On April 21, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that data from its market-leading Decipher Prostate Genomic Classifier are available in a new specialized database that the National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) Program just released (Press release, Veracyte, APR 21, 2025, View Source [SID1234651996]). This database will enable eligible researchers to evaluate Decipher Prostate test results in the context of real-world patient outcomes, prostate cancer characteristics, treatment protocols, demographics and other factors.

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"We are excited about the numerous opportunities that our collaboration with the NCI SEER Program will enable for prostate cancer researchers and, ultimately, for patients," said Philip Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. "It also reinforces Veracyte’s commitment to building clinical evidence for our tests and to advancing scientific understanding of cancer and its biological underpinnings."

The NCI SEER Program is an authoritative source of population-based information on cancer incidence and survival in the United States. The SEER specialized database containing de-identified Decipher Prostate Genomic Classifier data is based on a linkage conducted by the SEER registries and included over 560,000 prostate cancer cases diagnosed from 2010 to 2018. The Decipher Prostate test has been available for use on radical prostatectomy specimens since 2013 and on biopsy tissue since 2016.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 85 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

On April 21, 2025 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), reported that it will present exciting new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies, corresponding with improved survival benefit in patients with melanoma and head and neck cancer at the 2025 Annual Meeting of American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago on April 29, 2025 (Press release, Vaccinex, APR 21, 2025, View Source [SID1234651995]). Elizabeth Evans, PhD, Senior VP Discovery and Translational Medicine, will present results of these studies in two presentations.

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AACR Conference Information:

Date: Tuesday, April 29, 2025
Presentation title: Regulating dendritic cells to promote mature tertiary lymphoid structures and enhance anti-tumor immunity. Presentation #3975
Time: 9-12 AM CDT/10 AM – 1 PM EDT.
Session Title: The Tumor Immune Interplay as a Driver of Progression

Presentation title: Neoadjuvant pepinemab enhances DC function associated with mature tertiary lymphoid structures and activity of immune checkpoint blockade in patients with metastatic melanoma. Presentation #6007
Time: 2-5 PM CDT/ 3-6 PM EDT.
Session Title: Therapeutic Antibodies, Including Engineered Antibodies 2
Access: Posters will be presented in-person on Tuesday, April 29 at McCormick Place Convention Center, Chicago, Illinois, and on AACR (Free AACR Whitepaper) 2025 virtual meeting platform at 1:00 PM ET on Friday, April 25, 2025.

Previously reported data from these two clinical studies suggest a crucial role of pepinemab to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses. New data will characterize clinical outcomes, biomarkers, and mechanisms of these interactions in patients treated with pepinemab in combination with immune checkpoint therapy.

Boosting TLS within tumors is an area of growing excitement because the presence of TLS has been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. A limitation in the field has been identification of safe and effective therapies that can induce formation and harness the potential of TLS to enable durable benefit to patients. Pepinemab may represent a solution to this problem, as our data demonstrate the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative and PD-L1-low head and neck cancer, into hot immune centers by inducing robust and mature TLS.

Neoadjuvant immunotherapy has emerged as a promising approach in the treatment of various cancers, showing improved immune and clinical benefit in the preoperative setting compared to standard post surgery adjuvant treatments. Despite these advances, many patients who initially benefit from antibodies that block inhibitory checkpoint molecules (e.g. PD-1, CTLA 4) will progress. More effective combination therapies are needed. Neoadjuvant treatment with pepinemab enhanced TLS maturity and correlated with longer recurrence-free survival when combined with immune checkpoint inhibitors in patients with metastatic melanoma. Evaluation of pepinemab in the neoadjuvant setting for patients with head and neck cancer is ongoing and will be reported at upcoming scientific meeting this Spring.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications.

On April 21, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to TPST-1495, the company’s novel dual receptor inhibitor of prostaglandin (PGE2) signaling, for the treatment of patients with Familial Adenomatous Polyposis (FAP) (Press release, Tempest Therapeutics, APR 21, 2025, View Source [SID1234651994]).

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"Receiving orphan drug designation for TPST-1495, our second clinical program, is a significant milestone in our mission to bring innovative therapies to patients with unmet medical need," said Stephen Brady, President and CEO of Tempest. "This designation for the treatment of FAP underscores Tempest’s mission to make a meaningful difference in the lives of patients and builds on the momentum from prior designations received for amezalpat in hepatocellular carcinoma."

A Phase 2 study evaluating TPST-1495 in patients with FAP is set to begin this year, conducted by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention. Data from this study are expected in 2026.

About Familial Adenomatous Polyposis

FAP is a high-risk inherited syndrome associated with the development of cancer in affected patients and has no approved medical therapies. In the US, the disease affects approximately one in 5,000 to 10,000 individuals2. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. Patients with FAP develop large numbers of adenomatous polyps throughout the gastrointestinal tract, often starting in their teenage years. These growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum, rectum, and other tissues. Standard of care treatment for patients with FAP is surgical removal of the colon (colectomy) early in life to reduce the likelihood of cancer development. Even after colectomy, patients must receive careful surveillance for development of cancer elsewhere in the GI tract throughout their lifetime. While surgical management and surveillance have improved the prognosis for patients with FAP, cancer remains a major cause of death for patients with FAP.

On April 21, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, APR 21, 2025, View Source [SID1234651993]):

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BofA Securities 2025 Health Care Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 13, 2025
2025 RBC Capital Markets Global Healthcare Conference at 11:00 a.m. ET on Tuesday, May 20, 2025
Bernstein 41st Annual Strategic Decisions Conference at 11:00 a.m. ET on Wednesday, May 28, 2025
Goldman Sachs 46th Annual Global Healthcare Conference at 10:40 a.m. ET on Monday, June 9, 2025

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

On April 21, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") reported the successful completion of its acquisition of Chimerix, Inc. ("Chimerix") for approximately $935 million in cash (Press release, Jazz Pharmaceuticals, APR 21, 2025, View Source [SID1234651992]). Chimerix is now a wholly owned subsidiary of Jazz.

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"Bringing Chimerix into Jazz adds a novel medicine to our oncology portfolio and advances our efforts to address unmet patient needs," said Bruce Cozadd, chairman and chief executive officer of Jazz. "Dordaviprone has the potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and offers a promising near-term commercial opportunity, if approved. We are excited to welcome Chimerix’s talented team as we collectively continue to advance dordaviprone, leveraging our development and commercial capabilities to deliver this therapy to patients as soon as the second half of this year."

The addition of dordaviprone, a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, further diversifies and adds near-term commercial opportunity to Jazz’s oncology pipeline. Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.

Transaction Details

Jazz’s tender offer for all outstanding shares of common stock, par value $0.001 per share, of Chimerix expired at one minute after 11:59 p.m., Eastern Time, on April 17, 2025. Jazz has accepted for payment of $8.55 per share, in cash, without interest and subject to reduction for any applicable withholding taxes, all shares that were validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Jazz completed the acquisition of Chimerix through the merger of Pinetree Acquisition Sub, Inc., a Delaware corporation, an indirect wholly owned subsidiary of Jazz ("Purchaser") with and into Chimerix (the "Merger"). As a result of the Merger, the separate existence of Purchaser ceased, and Chimerix continued as the surviving corporation and an indirect wholly owned subsidiary of Jazz. Additional details regarding the tender can be found in a form 8-K filed by Jazz today with the SEC.

About Dordaviprone

Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Dordaviprone’s unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas.