On January 21, 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 that the first patient has been dosed in the global randomized phase 1b/2 clinical study evaluating NKT2152, a highly potent, selective and orally bioavailable small molecule HIF2α inhibitor, in combination with standard-of-care regimen of atezolizumab (Tecentriq) and bevacizumab (Avastin) in the first-line treatment of patients with advanced or metastatic HCC (Press release, NiKang Therapeutics, JAN 21, 2025, View Source [SID1234649808]). This study is being conducted under a clinical trial collaboration with F. Hoffmann-La Roche Ltd ("Roche") as part of Roche’s MORPHEUS-liver platform trial (NCT04524871).

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"The commencement of this randomized study of NKT2152 in partnership with Roche represents a significant milestone in the advancement of NKT2152 for the treatment of tumors beyond ccRCC," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "NKT2152 has demonstrated significant anti-tumor efficacy and a favorable safety profile not only in human ccRCC patients but also in preclinical xenograft models of solid tumors beyond ccRCC, underscoring its potential for broad application in human cancer treatments. HCC is of particular interest due to the compelling scientific rationale supporting NKT2152 and robust preclinical data. With high potency, selectivity, and unique human pharmacokinetic (PK) profile characterized by higher systemic exposure, a larger volume of distribution, and a longer half-life, NKT2152 emerges as an ideal candidate for combination with antibody-based regimens to treat solid tumors beyond ccRCC, where higher drug exposure may be necessary. We are enthusiastic about further exploring NKT2152’s potential in the first-line treatment of HCC patients through this randomized trial".

About NKT2152
NKT2152 is a potent, selective and orally available small molecule HIF2α inhibitor which binds to HIF2α allosterically and disrupts the HIF2α/HIF1β transcription factor complex, thereby reducing the production of proteins which lead to tumorigenesis. NKT2152 is currently under evaluation in a Phase 1/2 clinical study in ccRCC as a single agent (NCT05119335) and a Phase 2 clinical study in ccRCC in combination with palbociclib and sasanlimab (NCT05935748). A third clinical study, as part of Roche’s MORPHEUS-liver platform trial, evaluating the combination with standard-of-care atezolizumab and bevacizumab in first-line unresectable/advance hepatocellular carcinoma (HCC) (NCT04524871) is ongoing.

On January 21, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the first set of abstracts have been released from several studies that will be shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 – 25, 2025 in San Francisco, CA (Press release, Natera, JAN 21, 2025, View Source [SID1234649807]).

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BESPOKE CRC Study

New data will be presented in an oral presentation on Jan. 25 from BESPOKE CRC, a multicenter, prospective, observational study in colorectal cancer (CRC). The study underscores Signatera’s capability as a prognostic and a predictive biomarker in a cohort of over 1,000 patients wherein post-surgical Signatera-positivity was predictive of inferior outcomes in stage II patients [disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages II-III combined were 91.7% for Signatera-negative and 41.4% for Signatera-positive. Signatera-positive patients benefitted from adjuvant treatment while Signatera-negative patients did not, and clearance of ctDNA during and after treatment led to superior DFS outcomes.

Additional data from the study will be shared during the symposium illustrating the impact of MRD detection on clinical decision-making. The data show that even in the early days of MRD commercialization, a significant number of oncologists escalated or de-escalated post-surgical chemotherapy plans based on Signatera results, and the vast majority of oncologists found that Signatera results strengthened the treatment plan under consideration. In addition, surveillance with Signatera enabled a high rate of curative-intent surgery among recurrent patients.

Readouts in Tissue-Free MRD and Early Cancer Detection

Initial results from a clinical performance study on Natera’s novel tissue-free MRD detection test will be presented, where high sensitivity and specificity were observed in patients evaluable for clinical outcomes. The study demonstrated that the tissue-free MRD assay was prognostic, with MRD-positive patients showing inferior recurrence-free survival. The data also showed that the test was predictive, as MRD-positive patients benefited from adjuvant therapy whereas MRD-negative patients did not. In addition, the data showed strong concordance between the tissue-free MRD test and the gold standard Signatera test, with a positive percent agreement of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95% CI: 95-100%).

Natera will also present case-control data in early cancer detection, including data from screen-detected colorectal cancer cases from the CIRCULATE study and controls from the PROCEED-CRC study, respectively. The data reports an overall sensitivity of 95% (95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals.

