On April 29, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients, reported that five presentations of clinical and preclinical data from the Company’s induced pluripotent stem cell (iPSC) product platform will be featured at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting, being held in New Orleans, Louisiana on May 13-17, 2025 (Press release, Fate Therapeutics, APR 29, 2025, View Source [SID1234652308]).

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The Company has been selected to deliver an oral presentation on the translational data from its Phase 1 clinical trial of FT522, an off-the-shelf, CD19-targeted CAR NK cell product candidate, in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334). FT522 is the first product candidate to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In addition, the Company will highlight preclinical data from its off-the-shelf, iPSC-derived, CAR T-cell product platform across autoimmune disease, hematological malignancy and solid tumor indications.

Accepted abstracts are available on the ASGCT (Free ASGCT Whitepaper) Annual Meeting website. Presentation details are as follows:

Oral Presentation

Phase 1 Translational Assessment of an Off-The-Shelf CAR NK Cell Armed with Alloimmune Defense Technology for Conditioning-free Therapy

Session: Innovation in Alternative Cell Therapy Sources
Location: Room 391-392
Presentation Date / Time: Saturday, May 17, 2025, 11:00 AM CT

Poster Presentations

Alloimmune Defense Receptor Combined with Genetic Ablation of Adhesion Ligand CD58 is a Comprehensive Approach to Promote Functional Persistence of Allogeneic Cell Therapies without Conditioning Chemotherapy

Poster Number: 758
Presentation Date / Time: Tuesday, May 13, 2025, 6:00 PM CT

Targeting UPAR With Multiplexed-Engineered iPSC-Derived CAR T Cells to Reverse Age- and Insult-Related Fibrotic Disease

Poster Number: 789
Presentation Date / Time: Tuesday, May 13, 2025, 6:00 PM CT

Next-Generation Off-the-Shelf CAR T-Cell Therapies for Conditioning-Free Treatment of a Broad Spectrum of Autoimmune Diseases and Hematologic Malignancies

Poster Number: 1259
Presentation Date / Time: Wednesday, May 14, 2025, 5:30 PM CT

FT836, a Novel MICA/B-targeting CAR T-cell Therapy Engineered to Eliminate the Need for Conditioning Chemotherapy with Broad Activity Across Solid Tumor Indications

Poster Number: 1229
Presentation Date / Time: Wednesday, May 14, 2025, 5:30 PM CT

On April 29, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA TROP2 (EPR20043) RxDx Device (Press release, Hoffmann-La Roche, APR 29, 2025, View Source [SID1234652307]). This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

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"This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology," said Matt Sause, CEO of Roche Diagnostics. "This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment."

The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the VENTANA TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.

The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods.

"This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

About the VENTANA TROP2 (EPR20043) RxDx Device
The VENTANA TROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration (AGA) most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). A qualified pathologist is responsible for reviewing staining and image quality, as well as ensuring adequate tumor detection sensitivity and precision, in conjunction with histological examination, relevant clinical information, and proper controls.

Following the pathologist assessment, the nDP TROP2 algorithm independently detects tumor cells and generates associated measures of TROP2 IHC staining intensity in both membrane and cytoplasm to compute the Normalised Membrane Ratio (NMR) score. The algorithm then classifies the TROP2 status as positive or negative based upon the pre-defined NMR cutoff.

On April 29, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that the Company will be presenting a poster at the upcoming European Society for Medical Oncology’s ("ESMO") Breast Cancer meeting, following its promising survival observations among patients with metastatic triple-negative breast cancer ("mTNBC") treated with leronlimab (Press release, CytoDyn, APR 29, 2025, View Source [SID1234652305]). The conference will take place on May 14-17, 2025, in Munich, Germany, and CytoDyn’s presentation is scheduled for May 15, 2025.

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As announced in February 2025, a review of patients treated with leronlimab during CytoDyn’s prior clinical trials in oncology revealed observed survival rates at 12, 24, and 36 months that compare favorably to expected outcomes with currently approved therapies. The Company has also now confirmed survival outcomes in a group of patients with mTNBC and four prior lines of treatment who are alive more than 48 months after receiving leronlimab. This includes four patients who currently identify as having no evidence of ongoing disease and a fifth patient who is alive with stable disease. CytoDyn has already initiated a follow-up protocol to continue to monitor these surviving patients into the future.

"We look forward to sharing details on the progress we have made advancing our clinical development pipeline for leronlimab in oncology," said Dr. Lalezari. "We are also excited to share information about the apparent mechanism of action in long-term surviving patients that we see as a potentially paradigm-shifting development in solid tumor oncology."

Dr. Lalezari will be joined at the conference by Dr. Richard Pestell, MD, PhD, AO, Lead Consultant in Preclinical and Clinical Oncology, who will present during the poster display session in Hall B0 on Thursday, May 15 from 12:00-12:45PM CEST. Several other CytoDyn key opinion leaders will also be attending the conference.

On April 29, 2025 Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing therapeutics targeting metalloenzymes, reported the company will present data on its oncology program targeting flap endonuclease 1 (FEN1), a structure-specific metallonuclease that cleaves 5′ DNA flaps during replication and repair, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30 at the McCormick Place Convention Center, Chicago, IL (Press release, Blacksmith Medicines, APR 29, 2025, View Source [SID1234652304]).

