1stOncology™: Cancer Intelligence Service – Page 545 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Zai Lab Announces Oral Presentation of Updated Data from Global Phase 1 Trial of Zocilurtatug Pelitecan (ZL-1310), a Potential First-in-Class DLL3-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

On October 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC 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), taking place October 22-26, 2025, in Boston, Massachusetts (Press release, Zai Laboratory, OCT 13, 2025, View Source [SID1234656606]). The presentation will include additional follow-up from patients from the ongoing trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Zoci is the Company’s potential first- and best-in-class, Delta-like ligand (DLL3)-targeted antibody-drug conjugate (ADC) being developed for patients with extensive-stage small cell lung cancer (ES-SCLC). The ongoing Phase 1 study is evaluating the safety and antitumor activity of zoci at various doses in patients who have progressed after at least one prior platinum-based chemotherapy regimen. The study is being conducted across multiple global sites.

"The critical need for expanded treatment options for patients with small cell lung cancer propels our strategy to advance zoci as a novel therapeutic option as quickly as possible," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We remain on track to initiate our Phase 3 registrational study in previously treated SCLC by year-end. We look forward to sharing updated results demonstrating zoci’s continued potential at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference."

Zai Lab will hold an investor conference call and webcast to highlight updated zoci data at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference and outline next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: October 24, 2025, at 11 a.m. ET / 11 p.m. HKT, please register at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President and Head of Global Research and Development, Zai Lab

Details regarding the zoci oral presentation are as follows:

Title: Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer
Presenter: Grace K. Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY
Session Title: Plenary Session 3: Antibody Drug Conjugates
Date/Time: Friday, October 24, 2025, 9:17 a.m. – 9:27 a.m. ET (presentation), 9:27 a.m. – 9:45 a.m. ET (panel discussion)
Location: Hynes Convention Center, Level 3, Ballroom AB

About Small Cell Lung Cancer and Zocilurtatug Pelitecan (zoci)

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. Zocilurtatug pelitecan (zoci), formerly known as ZL-1310, comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

Zoci received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

Repare Therapeutics to Present Initial Data from Phase 1 LIONS Clinical Trial at 37th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 13, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it will share initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS trial in a poster presentation at the 37th AACR (Free AACR Whitepaper)-NCI-EORTC 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 October 22-26, 2025 in Boston, MA (Press release, Repare Therapeutics, OCT 13, 2025, View Source [SID1234656605]).

The LIONS clinical trial (NCT06232408) is a first-in-human, multicenter, open-label Phase 1 study to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a potential first-in-class, highly selective, oral PLK4 inhibitor, for the monotherapy treatment of adult and adolescent patients with TRIM37-high solid tumors.

Poster Presentation Details:

Title: Preliminary safety and antitumor activity of RP-1664, a first-in-class PLK4 inhibitor, as monotherapy in advanced solid tumors with and without TRIM37 amplification
Presenter: Benjamin Herzberg, MD, Columbia University
Abstract Number: LB-C002
Session: Poster Session C
Session Date and Time: Saturday, October 25 | 12:30 p.m. – 4:00 p.m. ET
Session Location: Level 2, Exhibit Hall D

A copy of the poster presentation will be available on the Scientific Resources page of the Repare Therapeutics website at the start of the poster presentation session.

About RP-1664

RP-1664 is a potential first-in-class, highly selective, oral PLK4 inhibitor designed to harness the synthetic lethal relationship with TRIM37 amplification or overexpression in solid tumors. Tumors rely on PLK4 for centriole biogenesis in S-phase of the cell cycle when TRIM37, an E3 ligase that reduces pericentriolar material, is high. Preclinical studies demonstrate that RP-1664 selectively inhibits PLK4 and drives potent synthetic lethality in TRIM37-high tumor models, both in vitro and in vivo. Elevated TRIM37 is a feature found across a range of solid tumors and in approximately 80% of all high-grade neuroblastomas. RP-1664 is the only selective PLK4 inhibitor known to be in the clinic.

Foundation Medicine Spotlights Scientific Achievements Across its Portfolio of High-Quality Biomarker Tests at the 2025 European Society for Medical Oncology (ESMO) Congress

On October 13, 2025 Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, reported that the company and its research collaborators will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 17-21 in Berlin, Germany (Press release, Foundation Medicine, OCT 13, 2025, View Source [SID1234656604]).

