On March 10, 2025 REVEAL GENOMICS, a pioneering Barcelona-based biotech company dedicated to advancing precision oncology, reported the publication of a groundbreaking study demonstrating the clinical impact of HER2DX, its genomic diagnostic test designed for early-stage HER2-positive (HER2+) breast cancer (Press release, REVEAL GENOMICS, MAR 10, 2025, View Source [SID1234651052]).

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The study, now published in ESMO (Free ESMO Whitepaper) Real World Data and Digital Oncology, is the first prospective real-world investigation assessing the impact of HER2DX results on treatment decision-making in clinical practice.

The study, led by Dr. Olga Martínez-Sáez, Dr. Juan Miguel Cejalvo, and Dr. Antonio Llombart-Cussac, evaluated how HER2DX impacted treatment decisions in a cohort of 297 patients with stage I-III HER2+ breast cancer across multiple hospitals in Spain. The primary findings reveal that HER2DX led to a modification in the treatment plan in 48.1% of cases, with most changes (75.5%) leading to a reduction in treatment intensity, reducing chemotherapy and/or anti-HER2 without compromising outcomes.

HER2DX also demonstrated strong predictive capability, accurately identifying patients with a higher likelihood of achieving a pathologic complete response (pCR), reinforcing its role as a crucial tool in therapy selection.

Additionally, oncologists reported a significant increase in confidence when making treatment decisions based on HER2DX data. Finally, the study also underscored the economic benefits of incorporating HER2DX into clinical practice, with healthcare cost savings when drug costs and type of vein access were taken into account, further validating its role in optimizing treatment strategies and reducing unnecessary interventions.

Dr. Olga Martínez Sáez, breast medical oncologist at Clinic Barcelona Comprehensive Cancer Center and Principal Investigator (PI) of the study, added: "This study represents a significant step forward in personalized oncology. HER2DX enables physicians to make precision-guided decisions with greater confidence, improving patient care."

Dr. Juan Miguel Cejalvo, breast medical oncologist at Hospital Clínico Universitario de Valencia/INCLIVA, and co-PI of the study, emphasized the importance of integrating genomic tools into routine clinical practice, "These results confirm that HER2DX provides valuable information that can refine treatment strategies, allowing for more personalized care while maintaining excellent outcomes."

Dr. Antonio Llombart-Cussac, head of the medical oncology department at Hospital Arnau de Vilanova in Valencia, and investigator of the study, highlighted the impact on clinical practice, "The capacity to forecast a patient’s therapeutic response prior to treatment initiation allows oncologists to adjust treatment intensity appropriately, effectively reducing unnecessary toxicity and healthcare costs."

Patricia Villagrasa, CEO of REVEAL GENOMICS, underscored the company’s mission, "Our goal is to revolutionize cancer care with cutting-edge genomic insights, helping oncologists make more informed decisions and benefiting patients. The results of this first clinical utility study confirms HER2DX as a key tool in precision medicine for HER2+ breast cancer."

About HER2DX

HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX is a prognostic and, predictive assay based on clinical and genomic data. The test integrates clinical information (i.e. tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About HER2+ breast cancer

HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

On March 10, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC (Press release, Immunome, MAR 10, 2025, View Source [SID1234651051]).

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"Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients," said Bob Lechleider, M.D., Chief Medical Officer at Immunome. "The dosing of our first patient with IM-1021 advances that mission, as we work to establish safety and explore efficacy of IM-1021 in patients with high unmet need in B-cell lymphomas and solid tumors."

IM-1021 is an optimized, ROR1-targeted ADC that incorporates Immunome’s proprietary TOP1 inhibitor, HC74. The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

On March 10, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported the enrollment of the first patients in the HEROES clinical trial. HEROES is a multi-center, phase II trial that explores the discontinuation or de-escalation of anti-HER2 targeted therapy among patients with metastatic HER2+ breast cancer (Press release, Natera, MAR 10, 2025, View Source [SID1234651050]). The trial is supported by funding from the French Ministry of Health through the Hospital Clinical Research Program (PHRC) and is being sponsored by Unicancer. It is being developed within Unicancer’s French Breast Cancer Intergroup (UCBG) network.

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Human epidermal growth factor receptor 2 (HER2) is a type of protein found in cancer cells that can cause rapid cancer growth when higher than normal levels are present. Between 15%-20% of breast tumors are HER2+.¹ Current standard-of-care (SOC) recommendations for maintenance treatment include the use of anti-HER2 therapies, which for many patients means remaining on the drug for life.

