Regeneus receives milestone payment from Kyocera

Australian biotechnology and life sciences online news source, BiotechDaily, reported that Regeneus received a non-refundable milestone payment of approximately $1.6 million (100 million Japanese Yen) from Kyocera Corporation as set out in the non-binding Memorandum of Understanding (MOU) signed on 2 March 2020.

Read the full article here.


Regeneus inks agreement with high profile Japanese life sciences group

Online investment publication Finfeed reported that Regeneus signed a non-binding memorandum of understanding (MOU) with Kyocera Corporation (Kyocera, TYO:6971), a diversified Japanese-based manufacturer with a strong position in the life sciences industry.

Read the full article here.


Regeneus (ASX:RGS) signs MOU with Kyocera for Progenza

The Market Herald - a leading source of authoritative breaking stock market news for self-directed investors - published an article reporting on Regeneus signing a non-binding memorandum of understanding with Kyocera Corporation.

Read the full article here.


ASX:RGS - Regeneus AGC Agreement termination paves way for commercial partner

Regeneus AGC Agreement termination paves way for commercial partner

Boardroom Media

Regeneus’ CEO Leo Lee spoke with Boardroom Media to discuss the recent termination of our AGC agreement and what it means for potential partners for our lead candidate, Progenza OA in Japan.

Listen to the full interview at Boardroom Media


ASX:RGS - Regeneus AGC Agreement termination paves way for commercial partner

Regeneus AGC Agreement termination paves way for commercial partner

Boardroom Media

Regeneus’ CEO Leo Lee spoke with Boardroom Media to discuss the recent termination of our AGC agreement and what it means for potential partners for our lead candidate, Progenza OA in Japan.

Listen to the full interview at Boardroom Media


Dr Boreham's Crucible: Regeneus

Biotech Daily: Dr Boreham’s Crucible: Regeneus

By TIM BOREHAM

Flush with fresh funding, the stem cell play’s overhauled management is supremely confident of striking a partnering deal in Japan pertaining to its lead osteoarthritis treatment Progenza.

This confident assertion - accompanied by a $5.54 million capital raising - lifts a burden of guilt for your columnist, who late last year put the mozz on the company by describing its board - barely changed since the company’s listing in 2013 - as remarkably stable.

Lo and behold, in January CEO John Martin resigned to pursue other opportunities, to be replaced by existing director Leo Lee.

Mr Martin stayed on as a director, but in early April both he and chairman (and biotech legend) Dr Roger Aston resigned.

As the Aston-Martin MkII combo motored off, they were replaced with another biotech hero, Dr John Chiplin and Florida-based Dr Alan Dunton, who has sat on more life sciences boards than he has consumed syrupy waffles for breakfast.

The rationale behind the management shake-up is to sharpen the company’s focus on neuropathic pain - a quest that has been vindicated by positive new clinical results (see below).

Regeneus’s institutional investors like what they hear, having subscribed $2.34 million in a placement at eight cents apiece. The company is now in the throes of a one-for-six rights issue to raise up $3.2 million more.

Who let the dogs out?

With patents in the US, Europe and Japan, Regeneus began with adipose (fat) based stem cells for knee joints in dogs – and hopefully humans – but has changed its focus to mesenchymal stem cells. More specifically, it’s about the secretions from these cells that have the ability to be clinically developed to treat multiple candidates.

Progenza is an off the shelf (allogeneic) treatment for osteoarthritis pain. Progenza cells secrete cytokines - a protein that regulates the cells and sends signals to them - and other growth factors.

Osteoarthritis pain is usually treated with non-steroidal anti-inflammatory drugs, which can induce side-effects including stomach ulcers and gastro-intestinal bleeding.

The company’s second product, Sygenus is a topical acne treatment. It has also shown a strong analgesic effect in post-operative pain studies, with longer lasting effects compared with morphine.

While Progenza has been subject to phase I testing, Sygenus is at the laboratory stage.

Regeneus focuses on a subset of secretions called exosomes, which are not a direct regeneration agent but signal to the body that a cartilage (or other defective part) should be repaired.

