List of Biologics Companies in Israel - 40

Valuing Life, Granting Advanced Therapies to Patients- that Is Adva Biotechnology’s Vision and goal. Adva Biotechnology developed the ADVA-X3- a simple, smart, easy to use, automated, sensors-based, flexible cell manufacturing platform. The ADVA-X3 enables full manufacturing process based on the CAMP™ technology, of different applications, such as CAR-T, TCR, TIL, NK, Exosomes, Viruses and More.

ART BioScience was founded in December 2015 by Mr. Oren Ozeri and Mr. Alon Hazan, fathers of two children diagnosed with Duchenne. After co-founding the Israeli Duchenne Parent Association and increased involvement in following current research, Alon and Oren swore to do everything possible to save the lives of their children and dedicated their time and resources to trying to find a cure for the disease. The result of their intensive research and involvement in the field led them to the decision to establish ART, a company based on novel messenger RNA (mRNA) technologies for the development of new therapeutics that can potentially change the course of the disease. ​We are developing Dystrophin modified mRNA encapsulated in LNP (Lipid Nanoparticles) proprietary delivery system as: 1.) Protein Replacement Therapy 2.) CRISPR Cas9 mRNA as Gene Editing Therapy

BioGenCell was founded with the vision of developing safe, effective, and long-lasting effective treatment for incurable, blood vessel diseases that will be both accessible and patient friendly. Our disruptive TRACT technology platform provides a comprehensive approach for rapid manufacturing and commercialization of cell-therapies.

Biokine Therapeutics is a private biopharmaceutical company founded in 2000. Biokine lead product BKT140/BL8040, is a high affinity, long-acting CXCR4 receptor inhibitor that already passed successful Phase III for Stem Cell Mobilization and Phase I/II for Immunotherapy for cancer together with immune check point inhibitor Pembrolizumab (Keytruda, Merck) and Atezolizumab (Tecentriq, Genentech/Roche). BL8040 was licensed to BiolineRx and is being developed in the clinic together with BiolineRx Ltd. (NASDAQ:BLRX). Biokine has also developed a suite of unique technologies, MigHit™ – which is a phenotypic screen that allows identification of small molecules targeting migration and survival pathways in cancer and ImmunHit™ which is platform technology enables identification of small molecules targeting IFN-g mediated immune response in cancer and inflammation.

BioLineRx Ltd., a clinical-stage biopharmaceutical development company, focuses on oncology. Its development pipeline consists of clinical-stage therapeutic candidates, which include BL-8040, a peptide for the treatment of solid tumors, hematological malignancies, and stem cell mobilization; AGI-134, an immuno-oncology agent in the development for solid tumors; and BL-5010, a customized, proprietary, pen-like applicator for the non-surgical removal of skin lesions. The company has collaboration agreement with MSD for the cancer immunotherapy field; MD Anderson Cancer Center to investigate the combination of BL-8040 with KEYTRUDA (pembrolizumab) in pancreatic cancer; and Genentech Inc. to investigate the combination of BL-8040 for solid tumors. BioLineRx Ltd. was founded in 2003 and is headquartered in Hevel Modi'in, Israel.

Biolojic Design makes developable, active human antibodies directed against functional epitopes, including targets for which existing technologies fail.

Biomica is an emerging biopharmaceutical company developing innovative microbiome-based therapeutics utilizing Evogene's Computational Predictive Biology (CPB) platform.

Biond Biologics is an Israeli clinical-stage biopharmaceutical company Biond is an innovative biotech company developing breakthrough immunotherapies and a pioneering intracellular drug delivery platform for the treatment of cancer patients. Our innovation: Biologics targeting novel immune evasion mechanisms, discovered through in-house research utilizing real-world patient and tumor samples A transformative intracellular delivery platform for biologics, e.g., antibodies or enzymes, inside cells, allowing to drug intracellular targets currently considered "undruggable". Biond Biologics – Novel and innovative immunotherapies for cancer and auto-immune diseases.

Chemomab is a clinical stage biotechnology company discovering and developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of the chemokine CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies to date, CM-101 appears safe and well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. The company has reported encouraging results from a Phase 2 biomarker study in NASH patients and an investigator study in patients with severe lung injury. A Phase 2 trial in primary sclerosing cholangitis patients is ongoing.

