Human Papillomavirus-Related Squamous Cell Carcinoma

WALTHAM, Mass.--(BUSINESS WIRE)-- Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced new data to be presented at The American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from May 31 – June 2, 2024. These presentations underscore Naveris' continued innovation with the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test aiding in the detection and management of HPV-driven cancers. "ASCO provides an unparalleled platform to showcase the versatility and clinical value of NavDx across various stages of cancer management from early detection to post-treatment surveillance," said Barry M. Berger, MD, Chief Medical Officer at Naveris. "We are pleased to present new data highlighting the high predictive value of TTMV-HPV DNA and its utility in monitoring disease status during treatment. These results demonstrate how NavDx is transforming the care landscape for patients with HPV-driven cancers." These presentations also highlight Naveris’ on-going commitment to patient-centered innovation and collaboration with stakeholders across the cancer care ecosystem. Lillian Kreppel, Co-Founder and Executive Director of the HPV Cancers Alliance, commented, "The HPV Cancers Alliance celebrates the innovation of tests that can more accurately detect a recurrence of cancer before it is found through a visual exam. This can result in more informed patients, an earlier indication of possible recurrence, more targeted care options for patients, and ultimately more lives saved. The HPV Cancers Alliance desires the best quality of life and outcomes possible for all cancer survivors and their families." The presentations at ASCO will report on the efficacy of Naveris’ circulating tumor HPV DNA-based approach for monitoring disease status, predicting recurrence, and guiding therapy in HPV-driven cancers: Poster Presentation | Abstract #6066 Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai Can TTMV clearance predict recurrence in HPV HNSCC? This study evaluates the predictive value of TTMV-HPV DNA in patients with locally advanced HPV-positive head and neck squamous cell carcinoma (HNSCC). Patients with rapid clearance of TTMV after induction chemotherapy (IC) remained disease-free, while 27% of those with persistent TTMV experienced relapses. The negative predictive value (NPV) of TTMV was 100%, and the positive predictive value (PPV) was 96%, supporting its use in guiding treatment intensity and surveillance. Poster Presentation | Abstract #6067 Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai TTMV and association with relapse in patients with HPV-related SCCHN undergoing CRT This study explores the use of TTMV-HPV DNA to monitor disease status in patients with HPV-related squamous cell carcinoma of the head and neck (SCCHN) undergoing chemoradiation therapy (CRT). TTMV can identify recurrence or persistence and can synergize with PET to guide therapy, as all 3 post-CRT recurrences were detected using TTMV and confirmed with PET and biopsy. The combination of TTMV with PET enhances response assessment and helps guide treatment strategies. Poster Presentation | Abstract #TPS6119 Presenter: James Edward Bates, MD, Emory University Biomarker-driven radiation therapy dose reduction after transoral robotic surgery for the treatment of HPV-positive oropharyngeal cancer This trials in progress abstract highlights an ongoing multi-institutional phase II trial evaluating the efficacy of reducing radiation therapy doses based on biomarker data post-transoral robotic surgery for HPV-positive oropharyngeal cancer. Patients with undetectable post-operative TTMV-HPV DNA without high-risk pathologic factors undergo de-escalation of adjuvant radiation therapy to 36 Gy, aiming to improve long-term swallowing function. Publication Only | Abstract #e15045 Presenter: Scott Roof, MD, Icahn School of Medicine at Mount Sinai The NAVigate-HPV Registry: A comprehensive biomarker evidence base for HPV-driven cancers This abstract outlines the structure and objectives of the recently launched NAVigate-HPV Registry, emphasizing its role in establishing a robust evidence base for the clinical utility of circulating tumor HPV DNA in managing HPV-driven cancers. The registry will systematically collect and analyze integrated biomarker and clinical data from various US cancer centers. The registry brings together representatives from 14 geographically diverse sites, expected to include over 1,000 patients within one year and grow to over 5,000 within five years. Publication Only | Abstract #e18032 Presenter: Olga Russial, MD, Thomas Jefferson University Hospital Clinical utility of circulating tumor tissue-modified viral HPV DNA testing in HPV-driven oropharyngeal cancer arising in women This study evaluates the clinical utility of TTMV-HPV DNA testing in women with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). This is the first single institutional report evaluating the clinical utility of TTMV-HPV DNA in a female cohort treated for HPV+ OPSCC. Utilization of this testing in a female population appears feasible in a community-based hospital setting. All patients had TTMV resolution after treatment and remained undetectable without recurrence. Naveris and the NavDx test will be on exhibit at ASCO 2024 at Booth #31142. More information can be found on the ASCO website here. About Naveris Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit and . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).

