List of Biologics Companies in Australia - 38

Antibody-based therapeutics for tissue repair applications

Development of antibodies from phage display discovery

AdAlta (ASX:1AD) is the pioneer of a novel technology platform that mimics the shape and engineers key stability features of the antigen binding domain of shark antibodies into human proteins to create unique compounds, known as i-bodies, for therapeutic intervention in disease. AdAlta is utilising the power of its i-body technology platform to develop a pipeline of i-bodies (drugs), with an initial focus on treating fibrotic diseases.

Aravax is a clinical stage biotechnology company developing a novel peptide-based immunotherapy, PVX108, for the treatment of peanut allergy. Aravax is striving to improve the lives of patients living with peanut allergies by developing a therapy that precisely targets the underlying cause of disease, bringing benefits in safety and convenience.

Arovella Therapeutics (ASX: ALA) is the only Australian biotech developing an iNKT cell therapy platform to create therapies for people to live longer, healthier lives.

Beroni Group is an international biotechnological company listed on the National Stock Exchange (Australia) and traded on the OTC markets in the U.S.A. with business presence in Australia, China, Japan and the USA. It currently has four core businesses – cell therapies, developing new anti-cancer drugs, e-commerce platform for pharmaceutical and healthcare products, and detection & diagnosis of infectious diseases. Beroni Group’s overall strategic goal is to become a world’s leading enterprise in the biotechnology, life sciences, and environmental science industries.

Carina Biotech An Australian clinical stage immunotherapy company established to research and develop chimeric antigen receptor T cell (CAR-T) therapies to treat solid cancers. Carina are working towards producing broad-spectrum CAR-T therapies that can be used to treat multiple solid cancers yet are patient-specific and result in little, if any, off-cancer damage. Using its proprietary platforms, Carina is also developing technologies to improve access to, and infiltration of, solid cancers, and to enhance CAR-T cell manufacturing. We are working to… 1. Expand the clinical indications for T cell therapies 2. Improve the commercial viability of T cell therapies by developing supporting technologies that make T cell therapies more effective or economically viable Headquartered in Adelaide, South Australia, Carina has strong T cell R&D capability across a network of research providers and collaborators including leading scientists at the UniSA, the Women's & Children's Hospital in Adelaide, the University of Adelaide, the Royal Prince Alfred Hospital in NSW and the Seattle Children's Hospital in the United States.

Cartherics works to create precisely-defined immunotherapy treatments to combat a variety of cancers. We take a multi-platform approach combining the best components of immune defences utilising gene editing and CAR technology. Our team has strong backgrounds in research, development, and product commercialisation. And we partner with leading commercial and academic groups with complementary technology to push the boundaries of cell therapy for cancer.

Born in 2005 as a biotech company, Anagenics (ASX: AN1) has evolved into a growing beauty, health and wellness business with a strong portfolio of functional skin, hair and wellness brands. We own a beauty distribution company, BLC Cosmetics, which distributes some of the leading names in the beauty and skincare sector. We also develop, manufacture and market two beauty and wellness brands; Uspa and evolis. To learn more, please visit anagenics.com

Cell Therapies Pty Ltd is a contract development and manufacturing organization (CDMO) that manufactures and deploys advanced cell-based therapies to the global market. Established in 2003, Cell Therapies is one of the most experienced GMP compliant manufacturers of cell therapies, gene therapies, cellular immunotherapies, and regenerative medicine products globally. We have a 13-cleanroom GMP facility that meets global regulatory and international organisation for standardisation (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S). Our services cover the complete manufacturing process from development to deployment, providing needle-to-needle control with clinical integration. Our facility is co-located with the Peter MacCallum Cancer Centre in Melbourne, Australia, providing access to hospitals, research institutes, and universities to support product development, translation to the clinic, and patient access. Please contact us through our website to discuss potential collaborations.

Celosia Therapeutics is a privately held pre-clinical stage gene therapy company, developing solutions for neurodegenerative diseases that have limited alternative therapeutic options.