Regeneus was the brainchild of inventor Pro Graham Vesey and was founded by Prof Vesey and Dr Benjamin Ross. Both have strong Macquarie University links.

Chipping in for Dr Chiplin

Dr Chiplin is the managing director of biotech wheeler and dealer New Star Ventures. He is also on the boards of the ASX listed Adalta, the London-listed immunotherapy play Scancell Holdings and the private Batu Biologics.

Up to mid-May he was on the board of ASX listed stem-cell chum Cynata Therapeutics.

But he is best known here for heading ASX-listed cancer immunotherapy house Arana Therapeutics (formerly Peptech with Evogenix inside), which Cephalon Inc (now Teva) acquired in July 2009 for $329 million - a 70 percent premium despite the ravages of the global financial crisis.

Dr Chiplin also is very adept at passing the hat, having mustered GBP20 million ($A36 million) for Scancell. He also steered the ASX-listed gene-silencing play Benitec’s Nasdaq listing that raised $46 million (okay, Benitec’s fortunes have soured since then and the company’s in danger of being turfed from the Nasdaq, but that’s not the point).

“That’s where my Rolodex comes in handy,” Dr Chiplin says. “Like other Aussie biotechs, Regeneus needs to think global for funding. In one block of Manhattan there’s more money for life sciences than the whole of Australia - but it’s not easy money.”

Dr Dunton founded the pharma consultancy Danerius LLC.

Mr Lee meanwhile was Japanese president of Merck, Sharp and Dohme and Allergan and is fluent in Japanese and Mandarin. As Matildas’ skipper Sam Kerr would say, “Suck on that Kevin Rudd”.

Turning Japanese

As with ASX-listed stem cell peers Mesoblast and Cynata, Japan is a tempting market for Regeneus because of favorable regulatory settings and a creaking, ageing population.

Regeneus has a 50:50 manufacturing partnership with AGC, an arm of Mitsubishi AGC Asahi Glass. But it’s also been working on that elusive partnership to distribute its knee osteoarthritis product in Japan.

Last November, management promised that, like the Great War, it would be done and dusted by Christmas that year.

“It’s a work in process, it’s been mooted for a while,” concedes Dr Chiplin, who describes Japan as “one of the most enlightened regulatory environments in the world”.

In Japan, Mesoblast is marketing the graft-versus-host disease treatment Temcell (acquired from Osiris in 2014).

Cynata is partnered with Fujifilm for its graft-versus-host disease treatment Cymerus, but like a nervous suitor it’s waiting for Fujifilm to commit (Cynata has also fielded a non-binding takeover offer from another party).

Mr Lee says Regeneus intends to commence a phase II study in Japan “in the near future” - probably 2021.

“We expect to have a product in market in 2023, which is very good news for us,” he says.

http://regeneus.com.au/media/news/Biotech%20Daily-%20Tim%20Boreham%20article%20for%20New%20Criterion.pdf


90 Seconds With...Dr Alan Dunton

Regeneus (ASX:RGS) is a leading pain management and clinical-stage regenerative medicine company.

In a bid to fast-track its push for global growth, the company recently appointed two experienced leaders in life sciences and biotechnology to its board, including Dr Dunton.

Dr Dunton is a pharmaceutical and biotechnology industry leader with over 35 years of experience in senior company leadership roles, spanning pharmaceutical research and development to private biotechnology companies focussed on prescriptive treatment and the commercialisation of over-the-counter drugs on a global scale.

Of the appointment, Regeneus CEO Leo Lee said: “Dr Dunton’s wealth of knowledge in commercialising drugs on a global scale places Regeneus in a strong position to create a huge uplift in value for shareholders.”

Stockhead spoke with Dr Dunton about his recent appointment and the potential of Regeneus’ cell therapy technology.

Click the image below to view the complete video interview with Stockhead.


Positive promise of stem cell therapy

Regenerating every cell, tissue or organ in the body, curing genetic disorders and chronic diseases, alleviating pain and delaying the onset of ageing, these are the altruistic promises of stem cell therapy.

A key driver of the regenerative medicine market, stem cell therapy’s infinite applications have biotechs racing to the clinical trial finishing line. More than 600 stem cell patents have been filed within Australia in the last five years and over 500 companies globally are involved in stem cell product development.

Oncology, cardiology and neurology remain the crucial areas of spend, but with the global pain market estimated to be worth $US69 billion and forecast to reach $US79 billion by 2024, Australian biotech Regeneus, a player in osteoarthritic and neuropathic pain, is in a prime position.

Regeneus’ unique mesenchymal stem cell (MSC) platform comprises a combination of stem cells and secretions offering amore powerful therapeutic effect than stem cells alone.

MSCs are the main type of cell used in stem cell therapy. They heal and repair cells, secreting cytokines – immunesystem signalling and regulating proteins, growth factors, and exosomes – byproduct extracellular components.

It’s these secretions that Regeneus CEO Leo Lee says are the differentiator behind their cell therapy technology, and allogeneic cell topical treatment platforms, and for which they received their first patent in 2011.

‘‘When we first started treating peoplewith their own stem cells, we noticed an onset of activity which couldn’t be explained by the stem cells creating cartilage,’’ says Lee.

‘‘We postulated at the time, and found through research, that secretions including exosomes, added a lot of extra benefit."

‘‘Further, and unlike cell mediated therapy, secretions doesn’t involve live cells and are more stable, enabling a lot more treatment options.’’

Regeneus believes secretions which contain exosomes will be the future. One can think of exosomes as ‘‘the nuggets in chicken soup’’.

Lee says they improve viability and functionality of stem cells, a fact proven by the more than 3000 publications on the subject, and with others in the market now following in their footsteps.

With existing patents in Australia, the US, EU and Japan, Regeneus has recently received patent confirmation from the US and Europe, affording it commercial rights in the US and across 38 European member states until 2032.

Please click here to see the full article in pdf.


Regeneus Presentation - FNN Investor Event

Key points:

A clinical-stage regenerative medicine company

Portfolio of innovative cellular therapies

These target significant unmet medical needs with a licence-driven strategy

Focus on osteoarthritis and other musculoskeletal disorders

Focus on neuropathic pain and dermatology

Lead drug in knee osteoarthritis (US$5 billion addressable market)


Regeneus prepares for global growth with appointment of life sciences industry leaders

Regeneus prepares for global growth with appointment of life sciences industry leaders

Friday, 10 May 2019

ASX listed regenerative medicine company Regeneus (ASX: RGS) has today announced the appointments of John Chiplin, PhD and Alan W. Dunton, M.D. to its board of directors.

Joining Regeneus as Non-Executive Directors, both Chiplin and Dunton bring significant experience in leading and growing large-scale life sciences and biotechnology companies internationally.

The appointments come at a time when Regeneus is seeking to roll out its global growth strategy targeting the global pain market.

The neuropathic pain market alone is estimated to be worth US$69 billion and forecast to reach US$79 Billion by 2024.

The addition of Chiplin and Dunton to the board and their proven successes in sourcing global capital and global drug commercialisation will be key in supporting Regeneus as it enters this next phase of growth.

Regeneus CEO Leo Lee commented on the significance of the two Non-Executive Directors and the role the appointees will play in the company’s growth strategy.

“I am very pleased to welcome both Alan and John to the Board to support us through the Company’s next phase of growth and commercialisation.”

“Their appointments bring a new mix of invaluable skills to support us through our next phase of growth, as we focus on commercialising our technology to address the huge and growing global pain market.”

“With the deep experience John brings in raising capital internationally and Alan’s extensive experience in commercialising drugs on a global scale, I am confident of the significant value that will result from their strategic guidance and international connections.”

Chiplin, a veteran in the life science and technology industries, has served as CEO at three leading publicly-listed software, biotechnology and cancer immunotherapy companies.

Currently the Managing Director of Newstar Ventures, Chiplin also holds positions on the boards of Adalta (ASX:1AD), Batu Biologics, Cynata Therapeutics (ASX:CYP), Scancell Holdings (LSE: SCLP, Chairman) and ScienceMedia.

Chiplin adds to the Regeneus board a proven track record in sourcing global capital, aligning well with the company’s expanding global growth strategy.

As Executive Chairman at Scancell, Chiplin successfully led a GBP 20 million fundraise from institutional investors.

