ADC Therapeutics Announces Abstracts Accepted for Presentation at the American Association for Cancer Research Annual Meeting 2025

On March 25, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported abstracts detailing multiple preclinical programs have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025, in Chicago, Illinois (Press release, ADC Therapeutics, MAR 25, 2025, View Source [SID1234651431]).

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"We are excited to present preclinical data on our exatecan-based Claudin-6, PSMA, and ACST2-targeting antibody-drug conjugates," said Patrick van Berkel, PhD, Chief Scientific Officer of ADC Therapeutics. "These ADCs hold promise for targeted cancer treatment in a broad range of cancer types, and we are pleased to have the opportunity to share our learnings across select solid tumors where there remains unmet need."

Details of ADC Therapeutics’ oral presentation at AACR (Free AACR Whitepaper) are as follows:

Title: Preclinical investigation of ADCT-242, a novel exatecan-based antibody drug conjugate targeting Claudin-6, as single agent or in combination in ovarian and non-small lung cancer models
Abstract: 1163
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody-Based Cancer Therapeutic Agents
Date and Time: Sunday, April 27, 2025, 3:00-5:00 p.m. CT
Presenter: Chris Pickford, Head of Clinical Research, ADC Therapeutics

Details of ADC Therapeutics’ poster presentations at AACR (Free AACR Whitepaper) are as follows:

Title: Preclinical Development of ADCT-241, a Novel Exatecan-based Antibody-Drug Conjugate Targeting PSMA for the Treatment of Prostate Cancer
Abstract: 6736
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody-Based Cancer Therapeutics 4
Date and Time: Wednesday, April 30, 2025, 9:00 a.m. – 12:00 p.m. CT
Presenter: Ben Leatherdale, Senior Scientist, ADC Therapeutics

Title: HuB14-VA-PL2202, a novel antibody-drug conjugate targeting ASCT2, a novel ADC target over-expressed in both solid and hematological cancers
Abstract: 1580
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody-Based Cancer Therapeutics 1
Date and Time: Monday, April 28, 2025, 9:00 a.m. – 12:00 p.m. CT
Presenter: Danilo Cucchi, Senior Scientist, ADC Therapeutics

Adcentrx Therapeutics to Showcase Novel STEAP1 and NaPi2b ADCs with Oral and Poster Presentations at AACR 2025

On March 25, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, (April 25-30, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, MAR 25, 2025, View Source [SID1234651430]).

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The company will deliver an oral presentation on ADRX-0405, its clinical-stage STEAP1 ADC, and a poster presentation on ADRX-0134, its preclinical NaPi2b ADC. The presentations will underscore the versatility of Adcentrx’s ADC platform, showing advancements in therapeutic window expansion, bystander effect optimization, and payload delivery improvements for targeted cancer therapy. These innovations are powered by Adcentrx’s proprietary i-Conjugation technology, which integrates stable conjugation chemistry and a cleavable linker to optimize ADC properties, ensuring optimal payload delivery and therapeutic efficacy.

ADRX-0405, Adcentrx’s second clinical program and potential first-in-class STEAP1 ADC, has the opportunity to expand treatment options for metastatic castration-resistant prostate cancer (mCRPC) and other STEAP1-expressing tumors, where targeted therapy options remain limited. Featuring a novel topoisomerase inhibitor linker-payload, ADRX-0405 represents a distinct therapeutic approach for this disease with a high unmet need for more tolerable and effective therapies.

ADRX-0134 is a preclinical NaPi2b ADC incorporating AP052, the same clinically validated microtubule inhibitor payload used in Adcentrx’s lead program, ADRX-0706 (Nectin-4 ADC), currently enrolling patients in Phase 1b (NCT06036121). ADRX-0134 offers a differentiated approach for patients with lung and ovarian cancers, where few viable treatment options are available.

Details of the oral and poster presentations are as follows:

Oral Presentation
Title: Preclinical characterization of a novel STEAP1 antibody-drug conjugate ADRX-0405 for the treatment of mCRPC
Abstract Number: 1159
Session Date & Time: Sunday, April 27, 3:25 p.m. – 3:40 p.m. CST
Session Title: Antibody-Based Cancer Therapeutic Agents

Poster Presentation
Title: ADRX-0134 as a novel auristatin-based NaPi2b antibody-drug conjugate with widened therapeutic window
Abstract Number: 1563
Session Date & Time: Monday, April 28, 9:00 a.m. – 12:00 p.m. CST
Session Title: Antibody-Based Cancer Therapeutics 1

About i-Conjugation Technology
Adcentrx’s proprietary i-Conjugation technology platform is an important component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0405
ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody and novel topoisomerase inhibitor linker-payload conjugated at a drug-to-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

About ADRX-0134
ADRX-0134 is a state-of-the-art preclinical ADC targeting NaPi2b, a cell surface sodium-dependent phosphate transporter expressed in lung and ovarian cancers with minimal expression in normal healthy tissues. The ADC is a human IgG1 antibody conjugated at DAR8 with Adcentrx’s clinically validated AP052 tubulin inhibitor payload, substantially expanding the therapeutic window of auristatin-based ADCs beyond existing vedotin technology. ADRX-0134 preclinical studies have demonstrated strong efficacy in lung and ovarian tumor models, and the ADC’s pharmacokinetics and safety profile are also favorable.

