Amendment 0001.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

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Previous edition unusable

NCI-EXEC

Mandie S. White

The purpose of this amendment is to respond to questions regarding solicitation 75N91024R00006.

Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30 (SF-30) signed by your organization's signature authority and submitted with your proposal.

Solicitation questions must be received by February 15, 2024, 5:00 PM EDT (Unchanged). Please send questions to the ARPA-H SBIR/STTR Program mailbox (sbir@arpa-h.gov).

Proposal Due Date: February 22, 2024, 5:00PM EDT (Unchanged).

National Institute of Health National Cancer Institute Bethesda, MD 20892-7511

To all potential offerors 75N91024R00006

1 15

02/07/2024

02/07/2024

ARPA-H SBIR SOLICITATION 75N91024R00006

Amendment #1 Questions and Answers

Please note questions are due by February 15, 2024 5:00 PM EST. Multiple question and answer amendments are anticipated prior to the solicitation closing date.

Topic ARPA-H 05 has been revised to “at least 12MHz” from “12 mHz”. The remainder of the topic remains unchanged.

The term “Neoadjuvant” has been removed from Topic ARPA-H 04. The remainder of the topic remains unchanged.

1. QUESTION: We are looking to apply for SBIR funds via ARPA-H. Do you happen to have templates for the full proposal so we can plan accordingly? Perhaps from a previous RFP?

ANSWER: Please see SECTION 4: PROPOSAL PREPARATION AND INSTRUCTIONS of the solicitation.

2. QUESTION: We have extensive experience in developing a fully autonomous echography system. What are the specifications for the ARPA-H 05 topic, such as:

- Is there any particular expected challenge to be tackled? i.e., difficulty placing the ultrasound probe in an optimal pose to obtain diagnostically useful images? Or more on diagnosis/data interpretation.

- Is there any particular solution interested to achieve full automation? i.e., a robot-assisted solution or wearable device.

ANSWER: Please refer to the objectives and background for Topic 05.

3. QUESTION: We are interested in submitting a proposal for ARPA-H 04 – Personalized

Medicine platform for predicting response to immunotherapy. Would you please so kind to advise us the procedure for the submission?

ANSWER: Please review Sections 4 and 5 of the solicitation for submission instructions.

4. QUESTION: We Our company has a GMP platform for delivering cargo to CART and other immunotherapy cells. We have a number of studies with clinical collaborators interested personalized tracking of the cell therapy product in vivo after administration to ensure the cells traffic to the appropriate target (tumor location, etc.). A few publications describing the approach are below with multimodal imaging technologies (MRI, PET, Ultrasound). The trafficking of immune cells are key for predicting whether the therapy will work without waiting months for tumor reduction.

• “In vivo imaging of nanoparticle-labeled CAR T cells” https://www.pnas.org/content/pnas/119/6/e2102363119.full.pdf

• “Instant labeling of therapeutic cells for multimodality imaging” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255004/

• “Mechanoporation enables rapid and efficient radiolabeling of stem cells for PET imaging” https://www.nature.com/articles/s41598-022-06938-6

ANSWER: The intention of the topic is to develop technologies that can predict response to immunotherapy *PRIOR* to the treatment start. This can come in the form of blood tests, genetic testing, imaging, etc.

5. QUESTION: I’m a physician scientist that is interested in this funding opportunity. I lead many collaborative efforts within an academic medical institution as pertaining to checkpoint inhibitor mechanisms of response / resistance, but do not have active collaborations with a small business. Is an ‘industrial’ collaboration necessary for this award? Is this award solely meant for small business owners? In addition, would there be an option for funding for pure academic collaborations?

ANSWER: Please refer to Section 10 General Definitions of the solicitation. There you can find what defines a Small Business Concern and eligibility under this requirement. The ARPA-H Open BAA (Open Broad Agency Announcement | ARPA-H) is another option if your company does not qualify as a small business.

6. QUESTION: For Topic ARPA-H 01 , does that mean virus production in plants (i.e., restricted to vegetation-based systems) or does it refer to a manufacturing plant for viral production. Could you clarify?

ANSWER: ARPA-H 01 refers to virus production in vegetation-based systems.

7. QUESTION: We have patented a whole blood culture system for assessing individualized patient responses to diverse therapeutic strategies for virus infections and are expanding into cancer applications. We are also working in cancer indications, initially with blood cancers. Since the full solicitation is not yet posted, my question is whether this could be an appropriate technology to meet the needs outlined in ARPA-H04. Indications are not specified there, but we can support immunotherapeutic strategies such as checkpoint inhibitors, CARs and BNAbs/MAbs in the culture system that others may not. Do you have additional information?

ANSWER: For topic ARPA-H 04, we are interested in approaches that can predict if a patient will respond to immunotherapy prior to the treatment being started. We are not prescriptive as to what technology may be employed for this purpose.

8. QUESTION: We develop a single nanoparticle detection and analysis instrument. Would a quality control system for viral vector manufacturing be responsive to this solicitation? We do not manufacture viruses.

ANSWER: Solely developing a Quality Control (QC) system for viral vectors is outside the scope of Topic 01.

9. QUESTION: We are interested in applying for a solution on Inexpensive plant-based manufacturing of viruses. Can we apply as a STTR instead of a SBIR, and if this is structured as Phase 1 Phase 2 as the standard solicitations?

ANSWER: SBIR Phase I, Direct to Phase II, and Fast-Track applications are only being accepted for this solicitation.

10. QUESTION: Do you happen to know whether there will be more of these announcements, and anything specifically in the NIA mission?

ANSWER: Please sign up for our Vitals Newsletter (News & Events | ARPA-H) to stay up to date on the latest news/releases at ARPA-H. Additionally, please feel free to visit our website with our updated Program Manager list to see if there is alignment with your area of expertise/area of interest.

11. QUESTION:

Will this solicitation support SBIR phase I, or are only phase II proposals allowed?

For topic ARPA-H 04, is there any limit on the kind of patient populations/diseases that the program will or prefers to support?

Will it be an appropriate project for topic ARPA-H 04 if we propose to develop a point-of-care platform for personal, near real-time monitoring of immunosuppressant levels and rejection biomarkers in responding to immunosuppression therapy in organ transplant recipients?

ANSWER: ARPA-H is only accepting SBIR Phase I, Direct to Phase II, and Fast- Track proposals for this solicitation. Please refer to each Topic as to what type of proposals are being accepted.

Applications focusing solely on basic science research such as biomarker identification in in vitro and/or animal models, generation of new animal models and/or mechanistic studies are out of scope for topic 04. The platform must be capable of providing response prediction prior to the patient undergoing initial treatment – hence, not include any markers measured past treatment start. In addition, platforms that would take an unreasonable amount of time to deliver a clinically actionable prediction or submissions that do not aim to successfully predict response across a range of cancer types will not be considered. Proposers should recognize that neoadjuvant therapy (i.e., chemotherapy in combination with ICI) is the current standard of care in the United States.

Regarding the last bullet, the idea proposed is not consistent with the intention of Topic 4.

12. QUESTION: Is this funding for an echocardiography device per se, or would you be interested in a neural network-based software system that interprets cardio signals? Is this the only year that this theme will be promoted within ARPA funding?

ANSWER: The solicitation notice was published 1/23/2024 through SAM.Gov and provides additional information. The topics listed in the current solicitation likely will not be listed in a future solicitation.

13. QUESTION: With regard to RFP for ARPA-H 06 - Improving Identity and Access Management with Clinical Context, we have some questions.

Is use of open source IAM best practice modules acceptable in the proposed solution?

Our understanding is that AI for healthcare specific anomaly detection and flagging for human attention in under resourced IT environments is one of the requirements of the proposal. Is this correct interpretation? Can this AI design be one of the core elements of the proposal.?

We understand "limited overhead IAM model " is critical component of phase 1. Can you comment on what aspects/metrics are used to measure the overhead and how we can think about the baseline?

Does use of a smartphone app as part of the proposed IAM design solution acceptable with the scope of the proposal?

