On May 27, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update (Press release, BioLineRx, MAY 27, 2025, View Source [SID1234653388]).

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"Following our announcement last November that we out-licensed APHEXDA, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."

"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.

Financial Updates

Completed financing in January 2025 raising gross proceeds of $10 million.
Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company’s U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update

APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million.
Clinical Updates

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, May 31st. Key highlights include:
Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children’s Research Hospital.
Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis.
Financial Results for the Quarter Ended March 31, 2025

Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company’s operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales.
Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price.
Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits.
Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024.
As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On May 27, 2025 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), reported that it will present new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies in the neoadjuvant setting that are associated with improved pathologic response in patients with head and neck cancer (Press release, Vaccinex, MAY 27, 2025, View Source [SID1234653404]). Lead investigator and collaborator, Conor Steuer, MD from Winship Cancer Center at Emory University, will present results at the 2025 Annual Meeting of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago on June 1, 2025.

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ASCO Conference Information:

Date: Sunday, June 1, 2025

Presentation title: Neoadjuvant biomarker trial of pepinemab to enhance nivolumab or ipilimumab activity in resectable head and neck cancer. Abstract 103.

Time: 9:45-11:15 AM CST/10:45 AM – 12:15 PM EST.

Session Title: Clinical Science Symposium – Turning "Cold" Tumors "Hot"

Previously reported data from our collaboration with Emory University suggest a crucial role of pepinemab treatment in melanoma patients to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses.

New data presented at ASCO (Free ASCO Whitepaper) will characterize the mechanisms of neoadjuvant treatment with pepinemab in patients with resectable head and neck cancer (HNSCC). Standard of care for these patients often involves toxic chemotherapy and/or radiotherapy, in addition to surgery, which can significantly impact their quality of life. Peri-operative treatment with immunotherapy has recently reported promising and potentially practice-changing results. Certain HNSCC with hot beds of immune cells organized into TLS have been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. However, many HNSCC are considered immunologically "cold" tumors, due to exclusion of immune cells from tumor and/or high levels of immune suppressor cells, making them resistant to immune checkpoint therapy.

Pepinemab has potential to be a major advance for HNSCC patients with cold and resistant disease, with capacity of a well-tolerated and effective treatment that can induce formation and harness the power of TLS to optimize the clinical benefit of immunotherapy. Our data demonstrate that the addition of pepinemab to neoadjuvant immune checkpoint treatments did not compound toxicities, yet it enhanced TLS maturity that correlated with improved pathologic response. Collectively, these results highlight the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative head and neck cancer, into hot immune centers by inducing robust and mature TLS.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications.

On May 27, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported that six abstracts have been accepted at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), scheduled to take place May 31 – June 3, 2025, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, MAY 27, 2025, View Source [SID1234653420]). BostonGene will also exhibit at booth #15147.

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BostonGene will showcase the impact of its validated, multimodal AI platform, which combines deep molecular profiling, immune system characterization and advanced analytics to accelerate and de-risk oncology drug development. Across six accepted studies—conducted independently and in collaboration with leading academic institutions—BostonGene will demonstrate how its platform uncovers novel biomarkers, refines patient stratification and predicts therapeutic response across a range of tumor types. Presentations will highlight advancements in transcriptomic analysis, immune microenvironment profiling, histomolecular subtyping and blood-based predictors—key tools for improving clinical trial design and driving precision treatment strategies.

Details about the abstracts selected for presentation can be found below:

Abstract number: 11536
Title: Molecular subtyping and insights into sarcoma biology and prognosis
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Nikita Kotlov, BostonGene

In this study, BostonGene’s multiomic Tumor PortraitTM test was used to identify distinct molecular patterns in various sarcoma subtypes that correlated with survival outcomes. These findings demonstrate the potential clinical impact of advanced analytics paired with molecular sequencing in diverse diseases such as sarcoma.

