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)

On April 23, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported it will present data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Corcept Therapeutics, APR 23, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-present-late-breaking-data-pivotal-phase-3-rosella-trial [SID1234652052]). The data will be presented in a late-breaking oral presentation on Monday, June 2, 2025.

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Title: ROSELLA: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Patients with Platinum-Resistant Ovarian Cancer​ (GOG-3073, ENGOT-ov72)
Oral Abstract Session – Gynecologic Cancer
June 2, 2025, 8:00 AM – 11:00 AM CDT
Abstract Number: LBA5507
The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.

On April 23, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL (Press release, Candel Therapeutics, APR 23, 2025, View Source [SID1234652051]). The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer.

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Details are as follows:

CAN-2409 – Localized Prostate Cancer

•
Abstract Title: Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer
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Presenter: Theodore DeWeese, M.D. *, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine

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Session Title: Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile

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Session Date/Time: Tuesday, June 3, 2025; 9:45 AM – 12:45 PM CT

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Location: Hall A, McCormick Place Convention Center, Chicago, IL

Full abstracts will be released by ASCO (Free ASCO Whitepaper) on Thursday, May 22, 2025, at 5:00 PM ET. Details from the presentations will be available following the event on the Candel website at Candel Media.

Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. He has never received reimbursements, consulting fees, or EAB fees from Candel, and he has no shares of common stock, options to purchase common stock or other stake in Candel.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic nucleotide analogue that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of the patient’s own tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care (SoC) radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile reported to date, supporting the potential for combination with other therapeutic strategies.

Candel’s clinical development program for CAN-2409 includes completed positive phase 2a clinical trials in both non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), as well as a positive pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in this phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant and clinically meaningful improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy.

In the Company’s randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC, positive survival data showed notable improvement with an estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus SoC versus 12.5 months in the control group in patients with PDAC who only received SoC. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. The final survival data from the phase 2a clinical trial of CAN-2409, in patients with stage III/IV NSCLC, showed an mOS of 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that had progressive disease at baseline, despite Immune Checkpoint Inhibitor treatment. CAN-2409 plus prodrug has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized prostate cancer. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in newly diagnosed, localized prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA.