On May 21, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial of cell therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis following its 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Oral Presentation in Chicago, IL (Press release, Immix Biopharma, MAY 21, 2025, View Source [SID1234653270]).

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The virtual KOL event will take place on Tuesday, June 3, 2025 at 3:00pm ET.

A live question and answer session will follow the discussion.

The event will feature Heather Landau, MD (Memorial Sloan-Kettering Cancer Center), Shahzad Raza, MD (Cleveland Clinic), and Jeffrey Zonder, MD (Karmanos Cancer Institute) who will discuss their clinical experience with NXC-201 cell therapy and the evolving treatment landscape for relapsed/refractory AL Amyloidosis.

Investors and other interested parties may join the live webcast through this weblink or visit the Immix website under Presentations & Events.

About Heather Landau, MD
Heather Landau, MD, is the Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York, with extensive experience designing clinical trials in hematology and oncology, novel treatment approaches for AL amyloidosis, and thought leadership.

Dr. Landau has authored more than 100 peer-reviewed publications. Dr. Landau received her medical degree from SUNY Upstate Medical University, completed her Internal Medicine residency at University of Colorado and her Hematology & Oncology fellowship at Memorial Sloan Kettering Cancer Center. Dr. Landau is board certified in Internal Medicine, Medical Oncology and Hematology.

About Shahzad Raza, MD
Shahzad Raza, MD is a hematologist/oncologist at Cleveland Clinic specializing in plasma cell dyscrasias, including AL Amyloidosis. Dr. Raza has authored numerous peer-reviewed publications over the last decade in academic medical practice. Dr. Raza completed his residency in internal medicine at the Brookdale Hospital Medical Center and his fellowship at the University of Missouri Hospitals & Clinics.

About Jeffrey Zonder, MD
Jeffrey Zonder, MD leads the Amyloidosis multi-disciplinary team at the Barbara Ann Karmanos Cancer Institute. He is Professor, Department of Oncology, Wayne State University School of Medicine, Detroit, MI. Dr Zonder is also the co-leader and a scientific member of the Molecular Therapeutics Program at the Barbara Ann Karmanos Cancer Institute. Dr. Zonder received his medical degree from Wayne State University, completed his residency at Strong Memorial Hospital of the Univ. of Rochester and his fellowship at Wayne State University.

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. U.S. Phase 1/2 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 May 21, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Development Officer Judith Klimovsky will participate in a fireside chat at the 2025 Jefferies Global Health Care Conference in New York City, New York at 9:20 EDT (3:20 PM CEST) on June 5, 2025 (Press release, Genmab, MAY 21, 2025, View Source [SID1234653269]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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On May 21, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Phase III TALENTACE study, evaluating the efficacy and safety of Tecentriq (atezolizumab), Avastin (bevacizumab), and on-demand transarterial chemoembolization (TACE) in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic treatment, met its primary endpoint with positive results (Press release, Chugai, MAY 21, 2025, View Source [SID1234653268]).

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The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from this study will be presented at an upcoming academic congress.
*TACE PFS: Defined as the time from randomization to untreatable progression or TACE failure/refractoriness or death by any cause as determined by the investigator, and OS (overall survival), defined as time from randomization to death from any cause.
**RECIST v1.1: Response Evaluation Criteria in Solid Tumors guideline

Initiated in collaboration in China and Japan, the TALENTACE study aimed to assess whether combining Tecentriq and Avastin with TACE could improve outcomes for patients with unresectable HCC. This marks the Phase III study in Asia showing a TACE PFS benefit from cancer immunotherapy and target therapy in combination with TACE for unresectable HCC. The safety profiles of atezolizumab and bevacizumab were consistent with the well-established safety profile of each therapeutic agent and the underlying disease.

About the TALENTACE Study

TALENTACE study is a phase III, open-label, randomized study of on-demand transarterial chemoembolization (TACE) combined with Tecentriq + Avastin or on-demand transarterial chemoembolization (TACE) alone in patients with unresectable hepatocellular carcinoma who have not received prior systemic treatment. The TALENTACE study enrolled 342 patients in China and Japan who were randomized on a 1:1 ratio to receive TACE + Tecentriq/Avastin or TACE alone. TACE was performed on-demand. The co-primary endpoints are TACE PFS (TACE progression-free survival) and OS (overall survival). Secondary endpoints include PFS by RECIST v1.1 and others.

