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BioNTech to Present Clinical and Preclinical Data Across mRNA and Next-Generation Immuno-Oncology Priority Programs at AACR 2025

On April 24, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025 (Press release, BioNTech, APR 24, 2025, View Source [SID1234652098]). The oral and poster presentations underline both the progress of BioNTech’s advanced priority oncology programs as well as the execution of the Company’s combination strategy in oncology, with first data to be presented for the combination of the PD-L1xVEGF-A bispecific antibody candidate BNT3271 plus antibody-drug conjugates ("ADCs").

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"We believe that the future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our data presentations at this year’s AACR (Free AACR Whitepaper) support our approach to combine complementary mechanisms of action with the aim of driving synergistic anti-tumor activity. The data we present indicate that we are well positioned to work towards our vision of improving outcomes for patients across the full continuum of cancer disease."

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

BioNTech will present preclinical data characterizing the mode of action of BNT327. BNT327 is an investigational next-generation bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity superior to single PD-1/PD-L1 blockade or anti-VEGF-A treatment was observed in multiple tumor models.

First data for the combination of BNT327 with various ADC candidates, which are being jointly developed by BioNTech and Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), will be presented. The presentation will include preclinical evaluation of BNT327 plus ADCs, showing inhibition of tumor growth that is superior to each candidate alone. Further, early clinical data of the ongoing global Phase 1/2 trial (NCT05438329) of BNT327 in combination with BNT325/DB-1305, a TROP2-targeting ADC candidate, including safety and early efficacy data, will be presented in the poster session.

BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) for its mRNA cancer immunotherapy candidate BNT116 in combination with the anti-PD1 cemiplimab in an oral presentation. The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer ("NSCLC") who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile.

Preclinical data for the EpCAMx4-1BB antibody candidate BNT314/GEN1059, which is being developed in collaboration with Genmab A/S ("Genmab"), will be presented in a poster session. BNT314/GEN1059 was evaluated in combination with PD-1 inhibition in a tumor model unresponsive to each single treatment. The data showed anti-tumor activity, delayed tumor outgrowth and prolonged survival for the combination treatment compared to both single treatments. The immunomodulatory activity of BNT314/GEN1059 was further potentiated in combination with PD-1 blockade.

BioNTech has established a diversified oncology portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, comprising ADCs and cell therapies, to develop novel treatment approaches for patients living with cancer. The Company is further maturing its clinical oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and Phase 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 AACR (Free AACR Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentation

Asset: BNT116
Session Title: "ADCs and Immunooncology-focused Biological Approaches"
Abstract Title: "Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC)"
Abstract Number: CT013
Location: Room S100 A (Grand Ballroom A)
Date: Sunday, April 27, 2025
Time: 4:20 PM – 4:30 PM CDT

Poster presentations

Asset: BNT327 + BNT325/DB-1305
Session Title: "Combination Immunotherapies"
Abstract Title: "Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations"
Poster Number: 648 / 14
Location: Section 28
Date: Sunday, April 27, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT327
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "Dual PD-L1 blockade and VEGF-A neutralization with the bispecific antibody BNT327/PM8002 shows potent antitumor activity in preclinical models"
Poster Number: 6061 / 2
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT314/ GEN1059
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "The combination of an EpCAMx4-1BB bispecific antibody with PD-1 blockade exhibits antitumor activity in a murine tumor model unresponsive to each individual antibody"
Poster Number: 6075 / 16
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Bio-Techne Announces Early Access Program for Next-Generation Spatial Protein Proximity Detection

On April 24, 2025 Bio-Techne Corporation (NASDAQ: TECH), a global provider of cutting-edge life science tools, reported an Early Access Program for its latest advancement in spatial biology: a powerful new assay for in situ detection of protein proximity (Press release, Bio-Techne, APR 24, 2025, View Source [SID1234652097]). Built upon Advanced Cell Diagnostics RNAscope technology, this next-generation assay is designed to reveal functional interactions between proteins within intact tissues, delivering a spatial solution to explore how molecular signaling shapes disease processes — offering a truly integrated spatial multiomic view.

"This new protein proximity assay opens the door to seeing functional interactions between proteins and not merely their presence in a tissue," said Dr. Matt McManus, President of Bio-Techne’s Diagnostics & Spatial Biology Segment. "It’s a powerful step forward in understanding the dynamic interplay within tissues that drives biology and disease."