Abstract number: 1049
Title: Macroscale Genomic Alterations in Histomolecular Invasive Lobular Carcinoma Compared to Other Breast Cancer Subtypes
Date & time: June 2 | 9:00 AM – 12:00 PM
Presenter: Jason Mouabbi, MD, The University of Texas MD Anderson Cancer Center

In collaboration with MD Anderson, BostonGene used its advanced analytic platform to identify unique histologic and molecular findings in invasive lobular carcinoma (ILC), a subtype of breast cancer for which treatment options are often inferred. Profiling of over 600 patients resulted in the discovery of biologic mechanisms and alterations that could direct future therapeutic and drug development strategies.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 11561
Title: Detecting hotspots of intra- and transchromosomal fusions in liposarcomas by RNA sequencing
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s extensive internal cohort and advanced sequencing technologies, this study conducted transcriptome analysis of Liposarcoma (LPS) samples, revealing novel hotspots of gene fusions in LPS patients. These discoveries can be used to improve diagnostic accuracy and the development of novel therapeutics in LPS and similar diseases.

Abstract number: 4198
Title: Uncovering the Tumor Microenvironment (TME): Exploring survival and immunotherapy (IO) response in Cancer of Unknown Primary (CUP)
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Joelle Allam, MD, The Texas University MD Anderson Cancer Center

In this study, BostonGene utilized its Tumor PortraitTM test to characterize Cancer of Unknown Primary (CUP). The analysis revealed correlations of clinical factors, the tumor microenvironment and immunotherapy response with survival outcomes, offering new insights into this challenging and poorly defined cancer.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 2634
Title: Tertiary lymphoid structures and their association with immune checkpoint inhibitor response and survival outcomes in patients with non-small cell lung cancer
Date & time: June 2 | 1:30 PM – 4:30 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s AI-driven Kassandra deconvolution algorithm to analyze transcriptomic data from patients with non-small cell lung cancer, this study identified unique tertiary lymphoid structures within the tumor microenvironment that may serve as predictive and prognostic biomarkers, enhancing the efficacy of immune checkpoint inhibitor therapy.

ONLINE ONLY:
Title: The impact of PTEN deletion, TMPRSS2:ERG fusion, and androgen receptor variant 7 (AR-V7) on resistance to novel hormone therapies (NHTs) in castrate-resistant prostate cancer

This study demonstrated the clinical utility of the BostonGene Tumor PortraitTM test in guiding treatment selection for castrate-resistant prostate cancer based on tumor microenvironment-related gene signatures. These findings underscore the importance of precision medicine in managing cancer subtypes that are resistant to traditional interventions.

For more information, please visit the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

On May 27, 2025 Sanofi reported the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company (Press release, Sanofi, MAY 27, 2025, View Source [SID1234653524]). The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline.

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DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis.

Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B- cell depletion has the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones. Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents.

On May 27, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025 (Press release, BioNTech, MAY 27, 2025, View Source [SID1234653389]). The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates ("ADCs").

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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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"We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting show how we aim to help shape this era," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients."

Highlights of BioNTech’s oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2025:

•Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer ("ES-SCLC") and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer ("NSCLC"). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity.

•Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer ("CRPC") will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

•Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival ("OS") and an ad-hoc analysis of next-treatment free survival ("NTFS"), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").

•Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies.

BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentations

Asset: BNT327
Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Abstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma 
Location: E451
Abstract Number: 8511
Date: June 3, 2025
Time: 9:45 AM – 11:15 AM CDT

Asset: BNT324/DB-1311
Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)
Location: Hall D2
Abstract Number: 5015
Date: June 1, 2025
Time: 4:30 PM – 6:00 PM CDT

Asset: BNT142
Session Title: Oral Abstract Session | Developmental Therapeutics—Immunotherapy
Abstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.
Location: Hall D2
Abstract Number: 2501
Date: May 31, 2025
Time: 3:00 PM – 6:00 PM CDT

Poster Presentations

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Poster Board: #242a
Abstract Number: TPS8129
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
Poster Board: #138b
Abstract Number: TPS8670
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Melanoma/Skin Cancers
Abstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitors
Poster Board: #34
Abstract Number: 9551
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Poster Board: #266
Abstract Number: 5067
Date: June 2, 2025
Time: 9:00 AM – 12:00 PM CDT