On March 17, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that new data will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 taking place April 17–22, 2026, in San Diego, California. These data include updated results from the TRUST-I and TRUST-II clinical studies highlighting the efficacy and safety of IBTROZI (taletrectinib) for the treatment of ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in both tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with ROS1+ NSCLC. The data to be presented represent nearly an additional year of follow-up from the data that supported IBTROZI’s line-agnostic FDA approval in June 2025.

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"We’re excited to present even longer-term follow-up data from our pivotal trials for IBTROZI, which further reinforce the depth and durability of responses in patients with advanced ROS1+ NSCLC across lines of therapy," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "In particular, with a median duration of response (DOR) now exceeding four years in TKI-naïve patients, these data continue to highlight IBTROZI’s sustained and clinically meaningful benefit for patients with a manageable safety profile."

Oral Presentation Overview:
Title: Taletrectinib in tyrosine kinase inhibitor (TKI)-naïve patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II
Presenter: Lyudmila Bazhenova, M.D., Moores Cancer Center, University of California San Diego
Session Category: Advances in Precision Oncology
Date: Tuesday, April 21, 2026
Session Time: 2:30-4:30 p.m. PST
Abstract Number: #CT300

Poster Presentations Overview:
Title: Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II
Presenter: Geoffrey Liu, M.Sc., M.D., Professor, Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto
Session Title: Phase II Clinical Trials
Date: Tuesday, April 21, 2026
Session Time: 2:00-5:00 p.m. PST
Poster Board Number: 9
Abstract Number: #CT244

Title: Taletrectinib, a next-generation selective ROS1 inhibitor, demonstrates a differentiated profile in ROS1 fusion models
Presenter: Hitisha Patel, Ph.D., Senior Director of Research, Nuvation Bio
Session Category: Experimental and Molecular Therapeutics
Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors
Date: Tuesday, April 21, 2026
Session Time: 2:00-5:00 p.m. PST
Poster Board Number: 2
Abstract Number: #5864

The materials will be made available in the Publications section of Nuvation Bio’s website after the sessions. To learn more about Nuvation Bio, visit Booth #4459 at the AACR (Free AACR Whitepaper) Annual Meeting.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

U.S. Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

(Press release, Nuvation Bio, MAR 17, 2026, View Source [SID1234663634])

On March 17, 2026 Verismo Therapeutics, a clinical-stage immuno-oncology company developing a novel multi-chain KIR-CAR platform technology, reported its participation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, which will be held April 17-22 in San Diego, California. The company will present new clinical, preclinical, and translational KIR-CAR data in three separate presentations, supporting the advancement of Verismo’s lead pipeline candidates, SynKIR-110 for patients with advanced mesothelin-expressing solid tumors, such as ovarian cancer, mesothelioma, and cholangiocarcinoma, and SynKIR-310 for patients with relapsed or refractory B cell non-Hodgkin lymphomas, as well as preclinical data from University of Pennsylvania collaborators reporting on a novel EGFR-targeted multi-chain KIR-CAR for treatment of glioblastomas.

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"These presentations at AACR (Free AACR Whitepaper) 2026 mark a defining moment in immuno-oncology as we transition from compelling preclinical evidence to first-in-human clinical data from our two lead KIR-CAR-based therapies," said Laura A. Johnson, Ph.D., Chief Scientific Officer and Chief Operating Officer at Verismo Therapeutics. "By moving beyond ‘always-on’ single-chain CAR T to multi-chain KIR-CAR science, we believe we may have the potential to overcome current CAR T therapy limitations to successfully treat patients with solid tumors and to improve clinical responses in patients with blood cancers."

Verismo’s presentations will include:

First clinical data to be released on SynKIR-110 KIR-CAR Phase 1 clinical trial for patients with advanced ovarian cancer, mesothelioma, or cholangiocarcinoma

An oral late-breaking presentation, highlighting the initial clinical results of SynKIR-110 multi-chain KIR-CAR T cell product investigated in STAR-101 Phase 1 Clinical Trial (NCT05568680)

Location: San Diego Convention Center

Abstract Presentation Number: CT104

Presentation Title: Initial results of a first-in-human dose-escalation study of KIR-CAR in patients with advanced mesothelin-expressing solid tumors

Presenting Author: Lead Clinical Investigator Janos L. Tanyi, M.D., Ph.D., Perelman School of Medicine at the University of Pennsylvania

Session Title: Clinical Trials Plenary 3: Cellular Therapies and Complex Immunotherapies
Session Time: 4/20/2026 10:15 AM – 12:15 PM PT
Preclinical and early clinical data to be released on SynKIR-310 for B cell Non-Hodgkin Lymphomas

