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United States securities and exchange commission logo
October 5, 2022
Peter Blume-Jensen, M.D., Ph.D.
Chief Executive Officer
Acrivon Therapeutics, Inc.
480 Arsenal Way, Suite 100
Watertown, MA 02472
Re: Acrivon
Therapeutics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted September
22, 2022
CIK No. 0001781174
Dear Peter Blume-Jensen:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted
September 22, 2022
Prospectus Summary
Overview, page 1
1. We note your response
to comment 1 and reissue. We disagree with your conclusion that
it is appropriate to
state that your OncoSignature test has achieved "preclinical validation"
or "has been validated
in preclinical studies." We note the U.S. Food and Drug
Administration ( FDA
), draft guidance Principles for Codevelopment of an In Vitro
Companion Diagnostic
Device with a Therapeutic Product from July 16, 2016 you
reference in your
response, defines "analytical validation" as the demonstration that the in
vitro companion
diagnostic can accurately and reliably detect or measure the analyte it is
intended to detect or
measure. If accurate, you can state that your OncoSignature test has
Peter Blume-Jensen, M.D., Ph.D.
FirstName LastNamePeter
Acrivon Therapeutics, Inc. Blume-Jensen, M.D., Ph.D.
Comapany
October NameAcrivon Therapeutics, Inc.
5, 2022
October
Page 2 5, 2022 Page 2
FirstName LastName
completed the clinical trial assay "analytical validation" prior to
entering the phase 2
clinical trials. However, your disclosure should also clarify that
OncoSignature
companion diagnostic test has not been approved or otherwise advise.
Our Lead Clinical Candidate ACR-368, page 3
2. We note your response to comment 5 and revised disclosure on page 4.
Please revise
further to provide balancing disclosure that there can be no assurance
that the FDA will
permit you to utilize and expedited approval process or that your
intended approach will
be sufficient for regulatory approval.
Our Pipeline, page 3
3. We note your response to comment 6 and reissue in part. Please revise
your pipeline
tables here and on page 106 to change the "registrational" column to
"Phase 3" because
you may be required to conduct a Phase 3 clinical trial prior to
registration for all of your
product candidates currently included in your pipeline table. We do
not object to you
disclosing in a footnote that you believe your Phase 2 trial for
ACR-368 could potentially
be registrational under an accelerated approval pathway if accurate.
4. We note your response to comment 9 and disagree with your reasons for
continuing to
include ACR-368 multiple times for each indication. You may add
narrative disclosure
either before or after your pipeline table to discuss the different
trials you plan to conduct
based on whether or not a potential patient is OncoSignature-positive
or negative.
Clinical development of ACR-368 for patients with ovarian and other solid
cancers of high
unmet treatment need, page 118
5. We note your disclosure elsewhere that "[yo]ur OncoSignature test is
being developed
with Akoya Biosciences, