On March 17, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that preliminary results from an investigator-sponsored study evaluating botensilimab (BOT) in combination with balstilimab (BAL) in first-line microsatellite stable colorectal cancer (MSS CRC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 18–23 in San Diego, CA.

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The BBoPCO study (Botensilimab and Balstilimab Optimization in Colorectal Cancer; NCT06268015) is the first trial of its kind to advance a combination immunotherapy approach in the first-line setting for MSS mCRC, evaluating BOT+BAL in patients without liver, bone, or brain metastases—a population historically resistant to immunotherapy. This investigator-sponsored study was expanded to a Phase 2 and reflects a growing shift toward introducing immunotherapy earlier in the disease course, with the goal of harnessing the immune system to reduce reliance on chemotherapy and improve durability of response.

Colorectal cancer remains a leading cause of cancer-related death worldwide, with rising incidence in younger populations, and treatment continues to rely heavily on intensive, toxic chemotherapy regimens that can significantly impact quality of life, with neuropathy, organ toxicity, decrease fertility, among others. Despite advances, patients with MSS mCRC, which accounts for approximately 95% of metastatic cases, have seen limited benefit from conventional immunotherapy, underscoring a critical unmet need.

Botensilimab, an Fc-enhanced multifunctional anti-CTLA-4 antibody, is designed to activate both innate and adaptive immune responses, while balstilimab (anti–PD-1) is designed to sustain immune activity. Together, the combination is intended to target complementary immune pathways and expand the potential of immunotherapy in traditionally "cold" tumors.

The BBOpCo study adds to a growing body of research evaluating BOT+BAL across earlier lines of therapy and in settings where immune activation may have greater impact.

Presentation Details:

Poster Presentation Title: Preliminary results of first-line botensilimab (BOT) and balstilimab (BAL) optimization in microsatellite stable colorectal cancer (MSS CRC) without liver, bone, or brain metastasis (BBOpCo)

Presenting Author: Nicholas C. DeVito MD, Duke University, Assistant Professor of Medicine, Duke University, Division of Medical Oncology
Abstract No.: CT184
Session Title: Phase I Clinical Trials
Session Date: Tuesday, April 21, 2026
Session Time: 9:00AM – 12:00 PM PT / 12:00-3:00 PM ET
Location: Poster Section 50
Board No: 6

(Press release, Agenus, MAR 17, 2026, View Source [SID1234663644])

On March 17, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent business developments.

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Recent Milestones & Business Highlights

Expanding Preclinical Validation Across KRAS-Driven Cancers: Throughout 2025, Silexion generated additional preclinical data supporting the broad therapeutic potential of SIL204. In human KRAS-mutated cancer cell line models, SIL204 demonstrated very high inhibition levels of cancer cell growth across multiple models and showed activity against eight distinct KRAS mutations: G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D. Preclinical efficacy was observed across four cancer types, including pancreatic, colorectal, lung, and gastric cancers. In orthotopic pancreatic cancer models, systemic administration of SIL204 resulted in significant reductions in primary tumor growth and metastatic spread to secondary organs.

Completion of Toxicology Studies and Clinical Trial Infrastructure Build-Out: In the fourth quarter of 2025, the Company completed two-species GLP toxicology studies for SIL204, supporting planned regulatory submissions and Phase 2/3 clinical readiness. During the year, Silexion also announced it has engaged AMS Advanced Medical Services GmbH as contract research organization (CRO) for its planned Phase 2/3 program and advanced manufacturing and operational partnerships to support scaled clinical execution.

Regulatory Advancement Toward Phase 2/3 Initiation: Silexion received written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) regarding the design of its planned Phase 2/3 clinical trial. The Company subsequently submitted its Phase 2/3 clinical trial application to the Ministry of Health in Israel for SIL204 in locally advanced pancreatic cancer and anticipates receiving initial regulatory feedback in the first quarter of 2026. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of the first quarter of 2026, with additional regulatory filings across the European Union planned in early 2027.

Strengthened Financial Position and Nasdaq Compliance: During 2025, the Company raised over $18.6 million in aggregate gross proceeds through public offerings and warrant exercises transactions. In September 2025, Nasdaq confirmed that Silexion had regained full compliance with Listing Rules 5550(a)(2) and 5550(b)(1), securing continued listing on the Nasdaq Capital Market.

Phase 2/3 Clinical Trial Planned for the Second Quarter of 2026: The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204’s dual-route administration approach in combination with standard chemotherapy in patients with locally advanced pancreatic cancer.

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "We made meaningful progress during the fourth quarter and throughout 2025 as we executed across scientific, operational, and regulatory priorities to advance SIL204 toward the clinic. With our toxicology package completed, written Scientific Advice from Germany, and the submission of our Phase 2/3 clinical trial application in Israel, we believe we are well-positioned to continue advancing toward our planned Phase 2/3 clinical program initiation in 2026. We remain focused on disciplined execution as we work to bring an RNAi-based approach to patients with KRAS-driven cancers."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During 2025, we strengthened our financial position while maintaining a determined operating approach. We ended the year with approximately $6.0 million in cash and cash equivalents, and we believe our capital structure and focus on clinical progress support our planned development and regulatory and clinical milestones as we advance SIL204."

Financial Results for the Three Months Ended December 31, 2025

Research and development ("R&D") expenses for the three months ended December 31, 2025, were approximately $3.4 million, compared to approximately $0.9 million for the same period in 2024.This quarter-over-quarter increase primarily reflected the Company’s continued progression toward clinical readiness, including increased development and external program execution activities.

General and administrative ("G&A") expenses for the three months ended December 31, 2025, were approximately $1.0 million, compared to approximately $1.0 million for the same period in 2024.

Net loss for the three months ended December 31, 2025, was approximately $4.4 million, compared to approximately $1.7 million in the same period of 2024.
Financial Results for the Year Ended December 31, 2025:

R&D expenses for the year ended December 31, 2025, were $7.1 million, compared to $5.8 million for the year ended December 31, 2024. The increase was primarily driven by higher subcontractor and consultant expenses related to GMP production batches of the active pharmaceutical ingredient (API) and formulation development intended to support initiation of the planned human clinical trial expected in the second quarter of 2026, partially offset by the absence of non-cash share-based compensation expenses recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination.

G&A expenses for the year ended December 31, 2025, were $4.5 million, compared to $6.8 million for the year ended December 31, 2024.The decrease primarily reflecting the absence of significant non-cash share-based compensation expenses and transaction costs recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination, partially offset by higher professional services costs including director compensation, legal and other expenses associated with the transition to a public company subsequent to the Closing of the Business Combination, and more.

Net loss for the year ended December 31, 2025, was $11.9 million, compared to a net loss of $16.5 million for the year ended December 31, 2024.
Balance Sheet Highlights:

As of December 31, 2025, the Company had cash and cash equivalents of $6.0 million, compared to $1.2 million as of December 31, 2024. The Company believes that its current cash balance will support in its continued advancement toward the initiation of Phase 2/3 clinical trial expected in the second quarter of 2026.

Total shareholders’ equity was $2.6 million as of December 31, 2025, compared to a capital deficiency of $(4.0) million as of December 31, 2024. During 2025, the Company completed multiple financing transactions, including approximately $11.0 million in gross proceeds from public offerings in January and September, approximately $2.6 million from warrant exercises, and approximately $5.0 million from warrant exercise inducement transactions (before related issuance costs).

(Press release, Silexion Therapeutics, MAR 17, 2026, View Source [SID1234663660])

On March 17, 2026 Liminatus reported plans to initiate a Phase 1 clinical trial evaluating IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and complement established immuno-oncology therapies.

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IBA101 is engineered to target the CD47 "don’t-eat-me" signal, a mechanism that enables tumor cells to evade innate immune surveillance. By enhancing macrophage-mediated tumor clearance and antigen presentation, IBA101 is designed to work alongside PD-1/PD-L1 checkpoint inhibitors, which remain the backbone of treatment across multiple solid tumor indications.

The planned Phase 1 study is designed as a seamless clinical program, beginning with monotherapy dose escalation to evaluate safety, tolerability, and pharmacokinetics, followed by combination cohorts with PD-1/PD-L1 therapies within the same protocol. This approach is intended to efficiently generate early clinical and translational insights while supporting disciplined dose selection for future development.

