Transgene Provides Business
and Financial Update for Q1 2025

On April 24, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update, including its financial position as of March 31, 2025 (Press release, Transgene, APR 24, 2025, View Source [SID1234652111]).

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Key events and upcoming milestones

Over the first quarter of 2025, all of Transgene’s preclinical and clinical assets progressed in line with expectations.

Individualized neoantigen therapeutic cancer vaccine (TG4050)

Transgene will deliver a rapid oral presentation on TG4050, its lead individualized neoantigen therapeutic cancer vaccine based on its myvac platform and powered by NEC’s AI technologies, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 annual meeting in Chicago (USA).

This oral presentation, which will take place on June 1, 2025, is part of a session that highlights clinical data that stood out among many submissions.

The updated data will include disease-free survival (DFS) data at 24-month follow-up for all patients in the Phase I part of the trial evaluating TG4050 as adjuvant treatment for head and neck cancer.

As the treatment landscape evolves, these updated clinical data in the adjuvant treatment of operable head and neck cancer will be instrumental in determining TG4050’s optimal development path towards registration in this indication.

In the Phase II part of the trial, patient enrollment continues to progress at a good pace and randomization is expected to be completed on schedule in Q4 2025.

The myvac individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025.

TG4001

The Company will present a poster on clinical data from the randomized Phase II trial of TG4001 in combination with avelumab in HPV16-positive recurrent/metastatic anogenital and cervical cancer at ASCO (Free ASCO Whitepaper). While the primary endpoint of the Phase II study was not met, positive signals in the cervical cancer subgroup have been observed and further details will be included in the poster presentation.

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

Governance

Dr. Simone Steiner joined Transgene as Chief Technical Officer (CTO) on April 1, 2025. She is responsible for manufacturing and process development for Transgene’s innovative immunotherapy product pipeline and leads the optimization of the manufacturing process for individualized neoantigen therapeutic vaccines. She is also involved in the development of potential new candidates based on the myvac platform, as well as in planning potential future clinical studies.

Dr. Steiner reports to Chairman and CEO, Alessandro Riva, and is a member of the Executive Committee.

Upcoming milestones

TG4050

24-month follow-up data of all patients recruited
in the Ph. I part – Rapid Oral Presentation

ASCO annual conference (June 1, 2025)

Ph. II part – Randomization complete

Q4 2025

Other indication – Additional Ph. I trial to start

Q4 2025

TG4001

Clinical data to be presented – cervical cancer
Poster

ASCO annual conference (June 2, 2025)

TG6050

Initial data expected (Phase I)

Q2 2025

BT-001

Updated data expected (Phase I/IIa)

H2 2025

Operating revenue

Q1

In millions of euros

2025

2024

Research Tax Credit

2.3

1.6

Revenue from collaborative and licensing agreements

0.1

Other income

0.1

0.1

Operating revenue

2.5

1.7

During the first quarter of 2025, operating revenue mostly comprised Research Tax Credit of 2.3 million compared to €1.6 million for the same period in 2024. This increase reflects the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer.

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €15.6 million as of March 31, 2025, compared to €16.7 million as of December 31, 2024. In the first quarter of 2025, Transgene’s net cash burn was €14.8 million compared to €11.2 million for the same period in 2024. This results from progress in the Phase II part of the trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.

In March 2025, the Company signed a new amendment to the current account advance agreement with TSGH (Institut Mérieux), which increases the total amount of the facility by €15 million to €48 million. The Company has drawn down €22.5 million from this facility as of March 31, 2025.

With this credit facility and the support of TSGH (Institut Mérieux), Transgene is now able to fund its business until the end of April 2026, enabling the Company to reach important development milestones and deliver significant news flow on its portfolio.

Agilent Showcases Solutions and Partnerships Transforming Cancer Research and Therapeutics at AACR 2025

On April 24, 2025 Agilent Technologies Inc. (NYSE: A) reported its participation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 25-30, 2025 in Chicago, Illinois (Press release, Agilent, APR 24, 2025, View Source [SID1234652127]). Innovative Agilent products and partnerships playing a crucial role in transforming cancer research, diagnostics, and therapeutics will be featured, including:

