On March 17, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported that the U.S. Food and Drug Administration (FDA) has approved the MyChoice CDx Test as the Companion Diagnostic (CDx) for Zejula (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer.

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This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency (HRD) status and was used to stratify advanced ovarian cancer patients.

The MyChoice CDx is the only FDA-approved companion diagnostic test in the United States to identify patients with HRD-positive status eligible for treatment with Zejula. The test determines HRD status by leveraging next generation sequencing technology to conduct a comprehensive assessment of BRCA1/2 genes — including large rearrangements — and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST).

"The FDA approval reinforces Myriad’s long-standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. "By enabling precise identification of patients who may benefit from PARP inhibitors, MyChoice CDx helps ensure that treatment decisions are guided by robust genomic insights."

Nearly 50% of patients with advanced ovarian cancer have HRD positive (HRD+) tumors.1 Identifying these patients is critical to ensuring appropriate use of PARP inhibitor therapy and improving personalized treatment decisions.1-4

Zejula is a prescription medicine used for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer is associated with HRD+ status defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability. Zejula is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy (Zejula indications referenced here apply to the US only). (For other indications, see "About Zejula" section below).

To learn more about the MyChoice CDx Test and how it can support treatment decisions for patients eligible for Zejula, please visit View Source

About the MyChoice CDx Test
The MyChoice CDx Test is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) guidelines for selecting patients with ovarian cancer who may benefit from poly [ADP-ribose] polymerase (PARP) inhibitors.5 The MyChoice CDx Test determines HRD status by conducting a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST). The MyChoice CDx Test can identify 34% more patients with HRD than other tumor tests that use %LOH alone.1

About Zejula (niraparib)
Zejula is an oral, once-daily poly (ADP ribose) polymerase (PARP) inhibitor that works by preventing DNA repair in tumor cells, ultimately leading to their death. Zejula is indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Zejula is also indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula (Zejula indications referenced here apply to the US only).

(Press release, Myriad Genetics, MAR 17, 2026, View Source [SID1234663676])

On March 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported two abstracts accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in San Diego, California, April 17-22, 2026.

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One abstract will include new biomarker and immunogenicity data for cancer vaccine EVX-01. Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

The data stems from the phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

The other abstract includes data on the use of AI-Immunology to identify endogenous retrovirus (ERV)-derived neoantigens to include in personalized vaccines to treat glioblastoma, a deadly brain cancer, for which limited therapeutic options exist.

In line with our strategy to identify potential partners and opportunities for both business partnerships and scientific collaborations, we will also participate in the AACR (Free AACR Whitepaper) Oncology Industry Partnering event taking place ahead of the annual meeting.

Presentations details:
Abstract title: AI-designed personalized neoantigen vaccine, EVX-01, induces durable de novo T-cell responses in advanced melanoma patients
Poster#: 7741
Session category: Clinical research
Session title: Immune response to therapies
Location: Poster section 42
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Mads Lausen Nielsen, PhD, Project Manager at Evaxion

Abstract title: Endogenous retrovirus-derived neoantigens enable a personalized cancer vaccine strategy for glioblastoma
Poster#: 6975
Session category: Immunology
Session title: Novel Models of Immunotherapy Response
Location: Poster section 8
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Megan Benz, Duke University Medical Center

(Press release, Evaxion, MAR 17, 2026, View Source [SID1234663674])

On March 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 two poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.

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"We are excited to highlight the potential to expand the opportunity for azenosertib as a combination therapy with cytotoxic agents, including antibody drug conjugates (ADC) and chemotherapy, for Triple-Negative Breast Cancer, a subtype of breast cancer with elevated Cyclin E1 expression. These data support clinical study of azenosertib in tumor types beyond ovarian cancer," said Julie Eastland, Chief Executive Officer. "In addition, the Cyclin E1 biomarker findings in ovarian cancer based on real world data reinforce the high unmet need for this biomarker-selected patient population with poor prognosis. Our biomarker-driven strategy for azenosertib monotherapy in Cyclin E1-positive platinum-resistant ovarian cancer has potential to address this unmet need."

AACR poster presentation details are below:

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 at the time of each presentation’s session.

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.

(Press release, Zentalis Pharmaceuticals, MAR 17, 2026, View Source [SID1234663673])

On March 17, 2026 Enara Bio, a pioneer in Dark Antigen discovery and bispecific T cell engager innovation, reported new data to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlighting its lead clinical candidate, ENA101, a first-in-class bispecific T cell engager (TCE) targeting DARKFOX, a novel cancer-specific Dark Antigen discovered with Enara’s EDAPT platform.

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ENA101 was engineered using Enara’s proprietary EnTiCE T cell engager platform, enabling potent redirection of T cells to destroy cancer cells while maintaining exquisite specificity and robust manufacturability. In multiple preclinical studies, ENA101 demonstrated:

Picomolar binding affinity to the DARKFOX-A3 peptide-HLA complex using an optimized TCR mimic.
Robust cancer cell killing across a range of DARKFOX-A3⁺ solid tumor models with low pM EC50 values.
Compelling in vivo anti-tumor activity, achieving deep tumor regression in xenograft models while maintaining a large preclinical safety window.
A New Class of Cancer Targets: DARKFOX and the Power of the Dark Proteome in Cancer

DARKFOX, encoded by a previously unknown alternative open reading frame (alt-ORF) of FOXM1, is one of the most advanced antigens emerging from Enara’s transformational EDAPT discovery engine.

It is highly prevalent, tumor-specific, and homogeneously expressed, addressing longstanding limitations in solid‑tumor target specificity.
Its HLA-A*03:01–presented peptide (DARKFOX-A3) has a robust cell surface copy number providing a clinically targetable and therapeutically attractive interface for T cell engager design.
Enara’s EDAPT platform applies genomic, proteomic, and machine learning-driven strategies to uncover and validate noncanonical antigens (Dark Antigens), creating a new horizon of targets for immunotherapy development.

Upcoming AACR (Free AACR Whitepaper) Oral Presentation

Enara’s Chief Scientific Officer, Dr. Joe Dukes, will deliver an oral presentation titled:

"ENA101: A first-in-class bispecific T cell engager targeting a DARKFOX peptide presented by solid tumors."

Session: Advances in Therapeutic Antibodies
Date/Time: Monday, April 20, 2026, 2:30–4:30 p.m. PST
Abstract Presentation Number: 4052
The presentation will highlight the clinical opportunity associated with DARKFOX, the engineering of ENA101, and the comprehensive preclinical dataset supporting its advancement into clinical development.

Abstracts are available on the AACR (Free AACR Whitepaper) website.

(Press release, Enara Bio, MAR 17, 2026, View Source [SID1234663672])

On March 17, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that preclinical data on SLS009 (tambiciclib), a potent, selective CDK9 inhibitor, will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place April 17-22 at San Diego Convention Center in San Diego, CA. The abstracts will be published in the online Proceedings of the AACR (Free AACR Whitepaper).

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Exposure of acute myeloid leukemia (AML) cell lines to increasing concentrations of SLS009 for 6 hours resulted in increased active caspase-3 levels and decreased MCL-1 expression. When cells were treated repeatedly for 8 hours up to 3 doses, the IC50 decreased from 50 nM to about 20 nM, demonstrating enhanced potency with repeated exposure. Changes in caspase-3 and MCL-1 were observed as early as 6 hours after completion of treatment and became more pronounced at 24 hours. Lower levels of MCL-1 and survivin were strongly correlated with increased apoptosis.

"These new data show tambiciclib’s promise in using optimized, clinically actionable schedules at patient-relevant concentrations," said Dr. Philip Amrein, clinician investigator at Mass General Brigham Cancer Institute and Assistant Professor of Medicine, Harvard Medical School, who designed and conducted experiments.

Notably, SLS009 demonstrated activity even in AML models harboring ASXL1 and TP53 mutations, which are typically associated with high resistance and poor clinical outcomes.

"These data demonstrate that SLS009 effectively targets AML cell survival mechanisms and induces apoptosis across diverse molecular subtypes, including high-risk genetic backgrounds," said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. "The ability to lower apoptotic threshold in AML cells by suppressing key survival pathways and enhancing potency with repeated exposure further supports the development of SLS009, including in combination regimens. We look forward to sharing the findings at this year’s AACR (Free AACR Whitepaper) conference."

Poster presentation details:

Title: Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines

Session Title: Cell Death Pathways and Treatment

Session Date and Time: 4/21/2026 2:00:00 PM

Location: Poster Section 11

Abstract Presentation Number: 5666

(Press release, Sellas Life Sciences, MAR 17, 2026, View Source [SID1234663671])