Foundation Medicine’s research to be presented at the meeting spans seven disease areas and includes new insights from the company’s tissue-free monitoring assay FoundationOneMonitor, which will soon be available for clinical use. The abstract showcases that an early reduction of circulating tumor DNA using FoundationOne Monitor was associated with improved outcomes in patients with triple negative breast cancer.

Two additional studies spotlight data from FoundationOneRNA, a tissue-based RNA sequencing test for the detection of cancer-related fusions across 318 genes. Respectively, the results demonstrate the test’s strong concordance with results from the company’s FDA-approved tissue-based comprehensive genomic profiling test, FoundationOneCDx, as well as with IHC/FISH tests.

"At this year’s ESMO (Free ESMO Whitepaper) Congress, we’re looking forward to sharing our latest data which reinforces the value of our high-quality tests to support the best precision care for patients," says Foundation Medicine’s Vice President, Head of Clinical Development, Amaya Gascó, M.D., Ph.D. "In particular, a new study using FoundationOne Monitor demonstrates the test’s ability to inform a patient’s response to treatment and guide next steps in care. Additionally, our FoundationOne RNA studies highlight the powerful insights our RNA sequencing test can deliver as a complement to comprehensive genomic sequencing with FoundationOneCDx and other diagnostic tests, such as IHC/FISH, to provide healthcare providers with the confidence they need to make informed decisions for their patients."

To access all the abstracts being presented at the 2025 ESMO (Free ESMO Whitepaper) Congress, please visit ESMO (Free ESMO Whitepaper).com.

Follow Foundation Medicine on LinkedIn, X, Instagram and Bluesky for more updates from #ESMO25, and join us in person at Booth #3028 in Hall 3.2 for our "Booth Talk Series" where you will hear from our team of experts on the latest advancements that are driving innovation in precision diagnostics.

Complete list of Foundation Medicine’s abstracts at the 2025 ESMO (Free ESMO Whitepaper) Congress

Presentation Number

Title

Product

Saturday, October 18

Oral Presentation

2610MO

Genomic analysis of papillary renal cell carcinoma (PRCC): MET alterations are uncommon and enriched in patients of African ancestry

FoundationOneCDx

Poster Presentations

1146P

Genomic landscape of HRD signature (HRDsig), CCNE1 amplified (amp) and ERBB2 altered (alt) ovarian cancers (OC)

FoundationOneCDx

1936P

Genomic alterations (GA) in TP53 including the targetable TP53 Y220C mutation in clinically advanced non-small cell lung cancer (CANSCLC)

FoundationOneCDx

157P

Homologous recombination signature (HRDsig) in non-small cell lung cancer (NSCLC): Implications for PARP inhibitor (PARPi) treatment

FoundationOneCDx

1931P

Prevalence, co-alterations and preclinical characterization of FGFR variants of unknown significance in non-small cell lung cancer

FoundationOneCDx

Sunday, October 19

2150P

Homologous recombination deficiency signature in gastric adenocarcinoma

FoundationOneCDx

Monday, October 20

579P

Gene expression profiling by RNA sequencing accurately predicts estrogen, progesterone, and HER2 receptor status by immunohistochemistry in breast cancer

FoundationOneCDx, FoundationOneRNA

580P

Androgen receptor splice variant 7 (AR-V7) and ESR1 fusion detection in breast cancer utilizing comprehensive combined DNA and RNA sequencing

FoundationOneCDx, FoundationOneRNA

2697P

Comprehensive genomic profiling in chordoma by subtype classification

FoundationOneHeme, FoundationOne, FoundationOneCDx

2701P

Estrogen receptor and AKT pathways as potential novel targets for MDM2-amplified well-differentiated and dedifferentiated liposarcoma (WD/DD LPS)

FoundationOneHeme, FoundationOne, FoundationOneCDx

558P

Circulating tumor DNA dynamics correlate with response to carboplatin with or without nivolumab in metastatic TNBC

FoundationOneMonitor

Published Online

2525eP

RNA sequencing enhances TMPRSS2 fusion detection beyond DNA sequencing alone and reveals associations with androgen receptor (AR) biology in prostate cancer

FoundationOneCDx, FoundationOneRNA

1458eP

Ameloblastoma of the head and neck (HNAmelo): A biomarker and genomic landscape study

