On May 15, 2026 Accuray Incorporated (NASDAQ: ARAY) and the University of Wisconsin School of Medicine and Public Health (UW SMPH) reported a new 10‑year strategic collaboration to advance personalized cancer treatments using Accuray’s Stellar adaptive radiation therapy platform. This agreement builds on longstanding shared history of partnership between Accuray and the school to develop precision radiation therapy technologies using imaging to precisely deliver dose sculpting for cancer treatments. This newest collaboration will support clinical research, education and training, and the development of adaptive therapies that help empower medical care teams to continually raise the standard in cancer care.

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"Our success depends on collaboration, innovation, and the energy that comes from addressing meaningful clinical needs for patients," said Steve La Neve, President and CEO of Accuray. "This Master Research Agreement formalizes and expands our longstanding relationship with the University of Wisconsin–Madison and grounds our innovations in real-world clinical practice and impactful patient care. By leveraging our respective strengths, we aim to extend the curative power of radiotherapy so departments of all sizes around the world can benefit from advanced adaptive therapies."

In the late 1980s, University of Wisconsin-Madison Professor of Medical Physics, Human Oncology, and Engineering Thomas "Rock" Mackie and his team invented technology that would later be commercialized as Accuray’s first helical radiation delivery platform, the TomoTherapy System. This ushered in a new era in radiation medicine, enabling clinicians for the first time to integrate helical 3D image-guidance with intensity-modulated radiation therapy (IG-IMRT), increasing treatment precision and accuracy to help improve patients’ cancer care. Since its introduction, Accuray has continued to enhance the helical platform, introducing advances in image quality, speed, versatility, and workflow efficiency.

The new agreement between the UW School of Medicine and Public Health and Accuray will build on this shared history to advance the next generation of adaptive radiotherapy approaches, according to Zachary Morris, MD, PhD, professor and chair of human oncology. "At UW we have exceptionally talented innovators in radiation medicine across the spectrum from discovery science to translational and clinical research and we have a track-record of advancing discoveries to clinical practice. This agreement with Accuray is an exciting next step that will accelerate the process of translating research innovation into technologies that better serve patients, leveraging a robust academic-industry collaboration to advance personalized radiotherapy treatments," said Morris.

"This framework enables us to build on a long history of shared innovation with Accuray to deepen our collaboration, bring future innovations from bench to bedside, and create translational research and training opportunities that keep patients at the center of our work," said Nita Ahuja, MD, MBA, Dean of the UW School of Medicine and Public Health and Vice Chancellor for Medical Affairs at the University of Wisconsin–Madison.

(Press release, University of Wisconsin, MAY 15, 2026, View Source [SID1234665794])

On May 15, 2026 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

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In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab, and pertuzumab (THP) has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, Enhertu has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment.

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, said: "HER2-positive breast cancer is an aggressive disease, and our goal is to reduce the risk of recurrence for patients as early as possible to achieve the best long-term outcomes. The neoadjuvant setting offers the earliest opportunity to improve outcomes, while the adjuvant setting provides another important chance to prevent recurrence for patients with residual disease after surgery. These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings and support trastuzumab deruxtecan as a potential new standard of care in early-stage disease."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "HER2-positive early disease is considered highly curable, however up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting. These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. said: "Enhertu has redefined the treatment of HER2-expressing breast cancer with practice-changing data across six breast cancer indications in seven years. Enhertu is now approved in the US across both early and metastatic HER2-positive breast cancer, accomplishing what we set out to achieve a little over a decade ago for patients at the start of our comprehensive clinical development programme."

Victoria Smart, Senior Vice President, Mission, Susan G. Komen, said: "Providing patients with early breast cancer more options to help prevent progression to metastatic disease can lead to improved outcomes. Progression and recurrence remain among the most significant unmet needs for those diagnosed with early breast cancer, and continued advances in treatment bring new hope to patients and families facing this disease."

In DESTINY-Breast11, Enhertu followed by THP as a neoadjuvant treatment demonstrated a pathologic complete response (pCR) rate of 67.3% compared with 56.3% for dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP], an improvement of 11.2% (95% confidence interval [CI] 3.9-18.3; p=0.003). At the time of the pCR analysis, 29 patients (4.5%) had event-free survival (EFS) events, and 12 patients (1.9%) had overall survival (OS) events. The results were published in Annals of Oncology.1

In DESTINY-Breast05, Enhertu as an adjuvant treatment reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy (hazard ratio [HR] 0.47; 95% CI 0.34-0.66; p<0.0001). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm, with 51 (6%) events in the Enhertu arm and 102 (12%) in the T-DM1 arm. The results were published in The New England Journal of Medicine.2

Data from both trials were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Based on the DESTINY-Breast05 results, trastuzumab deruxtecan (Enhertu) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 recommended treatment in the adjuvant setting for patients with HER2-positive early breast cancer with residual disease and a high risk of recurrence following preoperative therapy. See NCCN Guidelines for detailed recommendations.