ANSWER:

Yes.

Any technology that reduces the IT burden for effective IAM required is within scope.

We encourage proposers to submit the metrics that best capture the impact of their solution.

Yes, this is within scope.

14. QUESTION: Is there any flexibility in the required allocation between the small business and Research Org work distribution for a small business (66% under SBIR) and 40% under STTR? Can the small business have even less than the 66% or 40%

ANSWER: Please be advised that this solicitation is for SBIRs, not STTRs.

Please refer to section 6.2 of the solicitation. To receive SBIR funds, each awardee of a SBIR Phase I or Phase II award must qualify as a small business concern (SBC) at the time of award and at any other time set forth in SBA's regulations at 13 CFR 121.701-121.705. Each applicant must qualify as a small business for research or research and development purposes and certify to this on the Cover Sheet (Appendix A) of the proposal. Additionally, each awardee must submit a certification stating that it meets the size, ownership and other requirements of the SBIR Program at the time of award, and at any other time set forth in SBA's regulations at 13 CFR 121.701-705.

For Phase I, a minimum of two-thirds of the research or analytical effort must be performed by the awardee.

For Phase II, a minimum of one-half of the research or analytical effort must be performed by the awardee. The percentage of work will be measured by total award dollars.

For both Phase I and II, the principal investigator must be primarily employed with the SBC. Primary employment means that more than one half (50%) of the employee's time is spent with the small business. Primary employment with the SBC precludes full-time employment at another organization.

For both Phase I and Phase II, all research or research and development work must be performed by the SBC and its subcontractors in the United States.

Based on rare and unique circumstances, deviations from these performance requirements may be considered on a case-by-case basis. Deviations must be approved in writing by the funding agreement officer after consultation with the agency SBIR Program Manager/Coordinator.

15. QUESTION: ARPA-H 03 - Continuous Monitoring of Vascular health using Smart Biomimetic Implantables: Is the device supposed to be implantable? Vascular health biomarkers exist in the exhaled breath but in lower concentration.

ANSWER: The device should be implantable.

16. QUESTION: Can a small business ask for 40% G&A or is an analysis needed?

Are these cost plus fee contracts?

ANSWER: Please refer to Section 8.13 of the solicitation. SBIR offerors who propose a G&A/IDC rate of 40 percent of total direct costs or less will not be required to negotiate Final Indirect Rates with the NIH Division of Financial Advisory Services (DFAS), or other cognizant auditing agency. However, awarding Contracting Officers may require offerors to document how they calculated their IDC rate(s) in order to determine that these costs are fair and reasonable. Furthermore, the Division of Financial Advisory Services (DFAS) will retain the authority to require well-documented proposals for G&A/IDC rates on an ad hoc basis. If the SBC has a currently effective negotiated indirect cost rate(s) with a Federal agency, such rate(s) shall be used when calculating proposed G&A/IDC costs for an NIH proposal. (However, the rate(s) must be adjusted for IR&D expenses, which are not allowable under HHS awards.)

SBCs are reminded that only actual G&A/IDC costs may be charged to projects. If awarded at a rate of 40 percent or less of total direct costs, the rate used to charge actual G&A/ID costs to projects cannot exceed the awarded rate unless the SBC negotiates an indirect cost rate(s) with DFAS.

Please also refer to Section 4 of the solicitation. The award will result in a Firm- Fixed Price (FFP) contract type.

17. QUESTION: Can we include the SBIR fee of 7% in the budget?

ANSWER: Yes. A reasonable fee, not to exceed 7 percent of total costs (direct and indirect) for each phase (Phase I, Phase II, or Phase IIB) of the project, is available to small businesses receiving awards under the SBIR and STTR programs. The fee is intended to be a reasonable profit factor available to for-profit organizations, consistent with normal profit margins provided to profit-making firms for research and development work. The fee may be used by the small business for any purpose, including additional effort under the SBIR or STTR award and/or to pay for a tax liability. The fee is intended for the small business awardee; however, the SBIR or STTR recipient may decide to pay a portion of the fee to a contractor upon their discretion. Please see https://seed.nih.gov/faqs for more information.

18. QUESTION: For ARPA-04 (personalized medicine), are you looking for the contract deliverables that are actual materials, as in grams of reagent?

ANSWER: The outcome should be a validated methodology that works in preventing patients from being administered therapy that is not effective. That validated methodology may include a validated blood test, genomics screening, image analytics, etc.

19. QUESTION: The ARPA-H funding model is unique and looks to engage with novel technology platforms such as ours, and we were curious if it is possible to submit a proposal beyond the bulleted list provided? We have several ideas around miniaturizing Raman sensors, wearable systems for continuous analyte quantification, and more. Is there is an avenue for application outside of the stated interests?

ANSWER: This solicitation only invites proposals that are in scope of Topics 01- 06 per the solicitation. If you have an idea outside of the listed topics, you may consider applying to the ARPA-H Open BAA(Open Broad Agency Announcement | ARPA-H).

20. QUESTION: We are interested in submitting a proposal for solicitation ARPA-H 04 (Personalized medicine platform for predicting response to immunotherapy). Among the phase I activities and deliverables is the following: "Proposers must identify an appropriate number of clinical partners able to collect data in patients treated with neoadjuvant immunotherapy alone (as opposed to the standard of care chemotherapy + immunotherapy)”

The neoadjuvant setting is one of many possible settings in which immunotherapy can be used. Are applicants expected to focus on this setting in their proposal, or was this qualifier included by accident?

ANSWER: The term "neoadjuvant" was included accidentally and has been removed under this Amendment. The main aim of the topics refers to all uses of immunotherapy, to reduce instances when immunotherapy is given to patients who will ultimately not respond.

21. QUESTION: Is there a ARPA-H database for large technology companies like ours to look up small businesses with who we can team and scale our solutions?

ANSWER: At this time, we do not have this resource available. However, ARPA- H will publicly announce which small businesses were funded under this solicitation.

22. QUESTION: Would the proposal we would make which has a strong R & D component have to lie within these particular rubrics or are these meant not to be exhaustive but to be suggestions of the kinds of proposals that ARPA-h seeks? What about STTR - does this solicitation only cover SBIR or is STTR also eligible? Is there any webinar you give to teach companies about these new solicitations?

ANSWER: The solicitation only invites applicants for the specific topics listed in the solicitation. The topics are SBIR specific and do not include STTR. At this time, we do not have a webinar or event scheduled for the current solicitation.

23. QUESTION: Do you think this same topic will be listed in a later solicitation, so that I can apply for an ARPA-H grant in that category once I have started my company? I am also planning on applying for an SBIR-TT grant in September -am I allowed to apply for and be awarded both the SBIR-TT grant and the ARPA-H grant?

ANSWER: The topics listed in the current contract solicitation are not guaranteed to be listed in a future solicitation. Companies are welcome to apply for opportunities outside of ARPA-H as they see fit. Please note that multiple applications should not overlap in content. Please note this is a contract solicitation and not a grant funding opportunity.

24. QUESTION: We are interested in submitting a proposal for solicitation ARPA-H 04 (Personalized medicine platform for predicting response to immunotherapy). Among the phase I activities and deliverables is the following: "Validation of predictive utility in relevant animal models (e.g., patient-derived xenograft models) using two ICI antibodies (e.g., vehicle vs.

PD-1 vs. CTLA-4 vs. PD-1 & CTLA-4 combination)." If animal modeling is not relevant for our approach (i.e. we perform analyses directly with clinical samples), are we permitted to omit such studies from our proposal?

ANSWER: Yes, you are permitted to skip such studies if they are not scientifically relevant to your proposal.

25. QUESTION: I watched the non-dilutive funding summit presentation of ARPA-H you gave in SF and wanted to ask a follow up question. While current topics are more focused on larger scale health or biosystems, I'm wondering what role you see biochemistry and biomanufacturing solutions playing in ARPA-H's SBIR project roadmap. My start-up company stabilizes enzymes for the manufacturing of a broad range of molecules, from greener chemicals to small molecule therapeutics. Would you expect that future topics will be more oriented towards the molecular world? And if so, would a broad platform with both industrial biotech and health ramifications be interesting to ARPA-H? Or is the focus on platforms and companies with a primarily health focus?

