APG-157 Reduces HPV Viral Load and Activates Anti-Tumor Immunity in Head & Neck Cancer: Presentation at AACR 2026

On April 9, 2026 Aveta Biomics, together with researchers from the VA Greater Los Angeles Healthcare System (VAGLAHS), reported new Phase 2A subpopulation data for APG-157 in head and neck squamous cell carcinoma (HNSCC) from patients at one of the clinical trial sites, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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HNSCC is a disease with limited durable treatment options, driven by multiple biological mechanisms, including persistent HPV16 infection in a growing subset of patients and chronic NF-κB-mediated immune suppression across the broader population. APG-157, an oral immunotherapy, is designed to address these drivers simultaneously.

The new analysis reveals distinct yet complementary effects across patient subpopulations. In HPV-positive patients, APG-157 reduces HPV16 expression in both tumor tissue and saliva, supporting antiviral activity. Across the broader population, treatment is associated with activation of systemic immune responses, including expansion of B and T cells.

These preliminary translational findings contain TWO CLINICALLY SIGNIFICANT observations that, to our knowledge, no therapy in HNSCC has previously reported. First, it showed a reduction in HPV viral load, addressing the root viral driver of disease in HPV-positive patients. Second, activation of gigaxonin and its downstream modulation of Snail and E-cadherin, pointing to a novel mechanism for reducing metastatic potential. While the confirmation in larger studies is the next step, these findings point to mechanisms of real clinical significance.

"The multiple mechanisms of action of APG-157 demonstrate strong potential, particularly in head and neck cancers that respond poorly to currently available chemotherapy and immunotherapy agents," said Dr. Marilene Wang, Professor of Head and Neck Surgery at the David Geffen School of Medicine at UCLA and lead investigator.

"APG-157 appears to activate gigaxonin, a novel regulator linked to NF-κB degradation, and modulates EMT markers with decreased Snail and increased E-cadherin, consistent with a less invasive, lower-metastatic-risk phenotype," added Dr. Eri S. Srivatsan, professor of surgery and senior Author at the David Geffen School of Medicine at UCLA and VAGLAHS.

These findings build on data previously presented at ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) 2025, adding further mechanistic depth to the emerging clinical profile.
The implications of these early observations may extend beyond HNSCC. HPV16 is a key driver of multiple anogenital cancers globally, and NF-κB activation is a hallmark across many solid tumors.

"These early findings of reduced HPV viral load may extend to other HPV-driven cancers, including cervical cancer. The observed shift toward a less invasive phenotype also suggests broader potential across solid tumors where reducing metastatic risk remains a key unmet need," said Dr. Selda Samakoglu, Chief Medical Officer of Aveta Biomics.

PRESENTATION DETAILS
• Title: Downregulation of HPV 16 and NF-κB and upregulation of gigaxonin and immune markers in APG-157 treated head and neck cancer: A phase 2A clinical investigation
• Presenter: Dr. Saroj Basak, Research Scientist, VAGLAHS
• Session: Biomarkers Predictive of Therapeutic Benefit
• Date: April 21, 2026
• Time: 9:00 AM – 12:00 PM
• Location: Section 42

(Press release, Aveta Biomics, APR 9, 2026, View Source [SID1234664535])

Verrica Pharmaceuticals Announces Acceptance of Late-Breaking Abstract Highlighting Potential Abscopal Effect of VP-315 for the Treatment of Basal Cell Carcinoma at the Upcoming 2026 Society for Investigative Dermatology Annual Meeting

On April 9, 2026 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported acceptance of a late-breaking abstract reporting Phase 2 exploratory data of VP-315, Verrica’s novel oncolytic peptide for the treatment of basal cell carcinoma. The data will be presented at the upcoming 2026 Society for Investigative Dermatology (SID) Annual Meeting, which will take place from May 13-16, 2026, in Chicago, Illinois.

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Presentation Details:

Title: "VP-315 Demonstrates Potential Abscopal Effect in Untreated Non-Target Basal Cell Carcinoma (BCC) Tumors"

Poster Number: LB1190

Category: Non-Melanoma Cancers and UV Biology/Injury

Poster Session Dates and Time:

Friday, May 15, 2026 (4:30 pm – 6:00 pm)

Location: (Salons B,C,D – Lower Level, Hilton Chicago)

About VP- 315 (ruxotemitide)
VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, which may offer a non-surgical option for patients suffering from skin cancer. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials.

About Basal Cell Carcinoma
Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3.6 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring.

(Press release, Verrica Pharmaceuticals, APR 9, 2026, View Source [SID1234664295])

Myriad Genetics Underscores Commitment to Cancer Care Continuum with New Data Presentations at SGO Annual Meeting

On April 9, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported that it will share new data at the Society of Gynecologic Oncology (SGO) Annual Meeting, including two oral presentations and two posters.

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"Having four abstracts accepted at the prestigious SGO annual meeting underscores the importance of the data we are sharing and our commitment to the cancer care continuum," said Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. "We are particularly pleased to be presenting the latest Precise MRD data, showing that Precise MRD testing after adjuvant therapy for ovarian cancer was significantly prognostic of recurrence during the monitoring period. Importantly, recurrence risk tracked with the quantitative ctDNA fraction detected by Precise MRD, with elevated risk observed even at ctDNA levels detectable only by an ultrasensitive assay."

The remaining three presentations use data from the Myriad Collaborative Research Registry (MCRR), one of the largest pan-cancer registries accessible for research use, including de-identified data for more than 1.3 million participants. The studies demonstrate Myriad’s commitment to externally driven research that addresses diverse questions with immediate clinical implications:

Germline pathogenic and likely pathogenic variant prevalence is associated with age and ancestry in patients diagnosed with ovarian cancer before age 40;
Ovarian cancer diagnosis varies by Lynch syndrome gene, informing counseling and risk-reducing surgery recommendations;
Universal hereditary cancer screening identifies more individuals at high risk for endometrial cancer compared to age-based screening.

These studies will be presented at the Society of Gynecologic Oncology Annual Meeting on April 10-13 at the Puerto Rico Convention Center in San Juan. Myriad will exhibit at booth #523. For more information, visit: View Source

Myriad Genetics Presentations
Precise MRD
Evaluation of the Relationship of Molecular Residual Disease Testing to Ovarian Cancer Recurrence
Poster Board Number: 1590
Sun., April 12 at 12:00-1:00 pm AST
Presenter: John Nakayama, MD, Allegheny Health Network

MCRR
Prevalence of germline pathogenic variants in patients with endometrial cancer diagnosed before and after 65 years old within a laboratory-based research registry
Rapid Fire Oral I: Genetics Prevention and Surgery
Sat., April 11 – 3:05-3:08 pm AST
Presenter: Kieran Seay, MD, University of Pittsburgh Medical Center

Broad landscape of genetic variants and ancestry associated with ovarian cancer before age forty
Poster Board Number: 1450
Sun., April 12 – 4:00-4:45 pm AST
Presenter: Eliya K. Shachar, MD, University of California, Los Angeles

Age at ovarian cancer diagnosis varies by lynch syndrome gene: a genetic testing laboratory registry study
Focused Forum X: Genetics – Keeping up with the Genes
Mon., April 13 – 9:30-10:30 am AST
Presenter: Ying L. Liu, MD, MPH, Memorial Sloan Kettering Cancer Center

(Press release, Myriad Genetics, APR 9, 2026, View Source [SID1234664294])

Zentalis Pharmaceuticals Announces 400mg QD 5:2 Azenosertib Monotherapy as the Pivotal Study Dose in Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

On April 9, 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 the selection of 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the optimal monotherapy dose of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC) based on the prespecified interim data analysis from DENALI Part 2a. This dose will be carried forward in the ongoing potentially pivotal DENALI Phase 2 clinical trial as well as the confirmatory ASPENOVA Phase 3 clinical trial.

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"Selecting the pivotal monotherapy dose for azenosertib is a key inflection point that supports our registration-intended path. Beyond executing on DENALI and ASPENOVA, we are initiating launch preparedness by adding commercial capabilities to our organization, scaling manufacturing capacity, and advancing companion diagnostic development," said Julie Eastland, Chief Executive Officer of Zentalis. "Importantly, the therapeutic profile of the selected dose from the DENALI Part 2a interim analysis provides us confidence to further pursue expansion of the clinical pipeline for azenosertib into first-line maintenance, or platinum sensitive, ovarian cancer and explore combinations in new tumor types."

"The emerging DENALI Part 2a data from the planned interim analysis provide a favorable benefit-risk profile at the 400mg QD 5:2 dose over 300mg QD 5:2. A meaningful, differentiated response rate with the selected dose and comparable safety profiles across both dose groups were observed in this interim analysis," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "While DENALI is an ongoing trial, we are encouraged by the interim Part 2a data and continued momentum of the clinical study. As an oral monotherapy, azenosertib may offer Cyclin E1-positive PROC patients an efficacious, convenient alternative to current standard-of-care intravenous chemotherapy, if approved."

DENALI Part 2a Interim Analysis

A comprehensive review of the interim data from DENALI Part 2a informed the selection of the 400mg QD 5:2 dose over 300mg QD 5:2. A prespecified interim analysis showed:

A meaningful and clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 dose
Comparable safety profiles across the two dose groups and observed improvements in several key measures, such as a discontinuation rate due to adverse events at approximately half of the rate reported in DENALI Part 1b and no treatment-related deaths.

Consistent with the seamless design of the registration-intended DENALI Part 2 trial, data from Part 2a will be included in the ongoing, full Part 2 dataset after the trial is completed, rather than reported separately. This approach is intended to preserve the integrity of the overall pivotal dataset and support the potential accelerated approval pathway.

DENALI Part 2 Trial Design Updated to Address Evolving PROC Landscape

The treatment landscape in PROC is evolving. The DENALI Part 2 study has been expanded to maintain alignment between the study population and available approved treatment options.

A new DENALI cohort that broadens inclusion to patients previously treated with a taxane-containing regimen for PROC, called Part 2c, intends to further align the study with the evolving treatment landscape. Enrollment in Part 2c is planned to initiate in Q2 2026.

Together, all three DENALI Part 2 cohorts are designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker selected patient population, subject to regulatory review. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.

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.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:

Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
Part 2b: Enrollment expansion at the selected dose up to approximately 100 patients, including patients at the 400mg QD 5:2 dose in Part 2a. This cohort is currently enrolling.
Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. Enrollment is expected to initiate in this cohort in Q2 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial will enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The trial design was aligned with the U.S. FDA to meet requirements for the accelerated approval pathway and potential conversion to full approval. ASPENOVA is expected to initiate in Q2 2026.

(Press release, Zentalis Pharmaceuticals, APR 9, 2026, View Source [SID1234664293])

Boehringer Ingelheim to evaluate innovative combination of DLL3‑targeting T‑cell engager plus PD‑L1/VEGF‑A bispecific antibody in small cell lung cancer

On April 9, 2026 Boehringer Ingelheim reported a clinical trial collaboration with BioNTech to evaluate a novel immuno‑oncology combination in extensive‑stage small cell lung cancer (ES-SCLC), one of the most aggressive and underserved forms of cancer. Under the agreement, BioNTech will supply pumitamig (BNT327/BMS‑986545), a PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb, and Boehringer Ingelheim will be the regulatory sponsor of the Phase Ib/II study. The aim is to assess safety, tolerability and early clinical activity of obrixtamig (BI 764532), Boehringer Ingelheim’s investigational DLL3/CD3 T‑cell engager, in combination with pumitamig.

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SCLC is the most aggressive subtype of lung cancer and represents around 15–20% of all lung cancer cases. It progresses rapidly, metastasizes early and almost always recurs within a year after initial treatment. While the addition of immune checkpoint inhibitors to chemotherapy has led to improved survival outcomes for patients with extensive-stage disease, most patients progress within months after treatment, and the prognosis remains poor. The collaboration combines two complementary immunotherapeutic mechanisms to explore a potential new path to enhance and sustain antitumor immunity. Obrixtamig redirects T-cells to kill DLL3 expressing tumor cells, while pumitamig aims to restore T-cells’ ability to recognize and destroy tumor cells while cutting off the blood and oxygen supply that feeds the tumor with the intention of preventing it from growing and proliferating.

"By uniting T‑cell redirection against DLL3 with PD-L1 and VEGF pathway modulation, we aim to address two central barriers in SCLC – immune evasion and an immunosuppressive, pro‑angiogenic microenvironment," said Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim. "We are committed to advancing combinations that could deliver more durable benefit for people living with ES‑SCLC."

Obrixtamig is Boehringer Ingelheim’s investigational bispecific DLL3/CD3 T‑cell engager, designed to direct immune cells to attack DLL3‑expressing cancer cells, a hallmark of small cell lung cancer and other neuroendocrine carcinomas. In the global Phase I first‑line ES‑SCLC study DAREON‑8, in combination with chemotherapy and atezolizumab, obrixtamig achieved a 68% confirmed objective response rate, 89% disease control rate, and a 9‑month progression‑free survival rate of 52%, with a favorable safety profile1. Obrixtamig is being evaluated across multiple global studies and is advancing into a global Phase III trial (DAREON‑Lung‑1, NCT07472517). It has received FDA Fast Track and Orphan Drug Designations, as well as Orphan Drug status from the European Commission for neuroendocrine carcinomas.

Pumitamig is an investigational PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb that combines two complementary, validated mechanisms in one single molecule – immune checkpoint inhibition and anti-angiogenesis. In a global Phase II first‑line ES‑SCLC study in combination with chemotherapy, pumitamig demonstrated a 76.3% confirmed objective response rate, 100% disease control rate, and median progression-free survival of 6.8 months, with a manageable safety profile2. The program has advanced into a global Phase III trial (ROSETTA LUNG‑01, NCT06712355) and received FDA Orphan Drug Designation in 2025 for the treatment of SCLC.

Under the terms of the agreement, BioNTech will supply pumitamig and Boehringer Ingelheim will be the regulatory sponsor of the study. Both companies retain full rights to their respective assets, and the agreement is mutually non-exclusive. The trial will begin dosing patients in the second half of 2026.

(Press release, Boehringer Ingelheim, APR 9, 2026, View Source [SID1234664292])