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AdAlta Limited today announced the first publication of a scientific peer review paper describing the multiple potential applications of its i-body platform technology to address a number of major unmet medical needs.

The publication describing the i-body will appear in the prestigious and well respected international scientific journal “The Journal Of Biological Chemistry”.

The paper describes the new class of small, highly specific and stable fully human protein therapeutics that have been designed to mimic the highly stable structure or shape and exceptional targeting and antigen binding properties of shark antibodies. AdAlta scientists and collaborators have demonstrated that the long binding loop of the i-body, that is lacking in traditional antibodies, can bind to a diverse range of different therapeutically-relevant targets including those that are difficult/intractable to access by current antibody therapies such as G-protein coupled receptors (GPCRs).

In 2015, sixty percent of sales from the world top 20 drugs, were from antibodies, with global sales of US$81 billion from these antibodies alone.

G-protein coupled receptors (GPCRs) and ion channels have traditionally been targeted by small molecule drugs, which account for approximately 40% of all drugs currently on the market. Small molecules can have an increased risk of toxicity and off target side effects due to their lack of specificity. With their high affinity and specificity and long binding loop, the i-body can access GPCRs and ion channels without the off-target side effects common with small molecule drugs.

AdAlta Chief Executive Officer Sam Cobb said, “The publication confirms the significant potential benefits and potential value of AdAlta’s unique i-body and highlights our research among the broader international scientific community”.

AdAlta is utilising the power of its i-body technology platform to develop a pipeline of i-bodies, with an initial focus on treating fibrotic diseases.

Read the publication here.

AdAlta Pty Ltd in partnership with The University of Melbourne, La Trobe University, Centre for Eye Research Australia and Monash University has been awarded a two year NHMRC Development Grant to examine the novel i-body for treatment in a number of eye diseases.

Retinal vascular diseases are leading causes of blindness in Australia and the Western world. Pathological growth of blood vessels and subsequent scarring and fibrosis are central features of wet AMD, proliferative diabetic retinopathy and also retinopathy of prematurity, major causes of vision loss.

This NHMRC Development project will generate data to demonstrate the advantages of the i-body for use in the treatment of these eye diseases.

The i-body is a novel next generation antibody – with extreme stability and an ability to access difficult drug targets such as GPCRs and ion channels previously inaccessible with conventional antibodies. It has the potential for shelf stable products and topical application due to its stability and AdAlta is undertaking manufacturing scale-up to take its lead i-body candidate into clinical trials for pulmonary fibrosis.

AdAlta’s CEO Sam Cobb said, “We are excited to be working with these Melbourne based groups who have significant expertise in ocular diseases, to further explore the anti-fibrotic effects of AdAlta’s lead candidate and the advantages of the i-body platform.”

“AdAlta is committed to drive innovation with the i-body platform and its lead anti-fibrotic candidate by collaborating with world class researchers. This non-dilutive funding supports this cutting edge science without compromising our main goal of advancing AdAlta’s lead for the treatment of pulmonary fibrosis.”

Lead investigator Professor Erica Fletcher from the University of Melbourne said “I am delighted to be working with AdAlta to develop these novel treatments for age related macular degeneration”.

About AdAlta

AdAlta Pty Ltd is an Australian based biotechnology company developing its lead fibrosis candidate with a next generation biological i-body platform.

The i-body is a novel human protein scaffold which combines the advantages of monoclonal antibodies (high target specificity and affinity) with advantages of small molecules including stability and ability to access difficult targets such as GPCRs and ion channels The i-bodies are extremely stable at high temperatures and low pH and can be manufactured in yeast or bacterial systems. In addition to the stability, the i-body has a long binding loop that human antibodies and other next generation antibodies do not have. The i-body with this long binding loop can target sites that traditionally antibodies cannot, such as clefts in cell surface receptors or the active sites of enzymes or targets such as GPCRs and ion channel targets. Further information can be found at www.adalta.com.au.