A poster presentation, highlighting the preclinical data and early clinical data from SynKIR-310 KIR-CAR T cell product investigated in CELESTIAL-301 Phase 1 Clinical Trial (NCT06544265)

Location: San Diego Convention Center, Poster Section 40
Poster Board Number: 11

Poster Number: 5193

Title: Novel SynKIR-310 outperforms CD3-based second-generation CD28 or 41BB co-stimulated CAR T in B cell non-Hodgkin lymphoma xenograft mice and shows early clinical signal

Presenting Author: Megan Blair, Ph.D., Verismo Therapeutics

Session Category: Clinical Research
Session Title: Adoptive Cell Therapy 2
Session Time: 4/21/2026 9:00 AM – 12:00 PM PT
First preclinical data to be released on EGFR-targeted multi-chain KIR-CAR T for Glioblastoma

A late-breaking poster presentation, highlighting preclinical data of EGFR-targeted KIR-CAR T cells supporting clinical translation

Location: San Diego Convention Center, Poster Section 53
Poster Board Number: 3

Abstract Presentation Number: LB138

Title: Natural killer cell-based signaling in EGFR-targeted KIR-CAR T overcomes CD3-based CAR T functional deficits to eliminate resistant glioblastomas in vivo

Presenting Author: Jun Xu, Ph.D., Verismo Therapeutics

Session Title: Late-Breaking Research: Immunology 2
Session Time: 4/20/2026 9:00 AM – 12:00 PM PT

(Press release, Verismo Therapeutics, MAR 17, 2026, View Source;including-initial-clinical-trial-results-for-lead-immuno-oncology-candidates-synkir-110-and-synkir-310–at-aacr-annual-meeting-2026-302716606.html [SID1234663633])

On March 17, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that its first-in-class investigational drug Pidnarulex (CX-5461) has demonstrated a significant research breakthrough in the field of photodynamic therapy (PDT). The research findings have been selected for presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)—one of the world’s most influential conferences in oncology research—highlighting the innovation of the mechanism and its promising clinical development potential recognized by the international scientific community.

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In recent years, photodynamic therapy (PDT) has increasingly emerged as a promising cancer treatment strategy attracting strong interest from the global pharmaceutical industry. Several major pharmaceutical companies—including Novartis, AstraZeneca, and Roche—have actively invested in related research, acquisitions, and collaborations, exploring the integration of next-generation photosensitizers with photo-immunotherapy approaches.

The pre-clinical study shows that CX-5461 possesses photosensitizing properties. When exposed to ultraviolet (UV) light, the compound generates reactive oxygen species (ROS), leading to oxidative DNA damage and enhanced cancer cell death through both direct cytotoxicity and immune-mediated mechanisms. Under the same drug concentration conditions, cytotoxicity against cancer cells increased by approximately ten-fold.

Further investigation revealed that CX-5461’s binding to G-quadruplex (G4) DNA structures works synergistically with light-induced ROS generation, significantly enhancing anti-tumor activity and prolonging survival. These findings suggest that, beyond its established anti-cancer mechanisms, CX-5461 also has the potential to be developed as a novel photosensitizer for photodynamic and novel photoimmuno-therapy.

This emerging therapeutic strategy could potentially be applied to superficial tumors, skin cancers, and other localized treatment settings, enabling a cross-indication cancer treatment approach and opening new clinical applications in oncology.

The AACR (Free AACR Whitepaper) Annual Meeting serves as a premier global platform for validating groundbreaking science and presenting first-in-class mechanisms of action. Research presented at AACR (Free AACR Whitepaper) frequently shapes future directions in biomedical innovation and often facilitates strategic collaborations, licensing agreements, and co-development opportunities with global pharmaceutical companies. Selection of this study for presentation further enhances the global visibility of CX-5461 in the field of innovative cancer therapeutics.

The research will be presented during the "Radiation and Photodynamic Therapy Response Modifiers" clinical research session at the AACR (Free AACR Whitepaper) 2026 Annual Meeting. Jason Huang, M.D., Chief Medical Officer of Senhwa Biosciences, and Kai‑Wei Hsueh, Ph.D., Associate Director of Clinical Research, will attend the conference and present the findings.

Photodynamic therapy is a medical technology that combines a photosensitizing agent with specific wavelengths of light to activate the compound and generate singlet oxygen or free radicals, selectively destroying diseased cells or tissues. It is widely considered a minimally invasive treatment modality with relatively low systemic toxicity. PDT has already been applied in a range of diseases, including skin cancers, head and neck cancer, esophageal cancer, lung cancer, bladder cancer, and cervical cancer.

