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IN8bio to Present Clinical and Preclinical Data from Gamma-Delta T Cell Platform at Upcoming Scientific Conferences

On April 29, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported that it will present new clinical and preclinical data from its pipeline of gamma-delta T cell therapies at several upcoming scientific conferences (Press release, In8bio, APR 29, 2025, View Source [SID1234652311]).

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"The breadth of data we’re presenting at upcoming medical conferences reflects the scientific rigor and clinical potential of IN8bio’s gamma-delta T cell platform," said William Ho, CEO and co-founder, IN8bio. "From our INB-200/400 program in newly glioblastoma to our novel T cell engager technologies, we are expanding the therapeutic applications of this unique class of therapies. These presentations highlight IN8bio’s capabilities, know-how in manufacturing, and the clinical potential of our programs to help patients with significant unmet needs across oncology and immune-mediated diseases."

Upcoming presentations:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025

Poster Title: A novel gamma-delta T cell engager platform for cancer immunotherapy
Abstract Presentation Number: 7321 (Poster Board 7)
Session Title: Immunology/T Cell Engagers and Novel Antibody-Based Therapies
Date/Time: Wednesday, April 30, 2025, 9:00 – 12:00 PM CDT
Location: McCormick Place Convention Center, Chicago, IL
More information: www.aacr.org/meeting/aacr-annual-meeting-2025/abstracts.

International Society for Cell & Gene Therapy (ISCT) 2025

Oral Presentation Title: From Donor to Therapy: How Robust Manufacturing Shapes the TCR Repertoire and Cytotoxic Power of Donor-Derived Allogeneic ex vivo Expanded and Activated γδ T Cell Products*
Date/Time: Friday, May 9, 2025, 3:00 – 4:00 PM CDT
Presenter: Mariska ter Haak, Senior Director Analytical Development, IN8bio
Session: Oral Abstract Session – Immunotherapy (CAR-T, T Reg, NK Cells etc.)
*Host Region (US East) Abstract Award

Poster Presentation Title: Selection and Implementation of the Electronic Quality Management System for High Complexity Clinical Stage Cellular Therapy Company
Date/Time: Thursday, May 8, 2025, 6:00 – 7:30 PM CDT
Presenter: Guoling Chen, Senior Director of Quality Operations, IN8bio
More information: View Source

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2025 Conference

Poster Presentation Title: INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells
Date/Time: Thursday, May 15, 2025, Time: 5:30 – 7:00 PM CDT
Presenter: Lawrence Lamb, Ph.D., Co-Founder and Chief Scientific Officer, IN8bio
Location: Poster Hall I2, New Orleans Ernest N. Morial Convention Center

Oral Presentation Title: Decoding the Molecular Signature of Expanded Gamma-delta T Cell Products; TCR and Immune Gene Expression from Allogeneic derived Products
Title: Molecular and Cellular Methods – Applications
Date/Time: Saturday, May 17, 2025, 10:30 – 10:45 AM CDT
Presenter: Mariska ter Haak, Senior Director Analytical Development, IN8bio
Location: NOLA Theater B, New Orleans Ernest N. Morial Convention Center
More information: View Source

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025

Oral Presentation Title: INB-200: Phase 1 study of gene-modified autologous gamma-delta (γδ) T cells in newly diagnosed glioblastoma multiforme (GBM) patients receiving maintenance temozolomide (TMZ).
Presenter: Louis "Burt" Nabors, MD
Abstract #: 2007
Session: Central Nervous System Tumors
Session Type: Oral Abstract Session
Session Date and Time: May 30, 2025, 2:45 – 5:45 PM CDT
Presentation Time/Duration: 4:57 – 5:09 PM CDT
More information: View Source

iBio Raises $6.2 Million Through Warrant Inducement Transaction

On April 29, 2025 iBio, Inc. (Nasdaq: IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody therapies, announces reported that it has entered into an agreement with institutional investors that are existing holders of warrants to purchase shares of common stock of the Company for cash (the "Existing Warrants"), wherein the investors agreed to exercise the Existing Warrants to purchase 5,626,685 shares of common stock at a reduced exercise price of $1.11 per share, resulting in gross proceeds of approximately $6.2 million, before deducting advisory fees and certain other expenses (Press release, iBioPharma, APR 29, 2025, View Source [SID1234652310]). The Company intends to use the net proceeds for working capital and other general corporate purposes.

In consideration for the exercise of the Existing Warrants for cash, the investors received new warrants (the "New Warrants") to purchase up to an aggregate of 11,253,370 shares of common stock. The New Warrants are exercisable at $0.86 per common share, and expire five years from the issuance date. The closing of the warrant inducement transaction is expected to occur on or about April 30, 2025, subject to satisfaction of customary closing conditions.

