Cervical Intraepithelial Neoplasia

TUESDAY, July 9, 2024 -- A new urine test might help doctors more easily screen for cervical cancer, researchers report. The test looks for proteins generated by a type of cancer-causing human papillomavirus, HPV 16. HPV strains 16 and 18 are responsible for nearly all cervical cancers, according to the National Cancer Institute. These proteins, called E7 proteins, are associated with a high risk of cervical cancer, researchers said. “Our new urine test can detect HPV16 E7 proteins, which are critical markers of cervical cancer risk, at extremely low levels,” said lead researcher Etsuro Ito , a professor of biology at Waseda University in Japan. “This means that women may be able to screen for cervical cancer without the discomfort and inconvenience of a traditional Pap test.” The test detected E7 proteins in 80% of women with Stage 1 cervical intraepithelial neoplasia (CIN), a precursor to cervical cancer. It also found the proteins in 71% of women with Stage 2 CIN and 38% of women with Stage 3 CIN, results show. “We believe that the E7 oncoprotein is critical in the early stages of HPV-related cervical carcinogenesis and E7 may play a more significant role in the progression of CIN1 and CIN2 than in CIN3,” Ito said in a university news release. The availability of a simple urine test could aid efforts to eradicate cervical cancer by eliminating barriers related to screening, researchers said. “This new method holds great promise for early detection and prevention of cervical cancer,” Ito said. “We are optimistic that further development and validation of this assay will lead to its widespread use in clinical settings.” The study was recently published in the journal Microorganisms . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

GAITHERSBURG, MD, May 21, 2024 (GLOBE NEWSWIRE) -- Amplexd Therapeutics, Inc. (“Amplexd” or the “Company”), a clinical stage patient-scientist-led biotech company specializing in accessible treatments for human papillomavirus (HPV)-induced Cervical Intraepithelial Neoplasia (CIN), is pleased to announce major updates in 2024 toward the finalization of product development ahead of Phase 1/2 clinical trials for its non-invasive treatments of CIN, the precursor to cervical cancer. The Company has secured US$2 Million for this initiative from an Asia-based life sciences focused family office. “The funding marks a major milestone in our R&D efforts for our two therapies after extremely promising preclinical studies were completed. The capital will enable us to finalize development and IND submissions ahead of first-in-human clinical trials, expected to commence later this year,” said Co-Founder and CEO Alia Rahman. The strategic funding positions Amplexd Therapeutics to reshape the landscape in HPV and cervical precancer treatments with two topical, non-invasive options as potential alternatives to the “watch and wait” approach for low-grade CIN, and invasive surgery for high-grade CIN. Amplexd is poised to move the needle with the development of two low-cost therapies that favor patient comfort and increase access, and a vision to provide accessible solutions to target the often-overlooked public health crisis of HPV-induced cervical precancers. Figure 1 - Stages of Cervical Intraepithelial Neoplasia (CIN) Development Please click here to view figure Founded in 2022, Amplexd Therapeutics has been gaining prominence in the women’s health space as a company at the technological vanguard of the treatment of CIN, a disease which affects upwards of 178 million women globally every year. About 5% of cervical screenings in the US and Europe reveal abnormalities at any given time, with significantly higher rates in Asia, Latin America, and Africa. CIN results from certain oncogenic varieties of HPV, which can transform cervical cells into invasive cancer if left untreated. Cervical cancer is the fourth leading cause of cancer death globally in women and can largely be prevented by treatment at the CIN stage.1 Amplexd was born from Rahman’s personal experience with persistent CIN. Following a diagnosis of carcinoma in situ (high-grade CIN) and an invasive surgery, a 13-year journey with chronic CIN ensued. Eager to avoid a subsequent surgery, Rahman set out to develop a non-invasive topical therapy using a primary active ingredient, Epigallocatechin gallate (EGCG), a polyphenol derived from green tea. Evidence for the efficacy of green tea polyphenols against CIN had been investigated in a research setting but hadn’t been adequately developed from the perspective of becoming a commercial therapeutic. Seizing upon this gap, Amplexd Therapeutics was born. “I envisioned the advent of an alternative to ‘watching and waiting’ and surgery for this incredibly common condition, having myself experienced the psychological burden of chronic CIN, the trauma of the surgery itself, and the revolving door of doctors’ appointments. Our non-invasive treatments have the potential to be a game-changer both in terms of access and comfort, as they wouldn’t require surgery or physicians to implement, and are designed to minimize discomfort. My hope is that once approved, others can have an experience better than my own, without compromising quality of care,” Rahman added. About Amplexd Therapeutics, Inc. Amplexd Therapeutics is developing two low-cost, novel, non-invasive therapies for the treatment of Cervical Intraepithelial Neoplasia (cervical precancer). The first is an intravaginal suppository for low-grade CIN, and the second is a photodynamic therapy (PDT) system for high-grade CIN, each designed to selectively target neoplastic cells. These treatments are designed to both modernize the paradigm for women in developed nations by sparing the need for invasive surgeries, as well as provide access to potentially lifesaving care for those in low and middle-income regions. For more information about Amplexd Therapeutics, Inc., please visit amplexd.com. Contact: Media RelationsAmplexd Therapeutics, Inc.Email: press@amplexd.com Forward-Looking Statement: This press release may contain forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those expressed or implied in such statements. Factors that could cause actual results to differ include, but are not limited to, the regulatory and commercial success of Amplexd Therapeutics, as well as the competitive landscape in the women’s health, infectious disease, and oncology markets. Amplexd Therapeutics, Inc. assumes no obligation to update any forward-looking statements. 1 World Health Organization. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/cervical-cancer Accessed October 4, 2023.

