On April 17, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported data from two posters being presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA. The data show encouraging preclinical activity of azenosertib in triple-negative breast cancer (TNBC) and highlight the poor prognosis of Cyclin E1-positive ovarian cancer patients with currently available treatments in a real-world data analysis.

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Compelling Preclinical Activity in Triple-Negative Breast Cancer with Azenosertib

"The preclinical data in triple-negative breast cancer being presented at AACR (Free AACR Whitepaper) showed that azenosertib combinations can induce complete tumor responses in a model resistant to emerging ADC therapies, supporting the potential to broaden the impact of azenosertib beyond ovarian cancer," said Julie Eastland, Chief Executive Officer of Zentalis. "This includes potential development of azenosertib through differentiated combination strategies with antibody-drug conjugates (ADCs) and chemotherapy. As ADCs advance toward first-line use in TNBC, effective post-ADC treatment strategies represent a growing unmet need that azenosertib combinations may be uniquely positioned to fill. Our data suggest azenosertib may achieve this through multiple mechanisms – possibly resensitizing tumors to chemotherapy, enhancing the responses to ADC, and extending the duration of response – which is an exciting potential future direction for our pipeline."

Preclinical evidence supports azenosertib as a therapeutic strategy in TNBC:
•TNBC cell lines showed higher Cyclin E1 expression and greater sensitivity to WEE1 inhibition compared to other breast cancer cell lines
oAzenosertib monotherapy demonstrated meaningful antitumor activity across a diverse panel of 12 TNBC in vivo xenograft models (42-99% tumor growth inhibition)
•In a patient-derived xenograft model of TNBC with clinical resistance to sacituzumab govitecan, an approved topoisomerase 1 inhibitor (TOPO1i) ADC, azenosertib + enfortumab vedotin (EV):
oInduced complete responses in 7 of 8 mice (87.5%); 5 mice did not progress after treatment discontinuation
oPrevented tumor progression in 8 of 8 mice for more than 52 days compared to 100% progression observed within 30 days with EV alone
oDrove deep tumor regression in mice models refractory to sacituzumab govitecan or trastuzumab deruxtecan with large tumor volumes (average ~900mm3)

•Combinations of azenosertib with TOPO1i-payload ADCs (sacituzumab govitecan, datopotamab deruxtecan, or trastuzumab deruxtecan) enhanced both depth and duration of response compared to ADC monotherapy in ADC-naïve models
•Azenosertib + paclitaxel restored substantial sensitivity to paclitaxel in a model resistant to both paclitaxel and TOPO1i ADCs (51% tumor growth inhibition vs. 16% with paclitaxel alone)

Cyclin E1 Protein Overexpression Characterizes Ovarian Cancer Patients with Poor Prognosis

"The real-world data being presented at AACR (Free AACR Whitepaper) provide important validation that Cyclin E1-positive ovarian cancer patients face a particularly challenging disease trajectory with standard-of-care therapies," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "The consistency of worse outcomes across independent cohorts and multiple treatment settings underscores the significant unmet need in this population. These findings provide important context for Zentalis’ registration-intended DENALI and ASPENOVA studies, which are evaluating WEE1 inhibition with azenosertib monotherapy as a targeted approach for the Cyclin E1-positive population that currently has limited effective treatment options."

Real-world data from two independent cohorts (Tempus Lens Ovarian cancer dataset and Zentalis’ historical clinical trials) consistently demonstrated that Cyclin E1-positive ovarian cancer patients experience worse clinical outcomes:
•After first-line treatment, Cyclin E1-positive patients, with or without CCNE1 gene amplification, had shorter time to next treatment compared to Cyclin E1-negative patients (13.2 months and 14.9 months, respectively, compared to 19.5 months, p=0.002)
•Cyclin E1-positivity is associated with a trend toward reduced clinical benefit from standard-of-care PROC treatments

AACR Poster Details

Title: "WEE1 Inhibition as a Therapeutic Strategy in Triple-Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models"
Abstract Number: 2012
Date/Time: Monday, April 20, 2026, 2:00 p.m. – 5:00 p.m. PDT
Presenting Author: Alexandra Levy, MS

Title: "Real-World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1-Positive Ovarian Cancer"
Abstract Number: 1708
Date/Time: Sunday, April 19, 2026, 2:00 p.m. – 5:00 p.m. PDT
Presenting Author: Jinkil Jeong, PhD

The posters can be accessed on the Supporting Publications page of the Zentalis website.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

(Press release, Zentalis Pharmaceuticals, APR 17, 2026, View Source [SID1234664477])

On April 17, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported clinical data indicating zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (ADC), provides rapid and robust intracranial responses in patients with previously treated extensive stage small cell lung cancer (ES-SCLC) and brain metastases as measured by independent assessment using modified Response Assessment in Neuro-Oncology for Brain Metastases (mRANO-BM) criteria, as well as promising data in patients with other neuroendocrine carcinomas (NECs). These findings, as well as preclinical data evaluating ZL-6201 (LRRC15 ADC) and ZL-1222 (PD-1/IL-12), will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego.

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Results from an ongoing, global Phase 1 trial (NCT06179069) demonstrate that treatment with zoci results in significant intracranial lesion regression and reduced tumor size among patients with ES-SCLC whose cancer metastasized to the brain, a population with poor survival and limited effective treatment options.

"For patients with extensive stage small cell lung cancer who develop brain metastases, a frequent and clinically significant driver of disease progression, the prognosis is poor and existing therapeutic options delays systemic therapy and offer limited efficacy," said Luis Paz-Ares, M.D. Ph.D., senior investigator and Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center) in Madrid, Spain. "The data from these ongoing zoci clinical trials are encouraging, demonstrating not only rapid and robust responses across multiple dose cohorts, but also notable activity in patients regardless of prior intracranial radiotherapy. These findings suggest the potential for zoci to provide a novel treatment option for difficult-to-treat cancers with limited therapies, addressing significant unmet needs in this patient population."

Additionally, researchers will share preliminary data from a Phase 1b/2 clinical trial of zoci (NCT06885281) in patients with extrapulmonary neuroendocrine carcinomas (epNECs) and other selected solid tumors. These data indicate that zoci has antitumor activity, with an objective response rate (ORR) of 38.2% in an additional patient population with aggressive malignancies, poor prognosis, and limited treatment options. Notably, there are no approved standard therapies in previously treated epNEC and no targeted therapies in this disease.

Abstract title: Intracranial activity of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer and baseline brain metastasis: Analysis of a Phase 1 trial

Patients with ES-SCLC and baseline brain metastasis were enrolled in a clinical trial with zoci monotherapy administered intravenously every three weeks at varying doses (0.8, 1.2, 1.6, 2, 2.4, or 2.8 mg/kg). The data presented had a median follow-up of 7.9 months. Systemic efficacy was measured with RECIST v1.1 by investigator assessment and intracranial efficacy was assessed with mRANO-BM by blinded independent radiologic committee review.

Among 136 treated patients, 36% had baseline brain metastases.
In all patients with brain metastases and the opportunity to finish at least two post-baseline scans, intracranial objective response rate (iORR) among patients who received zoci was 53.7% (22/41), including seven complete responses. At the 1.6 mg/kg dose, confirmed iORR was 62.5% (10/16), including four complete responses. Fourteen patients were censored after a median follow-up of 9.2 months.
Intracranial tumor reductions occurred across multiple dose levels and responses were observed in both patients with (50%, 13/26) and without (60%, 9/15) prior radiotherapy.
Zoci demonstrated a manageable safety profile, with most treatment emergent adverse events (TEAEs) reported as low grade with minimal discontinuation. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6mg/kg. The most common grade ≥3 TRAEs included: neutropenia (9.6%, 13/136), anemia (8.8%, 12/136), thrombocytopenia (3.7%, 5/136), lymphopenia (2.9%, 4/136), and leukopenia (2.9%, 4/136). No intracranial metastasis complications or treatment-related neurologic serious adverse events were reported.
Abstract title: Preliminary results from the Phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and other selected solid tumors

In another important analysis for patients with high unmet need due to aggressive malignancies with limited treatment options, preliminary results from the multicenter Phase 1b/2 study of zoci in patients with NECs demonstrated clinically meaningful responses. Researchers administered zoci intravenously at 1.6 mg/kg every three weeks until disease progression or unacceptable toxicity, with a data cutoff date of February 18, 2026, representing a median follow up of 3.7 months in the Phase 1b portion of the study. Tumor response was evaluated by investigator-assessed RECIST v1.1 with additional assessments for some NECs.

Of the 46 patients who were pretreated with prior platinum-based chemotherapy and other prior systemic therapies, treatment with zoci decreased tumor sizes within multiple epNEC subtypes with confirmed responses in pretreated patients.
Among response evaluable patients, the overall response rate was 38.2% (13/34) across study cohorts and the overall disease control rate was 55.9% (19/34).
Zoci demonstrated a manageable safety profile; neutrophil count decrease (5.2%, 3/58) was the only Grade ≥3 TRAE occurring in more than one patient.
These findings highlight the potential for zoci across a broad range of DLL3-expressing NECs.

"The zoci data that we will present at AACR (Free AACR Whitepaper), alongside our ZL-6201 and ZL-1222 preclinical data, highlight the breadth, diversity and potential of our global oncology pipeline," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The rapid progression of zoci into pivotal development, with three registration-enabling studies planned by the end of this year, is a prime example of our strategy to deliver our first global oncology launch. This accelerated progress is made possible by our unique integrated U.S.-China infrastructure, which allows us to evolve drug discovery into life-changing medicines with a focus on speed and quality."

Data from two additional Zai Lab internally developed investigational oncology therapies will also be presented at AACR (Free AACR Whitepaper). Researchers will share promising findings from preclinical studies of ZL-6201, a leucine-rich repeat-containing protein 15 (LRRC15) targeting ADC for the treatment of sarcoma and epithelial tumors with LRRC15 expressing cancer-associated fibroblasts; and, ZL-1222, a potential next generation anti-PD-1 and interleukin-12 (IL-12) signaling attenuated mutein agonist immunocytokine for cancer immunotherapy.

Details regarding the webcast and conference call are as follows:

Date/Time: Monday, April 20, 2026, at 5:30 a.m. PT / 8:30 a.m. ET / 8:30 p.m. HKT
Registration available at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenters: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab; Luis Paz-Ares, M.D. Ph.D., Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center), Madrid, Spain; Rohit Thummalapalli, M.D., gastrointestinal medical oncologist, Memorial Sloan Kettering Cancer Center

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets DLL3, a validated therapeutic target for small cell lung cancer that is overexpressed in many neuroendocrine tumors and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across 2L+ SCLC, 1L SCLC and extrapulmonary neuroendocrine carcinomas by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage small cell lung cancer, as well as a backbone DLL3-targeting antibody drug conjugate in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.

About ZL-6201

Zai Lab is evaluating ZL-6201 as a potential first-in-class LRRC15-targeting antibody drug conjugate for the treatment of multiple solid tumors. LRRC15 is a type I transmembrane protein and an attractive target for cancer therapy because it is overexpressed in various mesenchymal tumors, such as sarcoma, glioblastoma and melanoma, as well as in cancer associated fibroblasts across many other tumor types.

About ZL-1222

Zai Lab is evaluating ZL-1222 as a potential next-generation bispecific immunocytokine comprising anti-PD-1 and attenuated IL-12 for cancer immunotherapy across multiple indications, with potential to combine potent antitumor activity with improved systemic safety. Previously, interleukin-12 therapies have shown potential benefit across a range of cancer types; however, narrow therapeutic windows and toxicity concerns have limited the utility of this therapeutic class.

(Press release, Zai Laboratory, APR 17, 2026, View Source [SID1234664493])

On April 17, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported it will present new preclinical data in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego, California. These data highlight the potential of Cardiff’s highly specific oral PLK1 inhibitor, onvansertib, in combination with the HER2-targeted antibody-drug conjugate (ADC), trastuzumab deruxtecan (T-DXd), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.

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"These preclinical findings highlight a potential new opportunity for onvansertib, demonstrating its ability to enhance the activity of ADCs, which are becoming mainstays in oncology across multiple indications," said Tod Smeal, Ph.D., Chief Scientific Officer of Cardiff Oncology. "By enhancing and prolonging DNA damage, this combination appears to drive greater apoptosis than either agent alone, offering a promising new approach for patients whose cancers have become resistant to standard-of-care treatments."

Poster Presentation Highlights:

Onvansertib + T-DXd synergistically inhibited the viability of HER2-low breast cancer cell lines, including fulvestrant- and CDK4/6i-resistant cells
In the resistant triple-negative breast cancer model and two hormone receptor-positive models, the combination drove tumor regression in nearly all mice, with complete response rates up to 62%
Increased tumor regression, improved tumor growth inhibition, and extended event-free survival across models
Combination showed favorable tolerability in vivo
Following the presentation on April 19, 2026 from 2:00–5:00 PM PT, the poster titled "PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models" will be available on the Scientific Publications page of the Company’s website.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

(Press release, Cardiff Oncology, APR 17, 2026, View Source [SID1234664509])

On April 17, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that all required regulatory approvals have been obtained for its previously announced acquisition of Arcellx and that Gilead has extended the expiration of the tender offer to purchase all outstanding shares of common stock of Arcellx.

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On April 13, 2026, the Australian Competition and Consumer Commission (ACCC) published its decision that the acquisition of Arcellx may be put into effect, subject to expiration of a 14-calendar day waiting period. Assuming that the ACCC’s determination remains unchallenged during this waiting period, the waiting period expires at 10:00 a.m., Eastern Time, on April 27, 2026. Additionally, the relevant review period for the Austrian competition authorities has expired. Accordingly, all required regulatory approvals for the transaction have been obtained, and the "Regulatory Approvals Condition" (as defined in the Offer to Purchase, dated March 6, 2026, relating to the offer) will be satisfied upon expiration of the 14-calendar day review period pursuant to Australian competition law.

The tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on April 24, 2026, has been extended to expire at 5:00 p.m., Eastern Time, on April 27, 2026, and remains subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares and other customary offer conditions.

The offer remains at a purchase price of (1) $115.00 per share, net to the seller in cash, without interest, subject to any withholding tax, plus (2) one contractual contingent value right (CVR), which represents the right to receive one contingent payment of $5.00 per CVR in cash, without interest, and subject to any withholding tax, payable on March 31, 2030, subject to cumulative worldwide sales of Arcellx’s anitocabtagene autoleucel (anito-cel) product exceeding $6.0 billion on or prior to December 31, 2029.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Gilead that, as of 4:00 p.m., Eastern Time, on April 16, 2026, approximately 10,271,823 shares have been validly tendered and not validly withdrawn in the tender offer, representing approximately 17.5% of the outstanding shares as of such date and time. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Innisfree M&A Incorporated, the information agent for the tender offer, by calling toll free (877) 800-5182.

(Press release, Gilead Sciences, APR 17, 2026, View Source [SID1234664478])

On April 17, 2026 Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, reported early data from the on-going Phase 1b FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). NG-350A combined with chemoradiotherapy (CRT) demonstrated a composite response rate of 50 percent across the first 10 patients who completed the 12-week active treatment period, with no serious adverse events or new safety signals identified related to NG-350A.

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The ongoing Phase 1b FORTRESS study (NCT06459869) is assessing the anti-tumor effects of NG-350A combined with CRT following a 12-week active treatment period to establish whether NG-350A can improve composite response rates in pMMR LARC patients relative to expected outcomes from CRT alone. The primary endpoint of the FORTRESS study is the composite response rate defined as the proportion of patients achieving a clinical complete response (cCR) or a near clinical complete response (ncCR) at 12 weeks. The benchmark composite response rate (cCR + ncCR) for CRT alone at 12 weeks is approximately 25 percent. The CEDAR study, an investigator-initiated trial of EnAd (a predecessor to NG-350A without a transgene) plus CRT in patients with LARC, demonstrated a composite response rate of 50 percent. The preliminary 50 percent composite response rate observed to date in the FORTRESS study provides confirmation of the CEDAR results and underscores the promise of NG-350A plus CRT to improve pMMR LARC outcomes relative to expectations for CRT alone.

"While still early data, observation of such a significant composite response rate with NG-350A plus CRT after only 12 weeks of treatment could be a significant development for locally advanced rectal cancer treatment," said Eric Miller, MD, PhD, associate professor of radiation oncology at Ohio State University and a FORTRESS study investigator. "A therapy that increases the proportion of patients who respond to treatment, as well as the speed with which that response is achieved, could enable responding patients to pursue a ‘watch-and-wait’ protocol, to both avoid surgery and preserve organ function."

LARC is defined by the spread of rectal cancer to nearby tissues or lymph nodes. Patients with pMMR tumors account for approximately 95 percent of all LARC cases (~30,000 newly diagnosed patients annually in the US). CRC is now the leading cause of cancer related death in patients under 50 years old in the US and the incidence of CRC continues to rise in this younger population. Consistent with this trend, the average age of pMMR LARC patients included in this initial FORTRESS data analysis is 52 years.

The composite response rate (cCR + ncCR) used as the primary endpoint in the FORTRESS study reflects the dynamic process of tumor regression. As a patient’s tumor begins to respond to therapy, the tumor moves through the ncCR phase (characterized by nearly complete disappearance of the tumor mass with some residual mucosal abnormality) before final achievement of a cCR (a return to fully healthy, normal mucosa). While the time to convert from ncCR to cCR can vary by patient and therapeutic intervention, across studies, achievement of a ncCR has been strongly predictive of subsequent achievement of a cCR, with up to 90 percent of ncCRs converting to cCRs following the initial assessment.

"We believe that these early FORTRESS data provide the first key evidence of clinical proof of concept for NG-350A plus CRT in pMMR LARC," said Howard Davis, PhD, CEO of Akamis Bio. "When treated with the current standard of care, patients need to undergo life-altering surgery to remove portions of the rectum. We believe that NG-350A plus CRT has the potential to advance the pMMR LARC standard of care, offering more patients access to a non-operative approach to management of their disease, as well as the opportunity for organ preservation – a critically important treatment goal as LARC continues to impact increasingly younger patient populations."

The data will be shared in a poster presentation on April 20th at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego.

AACR Poster Presentation Details

Title: Phase 1b trial of NG-350A, a CD40 agonist antibody expressing adenoviral vector, in combination with chemoradiotherapy (CRT), in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC): Initial results from the FORTRESS study
Session Title: Phase II and Phase III Clinical Trials
Date and Time: April 20, 2:00PM – 5:00PM PDT
Location: Poster Section 52
Poster Number: 19

About NG-350A
NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study
The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported CEDAR study which showed a significantly greater composite response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy (EnAd) and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint of the FORTRESS study is the composite response rate defined as the proportion of patients achieving a clinical complete response (cCR) or a near clinical complete response (ncCR) at 12 weeks. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor reduction grade [mrTRG]), and measurement of levels of circulating tumor DNA (ctDNA) clearance. The FORTRESS study continues to enroll pMMR LARC patients with recruitment expected to conclude in 2H 2026. Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

About Locally Advanced Rectal Cancer (LARC)
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States, and it has recently emerged as the leading cause in patients under 50 years of age. There are 159,000 people newly diagnosed with CRC each year, with about 53,000 of those people diagnosed specifically with rectal cancer of which approximately 30,000 are diagnosed with LARC. LARC is defined by the spread of rectal cancer to nearby tissues or lymph nodes. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs or structures and/or into the lymph nodes. Approximately 95 percent of LARC patients have mismatch repair-proficient (pMMR) tumors which have a functional DNA repair system.

(Press release, Akamis Bio, APR 17, 2026, View Source [SID1234664494])