No new safety concerns were identified with Enhertu in the DESTINY-Breast11 or DESTINY-Breast05 trials.

In DESTINY-Breast11, Enhertu followed by THP showed similar rates of drug-related overall adverse events (AEs) and interstitial lung disease (ILD)/pneumonitis as ddAC-THP, and lower rates of Grade 3 or higher AEs, serious AEs, AEs leading to treatment interruptions, left ventricular dysfunction and haematological toxicities.

In DESTINY-Breast05, Enhertu and T-DM1 showed similar rates of overall drug-related AEs and Grade 3 or higher AEs. Adjudicated drug-related ILD/pneumonitis occurred in 9.6% of patients in the Enhertu arm and 1.6% of patients in the T-DM1 arm. The majority of ILD/pneumonitis events were low grade in both arms. There were seven Grade 3 events and two deaths (Grade 5) in the Enhertu arm.

The DESTINY-Breast11 and DESTINY-Breast05 US regulatory submissions were both reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Separate regulatory applications for both trials are also under review in other countries. DESTINY-Breast05 previously received Priority Review and Breakthrough Therapy Designation by the FDA.

Enhertu is already approved in more than 95 countries, including the US, as a treatment for patients with HER2-positive metastatic breast cancer.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Financial Considerations
Following these approvals in the US, an amount of $155 million is due from AstraZeneca to Daiichi Sankyo as milestone payments for both these indications. Sales of Enhertu in the US are recognised by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

Notes

HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022, with an estimated 665,000 deaths globally.3 In the US, more than 320,000 cases of breast cancer are diagnosed annually with over 42,000 deaths.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.5 An estimated one in five cases of breast cancer is considered HER2-positive.6 Approximately one in three patients with HER2-positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis, and up to one in four will experience disease recurrence.7,8

HER2‑positive early breast cancer is generally treated across two phases: the neoadjuvant (pre‑surgical) phase and the adjuvant or post-neoadjuvant (post‑surgical) phase.

In the neoadjuvant setting, the current standard of care in many regions of the world involves combination chemotherapy regimens.9 In the US, the current standard of care consists of a combination regimen of carboplatin, trastuzumab, pertuzumab and a taxane.9,10 For patients with HER2-positive early breast cancer, achieving pCR, defined as no evidence of invasive cancer cells in the removed breast tissue or lymph nodes following treatment with neoadjuvant treatment, is an early indicator of improved long-term survival.11 Approximately half of patients (39-66%) who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.12-16

In the adjuvant setting, despite receiving additional treatment with current standard of care for residual disease, some patients still experience invasive disease or death.17 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.18

DESTINY-Breast11
DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4mg/kg) monotherapy or Enhertu followed by THP compared to ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer.

Patients were randomised 1:1:1 to receive either eight cycles of Enhertu monotherapy; four cycles of Enhertu followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The Enhertu monotherapy arm was closed early following a recommendation from the Independent Data Monitoring Committee.

The primary endpoint of DESTINY-Breast11 is rate of pCR – defined as no evidence of invasive cancer cells in the removed breast cancer tissue or lymph nodes following treatment. Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

Patients were randomised 1:1 to receive 14 cycles of Enhertu or T-DM1.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. Secondary endpoints include investigator-assessed DFS, overall survival, distant recurrence-free interval, brain metastasis-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) followed by THP is approved in the US and China as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, United Arab Emirates and Saudi Arabia as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 15 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, MAY 15, 2026, View Source [SID1234665793])

On May 15, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biotechnology company focused on oncology, AI-enabled drug development, and advanced drug delivery platforms, reported financial results for the quarter ended March 31, 2026 through its Quarterly Report on Form 10-Q, and is providing a corporate update highlighting progress across its therapeutic and platform initiatives.

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"We believe the first quarter of 2026 continues to provide validation for the strategic value of our diversified biotechnology platform," said Dr. Vuong Trieu, CEO of Oncotelic. "During the quarter, we continued advancing our oncology and AI-enabled development initiatives while maintaining the previously established fair value assessment of our GMP Bio joint venture interest as disclosed in our U.S. Securities and Exchange Commission ("SEC") filing."

