Immix Biopharma’s NXC-201 NEXICART-2 Clinical Trial Data Selected for Oral Presentation at ASCO 2025

On April 23, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported that Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held in Chicago, Illinois, May 30 – June 3, 2025, presented by lead investigator Heather Landau, M.D., Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York (Press release, Immix Biopharma, APR 23, 2025, View Source [SID1234652055]).

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ASCO Presentation Details

Title "Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201"
Presentation
Date/Time (Central Daylight Time)
Session Date: Tuesday, June 3, 2025
Session Time: 9:45am – 12:45pm CDT
Presentation Abstract Number: 7508
Session Name: 652. Oral Abstract Session – Hematologic Malignancies-Plasma Cell Dyscrasia

Event details are available on the Immix website in the Presentation & Events section at View Source

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. Phase 1/2 U.S. study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

Novita Pharmaceuticals Announces Oral Presentation of Phase 2 NP-G2-044 Data at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported that additional data from its Phase 2 Study of NP-G2-044 combined with anti-PD-1 therapy will be presented in an oral presentation as part of a Rapid Oral Session at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 30 to June 3, 2025, in Chicago, IL (Press release, Novita Pharmaceuticals, APR 23, 2025, View Source [SID1234652071]).

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Details of the presentation are as follows:

Abstract Title: Durable responses in ICI-refractory or acquired resistance: Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy.
Abstract Number: 2513
Session Type: Rapid Oral Abstract
Session Title: Developmental Therapeutics—Immunotherapy
Date and Time: June 1, 2025; 11:15 AM-12:45 PM CDT

Corporate presentation

On April 23, 2025 Intensity therapeutics presented its corporate presentation (Presentation, Intensity Therapeutics, APR 23, 2025, View Source [SID1234652056]).

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OncoHost to Showcase Plasma Proteomics Research in NSCLC at AACR 2025

On April 23, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved cancer patient outcomes, reported its acceptance to present a scientific poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25–30, 2025, in Chicago, IL (Press release, OncoHost, APR 23, 2025, View Source [SID1234652072]).

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The abstract, titled "Clinical and biological implications of plasma proteomic patterns in NSCLC patients treated with immune checkpoint inhibitors," investigates the proteins involved in the PROphetNSCLC model. PROphetNSCLC serves as a treatment guidance tool for patients with advanced stage non-small cell lung cancer (NSCLC). The study is the result of an international collaboration between academic institutions and leading cancer centers including The Ohio State University, UC Davis, Baylor University Medical Center, Roswell Park Comprehensive Cancer Center, and others.

"This research provides a deeper understanding of the biological underpinnings driving resistance to immunotherapy in NSCLC," said Dr. Michal Harel, Director of Science and Innovation at OncoHost and lead author of the study. "Our analysis of resistance-associated proteins (RAPs) identifies key proteomic signatures that not only explain clinical outcomes but can also help stratify patients and identify new therapeutic targets."

PROphetNSCLC is based on 388 plasma proteins, collectively termed RAPs. The study uncovered five distinct expression patterns across healthy individuals, NSCLC patients with clinical benefit (CB), and those with no clinical benefit (NCB) from immunotherapy. These patterns revealed mechanistic insights into treatment resistance that can be monitored in the plasma, highlighting processes such as angiogenesis, immune modulation, chemoresistance, and cell proliferation. In addition, the findings shows that 17.5% of the RAPs identified could be targeted with existing or investigational drugs. These findings suggest that RAPs can serve as a pool of novel targets for intervention, further strengthening the potential clinical significance of these RAPs.

"Being selected to present at AACR (Free AACR Whitepaper) reinforces the scientific and clinical relevance of our work," said Ofer Sharon, MD, CEO of OncoHost. "We are moving beyond predictive diagnostics into an era where understanding the ‘why’ behind treatment resistance is critical to driving real-world precision medicine. This study brings us closer to realizing the full potential of proteomics in oncology."

Poster Presentation Details
Title: Clinical and biological implications of plasma proteomic patterns in NSCLC patients treated with immune checkpoint inhibitors
Session Title: Predictive Biomarkers 3
Poster Board #: 27
Presenter: Michal Harel, PhD, Director of Science and Innovation, OncoHost
Date & Time: Monday, April 28, 2025, 9:00 AM – 12:00 PM CDT

Iovance Biotherapeutics Announces Participation in Upcoming Scientific Congresses

On April 23, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that pre-clinical data for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, will be presented at the 2025 AACR (Free AACR Whitepaper) Annual Meeting (Press release, Iovance Biotherapeutics, APR 23, 2025, View Source [SID1234652057]). In addition, five-year outcomes data from the C-144-01 study of lifileucel monotherapy in patients with advanced melanoma, and a poster on study design for lifileucel in frontline advanced non-small cell lung cancer, will be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

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2025 AACR (Free AACR Whitepaper) Annual Meeting, April 25-30, 2025, Chicago, IL

Poster: IOV-5001, autologous tumor-infiltrating lymphocytes armored with inducible membrane-tethered interleukin-12, shows enhanced antitumor efficacy with an improved cellular state (Abstract 4863)
Session: Immune Fitness and Metabolic Regulation of Cancer Immunity, Tuesday, April 29, 2025, 9:00 am – 12:00 pm CDT
2025 ASCO (Free ASCO Whitepaper) Annual Meeting, May 30-June 3, 2025, Chicago, IL

Rapid Oral Presentation: Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study (Abstract 9515)
Session: Melanoma/Skin Cancers, Monday, June 2, 2025, 9:45 am – 11:15 am CDT
Trial-in-Progress Poster: Phase 2, multicenter study of the lifileucel regimen and pembrolizumab after frontline platinum-doublet chemotherapy and pembrolizumab in advanced non-small cell lung cancer (Abstract 133A)
Session: Lung Cancer—Non-Small Cell Metastatic, Saturday, May 31, 2025, 1:30 pm – 4:30 pm CDT
Iovance will host a panel discussion on the evening of Saturday, May 31, 2025 at 6 pm CDT (7 pm EDT) featuring key opinion leaders in melanoma. The live and archived webcast will be available in the Investors section of the company’s website at www.iovance.com.