On November 11, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported new clinical results from the ongoing first-in-human Phase I trial (NCT05978102) of ILKN421H, presented during a Late-Breaking Clinical Oral Session at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD.

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The study evaluates ILKN421H, a lipid-nanoparticle (LNP)-formulated mRNA encoding a non-α HSA–IL-2 variant (IL-2v), as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including first-line non-small cell lung cancer (NSCLC). The presentation highlighted ILKN421H’s unique scientific design and distinct pharmacologic advantages that enable potent immune activation with a favorable safety profile.

Key Advantages of ILKN421H in Preclinical Research:

Stem-like CD8+ T Cell Amplification: ILKN421H selectively expands PD1- stem-like CD8⁺ T cells, a subset capable of self-renewal and durable antitumor immunity.
Lymphoid Specific Expression and Reduced Systemic Exposure: ILKN421H mRNA is predominantly expressed in lymphoid organs, such as the spleen and lymph nodes, with <5% expressed in liver and other organs. This targeted biodistribution reduces the systemic exposure of IL–2v while enhancing its immune activity.
Overcoming the Cytokine-Sink Effect and a Remarkable Amplification of CD8+ T and NK cells: Unlike protein-based IL-2 therapies that are rapidly internalized by the targeting cells which terminates the IL-2 signaling towards T cell proliferation, ILKN421H’s sustained mRNA–mediated production bypasses the cytokine-sink effect. This enables robust CD8+ T/NK cell proliferation with 1/100 of systemic IL-2v exposure compared with other protein based counterparts like PEG-IL-2v.
Favorable Safety and Tolerability
Across 45 patients with advanced solid tumors, ILKN421H was well tolerated with no dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) was not reached. There were no Grade 4 adverse events (AEs), no treatment-related deaths, and no serious adverse events (SAEs) occurring in more than one patient. The Grade 3 AEs observed in more than one patient included anemia, decreased neutrophil count, decreased platelet count, fever, and hypokalemia. The safety profile of ILKN421H in combination with pembrolizumab is generally similar to that of pembrolizumab alone. No vascular leak syndrome (VLS) or hypotension were observed. These findings highlight ILKN421H’s favorable safety and tolerability relative to earlier-generation IL-2 therapeutics.

Reliable and Robust PK/PD
Pharmacokinetic data from the Phase I study demonstrated prolonged IL-2v expression with a half-life of approximately 20 hours. Pharmacodynamic study showed marked increase of peripheral CD8⁺ T cells and NK cells, up to 10-fold and 25-fold respectively. No ADA was detected, and no sign of reduced IL-2v expression or pharmacological effect was observed after repeated administration up to 30 cycles (Q3W per cycle).

Clinical Efficacy
In patients with first-line (1L) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression levels (n=20), ILKN421H in combination with pembrolizumab demonstrated promising efficacy, with a confirmed objective response rate (ORR) of 80% (16/20 patients). When analyzed by PD-L1 status, ORR was 87% in PD-L1–positive patients and 60% in PD-L1–negative patients. Median progression-free survival (PFS) has not yet been reached and is projected to exceed 12 months. In the post–immunotherapy (post-IO) NSCLC cohort (n=3), ILKN421H combined with pembrolizumab achieved an ORR of 33.3% (1/3 patients), including one partial response (PR) and one patient with durable stable disease (SD) lasting more than 14 months. Together, these results highlight the clinical promise of ILKN421H in both first-line and post-IO NSCLC, supporting its continued development across treatment settings.

Advancement to Phase II Development
Based on these favorable Phase I results, the FDA has cleared iLeukon’s IND application and Phase II protocol to evaluate ILKN421H in combination with pembrolizumab for both 1L and post-IO treatment of NSCLC. "These Phase I results validate the novel design of ILKN421H and demonstrate its potential to deliver meaningful clinical benefit for patients with cancer," said Haining Huang, Ph.D., Chief Executive Officer of iLeukon Therapeutics. "ILKN421H defines the next evolution of IL-2 therapy by combining mRNA technology with selective immune activation to deliver durable efficacy and a favorable safety profile. We look forward to advancing this program into Phase II evaluation."

(Press release, iLeukon Therapeutics, NOV 11, 2025, View Source [SID1234659765])

On November 10, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it and its wholly owned subsidiary Genmab Finance LLC ("Genmab Finance") intend to offer, subject to market and other conditions, $1.5 billion of senior secured notes due 2032 (the "Secured Notes") and $1.0 billion of senior unsecured notes due 2033 (the "Unsecured Notes," and together with the Secured Notes, the "Notes").