The HEROES (NCT06450314) trial will enroll approximately 170 metastatic HER2+ breast cancer patients who have discontinued anti-HER2 maintenance therapy. The primary endpoint of the study is 1-year progression-free survival in the Signatera-negative cohort. It will also assess ctDNA dynamics and quality-of-life measures to gain deeper insights into the potential for ctDNA-guided de-escalation of treatment in patients with no detectable molecular disease burden.

Highlights from the study protocol include:

At baseline, all patients are currently being treated with SOC anti-HER2 targeted therapies and have been on therapy for two or more years.
Signatera-negative patients at baseline will stop treatment and will be monitored with serial Signatera testing and diagnostic imaging. If at any point during the trial radiological progression is confirmed or a patient becomes Signatera-positive, prior drug therapy will resume or a new treatment will begin.
Signatera-positive patients at baseline will continue maintenance therapy and will not move forward in the trial.
"The HEROES study could significantly reshape the way oncologists treat patients with metastatic HER2+ breast cancer," said Thibault de la Motte Rouge, M.D., Ph.D., principal investigator of the trial and medical oncologist at the Comprehensive Cancer Centre Eugène Marquis (Rennes, France), where he currently holds the position of research director. "This could also pave the way for future research into ctDNA-guided treatment de-escalation in breast cancer."

"We are excited to see the first patients enrolled in the HEROES clinical trial," said Angel Rodriguez, M.D., senior medical director of oncology at Natera. "Safely discontinuing treatment has been a long-lasting dilemma in HER2 metastatic breast cancer. With Signatera monitoring, we hope oncologists can identify the patients without detectable disease who may be able to avoid additional therapy that can be costly and potentially harmful to their care."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.

On March 10, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the successful completion of dosing the first cohort of patients in its Phase 1 dose escalation study of NKT3964 as a single agent. NKT3964 is a first-in-class, orally bioavailable small molecule that selectively degrades CDK2 (Press release, NiKang Therapeutics, MAR 10, 2025, View Source [SID1234651049]). NKT3964, with high potency, selectivity and sustained inhibition of the CDK2 pathway without cyclin E accumulation, has the potential to provide therapeutic benefits for patients with aberrant CDK2/cyclin E pathway activation, such as ovarian, endometrial, gastric and HR+HER2- breast cancers.

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The Phase 1 trial (NCT06586957) is an open-label, dose escalation study designed to evaluate safety, tolerability, PK, PD and preliminary anti-tumor activity to determine the recommended dose(s) for expansion of NKT3964 monotherapy in adults with advanced or metastatic solid tumors.

"We are thrilled to reach this milestone in the clinical development of NKT3964," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "Completing dosing in our first cohort brings us one step closer to understanding the potential of this groundbreaking CDK2 degrader, one of several molecules in our portfolio targeting the cell cycle. Initial PK data from the first cohort demonstrated good oral exposure that aligns with human PK projections. Additionally, NKT3964 has achieved CDK2 degradation levels in patients that are consistent with those observed in preclinical in vivo studies. These early observations are particularly encouraging as they address the considerable challenges of achieving oral bioavailability with a PROTAC degrader. These findings will help guide dose optimization as the trial advances. Our pipeline focused on cell cycle inhibition via CDK2 degradation or CDK2/CDK4 dual degradation enables us to have multiple opportunities for success. We are excited by this progress and remain committed to advancing transformative therapies to help patients fight cancer and live better lives."

About NKT3964

NKT3964 is a first-in-class, highly potent and selective, orally bioavailable CDK2 degrader, causing prolonged CDK2 pathway inhibition without cyclin E accumulation. It has the potential to maximally and selectively suppress the CDK2 pathway, thereby harnessing the full therapeutic benefits of CDK2 inhibition. NKT3964 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT06586957).

On March 10, 2025 Hoth therapeutics reported that HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments (Press release, Hoth Therapeutics, MAR 10, 2025, View Source [SID1234651048]). With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."

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NEW YORK, March 10, 2025 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies, reported its intention to submit an Expanded Access application for HT-001, its novel therapeutic candidate for the treatment of dermatological conditions associated with cancer therapy.

HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments. With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."

"Submitting an Expanded Access application is an important step in our commitment to ensuring patients who may benefit from HT-001 have the opportunity to receive this promising treatment," said Robb Knie, CEO of Hoth Therapeutics. "We remain dedicated to advancing solutions that address critical unmet medical needs and improve quality of life for patients undergoing cancer treatment."

The Expanded Access Program is designed to provide investigational treatments to patients with serious or life-threatening conditions who lack comparable treatment options. Through this program, Hoth Therapeutics seeks to offer HT-001 to eligible patients while continuing to gather valuable data on its safety and efficacy.

For more information about HT-001, ongoing clinical trials, or the Expanded Access Program, please visit www.hoththerapeutics.com