AdAlta Pty Ltd (AdAlta) has had its key patent granted by the Japanese Patent and Trademark Office which protects the development of i-bodies.

The patent, entitled “Binding moieties based on shark IgNAR domains”, provides an exclusivity period until June 2025. The patent specifically covers a method of modifying a number of human proteins called I-set domains to include features of the shark single domain antibody and this modified protein is what AdAlta calls the i-body. In addition to this newly granted patent in Japan, AdAlta has other granted patents in the USA and Australia and patents pending in other jurisdictions.

Sam Cobb, CEO of AdAlta said “The grant of this patent relating to the i-body platform underpins AdAlta’s unique drug discovery platform, to which we have identified our lead i-body for treatment of fibrotic diseases.”

i-bodies are a new class of therapeutic proteins that contain the unique structural and functional properties of the single domain shark antibody, including extreme stability and the ability to access alternative epitopes such as those of GPCR and ion channel targets. AdAlta is focused on developing the i-body based therapeutics against various disease targets exploiting some of the key benefits i-bodies have over conventional antibodies and other antibody fragments.

AdAlta is developing a pipeline of i-bodies, with a focus on treatment of fibrotic diseases and cancer. Recent animal studies have demonstrated positive in vivo data and AdAlta is developing an improved therapy for the treatment of fibrosis, prevalent in 45-50% of all diseases. AdAlta is currently raising funding to progress its lead to the clinic.

AdAlta Pty Ltd is pleased to announce that Dr Paul MacLeman has joined the AdAlta Board and has been appointed Chairman effective from 16 April 2015. He replaces Dr John Ballard who is standing down as Chairman and will leave the board in due course, having led the Board of AdAlta for over seven years.

CEO Sam Cobb, welcomed the appointment of Dr. MacLeman as the company’s new Chairman: “I am excited to welcome such an experienced industry professional as Dr MacLeman to the Board of AdAlta. Paul brings extensive expertise in the biotech industry, executive management and the investment community to AdAlta. AdAlta will benefit from Paul’s depth of life sciences commercial experience and his networks here and abroad. I would also like to take the opportunity to thank Dr John Ballard for his significant contribution to the success of the company as the Chairman of the Board since 2007.”

Dr. MacLeman, current CEO of IDT Ltd, joins the AdAlta Board, with more than 25 years biotech experience and having led a number of companies and businesses through significant turnaround and expansion programmes, successfully raising capital in both Australia and international markets.

“I am very excited to join the AdAlta Board and be appointed Chairman,” said Dr. MacLeman. “AdAlta is at a very interesting and critical stage of its development. The next phase of the programme will deliver proof of concept in fibrotic diseases, leading into development of the Company’s first products. I am looking forward to utilizing my experience in the sector to assist Sam and the rest of the AdAlta team to access the resources needed to advance the Company to its next milestones.”

Dr John Ballard has been the Chairman of AdAlta since 2007. “I’m a “true believer” in the potential of AdAlta’s technology and as a major shareholder look forward to watching the company’s continuing development,” said Dr John Ballard.

AdAlta is developing a pipeline of i-bodies, with a focus on treatment of fibrotic diseases. The i-body – a single domain, long loop protein. is a next generation biologic. The i-body combines the advantages of conventional monoclonal antibodies (mAbs) with some of the well known features of small molecule drugs, with significantly improved efficacy and reduced toxicity. Recent animal studies have demonstrated positive in vivo data and AdAlta is developing an improved therapy for the treatment of fibrosis, prevalent in 45-50% of all diseases. AdAlta is currently raising funding to progress its lead to the clinic.

 

AdAlta Pty Ltd is pleased to announce that Dr John Westwick has joined the AdAlta scientific advisory team.