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Agilent Avida DNA Cancer Panels – Based on cutting-edge next-generation sequencing (NGS) target enrichment solutions that enable simultaneous DNA and methylation profiling from a single sample, the Avida product portfolio has expanded to include three new DNA panels*. Optimized based on the requirements of the European OncNGS Consortium, these catalog panels deliver ultra-sensitive and rapid detection of cancer-related genomic alterations from circulating cell-free DNA (cfDNA) in liquid biopsy samples. The streamlined DNA workflow generates sequencing-ready libraries in just five hours, enabling scientists to go from cfDNA samples to sequencing in a single day shift. These DNA panels can be paired with an Avida methylation panel to provide deep multiomic insights.
Agilent SureSelect Cancer CGP Assay and Tagomics InterlaceTM Multiomics Assay – Agilent has partnered with Tagomics to gain early access to a novel, unbiased approach for epigenetic profiling. The combined workflow of the Tagomics Interlace Multiomics assay with the Agilent SureSelect Cancer CGP assay offers a comprehensive genomic profiling solution, delivering genome-wide epigenetic signatures alongside targeted DNA variant detection. This enables novel and informative multiomic insights into cancer biology to accelerate disease understanding and diagnosis.
Agilent SureSelect Cancer Pan Heme Assay – Co-developed with the Roswell Park Comprehensive Cancer Center, this new assay interrogates DNA and RNA to provide comprehensive genomic profiling for hematologic malignancies. It is the first kitted assay with walkaway automation via the Agilent Magnis NGS Prep System, and an integrated, optimized secondary and tertiary data analysis software powered by QIAGEN Clinical Insight (QCI). This significantly improves laboratory productivity, efficiency, and turnaround time.
Agilent and Abcam Strategic Collaboration for (IHC) Companion Diagnostics (CDx) – This collaboration establishes a seamless paradigm for Agilent to develop a novel IHC CDx using Abcam’s extensive portfolio of over 10,000 high-quality, extensively validated, and stringently manufactured recombinant monoclonal antibodies, RabMAbs. The collaboration enables Agilent to expedite the development of custom assays for drug development and accelerates the use of assays in early clinical trials.
"At Agilent, we are dedicated to pushing the boundaries of cancer research and diagnostics," states Simon May, president of Agilent’s Life Sciences and Diagnostics Markets Group. "Our innovative solutions and strategic partnerships are at the forefront of transforming cancer care, enabling us to deliver comprehensive multiomic insights and cutting-edge diagnostic tools that empower researchers and clinicians to make more informed decisions and ultimately improve patient care."

AACR attendees are invited to join Agilent at the Exhibitor Spotlight Theater on Sunday, 27 April from 1:30 to 2:30 p.m. for an educational session titled "Revolutionizing Multiomic Profiling: Tagomics’ Interlace Platform and Agilent’s SureSelect Cancer Pan Heme Assay."

Presenter Dr. Robert Neely, PhD, Co-founder, Director, and Chief Scientific Officer at Tagomics, will explore their Interlace platform. This platform revolutionizes multiomic profiling with a single sample input and minimal sequencing. Combining Agilent’s SureSelect reagents with Tagomics’ unique approach to methylation profiling delivers comprehensive genome-wide genetic and epigenomic insights.

Following this, Dr. Sean Glen, PhD, Vice Chair of Molecular Pathology at the Roswell Park Comprehensive Cancer Center, will present on the Agilent SureSelect Cancer Pan Heme Assay. This assay is a breakthrough in hematological malignancy testing. It provides a long-term solution by targeting relevant mutation types across all heme-related genes and integrating automated lab and analysis solutions for expedited reporting.

AACR attendees can also explore multiple Agilent research posters and a plethora of posters and platform presentations by customers highlighting Agilent instruments and solutions. For more details about these events, visit the Agilent booth #2306.

*Agilent Avida DNA Onco LB, Avida DNA Onco LB Plus, and Agilent Avida DNA Lymphoma panels were developed as part of the oncNGS Project, which received funding from the European Union’s Horizon 2020 Research and Innovation Programme.

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.

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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.

Keymed Biosciences Announces Approval of IND for CM518D1 by the National Medical Products Administration of China for the Treatment of Gastrointestinal Cancers

On April 24, 2025 Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") reported that CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors (Press release, Keymed Biosciences, APR 24, 2025, View Source [SID1234652113]). This milestone marks another breakthrough in Keymed’s ADC drug development, further strengthening its innovative therapeutic pipeline in oncology.

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CM518D1: a novel ADC drug targeting CDH17

CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis.

CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations.

Clinical development: providing a potential treatment regimen for gastrointestinal cancers

Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers.

Keymed’s ADC platform: a next-generation of proprietary ADC program for innovative drug development

Keymed’s proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics).

To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide.

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.

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"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.