Phanes Therapeutics, Inc.

This is the second Fast Track Designation granted to PT217 by the agency SAN DIEGO, Dec. 4, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). This is the second Fast Track Designation granted to PT217 by the FDA. Earlier this year, PT217 was granted Fast Track designation for extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor by the agency. PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma, including neuroendocrine prostate cancer (NEPC). In addition to Fast Track designation, PT217 was also granted orphan drug designations for the treatment of small cell lung cancer and neuroendocrine carcinoma (NEC), respectively. The multi-center Phase I/II clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of PT217 is also ongoing in China (CTR20242720). Earlier this year, Phanes entered into a clinical supply agreement with Roche to study PT217 in combination with Roche's anti-PD-L1 therapy, atezolizumab. ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AUSTIN, Texas--( BUSINESS WIRE )--Veravas, a leading innovator in clinical diagnostics, today announced the results of an analytical verification study of its VeraBIND™ Tau assay, a next-generation test being co-developed with Phanes Biotech, an early-stage biotech company focused on treatments for neurodegenerative diseases, for the detection of Alzheimer’s disease (AD). The test is designed to detect and measure disease pathology to enable the diagnosis of AD at its earliest, most treatable stages. Unlike first-generation tests that measure biomarkers indicative of potential disease, VeraBIND Tau is designed to detect active disease by studying measurable binding activity occurring in the brain between hyperphosphorylated tau (HPT) and normal tau (nTau), which is a hallmark of AD. 1 The test can also aid in the diagnosis of AD, giving clinicians an accessible, accurate, and affordable alternative to tau PET imaging. AD is the sixth leading cause of death in the United States, afflicting an estimated 6.9 million Americans aged 65 or older. 2,3 It’s critical that clinicians have accessible tools to quickly and accurately diagnose and distinguish AD from other dementias causing cognitive impairment to enable targeted treatment. In AD, lifestyle modifications and emerging tau-directed therapies have shown promise in slowing or delaying cognitive decline. Veravas demonstrated VeraBIND Tau’s ability to accurately measure the pathological activity of hyperphosphorylated tau. In this analytical verification study, the test protocol was performed on 100 retrospectively collected patient samples, including 52 confirmed positive for AD tau pathology via F18 MK6240 tau PET imaging (of which, 19 had normal cognitive function, 21 had mild cognitive impairment, and 12 had dementia), 38 healthy controls, and 10 patients positive for beta amyloid plaques but negative by tau PET. 4 The data showed 94.2% sensitivity and 89.6% specificity resulting in an overall VeraBIND Tau assay agreement of 92.0% against tau PET imaging. “These analytical data show that VeraBIND Tau can measure active tau pathology of AD both among individuals with and without cognitive impairment,” said Bernard Hanseeuw, M.D., Ph.D., Associate Head of the Memory Clinic, Neurology Department, Saint Luc University Hospital in Belgium and Instructor at Mass General Hospital, Boston, MA. “The implementation of such a test could not only one day speed the diagnosis of AD, it could also be used to inform the development and testing of tau-directed therapeutics. It also holds great promise for non-AD tauopathies, as the assay proved positive in 7 out of 8 cases tested with low-amyloid, and positive tau-PET data”. To co-develop the VeraBIND Tau assay, the companies used Veravas’s proprietary VeraBIND technology, a platform that is designed to capture and purify key proteins in blood to enable highly accurate protein detection and characterization. When combined with antibodies, VeraBIND magnetic nanobeads act as a filter for multiple sample types, enabling the removal of interfering substances that can obscure the biomarker of interest and potentially produce false results. This patented technology makes it possible to study low-abundance disease-causing proteins that may otherwise be undetectable by enriching samples pre-analytically to improve the detectability of the analyte. “These results demonstrate the transformative potential of VeraBIND Tau to upend the standard of care for management of patients suspected of potentially having Alzheimer’s disease,” said Josh Soldo, Chief Scientific Officer at Veravas. "Our highly accurate analytical test protocol can be performed quickly and cost-effectively and could potentially eliminate both the uncertainties associated with biomarker