Chimeric Therapeutics is a clinical stage cell therapy company focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer not just delay disease progression. To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development and commercialization of the most innovative and promising cell therapies.chm

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

Currus Biologics is utilising its proprietary BEAT technology to develop CAR-T cell therapies for the treatment of solid tumour cancers, traditionally difficult to treat with current CAR-T cell therapies. Currus Biologics’ proprietary Bispecific Engagers of Antigen Presenting Cells and T cells (BEAT) technology overcomes many of the challenges presented when treating solid tumours with traditional CAR-T cell therapy, demonstrating CAR-T cell proliferation and persistence, CAR-T cell trafficking to the tumour and immunological memory extending to additional antigens. Currus Biologics is a privately held biotechnology company based in Melbourne, Australia.

Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Clinical trials of Cymerus MSC products in osteoarthritis (Phase 3) and in severe complications arising from COVID-19 (Phase 2) are currently ongoing. Planning is also underway for further clinical trials of Cymerus MSC products in GvHD (through licensee Fujifilm), critical limb ischemia, idiopathic pulmonary fibrosis, renal transplantation, and diabetic foot ulcers. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of numerous diseases, including the clinical targets mentioned above, as well as asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.

Immuron Ltd (ASX:IMC) (NASDAQ:IMRN) is an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases. ACCEPTABLE USE POLICY We welcome your comments on our page but we ask that you help us comply with the Therapeutic Goods Advertising Code. Please consider these guidelines before commenting. We will remove any comments that may result in us breaching the Code. We love when you comment and tag your friends and family on our posts but we ask that you do not: • endorse our product if you are: o an employee or contractor of a government authority, a hospital or a healthcare facility o a health practitioner, health professional or medical researcher o involved with the production, sale, supply or marketing of our product o not using your own name on this social media platform • imply that a government authority, a hospital or a healthcare facility endorse our product • make comments about how a product works for you outside of its intended purpose, as these comments can be dangerous or misleading - our products are developed for particular purposes, as stated on the label and/or in our advertising • make comments about serious conditions, diseases, ailments or defects, such as comments about how a product helped with your treatment of a serious disease or how it will relieve a tagged person's serious condition We also have an obligation to make sure any advertisements we make, including endorsements and testimonials, are not misleading. Therefore we promise to disclose: • where a person has been, or will be, compensated for making a testimonial • where we have actors making the testimonial, such as in cases where the original person who made the testimonial does not want to appear in our advertisement • where the person making the testimonial is an immediate family member of anyone employed by our company.

Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies.

InterK Peptide Therapeutics functions largely as a virtual company and located in Sydney, Australia.The company’s R&D program is supported by Contract Research Organisations located within Australia and overseas. All three assets share the ability to inhibit cancer growth in vivo in murine models but also differ significantly in their respective immunomodulating effects on expression of cytokines, cytokine receptors and regulation of signalling pathways within T cells, natural killer cells and antigen-presenting cells.

Invion is a clinical-stage life-sciences company that is leading the global clinical development of the Photosoft™ technology for the treatment of cancers. Invion has been appointed exclusive distributor and licensee in Australia and New Zealand of Photosoft™. The appointment has been made by technology licensor, The Cho Group, a Hong Kong based group that has funded and successfully commercialised a number of unique and advanced technologies. Via an R&D services agreement between the two entities, the research and clinical trials of Photosoft™ are funded by The Cho Group. Invion has an alliance with leading Australian medical research institute, Hudson Institute of Medical Research, for the Photosoft™ research program.

Kazia Therapeutics Limited, an oncology-focused biotechnology company, develops anti-cancer drugs. Its lead development candidate is GDC-0084, a small molecule, brain-penetrant inhibitor of the PI3K/Akt/mTor pathway, which is developed as a potential therapy for glioblastoma. The company is also developing Cantrixil, which is being developed for the treatment of ovarian cancer and is in hospitals across Australia and the United States under an Investigational New Drug application. Kazia Therapeutics Limited has collaboration agreements with St Jude Childrens Hospital; Dana-Farber Cancer Institute; Alliance for Clinical Trials in Oncology; Memorial Sloan Kettering Cancer Centre; and University of Newcastle. Kazia Therapeutics Limited has collaboration with Dana-Farber Cancer Institute to investigate the use of Kazia’s investigational new drug, paxalisib, in primary central nervous system lymphoma; and Kintara Therapeutics, Inc. for the activation of paxalisib and VAL-083. The company was formerly known as Novogen Limited and changed its name to Kazia Therapeutics Limited in November 2017. Kazia Therapeutics Limited was founded in 1994 and is based in Sydney, Australia.

