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.