"This data at ASCO (Free ASCO Whitepaper) GI demonstrates the ongoing strength of Signatera complemented by our exciting innovation pipeline," said Adham Jurdi, MD, senior medical director in oncology at Natera. "The results from BESPOKE CRC highlight the potential value of Signatera-based MRD detection for treatment-decision making, with strong findings in clinical utility. Our readouts in early cancer detection and tissue-free MRD offer great promise for expanding Natera’s portfolio to help millions of additional patients with cancer."

Full list of Signatera presentations and activities during ASCO (Free ASCO Whitepaper) GI

Oral Presentations

Jan. 25, 1:00 PM PT | Abstract # 15 | Stage II-III Colorectal Cancer (Oral Presentation)
Presenter: Purvi K. Shah, MD, MBBS, Virginia Cancer Institute
Circulating Tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC sub cohort

Jan. 25, 1:00 PM PT | Abstract # LBA14 | Colon Cancer (Oral Presentation)
Presenter: Jonathan A. Nowak, MD, PhD, Brigham and Women’s Hospital
Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702

Posters

Jan. 23, 11:30 AM PT | Abstract # TPS512 | Gastroesophageal adenocarcinoma (Poster)
Presenter: Elizabeth Catherine Smyth, MD, Oxford University Hospitals NHS Foundation Trust
A single arm phase II trial of trastuzumab deruxtecan in patients with gastroesophageal adenocarcinoma cancer who are ctDNA and HER2 posiative: DECIPHER

Jan. 23, 11:30 AM PT | Abstract # 836 | Gastrointestinal cancers (Poster)
Presenter: Sakti Chakrabarti, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Short interval circulating tumor DNA (ctDNA) kinetics as a predictor of tumor response in patients with gastrointestinal (GI) cancer receiving immune checkpoint inhibitor (ICI)-based treatment

Jan. 25, 7:00 AM PT | Abstract # 266 | Tissue-free MRD testing (Poster)
Presenter: John Paul Y.C. Shen, MD, University of Texas MD Anderson Cancer Center
Development of a methylation-based, tissue-agnostic test for the detection of molecular residual disease by circulating tumor DNA

Jan. 25, 7:00 AM PT | Abstract # 232 | Early cancer detection: colorectal cancer (Poster)
Presenter: Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East
Performance of a blood-based screening test for the early detection of colorectal cancer

Jan. 25, 7:00 AM PT | Abstract # TPS306 | Early cancer detection: Trial in Progress (Poster)
Presenter: Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin, TX, USA
Trial in progress for a colorectal cancer detection blood test

Jan. 25, 7:00 AM PT | Abstract # LBA 22 | Colorectal cancer (Poster)
Presenter: Hideaki Bando, MD, National Cancer Center Hospital Japan
A Randomized, Double-Blind, Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus Placebo in Patients with Molecular Residual Disease Following Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study

Jan. 25, 7:00 AM PT | Abstract # 220 | Metastatic colorectal cancer (Poster)
Presenter: D.E. van Steijn, MSc, Netherlands Cancer Institute
Longitudinal ctDNA measurements for treatment response monitoring in patients with metastatic colorectal cancer undergoing systemic therapy: The ORCA trial

Jan. 25, 7:00 AM PT | Abstract # 284 | Locally advanced rectal cancer (Poster)
Presenter: Jun Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical University
Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2

Jan 25, 7:00 AM PT | Abstract # 263 | Rectal adenocarcinoma (Poster)
Presenter: Seth Felder, MD, H. Lee Moffitt Cancer Center
Correlation of mid-chemoradiation ctDNA results and clinical complete response to total neoadjuvant therapy (TNT) for locally advanced rectal adenocarcinoma

Jan 25, 7:00 AM PT | Abstract # 48 | Colorectal cancer (Poster)
Presenter: Elisabeth Arrondo, BSc, Translational Research Support Office, National Cancer Center Hospital East
Molecular characteristics and prognostic impact of GNAS mutation in colorectal cancer: An international collaborative study between United States and Japan

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 January 21, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported advancements in its intellectual property portfolio through the acquisition and expansion of patent applications to its innovative therapeutic pipeline (Press release, Hoth Therapeutics, JAN 21, 2025, View Source [SID1234649806]).

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These newly secured patents reflect Hoth’s commitment to pioneering cutting-edge treatments that address unmet medical needs, with a focus on enhancing therapeutic efficacy and broadening applications across various disease areas.

"Our expanding intellectual property portfolio supports Hoth’s position as a leader in innovative drug development," said Robb Knie, CEO of Hoth Therapeutics. "These provisional patent applications reinforce our proprietary approaches and our mission to deliver breakthrough therapies that improve patients’ lives."