Kira Biotech is an emerging Australian biotechnology company developing novel immunomodulatory compounds for the treatment of immune system disorders. Its lead candidate, KB312, is a first-in-class, selective, immune-cell depleting monoclonal antibody which targets activated immune cells and aims to restore homeostasis through induction of immune tolerance. Kira Biotech has attracted venture capital funding and is progressing KB312 through preclinical development and phase 1 clinical trials with a team of drug development experts led by well-known US-based rheumatologist and immunologist, Dr Dan Baker.

Lateral Pharma Pty Ltd Is a privately-owned Melbourne AU-based biotechnology company that commenced operations in May 2015 to repurpose LAT8881, a Phase 2 ready orally-available compound with extensive toxicology and human safety data, into new high potential pain and respiratory indications. Lateral aims to demonstrate efficacy in a human clinical Phase 2 proof-of-concept study using LAT8881 to treat neuropathic pain within the next 12 months. Lateral Pharma has discovered a new class of naturally-derived peptide motifs and their novel target family of proteins that restore normal tissue function in mammals under conditions of damage and cellular stress. Small synthetic peptides derived from growth hormone and at least three other proteins are active in animal models of neuropathic pain, osteoarthritis, obesity, COPD, severe influenza A and recently in initial data in SARS-CoV-2. Lateral has filed multiple patents protecting its intellectual property Lateral is focussed on developing its drugs for the treatment of Neuropathic pain but subject to additional funding will also explore development in respiratory diseases such as Influenza, SARS-CoV-2, COPD, Steroid resistant asthma, and Post-COVID Syndrome (Long-COVID).

Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular medicines to treat serious and life-threatening inflammatory diseases with significant, unmet medical needs. The Company's Phase 3 off-the-shelf mesenchymal lineage cell product candidates are: • RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) • Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection • REVASCOR® for advanced chronic heart failure, and • MPC-06-ID for chronic low back pain due to degenerative disc disease. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection.

Myrio Therapeutics ("Myrio Tx") is about to revolutionize the field of immuno-oncology by enabling antibody-based therapies to attack targets that are inside cells such as mutated cancer-causing and viral proteins. Proteins inside cells are routinely broken down into peptides which are displayed on the cell surface by Major Histocompatibility Complex (MHC), the targets of T-Cells. Myrio Tx’s protein-display system can discover antibodies against difficult to hit targets such as peptide-MHC complexes. This ability increases the number of addressable cancer or viral targets by a factor of ten. Based on fully-human sequences, discovered antibodies can be formatted to fit any purpose, from targeting CAR-T cells, antibody-drug conjugates, bispecifics or traditional antibodies. Myrio Tx's discovery platform can generate high affinity (low nM/pM) and highly selective scFv (antibody fragments) in a matter of days, allowing for rapid evaluation and optimization of product candidates. Myrio Tx is seeking partnerships to fully exploit the potential of its technology whilst also building an in-house portfolio of products.

NeuClone is a clinical stage biopharmaceutical company exclusively developing and commercialising high quality biosimilar products. Led by a team of industry veterans, we are focused on creating a deep pipeline of high quality biosimilars at the scale and price to meet demand in both new and established markets globally. NeuClone is differentiated by our deep and unmatched pipeline, as well as our Right From the Start® approach where we continually confirm biosimilarity at the earliest stages and throughout development.

NeuroScientific Biopharmaceuticals Ltd (ASX:NSB) is an Australian drug development company developing novel peptide-based pharmaceutical products that target a number of neurodegenerative conditions with high unmet medical need. Therapeutic indications include Alzheimer’s Disease, Multiple Sclerosis, Glaucoma and Post-Covid Lung Fibrosis. The companies lead compound, EmtinB works by effectively slowing down the death of dying cells and regenerating damaged nerves and tissue fibres.

Opthea Limited (ASX:OPT) is a public biotechnology company listed on the ASX and based in Melbourne, Australia. Opthea is developing OPT-302, a novel biologic inhibitor of VEGF-C and VEGF-D, for use in combination with VEGF-A inhibitors for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

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.