Dr John Westwick has extensive experience as a Drug Discoverer in the Pharmaceutical Industry and as a Professor of Pharmacology. With over 14 years at Novartis Institutes for Biomedical Research, John was responsible for the build-up and leadership of all aspects of drug discovery and early development from target validation to the completion of clinical proof of concept studies in the Respiratory Area, which included severe asthma, COPD, cystic fibrosis, pulmonary arterial hypertension, and pulmonary fibrosis. During his period of leadership at Novartis Respiratory, John was responsible for five global launches including Xolair, Podhaler, Onbrez, Seebri, and Ultibro. In addition he had 13 positive clinical proof of concept studies in Respiratory, which include a number of compounds and monoclonal antibodies which are now in phase III.

Sam Cobb, Managing Director of AdAlta commented, “We are excited to further expand our scientific advisory Board and work with John. John has extensive experience in drug discovery and development and AdAlta is extremely fortunate to have his input alongside both Dr David McGibney and Dr Brian Richardson in the development of its programs and progression of the i-bodies to the clinic.”

AdAlta has developed a platform that allows the production of an i-body – a single domain, long loop protein. The i-body, as a next generation biologic, combines the advantages of conventional monoclonal antibodies (mAbs) with some of the well known features of small molecule drugs, with significantly improved efficacy and reduced toxicity.

Recent animal studies have demonstrated positive in vivo data and AdAlta is developing an improved therapy for the treatment of fibrosis, prevalent in 45-50% of all diseases. Idiopathic pulmonary fibrosis, the lead AdAlta clinical target, will have an estimated market size of $1bn in the US and Europe alone by 2017. AdAlta is currently raising funding to progress its lead to the clinic.

AdAlta Pty Ltd is pleased to announce that Dr David McGibney and Dr Brian Richardson have joined the AdAlta scientific advisory team.

Dr McGibney is an experienced clinical and pharmaceutical development professional and has extensive experience in the successful development and registration of numerous medicines. Dr David McGibney was with Pfizer for over 20 years and during this time developed 10+ drugs. Dr McGibney joined Pfizer in 1982 and was appointed head of European Clinical Development for Pfizer Central Research in 1992. He was named Vice President of Clinical Research and a member of the Board of Directors of Pfizer Ltd. in 1995. Prior to leaving Pfizer in 2001, he was Senior Vice President of Pfizer Global Research and Development and Director of the R & D Laboratories in Sandwich, Kent, UK.

Dr Richardson was most recently a member of The Leadership Team and The Global Head of The Musculoskeletal Disease Therapeutic Area at The Novartis Institutes for Biomedical Research having previously held several other senior positions during a 42 year career in the Pharmaceutical Industry. In 1993 Dr Richardson was appointed Head of Preclinical Research for Sandoz Pharma AG in Switzerland and UK and in 1996 played a key role in the merger of the Sandoz and Ciba Research organisations that ultimately resulted in creation of The Novartis Institutes for Biomedical Research. Research conducted in Dr Richardson’s laboratories has led to the discovery, development and introduction of several new therapies. He has published more than 60 original peer reviewed research papers and contributed many book chapters in the fields of pathophysiology, endocrinology and receptor pharmacology.

Sam Cobb, Managing Director of AdAlta commented, “AdAlta is extremely fortunate to have the input of both Dr David McGibney and Dr Brian Richardson in the development of its programs and progression of the i-bodies to the clinic.”

AdAlta has developed a platform that allows the production of an i-body – a single domain, long loop protein. The i-body, as a next generation biologic, combines the advantages of conventional monoclonal antibodies (mAbs) with some of the well known features of small molecule drugs, with significantly improved efficacy and reduced toxicity.

Recent animal studies have demonstrated positive in vivo data and AdAlta is developing an improved therapy for the treatment of fibrosis, prevalent in 45-50% of all diseases. Idiopathic pulmonary fibrosis, the lead AdAlta clinical target, will have an estimated market size of $1bn in the US and Europe alone by 2017. AdAlta is currently raising funding to progress its lead to the clinic.

