Cervical Intraepithelial Neoplasia

EMERYVILLE, Calif.--(BUSINESS WIRE)-- Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, today announced that two poster presentations highlighting the company’s RNA therapeutics pipeline will be introduced at the 2024 American Association for Cancer Research (AACR) Annual Meeting. The first presentation entails LIGHT, an immunomodulatory cytokine that is one of the components of NTX-250, the company’s lead candidate for cervical intraepithelial neoplasia. The second presentation is on preclinical data for Nutcracker’s mRNA drug candidate for prostate cancer, NTX-470. This therapy is designed to target prostate cancer antigens with mRNA-encoded, multi-specific T cell engagers with a strong anti-tumor effect and low toxicity. Poster Presentations at AACR 2024 Title: NTX-470, a novel multispecific T cell engager expressed from mRNA targets PSMA and STEAP1 prostate cancer antigens to generate enhanced functional activity Abstract Number: 6725 Session Title: Targeted Immune Cell Engagers Session Date and Time: April 10, 2024, 9:00 a.m. to 12:30 p.m. Lead Author: Chris Rae Title: Enhanced membrane stability of mRNA nanoparticle derived TNFSF14 results in superior T- cell and NK cell stimulation Abstract Number: 6536 Session Title: Tumor Microenvironment and Cancer Immunity Session Date and Time: April 9, 2024, 1:30 p.m. to 5:00 p.m. Lead Author: Adrienne Sallets The 2024 AACR Annual Meeting takes place in San Diego from April 5-10. Full abstracts are available on the AACR Online Program Planner. More information about the conference can be found on AACR’s website. About Nutcracker Therapeutics, Inc. Nutcracker Therapeutics, Inc., is an RNA therapeutics company that has combined the power of advanced engineering with high-precision biosynthesis to deploy a complete RNA platform that encompasses the design, delivery, and manufacturing of RNA medicines. Armed with this high-tech advantage, the company has initiated multiple therapeutic programs with the support of clinical investigators at leading institutions. Nutcracker’s technology platform has the potential to significantly reduce costs and cycle times for RNA therapeutic development, with dramatic advantages in speed and capacity scaling over other RNA manufacturing approaches. For more information, visit .

Updated American Society of Colposcopy and Cervical Pathology ( ASCCP) guidelines recognize the importance of dual-stain biomarkers in managing early diagnosis of HPV- positive cervical precancer and cancer. Earlier detection may significantly reduce the number of women expected to be diagnosed with cervical cancer. CINtec® PLUS Cytology is the only FDA-approved dual-stain triage test for HPV-positive cervical cancer screening results. INDIANAPOLIS, March 11, 2024 /PRNewswire/ -- Roche Diagnostics today announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer. Roche's CINtec® PLUS Cytology is the only FDA-approved dual-stain triage test for HPV-positive cervical cancer screening results. Continue Reading Dual stain is a robust marker of CIN3+ risk and can be incorporated into clinical management strategies, according to the guidelines.∗ Existing clinical decision support tools (e.g., the ASCCP app) plan to incorporate these recommendations for use of DS. The guidelines examine data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study, and outline new recommendations on how to manage patients using dual-stain technology. The guidelines also note that compared with cytology, dual stain requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or greater earlier. "There is robust evidence that proves the use of dual-staining to risk stratify and triage patients is superior to cytology, making it a valuable tool for OB-GYNs," said Dr. Tamera Paczos, an OB-GYN and senior vice president, chief laboratory officer for BioReference, which operates large reference facilities nationwide. "Dual-stain triage provides excellent discrimination between HPV-positive individuals requiring direct colposcopy and those who can be safely followed in one year. It can provide peace of mind to women who are often asked to wait a year until their next screening before knowing whether their HPV infection may resolve on its own, or remain persistent and transform into cancer." When detected at an early stage, the five-year survival rate for women with invasive cervical cancer is 92%.1 In the IMPACT clinical trial, testing with CINtec PLUS Cytology as a triage detected cervical disease earlier than Pap cytology in seven out of 10 women who were already identified as HPV positive.2,3 The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology when used for the triage of HPV-positive women. This allows clinicians to treat disease earlier, a critical factor in improving cancer patient outcomes. "For the first time, ASCCP has included dual-stain testing as an option for the triage of HPV-positive women in HPV primary screening and co-testing settings," said Laura Shields, chief medical partner, Pathology Oncology at Roche Diagnostics. "With more advanced technologies, such as dual-stain, better access and more awareness, we can change the course of this disease with earlier detection, save lives and eventually eliminate cervical cancer." CINtec® PLUS Cytology detects the simultaneous presence within a single cell of the p16 and Ki-67 biomarkers, which are associated with HPV infections that are transforming and may lead to cervical cancer. A positive test result signals that a patient has a significantly higher risk for the disease. The dual-stain test is performed with the same sample as used for HPV or Pap cytology tests, so it does not require a repeat office visit for the patient. The Roche cobas ® HPV Test is the only test approved by the FDA for use with CINtec PLUS. ∗Please see ASCCP website (acssp.org) for full details on the updated guidelines. About the Roche Cervical Cancer Portfolio Roche's cervical cancer portfolio includes the cobas HPV Test, used for primary screening and co-testing, which tests for 14 types of high-risk HPV genotypes in cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.4 The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain product and CINtec® Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of precancerous cervical lesions. The IMPACT trial design, used to validate the clinical benefits of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and .3 percent American Indian or Alaskan Native participants. This diversity was critical to accurately assess the performance of dual stain in patient populations with higher incident rates of HPV.5 About Roche Founded in Basel, Switzerland, in 1896 as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. Roche Diagnostics U.S. Media Relations Krystina Monaco (317) 850-7521 [email protected] Lori McLaughlin (463) 207-2395 [email protected] [email protected] SOURCE Roche Diagnostics

GENT, Belgium & AMSTERDAM--( BUSINESS WIRE )--Fujirebio Europe and Self-screen B.V. today announced an expansion of their commercial collaboration with the distribution of the PreCursor-M AnoGYN methylation-specific molecular assay from Self-screen B.V. The test is intended for the detection of promoter hypermethylation of the genes ASCL1 and ZNF582 and is used to test the methylations status of anal specimens for research use only (RUO). It complements Fujirebio's HPV-associated molecular test portfolio. “The Human Papilloma Virus (HPV) test panel of Fujirebio Europe continues to grow with effective and accurate testing solutions, and we are pleased to add this new RUO methylation-based assay to our molecular testing toolbox,” says Christiaan De Wilde, CEO at Fujirebio Europe “With its unmatched accuracy and reliability, this innovative PreCursor-M AnoGYN assay represents a significant advancement for research studies in the field of anal cancer prevention. We wanted our customers to have access to this valuable research tool as soon as possible, ultimately catalyzing advancements in elimination of HPV-related diseases.” “ We are very happy with the continued partnership with Fujirebio in the distribution of Self-screen’s HPV tests and methylation tests, ” says Michelle Meijer, Chief Commercial Officer at Self-screen B.V. “ The PreCursor-M AnoGYN extends our offering of HPV products into the field of anal cancer. Also in this HPV-related cancer, methylation appears to be promising for future use as an accurate biomarker for objective risk stratification of anal lesions. The growing medical need for better and more supportive diagnostics tools for HPV related cancers such as anal cancer drove us to the development of the PreCursor-M AnoGYN RUO assay which is now available through Fujirebio.” About host cell DNA methylation and anal cancer Incidence of anal cancer is increasing worldwide. The majority of anal cancers are squamous cell carcinoma (SCC) and are, like cervical cancer, mainly caused by a persistent high-risk HPV infection and preceded by high-grade squamous intraepithelial lesion (HSIL). In analogy with cervical cancer screening, the screening and treatment of HSIL to prevent anal cancer in high-risk groups are under debate. Host cell DNA methylation is an epigenetic hallmark of HPV-induced carcinogenesis. The PreCursor-M AnoGYN assay is a robust and reliable tool to further investigate host cell DNA methylation in anal carcinogenesis and study its potential as a valuable biomarker for the detection of anal (pre-)cancer. 1-4 Please contact Fujirebio for further information about the local availability of the test. About Self-screen B.V. Self-screen B.V. is a company highly experienced in translational HPV related research, assay development and commercialization of In Vitro Diagnostics (IVD). Our dedication is towards the development and clinical application of molecular assays for the early detection of anogenital and head & neck (pre)cancers, to the benefit of patients and health care programs around the world. Our main focus is on cervical (pre)cancer screening and prevention. Self-screen markets two clinically validated CE-IVD assays. The HPV-Risk-Assay and the PreCursor-M+ Methylation Test, for screening and triage respectively, to support full molecular cervical screening and to assist the clinician in management of women with high-grade CIN. Recently PreCursor-M AnoGYN RUO is added. For more information, visit www.self-screen.nl . About Fujirebio Fujirebio is a global leader in the field of high-quality IVD testing. We have more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products. Fujirebio has a long-lasting tradition for developing high-quality routine and truly novel biomarkers. Our IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states. Our global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network. For more information, visit www.fujirebio.com . References: van der Zee R.P. , et al. Host cell deoxyribonucleic acid methylation markers for the detection of high-grade anal intraepithelial neoplasia and anal cancer. Clin. Infect. Dis., 68 (7); 1110-1117, 2019 van der Zee R.P. , et al. Cancer risk stratification of anal intraepithelial neoplasia in human immunodeficiency virus-positive men by validated methylation markers associated with progression to cancer. Clin. Infect. Dis., 72 (12); 2154-2163, 2021 van der Zee R.P. , et al. DNA methylation markers have universal prognostic value for anal cancer risk in HIV-negative and HIV-positive individuals. Mol. Oncol., 15 (11); 3024-3036, 2021, 2021 Rozemeijer K, et al . Analytical validation and diagnostic performance of the ASCL1 / ZNF582 methylation test for detection of high-grade anal intraepithelial neoplasia and anal cancer. Tumour Virus Res. 30;17:200275, 2023