List of Personalized Medicine Companies with Phase 2 Active Clinical Trial - 39

Aadi Bioscience, Inc. is a commercial-stage biopharmaceutical company developing precision therapies for genetically-defined cancers.

We’re leveraging advances in genetics and precision medicine to develop new therapeutics that target shared, underlying biology in rare and common diseases — bringing meaningful medicines from one to many. With expertise in genetics, drug discovery and data sciences, we seek to identify programs where both biological and technical risk can be minimized to streamline the drug development process and bring forward exceptionally potent and precisely targeted therapeutics for patients.

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing patients with early stage breast cancer and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient. MammaPrint®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is the only commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint® and BluePrint® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that improve patient outcomes and support the evolving clinical needs of patients with breast cancer and their physicians every step of the way, from initial diagnosis to cancer-free. Agendia’s assays can be ordered on core biopsies or surgical specimens to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com. For view our social media policies, please visit https://agendia.com/legal-compliance/

AMRA Medical is a health informatics company founded in 2010, originating from Linköping University in Sweden. With a team of over 30 employees and a global presence, AMRA specializes in AI-driven medical imaging and precision medicine, particularly in advanced MRI analytics for body composition assessment. The company has achieved regulatory clearances, including CE-Marked medical device status, and collaborates with major industry players like Pfizer Inc. AMRA offers next-generation phenotyping that utilizes AI to analyze whole-body MRI scans, providing precise fat and muscle biomarkers for personalized health insights. Their cloud-based platform ensures secure, quality-controlled results with a quick turnaround and is compatible with various MRI scanners. The company also develops imaging biomarkers and disease phenotypes through partnerships, aiming to create a global representative database. Under the leadership of CEO Eric Converse and co-founders Magnus Borga and Olof Dahlqvist Leinhard, AMRA focuses on equipping clinicians and researchers with actionable data to manage conditions such as obesity and metabolic disorders.

BioCytics via the Human Applications Lab is focused on bringing personalized oncology treatments to the market. BioCytics has an ongoing IRB-approved clinical trial (BioCytics 0001; NCT00571389) that allows for the collection and study of blood and tissue samples from consenting cancer patients. We are incubated within Carolina BioOncology - a preferred cancer treatment and Phase I drug testing facility. BioCytics was founded by Dr. John Powderly, MD, medical board certified oncologist and a certified physician investigator (CPI), who is also president of Carolina BioOncology Institute (CBOI).

Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes over 120 biomarkers in real time and identifies shifts that require proactive interventions. This vital innovation enables Biofourmis to offer people everywhere connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospitalization readmissions, accelerates drug development, and closes critical gaps in care—with the goal of making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston with key offices in Singapore and India. For more information, visit biofourmis.com and follow Biofourmis on LinkedIn, Twitter and YouTube.

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. Our mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. We offer OGM solutions for applications across basic, translational and clinical research. Bionano also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through our Bionano Laboratories business, wey also offer OGM-based diagnostic testing services.

BioTherapeutics Inc (BTI) synergistically combines the power of advanced computational modeling, data analytics and artificial intelligence with translational experimentations to accelerate the development of innovative products for precision medicine and health. Our computational platform assembles biomedical and healthcare data from the molecular, cellular, tissue and population levels and leverages the latest innovations in technology to turn those data into answers to complex biological questions and solutions to healthcare's problems.

Bivision is a China-based biopharmaceutical company that develops visually targeted radionuclide therapies for the treatment of cancer across the globe.

Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry.

BlueSphere Bio was founded to unlock the potential of personalized T cell therapy for the treatment of cancer by harnessing the unique specificity of each patient’s own T cells for the particular molecular fingerprint of each patient’s own cancer through our novel TCXpress technology. Our proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s own immune defenses to attack their cancer specifically, and is designed to leave normal tissues untouched, thereby reducing harmful side effects. The platform and implementation allows us to deliver rapid, personalized T cell treatments for a variety of cancer indications.

Carbiotix is an award-winning biotechnology company pioneering the onsite upcycling of plant-based side-streams. Carbiotix mission is to improve the health of people by increasing the consumption of prebiotics and other active ingredients from upcycled side-streams. Carbiotix offers one core service today called NutraCycle, an on-site upcycling and fortification service allowing food & beverage, ingredient, and feed producers to turn plant-based products into healthier, more profitable, and sustainable products.

Chordia Therapeutics is a clinical-stage biotech company engaged in the research and development of novel therapies for cancers with high unmet medical needs. The Company was spun out from Takeda Pharmaceutical in November 2017.

Corteria Pharmaceuticals - FOCUSED ON THE DEVELOPMENT OF TRANSFORMATIVE THERAPIES FOR THE TREATMENT OF WORSENING AND ACUTE DECOMPENSATED HEART FAILURE Founded in 2021, Corteria Pharmaceuticals is a privately held company developing first-in-class drugs for indications of high unmet medical need, such as heart failure, sarcopenia and obesity subpopulations. Our strategy implies innovative patient stratification and target selection based on human evidence and a better understanding of the disease biology in patients. We are using cutting-edge methods to stratify the patients and identify those who will benefit the most from our treatments. Our focus is on worsening and acute heart failure, right heart failure, sarcopenia (including age-related sarcopenia and obesity-related sarcopenia) and obesity with established complications.

Encoded Therapeutics is creating one-time, disease-modifying gene therapies for pediatric central nervous system (CNS) disorders with its cell-selective targeting and regulation platform. The Encoded approach offers potentially unprecedented gene specificity and cell selectivity to unlock novel opportunities by targeting a range of disease mechanisms. Encoded’s technology is compatible with any delivery system to control where and when therapeutic transgenes are expressed, thereby shaping the functionality of target cells and holding broader therapeutic potential beyond CNS disorders.

Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead investigational candidate, ENV-101, is an inhibitor of the Hedgehog (Hh) signaling pathway in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The company’s second investigational candidate, ENV-501 is a human epidermal growth factor 3 (HER3)-targeted antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors.

At Exact Sciences, our purpose is to help eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment. We're hiring! Our organization offers something for everyone, at all stages of careers and from all backgrounds. Let's take on cancer, together.

Fore Biotherapeutics - We are a precision oncology company pioneering the development of cancer therapies guided by our proprietary functional genomics. Deeply rooted in science and innovation, our vision is to compassionately contribute to solving cancer.

Genetesis is a rapidly growing medical imaging company leveraging data science and biomagnetism in the fight against cardiovascular disease.

Genetron Holdings Limited ("Genetron Health" or the "Company") is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive product and service portfolio that cover the full-cycle of cancer care from early screening, to diagnosis and treatment recommendations, to continuous monitoring and continuous care.

Inocras is a company for whole genome sequencing, providing a comprehensive view of a patient's entire genetic profile through WGS analysis and interpretation. Focusing on cancer and rare diseases, we aspire to fundamentally change how the world treats genetically driven diseases with an unsurpassed WGS databank and an integrated platform for generating, collecting, and analyzing genomic data.

Locate Bio bring together Programmed Drug Release and Instructive Tissue Scaffolds to develop the next generation of products with significant disruptive potential for musculoskeletal conditions.

Marea Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing small molecules to address hypertriglyceridemia and other metabolic diseases.

Mirxes is a Singapore-headquartered biotechnology company whose mission is to save lives through early, actionable, and personalized diagnoses across the care continuum. We are Asia-centered, starting with Southeast Asia, and have global ambitions. We have research, development, manufacturing, and clinical diagnostic operations in Singapore, USA, Japan, and China. We have sales and distribution networks worldwide. Our flagship product is GASTROClear, the world’s first molecular blood test for early detection of gastric cancer, able to detect around 90% of patients with Stage I and II cancers. We continue to build a comprehensive cancer portfolio with early detection tests for lung and thyroid cancer (2022), colorectal and breast cancer (2023), liver and ovarian cancer (2024). We are concurrently building a precision oncology portfolio to provide clinical insights for the complete patient journey. MiRXES was spun off from A*STAR’s Bioprocessing Technology Institute in 2014 to commercialize an industry-leading qPCR-based technology for microRNA detection. Our ID3EAL discovery tool and workflow has been adopted by top academic and industry partners globally and is backed by the world’s first industry standard for microRNA-base diagnostics. Our versatile platform technology and capabilities have broad applications in the discovery of biomarkers and diagnosis of diseases. We are starting with early cancer detection, but we will also be addressing unmet clinical needs in cardiovascular, metabolic, and infectious diseases. We responded to COVID-19 by leveraging our capabilities to mass produce and distribute over 5 million units of the Fortitude COVID-19 RT-PCR test. This made-in-Singapore diagnostic test, developed by A*STAR and Tan Tock Seng Hospital, has been deployed in 13 Singapore hospitals and clinical labs and exported to over 45 countries worldwide. Post-COVID, we will leverage this network to commercialize multi-cancer early detection tests.

At MyOme, we help families understand their DNA, and how it impacts their health throughout their lives, with secure and portable data using the latest technologies. We are always interested to hear from smart, passionate people with a background in bio stats, data science, and ML. Connect with us!

Neuron23™ Inc. is a leading clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases. Neuron23 combines recent advances in human genetics with a state-of-the-art drug discovery and biomarker platform using advanced techniques in machine learning and artificial intelligence to advance therapeutics for devastating diseases. The Company’s focus areas are neurodegenerative diseases, neuroinflammatory diseases, and systemic autoimmune and inflammatory diseases. Founded in 2018, Neuron23 has assembled a world-class team of experts and entrepreneurs located in South San Francisco, CA.

Nido Bio is translating today’s neuroscience breakthroughs into tomorrow’s treatments for severe neurological diseases. Leveraging human genetics, we develop precision medicines that address the fundamental biology of disease and restore healthy cell function. NIDO-361, our clinical-stage candidate, is a treatment for Spinal and Bulbar Muscular Atrophy which is a rare and debilitating neuromuscular disease. Additional pipeline programs center around a novel target with the potential to address multiple disease mechanisms and that has broad clinical application across neurodegenerative and peripheral inflammatory diseases. We are creating a sustainable pipeline for the company by utilizing a functional genomics discovery platform based on human cell lines to identify novel targets. Through our approach we seek to transform patient lives in meaningful ways.

Oryzon Genomics, S.A. is a clinical stage biopharmaceutical company and the European leader in the development of epigenetics-based therapeutics, with a strong focus on personalized medicine approaches to CNS disorders and oncology. Oryzon has a broad and growing portfolio, with two compounds in clinical trials: iadademstat, a highly potent and selective LSD1 inhibitor, in Phase IIa clinical trials for the treatment of acute myeloid leukemia and small cell lung cancer, and vafidemstat, a CNS optimized LSD1 inhibitor in multiple Phase II trials for the treatment of CNS and psychiatric diseases. Phase IIb trials for both compounds are under preparation. Our pipeline also includes ORY-3001, a selective LSD1 inhibitor in preclinical development for the treatment of non-oncological diseases, and additional programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurological diseases. Oryzon has been listed on the Spanish Stock Exchange since December 2015 (ORY, ISIN Code: ES0167733015). Since then, the company has attracted specialized investors from US, Israel and Europe in several PIPEs led by different US investment banks. The company was founded in 2000 and has offices in Spain and the United States.

Perspectum's imaging solutions are safe, fast, and can offer more comprehensive diagnostics. We help doctors understand complex data and help deliver precision care to more patients. We believe the voice of the patient matters and that each case is unique. Our goal is to enable health care providers to tailor precision medicine to the needs of the individual.

PolTREG was established as a spin-off from the Medical University of Gdańsk in order to develop and commercialize patented TREG method. PolTREG is the most advanced company in TREGS cellular therapies worldwide, breakthrough therapies for type 1 diabetes (T1D) and multiple sclerosis (MS). PolTREG has very promising results regarding the safety and efficacy of TREGS therapy (completed phase I/II clinical trials in T1D and phase I in MS), ready for the next phase of trials. The company is after EMA Scientific Advice procedure.

PreciseDx® is innovating oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis. Combining AI with our patented Morphology Feature Array® (MFA), PreciseDx provides access to unmatched disease insights and accurate, actionable intelligence for more comprehensive decision-making throughout the cancer care continuum.

Prescient Therapeutics (ASX: PTX) is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies. Cell Therapies OmniCAR: is a universal immune receptor platform enabling controllable cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to immune cells. OmniCAR is based on technology licensed from Penn and Oxford University; and other assets. Prescient is developing OmniCAR-T cells programs for next-generation CAR-T therapies for AML; Her2+ solid tumours, including breast, ovarian and gastric cancers; and GBM. CellPryme: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non-disruptive process during cell manufacturing. Targeted Therapies PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it has shown encouraging efficacy signals and safety. PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia. Unlike other drug candidates that target Akt inhibition, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects.

Rapport Therapeutics aims to transform the treatment of neurological disorders through a precision medicine approach, precisely targeting disease-driving neurocircuits by leveraging receptor-associated proteins (RAPs). With this approach, Rapport can overcome the well-established limitations of today’s neuromedicines that act indiscriminately throughout the nervous system, resulting in suboptimal efficacy and burdensome side effects. Leading the hunt for precision medicines is a team with established track records of innovation in neuroscience and drug discovery. Rapport was conceptualized and created through a partnership between Third Rock Ventures and Johnson & Johnson Innovation-JJDC, Inc. (JJDC) and launched in March 2023. Rapport is based in San Diego, CA and Boston, MA. For more information, please visit www.rapportrx.com.

Rna Diagnostics Inc. is a clinical stage molecular diagnostics company for personalized cancer therapy management. We are working with physicians around the globe to improve cancer treatment and the quality of life for patients, while reducing healthcare costs. Our predictive biomarker platform technology, Veridapt DX™, now in clinical trials, is designed to measure early solid tumor response to neoadjuvant cancer treatment. The Veridapt DX predictive biomarker identifies non-responsive solid tumors by monitoring the degree of RNA (rRNA) disruption in the cells. Once validated, the test will enable physicians to escalate or de-escalate therapy, or select an alternative strategy, as early as 5 weeks into a standard 6-month treatment regimen. A series of pre-clinical studies, and retrospective and ongoing prospective clinical data, have shown strong evidence for clinical effectiveness. A large-scale study is now under way to validate Veridapt DX (formerly known as the RNA Disruption Assay) as a tool to manage primary breast cancer treatment: the Breast Cancer Response Evaluation for Individualized Therapy (BREVITY) clinical trial. Phase 1 results, published in JNCI Cancer Spectrum, demonstrate Veridapt DX’s strong capability (Negative Predictive Value >93%) to accurately predict therapy efficacy/outcomes during early treatment. Phase 2 is now under way in 7 countries. Our initial focus is on primary breast cancer; however, our assay platform has the potential to apply to any solid tumor and any cancer drug therapy for personalized, precision medicine. We welcome inquiries from clinicians interested in collaborative trials for early assessment of treatment for solid tumor cancers.

Salvia BioElectronics is pioneering neuromodulation therapy aiming to transform the migraine treatment landscape. Designed to provide meaningful relief, MySalvia Therapy features an ultra-thin implant that comprehensively targets key nerves involved in migraine. ‍Salvia is driven by the belief that people with chronic migraine deserve the opportunity to reclaim their lives. Founded in 2017 and headquartered in Eindhoven, The Netherlands, Salvia is led by a team of industry veterans with extensive experience in medical devices and neuromodulation. Active in the United States, Europe and Australia, the company is advancing clinical development with the support of leading investors. Salvia is also exploring the potential of its technology for the treatment of cluster headache.

Scipher Medicine is building the future of patient treatment. Most patients who are prescribed blockbuster therapies today don’t respond to the treatment, costing the health care industry billions in wasted drugs while patients continue to suffer. Scipher's platform identifies which drug will work based on the patient's fundamental disease biology, and not based on symptoms, disease classification, or medical bias. A simple test predicts which drug he/she will respond to, ensuring that most optimal treatment is prescribed from day one. The molecular data generated by our tests is then used to fuel novel target discovery to address a clear unmet medical need in patients who do not respond to any existing therapy.

Scorpion is a clinical-stage, precision oncology company developing transformational targeted therapies for patients with cancer. We have built proprietary and fully-integrated discovery capabilities leveraging the most advanced technologies across cancer biology, medicinal chemistry and data sciences. Our current pipeline, led by our mutant-selective PI3Ka program STX-478, consists of three internally discovered clinical product candidates in addition to multiple discovery-stage programs. Our focus is on solving current gaps in therapeutic options for patients with cancer by discovering and developing exquisitely-selective product candidates against well-validated, previously undruggable targets to improve patient outcomes.

STALICLA SA is a Swiss clinical-stage biopharmaceutical company pioneering Neuro Precision Medicine in neurodevelopmental and neuropsychiatric disorders. With state-of-the-art technology platforms and clinical trials for Autism Spectrum Disorder (ASD) and Substance Use Disorder (SUD), STALICLA is changing the landscape of brain disease treatments. Neurodevelopmental Disorders: To propel neurodevelopmental research, STALICLA have identified patient subgroups and their matching candidate drugs within Autism Spectrum Disorder using its trailblazing, multi-omics DEPI platform. STALICLA is currently preparing Phase 2 trials for STP1, STALICLA's first patient subgroup-matched precision treatment. Substance Use Disorder research: STALICLA is working in partnership with the National Institute of Drug Abuse (NIDA) to advance Phase 3 clinical trials for the most clinically advanced drug candidate for cocaine abuse disorder, STP7. STALICLA is now raising series C funding to advance both verticals. For more information visit: https://stalicla.com.

Strata Oncology is a high-growth, state-of-the art, precision oncology company, delivering a new standard of care that integrates molecular profiling, decision support and clinical trial participation into routine practice. We do this by partnering with major healthcare systems across the country, who systematically send their cancer patients’ biopsies to our high-throughput CLIA lab for genomic sequencing, with results provided to the oncologist within days, indicating the tumor profile, and matches to appropriate therapies and drug trials. This accelerates the move to personalized medicine – right medicines to the right patients at the right time. Our personnel are passionate about and committed to making a positive difference, now, in the lives of cancer patients and their families. Clinicians, pathologists, bioinformaticists, software engineers, lab technicians and more, coming together to give access to those without, uncovering insight that might be hidden, all while spreading urgency to all. Experience a career that connects a fast-paced team environment with a worthy pursuit – feel good about what you’ve accomplished at the end of every day!