On December 2, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported that 11 studies featuring the Breast Cancer Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions.

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"These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care," said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. "This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types."

Among the new findings to be presented, one study, "Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]," explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^*

"As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life," said primary study author Dr. Ruth O’Regan, MD. "The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects."

A full list of studies to be presented at the 2025 SABCS conference includes:

Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST
Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants.9*
Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision.10*
Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence.8^*
Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease.11*
Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns.12*
Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples.13*
Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including:

Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18]14
Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10]15
Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19]16
Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23]17
Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST
Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08]18
"The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test," said Schneiders. "With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients."

About the Breast Cancer Index Test

The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7

The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

(Press release, Hologic, DEC 2, 2025, View Source [SID1234661067])

On December 2, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that the China National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for the Phase Ib/II CLINCH-2 study evaluating ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as well as ATG-022 in combination with pembrolizumab and chemotherapy.

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CLINCH-2 is a Phase Ib/II study that will be led by its principal investigator Prof. Lin Shen at Beijing Cancer Hospital, the lead trial center. The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C). The primary objective of the study is to assess the safety and tolerability of the two combination regimens, while the secondary objectives include evaluating the regimens’ preliminary antitumor activity, assessing ATG-022’s immunogenicity, and characterizing its pharmacokinetic (PK) profile.

Antengene released updated clinical data from the Phase I/II CLINCH study of ATG-022 monotherapy in patients with advanced GC/GEJC at the European Society for Medical Oncology Congress 2025 (ESMO 2025). For details of the dataset, please refer to the press release published on October 20, 2025 (View Source). The results demonstrated clear differentiation for ATG-022 in both safety and efficacy. In the 1.8 mg/kg dose cohort, the incidence of grade 3 or higher treatment-related adverse events was only 18.2%. Moreover, the study did not observe any ocular toxicity or interstitial lung disease, and the incidence of peripheral neuropathy reported in the study was relatively low. The efficacious doses (1.8mg/kg and 2.4mg/kg) have both demonstrated an objective response rate (ORR) of 40%. This is a strong validation of ATG-022’s potential in combination with pembrolizumab and chemotherapy in the frontline setting. In addition, antitumor activity was observed across high, medium, and low CLDN18.2 expression levels, supporting the use of IHC 1+ ≥1% as the enrollment threshold for frontline combination therapy, indicating potential applicability to a much broader patient population compared to other CLDN18.2-targeting therapies. Furthermore, in the basket cohort of other CLDN18.2+ tumor types, efficacy was observed in a gynecologic tumor subtype, providing early proof of concept for potential expansion into tumor types beyond gastric cancer.

Antengene will continue to advance both the ongoing CLINCH study and the newly approved CLINCH-2 study, with plans to share updated results at upcoming medical conferences to further demonstrate the clinical potential of ATG-022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is a CLDN18.2-targeted antibody-drug conjugate (ADC) with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high, low, and ultra-low CLDN18.2 expression.

ATG-022 has been granted two Orphan Drug designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer, and obtained Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for treating CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received at least two prior lines of therapy.

(Press release, Antengene, DEC 2, 2025, View Source;chemotherapy-302630024.html [SID1234661066])

On December 2, 2025 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it will present details from its first-in-human Phase 1 clinical trial of STX-0712, the company’s novel CCR2-CyTAC (Chemokine Receptor Type 2 Cytotoxicity Targeting Chimera) for the treatment of chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) in a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 6–9, 2025, in Orlando, Florida.

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The poster will highlight the design of the ongoing Phase 1, open-label, multicenter study, which is evaluating STX-0712 as monotherapy in patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML. Primary objectives include safety, determination of dose limiting toxicities, and determination of recommended Phase 2 dose. Secondary objectives include pharmacokinetic and pharmacodynamic characterization of STX-0712, tolerability, and preliminary evidence of antitumor activity. Key elements of the study design include dose escalation using a Bayesian Optimal Interval approach, planned dose expansion, and exploratory analyses assessing CCR2+ cell depletion, biomarkers, immune cell profiling and patient-reported outcomes.

STX-0712 is a CyTAC targeting the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes in these indications, which are key drivers in certain hematologic cancers. By targeting CCR2, STX-0712 is designed to selectively eliminate these malignant cells.

