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Collaborating to clobber COVID-19

NIH and FNIH are leading a public-private parternship to defeat COVID-19

An overlapping set of collaborations is focusing the combined intellectual, logistic and economic resources of the life sciences industry, government, academia and non-profits against SARS-Cov2, the virus that causes COVID-19.

The latest and broadest collaboration was disclosed Friday when NIH and the Foundation for the NIH (FNIH) announced Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership to coordinate and accelerate the development of medical countermeasures.

ACTIV membership includes 16 biopharma companies, FDA, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA, the U.S. biodefense preparedness funding agency, which is backing at least eight COVID-19 programs, is part of ASPR.

Though EMA is involved in ACTIV, the partnership is focusing its activities on the U.S.

ACTIV has overlapping membership and is closely coordinating with two other consortia, one organized by the Gates Foundation and Novartis AG (NYSE:NVS; SIX:NOVN), and the other COVID R&D, a separate group of pharma R&D leaders that was first disclosed by BioCentury (see “Overlapping Collaborations”).

Figure: Overlapping collaborations

Biopharma companies have banded together to address the challenge of COVID-19, forming collaborations with each other and with government agencies and non-profits. There is a high degree of overlap in industry membership in three of the largest consortia: COVID R&D, which consists of the R&D leaders of 15 companies, two VCs and one unaffiliated individual, Keith Gottesdiener, former CEO of Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM); Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), organized by NIH and FNIH; and the COVID-19 Therapeutics Accelerator, launched by the Bill & Melinda Gates Foundation, the Wellcome Trust and Novartis AG (NYSE:NVS; SIX:NOVN).

National governments have launched smaller-scale collaborations. For example, the U.K. Vaccine Taskforce includes academic researchers, government officials, AstraZeneca plc (LSE:AZN; NYSE:AZN) and the Wellcome Trust.

In addition, the European Commission announced March 6 that it had selected 17 COVID-19 programs for funding via Horizon 2020, and the Innovative Medicines Initiative, which is jointly funded by the EC and the European pharmaceutical industry, is reviewing 144 proposals to develop medical countermeasures.

The Coalition for Epidemic Preparedness Innovations (CEPI) is funding at least eight COVID-19 vaccine development and manufacturing initiatives.

Sources: NIH; BioCentury; Gates Foundation

BioCentury has coordinated with the pharma R&D consortium to collate publicly available information on molecules under investigation for COVID-19 and is accepting nominations of assets to include in its databases of candidate COVID-19 therapies and vaccines. BioCentury is not a member of the consortium (see “COVID R&D: Pharmas Align Behind Crowdsourcing Solution” and “BioCentury Launches Gateway for Submission of Compounds to the COVID-19 Resource Center”).

ACTIV has established four working groups that are tasked with: standardizing and sharing preclinical evaluation methods; prioritizing and accelerating clinical evaluation of therapeutics with near-term potential; maximizing clinical trial capacity and effectiveness; and advancing vaccine development.

“There’s been a collection of a kind of deep registry by BioCentury.”

Francis Collins, NIH

The partnership is not addressing pricing or IP issues, NIH Director Francis Collins told reporters Friday.

Knocking down barriers to collaboration

NIH and industry leaders started discussing the formation of a partnership a month ago, Collins said. The conversations were centered on “how in a circumstance of this sort some of the traditional boundaries between components of the biomedical research ecosystem might be knocked down, or at least become more porous, so that we would have the full power of this enterprise devoted to finding solutions.”

Attention quickly focused on the Accelerating Medicines Partnership (AMP) as a model, a public-private partnership between NIH, FDA, multiple biopharmaceutical and life science companies and non-profits that is focused on identifying and validating new disease targets and biomarkers, Collins said.

Like AMP, ACTIV is being managed by FNIH.

While it took years to create AMP, ACTIV held its first meeting on April 3, two weeks after the idea was first proposed. “There was unanimous agreement that the time has come to put aside any of the obstacles that might normally get in the way of such a public-private partnership and bring all the full resources and ideas together in a variety of ways that neither sector could do alone,” Collins said.

Collins noted that ACTIV is collaborating closely with other consortia. “There are a number of other gatherings and groupings because it is such an incredibly important public health challenge. We are glad for all of those and want them to flourish. If there are ways that we could work with those and avoid duplication, we're going to do everything we can to achieve that.”

R&D leaders of 11 of ACTIV’s industry members are participating in the pharma R&D consortium. “There was a group of companies -- and I think actually BioCentury actually broke that story a couple of weeks ago - [that] for the most part have all joined ACTIV, but are still continuing some other interactions with each other, which we think is great,” Collins said.

Prioritizing compounds

ACTIV has formed a steering committee to set criteria and rank potential candidates for first-wave and subsequent testing. The criteria include the capacity to manufacture a compound at scale if safety and efficacy in treating or preventing COVID-19 is demonstrated, Collins said.

The committee is reviewing compounds from several sources, including the databases BioCentury has created and curated in collaboration with the pharma R&D consortium, Collins told reporters.

“There's been a collection of a kind of deep registry by BioCentury as part of the effort that was started by Andy Plump and Rupert Vessey,” Collins said. Plump is president of R&D at Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) and Vessey is president of research and early development at Bristol Myers Squibb Co. (NYSE:BMY). Collins also noted a tracker created by FasterCures, part of the Milken Institute.

“A master protocol structure where you are testing multiple different therapies simultaneously is probably the only way to do this efficiently.”

David Wholley, FNIH

“We're just trying to take all of those inventories, merge them together and make sure we have a pretty good idea of all the ideas that are out there,” Collins said.

“Of the more than 100 candidates that are out there, there are frankly quite a lot of those that are not going to be very well supported, and there may be some sort of diamonds in the rough that haven't been appreciated for what their potential might be,” Collins said.

Prioritizing a relatively small number of compounds for appropriately powered trials is “more appropriate than having a very large number of scattered trials, some of which may be focused on compounds that actually aren't that compelling in terms of the reason to test them and study designs may not be of size to give you a clear answer,” Collins said.

ACTIV is placing therapeutic candidates into three buckets, Collins said.

One bucket is “small molecules that perhaps have a well-established mechanism of action where you have a confidence that this is actually going to interfere with the viral lifecycle or somehow protect the host cell.”

Another bucket will be filled with immune therapies, including mAbs.

A third bucket consists of immune suppressants, “the kind of therapies that are necessary for people with advanced lung disease, where it may well be that the immune system has over reacted, creating a cytokine storm.”

A network of clinical trial networks

ACTIV is forming an ad hoc network of existing clinical trial networks to test candidate COVID-19 therapies and vaccines, and is developing master protocols for the trials.

The network will include clinical trial systems NIH has created for a number of purposes, including academic centers in the Clinical and Translational Science Awards Program and networks created for specific diseases. It will also include trial networks created by drug companies that are part of ACTIV.

Pharmas have expressed a willingness to make resources, including trial networks, available to commercial competitors, Collins reported. He said pharmaceutical companies have offered to allow competitors to use their clinical trial networks to test prioritized COVID-19 therapeutic candidates.

ACTIV will not attempt to prevent companies or academics from testing approaches that the partnership has not blessed, but it could be very difficult for them to do so in the U.S.

“There's nothing to say that somebody who thinks their therapeutic is still the best possible approach to this to see if they can find a way to test it,” Collins said. “On the other hand, we will have control of an awful lot of the publicly funded clinical trial networks.”

ACTIV is looking at seven or eight existing master protocols as templates for testing COVID-19 therapies, David Wholley, SVP of research partnerships at FNIH told reporters. “Everyone agrees that a master protocol structure where you are testing multiple different therapies simultaneously is probably the only way to do this efficiently.”

Wholley said that master protocols will test multiple compounds against a common standard of care or placebo arm, and will likely be oriented to different stages of COVID-19.

Any trials resulting from ACTIV’s initiatives will be large enough to provide definitive results and to pass muster with FDA, Collins said.

Smoothing the path for vaccines

ACTIV’s vaccine working group is facilitating the development and sharing of insights into natural- and vaccine-induced immune responses by mapping epitopes, developing assays, and establishing protocols for sampling, immunological analysis and reagent use. It is also “collecting clinical data on immunological responses and endpoints, to enable meta-analysis of correlates of protection,” according to a statement released by NIH.

With regulators, NIH is collaborating on surrogate endpoints for clinical evaluation.

“We are aiming to try to look at every step in that process and particularly looking at the way in which FDA oversees the usual Phase I, II and III process to see if there might be ways to speed that up,” Collins told reporters.

While it has not yet finalized an approach, Collins said that “FDA is a significant part of that working group and have been very open to creative ideas about ways that might be a bit more forward looking and rapid moving than the traditional” processes.

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