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Genmab also launched the syndication of a new $2.0 billion senior secured term loan "B" facility, which term loan "B" facility is in addition to a $1.0 billion senior secured term loan "A" facility and $500 million senior secured revolving credit facility (collectively, the "New Credit Facilities") that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the "Acquisition") of Merus N.V. ("Merus").

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated securities accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, Genmab, NOV 10, 2025, View Source [SID1234659714])

On November 10, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported that company management will participate at multiple upcoming investor conferences:

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TD Cowen Immunology and Inflammation Virtual Summit
Date: Wednesday, November 12, 2025
Presentation Time: 3:00 p.m. ET / 12:00 p.m. PT
Piper Sandler 37th Annual Healthcare Conference
Date: Tuesday, December 2, 2025
Presentation Time: 2:00 p.m. ET / 11:00 a.m. PT

Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations.

(Press release, Xencor, NOV 10, 2025, View Source [SID1234659730])

On November 10, 2025 Iambic, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported raising over $100 million in an oversubscribed financing round with balanced support from new and existing investors, including Abingworth, Alexandria Venture Investments, Alumni Ventures, ARK, Ascenta, Catalio, Everbright Biofund, Freeflow Ventures, Illumina Ventures, Mubadala, Pegasus Tech Ventures, Qatar Investment Authority, Regeneron Ventures, Sequoia, Tao Capital Partners, Terra Magnum Capital Partners, Wilson Sonsini Goodrich & Rosati, and others.

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"We are thrilled to have the support of many outstanding and committed investors who are partnering with Iambic to advance our mission of creating technologies to bring better medicines to patients," said Tom Miller, PhD, Iambic Co-Founder and CEO. "We are proud of the scientific and business progress Iambic has made across its pipeline, partnerships, and platform over this past year and view this fundraise as a testament to the exceptional work of the Iambic team. We look forward to continuing Iambic’s progress and anticipate our KIF18A and CDK2/4 programs entering the clinic as well as additional discovery and technology enablement collaborations in the near term."

The announcement of this financing closely follows Iambic’s presentation of clinical data for IAM1363 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, where IAM1363 demonstrated anti-tumor activity and a favorable safety profile across HER2-wild-type and HER2-mutated cancers, as well as in multiple disease indications. Subsequently, Iambic announced a research collaboration with Jazz Pharmaceuticals to evaluate combination therapy with zanidatamab with IAM1363 in patients with HER2-positive breast cancer previously treated with Enhertu.

Earlier this year, Iambic announced a novel technology-enablement collaboration with Revolution Medicines which is providing access to proprietary data and Iambic is providing access to its NeuralPLexer technology for protein-ligand structure prediction. Iambic also reported industry-leading benchmarks for Enchant, its multimodal transformer model that makes high-confidence predictions of clinical and preclinical endpoints.

(Press release, Iambic Therapeutics, NOV 10, 2025, View Source [SID1234659750])

On November 10, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the third quarter ended September 30, 2025, and provided operational updates.

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"The successful completion of our most recent PIPE financing strengthens our balance sheet and provides the resources to further invest in ZYNLONTA as we anticipate advancing into earlier lines of therapy for DLBCL and into indolent lymphomas," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We look forward to multiple upcoming clinical catalysts expected across LOTIS-7, LOTIS-5, and the ongoing Phase 2 IITs, starting with LOTIS-7 before the end of this year and continuing with data readouts throughout 2026."

Third Quarter 2025 Operational Updates & Recent Highlights

•Completed private investment in public equity (PIPE) financing. The Company entered into a securities purchase agreement for the sale of its equity securities to certain institutional investors in a $60 million PIPE financing, of which the net proceeds of approximately $57.6 million are anticipated to fund the commercial expansion of ZYNLONTA and strengthen the Company’s balance sheet.
•Updated data from LOTIS-7 expected by the end of the year. Beyond the initial results reported at European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) and at the International Conference on Malignant Lymphoma (ICML) in June from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the Company expects to share additional data from the LOTIS-7 trial through a corporate update by the end of the year. Once sufficient data with longer follow-up is available, the Company plans to engage with the U.S. Food and Drug Administration (FDA). In addition, the Company plans to pursue publication and compendia inclusion in the first half of 2027.
•LOTIS-5 topline results anticipated in 1H 2026. The Company expects to provide topline data in the first half of 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of progression-free survival (PFS) events is reached and data are available. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to regulatory authorities will follow, with potential confirmatory approval in 2L+ DLBCL as well as publication and compendia inclusion in the first half of 2027.
•Updated data from the Phase 2 investigator-initiated trial (IIT) of ZYNLONTA in r/r follicular lymphoma (FL) presented at the 22nd International Workshop on Non-Hodgkin Lymphoma (iwNHL). Juan Pablo Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, presented updated data at iwNHL in September from the Phase 2 IIT evaluating ZYNLONTA in combination with rituximab in r/r FL. Data from the 55 efficacy evaluable patients to date in this trial continue to demonstrate encouraging results with an overall response rate (ORR) of 98.2%, a complete response rate (CR) of 83.6%. After median follow-up of 28th months, median PFS was not reached, and the 12-month PFS was 93.9%. Safety was consistent with the known profile of ZYNLONTA. The trial has been expanded to enroll 100 patients, and the Company plans to assess regulatory and updated compendia pathways as soon as sufficient data are available.
•IND-enabling activities advancing for PSMA-targeting ADC. IND-enabling activities are ongoing for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC with completion of these activities expected by the end of 2025.