ANSWER: Solicitation topics are ARPA-H Program Manager driven, so the topics for the Small Business Program will vary depending on what topics the Program Manager’s submit. We encourage you to check our website (ARPA-H Home | ARPA-H) with our updated Program Manager list to see if there is alignment with your area of expertise/area of interest. Also please make sure to sign up for our Vitals Newsletter to stay up to date on the latest news/releases at ARPA-H.

26. QUESTION: I understand from the SBIR NIH policy that work needs to be performed in the US, but this will not be possible due to the unique material that can best be prepared there. I estimate about 20-25% of the work (budgetary and effort) will need to be performed in a lab across both phases. I was wondering if there is a waiver or suggestion on how to best approach this collaboration for this proposal. I am happy to furnish further details or craft a letter on the need for such collaboration.

One particular clarification is whether "retrospective studies" will be needed (or suitable) for the ARPA-H 04 phase II study.

ANSWER: Please refer to section Section 9 – Disclosure of Foreign Relationships. Regarding Phase II activities, running prospective observational trials with markers deemed important from phase I activities is part of the deliverable.

27. QUESTION: Is ARPA-H planning to release additional SBIR solicitations for other topic areas later this year? If so, can you provide an approximate expected date of release for our planning purposes?

ANSWER: Yes, we anticipate the release of a second solicitation later this year which will include new topics. Please monitor https://arpa-h.gov/engage-and-transition/sbir for future opportunities.

28. QUESTION: I am looking for clarification with regard to Topic ARPA – H 03 Continuous Monitoring of Vascular Health using Smart Biomimetic Implantables

How often are measurements (flow, pressure, troponin) envisioned to be taken? ANSWER: The frequency of measurements is flexible, but should be at least once daily.

How often are those measurements envisioned to be available to the user/EHR (as soon as the measurement is taken, once and hour, once a day, etc.)?

ANSWER: Once the measurement is taken.

Is it acceptable to have a component of the system wrap around the artery that the stent is in, for measurement purposes? ANSWER: Yes

Is it acceptable to have an implanted device in addition to the stent itself? (for example, a pacemaker size device that handles the power/data transfer, sensor interfacing, etc. located closer to the skin) ANSWER: It is preferable to have the only implantable component be the stent, however other designs are also acceptable.

How far away from the body is the wireless power source envisioned to be?

ANSWER: This can vary, but up to ~1M. Essentially to make it practical for the user to sync/power when entering a room containing the external power/data hub.

Is it acceptable to place a device on the body (externally) occasionally to do wireless power transfer (for example, to recharge a battery in the implant)?

ANSWER: Yes

Can you further define “integrated data hub”? ANSWER: An external device left in a room that will serve as both a wireless powering and data transfer source.

Is the “data/power hub” envisioned to be the receiver of the data, or should data go directly to the smartphone? ANSWER: It is envisioned that the hub will be the receiver of the data, which can then be transferred to a smartphone.

29. QUESTION: SBIR APRA-H04 inquiry: We would apply for the Fast-track application route with Phase I and Phase II awards. My questions are:

Can either or both phases be STTR? ANSWER: Only SBIR applications will be accepted in this solicitation. You may, however, include academic collaborators as part of the contract proposal.

NIH has rules around percent of costs going to sub-awards (e.g. <30% for Phase I, <50% for Phase II). Does this apply in ARPA-H too? Since this is a contract and only sub-contractors are allowed, does this not apply?

o Any $ amount or % budget limits on sub-contractors/ CROs?

o Any $ amount or % budget limits on budget going to collaborating sites (for human subject recruitment)?

ANSWER: Please refer to question 14 above.

