On April 24, 2025 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, reported that the Phase Ib/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, USA, May 30-June 3, 2025 (Press release, Mabwell Biotech, APR 24, 2025, View Source [SID1234652114]). Clinical data from 3 ADC clinical studies will also be published as poster presentations at the meeting.

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Oral Presentation

1. Title: 9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naive patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study.
Abstract Number for Publication: 4519
Presenter: Prof. Sheng Xinan, Chief Physician, Dept. of Urologic Oncology (Beijing Cancer Hospital)
Session Type and Title: Rapid Oral Abstract-Genitourinary Cancer-Kidney and Bladder
Session Date and Time: 5/31/2025, 1:15 PM-2:45 PM CDT

Poster Presentation

1. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors.
Abstract Number: 3035
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 350
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

2. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer.
Abstract Number: 3036
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 351
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

3. Title: A first-in-human clinical study of 9MW2921, a novel TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Abstract Number: 3029
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 344
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

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.

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.

On April 24, 2025 PharmaMar (MSE:PHM) a global leader in the research, development, and commercialization of marine-derived oncology therapies, reported it will be present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), that will take place between the 30th of May and the 3rd of June in Chicago, U.S.A (Press release, PharmaMar, APR 24, 2025, View Source [SID1234652110]).

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Included among the key presentations an oral abstract of the Phase 3 IMforte trial. "Statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) data for lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) underscore potential of first line maintenance therapy for extensive stage small cell lung cancer (ES-SCLC), a much-needed advancement for patients", commented Javier Jiménez, Chief Medical Officer of PharmaMar.

The Company also will host an investor webcast on June 12th to review Phase 3 IMforte data being presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting. The webcast will include commentaries from leading European experts in small cell lung cancer. The webcast can be accessed at View Source Additional details will be provided prior to the webcast.

The full list of PharmaMar or partner-supported presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting are:

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the Phase 3 IMforte trial Luis G. Paz-Ares, MD, PhD TYPE: Oral Abstract SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8006 DATE: June 2nd, 2025 (03:00 PM- 06: PM CDT)
Safety and Efficacy of Lurbinectedin Plus Atezolizumab as Second-Line Treatment for Advanced Small-Cell Lung Cancer: Results of the 2SMALL Phase 1/2 Study (NCT04253145) Santiago Ponce, MD, PhD TYPE: Rapid Oral Abstract SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8013 DATE: June 1st, 2025 (04:30 PM- 06:00 PM CDT)
Evaluation of combination of lurbinectedin plus atezolizumab in humanized mouse model Antonio Calles, MD, PHD TYPE: e-poster ABSTRACT: e14614 DATE: May 22nd, 2025 (05:00 PM CDT)

On April 24, 2025 PharmaMar Group (MSE: PHM) reported 19% growth in recurring revenues in the first quarter of 2025 (Press release, PharmaMar, APR 24, 2025, View Source [SID1234652109]). This revenue, which is the sum of net sales plus royalties received from our partners, amounted to €37.8 million as of March 31st, 2025. This increase was mainly driven by the good performance of lurbinectedin revenues in both Europe and the US.

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As of March 31st, 2025, total oncology revenues increased by 22% to €23.1 million, compared with €19.0 million in the same period of last year. This increase was due to the positive performance of lurbinectedin revenues in Europe, where revenues recorded under the compassionate use program – mainly in France – rose 26% to €8.0 million, compared to €6.3 million as of March 31, 2024. In addition, commercial sales of Zepzelca in Switzerland amounted to €4.3 million in the first quarter of the year, compared with €4.2 million in the same period of 2024.

Also, raw material sales of both Yondelis (trabectedin) and lurbinectedin to our partners amounted to €5.7 million, representing an increase of 72.3% compared to the €3.3 million recorded in the same period of the previous year.

Sales of trabectedin in Europe through March 31st, 2025, remained stable at €5.2 million.

At the end of the first quarter of 2025, oncology royalty revenues amounted to €14.7 million, an increase of 16% over the same period of the previous year. This growth was led by royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the US, which increased by 9% to €12.7 million[1].

In addition to the royalties received from Jazz Pharmaceuticals through March 31st, 2025, royalties on trabectedin sales from our partners in the U.S. and Japan totaled €2.0 million, almost double the €1.1 million recorded in the first quarter of 2024.

With regard to non-recurring revenues from licensing agreements, at the end of the first quarter of 2025, these amounted to €1.0 million, compared with €6.0 million as of March 31st, 2024. Both figures come from the recognition as revenue of a portion of the deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to Zepzelca.

In the current fiscal year, the annual imputation of income related to this agreement is estimated at €4 million, while the total for the previous year was approximately €23 million. Of the total €300 million of income received in 2020 in connection with this agreement, 93% has already been taken to income in recent years. The remaining 7% will be recognized in future fiscal years.

As a result, PharmaMar Group reported 2% growth in total revenues in the first quarter of 2025, to €38.9 million.

PharmaMar Group R&D expenditure amounted to €21.3 million, 22% less than in the first quarter of 2024.

Of total R&D expenditure in the period, the oncology segment accounted for €19.8 million, compared with €24.6 million at March 31st, 2024. This change is mainly due to the completion of recruitment in December 2024 for the LAGOON Phase III clinical trial with lurbinectedin in small-cell lung cancer.

In the RNAI segment 1.5 million was allocated, compared with €2.6 million in the same period of the previous year. This variation is due to the completion in the first months of 2024 of the PIVO1 phase III clinical trial with tivanisiran for dry eye disease.

In addition, the Company continues to invest in the clinical development of three molecules at earlier stages. Two Phase II clinical trials are underway with ecubectedin, as well as Phase I clinical trials with PM534 and PM54, all for the treatment of solid tumors.

EBITDA improved, compared to the same period of the previous year, standing at- € 1.1 M compared to € -2.7 M in the first quarter of 2024.

Net income, as of March 31st, 2025, stands at -€3.9 M compared to a profit of € 2.3 as of March 31st, 2024. This difference is due to the positive financial results recorded in March 2024 in addition to a positive income tax balance.

At March 31st 2025, the PharmaMar Group recorded a cash and cash equivalents balance of €142.2 million, with total financial debt of €48.5 million. As a result, the net cash position at end of the first quarter of 2025 was €93.7 million.