Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias

On April 29, 2026 Laguna Biotherapeutics, Inc. (Laguna), a clinical-stage biotechnology company focused on novel live bacterial therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, granting a "safe to proceed" for its lead clinical candidate from the QUAIL platform, LGNA-100.

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LGNA-100 is a first-in-class, attenuated live bacterial immunotherapy designed to safely harness our immune system’s evolved response to Listeria; robustly and durably expanding and activating endogenous γδ T cells that can directly kill cancer cells while also improving existing immunotherapies. The Phase 1 first-in-human study will validate the QUAIL platform and evaluate LGNA-100 in patients with high-risk leukemia following hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.

"The IND clearance of our first clinical study is a defining moment and transformative milestone for Laguna as we transition into a clinical-stage company," said Jonathan Kotula, Ph.D., CEO of Laguna. "Our goal is to create systems-level therapies for complex diseases. With LGNA-100, and the QUAIL platform we are taking a fundamentally new approach to selectively stimulate innate T cells to improve long-term outcomes for pediatric patients with high-risk leukemia."

The clinical rationale for the QUAIL platform builds directly upon decades of research into the human γδ T cell response to Listeria, and the protective role of γδ T cells against leukemia recurrence following HSCT. A presentation covering our clinical rationale will be presented at the ISCT 2026 Annual Meeting on May 6 in Dublin, Ireland.

"In the setting of αβ-depleted HSCT, γδ T cells are critical effectors that provide potent graft-versus-leukemia activity without driving graft-versus-host disease," said Dr. Alice Bertaina, MD, PhD, Co-Director of the Bass Center for Childhood Cancer and Blood Diseases, Lucile Packard Children’s Hospital at Stanford University and lead Clinical Advisor for Laguna. "While early pharmacologic activators like zoledronic acid (ZOL) showed the clinical potential of this approach, intense ZOL stimulation pushes these cells into a more mature, terminally differentiated and exhausted state. Our comprehensive preclinical evaluations demonstrate that LGNA-100 drives a distinct, multifunctional γδ T cell response with improved kinetic, phenotypic, and functional features compared to ZOL, supporting more durable activation without hyperactivation or early exhaustion. I am very excited to see this translated into the clinic for these high-risk leukemia patients."

"Pediatric AML remains one of the most challenging frontiers in oncology, demanding novel modalities that can detect and kill the disease without compounding toxicities," said Bill Newell, former CEO of Sutro Biopharma and Strategic Advisor to Laguna. "Having spent years evaluating platforms to tackle these exact malignancies, I believe Laguna’s approach using γδ T cells to potentially solve the problems associated with high-risk leukemia is a massive leap forward. Securing this IND is a testament to the rigor of their science and positions LGNA-100 as a highly differentiated asset in the cancer immunotherapy space."

The Phase 1 clinical study is a company-sponsored open-label, first-in-human, single ascending dose study designed to assess safety and tolerability, and support the proof of LGNA-100’s mechanism of action. The study will evaluate LGNA-100 administered via intravenous (IV) infusion in pediatric and young adult participants with high-risk acute leukemias and MDS who have received an αβ-depleted HSCT.

About LGNA-100

LGNA-100 also known as QUAIL-100 is an investigational cancer immunotherapeutic agent derived from Listeria monocytogenes (Lm), developed from the QUAIL platform, designed to activate and expand a patient’s endogenous γδ T cells.

(Press release, Laguna Bio, APR 29, 2026, View Source [SID1234664922])

U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA

On April 29, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA (tislelizumab) in combination with ZIIHERA (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication.

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Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

"HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients."

Data supporting sBLA filing

The sBLA submission is based on the first interim analysis (IA1) of HERIZON-GEA-01, a global Phase 3 clinical trial designed to evaluate ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ GEA. Key findings of the trial include:

Overall survival (OS): The arm in which TEVIMBRA was added to ZIIHERA and chemotherapy resulted in a statistically significant improvement in OS (median OS of 26.4 months) at IA1. The ZIIHERA plus chemotherapy arm achieved a median OS of 24.4 months and the control arm resulted in a median OS of 19.2 months.
Progression-free survival (PFS): Both ZIIHERA-containing arms delivered a statistically significant and clinically meaningful improvement in median PFS of 12.4 months compared with 8.1 months in the control arm.
Improvement in OS and PFS was observed regardless of PD-L1 status.
The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of the components of the combination regimen, and no new safety signals were identified.
Project Orbis pathway

