Moving an HIV Vaccine from Lab to Clinic: The Importance of Industry Engagement

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1 Canadian HIV Vaccine Initiative (CHVI) Research and Development Alliance Coordinating Office (ACO) Annual Meeting 2013: Moving an HIV Vaccine from Lab to Clinic: The Importance of Industry Engagement Executive Summary Prepared for: Canadian HIV Vaccine Initiative (CHVI) Research and Development Alliance Coordinating Office (ACO) Prepared by: James Paterson Scientific Insights Consulting Group Inc. May

2 Executive Summary The Canadian HIV Vaccine Initiative (CHVI) exists to advance the HIV vaccine development program in Canada. The CHVI Alliance allows Canada to take a role on the international stage of vaccine development and represents a network of stakeholders with the goal of developing innovative solutions to the challenges facing HIV vaccine development. The founding partners (Bill & Melinda Gates Foundation [BMGF] and the Government of Canada [GoC]) established a Memorandum of Understanding (MOU) which lead to the creation of the Alliance, including a coordinating office (ACO) to build the Alliance, advising on research gaps and potential innovations to respond to the gaps, and promote synergy among Alliance members. In April 2013, the CHVI Research and Development Alliance Coordinating Office (ACO) hosted a one-day satellite symposium to the Canadian Association of HIV Researchers (CAHR) conference as its annual meeting, titled Moving an HIV Vaccine from Lab to Clinic: The Importance of Industry Engagement. The objectives of the meeting, in support of the overall objectives of the ACO were: To highlight the important role of industry and its' needs in the discovery and development process leading to an HIV vaccine; To share information and knowledge on vaccine development; and To collaborate in addressing challenges and solutions in vaccine development. The meeting was broadly structured into three main themes: Understanding Needs; Sharing Information and Knowledge; and Building Collaborations. Each theme area included presentations, panels, and discussions outlining the challenges, the resources, and future considerations for that particular theme. 1.1 Understanding Needs To help understand the needs of small- and medium-sized enterprises (SMEs), a panel of representatives from five Canadian HIV Technology Development Industrial Research Assistance Program (CHTD- IRAP) funded companies were assembled, each presenting their current research into HIV vaccines and related technology, and summarizing the challenges they face moving into the future. The companies included ico Therapeutics Inc., Alethia Biotherapeutics, Sumagen Canada, Akshaya Bio Inc., and Plantform Corporation, located across the country. CHTD-IRAP is a program that was put in place to support the growth of SMEs through innovation and technology to assist in commercializing their products. The CHTD program, a partnership between Industry Canada (IC) and the National Research Council (NRC), encourages the development of HIV vaccines and related technology through the IRAP program. To date, 14 projects have been funded, with several projects in the pipeline. All the presentations highlighted products that are either in preclinical or early clinical development and identified challenges with moving the programs forward. Some of these included: Preclinical expertise There were specific gaps in the preclinical development process; while there had been some success overcoming these gaps, there were still barriers to advancement. Certain animal models were problematic, as well, in some cases, as meeting the specific requirements for proof of concept (POC) in laboratory studies. Companies that are more involved in the development of technology, such as diagnostic tests or vaccine supportive platforms (rather than developing HIV vaccines directly), had greater difficulty in identifying sources of expertise to help prove the technology. April 11, 2013 Executive Summary Page 1

3 Funding or partnerships Although the CHTD-IRAP program was helpful for preclinical development, the companies identified that further funding beyond these programs was required. In many cases, collaborations were being sought with larger commercial entities, with variable success. Manufacturing issues There were a number of projects having difficulty identifying suitable manufacturing facilities to support continued clinical development of their products, particularly biosafety level three (BSL3) good manufacturing practice (GMP) facilities in Canada with the capacity required. Clinical development support and collaboration The companies often did not have a clear mechanism to engage with the support required to move their products through clinical development. Specific issues included collaboration for the design and implementation of clinical trials, the manufacture of sufficient trial material, the analysis of data, and the recruitment of subjects. It is notable that many of the gaps identified by these SMEs have been addressed through a number of other programs described at the meeting by organizations such as the Collaboration for AIDS Vaccine Discovery (CAVD) for their stakeholders (grantees), or the International AIDS Vaccine Initiative (IAVI); however, the SMEs did not have knowledge, access, or ability to utilize these resources. Beyond SMEs, there are other stakeholders with certain needs that are not being met. The HIV and AIDS community in Canada has generally not been consulted or included in much of the vaccine research being conducted. According to Monique Doolittle-Romas of the Canadian AIDS Society (CAS), the most effective way to ensure the successful development of any vaccine is to inform and include the broader community. This will encourage champions in the country, to help address any potential issues that may interfere with trials before they arise, and identify any issues that may come up once a vaccine is introduced into the community. Communications are currently poor and the research community must make efforts to include representatives from the HIV affected community. Scientifically, there is a need to reduce the investment risk for HIV vaccine development. This requires the identification of correlates of protection that can be used as surrogate markers early in the development process allowing for the selection of the most promising candidates. Without this selection mitigating risk, potential large partners may perceive that the risk involved in development is too great, and they may choose not to participate. 1.2 Sharing Information Sharing information and collaborations are essential for the effective and speedy development of vaccines. The second theme of the day, sharing information, reflected this need. Speakers presented a number of advances that may assist with the development of an HIV vaccine. The theme was presented in four parts: An overview of the challenges associated with vaccine development; The process of vaccine development; Regulatory issues to consider; and Future trends in vaccine development. Sharing information in the modern age presents a number of issues. There are overall concerns with the ownership of intellectual property (IP); however there is a pressing need to build on previous work to efficiently develop therapeutic or prophylactic vaccines. One mechanism to overcome the apparent tension between the two is to develop central service facilities (CSFs) that can provide the required resources and information without infringing on IP. The BMGF has implemented a pilot CSF with IAVI to provide advice on preclinical, product development and regulatory issues to CAVD grantees. This support is available as needed by researchers to advance their products to early phase clinical studies. This is mainly available to CAVD researchers (although support may be available to others by contacting the April 11, 2013 Executive Summary Page 2

4 BMGF, if researchers use their own funds for manufacturing, preclinical and clinical studies). Pan- Provincial Vaccine Enterprise (PREVENT) at Vaccine and Infectious Disease Organization International Vaccine Centre (VIDO-InterVac) offers support for the development of vaccine-related products from preclinical to early phase II clinical development, although HIV vaccines are not part of their present mandate. There are a number of facilities that can assist with the development of vaccine candidates. Currently, there are a number of trends in vaccine development. Broadly neutralizing antibodies have been identified and have reinvigorated the hope that an effective vaccine can be developed. Other technologies may allow for the use of neutralizing antibodies directly in subjects either by injection or through the use of vectors that would introduce the gene for the antibody into host cells, allowing continuing production of the antibody. The GeoVax Inc. vaccine candidate (both first and second generation) are now in trials. The extension of the RV144 trial is planned in Southern Africa to attempt to build on and improve the observed efficacy. New production methods, such as those being developed at MabNet may allow for bulk production of the most effective glycoforms of current antibodies, as well as developing technology to re-engineer antibodies with potentially greater tissue penetration. MabNet is a large consortium of university, industry and research institutes focused on the development of a production method for single glycoform therapeutic monoclonal antibodies. 1.3 Collaborations The importance of collaborations was highlighted during the ACO annual meeting. Collaborating partners bring expertise for projects when needed as well as provide funding or resources. In the absence of collaborations, the development of HIV vaccine candidates is slowed or stopped. Examples of partnerships are the CAVD network established by BMGF and the Pox-Protein Private Public Partnership (P5). Established in 2010, P5 is designed to build on the RV144 trials to ultimately determine if data support to license the pox-virus / protein based vaccine. The collaboration includes industry, BMGF and NIH, MHRP to manufacture products and conduct clinical trials in South Africa and Thailand. The product development focus is attractive to industry partners, an important source of development expertise. The second BMGF collaboration is CAVD, launched in 2006, to assist in the collaborative research necessary for the development of HIV vaccines. The CAVD is a framework for researchers to develop consortiums to advance vaccine candidates, and can also use central service facilities that provide analytical, statistical and product development services. There have been significant issues trying to involve pharmaceutical companies in collaborations. There is a perception of significant risk associated with the development of an HIV vaccine, and there is more interest in the relatively greater commercial success of non-vaccine prevention of HIV. However, nonvaccine methods, such as anti-retroviral (ARV) treatment to prevent infection, may ultimately fail either due to lack of adherence or drug resistance of HIV. New drugs that may evade the drug resistance, such as dolutegravir (DTG), could present significant opportunities as well as offer a new class of attenuated virus that can be used in the development of vaccines. However, large partnerships such as The Centre for Drug Research and Development (CDRD) may offer mechanisms for researchers to join collaborations and, through the associated CDRD Ventures Inc., begin the commercialization process in the absence of large pharmaceutical partners. The Canadian Institutes of Health Research (CIHR) offers a number of programs that may also prove attractive to pharmaceutical partners by mitigating some of the risk associated with product development through matching funds. IAVI offers several services as well, although, as noted, access may only be available by invitation or application of and funding of proposals through the CAVD. The Canadian HIV Trials Network (CTN) facilitates many similar services in Canada, though with more focus on running clinical trials for vaccines. 1.4 Recap The current development of HIV vaccines is entering an exciting phase. The identification of broadly neutralizing antibodies has renewed interest in the development of both therapeutic and prophylactic vaccines for HIV. A number of innovations and technologies are beginning to mature, and with this, the products and associated benefits are starting to appear. The next few years will see a number of trials of candidate HIV vaccines, but there are barriers that must be overcome. There is still a high risk associated with HIV vaccine development as there are no correlates of protection that can be assessed prior to full April 11, 2013 Executive Summary Page 3

5 clinical trial. While there are numerous established support networks, these may not be fully accessible to many smaller companies that are developing candidates. Larger pharmaceutical companies have largely drawn back from their own internal HIV vaccine development because of the risk and so the model of public-private partnerships is being used to advance candidate HIV vaccines into late-stage clinical trials. More work is necessary to foster the smaller companies that are developing innovative vaccine candidates and to support technologies that will contribute to successful clinical trials and availability of an HIV vaccine. April 11, 2013 Executive Summary Page 4

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