Chiplin’s expertise are further showcased from his time as Executive Director at Benitec Inc, where he led the company’s IPO on the NASDAQ and a US$46 million raising with US-based institutional investors.

Complementing Chiplin’s vast industry experience is the appointment of Dunton, a senior figure in the commercial biotech and pharmaceutical industries.

Boasting close to three decades of senior leadership experience in the sector, Dunton is a specialist in direct stem cell research and pain management, and is a veteran of the commercial drug and pain management market.

Dunton’s experience spans leadership roles for large pharmaceutical research and development organisations to private biotechnology companies focused on prescriptive treatment and over-the-counter drug development on a global and local scale.

Dunton has served as a director of 18 companies and is the founder and principal of Danerius LLC, a consultancy that provides specialised advisory services to pharmaceutical and biotechnology organisations both in the private and public sectors.

Over the last few years, Dunton has also served as an independent board director for a variety of publicly-listed biopharmaceutical and drug development companies such as Oragenics (NYSE:OGEN), Palatin Technologies (NYSE:PTN) and Cytogel Pharma.

The appointments of Chiplin and Dunton to the Regeneus board will provide invaluable support the company in the further development and commercialisation of its Progenza and Sygenus platforms.

Coinciding with the appointment of Chiplin and Dunton, Regeneus announced Mr Roger Aston and Mr John Martin have stepped down from their roles as Non-Executive Chairman and Non-Executive Director respectively.

Click here for the original article published in Star Investing


90 Seconds With...Leo Lee

Regeneus (ASX:RGS) announced this week that Dr John Chiplin, PhD and Dr Alan Dunton, M.D. have joined its board to support the company’s global growth strategy.

Dr Chiplin is Managing Director of Newstar Ventures and has significant operational, investment and transactions experienced in the international life science and technology industries.

Previously, he’s served as CEO at three publicly-listed software, biotechnology and cancer immunotherapy companies.

Dr Dunton is a senior pharmaceutical and biotechnology industry leader with experience across large pharmaceutical research and development organisations as well as private biotech companies focused on prescriptive treatment and the development and commercialisation of over-the-counter drugs on a global and local scale.

Regeneus’ CEO Leo Lee spoke with Stockhead about the potential impact of the new appointments.

Click the image below to view the complete video interview with Stockhead.


Regeneus ramps up global focus with addition of industry leaders

Regeneus Ltd (ASX: RGS), a leading pain management and clinical-stage regenerative medicine company, has fast-tracked its push for global growth following the appointments of two highly successful leaders in life sciences and biotechnology to its board.

Both Dr John Chiplin, PhD and Dr. Alan Dunton, M.D, bring significant experience and a successful track record in leading and scaling high-growth life sciences and biotechnology companies internationally, with their appointments effective as of 29 April 2019.

Commenting on the announcement, Regeneus Chief Executive Officer Leo Lee said John and Alan’s appointments were a game-changer for the company as it looks to build on the strength of its highly-scalable flagship solutions, Progenza and Sygenus, and their potential to change people’s lives across the world.

“Dr Chiplin’s deep experience in raising capital internationally and strategic guidance will prove invaluable to us and Dr Dunton’s wealth of knowledge in commercialising drugs on a global scale places Regeneus in a strong position to create a huge uplift in value for shareholders,” Lee added.

Lee underlined his growth ambitions for Regeneus, saying the board now possessed the right mix of leadership capabilities and industry nous to tackle a wealth of emerging opportunities in servicing the neuropathic pain market worldwide.

“I am very pleased to welcome both Alan and John to the Board to support us through the Company’s next phase of growth and commercialisation,” he said.

“This is a tremendous time for Regeneus, their appointments bring invaluable experience to support us through our next phase of growth, particularly as we focus on commercialising our technology to address the huge and growing global pain market.”

Solid experience in sourcing global capital

For almost two decades, Dr John Chiplin served as CEO at three leading publicly-listed software, biotechnology and cancer immunotherapy companies. He has a wealth of experience in operational, investment and transactions across the international life science and technology sectors.

