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.

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

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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.

On April 23, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported upcoming presentations on its lead cell therapy product candidate, IMA203 TCR T-cell therapy targeting PRAME, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held from May 30 – June 3, 2025, in Chicago, Illinois (Press release, Immatics, APR 23, 2025, View Source [SID1234652054]).

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Updated data from the Phase 1b trial of IMA203 in patients with metastatic melanoma with substantially longer follow-up compared to the last presentation in October 2024, and including data from additional uveal melanoma patients enrolled since then, will be highlighted in an oral presentation.

In addition, a trial-in-progress poster on SUPRAME, the ongoing Phase 3 clinical trial evaluating IMA203 in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor, will be presented at the conference.

Full abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5:00 pm ET.

Oral Presentation

Title: Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanoma
Presenting author: Martin Wermke, MD
Session: Developmental Therapeutics – Immunotherapy
Date / Time: May 31, 2025 / 3:00 – 6:00 pm CDT
Abstract ID: 2508

Poster Presentation

Title: SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR T) vs investigator’s choice in patients with previously treated advanced cutaneous melanoma
Presenting author: Jason Luke, MD, FACP, FASCO
Session: Developmental Therapeutics – Immunotherapy
Date / Time: June 2, 2025 / 1:30 – 4:30 pm CDT
Abstract ID: TPS2673

About IMA203 TCR T-cell Therapy and Target PRAME
IMA203 is an autologous, engineered T-cell receptor T-cell therapy (TCR T) that targets PRAME, an intracellular protein displayed as a peptide antigen on the surface of multiple solid tumors via HLA-A*02:01, with minimal expression on healthy tissues. With precise targeting and a turnaround time of approximately 14 days, IMA203 has demonstrated a favorable clinical profile in patients with unmet medical needs.

IMA203 TCR T-cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, "SUPRAME," in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after at least one PD-1 inhibitor. In parallel, the Phase 1b clinical trial in patients with solid tumors expressing PRAME is ongoing with a focus on uveal melanoma.

On April 23, 2025 Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, reported that it has raised NOK62 million (US$6m) largely from existing investors, led by Sandwater (Press release, Cytovation, APR 23, 2025, View Source;utm_medium=rss&utm_campaign=cytovation-raises-us6m-to-advance-phase-2-development-of-cy-101-in-adrenocortical-carcinoma-to-first-clinical-readouts [SID1234652053]).

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These funds will be used to advance CY-101 into a multi-national Phase 2 clinical trial in patients with adrenocortical carcinoma due to start in late 2025 and with first clinical readouts expected in 2026. The trial will be conducted through a partnership between Cytovation, Cancer Research UK and the Norwegian Cancer Society under an agreement announced in January 2025 (click here for press release).

CY-101, a membranolytic inhibitor of the Wnt/β-catenin pathway, has demonstrated early signs of antitumor activity in the Phase 1 CICILIA trial – particularly in tumors with dysregulated Wnt/β-catenin signaling.

New preclinical data being presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (Chicago, IL; April 25-30, 2025) by Cytovation and its collaborators at the Luxembourg Institute of Health, provide further insights into the mechanistic basis of CY-101’s activity.

The studies, conducted in in vivo immune-refractory models of ACC, colorectal carcinoma (CRC) and melanoma, demonstrated that CY-101 eliminates ACC and CRC tumors, enhances the efficacy of anti-PD-1 activity and triggers a systemic antitumor immune response.

These findings support the potential of CY-101 as a novel therapeutic for difficult-to-treat cancers such as ACC, and more broadly for tumors with dysregulated Wnt/β-catenin signaling, like CRC and hepatocellular carcinoma (HCC), among others.

"As we continue to explore the novel mechanism of action of CY-101 and its translation into meaningful clinical activity, our conviction in its potential to address tumors driven by the Wnt/β-catenin pathway only grows stronger," said Lars Prestegarden, CEO of Cytovation. "We are grateful for the continued support of our investors, whose confidence – alongside the strength of our outstanding partners – positions us well to advance CY-101 into Phase 2 trials and generate impactful clinical data."

Poster Presentation at AACR (Free AACR Whitepaper)

Title CY-101 Inhibits Tumor Growth and Improves Anti-PD-1 Immunotherapy in Beta-Catenin-Driven Tumors

Poster Number 2231

Session Title PO.IM01.02 – Modulation of Tumor Microenvironment: Enhancing Immunogenicity and Counteracting Suppression

Date / Time April 28, 9:00am-12:00pm Central Time

Authors Margaux Poussard et al.

Link to abstract Abstract 2231 Cytovation-AACR

Link to ePoster Poster 2231 Cytovation-AACR (available from 12pm CT on April 28)