On May 12, 2025 Grit Biotechnology Co., Ltd. ("Grit Bio"), a clinical-stage biotech pioneering novel immunotherapies reported that three research programs, in collaboration with Vitalgen BioPharma Co., Ltd. ("Vitalgen"), will be showcased in one oral presentation and two poster sessions at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th annual meeting in New Orleans, LA from May 13th to 17th (Press release, Grit Bio, MAY 12, 2025, View Source [SID1234652897]).

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Grit Bio will provide the updates of three preclinical programs, including APC-targeted neoantigen cancer vaccine, non-viral-nanoparticle-directed in vivo CAR-T, and LNP-mediated gene editing in tumor infiltrating lymphocyte (TIL). The details of three presentations are:

Title: APC-Targeted LNP Enables Systemic Delivery of Neoantigen mRNA Vaccines and Enhanced Antigen-Specific T Cell Responses
Presentation Type: Oral
Time: 5:15-5:30 pm local time, Thursday, May 15th
Speaker: Pin Wang, Ph.D., CSO of Grit Biotechnology
Title: In Vivo CAR-T Therapy Powered by Novel CLAMP Technology for T cell-Targeted mRNA Delivery
Presentation Type: Poster
Time: 5:30-7:00 pm local time, Wednesday, May 14th
Poster #: 1282
Title: Enhancing Production and Functional Potential of Tumor-Infiltrating Lymphocytes via Lipid Nanoparticle-Mediated CRISPR/Cas9 Gene Editing
Presentation Type: Poster
Time: 5:30-7:00 pm local time, Thursday, May 15th
Poster #: 1776
"Through a strategic collaboration with Vitalgen, we are pioneering next-generation immunotherapies and precision delivery technologies. This synergy accelerates the development of advanced therapies with transformative improvements in safety and efficacy. We are now expanding those innovations toward global clinical implementation." said Dr. Yarong Liu, founder and Chief Executive Officer of Grit Biotechnology.

On May 12, 2025 Caris Life Sciences(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals (Press release, Caris Life Sciences, MAY 12, 2025, View Source [SID1234652896]). This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies.

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Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies.

"To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC," said Caris President David Spetzler, MS, PhD, MBA. "With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals."

Key Highlights of MET IHC Testing:
Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors.

Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies.

Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life.

Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris’ dedication to improving patient care and outcomes.

Caris’ comprehensive molecular profile testing includes MI Cancer Seek and Caris Assure. Caris received FDA approval in November of 2024 for MI Cancer Seek, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay.

On May 12, 2025 Abbisko Therapeutics Co., Ltd. (02256.HK) reported that updated results from the phase 2 study of irpagratinib (ABSK011) in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the 2025 ESMO (Free ESMO Whitepaper) GI Congress, taking place in Barcelona, Spain from July 2 to July 5 (Press release, Abbisko Therapeutics, MAY 12, 2025, View Source [SID1234652895]). The oral presentation will highlight the regimen’s favorable safety and promising anti-tumor activity in both treatment-naive and previously treated FGF19+ HCC patients. The evident objective response rate (ORR) and progression free survival (PFS) benefit underscores the potential of irpagratinib-based combinations in the treatment of HCC.

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Event Details:

Session: Mini Oral session – Innovation in GI cancers
Presentation Format: Oral Presentation

Title: Irpagratinib (ABSK-011) plus Atezolizumab in First-line (1L) and Immune Checkpoint Inhibitors (ICIs) Treated Advanced Hepatocellular Carcinoma (HCC) with FGF19 Overexpression (+): Updated Results of the Phase 2 ABSK-011-201 Study

Presentation number：149MO

Presenter: Qi Cheng
Date and Time: Beijing Time 2Jul2025 23:15-23:20
Local time 2Jul2025 17:15-17:20

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of aHCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the previous 2024 ESMO (Free ESMO Whitepaper) GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy.

