and the United Kingdom providing comprehensive analysis of diffuse large B-cell lymphoma and multiple myeloma management, demonstrating Flatiron’s ability to generate high-quality, multinational real-world evidence.
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Abstracts and Poster Presentations

Use and Outcomes Following Blinatumomab Rechallenge in Adolescents and Young Adults (AYA) and Adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Michaela Liedtke, Nikesh N. Shah, Jessica T. Leonard, Anthony Proli, Yazan K. Barqawi, Hui-Han Chen, Alan Yong, Vikram Shetty, Elias Jabbour, Mark B. Geyer
Author Affiliations: Stanford Cancer Institute, Tampa General Hospital Cancer Institute, Knight Cancer Institute, AstraZeneca, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Flatiron Health
Session Name: 612. Acute Lymphoblastic Leukemias: Clinical and Epidemiological: Poster I
Publication Number: 1555
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

What Remains Matters: Real-World Impact of Measurable Residual Disease Testing in Multiple Myeloma
Ahmed Sawas, Farhad Khan, Jingru Wang, Evan Vietorisz, Yulia Kuznetsova, Amy Pierre, Siobhan Halloran
Session Name: 907. Outcomes Research: Plasma Cell Disorders: Poster I
Publication Number: 2789
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Biallelic TP53 Alterations Predict Poorer Survival in Mantle Cell Lymphoma: Insights from a National Real-World Cohort
Patrick Bliven, Xiaoyan Wang, Morgan Lael, Anosheh Afghahi, Mayur Narkhede
University of Alabama Birmingham, Flatiron Health
Session Name: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Publication Number: 1830
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Mediators of Racial and Ethnic Inequities in Access to Front-Line Therapies for Chronic Lymphocytic Leukemia in the United States: A Real-World Evidence Study
Joanna M. Rhodes, Adam S. Kittai, Paul J. Hampel, Xiaoliang Wang, Qianhong Fu, Danni Zhao, Smriti Karwa, Olive Mbah, Ahmed Sawas, Benji Wagner, Rachel Myers, Derrick van Beuge, Gregory A. Maglinte, Erlene K. Seymour, Jacqueline C. Barrientos
Author Affiliations: Rutgers Cancer Institute, Icahn School of Medicine at Mount Sinai, Mayo Clinic, BeOne Medicines, Mount Sinai Comprehensive Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I
Publication Number: 2720
Poster Session Date/Time: December 6, 2025, 5:30 PM – 7:30 PM

Real-World Insights into Diffuse Large B-Cell Lymphoma from EHR-Derived Data in Germany and the United Kingdom
Christoph Buhl, Ahmed Sawas, Arun Sujenthiran, Mohamed S Ali, Blythe Adamson
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4487
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Measurable Residual Disease (MRD) Testing Patterns and Associated Outcomes in Patients with Philadelphia-Negative B-Cell Acute Lymphoblastic Leukemia
Anthony Proli, Jason Sharpe, Jingru Wang, Jenna Collins, Ahmed Sawas
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4484
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Treatment Patterns and Survival Outcomes in Second and Third Line Settings in Large B-Cell Lymphoma (LBCL)
Joseph P. McGuirk, Miguel-Angel Perales, Mark R. Fesen, Jeremy Snider, Matt Bye, Anthony J. Proli, Blythe Adamson, Samuel Hong, Babatunde Adedokun, Hil Hsu
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4503
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Real-World Treatment Patterns and Clinical Outcomes in High-Risk Mantle Cell Lymphoma: A Retrospective Analysis
Preetesh Jain, Anna Teschemaker, Essam Ibrahim, Taavy Miller, Danni Zhao, Ayush Kris, Ahmed Sawas, Debbie Adkins, Anouchka Chelles, Victoria Otero, Tycel Phillips
Author Affiliations: The University of Texas MD Anderson Cancer Center, AstraZeneca, City of Hope Comprehensive Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II
Publication Number: 4482
Poster Session Date/Time: December 7, 2025, 6:00 PM – 8:00 PM

Beyond the Trial: Real-World CRS, ICANS, and Healthcare Burden of CAR T-Cell Therapy Across US Oncology Practices
Taiga Nishihori, Li Chen, Benjamin Wagner, Niquelle Wadé, Selina Radlein, Spencer Langerman, Trong Le, Ahmed Sawas, Christina Fullerton
Author Affiliations: Moffitt Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III
Publication Number: 6263
Poster Session Date/Time: December 8, 2025, 6:00 PM – 8:00 PM

Barriers and Bridges: Real-World CAR T Delivery Across US Oncology Practices
Taiga Nishihori, Maneet Kaur, Spencer Langerman, Christina Fullerton, Ahmed Sawas
Author Affiliations: Moffitt Cancer Center, Flatiron Health
Session Name: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III
Publication Number: 6262
Poster Session Date/Time: December 8, 2025, 6:00 PM – 8:00 PM

Real-World Insights into Multiple Myeloma Management: An Analysis of EHR-Derived Data in the UK and Germany
Christoph Buhl, Harlan Pittell, Arun Sujenthiran, Ahmed Sawas, Golnessa Mojtahedi, Blythe Adamson
Online only

The Bispecific Blind Spot: Uncovering Real-World Inequities in Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Multiple Myeloma Therapy Access
Gene G. Ho, Olive M. Mbah, Cleo A. Ryals, Amy E. Pierre
Online only

(Press release, Flatiron Health, NOV 4, 2025, View Source [SID1234659401])

On November 4, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported the publication online of Part 1 results from its Phase 1 first-in-human study of tolododekin alfa in Nature Communications in the September 29, 2025, issue. Ankyra recently completed dose escalation of a phase 1 first-in-human study of monotherapy tolododekin alfa, the first anchored IL-12 designed for local tumor retention. The study was conducted at several centers in the United States and Canada in patients with progressive solid tumors. Data from Part 1 of the study focused on patients with superficially accessible tumors. "Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of cancers", said Howard L. Kaufman, MD. "This data opens the door for realizing the therapeutic potential of interleukin-12 for patients with cancer."

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"The emerging data supports the proposed mechanism action for tolododekin alfa", stated Joe Elassal, MD, chief medical officer at Ankyra Therapeutics, "and provides initial proof of concept for the anchored drug conjugate platform". The company has an emerging pipeline and will be presenting initial data with their ANK-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 7, 2025.

Ankyra Therapeutics Announces Multiple Scientific Presentations at SITC (Free SITC Whitepaper) Meeting

Highlights include:

NKT Cells as Predictive Biomarkers of Response to IL-12 Conjugate Immunotherapy Abstract# 189 (oral presentation)
Exploratory analysis of phase 1 solid tumor patients treated demonstrates baseline levels of circulating natural killer T (NKT) cells may serve as predictive biomarkers of response to anchored IL-12 treatment.
First-in-Class ANK-201 Data Abstract # 999
Preclinical results from Ankyra’s next-generation candidate, ANK-201, will be presented for the first time, highlighting the expansion of the company’s pipeline beyond cytokines.
Combination anchored IL-12 and HDAC inhibitor therapy improves therapeutic responses Abstract #631
Results from an ongoing collaboration with the National Cancer Institute Center for Immuno-Oncology will report on anchored murine IL-12 in combination with a histone deacetylase (HDAC) inhibitor in checkpoint-refractory tumor models.
Pharmacologic evaluation of a canine anchored IL-12 (JEN-101) in dogs with melanoma Abstract #1195
In collaboration with Timothy M. Fan, DVM, PhD from the Department of Veterinary Clinical Medicine and Cancer Center at Illinois, University of Illinois at Urbana-Champaign and Jenga Biosciences, new data will be presented from a clinical trial of weight-based versus volume-based dosing of JEN-101, a canine anchored IL-12 conjugate, in dogs with melanoma.
"We are pleased with the data to be presented at the SITC (Free SITC Whitepaper) meeting showing the therapeutic potential of anchored immunotherapy", stated Howard Kaufman, MD.

About Tolododekin alfa (ANK-101)
Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 4, 2025, View Source [SID1234659400])

On November 4, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended September 30, 2025.

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Revenue grew 84.7% year-over-year to $334.2 million in the third quarter of 2025
Gross profit reached $209.9 million in the third quarter of 2025, an improvement of 98.4% year-over-year
217,000 clinical tests delivered in the quarter, representing 33% year-over-year volume growth, with Oncology volume growth accelerating to 27% and Hereditary at 37%
Insights bookings of $150 million across multiple new contracts with year-over-year revenue growth of 37.6% in the quarter
Increasing full year 2025 revenue guidance to $1.265 billion, representing approximately 80% growth year-over-year
Ended the quarter with $764.3 million of cash and marketable securities
"Not only are we growing at an incredible rate, reaching positive adjusted EBITDA marks an important milestone and reflects the strength of our underlying business," said Eric Lefkofsky, Founder and CEO of Tempus. "One of the hardest things to do, and a sign of business model endurance, is being able to slow down the rate of reinvesting back into the business and still maintain growth, which is exactly what we achieved this quarter."

Third Quarter Summary Results

Quarterly revenue increased 84.7% year-over-year to $334.2 million in the third quarter of 2025.
Revenue from Genomics totaled $252.9 million in the third quarter of 2025, growing 117.2% compared to the third quarter of 2024.
Oncology testing (Tempus genomics) contributed $139.5 million, up 31.7% year-over-year in the third quarter of 2025, with approximately 27% volume growth.
Hereditary testing (Ambry genetics) contributed $102.6 million of revenue in the third quarter of 2025, an increase of 32.8% on a pro forma1 basis after giving effect to the Ambry acquisition, with approximately 37% volume growth.
Revenue from Data and services totaled $81.3 million in the third quarter of 2025, delivering 26.1% growth versus the third quarter of 2024, led by Insights (data licensing), which grew 37.6% year-over-year.
Recorded $209.9 million in quarterly gross profit, representing a 98.4% improvement year-over-year.
Reported a net loss of ($80.0 million) in the third quarter of 2025, including $35.0 million in stock compensation expense and related employer payroll taxes, increased amortization expense of intangibles related to the Ambry acquisition, and a one time $12.0 million expense related to the loss on debt extinguishment, compared to a net loss of ($75.8 million) in the third quarter of 2024.
Adjusted EBITDA of $1.5 million in the third quarter of 2025 compared to ($21.8 million) in the third quarter of 2024, an improvement of $23.3 million year-over-year.
1

The pro forma amounts have been calculated after applying the Company’s accounting policies

Third Quarter and Recent Operational Highlights

Acquired Paige, an AI company specializing in digital pathology, to expand our dataset and technical team, and establish a leading footprint in digital pathology.
Selected by Advanced Research Projects Agency for Health (ARPA-H) to provide testing and CRO services in support of the agency’s ADAPT (Advanced Analysis for Precision Cancer Therapy) program.
Obtained 510(k) clearance from the U.S. FDA for xR IVD (RNA NGS in vitro diagnostic device), which will support life sciences’ drug development programs.
Received U.S. FDA 510(k) clearance for updated Tempus Pixel, an AI-powered cardiac imaging platform and for Tempus’ ECG-Low ejection fraction software, which leverages AI to identify patients who may have a low left ventricular ejection fraction.
Expanded collaboration with Northwestern Medicine to integrate David, Tempus’ generative-AI clinical co-pilot within the EHR platform to transform clinical workflows.
Expanded Tempus Next into breast cancer, providing real-time insights to close guideline-based care gaps.
Third Quarter Financial Results

Three Months Ended September 30,

2025

2024

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

334,206

$

180,929

84.7

%

Gross profit

$

209,942

$

105,839

98.4

%

Loss from operations

$

(60,996

)

$

(53,616

)

13.8

%

Net loss

$

(79,982

)

$

(75,840

)

5.5

%

Adjusted EBITDA

$

1,476

$

(21,843

)

106.8

%

Net loss per share attributable to common shareholders, basic and diluted

$

(0.46

)

$

(0.46

)

—

Non-GAAP net loss per share

$

(0.11

)

$

(0.24

)

54.2

%

Financial Outlook and Guidance

Tempus increased full year 2025 revenue guidance to approximately $1.265 billion, which represents ~80% annual growth. Given the acquisition of Paige, which we expect will increase losses by approximately $5 million per quarter, we expect Q4 Adjusted EBITDA to be ~$20 million, resulting in slightly positive Adjusted EBITDA for the full year.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, November 4, 2025 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 5436492
Domestic Dial-in Number: (800) 715-9871
International Dial-in Number: (646) 307-1963
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, NOV 4, 2025, View Source [SID1234659399])

On November 4, 2025 Radiant Biotherapeutics, a biotechnology company committed to advancing a breakthrough antibody approach, the Multabody, for a broad range of therapeutic areas, including cancer and infectious diseases, reported new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting demonstrating its lead oncology candidate, RBT-101, exhibited robust, durable and complete tumor regression while avoiding liver toxicity, in a MC38 colorectal mouse tumor model.

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Radiant’s proprietary Multabody technology uniquely harnesses natural mechanisms to effectively engage multiple disease targets with unmatched strength, precise tunability, and exceptional breadth. 4-1BB is a clinically validated immune checkpoint target that elicits potent anti-tumor immunity and enhanced T cell responses but has eluded safe and effective therapeutic targeting by traditional 4-1BB agonists due to systemic and Fc-mediated liver toxicity. Radiant has leveraged its Multabody platform to develop RBT-101, a multivalent 4-1BB agonist that does not rely on traditional antibody methods to enhance potency, binding strength or durability.

Key Highlights from SITC (Free SITC Whitepaper) 2025 Poster Presentation:

RBT-101 achieved sustained complete tumor regression in MC38 colorectal mouse tumor model
RBT-101 demonstrated long-lived anti-tumor immunological memory; no detectable tumor growth was observed in mice that were re-challenged with MC38 tumor cells after previous successful treatment
RBT-101 demonstrated no signs of liver toxicity, in contrast to benchmark 4-1BB agonist urelumab
"Our data to be presented at SITC (Free SITC Whitepaper) demonstrates that RBT-101 achieves what first-generation 4-1BB agonists could not – delivering robust anti-tumor activity without liver toxicity," said Jo Hulme, Ph.D., CSO of Radiant. "This validates our Multabody platform’s potential to address a broad range of therapeutic targets while avoiding the inherent limitations of conventional antibody-based approaches, as RBT-101 drove potent, tunable and safe agonism of 4-1BB that more closely mimicked natural ligand biology. We look forward to the continued development of Multabodies as promising therapeutics in oncology and other disease areas."

The poster, titled "Multabodies: A next-generation approach for cancer immunotherapy and 4-1BB agonist therapy," will be presented onsite on Friday, November 7, 2025, and will also be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning November 7 at 9 a.m. ET.

(Press release, Radiant Biotherapeutics, NOV 4, 2025, View Source [SID1234659398])

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])