BeOne plans to participate in the FDA’s Project Orbis, an initiative that provides a framework for collaborative review of oncology products among international partners, for the submission of the HERIZON-GEA-01 data in territories in which BeOne holds the ZIIHERA license. With this pathway, BeOne aims to accelerate approval and patient access to this treatment, recognizing the global significance of the HERIZON‑GEA‑01 results, which demonstrated meaningful survival improvements in a disease where outcomes have remained largely unchanged for more than a decade.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma

Gastroesophageal adenocarcinoma (GEA), which includes cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide. Approximately 20% of GEA patients have HER2-positive disease1,2,3, which has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes more than 15,000 patients enrolled to date in 30+ countries and regions across 72 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 50 countries, and more than 1.9 million patients have been treated globally.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, APR 29, 2026, View Source [SID1234664906])

Tacalyx Secures €11 Million to Advance Lead TACA-Targeting ADC Programme Toward the Clinic

On April 29, 2026 Tacalyx, a leader in the discovery and development of cancer therapies directed at Tumour Associated Carbohydrate Antigens (TACAs), reported the selection of its first clinical candidate, TCX-201, which is being advanced toward clinical development with the goal of filing a clinical trial application (CTA) in 2027. In support of this progress, the company has secured €11 million in a first closing of its seed extension round from its existing international investor syndicate, including Boehringer Ingelheim Venture Fund (BIVF), Kurma Partners, High-Tech Gründerfonds (HTGF), Eurazeo, Creathor Ventures, and Thuja Capital. The company intends to expand the round with additional investors in a subsequent closing. The proceeds will be used to see TCX-201 through preclinical development while advancing the company’s broader pipeline.

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TCX-201 is an antibody drug conjugate (ADC) against an undisclosed TACA, developed using the company’s proprietary platform for the treatment of gastrointestinal malignancies and other solid tumours. TACAs represent a largely untapped class of targets found on tumour cell surface structures that may enable the development of highly selective therapies for patients with hard-to-treat tumours. In parallel, the newly secured capital will allow Tacalyx to continue to progress and expand its rich portfolio of first-in-class and best-in-class programmes designed to address multiple solid tumour indications with a high unmet medical need. The selection of the next clinical candidate is planned for the end of 2026.

"We are deeply grateful to our investors for their unwavering commitment in our mission to develop novel and effective treatments against solid tumours", said Jean Engela, CEO of Tacalyx. "Over the past years, we have built a powerful platform capable of reliably discovering and developing high-affinity antibodies against TACAs, sugar structures specifically found on tumour cells. Heralding a new stage for the company, Tacalyx has selected a clinical candidate for its TCX-201 programme and is now progressing preclinical activities to prepare for the CTA submission. With that, we are now redoubling our laser focus on translating the cutting-edge science on which the company was founded into transformative cancer therapies. Cancer patients cannot wait."

Klaus Schollmeier, Chairman of the Board of Tacalyx, said: "Tacalyx has delivered on its promise to unlock the therapeutic potential of TACAs, a frontier in oncology that has long been considered undruggable. With the selection of its first clinical candidate and significant advances with its earlier pipeline, the company is now rapidly transitioning from discovery research to a clinical-stage biotech. I am proud of the team’s achievements."

TACAs are distinctive glycan structures that are uniquely expressed or overexpressed on tumour cells and often play critical roles in tumour progression, including cell adhesion, immune evasion and metastasis. Because TACAs are found across a range of diverse cancer types, they represent promising targets for the development of pan-cancer therapeutics. Importantly, TACAs remain consistently expressed even in tumours lacking actionable genomic alterations or after standard therapies fail, positioning them as a differentiated and largely untapped class of cancer-specific targets with the potential to address treatment resistance. However, these novel targets have historically been difficult to address with antibodies, leaving much of this therapeutic space largely unexplored. Tacalyx is a pioneer in the discovery and development of therapies targeting TACAs. The company has built a proprietary discovery platform capable of reliably identifying and generating high-affinity antibodies against TACAs, enabling these previously inaccessible targets to become druggable. These antibodies can be further developed into novel antibody-based therapeutics tailored to specific clinical needs, including ADCs, TCEs and multi-specifics.