• Under an XS™ Microbial Expression Research Evaluation Agreement, AdAlta evaluated Lonza’s system in house with successful results for novel i-body proteins
• Lonza to conduct focused strain development study with XS™ Pichia Systems and manufacture non-GMP material at its microbial facility in Visp
• AdAlta to continue using Lonza’s XS™ Expression Technologies in their laboratory to screen their broader i-body platform under the XS™ Research Evaluation Agreement

Basel, Switzerland and Melbourne, Australia, 18 Dec 2014 – Lonza and AdAlta announced today that they have entered into a strain development agreement for AdAlta’s alternative scaffold proteins, called i-bodies. Lonza will conduct strain development studies with the XS™ Pichia systems for several i-body molecules that AdAlta successfully expressed at research levels in their Melbourne-based laboratory. Strain development and manufacturing will be conducted by Lonza at its microbial facility in Visp, Switzerland to establish a commercially viable manufacturing process.

The XS™ Research Evaluation Agreement (REA) provided AdAlta scientists with access to Lonza’s proprietary microbial expression systems, protocols and technical expertise. The licensable XS™ Technology Platform consists of multiple hosts and promoter systems that have been optimized for soluble expression driving simpler recovery and downstream processing, which saves development time and costs. After evaluating several E.coli and Pichia host systems, AdAlta found the best expression performance with one of Lonza’s Pichia systems for several i-bodies that are under development for fibrosis and other diseases.

Under the strain development contract, Lonza will conduct broader process development for these i-bodies including larger scale, fed-batch production with one or more XS™ Pichia Systems to assess cell growth and productivity. Lonza will produce non-GMP material for further evaluation at AdAlta.

“We are pleased that the diversity of the XS™ Expression Toolbox is a successful option to express these alternative scaffold molecules which demonstrates the versatility of the technology,” said Anne Hays, Head of Lonza’s Custom Development Services Organization. “This is the goal of our approach – to enable customers to do early research in their own labs, then come to Lonza for next-phase product needs.”

“We are pleased to be working with a partner such as Lonza with extensive experience in protein expression,” said CEO Samantha Cobb. “The strain development with Lonza will allow AdAlta to advance our novel i-body candidates to the clinic as quickly as possible.”

AdAlta will continue to screen their broader i-body platform with the XS™ systems available under the XS™ REA.

About Lonza

Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.

Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found atwww.lonza.com.

About AdAlta

AdAlta Pty Ltd is an Australian based biotechnology company developing its lead fibrosis candidate with a next generation biological platform.

AdAlta is pioneering a new technology, the i-body that uses a human protein equivalent of the single domain antibody of the shark The i-body, as a next generation biologic, combines the advantages of monoclonal antibodies (high target specificity and affinity) with advantages of small molecules including stability and ability to access difficult targets such as GPCRs and ion channels The i-bodies are extremely stable at high temperatures and low pH and can be manufactured in yeast or bacterial systems. In addition to the stability, the i-body has a long binding loop that human antibodies and other next generation antibodies do not have. The i-body with this long binding loop can target sites that traditionally antibodies cannot, such as clefts in cell surface receptors or the active sites of enzymes or targets such as GPCRs and ion channel targets. Further information can be found at www.adalta.com.au.

 

Lonza Contact Information

Lonza Group Ltd	Lonza Group Ltd	Lonza Group Ltd
Head Investor Relations	Head Corporate Communications	Head External Communications
Dirk Oehlers	Dominik Werner	Constance Ward
Tel +41 61 316 8540	Tel +41 61 316 8798	Tel +41 61 316 8840
Fax +41 61 316 9540	Fax +41 61 316 9540	Fax +41 61 316 9840
dirk.oehlers@lonza.com	dominik.werner@lonza.com	constance.ward@lonza.com

 

AdAlta Contact Information

AdAlta Pty Ltd

CEO and Managing Director

Samantha Cobb

Tel: +61 3 9479 5159

s.cobb@adalta.com.au

 

Additional Information and Disclaimer

Lonza Group Ltd is headquartered in Basel, Switzerland, and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements. Lonza Group Ltd is subject to the listing rules of the SIX Swiss Exchange, which does not have specific requirements equivalent to the listing rules of the SGX-ST for interested person transactions, acquisition and realizations and delisting.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.