ARPA-H-SN-24-01 APECx.pdf

Special Notice (SN) ARPA-H-SN-24-01 Proposers’ Day Announcement for Advanced Research Projects Agency for Health

(ARPA-H)/Health Science Futures (HSF) Office Opportunity: Antigens Predicted for Broad Viral Efficacy through Computational

Experimentation (APECx)

I. KEY INFORMATION

General Information

• Purpose: Special Notice for Proposers’ Day for ARPA-H HSF Office and the Antigens Predicted for Broad Viral Efficacy through Computational Experimentation (APECx) Program

• Solicitation: Promote attendance of proposers at the APECx Proposers’ Day (see information below)

Table 1. Proposers Day Key Information

Proposers’ Day November 17, 2023, from 8:30 AM to 5:00 PM MT

Location Denver, CO

Website for registration https://arpa-h-apecx.powerappsportals.us/

Registration opens Tuesday, October 10th, 2023, at 12:00PM ET

Registration closes November 6, 2023, at 12:00 PM ET for in-person attendance or when capacity is reached, whichever comes first. Virtual attendance will remain open until the day of the event.

Technical Point of Contact

Dr. Andrew Kilianski, Program Manager, ARPA-H / HSF Office

Program email APECx@arpa-h.gov

Proposer deliverables, details below

1) One (1) physical poster (to fit within a space measuring 3.75 feet wide by 3.75 feet high - landscape layout preferred)

2) One (1) PDF page “teaming profile” (proposer’s capabilities, composition, research areas of interest, etc.)

II. INTRODUCTION

The Health Science Futures (HSF) Office of the Advanced Research Projects Agency for Health (ARPA-H) is sponsoring a Proposers’ Day (PD) for the planned proposer community in support of the Antigens Predicted for Broad Viral Efficacy through Computational Experimentation (APECx) program.

The PD will be held on November 17th, 2023, from 8:30 AM to 5:00 PM MT in Denver, Colorado.

Advanced registration is required.

The Proposers’ Day objectives are to:

• Draw attention of the scientific community to the APECx technical areas.

• Provide information about the program to potential proposers, including details about the overall program goals, abstract and full proposal structure for the forthcoming Broad https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h-apecx.powerappsportals.us%2F&data=05%7C01%7Cginni.arzadum%40arpa-h.gov%7C558fc265b45b469a77b008dbc5e779c9%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638321370215323934%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=89rkqUPMGbVwhunR8xjNcTY4FOnrOeEQ7YGy8scGVm8%3D&reserved=0 mailto:APECX@arpa-h.gov

Agency Announcement (BAA), and how they might respond to ARPA-H’s forthcoming solicitation.

• Share the intended scope, timeline, and scale of the APECx program and how the proposers, in collaboration with the ARPA-H team and resources, can accomplish the collective mission of accelerating equitable healthcare outcomes for all Americans.

• Initiate teaming arrangements among potential proposers to achieve program goals

The PD will include brief overview presentations by government personnel; posters for potential proposers highlighting technical capabilities and promoting teaming arrangements; and private sidebar meetings, each lasting no longer than 5 minutes, between the ARPA-H team and potential proposers. A limited number of sidebar meetings will be available to participants, and sidebar meetings must be scheduled via the registration website. ARPA-H will collect participant questions throughout the event and publish answers to a publicly available Frequently Asked Questions (FAQ) document.

Attendance at this event is not a requirement for submission of an abstract, full proposal, or selection for funding; however, it is anticipated that teaming arrangements will be needed to successfully innovate and integrate the critical technologies necessary to meet the APECx program goals. Information relayed during the PD will be made available on the APECx program page:

arpa-h.gov/engage/programs/apecx/

Attendance at this event is intended for the potential proposer community. It is not intended for patients, patient advocates, media or a general interest audience.

III. APECx– PROGRAM INFORMATION

This special notice is to announce and solicit attendees at the PD on November 17th, 2023, for ARPA-H's APECx program. The full details of the APECx program will be in the forthcoming APECx BAA, which will be published 14 days prior to PD. Below is only a brief description of the full program, and proposers should refer to the forthcoming APECx BAA for more details. In contrast, this SN is issued solely for information and potential new program planning purposes, and this SN does not constitute a formal solicitation for full proposals or proposal abstracts (See the full disclaimer below).