Kelun-Biotech’s Radionuclide-Drug Conjugate (RDC) SKB107 Receives NMPA Approval For The Treatment of Bone Metastases in Solid Tumors

On March 25, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration (Press release, Kelun, MAR 25, 2025, View Source [SID1234651429]). SKB107 is the first company RDC drug clinical project.

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SKB107 is jointly developed by the Company and Professor Chen Yue’s team of the Affiliated Hospital of Southwest Medical University (the "Affiliated Hospital of SMU"). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023.

About Bone Metastasis of Malignant Tumors

Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors[1]. Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients’ quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients’ quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients’ survival, and the development of new mechanisms of action and safer and more effective drugs is imminent.

WuXi Biologics Reports Solid 2024 Annual Results and Expects Accelerated Growth in 2025

On March 25, 2025 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its audited annual results for the year ended December 31, 2024 ("Reporting Period") (Press release, WuXi Biologics, MAR 25, 2025, View Source [SID1234651428]).

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Financial Highlights

Revenue: For the year ended December 31, 2024, the Group’s revenue grew 9.6% YoY to RMB18,675.4 million, with non-COVID revenue increasing 13.1% YoY. The growth was primarily driven by: (i) the successful execution of the Group’s "Follow and Win the Molecule" strategies, coupled with the leading technology platform, best-in-industry timeline and excellent execution track record; (ii) enlarged spectrum of services offered to the biologics industry, fast growing technology platforms including ADCs and bispecific antibodies; (iii) growth of research services revenue generated from the Group’s various cutting-edge technologies; and (iv) the utilization of existing and newly expanded capacities, including ramp-up of the manufacturing sites in Europe.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 12.1% YoY to RMB7,650.8 million, while adjusted gross profit rose 9.8% YoY to RMB8,479.5 million. IFRS gross profit margin reached 41.0%, with an adjusted gross profit margin of 45.4%. The increase in gross profit and margin was primarily due to the efficiency improvements driven from WBS and digitalization, and also the improvements of the ramp-up impacts from the recently commissioned facilities in Europe and the U.S. as expected.

EBITDA and EBITDA Margin: For the year ended December 31, 2024, EBITDA grew 16.7% to RMB6,547.8 million, while adjusted EBITDA increased 14.4% YoY to RMB7,999.3 million. EBITDA margin reached 35.1%, with an adjusted EBITDA margin of 42.8%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 10.5% YoY to RMB3,945.4 million. Net profit attributable to owners of the Company was RMB3,356.1 million, reflecting a slight YoY decline of 1.3%.

Adjusted Net Profit: Adjusted Net Profit for the period increased 9.0% YoY to RMB5,396.9 million. Adjusted net profit margin was 28.9%.

Basic Earnings Per Share (EPS): The Group’s basic earnings per share (EPS) remained flat at RMB 0.82 for the years ended December 31, 2024 and 2023. Diluted EPS slightly increased by 1.3% from RMB 0.77 for the year ended December 31, 2023 to RMB 0.78 for the year ended December 31, 2024.

Business Highlights

Integrated Project Wins
The Group added 151 integrated projects in 2024, bringing the total to 817. Notably, over half of the new projects originated from U.S. clients, reflecting strong client trusts and the Group’s resilience amid a dynamic environment. The Group supported 66 Phase III projects and 21 non-COVID commercial projects, strengthening its manufacturing pipeline.

During the Reporting Period, the Group continued to execute its "Win-the-Molecule" strategy, securing 20 post-IND projects, including 13 in late-phase and commercial stage, bringing total wins to 89 since 2018.

Research
By leveraging industry-leading technology platforms, the Group’s Research business has reached an inflection point following years of strategic cultivation. The Group has developed a portfolio of leading Immune Cell Engager (ICE) technologies, extending beyond traditional T-cell engagers (TCEs). Our diverse immune cell-targeting modalities—including CD3 Bispecific T Cell Engagers, Non-cytotoxic T Cell Engagers, γδ T Cell Engagers, NK Engagers, and Macrophage Engagers—are designed to unlock novel therapeutic potential in oncology and autoimmune diseases.