Market research also indicates continued growth in the global photodynamic therapy market. The oncology-focused PDT market was estimated at approximately USD 3.54 billion in 2024 and is projected to reach USD 5.89 billion by 2032, representing a compound annual growth rate (CAGR) of approximately 7–8%. With the increasing demand for precision oncology and minimally invasive therapies, photodynamic therapy is emerging as a key area of interest for global pharmaceutical development.

Senhwa Biosciences stated that the newly identified mechanism and application of CX-5461 in photodynamic therapy further demonstrate the compound’s potential as a multi-platform innovative anti-cancer therapeutic. The company will continue advancing related research and clinical development while actively exploring international partnerships and licensing opportunities to accelerate the global development of next-generation cancer treatments.

(Press release, Senhwa Biosciences, MAR 17, 2026, View Source [SID1234663632])

On March 17, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported multiple abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 17-22, 2026, in San Diego, CA.

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"Preclinical data accepted for presentation at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics and the AACR (Free AACR Whitepaper) Annual Meeting highlight our highly differentiated investigational asset VS-7375, an oral, KRAS G12D (ON/OFF) inhibitor in clinical development for pancreatic, lung, colorectal and other cancers harboring a G12D mutation, the most prevalent KRAS mutation in human cancers," said Jonathan Pachter, Ph.D., chief scientific officer at Verastem Oncology. "While most agents targeting KRAS G12D-driven cancers bind preferentially only to the "ON" (active) or "OFF" (inactive) state of KRAS, VS-7375 engages both active and inactive states with extremely high affinity and long residence time, which corresponds to superior efficacy across pre-clinical models of G12D mutated cancers."

Late-Breaking Abstracts

Late-breaking abstracts will be available on the AACR (Free AACR Whitepaper) Annual Meeting website on April 17, 2026, 12 p.m. PT.

Session: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Abstract #: LB183 / 5
Title: Strong durable tumor regressions with the KRAS G12D ON/OFF inhibitor VS-7375 in combination with PRMT5 inhibition in MTAP-deleted/KRAS G12D-mutant pancreatic cancer
Date and Time: April 20, 2026, 2 p.m. – 5 p.m. PT

Session: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Abstract #: LB197 / 19
Title: VS-7375, a non-covalent dual ON/OFF KRAS G12D inhibitor, displays superior activity to ON-only KRAS G12D inhibitors in preclinical models of pancreatic cancer
Date and Time: April 20, 2026, 2 p.m. – 5 p.m. PT

Regular Abstracts

The accepted abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website: AACR (Free AACR Whitepaper) Annual Meeting 2026

Session: Novel Antitumor Agents 3
Abstract & Poster Details: Abstract/Poster #7100, Poster Section #13, Poster Board #20
Title: VS-7375: An oral, selective KRAS G12D dual ON/OFF inhibitor with potent anti-tumor activity as a single agent and in combination with other agents
Date and Time: April 22, 2026, 9 a.m. – 12 p.m. PT

In the KP4 KRAS G12D pancreatic cancer model, VS-7375 (50 mg/kg twice daily), zoldonrasib (100 mg/kg once daily) and daraxonrasib (25 mg/kg once daily), produced similar initial tumor regression through day nine. By approximately day 20, however, zoldonrasib and daraxonrasib lost anti-tumor activity with tumor outgrowth, (mean tumor volume >850 mm by day 30) whereas VS-7375 maintained sustained tumor regression (mean tumor volume ~80 mm by day 30), consistent with pharmacodynamic analyses showing durable pathway inhibition only with VS-7375. VS-7375 also showed deeper tumor regression compared to these RAS ON-only inhibitors in KRAS G12D-mutated lung and colorectal xenograft models.

Session: Therapies Targeting Metastasis
Abstract & Poster Details: Abstract/Poster #2232, Poster Section #32, Poster Board #7
Title: Investigating the combined inhibition of RAF, MEK, and FAK in melanoma molecular subtypes
Date and Time: April 20, 2026, 9 a.m. – 12 p.m. PT

In mutant BRAF-driven models, the combination of the FAK inhibitor VS-4718 and the RAF/MEK clamp avutometinib, with or without the mutant BRAF inhibitor encorafenib, significantly delayed tumor onset, induced regression of established tumors and brain metastases, and prolonged overall survival.

AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics

At the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics held March 5-8, 2026, Dr. Jonathan Pachter, delivered a plenary oral presentation titled, "Anti-tumor efficacy of the selective oral KRAS G12D dual ON/OFF inhibitor VS-7375 as a single agent and in combination with targeted agents." This presentation can be found on the Company’s website on the Resources page.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem initiated VS-7375-101, an international Phase 1/2 clinical trial, in June of 2025 in the U.S., that is evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

About the GenFleet Therapeutics Collaboration

The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.

(Press release, Verastem, MAR 17, 2026, View Source [SID1234663631])

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])