Third Quarter and Year to Date 2025 Financial Results

•Product Revenues: Net product revenues were $15.8 million for the three months ended September 30, 2025, and $51.2 million for the nine months of 2025 as compared to $18.0 million and $52.9 million for the same periods in 2024. The period-over-period changes were primarily driven by lower sales volume, partially offset by higher sales price and favorability in gross-to-net sales adjustments.
•Research and Development (R&D) Expense: R&D expense was $26.8 million for the three months ended September 30, 2025, as compared to $32.5 million for the same period in 2024. The decrease in R&D costs for the three-month period was driven by a reduction in spending on discontinued programs and timing and enrollment of our ZYNLONTA clinical trials, partially offset by an increase in IND-enabling activities for our PSMA-targeting ADC. R&D expense was $85.8 million for the nine months ended September 30, 2025, as compared to $82.5 million for the same period in 2024. The increase in R&D costs for the nine-month period was driven by an increase in IND-enabling activities for our PSMA-targeting ADC and timing and enrollment of our ZYNLONTA clinical trials, partially offset by a reduction in spending on discontinued programs.
•Selling and Marketing (S&M) Expense: S&M expenses were relatively consistent at $10.7 million for the three months ended September 30, 2024, and 2025, respectively. S&M expense was $31.4 million for the nine months ended September 30, 2025, as compared to $32.8 million for the same period in 2024. The period-over-period decrease was primarily due to a reduction in marketing and advertising expenses.
•General & Administrative (G&A) Expense: G&A expense was $8.3 million and $27.1 million for the three and nine months ended September 30, 2025, respectively, compared to $10.0 million and $32.3 million for the same periods in 2024. The reductions in G&A expense were primarily due to lower external professional fees.
•Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.4 million and $13.5 million in restructuring, impairment and other related costs for the three and nine months ended September 30, 2025, which consisted of $6.2 million in employee severance and related benefit costs, $6.4 million in non-cash impairment of assets and $0.8 million in retirement costs in connection with the close down of the UK facility.
•Net Loss: Net loss for the three months ended September 30, 2025, was $41.0 million, or a net loss of $0.30 per basic and diluted share, as compared to a net loss of $44.0 million, or a net loss of $0.42 per basic and diluted share, for the same period in 2024. The lower net loss for the three-month period was primarily due to lower R&D and G&A expenses. Net loss for

the nine months ended September 30, 2025, was $136.2 million, or a net loss of $1.14 per basic and diluted share, as compared to a net loss of $127.1 million, or a net loss of $1.35 per basic and diluted share, for the same period in 2024. The higher net loss for the nine-month period was primarily due to the increase in R&D expense, the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan and lower interest income.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $25.5 million, or an adjusted net loss of $0.19 per basic and diluted share for the three months ended September 30, 2025, as compared to adjusted net loss of $29.4 million, or $0.28 per basic and diluted share, for the same period in 2024. Adjusted net loss for the nine months ended September 30, 2025, was $78.2 million, or an adjusted net loss of $0.66 per basic and diluted share, as compared to an adjusted net loss of $84.9 million, or $0.90 per basic and diluted share, for the same period in 2024. The decrease in adjusted net loss for the three-month and nine-month periods was due to lower operating expenses and a higher number of weighted average shares outstanding.
•Cash and cash equivalents: As of September 30, 2025, cash and cash equivalents were $234.7 million, compared to $250.9 million as of December 31, 2024. In October, the Company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million PIPE financing. Giving effect to the estimated net proceeds from the PIPE financing of approximately $57.6 million (after deducting placement agent fees and estimated offering expenses), the Company would have had approximately $292.3 million of cash and cash equivalents as of that date.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2025 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, NOV 10, 2025, View Source [SID1234659699])