Chardan acted as the exclusive financial advisor in connection with the transaction.

The securities in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. iBio granted registration rights to the purchasers of the New Warrants, and has agreed to file a registration statement with the Securities and Exchange Commission registering the shares of common stock issuable upon exercise of the New Warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Genprex Collaborators to Present Positive Preclinical Data on Diabetes Gene Therapy at the ASGCT 28th Annual Meeting

On April 29, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators have been selected to present at the upcoming American Society of Gene and Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting being held May 13-17, 2025 in New Orleans, Louisiana (Press release, Genprex, APR 29, 2025, View Source [SID1234652309]). The collaborators will present positive preclinical data and research from studies of GPX-002, the Company’s diabetes gene therapy drug candidate.

"We are proud of the preclinical data supporting our novel gene therapy program for diabetes, and we believe selection to present our program at one of the premier events in cell and gene therapy provides another point of validation for our diabetes program," said Ryan Confer, President and Chief Executive Officer at Genprex. "We look forward to sharing our GPX-002 data with industry leaders engaged in advancing the latest scientific research and new technologies."

The oral presentation details for the Genprex-supported abstract:

Abstract Title: Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model

Session Title: Challenges in Immunological Responses to Therapeutic Interventions

Presenter: Hannah Rinehardt, MD, University of Pittsburgh Medical Center

Presentation Date: May 16, 2025

Presentation Time: 4:15 – 4:30 p.m. CT

Location: Room 278-282

The featured Genprex-supported abstract to be presented for oral presentation at the ASGCT (Free ASGCT Whitepaper) 28th Annual Meeting:

Gene therapy using recombinant adeno-associated virus (rAAV) offers a promising opportunity for curative therapy in diabetes mellitus. Retrograde intraductal infusion of rAAV6 to deliver Pdx1 and MafA, converting alpha cells into beta-like cells that secrete insulin physiologically, reverses diabetes in mouse models. Little is known about the direct infusion of AAV into the pancreatic duct for gene therapy in non-human primates (NHPs). In clinical trials, anti-viral immunity to AAV can be a barrier to successful gene therapy. Researchers evaluated the immune response to direct infusion of rAAV into the pancreatic duct of NHPs with streptozotocin-induced diabetes and evaluated how to best manage immune responses.

Diabetes was induced with streptozotocin (STZ) in cynomolgus macaques. NHPs received retrograde intraductal infusion of rAAV via laparotomy for precise delivery to the pancreas. rAAV capsids were chosen based on tropism for endocrine cells, and pre-existing neutralizing antibody titers (NAbs) were negative. Blood work including serum C peptide and IV glucose tolerance tests were serially obtained to monitor therapeutic efficacy. Immune response monitoring was performed for up to 4 months post-infusion and included serial NAbs, ELISpot assays, and immunophenotyping. Pancreatic tissues were analyzed using IHC and RNA-scope for beta cell markers, as well as single-cell RNA transcriptomics.

One-month post-infusion, NHPs showed improved glucose tolerance and reduced insulin requirements. The AAV6 capsid with endocrine-specific promoters driving Pdx1 and MafA showed durable effects. ELISpot-positive cytotoxic T cells and neutralizing antibodies developed when steroids were absent. With steroid-sparing regimens, pancreatic B and T lymphocyte populations were noted on scRNA sequencing. Temporary immunosuppression (IS), using a combination of rituximab, rapamycin, and steroids, for a 3-month course is largely effective at preventing anti-viral immunity. Despite complete IS discontinuation at 3 months post-infusion, meaningful anti-viral immune response was not mounted up to one month after IS withdrawal as evidenced by low NAb titers and negative ELISpot analysis. Additionally, rAAV gene therapy in these animals remained effective and glucose tolerance continued improving in the absence of immunosuppression.

In conclusion, researchers developed a novel rAAV gene therapy approach and demonstrated that infusion of rAAV directly into the pancreatic duct of NHPs induces an anti-viral immune response. The anti-viral immune response in NHPs can be largely prevented by administration of a multi-agent IS and can allow for sustained therapeutic effects.

About GPX-002

GPX-002, which has been exclusively licensed from the University of Pittsburgh, is currently being developed using the same construct for the treatment of both Type 1 diabetes (T1D) and Type 2 diabetes (T2D). The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time in T1D mouse models. In T2D, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

Fate Therapeutics Announces Five Presentations on Off-the-Shelf CAR T-cell Product Platform at ASGCT Annual Meeting

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]).

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

Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer

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.

"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.