Overview Despite recent technological advances, current approaches to vaccine development are costly, time-consuming, and have not yielded broadly-efficacious vaccines for viral disease to date. Due to the technical complexities, most developers target a single virus species as the indication for a given vaccine, as the cost and time associated with evaluating the clinical efficacy of a vaccine leads to a risk-averse “one-virus, one-vaccine” development strategy. The Antigens Predicted for Broad Viral Efficacy through Computational Experimentation (APECx) program aims to create the toolkits that make broadly-efficacious and evolution-resistant vaccines for viral pathogens possible for all. More specifically, APECx seeks to develop an innovative viral antigen prediction pipeline for broad efficacy by combining expedited experimental protein structure, functional determination, and high-throughput antigen screening. This will be enhanced with structural and functional prediction and protein modeling algorithms. Product developers will contribute to modeling tool evaluation from the start of the program to ensure discoveries are linked with translational requirements. The combined effort of all the teams will create a toolkit that will enable the U.S. to achieve genus-level vaccine goals and prevent multiple viral diseases, including those responsible for cancer, acute disease, and chronic illness across the country.

Technical Approach

The APECx program will catalyze the discovery of Investigational New Drug-ready, broad-spectrum vaccine candidates against unknown and existing threats at the viral genus-level. The discovery process includes three technical areas (TA): high throughput biochemical analysis and protein engineering (TA1), novel modeling pipelines for antigen development (TA2), and translational candidate development and clinical evaluation (TA3).

• Technical Area 1 (TA1): High-throughput Biochemical Analysis and Protein Engineering. Accelerated throughput of viral antigen discovery with high accuracy, utilizing techniques including but not limited to high-throughput experimental structure determination, high-throughput functional analysis, and model system development for screening of leading antigen candidates.

• Technical Area 2 (TA2): Protein Modeling Toolkit Development for Antigen Design.

Leverage 3-dimensional structural and high-throughput functional data information from TA1 and existing viral protein structure data to confidently model challenging targets and predict and design consensus chimeric antigens suitable for genus-level vaccines against existing and emerging viral diseases.

• Technical Area 3 (TA3): Translational Candidate Development and Clinical Evaluation: Utilize the dataset generated by TA1 and TA2 to discover novel vaccines, optimize them for relevant delivery platforms that are efficacious at a viral genus-level and easily accessible to the public, and iteratively validate approaches generated by TA1 and TA2.

• Proposal details: Performers will have the option of submitting proposals that address all TAs (TA1 – 3) or TA2 alone. Teams that apply for TA2 independently will have an additional, unique set of milestones and deliverables to perform an integrative function across the TA1/2/3 teams. Antigen design iteration and validation will occur mostly within TA1 and TA2, although many of the design features of a translatable vaccine (immunogenicity, manufacturability, and platform delivery technologies) need to be consulted with TA3 from the onset and incorporated early. As teams advance product candidates through proof of concept studies, challenges, and clinical studies, TA1 and TA2 have opportunities to iterate and improve on the protein functional design, resolution, and modeling approaches that will be validated and guided by animal and human data for safety, immunogenicity, and efficacy.

To ensure the applicability of tools developed to the broader community and for the success of APECx candidates, performers must have demonstrated team capabilities in TA2 alone or across all TAs. Proposals that fail to address all the required technical areas will be deemed non-conforming and may be rejected without further review.

Program Structure

The APECx program will be accomplished over 2 sequential phases of increasing technical complexity. APECx Phase 1 for all TAs is 36 months. APECx Phase 2 for all TAs is 24 months.

Attendees of the PD should consider the timeline and program structure as well as the metrics information in the corresponding BAA within their poster sessions and teaming profiles.

IV. APECx – PROPOSERS’ DAY INFORMATION

Proposers’ Day Participation and Deliverables This SN and PD include two specific opportunities for prospective proposers to identify team members:

Posters Interested attendees and/or proposers are invited to request space for one poster (to fit within a space measuring 3.75 feet wide by 3.75 feet high - landscape layout preferred) that summarizes their interests and capabilities. A style guide and further directions pertaining to the poster will be provided upon your registration acceptance. At PD, proposers will be split in 3 categories (protein engineering, modeling, and translational candidate development) and have on the order of one hour to stand by the poster, present their work and answer questions to interested parties. Posters will be accepted on a first-come, first-served basis, until the maximum possible number of submissions given the space constraint for the PD is reached. Interested attendees must identify their intention to present a poster during registration. Poster presentations are restricted to those attending the meeting.

Teaming Profiles Interested parties are also invited to submit a ‘teaming profile’ via the Microsoft Forms link here and below. The teaming profile will describe the technical competencies, team capabilities, team composition, research areas of interest, unique facilities and other capabilities, as they relate to the program, and desired technical/other competencies sought from other potential team partners. The profile will include, at a minimum:

1. Contact information, to include name, organization, email, telephone number, mailing address, and website;

2. Brief description of the proposer’s technical competencies and relevant facilities;

3. Desired technical competencies and facilities from other potential team members, if applicable.

Specific content, communications, networking, and team formation are the sole responsibility of participants. ARPA-H does not endorse any participating organization or exercise any responsibility for improper dissemination of the team profiles.

Registration Information Participants must register in advance through the registration website. Due to in-person and webinar capacity limitations, in-person registration is limited to 150 participants. The registration cutoff date is November 6th, 2023, at 12:00 PM ET for in person attendance, or once attendance capacity is met, whichever comes first. Registration for viral attendance will remain open until the day of the event. There is no registration fee for the APECx Proposers Day. Note that there will be no same-day registration. An online registration form and various other meeting details can be found at the registration website, https://arpa-h-apecx.powerappsportals.us/ https://forms.office.com/g/vjidMBrUiG https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h-apecx.powerappsportals.us%2F&data=05%7C01%7Cginni.arzadum%40arpa-h.gov%7C558fc265b45b469a77b008dbc5e779c9%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638321370215323934%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=89rkqUPMGbVwhunR8xjNcTY4FOnrOeEQ7YGy8scGVm8%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h-apecx.powerappsportals.us%2F&data=05%7C01%7Cginni.arzadum%40arpa-h.gov%7C558fc265b45b469a77b008dbc5e779c9%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638321370215323934%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=89rkqUPMGbVwhunR8xjNcTY4FOnrOeEQ7YGy8scGVm8%3D&reserved=0

Upon entry to a physical meeting, all attendees will be required to present valid, Government-issued photo identification. Individuals who are unable to register because the deadline has passed, or capacity has been reached for the PD or for the optional sidebar meetings, will be added to a waitlist. If slots remain open after registration closes or become available due to cancellations, the slots will be filled on a first-come, first-served basis from the waitlist.

PLEASE NOTE: Registration closes on November 6th, 2023, at 12:00 PM ET.

Further administrative questions should be addressed to APECx@arpa-h.gov. Please refer to the APECx Proposers’ Day (ARPA-H-SN-24-01) in all correspondence. This announcement is not a request for abstracts or full proposals; any so sent will not be reviewed or receive a response”

V. SIGNIFICANT DATES AND TIMES

Table 2. Proposers Day Significant Dates and Times

Event Date Time

Registration opens October 10, 2023 4:00 PM ET

Registration closes+ November 6, 2023 12:00 PM ET*

Proposers’ Day November 17, 2023 Start: 8:30 AM MT

End: 5:00 PM MT

* 12:00 PM ET, or when capacity is reached, whichever comes first + All teaming profiles must be submitted before registration closes.

VI. POINTS OF CONTACT

Technical Point of Contact Dr. Andrew Kilianski, Program Manager, ARPA-H / HSF Office

Email: APECx@arpa-h.gov All inquiries should reference “APECx Proposers’ Day (ARPA-H-SN-24-01)” in the subject line of the email.

VII. WEBINAR INFORMATION

The link to the webinar registration confirmation will be released once registered. The registration will be limited to a first-come, first-served basis and the same from the waitlist.

VIII. DISCLAIMER

This SN is issued solely for information and potential new program planning purposes; the SN does not constitute a formal solicitation for proposals or proposal abstracts. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Submission is voluntary and is not required to propose subsequent Broad Agency Announcements (if any) or research solicitations (if any) on this topic. ARPA-H will not provide reimbursement for costs incurred in responding to this SN. Respondents are advised that ARPA-H is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted under this SN.