(Press release, Tacalyx, APR 29, 2026, View Source [SID1234664923])

Immutep Quarterly Activities Report & Appendix 4C Q3 FY26

On April 29, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 31 March 2026 (Q3 FY26).

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LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating eftilagimod alfa ("efti") in patients in first-line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

The futility analysis was based on data from approximately 170 patients and included a review of baseline disease characteristics, safety, and overall response rate ("ORR").

After carefully considering the recommendation of the IDMC, as well as conducting its own internal review of the data, Immutep has followed the IDMC’s recommendation and decided to discontinue TACTI-004. Notably, Immutep’s review included additional data such as early interim progression-free survival data.

More specifically, the Company decided that it was necessary to discontinue TACTI-004 because patients receiving a combination of efti, KEYTRUDA and chemotherapy (the "efti arm") were underperforming relative to patients receiving a combination of placebo, KEYTRUDA and chemotherapy (the "control arm"). This outcome was unexpected, given that efti combined with standard of care has typically produced higher response rates when compared to historical studies or controls. In particular, this outcome was notably inferior to results observed in INSIGHT-003 which was testing the same combinations in nonsquamous 1L NSCLC patients.

In response to the IDMC’s recommendation, enrolment in TACTI-004 has been halted and Immutep is implementing an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations.

While this is a disappointing outcome, it is important to note that this decision relates specifically to TACTI-004 and does not necessarily mean that efti as a broader development program will be discontinued.

Immutep is conducting a thorough review of available data to understand factors behind the futility outcome, examining clinical, operational, analytical, and manufacturing aspects. The process includes collecting and analysing patient samples from TACTI-004 across up to 150 sites and relevant data cleaning. This root cause analysis may extend into Q3 CY2026, depending on data availability and logistics, covering database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a key licensing partner for Immutep’s efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

"We continue to work collaboratively with Immutep on the ongoing evaluation of eftilagimod alfa, with a shared focus on determining the appropriate path forward" stated M.V. Ramana, CEO – Global Generics, Dr. Reddy’s.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 trial, in which dosing had been completed, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial was evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS).

The study met its primary objective and patients show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.2,3 Dosing is completed, and patients are being followed up for disease free survival.

In April 2026, Immutep announced that it had received an orphan drug designation for efti in this setting from the FDA.

Breast Cancer

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

Immutep continues to follow up patients in the AIPAC-003 Phase II trial which is evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2- negative/low metastatic breast cancer resistant to endocrine-based therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy.

Patients were randomised 1:1 (N=66) to receive either 30 mg or 90 mg efti in combination with chemotherapy to determine the optimal biological dose (OBD) of efti consistent with the FDA’s Project Optimus initiative. Dosing is complete, and patients are being followed up for overall survival.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

A proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients is on hold and subject to the root cause analysis related to TACTI004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In March 2026, Immutep announced an update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The single ascending portion of the Phase I trial has now been completed, with dosing up to 14 mg/kg and no safety concerns observed. The study is now continuing in the multiple ascending dose (MAD) phase, which is evaluating pharmacokinetics and safety at two dose levels, with completion expected in 3Q CY2026. The Company will present details on IMP761 at the upcoming EULAR 2026 Congress, which will be held in London, from 3–6 June 2026 and plans to release additional data in 2H CY2026.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted a new patent in Mexico directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody.

A new Japanese patent was also granted during the quarter directed to LAG525. The patent is co-owned by Immutep S.A.S. and Novartis AG and exclusively licensed to Novartis AG.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with a cash and cash equivalent, and term deposit balance as at 31 March 2026 of approximately A$110.6 million, which is better than the FY2026 budget. However, this cash balance will be reduced by the wind down costs of TACTI-004 and associated activities.

The total balance consists of 1) a cash and cash equivalent balance of A$84.3 million and 2) bank term deposits totaling A$26.3 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q3 FY26, cash receipts from customers were A$28.85 million, which is mainly due to the US$20 million (~A$28.84 million4 ) upfront payment from Dr. Reddy’s. The net cash used in G&A activities in the quarter was A$0.9 million compared to A$1.3 million in Q2 FY26.