The Group is advancing these innovations in close collaboration with its clients and partners, driving the development of next-generation anti-tumor and autoimmune therapies. In 2024, the Group enabled seven global programs for molecule discovery and is eligible to receive approximately $140 million in near-term payments, with total potential payments exceeding $2.3 billion. To date, the Group’s Research Services has enabled 50+ programs that are potentially eligible for future milestone payments and sales royalties, establishing a consistent revenue and profit stream.

Development
The Group added 148 new development projects in 2024, further strengthening one of the industry’s largest portfolios of complex biologics. This portfolio includes 151 bispecifics & multispecifics, 194 ADCs, 80 fusion proteins and 24 vaccines. The Group continues to advance cutting-edge technology platforms that accelerate biologics development and manufacturing. Key platforms include WuXia (cell line development), WuXiDARx (drug-to-antibody ratio technology), WuXiHigh (high concentration and high-throughput DP Development), WuXiUI (ultra-intensified fed-batch platform) and WuXiUP (ultra-high productivity continuous bioprocessing platform).

Highlighting the unique advantages of its CRDMO platform and industry-leading technologies, the Group’s client, Curon Biopharmaceutical’s investigational B-cell depletion therapy, CN201, was acquired by Merck & Co., Inc. in 2024. This asset was discovered through the Group’s proprietary TCE and WuXiBody platforms, while WuXiUP effectively addresses complex CMC challenges.

The Group has shortened the development timeline for monoclonal antibody projects from DNA to IND to just nine months and successfully supported over 600 IND applications by the end of the Reporting Period. These advancements help clients accelerate development cycles and achieve cost-effective solutions across the biologics value chain.

Manufacturing
In 2024, the Group supported 66 Phase III projects and 21 non-COVID commercial manufacturing projects, completed 16 process performance qualification (PPQ) projects, with 24 scheduled for 2025. The Group also achieved a DS and DP PPQ success rate exceeding 98%, establishing a solid foundation for commercial manufacturing operations.

To further support its growing commercial pipeline and meet client needs, the Group continues to execute its "Global Dual Sourcing" strategy, providing comprehensive manufacturing services through its global network.
Ireland: All three facilities have secured GMP certification from the Irish Health Products Regulatory Authority (HPRA) and completed multiple 16,000-liter PPQ runs. The site also initiated commercial production in 2024.
Singapore: The lifting of fabricated modules for XDC’s Production Facility has been completed, with critical utilities in the final phase of design and construction. Additionally, significant progress has been made in the design of Biologics’ Production Assets.
U.S: The Group continues the expansion of MFG11 at Worcester, MA, one of the largest single-use-technology facilities in the U.S., featuring six 6,000L upstream tanks connected to a single downstream line, with high-throughput processing and extensive automation. Upon completion, MFG11 will be integrated with MFG18 (Cranbury, NJ), and Boston Research Service Center, enabling the Group to offer end-to-end capabilities in the U.S., from research, development, clinical manufacturing, to both small- and large-scale commercial manufacturing.

Asset optimization
In January 2025, the Group and MSD International GmbH entered into an agreement for the asset transfer of WuXi Vaccine’s Dundalk, Ireland facility. This transaction enables MSD International GmbH to better integrate vaccine production within its global network while enhancing the Group’s operational flexibility, asset efficiency and margins. The Group will focus on its vaccines CDMO services from WuXi Vaccines’ Suzhou, China site.

Backlog
As of December 31, 2024, total backlog stood at US$18.5 billion, comprising US$10.5 billion in service backlog and US$8.0 billion in potential milestones. Backlog within 3 years was US$3.7 billion. Following the announced asset transaction with MSD International GmbH, approximately US$3 billion in services backlog was removed. Adjusting for this divestiture, backlog grew by approximately US$0.9 billion YoY.

Quality
The Group remains committed to the highest quality standards, safeguarding the interests of clients and patients. Backed by a world-class quality system, the Group has successfully completed 42 regulatory inspections by various national regulatory agencies since 2017, including 22 by EU EMA and U.S. FDA, with no critical issues and zero data integrity findings. In Q4 2024, the Group successfully passed the HPRA inspection in Ireland with no critical observations. These regulatory milestones further validate the Group’s premier quality system, which adheres to the highest global quality standards.

Talents
People are WuXi Biologics’ greatest assets. As of December 31, 2024, the Group’s total employee count reached 12,575, including 4,383 scientists, with a key talent retention rate of 95.8%. The Group’s successful global recruitment efforts strengthened its worldwide operations, enabling it to efficiently deliver project commitments and drive continuous innovation.