PARIS--(BUSINESS WIRE)--LinKinVax, a clinical-stage biotechnology company, is announcing capital funding for a total of €7,3 M from several individual tech executive investors including the co-founder André-Jacques Auberton-Hervé and its newest investor In-Q-Tel, Inc. (IQT), the non-profit strategic investor which delivers cutting-edge and critically needed technology capabilities that contribute to the national security of the United States and its allies. 'We are impressed by LinKinVax\u2019s team and its vision for developing world-class vaccine technology. Their work demonstrates great potential for a robust vaccine portfolio to combat emerging and existing infectious diseases.' This investment contributes to a first capital funding supporting LinKinVax next series A round up to €50 M. It signals that LinKinVax has huge capabilities to accelerate the clinical development of its innovative protein-based vaccine platform, which can be tuned to address multiple pathogens with adaptability to mutations including viral or bacterial infectious diseases and cancer treatments - HIV, SarsCov2, HPV, papillomavirus-related cancers, chlamydia -. LinKinVax’s innovative technology directly targets dendritic cells (“DC”), which play a crucial role in the immune system, stimulating and regulating immune responses. It is predicated on work by the Vaccine Research Institute/Inserm (VRI) in which Inserm, University of Paris Est Créteil (UPEC), and the Mondor Institute of Biomedical Research (IMRB) participate. Thanks to the potential of its technology platform and the advances in its portfolio (Phase I/IIa on a first indication), LinKinVax aims to make a decisive contribution to the global public health challenges of infectious diseases and cancer. J.D. Englehart, Director, IQT International Ltd UK: “We are impressed by LinKinVax’s team and its vision for developing world-class vaccine technology. Their work demonstrates great potential for a robust vaccine portfolio to combat emerging and existing infectious diseases.” André-Jacques Auberton-Hervé, CEO and co-founder of LinKinVax commented: “We are grateful that our breakthrough vaccine technology, designed to respond to high and growing global need, generated interest from In-Q-Tel. Based on the unprecedented potential of our protein-based vaccine platform, In-Q-Tel is supporting us in our next series A round up to €50 Million, allowing to push ahead the next stages of our ambitious clinical program. Our objective is to provide effective vaccines as rapidly as possible to help address the public health challenges linked to the various pathogens we are targeting.” LinKinVax has already risen to prominence in the French sector, with Bpifrance granting it €31 Million under a Covid-related PIA PSCP program and Government “Plan Relance”. This new financing, completed in December 2022, includes a seed funding from private shareholders, beginning of 2022. About LinKinVax technology LinKinVax’s vaccine platform is built around a humanized monoclonal antibody, which is fused with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. The results obtained demonstrate the benefits of this strategy owing to the small quantity of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response. The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years now. Three products are in or about to enter clinical trials: a prophylactic vaccine for HIV, currently in phase I/IIa led by VRI/Inserm/ANRS-EID), a SARS-CoV-2 vaccine covering variants of interest, and a therapeutic vaccine for human papillomavirus-related cancers. About LinKinVax LinKinVax was founded in 2020 and is led by two internationally renowned personalities in the worlds of medicine, industry and business, namely André-Jacques Auberton-Hervé, Honorary Chairman and founder of SOITEC, and Prof. Yves Levy, MD, PhD, immunologist, and Director of the Vaccine Research Institute (VRI/INSERM/UPEC). LinKinVax is developing an innovative protein-based vaccine platform that can accelerate availability of vaccines by leveraging the research conducted at the Vaccine Research Institute (VRI). This DC Targeting-based protein vaccine platform can adapt to changes and mutations in the target pathogens. For further information, please visit www.linkinvax.com About In-Q-Tel, Inc. IQT delivers cutting-edge and critically needed technology capabilities that contribute to the national security of the United States and its allies. IQT achieves this through market and trend analyses, strategic investments, technology adaptation, and applied research. Founded in 1999 as the independent, not-for-profit strategic investor to the CIA, IQT’s role and scope has since evolved, and IQT now partners with 10 U.S. government agencies. Its Sydney-based Australian subsidiary, IQT International Australia Ltd., collaborates with the Office of National Intelligence (www.oni.gov.au) on behalf of Australia’s national intelligence community to support a partnership between the intelligence and national security communities of the U.S., UK, and Australia. Learn more at www.iqt.org.