CollPlant is a regenerative and aesthetic medicine company developing innovative technologies and products for tissue regeneration and organ manufacturing. Our revolutionary plant-based technology is the only commercially viable technology for mass production of recombinant human Type I collagen (rhCollagen), which is identical to the collagen produced by the human body. This makes our rhCollagen the ideal building block for regenerative medicine. Leveraging on the unique properties of rhCollagen and biomaterial know-how, we are developing a pipeline of products aimed at 3D bioprinting of tissues and organs and medical aesthetics. Our mission at CollPlant is to deliver ground-breaking products for regenerative medicine that offer the optimal treatment options to patients.

Concenter BioPharma - a patented, unique, proven, novel platform of drugs with 3 modes of action. We are advancing a pipeline of products that demonstrate vast potential in addressing multi­billion markets for treating a range of diseases (that require common MoA’s – our Platform). We will become a global specialty biopharmaceutical company focused on people and providing innovative therapies for them. Our Platform will enable us to jump quickly from one product to another without having to rediscover and recreate an underlying technology for each product. we are committed to developing and delivering therapies that work harmoniously with the human body and advance the treatment landscape for people living with life-threatening diseases.

We named our company ELGAN Pharma, as we are dedicated to improving outcome for babies who are Extremely Low Gestational Age Newborns (ELGANs). This means they are born more than 3 months before term. ​ Premature birth is the number one cause of newborn deaths. With improved standard-of-care worldwide, survival rate increases, leading to the need of improving outcome and quality of life. ​ ELGAN Pharma is a neonatology-focused biotechnology company, dedicated to developing safe tailored therapies to address medical problems and developmental difficulties that are common in babies born very early.

Our mission is to establish new equilibriums – both in patients’ immune responses and in the field of immunotherapy. As a clinical-stage company focused on specialized cell immunotherapy, we intend to develop and commercialize an allogeneic drug pipeline for rebalancing all manner of immune hyper-responses. Our pioneering Allocetra™ cell-based therapy breaks with old paradigms, offering to effectively treat numerous acute conditions through a radically different clinical approach. By using the body’s native mechanisms to restore – rather than suppress – immune balance, we aim to reshape the way immune, autoimmune, and inflammatory conditions are both thought of and treated.

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide. Our corporate headquarters is located in Tel Aviv, Israel. For more information about Galmed, please visit our website at: www.galmedpharma.com

At Gamida Cell, we are striving to enable patients with blood cancers and serious blood disorders to reach cures through advanced cell therapy. We work with a sense of urgency and deeply held responsibility to address the clear need for new treatment options. And we believe that cell therapies should be available to patients who can benefit from them.

ImmunoBrain Checkpoint (IBC) is a clinical stage biopharmaceutical company transforming the fight against neurodegeneration and aging by targeting the immune system, restoring brain immune communications and boosting natural repair mechanisms. IBC’s lead program is a proprietary antibody targeting the inhibitory immune checkpoint pathway PD-1/PD-L1, to treat Alzheimer's disease. IBC's novel approach for the treatment of neurodegeneration is based on years of innovative, cutting-edge scientific discoveries made in the lab of Prof. Michal Schwartz at the Weizmann Institute of Science.

Kadimastem (TASE:KDST) A clinical stage biotech company introducing a cutting-edge TECHNOLOGY PLATFORM for the Development, Manufacturing, and Bio-Banking of functional human cells, providing OFF-THE-SHELF TREATMENT for multiple indications featuring ALS and Type 1 Diabetes as our top two leading projects.

KAHR Medical is developing an innovative and novel drug platform of immunotherapeutic bi-functional fusion proteins that harness the human immune system to target multiple cancer indications

Kamada is a growing commercial-stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions. The company is a leader in the specialty plasma-derived field focused on diseases with limited treatment alternatives, with 6 FDA-approved products selling in over 30 countries. The company is advancing an innovative development pipeline targeting areas of significant unmet medical need.

LipoMedix is a biopharmaceutical company that develops drugs for cancer diseases.

Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma’s lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis.

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study. For more information visit www.mediwound.com

Minovia Therapeutics is a clinical-stage international biotechnology company, established in hopes to bring life changing therapies to patients with Mitochondrial diseases, as fast as responsible. Following compassionate use cases performed in Sheba Medical hospital in Israel, using our proprietary Mitochondrial Augmentation Therapy, Minovia is now conducting the first of its kind clinical trial for Pearson syndrome, an ultra-rare pediatric disease.

Nectin Therapeutics is a biotech company focused on unlocking the power of the immune system. We are developing a collection of next-generation immunotherapy agents. Despite the unprecedented efficacy of existing immunotherapy agents, many patients either fail to respond, or following encouraging initial response, develop resistance over time. At Nectin, we have discovered novel resistance mechanisms and developed novel agents targeting these mechanisms for improved therapy. At Nectin, we are dedicated to the development of novel therapeutic options for cancer patients. We are developing a diverse pipeline of targeted antibodies based on the nectin pathways. These antibodies overcome inhibitory pathways deployed by the tumors and allow immune cells to effectively destroy cancer cells. Additionally, based on the unique expression patterns of several nectin proteins, we develop CAR-T and -NK drivers that directly target tumor cells in various indications, including hard-to-treat cancers.

NeoTX is a specialty biopharmaceutical company, with a focus on research and development in oncology immunotherapy. With a strong research and development team, our strategy is to build a patented, proprietary and unique product pipeline to capitalize on technologies that NeoTX is developing independently and through collaborative partnerships and license agreements.

NewStem is a biopharmaceutical company focused on Human Pluripotent Stem Cells (HPSCs) in general and Human Haploid Pluripotent Stem Cells (HHPSCs) in particular. These cells have the potential to change the face of medical research as they hold a pivotal role in regenerative medicine, disease therapy and cancer research. NewStem possesses pioneering intellectual property, reagents and experience related to the isolation and differentiation of HPSCs, their genetic manipulation, immunogenicity, tumorigenicity and their unique capacity in disease modeling. With this innovative research, and specialized drug and gene screening capabilities. NewStem is currently the only company worldwide to develop products based on this paradigm changing proprietary tech-nology, licensed from Yissum, Hebrew University’s technology transfer company, based on the findings and in-ventions of Prof. Nissim Benvenisty, of the Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem.

NurExone Biologic is developing a revolutionary biological exosome based technology drug platform to treat damage in the Central Nerve System. The breakthrough exosome-based technology was proven in preclinical studies to have the potential to treat spinal cord injuries.

OPKO Biologics Ltd. (formerly Prolor Biotech), a subsidiary of OPKO Health Inc., is a clinical stage company developing next-generation, bio-better, long-acting versions of therapeutic proteins and peptide drugs, utilizing CTP and reversible PEGylation technologies. The CTP technology involves fusing one or more copies of a naturally occurring glycosylated peptide by rDNA technology to the protein chain ends. When attached to a therapeutic protein, CTP significantly extends its longevity in the body. OPKO Biologics’ second technology is reversible PEGylation, a synthetic chemistry-based platform for enhancing the half-life of therapeutic peptides and small molecules. Using a hydrolysable linker bypasses the disadvantages of using a standard PEGylated molecule, i.e. the potential for steric hindrance that limits its function, and the limited ability to cross cellular membranes or the blood-brain barrier. OPKO Biologics currently presents two bio-better long-acting products: hGH-CTP (Somatrogon, MOD-4023): CTP-modified human growth hormone (hGH). OPKO completed a pivotal Phase 3 study in growth hormone-deficient (GHD) adults and is currently conducting a Phase 3 study in a GHD pediatric population. The company completed a Phase 2 study in GHD adults, demonstrating that a single weekly injection of hGH-CTP could potentially substitute seven consecutive daily injections of regular hGH, and showing an excellent safety profile. OPK88005: CTP-modified long-acting coagulation factor VIIa, potentiality supporting every-other-day prophylactic treatment or twice a week regimen in hemophilia patients. OPK88005 is currently evaluated in an ongoing Phase 2a clinical study.

Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine and food-tech and aims to establish partnerships that leverage the company’s 3D cell-based technology to additional industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.

Protalix (NYSE American, TASE: PLX) is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix’s unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix’s development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human α Galactosidase A protein for the treatment of Fabry disease; alidornase alfa or PRX 110, for the treatment of various human respiratory diseases or conditions; PRX 115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX 119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219, CM24 and IM1240. *NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. In a Phase 1/2 study of NT219, the Company is currently advancing it as a monotherapy treatment of solid tumors, and in a dose escalation in combination with cetuximab for the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) or colorectal adenocarcinoma (CRC). These studies will be followed by an expansion phase of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and metastatic SCCHN. *CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. *IM1240 is a preclinical, conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment. The third arm specifically targets the Tumor Associated Antigen (TAA) 5T4 that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. IM1240 has a cleavable capping technology that confines the compound’s therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients.

