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.

Watch Leo's full interview with Proactive Investors here.

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.

Read more via Edison here.

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.

Read the full announcement via the ASX here.

Regeneus: leveraging the power of MSC`s

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

Read the full article from CCRM here.

New hope for osteoarthritis sufferers

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.

Read the full article in The Australian Financial Review here.

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 the full announcement on the ASX here.

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 full announcement on the ASX 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 full announcement on the ASX here.

ARM Sector Newsletter

Alliance Regenerative Medicine has released their first newsletter for the year. The newsletter provides a summary of recent activity in Regenerative Medicine.

Read the full newsletter here.

Regeneus appoints Japan-based non-executive director with extensive pharmaceutical industry experience

Regeneus (ASX: RGS), a clinical-stage regenerative medicine company, is pleased to announce the appointment of Leo Lee as an independent non-executive director of Regeneus with effect from December.

Leo is a senior executive with over 20 years of experience in pharmaceutical innovation, commercialization, regulation and policy development. He has worked in North America and Asia and has spent the last 12 years living and working in Japan. Leo is President of Merck Serono, Japan and was previously the President of Allergan, Japan.

View the full announcement via the ASX here.

Regeneus to attend BioJapan in partnership with AGC

Regeneus featured in the Australian Financial Review on 9 October 2017 (page 35). The story focused on the evolution of stem cell technology and how Japan has become a key market for our cell based regenerative medicine technologies.

This is a good forerunner for BioJapan, Japan's largest biotech and regenerative medicine conference to be held between 11-13 October in Yokohama. Regeneus will be participating in meetings to promote Progenza and Sygenus as well as continuing our discussions with potential licensing and marketing partners.

Read the full article in The Australian Financial Review here.

AGC to Expand Production Capacity at Its Subsidiary CMC Biologics Copenhagen, Denmark Facility

Tokyo, September 25, 2017– AGC Asahi Glass (AGC), a world-leading manufacturer of glass, chemicals and high-tech materials, announces today that it has decided to increase its capacity at CMC Biologics, a 100% subsidiary of AGC. Specifically, five single use bioreactors with 2,000L volume will be built at the production site in Denmark, allowing for flexible production with scales from 2000L to 12000L in a single production suite.

The Bioreactor 6Pack can be run in single unit operations or in groups, simultaneously, sequentially or in staggered fashion to achieve desired production needs. Production is expected to be online in the third quarter of 2018.

The strategic expansion aims to meet the increasing demand for antibody drug development and production.

Read the full news release via AGC here.

Regeneus Ltd (ASX: RGS) ABN Interview with John Martin on Progenza and the Platform Technology

John Martin talks on the release of the financial results following the company's significant progress with Japanese partner AGC. John talks about the successful Progenza STEP trial and the granting of a Japanese patent for the company's Progenza platform technology.

Watch John's full interview with ABN Newswire here.

Regeneus achieves major milestones and secures critical Japan collaboration

John Martin, chief executive for Regeneus, speaks with Proactive Investors.

John Martin talks to Andrew Scott, Proactive Investors in London, discussing some of RGS' major achievements of FY17 in particular the critical Japanese collaboration with AGC, positive STEP Phase 1 results and IP protection for Progenza in Japan, which sets RGS up nicely for discussions with potential clinical partners.

Watch John's full video interview with Proactive Investors here.

Regeneus Focused on Developing Adipose - Derived Allogeneic MSC Product W/ Added Secretions

Regeneus is a firm that conducts research and development in adipose-derived cellular therapies for both human and veterinary use. In December 2016 the firm out-licensed the exclusive Japanese manufacturing rights for their adipose-derived allogeneic mesenchymal stem cell (MSC) product, Progenza, to AGC Asahi Glass. In line with this development, the two firms established a joint-venture, Regeneus Japan, in Shibuya, to assist in their search for a commercialisation partner for Progenza in Japan.

On June 9, 2017 Regeneus’ CEO, Mr. John Martin, and the firm’s Head of Licensing and Alliances, Dr. Duncan Thomson, answered some of this newspaper’s questions on their plans for Japan.

Read the full interview with Nikkei BP Japan here.

Regeneus is Solidifying Out-Licensing Partnering and Looking to Commence a Japanese Phase II Trial

Mr. John Martin, CEO of the Australian regenerative medicine venture company, Regeneus, relayed his plan to Japan Chemical Daily to locate an out-license partner for the firm’s Knee Osteoarthritis (OA) cellular therapy. Progenza is garnering interest from a number of companies on the back of Regeneus’ Australian Phase I data, which showed possible disease modifying properties. AGC Asahi Glass already has exclusive manufacturing rights for Progenza in Japan.

Read the full interview with Japan Chemical Daily here.

Regeneus Q2 2017 News Update

Regeneus released our Q2 2017 update newsletter designed to keep our investors and followers of the company up to date with all the company and industry news over the last quarter.

Read our Q2 2017 newsletter here.

Australia, a hotbed for Regenerative Medicine

An increasing number of Japanese and Australian companies are cooperating in the field of regenerative medicine.

Read the full article by Japan Chemical Daily here.

Australia’s Regeneus commences development of manufacturing process for their OA cellular therapy

Regeneus, an Australian regenerative medicine biotech, has commenced preparation (e.g. donor selection, manufacturing process development) for a Japan-based phase II clinical trial of Progenza, their cellular therapy under development for osteoarthritis (OA).

Read the full article by Japan Chemical Daily here.

Regeneus CEO taking part in delegation to Japan

Regeneus (ASX:RGS) CEO John Martin will be participating in Austrade’s business delegation to Japan on April 18 and 19 being led by Australia’s minister for trade, tourism and investments.

Austrade is the Australian government’s export, international education and foreign investment promotion agency.

The two-day mission will showcase leading Australian capabilities in a range of key sectors including regenerative medicine which is an area of particular interest in Japan.

Read the full article by Proactive Investors here.