detection tests and the high costs and wait times associated with tau PET imaging, thereby helping clinicians get answers to their patients much more rapidly.” “The VeraBIND Tau assay will enable Alzheimer’s disease diagnosis for the first time in geographies where tau PET imaging is not available” said Khalid Iqbal, Chief Scientific Officer of Phanes Biotech. For more information about the VeraBIND Tau assay and other VeraBIND products, visit www.veravas.com . About Veravas Veravas is a leading innovator in clinical diagnostics focused on early-stage detection and prognostic screening for Alzheimer’s disease and other neurological conditions. The company’s proprietary VeraBIND™ technology transforms challenging sample types into measurable biomarkers, enabling earlier disease detection and the development of novel diagnostic tests. Its VeraBIND Tau assay is a first-in-class blood-based test that measures the pathological activity of hyperphosphorylated tau in blood samples of cognitively normal individuals or individuals experiencing cognitive impairment which may be used to aid in the diagnosis of Alzheimer's disease. Learn more at Veravas.com or follow us on LinkedIn . About Phanes Biotech Phanes Biotech is an early-stage biotech company focused on developing breakthrough treatments for neurodegenerative diseases, including Alzheimer’s, macular degeneration, traumatic brain injury, stroke, Down syndrome-associated Alzheimer’s, and cognitive aging. Phanes takes a unique and differentiated approach to Alzheimer’s and other neurodegenerative diseases, setting it apart from existing therapies and drugs currently in development. The company’s pipeline includes innovative drugs: (1) Neuroregenerative small molecule P021 – This promising therapeutic aims to address Alzheimer’s disease by shifting the balance from neurodegeneration toward neural regeneration. (2) Immunotherapy PB43D – A potent, high-affinity antibody designed to target and bind to tau. It is the only antibody shown to reduce both tau and Aβ pathologies. Through a strategic partnership, Phanes leverages its portfolio of tau-targeting antibodies to develop a groundbreaking, first-in-class blood-based assay. This innovative diagnostic tool aims to detect and measure tau pathology activity in the brain, setting a new standard for diagnosing and tracking the progression of Alzheimer’s disease. Learn more at Phanesbiotech.com or follow us on LinkedIn . Thal DR, Tomé SO. The central role of tau in Alzheimer's disease: From neurofibrillary tangle maturation to the induction of cell death. Brain Res Bull. 2022;190:204-217. doi:10.1016/j.brainresbull.2022.10.006 Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5)." Ahmad FB, Cisewski JA, Anderson RN. Mortality in the United States — Provisional Data, 2023. MMWR Morb Mortal Wkly Rep 2024;73:677–681. DOI: http://dx.doi.org/10.15585/mmwr.mm7331a1 . Gérard T, et al. The spatial extent of tauopathy on [18F]MK-6240 tau PET shows stronger association with cognitive performances than the standard uptake value ratio in Alzheimer's disease. Eur J Nucl Med Mol Imaging. 2024 May;51(6):1662-1674.

SAN DIEGO, Nov. 5, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that Zev Wainberg, MD, an internationally renowned medical oncologist and professor at David Geffen School of Medicine at UCLA, has joined the Company's Clinical Advisory Board (CAB). "We are excited to have Professor Wainberg joining our Clinical Advisory Board," said Ming Wang, PhD, MBA, Phanes' Chief Executive Officer. "Dr. Wainberg is a leading medical oncologist in gastrointestinal malignancies. He will join the other leading experts on our CAB to provide valuable guidance and advice on the three clinical programs at Phanes. His extensive expertise and experience will enhance Phanes' strength in drug development and ability to deliver innovative therapies for cancer patients." Biograph of Professor Zev Wainberg Zev Wainberg, MD Dr. Wainberg is an academic medical oncologist at the David Geffen UCLA School of Medicine specializing in gastrointestinal malignancies. He currently serves as the co-director of the GI oncology program and medical director of the Pancreas Cancer Center at UCLA with a joint appointment in medicine and surgery. His research focus is on translational research of GI cancers with a particular focus on drug development. He also serves as the director of the Early Phase Clinical Research Program at the Jonsson Comprehensive Cancer Center at UCLA. He is currently the principal investigator on over 25 clinical trials focused on targeted therapeutics in patients with gastrointestinal cancers. Full CAB information at . ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit . For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED