List of Personalized Medicine Companies with Phase 1 Active Clinical Trial - 30

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.

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.

We now know that immune cells – not only in the body’s periphery but especially in the brain – can produce autoantibodies that cause severe neurological and psychiatric diseases. Founded to explore the latest discoveries in autoimmune neuropsychiatry, Arialys Therapeutics is developing new precision medicines to specifically block pathogenic autoantibodies in the brain and meaningfully expand the treatment possibilities for neuropsychiatric disorders driven by autoimmune disease.

Harnessing the power of RNA biology to find treatments for patients with unmet medical needs. Advance and utilize the cutting edge antisense technology (siRNA and ASO) to discover and develop next generation medicines for both large and rare disease indications.

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.

With a passion for outsmarting relentless cancers and autoimmune diseases, Byondis takes precision medicines to the next level. We are driven by one goal: providing novel treatments with high efficacy and low systemic toxicity for patients with high unmet medical needs. Many companies work in the areas of unmet need. What differentiates Byondis is its focus on producing a broad spectrum of molecular concepts, ranging from small molecule chemistries to complex protein structures. We engineer smaller and larger molecular functionalities that may be combined to target the right part of the body. This involves: • Next generation antibody-drug conjugates (ADCs), including proprietary linker-drug (LD) technology to generate multiple ADC candidates targeting different indications • Site-specific conjugation technology • Monoclonal antibodies (mAbs) • Highly selective, disease-targeting small molecules The success of our company fully depends on our people. To them, we aim to provide a fair, open and inspiring working environment, where there is room for ambition, entrepreneurship and new initiatives leading to new medicines that save and transform patients’ lives.

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.

CellProthera, a biotechnological company, has developed a unique therapeutic technique which enables the structural and functional regeneration of severe post-infarctus cardiac lesions. After European and national (FR/GB) authorization was obtained , CellProthera has started its I/IIB clinical trial in Humans.

Elucida Oncology is a biotechnology company that pioneers targeted cancer therapy with ultra-small nanoparticle C’Dot drug conjugates designed to penetrate deep into 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.

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.

IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRx’s lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). IDRx's pipeline also includes a second KIT inhibitor, IDRX-73. Founded in 2021, IDRx’s leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved drugs. To learn more, please visit www.idrx.com.

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.

Mirador Therapeutics is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to accelerate the next generation of precision medicines for immune-mediated 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.

Monopar Therapeutics is a clinical­-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of camsirubicin (Phase 1b) for the treatment of advanced soft tissue sarcoma; MNPR­101, a late-­stage preclinical antibody for radiopharmaceutical use in advanced cancers; and MNPR­202, an early-stage camsirubicin analog for various cancers.

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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.

PhotonPharma is an immuno-oncology company with a break-through technology that stimulates a patient's own immune system to seek out and destroy their cancer cells. We have a patent protected process that precisely inactivates DNA/RNA of a patient's own tumor cells while leaving the cells alive with all of unique tumor specific antigen targets (neoantigens) intact. The process is simple, fast and inexpensive. A patient's tumor cells can be extracted, inactivated and administered back on the same day. Efficacy and safety has been demonstrated in a dog trial (companion animals) and in mouse studies.

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.

ReCode Therapeutics is a clinical-stage genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s selective organ targeting (SORT) lipid nanoparticle (LNP) platform is a next-generation, genetic medicines technology that enables precise delivery to target organs and cells beyond the liver.

ReiThera is a company devoted to developing and producing biopharmaceutical products based on gene delivery technologies doe advanced therapies, in order to prevent and treat several serious or life-threatening diseases.

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.

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.

VERIGRAFT generates personalized tissue-engineered transplants for use in regenerative medicine. The company's unique technology platform turns donated allogeneic ("foreign") tissue into an autologous-like ("personalized") tissue and thus avoids transplant rejection and the need for life-long immunosuppression. Donated, allogenic tissue is patient-individualized by a combination of DC (Decellularization) and RC (Reconditioning/Recellularization) processes. VERIGRAFT's development pipeline comprises products in the areas of vascular regeneration as well as peripheral nerve repair.