Transgene to Provide Updated Phase I Data in a Rapid Oral Presentation on
Individualized Therapeutic Cancer Vaccine TG4050 at ASCO 2025

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.

Zai Lab to Present Data from Phase 1 Trial of DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310 at 2025 ASCO Annual Meeting

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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"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.

BriaCell Announces Four Clinical Data Presentations at ASCO 2025

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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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

Innate Pharma Regains Its Rights on CD123 Targeting ANKET® and Announces Sanofi’s Intention to Make a Strategic Investment in the Company

On April 23, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported review of their January 2016 Research Collaboration and License Agreement (the "2016 Agreement") with Sanofi (Press release, Innate Pharma, APR 23, 2025, View Source [SID1234652025]):

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As previously disclosed and in alignment with its current strategic priorities, Sanofi will opt to pursue the development of SAR’514/IPH6401 (BCMA ANKET) in autoimmune indications under the terms of the 2016 License Agreement;
In alignment with both company’s current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET); Innate will regain its rights on SAR’579/IPH6101 (CD123 ANKET).
As part of these discussions, Sanofi and Innate have agreed to a potential investment by Sanofi of up to €15M in new shares of Innate. The size and price of this equity investment will be determined on the basis of the ongoing market conditions, if they are satisfactory.

The 2022 research collaboration and license agreement remain unchanged.

"We are very pleased that Sanofi has chosen to further strengthen our relationship through a potential strategic equity investment in the company. This would further validate the innovation and scientific progress at Innate Pharma delivered by our research and development. We acknowledge Sanofi’s portfolio prioritization, and we are encouraged to see our ANKET platform being pursued in autoimmune indications. We will continue to evaluate, plan and execute next steps for our proprietary ANKET programs in oncology and beyond," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

SAR’579 (NCT05086315)/IPH6101

The originally Sanofi-led Phase 1/2 study with SAR’579 / IPH6101 (clinical study identifier: NCT05086315) is ongoing. Efficacy and safety results from the dose-escalation part, were shared in an oral presentation at the EHA (Free EHA Whitepaper) 2024 Congress. The data demonstrated that SAR’579 had clinical benefit and durable responses along with a favorable safety profile in patients with relapsed or refractory acute myeloid leukemia (AML), with 5 complete responses (4 CR / 1 CRi) achieved at 1 mg/kg, with durable CR (>10 months) observed in 3 patients.
In April 2024, Sanofi advanced SAR’579 / IPH6101 to the Phase 2 preliminary dose expansion of the trial.
The Parties will discuss a transition plan with regard to ongoing studies.
SAR’514/IPH6401:

The continued Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma will be terminated early and SAR’514/IPH6401 will now be refocused to pursue development in autoimmune indications.
IPH62 and one additional target

IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains the option of one additional ANKET target under the terms of the 2022 research collaboration and license agreement.

Alligator Bioscience announces initiation of HLX22 Phase 2 trial in breast cancer by Shanghai Henlius Biotech, Inc.

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. ("Henlius") has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator’s subsidiary, Atlas Therapeutics (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652046]). HLX22 is being developed by Henlius under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy.

Søren Bregenholt, CEO of Alligator, commented:
"Henlius’ progress with HLX22 underscores the continued clinical momentum behind this antibody. While Alligator is not directly involved in its development, we continue to monitor its progress with interest, as HLX22 may represent a potential future revenue stream for Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.