In respect of the upfront licence fee of US$20 million received from Dr. Reddy’s in January 2026, US$2.7million (A$4.1 million5 ) was recognised as revenue and US$17.3 million (A$25.8 million6 ) was recognised as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following the discontinuation of TACTI‑004, a payment obligation has arisen under the Company’s licence agreement with Dr. Reddy’s. Under the licence agreement terms, the Company must pay US$10 million to Dr. Reddy’s by June 2026 in these circumstances. No payment has been made to Dr. Reddy’s at the date of this announcement. The expected payment will result in a cash outflow of US$10 million in the June 2026 quarter and corresponding reduction in unearned revenue. The remaining balance of US$7.3 million in unearned revenue is expected to be recognised as revenue for the half-year ending 30 June 2026.

As previously disclosed, under the terms of the licensing agreement, Dr. Reddy’s has the exclusive rights to develop and commercialise efti in the licensed territories; Immutep has an entitlement to potential regulatory, development and commercial milestone payments of up to US$349.5 million; royalties on commercial sales in the licensed territories; and Immutep retains global manufacturing rights and will supply the product to Dr. Reddy’s in the licensed markets.

The cash used in R&D activities during the quarter was A$11.8 million, compared to A$9.9 million in Q2 FY26. Payment for staff costs was A$2.6 million in the quarter, remaining the same level as in Q2 FY26. Total net cash inflows from operating activities in the quarter were A$13.5 million compared to net cash outflow of A$9.4 million in Q2 FY26.

Payments to Related Parties (detailed in item 6.1 of the Appendix 4C) comprises NonExecutive Directors’ fees and Executive Directors’ remuneration of A$515k.

Total net cash inflow received in investing activities for the quarter was A$20k, which is mainly the refund of an office security deposit.

After the TACTI-004 Phase III futility outcome, the Company has started to initiate cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend into H1 of CY28.

(Press release, Immutep, APR 29, 2026, View Source;v=undefined [SID1234664907])

Candel Therapeutics Announces Commercialization Agreement with EVERSANA to Support Potential U.S. Launch of Aglatimagene Besadenovec in Localized Prostate Cancer

On April 29, 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 that it entered into a product commercialization agreement (the "Agreement") with EVERSANA, a leading provider of global commercialization services to the life sciences industry, to support the potential U.S. commercial launch of aglatimagene besadenovec (aglatimagene or CAN-2409) for the treatment of intermediate- to high-risk, localized prostate cancer.

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Under the terms of the agreement, EVERSANA will provide Candel with a broad suite of integrated commercialization services including data and analytics, medical affairs, market access and field operations. EVERSANA joins IDEA Pharma, a division of SAI MedPartners (IDEA), which has been providing path-to-market strategies and strategic positioning for aglatimagene. Candel has worked in close collaboration with both EVERSANA and IDEA on key pre-commercial workstreams as previously announced during Candel’s virtual Research and Development Day in December 2025.

This collaboration reflects Candel’s deliberate approach to building a world class commercial organization with global reach, designed from the ground up and leveraging a team of highly experienced professionals poised to support the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer, subject to regulatory approval. This operating model gives Candel access to leading commercial capabilities while maintaining financial flexibility, capital efficiency, and scientific focus that has driven Candel’s progress to date.

"From the beginning, we designed Candel’s commercial strategy around a partner-led model that allows us to stay focused on advancing the science and navigating the regulatory pathway, while having access to world-class commercial capabilities on demand," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "With the addition of EVERSANA, that model is fully in place, and with the progress we’ve already made across our pre-commercialization workstreams, we have confidence in our readiness for the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer. We look forward to working with EVERSANA and IDEA Pharma in providing a novel and potentially invaluable therapeutic for localized prostate cancer patients."

"We are proud to support Candel as it advances what could be a new and potentially transformative treatment option for patients with localized prostate cancer," said Gregory Skalicky, President of EVERSANA. "Candel’s unique approach to commercialization, building a dedicated and flexible platform with specialized partners, rather than a fixed pharmaceutical infrastructure, is exactly the type of model EVERSANA was designed to support. We have already integrated our resources alongside the Candel team, with key commercial workstreams actively underway, and we look forward to helping ensure that aglatimagene reaches patients efficiently and effectively upon potential approval."

(Press release, Candel Therapeutics, APR 29, 2026, View Source [SID1234664924])