“Regeneus is now entering its next phase, as it looks to accelerate its growth globally and raise the capital required to support the commercialisation of its technology platforms,” he said.

“I am looking forward to playing a strategic role in helping the Company access global capital, to fund an accelerated growth strategy into global pain markets.”

Deep industry knowledge

Dr Alan Dunton is a pharmaceutical and biotechnology industry leader with over 35 years of experience in senior company leadership roles, spanning pharmaceutical research and development to private biotechnology companies focussed on prescriptive treatment and the commercialisation of over-the-counter drugs on a global scale.

“I see great potential for this technology to address a large, global pain market and am excited to join the Board to help support the Company’s global growth plans and commercialise these technologies,” he said.

Changing of the guard

Regeneus also announced current board members, Roger Aston and John Martin, will step down from their roles as Non-Executive Chairman and Non-Executive Director respectively.

The company confirmed Barry Sechos will step into the role of Non-Executive Chairman, effective 29 April 2019.

Tapping into a US$79 billion opportunity

Figures from Datamonitor Healthcare – Neuropathic Pain Market Spotlight 2018 show the global neuropathic pain market alone is estimated to be worth US$69 billion.

The data revealed a total of 425.2 million prevalent cases of neuropathic pain in adults aged 20 years and older worldwide, with forecasts showing that number is set to rise up to 476.2 million cases by 2026.

The report found the global neuropathic pain market could reach a total of US$79 Billion by 2024 – an opportunity Regeneus looks set to capture with these exceptional new hires.

Click here for the original article published in Stockhead


Regeneus' newly-appointed CEO Leo Lee discusses strategic plans for growth

Leo Lee, the newly-appointed CEO of Regeneus Ltd (ASX:RGS), speaks to Proactive Investors about the Australian clinical-stage regenerative medicine company's operations, and the wider scientific field.

The company holds a number of patents, and is focusing on global expansion, as it advances treatments in the areas of osteoarthritis, cancer, and dermatology.

Click the image below to view the original story and complete video interview with Proactive Investors.


Several interested parties in Japan

Regeneus has revised expected timing of an osteoarthritis (OA) clinical development licence deal for Progenza in Japan to Q4 CY18 (vs Q218); it is currently in active discussions with several parties. A licence deal would trigger a US$5m milestone payment from partner AGC and would effectively see Progenza commence a Phase II trial in knee OA in Japan.
Regeneus is in separate discussions with potential licensees for other indications and territories for Progenza, as well as for its other pipeline products. We roll forward our rNPV model to FY19, which lifts our valuation to A$181m (vs A$170m) or A$0.87/share. Depending on the terms, we estimate an OA licence deal could add up to ~A$50m to our valuation.

http://regeneus.com.au/media/news/Edison-RegeneusUpdate040918.pdf


Positive clinical trial results for cancer vaccine

Regeneus (ASX: RGS), a clinical-stage regenerative medicine company, today announced positive results from its Phase 1 safety trial of its cancer vaccine which met the primary endpoint of safety and tolerability. The study known as the ACTIVATE trial, is the first clinical trial of RGSH4K, the company’s autologous tumour vaccine product for the treatment of solid tumours.

The single centre, open label, first-in-human Phase 1 study was designed to evaluate the safety and tolerability of RGSH4K and to identify the biologically active dose(s) to take into future trials. In this study,12 patients, heavily pretreated with chemotherapy or radiotherapy, with various advanced solid tumours received RGSH4K in 3 dose cohorts. A total of 3 vaccines were administered in the treatment phase, given at 3-week intervals, and patients had the option to continue dosing in an extension phase. All dose levels were safe and well tolerated, achieving the safety primary endpoint. There were no dose limiting toxicities and no serious adverse events related to the vaccine. Injection site reactions were the most common adverse event related to RGSH4K administration.

RGSH4K also showed encouraging signs of immune stimulation in some patients, as demonstrated by changes in cancer markers, immune cells and cytokines. This immune stimulation was seen in one or more patients at all three dose levels. Preliminary indications of anti-tumour activity were seen in some patients however long term follow up on 50% of the patients continues.

The Principal Investigators for the trial are leading medical oncologists, Professor Stephen Clarke and Associate Professor Nick Pavlakis from University of Sydney‘s Northern Clinical School at the Kolling Institute of Medical Research located at Royal North Shore Hospital in St Leonards, Sydney. The trial was conducted through the Northern Cancer Institute.

Professor Clarke said: “The immune response, including favourable changes in biomarkers, coupled with the benign safety profile for RGSH4K encourages proceeding to further clinical evaluation either as a single agent or in combination with other therapies.”

Regeneus CEO, John Martin said: “Data obtained from this first-in-human clinical study, including the preliminary evidence of clinical activity, is encouraging and highlights the clinical potential of RGSH4K. We are pleased with these results and we will use them to advance further studies and our partnering discussions with interested parties.”

About RGSH4K technology

The vaccine, known as RGSH4K, is produced from a patient’s own cancer cells and, combined with an immunostimulant, is designed to activate the immune system against the cancer cells to initiate a bodywide response. The immune system’s memory should recognise and respond to both existing and new tumours.

The cancer vaccine technology was developed at the Bill Walsh Translational Cancer Research Laboratory which is part of the Kolling Institute of Medical Research and is the research arm of the Medical Oncology Department, Royal North Shore Hospital.

Regeneus has the exclusive worldwide rights to develop and commercialise the vaccine technology for human and veterinary applications.

Read the announcement


Regeneus: leveraging the power of MSC`s

Article from CCRM 

Regeneus works to improve people and animals’ lives through the application of proprietary stem cell and immuno-oncology technologies.

Read the article


New hope for osteoarthritis sufferers

The Australian Financial Review

The company is excited about the potential for Progenza to address chronic pain relief ...
John Martin, Regeneus

According to Arthritis Australia, there are more than 3.9 million people suffering with arthritis and, as the Australian population ages, this is expected to grow to 5.4 million by 2030. Unless more is done to prevent and better manage the condition the costs to the health system are expected to rise from $5.5 billion to $7.6 billion by 2030.
However, there is hope ...
A recent Phase 1 knee osteoarthritis trial sponsored by Sydney-based biotech company Regeneus using its patented stem cell product Progenza, has now been published in the peer-reviewed Journal of Translational Medicine.

http://regeneus.com.au/media/news/AFR%20-%20New%20hope%20for%20osteoarthritis%20sufferers.pdf 


Positive trial results of Progenza for knee osteoarthritis

Regeneus (ASX: RGS) today announced that the previously reported positive results from its Phase 1 safety trial of Progenza in patients with knee osteoarthritis (OA) have been published in the Journal of Translational Medicine.

The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company’s allogeneic stem cell technology platform for the treatment of OA and other inflammatory conditions. The publication of the results in a well-respected journal further validates the trial results.

Read more


Progenza granted Advanced Therapy Medicinal Product designation by European Medicines Agency

Regeneus (ASX:RGS), a clinical-stage regenerative medicine company, today announced that Progenza has been granted an Advanced Therapy Medicinal Product (ATMP) classification by the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA), following consultation with the European Commission.

Progenza is the company’s allogeneic stem cell technology platform for the treatment of osteoarthritis and other inflammatory conditions for human applications.

“The granting of the ATMP classification for Progenza, is a step towards bringing Progenza to Europe as a novel cell therapy treatment for osteoarthritis. It’s important to have regulatory clarity as we invest in the development of Progenza,” said John Martin, CEO of Regeneus.

Read the announcement here 


Japanese Patent Office to grant patent for cancer vaccine technology

Regeneus (ASX: RGS), today announced that the Japanese Patent Office has issued a decision to grant a patent covering the use of cancer vaccine technology for the treatment of a range of cancers in humans and animals.

The Japanese Patent Office has issued a decision to allow a patent covering the company’s cancer vaccine technology for the treatment of cancer in humans and animals to be granted. The patent to be granted on Japanese Patent Application No. 2015-549902 entitled “Vaccines for the treatment or prevention of cancer and compositions for enhancing vaccine efficacy” will provide commercial rights in Japan through to 2033. A corresponding patent has been granted in Australia and corresponding patents are being pursued for grant in other key territories including the USA and Europe.

Read the announcement here