Research Program Renewal

BioCanRx v2.0: Setting the Stage for Network Renewal

 

CALL FOR EXPRESSIONS OF INTEREST

 

Bench to Bedside Transition of Innovative Cancer Biotherapeutics
Opportunity Description and Submission Guidelines

 

INVITATION

 

The Biotherapeutics for Cancer Treatment Network (BioCanRx) is a not-for-profit organization with a mission to improve outcomes for cancer patients by accelerating the development of cost-effective and curative biotherapies. In 2015, BioCanRx was awarded a 5-year funding award of $25 million from the federal government’s Networks of Centres of Excellence (NCE) Program, with additional contributions coming from partners in all sectors of the economy. Since the launch of the BioCanRx Network, a total of 44 projects and 5 core facilities have been funded. This portfolio of projects can be found here, containing staged investments in therapeutic development projects, and enabling studies and methodologies for their optimization and delivery. BioCanRx aims to accelerate the translation to clinic of emerging biological immunotherapies for the treatment of cancer: to date this portfolio includes investments in Oncolytic Viruses & Vaccines, Cell Therapy platforms (including Tumour-Infiltrating Lymphocytes, Engineered immune cells with CARs and TCRs), and Antibodies and Antibody-like molecules (including therapeutic antibodies, BiTEs).

 

Our initial NCE award for BioCanRx ends March 31, 2020, and at this time we are developing our research program strategic plan to bring forward our Cycle II application to the NCE in June 2019. This Expression of Interest (EOI) is your opportunity to assemble a team and propose research for consideration, and also to shape the overall renewed research program framework in alignment with our strategic priorities (see CYCLE II AREAS OF PRIORITY FOCUS) identified in consultation with our various stakeholder communities.

 

ELIGIBILITY

 

This call for EOIs is open to all investigators located at Canadian institutions eligible to receive peer-reviewed funding from any of the three federal research-granting councils (CIHR, SSHRC, NSERC). If you have questions regarding your eligibility, or that of your institution, please contact Kelley Parato.

 

THIS EOI WILL BE USED BY BIOCANRX TO:

 

  1. Inform the BioCanRx renewal application research program: BioCanRx has engaged in consultation with a variety of stakeholders and have identified key priority areas of research upon which to focus our current and future portfolio of biological immunotherapies, to optimize their translation to clinic and to achieve maximum benefit for Canadian patients and for the Canadian biologics ecosystem. The intake of proposals through this EOI process will inform BioCanRx about the scope and diversity of innovative approaches and technologies on offer in the academic landscape to address these priority areas. This will aid in our preparation of our renewal application to our funder in 2019.
  2. Cultivate projects to feature in the renewal application, and for funding upon renewal of BioCanRx: All teams submitting an EOI in response to this call will receive feedback from BioCanRx Management and the Research Program Executive Team regarding the project’s alignment to the developing research program strategy for Cycle II. This feedback will be vital to applicants when submitting a formal Letter of Intent application when BioCanRx opens its next funding call aimed to: a) select projects to showcase in the BioCanRx renewal application to the NCE, and b) be considered for invitation to Full Application to receive funding upon renewal of our Network grant. The BioCanRx Research Management Committee will review all BioCanRx Letters of Intent and Full Applications.

 

TIMELINES FOR RESEARCH PROGRAM DEVELOPMENT AND PROJECT SELECTION

 

  • July 31, 2018: Expressions of Interest will be received at BioCanRx and reviewed by BioCanRx Management and the Research Program Executive team.
  • September-October, 2018: The BioCanRx Renewal research program framework will be refined based on technologies, therapies, and solutions presented via the EOI process, and presented to the BioCanRx RMC for feedback, which will be incorporated and will inform the development of a call for funding proposals.
  • October 2018: EOI applicants will receive feedback from BioCanRx.
  • October 2018: The updated Research Program Framework and Funding Call will be presented to the BioCanRx RMC and Board of Directors for approval.
  • October 27, 2018: The updated Research Program Framework and call for proposal process will be presented to the BioCanRx Network during the Network Consultation workshop at the outset of the Summit for Cancer Immunotherapy in Banff, AB.
  • November 1, 2018 (est.): The Call for Proposals will be launched following the conclusion of the Summit conference.
  • Late January 2019: Letters of Intent will be due at BioCanRx.
  • February 2019: Review of LOI by the RMC. Projects will be selected for inclusion in the BioCanRx renewal application, and invited for Full Application.
  • Summer 2019: Full applications will be due at BioCanRx.

 

CYCLE II AREAS OF PRIORITY FOCUS

 

Moving forward into cycle II, BioCanRx encourages submission of project concepts to propose new research that enables further development of our current portfolio of assets, builds upon the momentum in our program, or brings forward for development new complimentary tools and technologies or platforms, aimed at addressing areas of priority focus (below) for our pipeline of technologies.

 

Projects in Cycle II will build upon BioCanRx investments between 2015-2020, furthering the development of the most promising biological immunotherapy products and platforms, and solutions for their delivery and adoption in Canada, considering critical challenges in the IO development landscape in Canada, and globally.

 

As a result of extensive consultation undertaken by BioCanRx with the Board of Directors, Research Management Committee, the Cancer Stakeholder Alliance, and representatives from our community of Network Researchers, the overarching goal of the Cycle II research program will focus on extending immunotherapy successes in the clinic beyond initial responders. To address this challenge while making use of technologies in the BioCanRx pipeline or by soliciting new complimentary technology, BioCanRx will invest in projects aimed to:

 

  1. Understand why some therapies only work in some patients and in some tumour types, and then improve therapies/trials/combinations approaches to overcome the identified limitations; and/or,
  2. Develop new biotherapeutics which have not yet been tested in the clinic, but which are developed as solutions to tumour resistance.

 

With this focus in mind, examples of anticipated research activities may include but are not limited to:

 

  1. Optimized solid tumour targets for cell therapy targeting;
  2. Turning “cold” tumours “hot”;
    1. Identifying or validating mechanisms of resistance of tumours to immunotherapy in the clinical setting (cellular, immunological, genomic, biomarkers, pathway obstacles, microenvironment)
    2. Biologically relevant cancer targeting (pathways, tumour microenvironment elements, immune cell subsets).
    3. Developing or refining combination approaches;
  3. Enhancing the inherent immune potentiating mechanism of action of Oncolytic viruses;

 

Research should be multidisciplinary and consider implementation in the Canadian context, whether addressing technological hurdles, commercialization hurdles, or policy/reimbursement/health system hurdles; examples of implementation solutions for our BioCanRx portfolio of existing or new therapeutic approaches may include:

 

  1. Point of care manufacturing capacity for cell therapy manufacturing;
  2. Early health technology assessments (HTA) to support development of combination therapy approaches with an eye to later stage reimbursement and adoption;
  3. Policy and HTA work to enable approvals for rare indications, and to enable pricing for therapies which work very well but for very small number of patients;
  4. Strategies for data sharing, using real world evidence;
  5. Optimized clinical trial designs for combination therapies;
  6. Tools and strategies to enhance efficiency of phase I and II clinical trials (eg. recruitment)
  7. Manufacturing innovation/efficiency.

 

OUR ANTICIPATED FUNDING PROGRAMS

 

BioCanRx intends to deliver its Cycle II research program through funding via our existing suite of programs (described below), plus a number of core facilities that are accessible to all members of the BioCanRx network. Three of the research programs are directed at therapeutic development and reflect the translational focus of BioCanRx, which organizes its investments into a pipeline-like structure common to the biotechnology industry (Catalyst, Enabling Studies, Clinical Trials). The fourth research program, Implementation Solutions, funds research into the clinical, social and economic impact of BioCanRx biotherapeutic platforms and technologies, with the ultimate goal of facilitating uptake of BioCanRx technologies by next stage receptors and beyond, to prepare for adoption and health care system implementation. While BioCanRx will not likely fund products through phase III clinical trials to market approval, we are acutely interested in development of policy research and HTA tools and methodologies to apply to our portfolio at earlier stages of development, in anticipation of later stage hurdles to adoption, reimbursement, and delivery in the Canadian health care landscape. All research programs are targeted at applicants who have already made substantial advances in their basic research programs and are now ready to work in collaborative, multidisciplinary, academic–industry teams to move their discoveries into the clinic in a rational, scientifically well-supported and highly disciplined fashion.

 

The Catalyst Program
This program will provide financial support for short-term, collaborative projects that have clear deliverables and will either result in an application to one of the other two BioCanRx programs, or will generate tools or methodologies that may be used by numerous BioCanRx members. Examples of projects that might be funded through this program include: preclinical validation of a new combination of biotherapeutics; or, the development of an innovative manufacturing technology. Catalyst projects are typically funded at $200,000 per project over a 1-2 year timeframe.

 

The Enabling Studies Program
This program will provide financial support and resources for GMP manufacturing and process development, GLP assay development and studies required to position biotherapeutic products or platforms for their translation to clinical testing. The anticipated deliverable from these projects will be a Clinical Trial Application (CTA) in Canada. Enabling studies are the most wide-ranging in terms of funded project budgets: in cycle I ESPs were funded from $43,000 to $1.2M over the life of the grant. For the purpose of this EOI, consider proposing a budget in the range of $500,000 over the life of the project.

 

The Clinical Trial Program
This program will provide financial support for the clinical evaluation in Canada of novel biotherapeutic products and platforms that have been substantially developed in Canada. The program is focused on clinical trials using biotherapeutics, including but not limited to: oncolytic viruses, immune cell therapies, and therapeutic antibodies, either as mono-therapies or in combination. The required deliverables include clinical data required to evaluate the case for advancing the therapeutic into later-stage clinical development. Historically Clinical Trial projects have been funded in the range of $400,000-$850,000.

 

Implementation Solutions: The Clinical, Social and Economic Impact Program
This program is intended to provide financial support for the implementation or application of research methodologies, tools or assets to identify gaps and advance solutions in the uptake of BioCanRx cancer biotherapeutics and companion technologies by receptors, including cancer patients, health-care delivery systems, commercial partners and health-care markets. The anticipated deliverables include data and key findings that: are related to specific projects, platforms or technologies in the BioCanRx research portfolio; assess economic, social, and/or commercial impact; and either informs decisions to advance BioCanRx-funded therapeutics into later-stage clinical development, or adds value to our technologies for their receptors. Projects in this area of research have been funded in the $100,000 to $500,000 range, over a 1 to 3 year period.

 

BioCanRx Core Facilities: Translational Acceleration for Innovative Technologies
Currently BioCanRx provides access to Core Facilities in GMP vector manufacturing and GLP immune monitoring for clinical trials executed by our network researchers. Our current suite of Core Facility offerings can be explored here. In addition to the standing Cores, BioCanRx has supported bringing cell therapy GMP manufacturing capacity to our network at the Deeley Research Centre in Victoria, BC, and this facility is expected to be online for new projects heading into Cycle II. Together with lentivirus manufacturing at the Biotherapeutics Manufacturing Centre (BMC) in Ottawa, this Cell Therapy facility is expected to be fully operational in delivering engineered T cell therapies such as CAR T cells, for testing in clinical trials at Canadian centres by the end of 2018. Furthermore, BioCanRx has funded a pilot project through our CSEI program in Cycle I to integrate systematic reviews, multi-stakeholder input including patient collaboration, and early Health Technology Assessment to optimize clinical trial design and execution of a made-in-Canada CAR T product. BioCanRx is exploring offering this clinical trial development platform as a Core Facility offering in Cycle II, for consideration when developing EOI submissions in response to the current call.

 

Our Research Investment Program

 

EOI PROJECT SCOPE AND REQUIREMENTS

 

This intake of project concepts is intended to inform BioCanRx Management, our Board of Directors, and our Research Management Committee of the range of projects and technologies within the Canadian landscape which are poised to address BioCanRx priorities and initiatives in the 2020-2025 funding cycle. While BioCanRx has engaged in an in depth consultation process to inform our cycle II strategic initiatives, this EOI call is vital to allow us to gather feedback from our existing and potential new network members on the focus and intended outcome of our next-stage strategic plan, and to validate this approach for our renewal application, such that we are positioned to capture the best technologies and solutions to cancer immune oncology therapeutic development and implementation in the Canadian context.

 

In considering the development of a team and a project concept to submit to this EOI opportunity, note that BioCanRx places high emphasis on project teams are multi-disciplinary and collaborative. At this time, as BioCanRx aims to maximize the utility and success of our Cycle I investments in our current portfolio of projects, applicants should aim to develop submissions which will further aid the transition of these technologies towards clinical testing and evaluation, capitalize on the opportunity to glean translational biology from projects in or near the clinical setting, or complement the use of these therapies in clinic.

 

Submissions must outline preclinical scientific rationale for the positioning of the product/platform for clinical testing and highlight the anticipated impact of the innovation within the field. Proposals must clearly situate the proposed product/platform within the translational continuum and provide a realistic plan for transition into clinical testing over a 1 to 3 year timeframe. Proposals should maximize the use of BioCanRx GMP manufacturing or GLP assay core facilities where appropriate.

 

Proposal teams can also consider coordination of complementary applications from different BioCanRx funding programs, where applicable. An example could include development of a clinical trial protocol for a novel therapeutic platform via the Enabling Studies program, in tandem with an application to the Implementation Solutions program to inform on HTA analyses to embed in the trial design in development.

 

Budget and partnerships
It is critically important to remember that fostering inter-sectoral and multi-institutional partnerships is at the heart of the NCE Program. Applications that are based on work of a single investigator with little external involvement will be administratively triaged. Applicants should note that, when evaluating proposals, BioCanRx will focus more on the quality of partner engagement than the number of partners involved. A letter of support will be far more favourably received if it demonstrates a partner that clearly understands the scope of the project, can describe their specific role within it, and articulates the value they are contributing to the project and receiving from project involvement/participation, as opposed to a letter describing a large discount on a major piece of equipment. Please refer to the BioCanRx Policy on Industry-Partnered Research in preparation of your research project concept.

 

Applicants should also be aware that BioCanRx is not overly concerned about their ability to demonstrate that partner dollars being pledged to the project are uniquely attributable to the BioCanRx investment; so, partnership already secured for other grants may be eligible. What is important to BioCanRx is that its funding be used to align all of these investments toward a common goal — that the BioCanRx funding brings together project funding for a greater impact than otherwise possible. If applicants are repurposing earlier investments to their BioCanRx project, they require updated letters of support from their partners that speak specifically to this BioCanRx project and confirm that the partners are comfortable with their investments being directed in this manner.

 

Please note that if applicants plan to use BioCanRx Core Facilities in the conduct of their proposed research, the facility leader(s) should be listed as an applicant team member and should receive funding in the proposed budget to conduct the planned work. The Core Facility budget should be developed in collaboration with the Core Facility leader or delegate.

 

Knowledge sharing
In keeping with the collaborative nature of the BioCanRx network and the investment of the NCE Program in creating and fostering networks, it is expected that project leaders will share data and/or research deliverables arising from their projects with other network investigators in a timely fashion, whenever possible.

 

Evaluation criteria
BioCanRx Management and the Research Program Executive Team will evaluate EOI submissions to validate the current proposed research program renewal strategy, and will also provide feedback to applicant teams to aid in preparation of a subsequent LOI submission to be considered for inclusion in the BioCanRx NCE renewal application, and subsequent funding in Cycle II, if successful. Evaluation criteria for EOI submissions will include:

 

  • Relevance to the BioCanRx mandate (i.e., transition of novel innovations in cancer biotherapeutics);
  • Scientific excellence, creativity and innovation, in an international context;
  • Applicability or benefit to the advancement of current technologies within the BioCanRx research portfolio, given the priority areas advanced by BioCanRx;
  • Multidisciplinary and collaborative aspect of the proposed team and research;
  • Potential for benefit to Canada in terms of clinical, social, and/or economic benefit;
  • Potential for benefit to other researchers in the BioCanRx network (knowledge sharing, training).

 

SUBMISSION PROCESS

 

To be eligible to apply, the applicant must be employed by a Canadian research institution and be eligible to receive research funds from CIHR, SSHRC or NSERC.

 

The application package must be delivered by email to applications@biocanrx.com and must be received by 11:59 am ET, Tuesday July 31, 2018.

 

Please direct questions about the program and application process to Kelley Parato, BioCanRx Director, Scientific Affairs (keparato@biocanrx.com; 613-739-6595) or Stéphanie Michaud, BioCanRx President and Chief Executive Officer) (smichaud@biocanrx.com; 613-739-6202).

 

CONFIDENTIALITY

 

All proposals submitted to BioCanRx will be kept confidential; all reviewers of submitted material will have signed a Confidentiality Agreement with BioCanRx.

 

A complete application includes:

 

Document 1: Application form: A single PDF file that includes the completed application form, in single spaced type, Times New Roman or Arial (minimum 11 pt font), with 1 inch margins. Please enter the project leader’s name in the header. The file name should include the project leader’s name (e.g., Bell_EOI.pdf).