Presentation Details:
Abstract Title: A First-in-Human Study of STX-0712, a CCR2+ Cytotoxicity Targeting Chimera (CyTAC), in Patients with Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)
Presenter: Guillermo Montalban Bravo, M.D., Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center
Date: Sunday, December 7, 2025
Time: 6:00pm-8:00pm EST
Location: Room OCCC- West Halls B3-B4
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Abstract Number: 14421

(Press release, Solu Therapeutics, DEC 2, 2025, View Source [SID1234661065])

On December 2, 2025 Physician-scientists from Rutgers Cancer Institute and RWJBarnabas Health reported it will share new discoveries from their basic science and clinical research programs to advance the understanding of blood cancers, such as lymphoma, leukemia and multiple myeloma, as well as classical hematology disorders at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6–9, 2025, in Orlando, Florida (and online). Rutgers Cancer Institute, New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center together with RWJBarnabas Health, will be featured prominently at this year’s meeting with a total of 93 accepted peer-reviewed scientific abstracts, including 32 oral presentations, 60 poster presentations and 1 satellite symposium.

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"ASH is a vital platform to present critical breakthroughs that are transforming the science and clinical care in blood diseases, and our prominent involvement reflects our commitment to deliver meaningful progress for patients and the exceptional scientific leadership of our research teams," said Andrew Evens, DO, MBA, MSc, Deputy Director for Clinical Services and Chief Physician Officer, Rutgers Cancer Institute and Jack & Sheryl Morris Cancer Center and System Director of Medical Oncology, RWJBarnabas Health. "Our faculty’s remarkable work highlights the innovation and ground-breaking discoveries that define Rutgers Cancer Institute and RWJBarnabas Health. With the Jack & Sheryl Morris Cancer Center, New Jersey’s only freestanding cancer hospital, now open, we are entering a new era of care and research that brings world-class inpatient and outpatient treatment together with leading science to accelerate discoveries and improve outcomes for patients and families across our state and beyond."

Key scientific contributions from Rutgers Cancer Institute and RWJBarnabas Health at ASH (Free ASH Whitepaper) 2025:

Abs25-2080: Data from a comparative study evaluated PET-adaptive BEACOPP- versus ABVD-based therapies for advanced-stage classic Hodgkin lymphoma (cHL). Researchers compared outcomes from escBEACOPP and ABVD across 2,381 adults using data from four clinical trials and adjusting for baseline risk with the A-HIPI prognostic score. escBEACOPP was associated with significantly better progression-free survival, and multistate modeling showed a lower likelihood of treatment failure both before and after achieving one-year remission. These findings suggest that escBEACOPP offers stronger disease control in PET-adaptive strategies, while the A-HIPI score remains a powerful predictor of risk throughout the treatment course.

Abs25-2547: A study assessed the performance of the advanced-stage Hodgkin lymphoma international prognostic index (A-HIPI) in the SWOG S1826 randomized trial of nivolumab-AVD versus brentuximab-AVD. Using locked model parameters and Cox regression analyses, the A-HIPI demonstrated strong prognostic capability, with clear separation of 3-year progression-free survival across predicted risk quartiles and superior discrimination compared with the historic IPS-7. The A-HIPI performed similarly across treatment arms and remained superior in multivariable modeling, confirming it as a more precise, treatment-agnostic tool for risk stratification in newly diagnosed advanced-stage classical Hodgkin lymphoma.

Abs25-12859: Researchers conducted a large multicenter real-world analysis evaluating the use and safety of peripheral intravenous catheters (PIV) versus central venous catheters (CVC) for frontline anthracycline-based chemotherapy in lymphoma. Among 1,414 patients treated with CHOP- or ABVD-based regimens across eight U.S. centers, extravasation was rare in both groups, with only one documented case in the CVC cohort and two suspected cases in the PIV cohort. No significant differences were observed in induration, phlebitis/cellulitis, venous thromboembolism, or erythema. While PIV use was associated with higher rates of local pain/tenderness and infiltration, events were uncommon and self-limited. Overall, PIV access was found to be safe with a low rate of serious complications over more than 9,000 treatments, supporting its selective use despite the common default to CVC placement.

Abs25-8890: A first report from Part 1 of the Phase 3 OLYMPIA-3 study examined odronextamab plus chemotherapy in previously untreated diffuse large B-cell lymphoma (DLBCL). The Part 1A analysis assessed two dose levels in 22 patients, with primary endpoints focused on dose-limiting toxicities and treatment-emergent adverse events. No dose-limiting toxicities occurred, and the safety profile was manageable, with neutropenia, cytokine release syndrome, anemia, and infections as the most common adverse events. All patients experienced Grade ≥3 TEAEs, though CRS events were limited to Grade 1–2 and no tumor lysis syndrome was observed. Preliminary efficacy was encouraging, with ORR of 77.8% and CR rate of 66.7% at DL1 and both ORR and CR of 100% at DL2, with median duration of response not reached. These early results suggest rituximab may not be required to achieve depth of response in this frontline setting.

Abs25-7103: A retrospective real-world evidence study investigated racial and ethnic inequities in access to guideline-preferred first-line therapies for chronic lymphocytic leukemia (CLL). Using data from 4,452 patients in the Flatiron Health Research Database linked with neighborhood-level social determinants of health, researchers found that Black and Hispanic patients were more likely to live in high-deprivation areas and were less likely than White patients to receive NCCN-preferred novel therapies. Structural factors—including residential segregation, socioeconomic status, limited internet access, vehicle ownership, and health insurance—were associated with lower use of preferred first-line treatments. Findings underscore the role of neighborhood-level barriers in limiting equitable access to novel therapies.

The full list of presentations at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition can be found here.

(Press release, Rutgers Cancer Institute of New Jersey, DEC 2, 2025, View Source [SID1234661064])

On December 2, 2025 Insilico Medicine ("Insilico"), a global leader in AI-powered drug discovery, and Atossa Therapeutics ("Atossa") (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel treatments for breast cancer and other serious conditions, reported the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM). The peer-reviewed article, now published in Nature’s Scientific Reports, represents one of the most comprehensive AI-enabled analyses to date exploring whether endoxifen, an active metabolite of tamoxifen with known activity in endocrine-resistant breast cancer, may offer new therapeutic opportunities for one of the deadliest malignant brain tumors in adults. The study aimed to identify new oncology indications with high therapeutic potential for endoxifen, as monotherapy or in combination, by applying Insilico’s AI-powered PandaOmics platform across a wide range of cancer types based on its mechanisms of action. Through this systematic evaluation, GBM emerged as a top candidate for further investigation.

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The publication highlights progress in understanding glioblastoma, an aggressive primary brain tumor with a five-year survival rate of roughly 4%. By applying multi-omics and AI-enabled methods—including transcriptomic integration, computational modeling, single-cell sequencing, survival analysis, and experimental validation—the study offers mechanistic insights that support further exploration of endoxifen’s potential role in this setting.

(Z)-Endoxifen, already clinically active in hormone-resistant breast cancer and known to act through both estrogen-dependent and estrogen-independent mechanisms, has long been considered a promising molecule for broader oncology applications, but has not been systematically explored in GBM. Using PandaOmics, researchers evaluated more than 900 cancer indications with weighted transcriptomic signatures from endoxifen-treated datasets. PandaOmics combined differential expression, pathway enrichment, protein–protein interaction networks, mechanistic NLP, and disease unmet-need modeling, ultimately ranking GBM among one of the highest-opportunity indications.

AI-driven analyses identified more than 1,400 genes shared between GBM tumors and endoxifen-treated cells, revealing strong reversal of biological programs that drive tumor growth and treatment resistance. Endoxifen was predicted to counteract pathways associated with uncontrolled proliferation, inflammation, metabolic dysregulation, and aggressive tumor behavior. Single-cell sequencing further pinpointed key malignant-cell genes linked to poor survival and aggressive subtypes, all of which were downregulated by endoxifen.

"This collaboration with Insilico Medicine provides a whole new indication in which we might explore the utility of endoxifen, and potentially significant new opportunities to address an extremely underserved set of cancer patients," said Steven Quay, M.D., Ph.D., CEO of Atossa Therapeutics. "Most of our joint projects have focused on advancing women’s health, but this study allowed us to extend our work into glioblastoma, a disease with an urgent and unmet need, and not unlike other highly ranked indications, including but not limited to Duchenne muscular dystrophy (DMD) and multiple gynecologic-related cancers for which (Z)-Endoxifen may have excellent therapeutic outcomes. The results of our collaboration with Insilico highlight how AI-enabled discovery can uncover entirely new opportunities for a well-characterized molecule like endoxifen."

Laboratory validation closely matched the computational predictions. In vitro, (Z)-endoxifen significantly suppressed GBM cell proliferation and induced apoptosis, demonstrating greater cytotoxic activity than high-dose temozolomide and showing enhanced effects in combination. In vivo studies confirmed that endoxifen was well tolerated across all doses. Together, the multi-omic analyses and experimental findings highlight endoxifen as a promising therapeutic candidate for GBM and showcase how AI-powered discovery can reveal new opportunities for drug repurposing and cancer treatment innovation.

"Atossa is deeply committed to scientific leadership in the prevention and treatment of high risk breast cancers, and Insilico is honored to collaborate with the company to advance genuine innovation and expand indications across different areas of oncology," said Alex Zhavoronkov, Ph.D., Founder and CEO of Insilico Medicine. "This publication represents one of the early fruits of our joint research, and much of our collaborative work remains unpublished. We are hopeful that these efforts will ultimately translate into meaningful therapeutic programs."

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development. While traditional early-stage drug discovery typically requires 3 to 6 years, from 2021 to 2024 Insilico nominated 20 preclinical candidates, achieving an average turnaround – from project initiation to preclinical candidate (PCC) nomination – of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, DEC 2, 2025, View Source [SID1234661063])