Conventional methods for studying molecular interactions in tissues that separately measure proteins and RNA risk losing spatial fidelity, while bulk proximity assays provide no localization data. Bio-Techne’s proximity detection technology addresses these gaps with a clear visual signal at subcellular resolution, built to be compatible with the RNAscope Multiomic LS workflow on BOND RX. This capability is particularly valuable for research areas where context matters — such as assessing immune checkpoint dynamics, investigating bispecific antibodies and studying protein interactions at synaptic junctions.

The Early Access Program is available to select institutions and researchers interested in incorporating spatial protein proximity capabilities into their workflows. Proof-of-concept data and case studies will be shared at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, presented by Bio-Techne’s scientific team.

Azitra Announces Share Purchase Agreement for up to $20 Million in Partnership with Alumni Capital to Fund Clinical Pipeline

On April 24, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it has entered into a share purchase agreement (SPA) with Alumni Capital LP (Alumni), an institutional investor (Press release, Azitra, APR 24, 2025, View Source [SID1234652096]). Azitra anticipates that this partnership will provide Azitra with a flexible source of funding, enabling the Company to progress its pipeline of live biotherapeutic precision products delivered topically to treat rare and severe dermatologic conditions.

As Azitra works towards key clinical milestones, the Company anticipates the SPA will allow the Company to minimize dilution while creating and sustaining shareholder value, enabling Azitra to be judicious and plan for the timing and amount of any equity sales, which will be critical as it strategically develops its pipeline focused on Netherton Syndrome, a rare skin disorder and EGFRi associated rash, which impacts approximately 150,000 people in the U.S.

Under the terms of the agreement, Azitra has the right to sell, and Alumni has the obligation to purchase up to $20 million worth of common stock and warrants to purchase shares of common stock over a 20-month period at prices that are based on the market price at the time of each sale to Alumni. Azitra, at its sole discretion, controls the timing and amount of all sales of common stock and warrants associated with the SPA, subject to the limitations contained in the SPA.

The issuance of the shares of common stock to Alumni is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. Pursuant to the SPA, the Company must register Alumni’s resale of the shares of the Company’s common stock purchased. The exercise of the warrants will be subject to shareholder approval.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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.

ITM and Alpha-9 Oncology Enter Into Supply Agreement for Therapeutic Medical Radioisotope Actinium-225

On April 24, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9), a clinical-stage biotechnology company advancing a distinctive portfolio of differentiated and highly targeted radiopharmaceuticals, reported the signing of a supply agreement for Actinium-225 (Ac-225) to support the development of Alpha-9’s radiopharmaceutical programs (Press release, Alpha9 Oncology, APR 24, 2025, View Source [SID1234652095]). Under the terms of the agreement, ITM will supply its therapeutic medical radioisotope, Ac-225, produced by ActineerTM Inc. (Actineer), the joint venture between ITM and Canadian Nuclear Laboratories. Actineer is advancing cutting-edge technologies to secure and expand its supply chain and produce industrial-scale quantities of Ac-225 at rapid speed to meet the growing global demand. Further contract details have not been disclosed.

"This agreement strengthens our ongoing collaboration with Alpha-9 and reaffirms our mission to supply Actinium-225 to companies pioneering novel radiopharmaceuticals for high unmet need cancer indications," said Dr. Andrew Cavey, CEO of ITM. "We deeply value Alpha-9’s continued trust in our capabilities to produce industrial-scale radioisotopes, supporting the development of breakthrough treatments that can potentially improve the lives of patients with cancer worldwide."

Ac-225 is a rare medical radioisotope used in radiopharmaceuticals to treat various cancer indications. It emits high-energy alpha particles with a short penetration range in tissue, enabling precise targeting of tumor cells. Studies with Ac-225 have shown it to cause double-stranded DNA breaks in cancer cells, leading to their destruction[i]. Its unique qualities along with its natural scarcity and manufacturing complexities make Ac-225 a highly sought after resource. With a comparatively short half-life of approximately ten days[ii], Ac-225 requires a highly sophisticated manufacturing and distribution network worldwide.

"With its global strength in providing high-quality radioisotopes including. Lutetium-177 and their growing capabilities for the production of Actinium-225, ITM is a valued partner as we progress our pipeline of clinical and discovery programs to meet the needs of cancer patients," said Alison Fleming Ph.D., COO of Alpha-9 Oncology.