Provectus Algae specializes in optimizing the production of microalgae species. The microalgae produce high-value biobased chemicals, specialty ingredients, and biologics for use in a wide array of industries and applications.

Recce Pharmaceuticals Ltd (ASX: RCE, FSE:R9Q) is pioneering the development and commercialisation of a new class of synthetic antibiotics with broad spectrum activity designed to address the urgent global health problem of antibiotic resistant superbugs. Its patented lead candidate known as RECCE® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Pre-clinical testing in laboratories and animal models, in Australia and overseas has demonstrated positive results to date. Recce Pharmaceuticals has manufacturing facilities in Australia and clinical research partners in the USA. Recce Pharmaceuticals has validated an automated process to manufacture its lead compound ahead of first-in-human clinical trials.

Cambium Bio Limited (ASX:CMB) is a Sydney-based clinical-stage regenerative medicine company focusing on the development of innovative biologics for ophthalmology and tissue regeneration applications. The Company's proprietary technology, based on human platelet lysate, is being leveraged to create a pipeline of novel therapeutics with a primary focus on ophthalmology. Cambium Bio's lead product candidate, Elate Ocular®, is being developed to address significant unmet medical needs in the treatment of dry eye disease. In addition, the Company's stem cell platform, Progenza™, is being applied to the development of therapies for knee osteoarthritis and other tissue repair indications. Cambium Bio is committed to advancing its pipeline through clinical development and commercialization, with the goal of providing transformative treatments to improve patient outcomes. For more information about the Company and its programs, please visit www.cambium.bio

SDIP has unique patented platform that will revolutionize the world of fixation implants. SDIP`s compounds totally adsorb to the body when the host cells repair the damaged tissue avoiding unnecessary removal surgical interventions. In last two decades, there have been numerous attempts to develop bioresorbable fixation implants, but these devices have fallen short in providing the optimal degradation and also they degrade to acidic by-products causing local inflammation and delayed tissue regeneration. SDIP leaves no acidic/basic by-products behind. The properties of SDIP can be tuned to address different clinical needs in fixing a range of damaged soft and interface tissues. At SDIP Innovations, we are committed to stick to the customer-driven strategies tightly in the mission of revolutionizing the resorbable implants and provide a universally safer option for the patients.

S2N’s vision is a world where neuronal loss no longer means loss. Our regenerative medicine technology starts with the human hair follicle and ends with production of millions of pure neurons, all gene modification free. We aim to transform health, science and society.

In collaboration with RMIT University, Snoretox is developing the world’s first injectable solution to treat obstructive sleep apnoea and other conditions involving low muscle tone. Our game-changing technology is based on molecules of tetanus toxin, modified to ensure they work around the tetanus vaccine. Just as Botox uses tiny amounts of botulinum toxin to relax muscles, our prototype therapeutic uses minute amounts of safe modified tetanus toxin to achieve the opposite effect – muscle toning.

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with commercial operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of radiopharmaceutical products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Tessara Therapeutics Pty Ltd is a regenerative medicine company developing RealBrain® technology to break therapeutic barriers in the biopharmaceutical industry. RealBrain® technology is based on human mimetic 3D neural micro-tissues designed to have high physiological relevance, manufactured at industrial scale for unprecedented reproducibility. Priority applications include a high-throughput drug screening platform that includes a range of models of healthy and diseased brain tissue, and a regenerative medicine platform to develop next generation safe and efficacious tissue therapies for significant unmet neurological medical needs.

VivaZome Therapeutics Pty Ltd (ABN 59 602 230 964) is a privately-held Australian biotech company, with operational headquarters at the La Trobe University in Melbourne, Australia. VivaZome aims to develop and commercialise customised exosome-based therapies for debilitating and life-threatening disorders, with a focus on neurological disorders, retinal disease and ischaemic conditions. VivaZome is developing new technologies, intellectual property and manufacturing processes that apply generically to exosome therapies. These will underpin the Company’s development of specific exosome products for its target indications. The VivaZome team has extensive expertise in the development and commercialisation of biological therapies, together with a wide network of expert contacts in the Australian and global biotech communities. VivaZome acknowledges the support of the Department of Industry and Science through the CRC-P program, and the contribution of its CRC-P partners: Australian National University, the University of Queensland, La Trobe University, Cytiva and SeerPharma Pty Ltd.