California Institute of Regenerative Medicine Issues Grants

The California Institute of Regenerative Medicine recently announced several grants to fund clinical stage research.  Importantly, CIRM has many different requirements than those offered under the Bayh-Dole Act.  The Press Release states:

South San Francisco, CA – The California Institute for Regenerative Medicine (CIRM), the world’s largest institution dedicated to regenerative medicine, today awarded $50.1 million to fund clinical-stage research projects aimed at advancing stem cell and gene therapy treatments for a variety conditions ranging from neurodegenerative diseases and blood cancers to HIV/AIDS.

The awards will support six projects in the Agency’s clinical program which provides funding for eligible stem cell and gene therapy-based projects through any stage of clinical trial activity.

The awards include: [Aspera Biomedicines, AcuraStem, Regenerative Path Technologies and the City of Hope].

Among the awards is a $12.4 million grant to support Regenerative Patch Technologies LLC in a Phase 2b clinical trial to evaluate the safety and efficacy of a retinal pigmented epithelial (RPE) implant. The implant will be evaluated in patients with geographic atrophy, a late-stage form of age-related macular degeneration (AMD), a common condition that can lead to vision loss in older adults.

The RPE is an important cell layer that supports the retina and plays a critical role in maintaining vision. In geographic atrophy, RPE cells break down over time, leading to impaired vision and a loss of independence.

The stem cell-based implant aims to promote the survival and function of the retina, protecting the eye from disease progression and potentially improving vision.

“This award supplies critical funding to support a Phase 2b clinical trial to achieve our goal of improving vision in patients with geographic atrophy”, said Jane Lebkowski, PhD, President of Regenerative Patch Technologies. “We want to thank CIRM for their support of this program.”

Geographic atrophy affects more than 8 million people worldwide and an estimated 1 million people in the United States. There are currently no approved therapies that are effective in improving vision in patients with geographic atrophy.

“CIRM is proud to continue to fund this groundbreaking stem cell therapy that has the potential to improve outcomes for the millions of people suffering from geographic atrophy,” said Maria T. Millan, M.D., President and CEO of CIRM. “This investment is follow-on funding to CIRM’s previous support to develop this therapy. It reflects our commitment to advancing cutting-edge science and underscores our dedication to addressing the unmet medical needs of those affected by degenerative diseases.”

This month’s clinical awards include two preclinical projects and four clinical-stage projects. That brings the number of CIRM-funded clinical trials to 95. For more information on CIRM’s clinical stage program, please visit our Funding Opportunities page.

Alliance for Regenerative Medicine: 2019 is Second Best Year in History for Regenerative Medicine Financing

The Alliance for Regenerative Medicine (ARM) has recently released its annual report.  Notably, ARM states that 2019 was the second-best year in history for regenerative medicine financing.  A whopping $9.8 billion US was raised globally.  $7.8 million was raised for gene modified and cell therapy.  Tissue engineering received $442 million.  The report further specifies deals for significant sums as well as public offerings.  The financing numbers are also broken down by type, such as venture capital, with comparison to 2018 and 2017 numbers.  VC financing is up almost a billion dollars in 2019 over 2018.  Financing numbers are also reviewed for the EU and Israel.  The report also specifies that there are 1,066 clinical trials proceeding at the end of 2019.  New approvals and expected approvals are also discussed. 

Embryonic stem cell research: ALLEA calls for patent protection, increased funding

The European Federation of Academies of Sciences and Humanities, ALLEA, has made a clarion call for greater funding for patentability and research funding relating to embryonic stem cells.  According to its statement, reproduced in relevant part below:

"With its third statement on “Patentability and Research Funding relating to embryonic Stem Cells”, ALLEA follows up on two previous statements regarding this issue – released in May 2011 and September 2012 respectively – both closely linked to the case Brüstle v Greenpeace and the corresponding Judgment of the Court of European Union (CJEU) [noted on the IPKat here]. 

The statement, prepared by the ALLEA Permanent Working Group on Intellectual Property Rights under the chairmanship of Professor Joseph Straus, raises concerns against a possible acceptance of the above mentioned Judgment which would most seriously affect research of essential importance to citizens of the European Union. Therefore, the competent bodies of the European Union are urged “not to accept the proposed amendments and to continue the well balanced funding of the respective research at the Union level”. It is furthermore argued that basic research in this field would need more EU funding rather than less.

In its previous statements, ALLEA had explicitly underlined that a lack of patent protection in the area of embryonic stem cell research could negatively affect the investment in developing therapeutics based on human pluripotent embryonic stem cells. It was also stated that serious concerns of the European scientific community regarding the effects for research in this important area of medicine would need to be taken into account. ..."

ALLEA's previous statements, background documents and further information on this topic can be downloaded here. The full text of this statement can be downloaded here.

ALLEA's credentials are impeccable and its arguments well-founded, but that is no guarantee that its voice will be heeded by a Europe in which decision-makers are frequently caught in the cross-fire of conflicting lobbying, strident campaigning and potent sound-bites.