On May 12, 2025 Elpis Biopharmaceuticals, a clinical-stage cell therapy company developing bispecific armored CAR-T therapies for solid tumors, reported that Founder and CEO Yan Chen, MD, PhD, will present new preclinical data on the company’s proprietary multi-mechanism armored CAR-T platform at the PEGS Protein & Antibody Engineering Summit on May 14, 2025, in Boston (Press release, Elpis Biopharmaceuticals, MAY 12, 2025, View Source [SID1234652894]).

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In the presentation, "Multi-Mechanism Armored CAR-T Effectively Overcomes Tumor Microenvironment Resistance and Eradicates Solid Tumors," Dr. Chen will highlight the discovery of Elpis’s multi-mechanism armor by fusing a precision-engineered IL-2 molecule to an anti-PD-L1 antibody, which has the potential to simultaneously overcome multiple resistance mechanisms within the tumor microenvironment (TME). The platform is designed to activate bystander immune cells, selectively target key immune cell types, and orchestrate the immune system for a durable anti-tumor response.

Elpis’s human bispecific armored CAR-T cells have demonstrated potent tumor regression, long persistence, and robust immune modulation across multiple solid tumor models—all at significantly lower doses. These attributes reflect the platform’s potential to improve drugability, safety and support more durable clinical outcomes.

"This is an exciting moment for Elpis," said Dr. Chen. "Our multi-mechanism armor is the result of years of innovation in precision cytokine engineering empowered by mRNA display technology. By addressing both TME resistance with armored cytokine and tumor heterogeneity through bispecific targeting, our platform has the potential to deliver safer, more effective and persistent CAR-T therapies in solid tumors."

Event:

PEGS Summit, Omni Boston Hotel

Session Title:

Multi-Mechanism Armored CAR-T Effectively Overcome Tumor
Microenvironment Resistance and Eradicate Solid Tumors

Session Date:

Wednesday, May 14, 12:30 pm ET

Presenter:

Dr. Yan Chen, Founder and CEO, Elpis Biopharmaceuticals

On May 12, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapies for unmet medical needs, reported compelling preclinical data for HT-KIT, its proprietary antisense oligonucleotide (ASO) therapeutic designed to target and silence aberrant KIT gene expression—implicated in a variety of rare, treatment-resistant cancers (Press release, Hoth Therapeutics, MAY 12, 2025, View Source [SID1234652893]).

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HT-KIT is engineered to selectively bind to mutant KIT mRNA transcripts and block their translation, thereby preventing the production of the KIT protein, a critical driver of tumor growth in cancers such as gastrointestinal stromal tumors (GIST), systemic mastocytosis, and certain acute leukemias.

Preclinical Milestones:

Over 80% reduction in KIT expression in vitro using cancer cell lines harboring activating KIT mutations.
Significant inhibition of tumor growth in GIST and mast cell tumor animal models following systemic administration of HT-KIT.
No observable off-target toxicity in liver, kidney, or bone marrow, suggesting a favorable safety profile.
"We believe HT-KIT represents a first-in-class approach to treating KIT-mutated cancers at the genetic level, offering hope for patients who have exhausted traditional therapies," said Robb Knie, CEO of Hoth Therapeutics. "The strength of our preclinical data positions HT-KIT as a powerful candidate for precision oncology. We are moving rapidly toward IND submission and are eager to begin human trials.

Current treatment options for KIT-driven cancers often rely on tyrosine kinase inhibitors (TKIs), which may lead to drug resistance or systemic side effects. HT-KIT offers a highly targeted alternative by attacking the disease at the mRNA level—upstream of protein expression—potentially avoiding the resistance mechanisms seen with small-molecule therapies.

Next Steps:

Hoth Therapeutics expects to file an Investigational New Drug (IND) application with the FDA in early 2026, with first-in-human Phase 1 trials planned shortly thereafter. The company is actively engaging regulatory advisors and contract research partners to accelerate clinical development.

About HT-KIT

HT-KIT is a synthetic antisense oligonucleotide developed using proprietary gene-silencing technology licensed exclusively by Hoth. It is designed to inhibit KIT gene expression in tumors where KIT mutations are known oncogenic drivers. Preclinical studies suggest HT-KIT has the potential to overcome resistance seen in patients previously treated with TKIs.