WBS (WuXi Biologics Business System)
The Group has been continuously focusing on its WBS initiatives, driving operational excellence and efficiency. In 2024, the Group executed over 260 WBS Kaizen events, achieving 1-point improvement in gross profit margin through cost-savings, enhanced labor productivities, and inventory reductions. Additionally, ESG-focused Kaizen projects reduced carbon emissions, water usage, waste generation, and material consumption. The Group remains committed to establishing WBS as a lean management system, fostering continuous improvement, talent development, and further enhancing value creation for its clients.

Sustainability
The Group has integrated Sustainability as a core pillar of its business growth strategy, earning widespread recognition from leading ESG rating agencies and institutional investors. Notable achievements encompass the inclusion in the Dow Jones Sustainability Indices, an AAA rating from MSCI ESG Ratings, a Platinum Medal from EcoVadis, and recognition as an ESG Industry Top-Rated and APAC Regional Top-Rated Company by Sustainalytics.

During the Reporting Period, the Group was also selected in the S&P Global Sustainability Yearbook 2024, MSCI ESG Leaders Indexes 2024, FTSE4Good Index Series, and Hang Seng ESG 50 Index.
Management Comment

Dr. Chris Chen, CEO of WuXi Biologics, stated, "In 2024, we navigated many crosscurrents in the macro environment, remained resilient and delivered a solid 9.6% YoY growth in the Group revenue. Empowered by our unique CRDMO business model and well-established ‘Follow and Win the Molecule’ strategies, we are confident in our ability to provide unparalleled support to our clients, ensuring the delivery of sustainable outcomes in 2025 and beyond."

Dr. Chen added, "Looking ahead, we anticipate accelerated and profitable growth in 2025 and beyond, driven by strong performances across all Research, Development, and Manufacturing platforms. With enhanced operational efficiencies, increasing adoption of next-generation technology platforms, and disciplined execution of our strategic initiatives, we are well-positioned to capture new opportunities and drive innovation."

Dr. Ge Li, Chairman of WuXi Biologics, concluded, "In 2024, we remained steadfast in our mission and vision – to empower anyone and any company to discover, develop and manufacture biologics from concept to commercial manufacturing. As we look ahead, we are committed to delivering exceptional value to our partners, reinforcing our position as a premier, one-stop service provider for the biologics industry, and advancing our vision that ‘every biologic can be made’."

Key Financial Ratios

(For the Twelve Months Ended Dec. 31)

Key Financial Ratio

2024

2023

Change

Revenue (In RMB million)

18,675.4

17,034.3

9.6 %

Gross Profit (In RMB million)

7,650.8

6,827.9

12.1 %

Margin (%)

41.0 %

40.1 %

Net Profit (In RMB million)

3,945.4

3,570.6

10.5 %

Margin (%)

21.1 %

21.0 %

Net Profit Attributable to Owners of
the Company (In RMB million)

3,356.1

3,399.7

(1.3 %)

Margin (%)

18.0 %

20.0 %

Adjusted Net Profit (In RMB million)

5,396.9

4,950.4

9.0 %

Margin (%)

28.9 %

29.1 %

EBITDA (In RMB million)

6,547.8

5,613.2

16.7 %

Margin (%)

35.1 %

33.0 %

Adjusted EBITDA (In RMB million)

7,999.3

6,993.0

14.4 %

Margin (%)

42.8 %

41.1 %

Adjusted Basic EPS (In RMB)

1.17

1.13

3.5 %

Rgenta Therapeutics Announces Presentation at the American Association for Cancer Research (AACR) 2025 Annual Meeting

On March 25, 2025 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that preclinical data will be presented on its lead program, RGT-61159, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, which will be held from April 25-30, 2025, in Chicago, IL (Press release, Rgenta Therapeutics, MAR 25, 2025, View Source [SID1234651427]).

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Title: RGT-61159, Best-in-class Oral Small Molecule Inhibitor of MYB via Selective RNA Splicing Alteration, Synergistic Anti-Tumor Activity When Combined with Standards of Care in Leukemia Disease Models Harboring AML Common Genetic Lesions and with NOTCH Inhibitors in ACC Disease Models
Authors: Norman Lu, Patricia Soulard, Kai Li, Xiubin Gu, Ibrahim Kay, Sam Hasson, Chris Yates, Zhiping Weng, Simon Xi, Travis Wager
Session category: Chemistry
Session title: Targeted Protein Degradation
Session date and time: April 30, 2025, 9:00 -12:00 PM CT
Abstract #: 7013 (Poster section 26 / Poster board #13)

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein and potential cell death of the cancer cells that overexpress the MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemia (AML), T-cell acute lymphoblastic leukemia (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics and target engagement and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).