Lung cancer has been selected as the initial focus of the Phase 1 program, reflecting the Widespread use of PD-1/PD-L1 inhibitors in current treatment paradigms and the ongoing need to improve depth and durability of patient responses.

The trial is planned to be conducted under the leadership of Dr. Se-Hoon Lee, a recognized expert in immuno-oncology clinical research. The study will incorporate translational analyses aimed at characterizing immune activity and identifying biological features associated with clinical benefit.

The company anticipates engaging with regulatory authorities as part of its clinical development planning and is targeting readiness to advance the program following completion of required manufacturing, nonclinical, and regulatory preparation activities.

(Press release, Liminatus Pharma, MAR 17, 2026, View Source [SID1234663677])

On March 17, 2026 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported four presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting new data in molecular residual disease (MRD) testing and multi-cancer early detection (MCED). The meeting will take place from April 17–22, 2026, in San Diego, CA.

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Exact Sciences will present new findings from the NSABP B-59/GBG-96-GeparDouze trial evaluating its tumor-informed circulating tumor DNA (ctDNA) test, Oncodetect, in early triple-negative breast cancer (TNBC), along with updated performance data from its multi-biomarker class MCED program supporting the Cancerguard test. Together, these results reinforce the company’s strategy to help detect cancer earlier and monitor disease after treatment.

"Our goal is to use molecular information to guide cancer care at every stage," said Jorge Garces, Ph.D., chief scientific officer at Exact Sciences. "By combining tumor-informed ctDNA analysis with multi-biomarker detection approaches, we’re building tools that give clinicians a clearer view of cancer biology and how disease evolves over time."

Detailed information on the AACR (Free AACR Whitepaper) presentations is provided below:

Expanding the clinical utility of MRD detection in breast and colorectal cancer

Title: Whole-exome sequencing tumor-informed circulating tumor DNA detection after completion of neoadjuvant treatment predicts non-pCR and distant recurrence in patients with early triple-negative breast cancer (TNBC)—Results from a sub-study of the NSABP B-59/GBG-96-GeparDouze Trial
Presenter: Dr. Marija Balic
Session: Saturday, April 18, 2026. Aiming for Cure: Perioperative Clinical Trials
Oral number: CT013
Key findings: Pre-surgery ctDNA status following neoadjuvant therapy (NAT) was strongly associated with both pathologic complete response (pCR) and distant recurrence-free interval (dRFI). These results highlight the potential utility of post-NAT presurgical ctDNA status as an early indicator of treatment resistance and risk stratification.

Title: Investigating the value of testing for actionable alterations and circulating tumor DNA in breast and colorectal cancers
Presenter: Dr. Gargi Basu
Session: Monday, April 20, 2026. Molecular/Cellular Biology and Genetics: Genomic Profiling to Understand Cancer Biology
Poster number: 3243
Location: Poster section 22
Key findings: Comprehensive tumor profiling identified actionable genomic alterations in nearly all breast and colorectal cancer patients tested for ctDNA. Approximately half of the samples had at least one alteration associated with FDA-approved therapies.

Advancing multi-cancer early detection with multi-biomarker innovation

Title: Performance of an optimized methylation-protein multi-cancer early detection (MCED) test classifier
Session: Sunday, April 19, 2026, Clinical Research, Early Detection Biomarkers 1
Poster number: 1109
Location: Poster section 43
Key findings: An optimized methylation–protein (MP V2) multi-cancer early detection classifier demonstrated improved early-stage sensitivity compared with the prior version while maintaining high specificity, supporting its potential to enhance detection of cancers at earlier, more treatable stages.

Title: The complementary contributions of methylation and protein biomarker classes in a multi-cancer early detection (MCED) test
Session: Sunday, April 19, 2026, Clinical Research, Early Detection Biomarkers 1
Poster number: 1108
Location: Poster section 43
Key findings: Results presented demonstrate that methylation and protein biomarker classes provide complementary and independent contributions to cancer signal detection, particularly in early-stage disease, supporting the value of a multi-biomarker approach in MCED testing.

(Press release, Exact Sciences, MAR 17, 2026, View Source [SID1234663612])

On March 17, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients with cancer, reported an additional 12 months of extended follow-up from its study of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC who had an inadequate response to prior ICI treatment. Among the 46 patients who received two administrations of aglatimagene (per-protocol population), 23 patients (50%) remained alive at 24 months. Additionally, 16 patients (35%) survived beyond 30 months, 12 patients (26%) survived beyond 36 months, 11 patients (24%) survived beyond 40 months, and 6 patients (13%) exceeded 50 months of survival. These outcomes represent an improvement from the prior data cut, in which 39% of the patients in the per-protocol population were alive at 24 months, with 10 patients surviving beyond 30 months, 6 patients each beyond 36 and 40 months, and 2 patients beyond 50 months. The extended follow-up further highlights the durability of anti-tumor immunity observed with aglatimagene-based therapy, and the persistence of a long-term survival tail in this difficult-to-treat population.

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Histologic analysis of available baseline and tumor biopsies demonstrated that among evaluable patients surviving beyond 24 months and with PD-L1 status available, (17/20) 85% had baseline PD-L1 TPS below 50% (a population typically less responsive to ICI). These findings highlight the ability of aglatimagene to convert immunologically "cold," ICI-resistant tumors into immune-active microenvironments.

mOS was 25.4 months among 46 evaluable patients who received two courses of aglatimagene (per-protocol population; cohorts 1 and 2). Among evaluable patients with progressive disease at baseline despite prior ICI therapy (cohort 2, n=41), mOS was 21.5 months, and 25.4 months in patients within cohort 2 with non-squamous histology (n=33). These outcomes compare favorably with historical reference mOS of 9.8–11.8 months reported for patients with progressive disease following ICI treatment receiving standard-of-care docetaxel1,2, representing approximately a two-fold improvement in mOS in this difficult-to-treat population. Aglatimagene maintained its generally favorable tolerability profile throughout the extended follow-up period.

Molecular profiling of paired baseline and post-treatment tumor biopsies revealed that long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and antigen presentation. In particular, enhanced interferon signaling and activation of myeloid and antigen-presenting cell programs were observed, including significant increases in the expression of IFNγ, CSF1, CX3CL1, and IL1β (p = 0.010, 0.026, 0.013, and 0.034, respectively). These findings reflect increased local inflammation and recruitment of immune effector populations within the tumor microenvironment following aglatimagene treatment and may have contributed to the durable anti-tumor immune responses observed in long-term survivors.

"These updated survival data further strengthen our previously reported findings, demonstrating the potential of aglatimagene to meaningfully extend survival for patients with advanced NSCLC who have limited treatment options after failing to respond to, or progressing despite, ICI therapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "With its differentiated mechanism of action and favorable safety profile observed to date, aglatimagene represents a novel therapeutic approach for solid tumors, with the potential to improve outcomes beyond current standards of care. These compelling results reinforce our commitment to advancing this program as we continue to develop new treatment options for patients facing this aggressive disease."

"The biomarker data presented here reinforces the multimodal anti-tumor activity of aglatimagene," said Francesca Barone, PhD, Chief Scientific Officer of Candel Therapeutics. "Consistent with its proposed prime-boost mechanism, we observed expansion of T-cell receptor diversity in both tumor tissue and peripheral blood following treatment, reflecting a broadening of the adaptive immune response. Notably, similar TCR repertoire expansion was previously reported in patients with glioblastoma treated with aglatimagene (see link: Neuro Oncol 2025;27:2617-2631), supporting a consistent immunologic signature across tumor types. Together with the observed activation of interferon signaling and antigen-presentation pathways, these findings highlight aglatimagene’s ability to drive both local and systemic anti-tumor immunity."

Based on these findings, together with a strong supporting mechanistic data package, the Company plans to advance this program into a pivotal phase 3 clinical trial in patients with NSCLC with non-squamous histology, with trial initiation expected in the second quarter of 2026. The U.S. Food and Drug Administration (FDA) has previously granted Fast Track designation for aglatimagene plus valacyclovir in combination with ICI therapy for the treatment of patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitor therapy and who do not harbor activating molecular driver mutations, or who have progressed on directed molecular therapy.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

(Press release, Candel Therapeutics, MAR 17, 2026, View Source [SID1234663629])