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products. Previously known as BiondVax Pharmaceuticals, the company has undergone significant changes, including a shift in focus and a rebranding to reflect a new strategic direction. Scinai Immunotherapeutics is also working on an innovative plaque psoriasis treatment that has shown encouraging preclinical results.

SKIP Therapeutics develops RNA-based therapies for rare genetic disorders and common diseases – utilizing a proprietary computational discovery engine to optimize target selection and therapeutic design. We employ sequence-based molecules, called Antisense Oligonucleotides (ASO), to restore function of mutated genes in rare genetic disorders or to modify functionality of key genes in major disease pathways. Convergence of SKIP’s novel computational discovery engine alongside strong experimental capabilities form a unique venture in the landscape of RNA-based therapies. Thousands of rare genetic disorders affect millions of people worldwide, however the small number of patients for each disease, further segregated by patient-specific mutations, has hindered development of dedicated treatments. Recent advancements in RNA-therapeutics offer an expanded molecular toolkit that can be deployed rapidly and at low costs to restore protein function of mutated genes. Identifying sub patient-populations that could potentially be suitable for treatment with RNA-based therapeutics and matching molecular treatment-strategies across the vast landscape of known disease-causing mutations could be assisted by computational methods. To facilitate development of dedicated treatments, Skip Therapeutics has developed a bioinformatic pipeline that analyzes disease-causing mutations and recognizes the best molecular strategy (if any) to restore protein function, using splice modulating antisense oligonucleotides (ASOs). Analyzing mutation data at scale, enables identification of treatable patient cohorts and optimizes target selection. Top candidates from the computational analyses are experimentally validated and pursued for therapeutic development.

SpliSense Ltd., is a growing and exciting biotechnology company, developing novel therapies for genetic diseases by inhalation. The company is currently focusing on splicing mutations in the CFTR gene for treating Cystic Fibrosis (CF) patients.

TargetGene is an innovative and agile biotechnology company in it’s development stage poised for expansion. TargetGene’s R&D is centered around creating efficient and supremely specific DNA editing solutions in living organisms. TargetGene, with it's patented and patent pending "T∙GEE"​ (Genome Editing Engine) platform is the first to invent RNA-guided gene-targeting. TargetGene is aiming to implement the "T∙GEE"​ platform for human gene-therapy with a focus on inherited diseases and cell-based immunotherapy. TargetGene’s platforms include In-Vivo assembling nucleases targeted to the cell's genetic material. Highly specific Targeting is achieved through use of the principle of nucleic acid hybridization. Keywords: Genome editing, Gene Targeting, Genome engineering, Nucleases, RNA-guided Genome Engineering (RGEN), Immunotherapy, Cell-based Therapy, Gene Thearapy, Immuno-oncology. Our new laboratories are situated in the Rehovot Science park, Oppenheimer 10, Rehovot, Israel.

Ukko is improving the lives of millions that suffer from food allergies and disorders. We are using cutting edge technologies in immunology, computational biology, and plant science to develop a new approach. We have offices in Tel Aviv, Israel and Palo Alto, California.

VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications expected to enter Phase 1 this year that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease.

Vensica Medical is a medical device company that is designing and developing and Ultrasound catheter for the treatment of bladder cancer. Currently, after surgical removal of tumors found in the bladder, a drug is instilled into the bladder via a catheter. This treatment method is inefficient and ineffective: Urinary bladder cancer has the highest recurrence rates among all types of cancer (70%). Using Vensica's device, the drug will be instilled in a quick, pain-free procedure subsequent to the delivery of ultrasound to the urinary bladder. Ultrasound improves the uptake of the drug and its penetration into the bladder wall and is expected to improve the treatment and reduce recurrence rates.

XTL Biopharmaceuticals Ltd. (NASDAQ:XTLB, TASE:XTLB.TA) is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of systemic lupus erythematosus (SLE). Treatments currently on the market for SLE are not effective enough for most patients and some have significant side effects. Robust clinical data on hCDR1 has been produced in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals.