On April 23, 2025 Incyte (Nasdaq: INCY) reported that multiple abstracts featuring new data from its oncology portfolio will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 30 – June 3, 2025, in Chicago (Press release, Incyte, APR 23, 2025, View Source [SID1234652076]).

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"The data featured at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, from both our approved medicines and early-stage pipeline, reflect our ongoing efforts to transform cancer care," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "We are advancing potential therapies across some of the most difficult-to-treat cancers and hematological diseases, including squamous cell anal cancer, ovarian cancer and myelofibrosis, with the hope of making a meaningful difference for these patients."

Key abstracts accepted for presentation:

Oral Presentations

INCB123667

Safety and Preliminary Efficacy from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Advanced Platinum-Resistant and Refractory Ovarian Cancer (OC)
(Abstract #5514. Session: Rapid Oral Abstract – Gynecologic Cancer. June 3, 9:42 a.m. ET (8:42 a.m. CT))

Pemigatinib

A Phase 2 Study of Pemigatinib for Pre-treated Glioblastoma or Other Gliomas with Activating FGFR1-3 Alterations: Results from FIGHT-209
(Abstract #2003. Session: Oral Abstract Session – Central Nervous System Tumors. May 30, 4:21 p.m. ET (3:21 p.m. CT))

Poster Presentations

Retifanlimab

Experience of Patients with HIV and Squamous Cell Carcinoma of the Anal Canal (SCAC) Treated with Retifanlimab
(Abstract #3521. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

POD1UM-303/INTERAACT2 Subgroup Analyses and Impact of Delayed Retifanlimab Treatment on Outcomes in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
(Abstract #3525. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Final Results of POD1UM-201, a Phase 2 Study of Retifanlimab, a Humanized Anti–PD-1 Antibody, in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC)
(Abstract #9536. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Long-term Outcomes After Discontinuation of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) in the POD1UM-201 Trial
(Abstract #9538. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB123667

Interim Safety and Antitumor Activity Data from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Metastatic Recurrent Endometrial Cancer
(Abstract #5603. Session: Gynecologic Cancer. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB057643

Safety And Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 In Patients (pts) with Relapsed or Refractory Myelofibrosis (r/r-MF) and Other Advanced Myeloid Neoplasms: A Phase (Ph) 1 Study
(Abstract #6574. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

More information regarding the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source

About Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

In Canada, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe, Japan and Canada.

Pemazyre and the Pemazyre logo are registered trademarks of Incyte.

* Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

About Zynyz (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Zynyz (retifanlimab) is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

In Canada, Zynyz (retifanlimab) is approved as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

Zynyz is marketed by Incyte in the U.S., Europe and Canada, in 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

On April 23, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, APR 23, 2025, View Source [SID1234652045]).

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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

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Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052.

The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706’s safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers.

Details of the poster presentation at the ASCO (Free ASCO Whitepaper) Meeting are as follows:

Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumors
Abstract Number: 3018
Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CST
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The full abstract will be published by ASCO (Free ASCO Whitepaper) in conjunction with the Meeting.

About i-Conjugation Technology

Adcentrx’s proprietary i-Conjugation technology platform is a core component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On April 23, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it will be delivering a rapid oral presentation of randomized Phase I trial data of individualized neoantigen therapeutic cancer vaccine TG4050 in head and neck cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Transgene, APR 23, 2025, View Source [SID1234652061]).

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A rapid oral presentation is part of a formal session, with a six-minute oral presentation format. It aims at sharing clinical data that stood out among many submissions.

The company will also present a poster on randomized Phase II data of TG4001 in combination with avelumab in the cervical cancer subgroup.

The 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), annual meeting will take place in Chicago from May 30 to June 3, 2025.

TG4050— Rapid oral presentation details:

Title: "Randomized Phase I trial of adjuvant personalized cancer vaccine TG4050 in resected locally advanced head and neck squamous cell carcinoma (HNSCC) patients."

· Session title: Rapid Oral Abstract Session

· Date and Time: Sunday, June 1, 12:06 p.m. CDT

· First Author: Prof. C. Le Tourneau

· Abstract Number: 6016

TG4050 is an individualized neoantigen therapeutic cancer vaccine being developed for solid tumors which is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence and machine learning expertise. TG4050 is being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Transgene intends to present 24-month follow-up data from patients enrolled in the Phase I part of the trial. Patients are currently being enrolled in the Phase II part of this trial.

TG4001— Poster presentation details:

Title: "Randomized Phase II trial evaluating the combination of TG4001, an HPV16 therapeutic cancer vaccine and avelumab in patients with immunotherapy-naïve recurrent and/or metastatic (R/M) HPV16-positive cervical or anogenital cancer."

· Session title: Developmental Therapeutics ̶ Immunotherapy

· Date and Time: Monday, June 2, 1:30 p.m. CDT

· First author: Prof. C. Le Tourneau

· Abstract number: 2638

The abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5 p.m. ET.

On April 23, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating ZL-1310, the Company’s potential first-in-class and best-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), will be presented during a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, Zai Laboratory, APR 23, 2025, View Source [SID1234652077]). The updated results will include additional patients and follow-up from the ongoing trial of ZL-1310 in patients with previously treated ES-SCLC after at least one prior platinum-based chemotherapy regimen.

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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

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"ZL-1310 reflects our company’s commitment to develop differentiated oncology therapies that address current limitations with many first-generation and current standard-of-care treatments," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We are focused on the development of ZL-1310, and we look forward to presenting updated results at ASCO (Free ASCO Whitepaper) 2025."

Details regarding the webcast and conference call are as follows:

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO (Free ASCO Whitepaper) and outline the next steps in clinical development.

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT, please register at:
Webcast presentation (preferred): View Source;
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

Details regarding the ZL-1310 poster presentation are as follows:

Title: ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update
Presenter: Manish R. Patel, M.D., Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL
Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date/Time: Monday, June 2, 2025, from 1:30 p.m. – 4:30 p.m. CT
Location: McCormick Place Convention Center, Hall A – Posters and Exhibits
Published Abstract Number: 3041
Poster Board: 356

About Small Cell Lung Cancer and ZL-1310

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. 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.

ZL-1310 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.

On April 23, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL (Press release, BriaCell Therapeutics, APR 23, 2025, View Source [SID1234652430]).

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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

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The details of the poster presentation sessions and publish-only abstract are listed below.

Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Abstract Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Abstracts will be released at 5:00 PM (ET) on Thursday, May 22, 2025.

Following the presentations, copies of the presentations will be posted on View Source