On January 22, 2025 Alligator Bioscience reported full year financial results for 2024 and for Q4 2024 and provides a business update (Press release, Alligator Bioscience, JAN 22, 2025, View Source [SID1234649820]).

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On January 22, 2025 Abbott (NYSE: ABT) reported financial results for the fourth quarter ended Dec. 31, 2024 (Press release, Abbott, JAN 22, 2025, View Source [SID1234649819]).

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Fourth-quarter sales increased 7.2 percent on a reported basis, 8.8 percent on an organic basis, and 10.1 percent on an organic basis, excluding COVID-19 testing-related sales.
Fourth-quarter GAAP diluted EPS of $5.27 and adjusted diluted EPS of $1.34, which excludes specified items (see table titled "Non-GAAP Reconciliation of Financial Information").
Full-year 2024 sales of $42.0 billion increased 4.6 percent on a reported basis, 7.1 percent on an organic basis, and 9.6 percent on an organic basis, excluding COVID-19 testing-related sales.
Full-year 2024 gross margin as a percent of sales improved 60 basis points on a GAAP basis compared to 2023 and improved 70 basis points on an adjusted basis.
Full-year 2024 GAAP diluted EPS of $7.64 and adjusted diluted EPS of $4.67, which excludes specified items (see table titled "Non-GAAP Reconciliation of Financial Information").
For the full-year 2024, Abbott achieved the upper end of the initial guidance ranges the company provided in January 2024 for both organic sales growth and adjusted earnings per share.
During 2024, Abbott announced more than 15 new growth opportunities coming from the company’s highly productive R&D pipeline. These include a combination of new product approvals and new treatment indications.
Abbott projects full-year 2025 organic sales growth to be in the range of 7.5% to 8.5%.
Abbott projects full-year 2025 adjusted operating margin to be 23.5% to 24.0% of sales, which reflects an increase of 150 basis points at the midpoint compared to 2024.
Abbott projects full-year 2025 adjusted diluted EPS of $5.05 to $5.25, which reflects double-digit growth at the midpoint.
"We finished the year with very strong momentum. Sales growth and earnings per share growth in the fourth quarter were the highest of the year," said Robert B. Ford, chairman and chief executive officer, Abbott. "We continued our track record for delivering on our commitments by achieving the upper end of our initial guidance ranges for 2024 and are well-positioned to deliver another year of strong growth in 2025."

FOURTH-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance in 2024, as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

On January 22, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial (Press release, Immutep, JAN 22, 2025, https://www.immutep.com/detail/patient-enrolment-completed-for-eftisarc-neo-phase-ii-trial.html [SID1234649801]). EFTISARC-NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).

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The Phase II trial conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients.

As previously announced, positive data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Among 21 patients available for primary endpoint assessment, the triple combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median 50%) at the time of surgical resection as compared to a historical median 15% from radiotherapy alone. This is an early surrogate endpoint at the time of surgery as tumour hyalinization/fibrosis has been associated with improved survival for STS patients.1,2

Additionally, the treatment has been safe with no grade ≥3 toxicities related to efti and pembrolizumab.

Data updates from EFTISARC-NEO are expected in 2025. For more information on the trial, please visit clinicaltrials.gov (NCT06128863).

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.