On March 25, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has entered into a letter of intent with VERDI Solutions, GmbH to develop personalized and off-the-shelf peptide vaccines for cancer patients (Press release, Anixa Biosciences, MAR 25, 2025, View Source [SID1234651433]).

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VERDI Solutions, headquartered in Vienna, Austria, is pioneering personalized cancer treatment by integrating artificial intelligence (AI) and advanced cloud computing to accelerate the development and implementation of personalized cancer vaccines. By combining computerized vaccine design with real-world data collection and clinical trials, VERDI is making personalized cancer vaccines accessible to more patients worldwide. At the core of VERDI’s innovation is its cloud-computing platform, which enables the rapid development of personalized peptide vaccines tailored to individual cancer patients. Additionally, the company is developing off-the-shelf cancer vaccines, paired with companion diagnostics to identify likely responders and optimize treatment outcomes.

In some European countries, oncologists may administer personalized cancer vaccines under Individueller Heilversuch (Individual Healing Attempt), which allows physicians to prescribe individualized treatments for patients with life-threatening conditions who lack satisfactory therapeutic alternatives. Unlike clinical trials, where only a limited number of eligible patients can be enrolled, Heilversuch offers an innovative treatment option for any cancer patient, potentially providing valuable insights into the efficacy and safety of personalized vaccines in real-world settings. Moreover, Heilversuch aligns with the increasing recognition by global regulatory agencies of real-world evidence (RWE) as a critical component of drug development. VERDI is pioneering a data-driven approach to accelerating regulatory validation and commercialization of personalized cancer vaccines.

VERDI has successfully developed personalized vaccines using sequence data from the primary tumors for three patients with bone metastases, which were administered by their oncologists under Heilversuch. These patients experienced clinical benefits, including significant pain relief caused by bone metastases and improved quality of life. While these outcomes highlight the potential of VERDI’s platform to scale personalized cancer care, further clinical validation is needed.

Under the letter of intent, VERDI has granted Anixa a six-month exclusive right to negotiate a transaction for the research, development, and commercialization of VERDI’s cancer vaccines. While VERDI continues to develop personalized vaccines for individual treatment attempts in Europe, VERDI and Anixa plan to initiate clinical trials in the United States.

"We utilize advanced cloud computing to develop a set of personalized VERDI vaccines for each patient from their sequence data. Our proprietary algorithm predicts the efficacy of the vaccines to recognize and eliminate tumor cells in the individual patient. Our unique approach models the complex mechanisms of tumor-specific immune responses at an individual level, potentially enabling faster and more effective personalized vaccine development using state-of-the-art science compared to existing neoantigen-based cancer vaccines. Our initial results in three patients are highly encouraging, and we are eager to demonstrate broader clinical benefits in additional patients," stated Dr. Julianna Lisziewicz, Founder and CEO of VERDI.

Dr. Amit Kumar, Chairman and CEO of Anixa stated, "We are very pleased to be working with VERDI Solutions on this exciting technology that has already demonstrated benefit to terminally ill patients. The letter of intent with VERDI provides us with the optionality to collaborate on the further development of VERDI’s technology, while preserving our ability to structure the relationship in a way that is mutually beneficial to both parties. Additionally, partnering with VERDI aligns with our strategy of implementing a capital-efficient business model for personalized cancer care."

On March 25, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 from April 25-30, 2025, in Chicago (Press release, Nuvalent, MAR 25, 2025, View Source [SID1234651432]).

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Details of the poster presentations are as follows:

Title: Mutagenesis screens support potential best-in-class profile for neladalkib (NVL-655), a brain-penetrant and TRK-sparing ALK inhibitor
Authors: Anupong Tangpeerachaikul*1, Henry E. Pelish1
Abstract Number: 1729
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 1
Session Date and Time: April 28, 2025, from 9:00 a.m.– 12:00 p.m. CT
Location: Poster Section 21
Poster Board Number: 4

Title: Crystal structure of drug-resistant ROS1 G2032R in complex with zidesamtinib, a clinical-stage ROS1 inhibitor with best-in-class potential
Authors: Joseph M. Magrino*1, Anupong Tangpeerachaikul1, Scot Mente1, Henry E. Pelish1
Abstract Number: 5616
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 3
Session Date and Time: April 29, 2025, from 2:00 p.m.– 5:00 p.m. CT
Location: Poster Section 20
Poster Board Number: 26

*Presenter, corresponding author; 1Nuvalent, Inc., Cambridge, MA, USA

About Zidesamtinib
Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

About Neladalkib
Neladalkib is a novel brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

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

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.

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.