About Liver cancer

Liver cancer is the third leading cause of cancer-related death globally and one of the few cancers with rising mortality rates.1,2 More than 500,000 people are diagnosed with liver cancer every year, translating to one person being diagnosed every 50 seconds.1 Despite advances in treatment, only one in five people with liver cancer are alive five years post-diagnosis, and survival rates for advanced disease are even lower.

On May 21, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-023 (formerly ARTS-023), a potential best-in-class, novel cyclin-dependent kinase 4 (CDK4) selective inhibitor (Press release, Avenzo Therapeutics, MAY 21, 2025, View Source [SID1234653267]). Avenzo has also exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing, and commercialization rights.

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Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study in the third quarter of this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination therapy with endocrine therapy and with AVZO-021, Avenzo’s potential best-in-class CDK2 inhibitor, in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other advanced solid tumors. AVZO-021 is currently being studied in HR+/HER2- metastatic breast cancer and other advanced solid tumors.

"The clearance of our IND for AVZO-023 represents an important milestone on our journey to transform cancer treatment," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-023 has the potential to be a best-in-class oncology therapy for patients with HR+/HER2- breast cancer and we look forward to initiating a Phase 1/2 clinical trial, and to studying the potential of AVZO-023 in combination with our potential best-in-class CDK2 selective inhibitor, AVZO-021."

Preclinical data for AVZO-023 were presented for the first time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in April 2025 and highlighted its sub-nanomolar potency against CDK4 while sparing other CDKs with high selectivity over CDK6, a key driver of hematologic toxicity. In addition, AVZO-023 demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with AVZO-021.

On May 21, 2025 AstraZeneca reported its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 30 May to 3 June 2025 (Press release, AstraZeneca, MAY 21, 2025, View Source [SID1234653255]).

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More than 80 abstracts will feature 20 approved and potential new medicines from the Company including two plenary presentations, one special late-breaking oral abstract session and 19 additional oral presentations. Highlights include:

SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Plenary #LBA4). Camizestrant is an investigational, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. This is the first positive Phase III trial for a next-generation oral SERD in this 1st-line setting and the first positive Phase III trial for camizestrant.
MATTERHORN Phase III trial of perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (Plenary #LBA5).
DESTINY-Breast09 Phase III trial of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab in the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Oral Abstract #LBA1008).
DESTINY-Gastric04 Phase III trial of Enhertu in patients with 2nd-line HER2-positive unresectable and/or metastatic gastric and GEJ cancers (#LBA4002).
NeoADAURA Phase III trial of neoadjuvant Tagrisso (osimertinib) with or without chemotherapy in resectable, early-stage EGFR-mutated non-small cell lung cancer (NSCLC) (Oral Abstract #8001).
TROPION-Lung02: Computational pathology biomarker analyses of the TROPION-Lung02 Phase Ib trial of Datroway (datopotamab deruxtecan) plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations (Oral Abstract #8501).
KOMET Phase III trial of Koselugo (selumetinib) in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas (Rapid Oral Abstract #3014).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Two key breast cancer presentations at ASCO (Free ASCO Whitepaper) will highlight the progress we are making with our innovative medicines and pipeline to change the treatment landscape. For camizestrant, SERENA-6 is the first pivotal Phase III trial to use circulating tumour DNA to inform a treatment switch, pioneering this technology in the first-line setting to delay disease progression in HR-positive, HER2-negative advanced breast cancer. In addition, DESTINY-Breast09 for Enhertu in combination with pertuzumab is the first trial in more than a decade to demonstrate superiority over first-line standard of care across a broad HER2-positive metastatic patient population."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The MATTERHORN data for perioperative Imfinzi in gastric and gastroesophageal junction cancers are a further example of our successful strategy to move immunotherapy into early stages of cancer where cure is the treatment goal. This is the seventh consecutive year AstraZeneca medicines will be featured in an ASCO (Free ASCO Whitepaper) plenary session, an extraordinary milestone which underscores the strength of our industry-leading oncology portfolio and pipeline across many types of cancer."

AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and Datroway, with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Koselugo (selumetinib), and with HUTCHMED to develop and commercialise Orpathys (savolitinib).

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20251

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Shitara, K

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study.

Abstract #LBA4002

Oral Abstract Session

31 May 2025

3:24pm

Tolaney, SM

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09.

Abstract #LBA1008

Oral Abstract Session

2 June 2025

7:30am

Dent, R

Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/-ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06).

Abstract #1013

Oral Abstract Session

31 May 2025

3:23pm

Levy, BP

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).

Abstract #8501

Oral Abstract Session

1 June 2025

8:12am

Waqar, SN

First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5).

Abstract #8521

Poster Session

31 May 2025

1:30pm

Tumour drivers and resistance

Turner, NC

Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.

Abstract #LBA4

Plenary Session

1 June 2025

2:41pm

Lu, S

Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.

Abstract #LBA8505

Oral Abstract Session

1 June 2025

9:48am

Levy, BP

Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).

Abstract #8513

Rapid Oral Abstract Session

2 June 2025

8:06am

Chaft JE

Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.

Abstract #8001

Oral Abstract Session

2 June 2025

3:12pm

Immuno-oncology & bispecifics

Janjigian, YY

Event-free survival in MATTERHORN: a randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC).

Abstract #LBA5

Plenary Session

1 June 2025

3:13pm

Powles, T

Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

Abstract #4503

Oral Abstract Session

1 June 2025

10:45am

Reck, M

Associations of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8009

Rapid Oral Abstract Session

1 June 2025

4:30pm

Barbie, DA

Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).

Abstract #8014

Rapid Oral Abstract Session

1 June 2025

5:12pm

Mayadev, J

Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.

Abstract #5502

Oral Abstract Session

2 June 2025

8:48am

Westin, SN

Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.

Abstract #5512

Rapid Oral Abstract Session

3 June 2025

8:30am

Erinjeri, JP

Outcomes by baseline tumor burden using the 6-and-12 score in EMERALD-1: a phase 3 study of durvalumab (D) ± bevacizumab (B) with transarterial chemoembolization (TACE) in embolization-eligible unresectable hepatocellular carcinoma (uHCC).

Abstract #4083
Poster Session

31 May 2025

9:00am

Cascone, T

Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.

Abstract #8046

Poster Session

31 May 2025

1:30pm

Zhou, J

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A.

Abstract #4080

Poster Session

31 May 2025

9:00am

Xu, R

ARTEMIDE-Gastric01: a phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC).

Abstract #TPS4204

Poster Session

31 May 2025

9:00am

Mathias, C

ARTEMIDE-Lung03: a phase 3, randomized, double-blind, multicenter, global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous non-small-cell lung cancer whose tumors express PD-L1.

Abstract #TPS8653

Poster Session

31 May 2025

1:30pm

Cell therapy

Yoo, C

RHEA-1: First-in-human (FIH) study of AZD9793, a first-in-class CD8-guided T cell-engager (TCE) for glypican-3-positive (GPC3+) advanced or metastatic hepatocellular carcinoma (HCC).

Abstract #TPS4215

Poster Session

31 May 2025

9:00am

Kim, TM

Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma.

Abstract #7046
Poster Session

1 June 2025

9:00am

Shadman, M

TITANium: An open-label, global multicenter Phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager (TCE), in patients (pts) with relapsed or refractory (r/r) B-cell malignancies.

Abstract #TPS7091

Poster Session

1 June 2025

9:00am

Le Gouill, S

SOUNDTRACK-E: A Phase 1/2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or Combination Therapy in Patients With Mature B-cell Malignancies.

Abstract #TPS7083

Poster Session

1 June 2025

9:00am

Rare disease medicines

Chen, AP

Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN): Primary analysis of KOMET (NCT04924608), a Phase 3, international, randomized, placebo-controlled study.

Abstract #3014

Rapid Oral Abstract Session

2 June 2025

8:00am