Promising preliminary monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in advanced solid tumors, which had favorable safety, tolerability, and efficacy profiles that support combination development BRAF Class 2 and 3 alterations have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors SAN DIEGO, CA, USA I December 20, 2022 I Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced dosing of the first patient in the HERKULES-1 Phase 1b trial evaluating ERK1/2 inhibitor ERAS-007 in combination with SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in patients with RAS/MAPK pathway-altered solid tumors. “We are pleased with our team’s efficient execution that resulted in dosing the first patient in our MAPKlamp trial in 2022 ahead of schedule,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “ERK and SHP2 inhibition with ERAS-007 and ERAS-601 targets critical downstream and upstream nodes in the RAS/MAPK pathway, offering a rational approach that is supported by early clinical data that we presented at our R&D Day in September. Notably, we reported four responses in nine patients with BRAF-driven tumors to either monotherapy ERAS-007 or ERAS-601. Three of these responses were in tumors with BRAF Class 2 or 3 alterations, including a confirmed response to monotherapy SHP2 inhibition in a patient with a BRAF Class 3 alteration, which is dependent on upstream receptor tyrosine kinase (RTK) activation. We look forward to exploring the potential to address the high unmet need in these BRAF subtypes, which have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors.” The MAPKlamp portion of HERKULES-1 will initially examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with ERAS-601 in patients with RAS/MAPK pathway-altered solid tumors. After a recommended dose is determined, the Phase 2 expansion portion will further evaluate the safety and efficacy of the combination in patients with different mutational subtypes, including BRAF Class 2 and 3 patients. ERAS-007 and ERAS-601 had favorable monotherapy safety and tolerability profiles with largely non-overlapping treatment-related adverse events that support combination development. Forty-four percent (4/9) of patients with BRAF-driven tumors responded (one confirmed and three unconfirmed PRs) to single agent ERAS-007 or ERAS-601, including three (one confirmed and two unconfirmed PRs) in tumors with BRAF Class 2 and 3 alterations. The clinical data referred to above was presented at Erasca’s September 7, 2022 R&D Day, and consisted of a retrospective pooled interim analysis of monotherapy ERAS-007 and ERAS-601 data, with data cutoff dates of 11/6/20, 7/11/22, and 5/16/22 for the ASN007-101, FLAGSHP-1, and HERKULES-1 trials, respectively. About ERAS-007 ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the RAS/MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across the series of HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer (NSCLC). HERKULES-3 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal (GI) cancers. About ERAS-601 ERAS-601 is a potential best-in-class oral, selective SHP2 inhibitor being investigated alone or in combination. SHP2 acts as a convergent node for receptor tyrosine kinase (RTK) signaling, relaying growth and survival signals from RTKs to intracellular signaling pathways. ERAS-601 combined with the ERK1/2 inhibitor ERAS-007 makes up Erasca’s first innovative MAPKlamp strategy. ERAS-601 is being investigated across a series of clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents. FLAGSHP-1 is a Phase 1/1b clinical trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC and human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). HERKULES-1 is a Phase 1b/2 clinical trial that includes evaluation of ERAS-601 in combination with ERAS-007 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial that includes evaluation of ERAS-601 in combination with various agents in patients with non-small cell lung cancer (NSCLC). About Erasca At Erasca, our name is our mission: To eras e ca ncer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled what we believe to be the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer. SOURCE: Erasca