Akoya Biosciences Expands Biopharma Service Portfolio with New ADC Breast Cancer Assay and Real-world IO60 Insights at AACR 2025

On April 24, 2025 Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, reported the availability of a new assay designed to advance antibody-drug conjugate (ADC) development in breast cancer (Press release, Akoya Biosciences, APR 24, 2025, View Source [SID1234652094]). The new assay will be featured alongside customer-generated real-world data from the PhenoCode Discovery IO60 panel—Akoya’s flagship ultrahigh-plex immuno-oncology solution—at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, taking place April 25–30 in Chicago, Illinois.

New ADC Assay: Advancing Breast Cancer Precision

The emergence of HER2- and TROP2-targeting ADCs—such as those used in the DESTINY, ASCENT, and TROPiCS trials—have transformed breast cancer treatment while introducing greater complexity in therapeutic decision-making. Akoya’s newly launched multiplex immunofluorescence (mIF) panel is designed to address these challenges by enabling more precise patient selection within established breast cancer subtypes.

This ADC-focused panel includes HER2, TROP2, Ki-67, ER/PR, and a proprietary membrane-localization cocktail. It allows for simultaneous quantification of ADC target expression with precise subcellular localization, providing:

Normalized protein expression
Membrane/cytoplasmic expression ratios
Comparative analysis with standard-of-care IHC biomarkers
Now available through Akoya’s Advanced Biopharma Services (ABS), the ADC panel includes comprehensive support—from assay customization to tissue staining, high-resolution imaging, image analysis, and reporting. ABS is purpose-built to accelerate the path from translational discovery to IUO and IVD, with capabilities anchored in:

A CLIA-certified laboratory for clinical-grade assay development
Integrated imaging and analysis workflows for multiplexed biomarker quantification
A clinical trial site and global CRO network for end-to-end study support
The panel is optimized for:

Identifying HER2-low and TROP2-high patients in clinical trial cohorts
Resolving membrane versus cytoplasmic marker expression—critical for ADC efficacy
Delivering consistent, quantitative scoring of each ADC marker
"Multiplexing key targets in context with state-of-the-art membrane resolution is a catalyst for designing precise ADC combination strategies," said Pascal Bamford, Chief Clinical Officer at Akoya. "Our goal is to equip translational and clinical teams with assays that reflect the complexity of the tumor microenvironment while preserving clinical relevance."

Real-World Impact of IO60: Proven in the Field

Originally launched at SITC (Free SITC Whitepaper) 2024, the PhenoCode Discovery IO60 panel remains the fastest ultrahigh-plex spatial proteomics solution for immuno-oncology research. At AACR (Free AACR Whitepaper) 2025, one of Akoya’s customers will present real-world data generated using IO60, showcasing its power in:

Deep immune phenotyping
Tumor microenvironment (TME) profiling
Translating biomarker discovery across oncology pipelines
"Seeing our partners generate impactful insights using IO60 is the strongest validation of our platform’s potential," said Brian McKelligon, Chief Executive Officer of Akoya. "This is how spatial biology becomes translational—by helping researchers get closer to patient-relevant outcomes."

Visit Akoya at AACR (Free AACR Whitepaper) 2025 – Booth #3045

Both innovations—the ADC-focused breast cancer panel and customer-generated data using IO60—will be featured at Booth #3045, where Akoya will highlight the full potential of spatial biology in translational research. Visit us to explore the PhenoCode panel portfolio, meet with our scientific team, and experience our latest innovations firsthand.

What to Look Forward To:

Live Atlas Demo with Enable Medicine – Translating spatial data into actionable insights: April 27 | 4:30–5:00 PM | Akoya Booth #3045
Spotlight Theatre Presentation: From Discovery to Translation: Scaling Spatial Biology for Oncology Breakthroughs: April 28 | 3:00–4:00 PM | Spotlight Theater A – South Hall A
CDx Strategy Discussion with Clinical Experts: April 28 | 4:15–5:00 PM | Akoya Booth #3045
Early access opportunities to Akoya’s newest translational panels and biopharma service offerings
For more information about Akoya’s AACR (Free AACR Whitepaper) 2025 presence, visit: View Source