[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45913-45914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Clinical Development and Commercialization of CD22-Targeting 
Chimeric Antigen Receptor (CAR) T-Cell Therapies for Children and Young 
Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia 
(ALL)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
seeking statements of capability and interest from prospective 
licensees and potential Collaborators interested in participating in 
collaborative research under a Cooperative Research and Development 
Agreement (CRADA) to develop autologous CD22 CAR T-cells (m971BBZ 
lentivirus transduced) for the treatment of B-cell ALL.

DATES: Statements of capability and interest should be submitted via 
email by September 1, 2020, with a formal proposal due by October 15, 
2020.

ADDRESSES: Statements of capability and interest should be directed to: 
Jim Knabb, Ph.D., Senior Technology Transfer Manager, NCI, at 240-276-
7856 or Email: [email protected].

SUPPLEMENTARY INFORMATION:

Collaboration Opportunity

    NCI is seeking a pharmaceutical or biotechnology company that can 
effectively and efficiently collaborate on the scientific and 
commercial development of CD22-CAR. The goal of the collaboration will 
be the successful transfer of clinical development of CD22-CAR from NCI 
to the Collaborator, which will be responsible for the rapid scale-up 
and clinical manufacture of the agent to support the pivotal clinical 
trial and subsequent BLA. The selected Collaborator will be responsible 
for the manufacture and provision of CD22-CAR lentivirus (m971BBZ 
lentivirus) and autologous CD22-CAR T-cell therapy product in 
sufficient quantities to complete the pivotal clinical trial. The 
selected Collaborator will prepare and submit a BLA to the FDA for 
CD22-CAR following the completion of the pivotal trial.
    Subject to federal statutes and NIH guidelines including those 
governing the establishment of CRADAs (15 U.S.C. 3710a) and the 
licensing of federally owned inventions (35 U.S.C. 207), it is 
anticipated that the Collaborator will pursue an exclusive or 
nonexclusive commercialization license to the CD22-CAR. Additionally, 
NCI is able to offer a CRADA Collaborator the right to use any and all 
data developed during the course of the collaboration for commercial 
development of the agent, as well as access to existing CD22-CAR 
clinical study data and regulatory documents for commercial development 
of the agent.
    Interested parties may sign a confidential disclosure agreement to 
obtain additional clinical data for its evaluation of the 
collaboration.
    Roles of Collaboration Partners:
    The roles of the National Cancer Institute in the CRADA may include 
but are not limited to the following:
    1. NCI will provide intellectual, scientific, and technical 
expertise and experience related to the ongoing development of CD22-
CAR.
    2. NCI will continue to support clinical manufacture and 
development of CD22-CAR pending transition of manufacturing to an 
appropriate site by the commercial partner and will make data available 
to the Collaborator as appropriate.
    3. NCI will collaborate in the design of protocols and the 
evaluation of results.
    4. NCI will provide all clinical data in its possession to 
Collaborator to support FDA regulatory filings.
    The roles of the CRADA Collaborator will include, but are not 
limited to the following:
    1. The Collaborator will provide clinical development strategy and 
financial and other support for the collaborative development leading 
to BLA filing and FDA approval of CD22-CAR.
    2. The Collaborator will provide intellectual, scientific, and 
technical expertise or experience to the development of CD22-CAR.
    3. The Collaborator will provide sufficient clinical supply of 
autologously-derived CD22 CAR T-cell therapy product for all clinical 
trials under the CRADA; this includes additional trials that may be 
needed for licensing as well as trials required to meet clinical need 
for pediatric patients prior to licensing.
    4. The Collaborator will prepare and submit regulatory documents to 
FDA, culminating in the submission of a BLA for CD22-CAR.
    5. The Collaborator will demonstrate its capability of providing a 
commercial supply of CD22-CAR in a timely manner.

Selection Criteria

    Interested parties should notify the NCI of their interest in 
filing a formal proposal no later than September 1, 2020. Potential 
licensees/CRADA Collaborators will have until October 15, 2020 to 
submit a formal proposal. Additional proposals will be considered after 
the posted deadline in the event that a Collaborator, meeting the 
necessary criteria, is not found during the initial posted time period. 
Selection criteria for choosing the CRADA Collaborator shall include, 
but not be limited to:
    1. Possession of or access to the resources needed to support and 
perform the activities required to expeditiously commercially develop 
CD22-CAR (e.g., facilities, personnel and expertise), including 
preparation and submission of regulatory documents;
    2. Demonstrated ability to access the expertise required for 
successful

[[Page 45914]]

commercial development of biologically active anti-cancer agents, with 
an emphasis on adoptive cell therapies;
    3. Demonstration of the necessary resources to produce and supply 
autologously-derived CD22-CAR in a timely manner for clinical trials at 
the NCI and additional clinical sites;
    4. Demonstration of access to financial resources required to 
support the CRADA collaboration and to successfully support the 
development of CD22-CAR for commercial sale;
    5. Willingness to cooperate with the NCI in the timely publication 
of research results;
    6. Willingness to accept the legal provisions and language of the 
CRADA and commercial license with only minor modifications, if any;
    7. Willingness to pursue a commercial license to the CD22-CAR in 
accordance with federal statutes; and
    8. The agreement to be bound by the appropriate HHS regulations 
relating to human subjects.

Proposal Content

    Please submit a proposal outlining your qualifications as a 
licensee/CRADA Collaborator for the advertised opportunity. Include any 
relevant information, however, please address the following in your 
proposal submission:
    1. Describe the type and level of resources you have available to 
commit to a CRADA collaboration with the NCI, including, but not 
limited to the following:
    a. What is your current capacity for production of CD22-CAR 
lentiviral vector and autologous T-cell product?
    b. Are you able to fund several potential clinical trials?
    c. Would you be willing to provide funding to the NCI to support 
the collaboration?
    Please describe the company's related experience in the development 
of therapeutics, specifically:
    a. Describe any experience or expertise with the development of 
adoptive cell therapy-based therapeutics, preferably autologous T-cell 
therapeutics.
    b. Describe related experience with FDA approval and 
commercialization of adoptive cell therapy-based therapeutics, 
preferably autologous T-cell therapeutics.
    c. Describe any experience determining administration of 
autologously-derived T-cell therapeutics.
    d. Describe any other collaborations with Federal or academic 
laboratories.
    Please provide relevant company information, including:
    a. Related Product Portfolio.
    b. Current Related Product Pipeline.
    c. Annual Revenues/financial resources.
    d. Size of company/affiliated companies.

    Dated: July 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-16487 Filed 7-29-20; 8:45 am]
BILLING CODE 4140-01-P