Recent Operational Highlights

Continued advancement of the Company’s deciparticle-based oncology programs through its Sapu Nano joint venture, including ongoing development activities related to Sapu003 (IV everolimus) and Sapu006 (IV docetaxel).
Continued expansion of the Company’s AI-enabled biomedical development initiatives, including integration of large language model and semantic analysis capabilities designed to support biomarker identification, translational analysis, and regulatory workflow enhancement.
Completion of additional strategic development activities related to the Company’s nose-to-brain delivery platform and associated CNS-focused programs.
Ongoing development of the GMP Bio manufacturing and development infrastructure intended to support clinical-stage and commercial-scale pharmaceutical manufacturing capabilities.

Financial Highlights

As disclosed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026 and 2025, filed with the SEC on May 14, 2026, the Company maintained the fair value of its 45% ownership interest in GMP Biotechnology Limited, our joint venture with Dragon Overseas Limited at approximately $388 million as of March 31, 2026.

The fair value of the Company’s ownership was supported by an independent third-party valuation analysis performed in accordance with ASC 820 fair value accounting guidance utilizing a combination of discounted cash flow and market-based methodologies for the year ended December 31, 2026. Management concluded that no material events occurred during the quarter requiring adjustment to the previously established fair value or valuation framework.

Management Commentary

Mr. Amit Shah, CFO of Oncotelic said, "We believe our integrated strategy combining oncology therapeutics, advanced drug delivery technologies, AI-enabled development tools, and manufacturing infrastructure creates multiple potential value drivers, directly and through GMP Bio, across the organization. We remain focused on advancing our programs in a capital-efficient manner while pursuing strategic opportunities that may enhance long-term shareholder value."

(Press release, Oncotelic, MAY 15, 2026, View Source [SID1234665792])

On May 15, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported an update on corporate progress and reported third quarter financial results as of March 31, 2026 (Year end June 30).

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Corporate and R&D Highlights

Executes Service Agreement with FyoniBio GmbH to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study

Management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors.

Executes Multi-Yr, Anti-Aging & Cancer Research Collaboration with the Universities of Jaén and Granada, Spain

A multi-year Joint Research Collaboration Agreement has been established with the Universities of Jaén (UJA) and Granada (UGR), Spain. The collaboration involves the evaluation of a senescence-modulating (i.e., anti-aging) compound to mitigate senescence and to complete experiments to further support the claims of recently filed fibrosis and cancer related patent applications, requested by Propanc Biopharma Inc. to the research group "Biological Technologies of The University of Jaén" and UGR’s Research Group, "Advanced Therapies: Differentiation, Regeneration and Cancer."

Corporate and Financial Updates

Propanc entered into a private placement agreement for up to $100 million to accelerate clinical development. The Company received an initial $1,000,000 investment upon issuance of 100 shares of Series C Convertible Preferred Stock. As of March 31st, a further $1,000,000 investment was received upon exercise of 100 shares of Series C Convertible Preferred Stock.

Q3 Financial Summary (Quarter Ended March 31, 2026)

Total assets: $14.33 million

Total liabilities reduced by $2.10 million

Convertible notes reduced to $55,000 (from $538,000)

Net cash from financing activities: $4.47 million

Quarter-end cash: $443,702

$0.5 million tranche from the Series C facility subsequently received
The Company expects the financing facility to continually support planned R&D activities, including advancement of PRP and Rec-PRP.

Management Commentary

"We are entering a pivotal phase of development for the Company’s lead asset, PRP, which is progressing to a world first, Phase 1b, First-In-Human study, in 30 – 40 advanced cancer patients suffering from solid tumors. Execution of an agreement with Fyoni Bio will facilitate method development and validation of the pharmacokinetics method in preparation for the pivotal clinical study. In addition, management is engaging with CDMOs (Contract Development and Manufacturing Organizations) for the GMP manufacture of PRP for supply of the finished drug product, CROs (Clinical Research Organizations) to discuss management of future clinical trial operations, as well as preparing regulatory documentation for the Clinical Trial Application targeting submission later this year," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Additionally, our multi-year research agreement with the Universities of Jaén and Granada will continue to support, strengthen and grow our intellectual property around the use of proenzymes not just in cancer, but also focusing on cell rejuvenation to overcome age-related, chronic diseases, such as fibrosis. I am confident we are on the right path to execute a rapid transformation of our Company to clinical stage for a range of incurable diseases which can offer renewed hope for patients."

(Press release, Propanc, MAY 15, 2026, View Source [SID1234665791])

On May 15, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported new results from extended follow-up of its randomized, double-blind, placebo-controlled pivotal phase 3 trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in intermediate- to high-risk localized prostate cancer. These findings demonstrate consistent clinical benefit across multiple exploratory endpoints, reinforcing the positive topline data announced in December 2024 after an additional 20 months of follow-up, with a cutoff date of March 15, 2026.

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The data were presented by Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine at Oregon Health & Science University, during the "Practice-changing, Paradigm-shifting Clinical Trials in Urology" oral plenary session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.

Key Highlights from AUA 2026 Presentation:

Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo (hazard ratio [HR] 0.61; 95% confidence interval [CI]: 0.44, 0.85; p=0.0031) after a median follow-up of 58 months (data as of March 15, 2026). Two prostate cancer-specific deaths occurred (1 in each arm) after median follow-up of less than 10 years.

We observed consistently favorable trends in the ITT population across all secondary and exploratory endpoints, including time to biochemical failure (TTBF; HR 0.72, CI 0.40,1.31), time to metastasis (TTM; HR 0.58, CI 0.21, 1.59), rate of metastasis [(1.6% (8/496) vs. 2.8% (7/249)], and time to salvage anti-cancer therapy (time to new treatment (TTNT) HR 0.72, CI 0.39, 1.31), when comparing the aglatimagene arm with placebo on top of standard-of-care radiotherapy.

Within the intermediate-risk subgroup (635 patients, 85% of the ITT population), the aglatimagene arm demonstrated 41% improvement in PCa-specific DFS (HR 0.59, 95% CI 0.41, 0.84, p=0.0034) relative to placebo. In addition, descriptive analyses showed 52% improvement in TTBF (HR 0.48, CI 0.22, 1.03), 90% improvement in TTM (HR 0.1, CI 0.01, 0.85), lower rate of metastatic disease [0.24% (1/422) vs. 2.35% (5/213)], and 49% improvement in TTNT (HR 0.51, CI 0.24, 1.1), when comparing the aglatimagene arm with the placebo arm.

In December 2024, we reported that aglatimagene significantly improved the rate of pathological complete response in 2-year biopsies compared with placebo, suggesting the cancer had been eradicated at a microscopic level.1 Previously published work has shown that histologic changes precede clinical evidence of recurrence and that prostate biopsies, positive for cancer cells ≥ 2 years after radiotherapy, are predictive of subsequent clinically meaningful outcomes, including biochemical failure and development of metastases.2 While the number of events for biochemical failure and development of metastases presented at AUA is, as expected, still too small to achieve statistical significance for most outcomes, the observed trends are consistent and in line with this published literature, supporting the potentially long-term clinical benefit of aglatimagene. We will continue to monitor the patients over time.

"After prolonged follow-up, these data further demonstrated that aglatimagene delivered a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival, with a 39% reduction in the risk of recurrence," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "Importantly, we are seeing consistent, favorable trends across multiple clinically relevant secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, and need for subsequent anti-cancer therapy. These findings, combined with earlier evidence of increased pathological complete response at two years, reinforce our confidence that aglatimagene has the potential to deliver durable control of both local and systemic disease and to meaningfully reduce the risk of recurrence for patients undergoing radiotherapy with curative intent for localized prostate cancer. We will continue to follow patients as these data mature, with the expectation that the long-term clinical benefit may become even more apparent over time."

"I am grateful for the opportunity to have presented these data at the AUA Annual Meeting on behalf of all of our study investigators," said Mark G. Garzotto, M.D. "What is particularly compelling is the clear translation of biologic activity into meaningful clinical benefit: patients are experiencing longer periods free from recurrence and the need for additional therapy. These results move us closer to what matters most to patients—living free from cancer—and underscore the potential of aglatimagene to potentially redefine the standard-of-care in localized prostate cancer."

Current standard-of-care radiation therapy for intermediate- to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately 30% of patients experience disease recurrence within 10 years. If approved, aglatimagene immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years. Candel continues to plan to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the fourth quarter of 2026. Details from the presentation are available on the Candel website at View Source

Conference Call and Webcast Replay:

Candel hosted a webcast and conference call on Friday, May 15, 2026, which discussed the Company’s extended follow-up data from the phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer.

The replay of the webcast can be accessed here and on the Candel website at View Source under Events & Presentations, in the Investors section of the website.

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 use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, MAY 15, 2026, View Source [SID1234665790])