Hoth Therapeutics continues to invest in robust research and development strategies, ensuring the protection and growth of its proprietary technologies. The company remains dedicated to advancing its pipeline and delivering impactful healthcare solutions.

On January 21, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC) (Press release, Inhibrx, JAN 21, 2025, View Source [SID1234649805]). These results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Annual Cancers Symposium.

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Efficacy was assessed in 10 of the 13 patients who received at least one dose of ozekibart, based on RECIST v1.1 criteria. Results demonstrated one complete response (CR), three partial responses (PR), and six cases of stable disease (SD). Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median progression-free survival (PFS) of 7.85 months. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). Notably, the patient achieving a CR had undergone three prior lines of therapy, and two PRs occurred in patients who had failed prior FOLFIRI-based treatments.

Ozekibart-related treatment-emergent adverse events (TEAEs) were reported in 84.6% of patients, with most being grade 1 or 2 in severity. Grade ≥3 TEAEs were observed in 30.8% of patients. The most common ozekibart-related TEAEs included nausea, increased alanine aminotransferase, diarrhea, and fatigue, with the majority being low-grade.

Encouraged by these preliminary results, Inhibrx has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in Q3 2025.

"We believe these interim results underscore the potential of ozekibart to provide meaningful clinical benefit for patients with advanced solid tumors, even in heavily pretreated populations. We are particularly encouraged by the durable disease control observed and look forward to further evaluating these findings in our expansion cohort," commented Josep Garcia, Chief Clinical Development Officer at Inhibrx.

About Colorectal Adenocarcinoma

Colorectal adenocarcinoma is the third most frequent cancer globally and the second leading cause of cancer-related death. According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths. Effective therapies beyond the second-line setting are limited. In the U.S., the five-year relative survival rate in patients with metastatic CRC is 15.7%, underscoring the need for better treatments.

About ozekibart (INBRX-109)

Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.
In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma, which is currently ongoing and expected to read out in the middle of this year. Additionally, in a Phase 1 trial, Inhibrx is investigating ozekibart in Ewing sarcoma in combination with irinotecan/temozolomide.

On January 21, 2025 Antennova, a clinical-stage biotech company focused on oncology reported the presentation of latest data from its Phase I/II CLINCH study ongoing in China and Australia evaluating ATN-022 (CLDN18.2 antibody-drug conjugate [ADC]) in patients with advanced or metastatic gastric cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2025 (ASCO GI 2025) (Press release, Antennova, JAN 21, 2025, View Source;302356818.html [SID1234649804]).

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The CLINCH study is a Phase I/II study ongoing in China and Australia with a dose escalation phase followed by a dose expansion phase. As of November 22, 2024, among 21 gastric cancer patients in dose expansion phase with CLDN 18.2 expression of IHC 2+ ≥ 20% who had at least 1 tumor evaluation, the overall response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2% (9 partial responses [PRs] including 8 confirmed PRs; and 11 stable diseases [SDs]).
Among 10 gastric cancer patients with CLDN 18.2 expression of IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg, the ORR was 30.0% (1 complete response [CR] and 2 PRs, all PR/CR were confirmed with CLDN 18.2 expression of IHC 2+ < 5%), and the DCR was 50.0%. The patient with CR has demonstrated durable response and has been on the study for over 14 months as of the cut-off date.
ATN-022 demonstrated a manageable safety profile and promising preliminary antitumor activity in late stage gastric cancer patients across various levels of CLDN18.2 expression, supporting further clinical investigations of ATN-022 in gastric cancer patients. The enrollment of gastric cancer patients for dose optimization and patients with other solid tumors is ongoing in China and Australia.
Details of the Poster Presentation:

ATN-022 (also known as ATG-022, CLDN18.2 antibody-drug conjugate)

Title: Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)

Abstract Number: 456

Session: Poster Session A: Cancers of Esophagus and Stomach and Other Gastrointestinal Cancers

Presenter: Jinfeng Ma Shanxi Cancer Hospital

Date: Thursday, January 23, 2025

Time: 11:30 AM – 1:00 PM (Pacific time)

3:30 AM – 5:00 AM, January 24, 2025 (Beijing time)

About ATN-022

ATN-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, pancreatic and other cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATN-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study of ATN-022 has shown promising clinical efficacy in gastric cancer patients with various levels of CLDN18.2 expression. The efficacy already observed across all levels of CLDN18.2 expression in patients with gastric cancer suggests that ATN-022 holds the promise as a competitive treatment option.