What level of novelty is desired for this project's biomarker? For our choice, MSI has strong evidence with FDA approved therapy and diagnostics. So if this would not be a suitable match, then it will help save our time - and we'd not apply. ANSWER: We are not looking for existing biomarkers.

Phase II instructions include a requirement for prospective data collection- this means residual, previously tested samples are inadequate, correct? ANSWER: Yes, that is correct.

o If so, would this fall under the definition of a clinical trial with higher amounts of regulatory paperwork? I would think not since there is not patient intervention.

o I want to confirm certain Phase I milestones can be skipped such as proving validity of MSI as a biomarker since it is already well documented with clinical response. ANSWER: as this topic is only accepting Phase II proposals, our expectation is that you already have access to feasibility data/results that would have been obtained under a Phase I proposal.

30. QUESTION: ARPA-H 04: I have a question about this solicitation and the activities and deliverables for Phase II proposals. Is it a hard and fast requirement that a prospective trial be performed? Or can we propose to run a retrospective clinical trial with a follow-along prospective trial with our clinical partner?

ANSWER: Phase II Deliverables include running prospective observational trial with markers deemed important from phase I activities. See Instructions, Human Subjects and Clinical Trials Information Form, Section 1.4. Clinical Trial Questionnaire, for further information and references.

31. QUESTION: We are planning to submit a proposal (Fast track- Phase I) in response to the Solicitation. Research topic of interest: ARPA-H 04 - Personalized Medicine Platform for Predicting Response to Immunotherapy

1) Do we need to focus on cancer disease models for our platform development or could we use other disease models like Multiple Sclerosis which also require immunotherapies?

2) Can we submit a Fast track- Phase I (6-9 months) proposal or do we need to submit both Phase I and II proposals at the same time?

ANSWER: This is mostly targeted to solid cancer applications, and specifically to those which have a relatively small percentage of patients who respond, yet many more patients are given a costly, and ultimately ineffective therapy.

Fast-Track applications require one complete Phase I and one complete Phase II application. See section 2.3 Fast Track Proposals in the solicitation.

32. QUESTION: We wish to apply for an award under ARPA-H’s SBIR solicitation for proposals from small businesses with the expertise to conduct innovative research and development into Personalized medicine platform for predicting response to immunotherapy.

“The Guide to SBIR/STTR Program Eligibility” states:

…For awards issued under §5107 (majority VC ownership) authority (see agencies using this authority), an awardee may be majority owned and controlled by multiple VC, hedge fund or private equity firms, so long as no one such firm owns a majority of the awardee equity…

ARPA-H is not in this list VC ownership authority | SBIR.gov. Could you please confirm whether they make awards under the section 5107 authority referred to? Thank you.

ANSWER: Appendix E section 6.6 addresses VCOC requirements.

33. QUESTION: We are developing a remote medication monitoring platform that is a good fit to respond to ARPA-H04. I have been poking around to find where to submit an abstract, but I have not found clear guidance. Can you please point me in the right direction?

ANSWER: The solicitation notice was published 1/23/2024 through SAM.Gov and provides additional information. Please refer to Section 4 and 5 regarding Proposal Preparation and Instructions as well as Proposal Submission.

34. QUESTION: We are in the process of preparing a proposal for solicitation 75N91024R00006, focusing on Research and Development (R&D) that aims to contribute to the mission needs of the Advanced Research Projects Agency for Health (ARPA-H) and align with the objectives of the Small Business Innovation Research (SBIR) program. In relation to the submission, could you please advise whether we should adhere to the BBA abstract format or if there are other guidelines or recommendations we should follow?

ANSWER: Please refer to Section 4 and 5 regarding Proposal Preparation and Instructions as well as Proposal Submission.

35. QUESTION: Some performers may have IP but have not yet established a start-up – can performers still apply with intent on forming a start-up?

ANSWER: At the time of submitting your proposal, you will need to complete all the required SAM.gov registrations concerning your company. This includes registering your small business with the SBA. Also, note that eligibility will also be verified at the time of award. Please refer to Section 10 General Definitions of the solicitation. There you can find what defines a Small Business Concern and eligibility under this requirement.