FoundationOneCDx

686eP

Clinical utility of DNA and RNA comprehensive genomic profiling (CGP) for the diagnostic workup of high grade gliomas (HGG)

FoundationOneCDx, FoundationOneRNA

SystImmune to Receive Milestone Payment from Bristol Myers Squibb Under Iza-Bren Collaboration

On October 13, 2025 SystImmune, Inc., a clinical-stage biotechnology company, reported the treatment of the first patient in the IZABRIGHT-Breast01 study (NCT06926868), a global Ph2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs (Press release, SystImmune, OCT 13, 2025, View Source [SID1234656603]). This milestone triggered a one-time payment of $250 million by Bristol Myers Squibb (NYSE: BMY), pursuant to the 2023 collaboration and exclusive license agreement between SystImmune and Bristol Myers Squibb. SystImmune is further eligible to receive up to an additional $250 million in contingent near-term payments and additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones.

Iza-bren is a potential first-in-class bispecific topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is being developed by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in China and jointly developed by SystImmune and Bristol Myers Squibb in territories outside of China.

"This milestone marks a significant step forward in the global clinical development of iza-bren," said Dr. Yi Zhu, Chairman, SystImmune. "The robust data generated from our China-based trials have played an important role in accelerating development timelines and informing global strategy. We are encouraged by the achievement of this milestone and Bristol Myers Squibb’s commitment to this program. We look forward to bringing iza-bren to patients worldwide under our shared vision with Bristol Myers Squibb."

"Together with Bristol Myers Squibb, we have made significant progress in developing iza-bren globally. We remain deeply committed to delivering this potentially transformative therapy to patients with triple negative breast cancer and other solid tumors," said Dr. Jie D’Elia, CEO, SystImmune. "This $250 million milestone not only reflects the progress of our collaboration but also significantly reinforces our financial position, enabling us to accelerate the global development of our differentiated ADC portfolio."

Iza-bren is currently being evaluated in multiple ongoing clinical trials, including BL-B01D1-LUNG-101 (NCT05983432), IZABRIGHT-Lung01 (NCT07100080), IZABRIGHT-Bladder01 (NCT07106762), and studies in China conducted by Biokin. The program recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with previously treated advanced EGFR-mutated non-small cell lung cancer.

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

ADC Therapeutics Announces $60 Million Private Placement

On October 13, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported that it has entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million private investment in public equity ("PIPE") financing (Press release, ADC Therapeutics, OCT 13, 2025, View Source [SID1234656602]). In the PIPE, ADC Therapeutics is selling 11.3 million common shares at $4.00 per share and pre-funded warrants to purchase 3.8 million common shares at $3.90 per pre-funded warrant, which is the price per common share in the PIPE minus the exercise price of CHF 0.08 per pre-funded warrant.

The PIPE is led by TCGX and includes participation from Redmile Group and other existing investors.

Gross proceeds from the PIPE financing are anticipated to be approximately $60.0 million before deducting placement agent fees and offering expenses. The PIPE is expected to close on October 27, 2025, subject to customary closing conditions. ADC Therapeutics intends to use the net proceeds from the PIPE to invest in the commercial expansion of ZYNLONTA and strengthen the balance sheet, in addition to funding working capital and general corporate purposes.

"This financing enhances our ability to prepare for and execute the potential relaunch of ZYNLONTA in 2027 and further strengthens our balance sheet relative to our previously disclosed cash runway into 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We believe we are well-positioned to accelerate our trajectory towards long-term sustainable growth for our company. We look forward to upcoming data catalysts later this year and throughout 2026."

The company expects net product revenues from sales of ZYNLONTA to be approximately $15.8 million for the third quarter ended September 30, 2025, with cash and cash equivalents totaling $234.7 million as of September 30, 2025. 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.

The offer and sale of the foregoing securities are made in a transaction not involving a public offering, and the foregoing securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or applicable state securities laws, and are being offered and sold in reliance on Section 4(a)(2) of the Securities Act. The securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and other applicable securities laws. ADC Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the common shares to be sold in the PIPE and the common shares issuable upon exercise of the pre-funded warrants to be sold in the PIPE.

Jefferies is acting as placement agent for the PIPE. Davis Polk & Wardwell LLP and Homburger AG are acting as legal advisors to ADC Therapeutics.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The Company has uploaded an updated corporate presentation to the Investor portion of its website.

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.