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Details of the poster presentation are as follows:

Abstract Number: 5720
Title: "Novel FEN1 nuclease inhibitor shows synergy with PARP-targeting drugs"
Session Category: Experimental and Molecular Therapeutics
Session Title: PARP Inhibitors
Session Date and Time: Tuesday April 29, 2025 2:00 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 7

The abstract is now available on the conference website at AACR (Free AACR Whitepaper) Annual Meeting 2025.

About FEN1
Flap endonuclease 1 (FEN1) is a structure-specific di-magnesium metallonuclease that cleaves 5′ DNA flaps during replication and repair. FEN1 is an attractive target for development of anticancer therapeutics because it is overexpressed in many tumor types and has a large number of synthetic lethality partners including genes in Homologous Recombination (HR) pathway.

About metalloenzymes and the Blacksmith platform
Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following:

A large proprietary fragment library of metal-binding pharmacophores (MBPs);
A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease;
A first-of-its-kind metallo-CRISPR library of custom single guide RNAs;
An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and
A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines.

On April 29, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the presentation of additional human imaging data that validate the potential of MT1-MMP, a tumor antigen overexpressed in many cancers, as a novel target for cancer treatment and demonstrate the positive properties of Bicycle Radioconjugates (BRC) for radiopharmaceutical imaging (Press release, Bicycle Therapeutics, APR 29, 2025, View Source [SID1234652303]). The data will be presented today during a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago.

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"The additional imaging data using an early BRC molecule continue to validate the potential of MT1-MMP as a novel cancer target, demonstrate the translatability of our preclinical data and position our technology for use as potential radiopharmaceutical therapies," said Michael Skynner, Ph.D., chief technology officer of Bicycle Therapeutics. "The new imaging data from the second patient with breast and bladder cancer presented today build on what was previously demonstrated in the first patient with advanced lung cancer, and we are encouraged that these data represent what we have seen so far in 12 patients with various solid tumors. We continue to advance our radiopharmaceuticals pipeline and look forward to sharing additional updates in the future, including initial human imaging data for our second target EphA2 later this year and the start of our first company-sponsored clinical radiopharmaceutical trials next year."

AACR 2025 Data Highlights

The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), will present human imaging data conducted with an early BRC molecule targeting MT1-MMP. Imaging was performed in a 65-year-old male diagnosed with advanced pulmonary adenocarcinoma, the most common type of non-small cell lung cancer, and an 84-year-old female diagnosed with invasive ductal breast cancer and high-grade urothelial (bladder) cancer.

The 65-year-old male patient with advanced pulmonary adenocarcinoma underwent fluorine-18-labelled FDG-PET/CT imaging and two weeks later underwent MT1-MMP-PET/CT imaging up to one hour post injection of the gallium-68-labelled BRC tracer. As presented at a previous medical meeting, the MT1-MMP-PET scan demonstrated BRC tracer uptake in the primary tumor in the lung and in the lymph nodes and bones where the cancer had spread, corroborating the findings of the FDG-PET scan. While MT1-MMP-PET imaging demonstrated lower BRC tracer uptake in the primary tumor compared to FDG-PET imaging [maximum standardized uptake value (SUVmax) 6.0 g/mL vs. 10.3 g/mL], MT1-MMP-PET BRC tracer uptake was comparable in lymph node metastases (SUVmax 4.7 g/mL vs. 4.4 g/mL) and higher in bone metastases (SUVmax 7.9 g/mL vs. 6.0 g/mL).

The 84-year-old female patient with invasive ductal breast cancer and high-grade urothelial cancer underwent contrast-enhanced CT imaging and later underwent MT1-MMP-PET/CT imaging up to one hour post injection of the gallium-68-labelled BRC tracer. The MT1-MMP-PET scan revealed higher BRC tracer uptake in the primary tumors in the breast (SUVmax 4.5 g/mL) and the bladder (SUVmax 6.6 g/mL) compared to contrast-enhanced CT imaging. The MT1-MMP-PET scan also showed the cancer spread to the lymph nodes, lower spine (sacral bone) and skull, and detected a mass in the adrenal gland above the left kidney. Surgery confirmed the patient had bladder cancer that spread to the lymph nodes, and immunohistochemistry (IHC) testing confirmed MT1-MMP expression in the tumor cells.

These data are representative of the results seen in 12 out of 14 patients with various cancers, including those affecting the lung, head and neck, and bladder, who have undergone MT1-MMP-PET imaging to date. Imaging was unsuccessful or inconclusive in two patients. Overall, the results demonstrate the rapid distribution of the BRC tracer throughout the body, high uptake of the BRC tracer in the primary tumor(s) and/or in metastases where the cancer spread in the body, and elimination through the kidneys. Scans showing retention in the kidneys were in line with expectations given the imaging was conducted using a pathfinder non-optimized BRC imaging agent. Additional and more detailed analyses of the data and confirmation of MT1-MMP expression in the tumors via IHC are ongoing.

The poster presentation, "Development and clinical translation of phage display derived MT1-MMP-specific bicyclic peptide for radiotheranostic applications," is available in the Publications section of the Bicycle Therapeutics website.