Data showed NTX-470 successfully engaged CD3 T cells, while retaining low bystander activity and reduced off-tumor binding Another set of data detailed the design of LIGHT, an immunomodulatory cytokine that is a component of lead drug candidate NTX-250 Company scientists engineered and iterated multiple RNA sequences for NTX-470 and LIGHT through its technology platform EMERYVILLE, Calif.--(BUSINESS WIRE)-- Nutcracker Therapeutics, Inc. a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, recently presented two posters at the American Association for Cancer Research (AACR) Annual Meeting in San Diego: one showcasing the latest preclinical data for the company’s mRNA drug candidate for prostate cancer, NTX-470; and the other highlighting data on the immunomodulatory cytokine, LIGHT. “Nutcracker is building a strong slate of drug candidates for oncology indications, with NTX-470 being one of the highlights of our pipeline,” said Chief Executive Officer Igor Khandros, Ph.D. “Through our technology platform, Nutcracker scientists were able to engineer multiple variants of LIGHT and NTX-470 to investigate the activities of each molecule, and determine which has the most potential to be a clinical product candidate. This type of discovery process was made possible by the nature of RNA, and I look forward to sharing more progress our team has made on other drug candidates in the near future.” NTX-470 There are limited treatment options for the 10 percent to 20 percent of prostate cancer patients who develop castration resistance. Bispecific T cell engagers targeting prostate-specific membrane antigen (PSMA) and six transmembrane epithelial antigen of the prostate 1 (STEAP1) have demonstrated promising preliminary clinical activity, but have faced challenges with durability and toxicity, primarily due to erroneous on-target, off-tumor binding. By building and iterating on RNA sequences through the proprietary CodonCrackerTM software and the Nutcracker Manufacturing Unit, Nutcracker’s scientists engineered a group of molecules with attenuated PSMA and CD3 (cluster of differentiation 3) binding to mitigate on-target, off-tumor binding and target-independent T cell activation. Of these, NTX-470 showed the strongest target cell killing activity – it was capable of engaging CD3 T cells, while displaying minimal activity in the absence of STEAP1- or PSMA-expressing target cells, retaining low bystander activity. “The data on NTX-470, as a promising preclinical candidate, expands upon work described in a previous presentation by our partners at the University of California, San Francisco,” said Chief Scientific Officer Samuel Deutsch, Ph.D. “We’re hopeful that with our continued work, NTX-470 will prove itself as a viable treatment for prostate cancer, and serve as another example of the beauty of engineering RNA to encode for complex therapeutic proteins that would be difficult to obtain in the traditional protein engineering paradigm.” LIGHT Also at this year’s AACR annual meeting, Nutcracker presented data on its engineered version of the immunomodulatory cytokine, LIGHT, a component of NTX-250, the company’s lead candidate for cervical intraepithelial neoplasia. LIGHT comes in two forms: membrane-bound or soluble, with the former generally having stronger activity, leading to the hypothesis that limiting membrane shedding would enhance advantageous activity. Nutcracker’s scientists engineered multiple variants of LIGHT with either flexible or rigid linkers in place of protease-sensitive sites, to explore how membrane shedding susceptibility affects immunomodulatory activity. Of the tested designs, membrane-stabilized variants of LIGHT enhanced HVEM stimulation over WT LIGHT and increased proinflammatory cytokines in the tumor microenvironment. 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 .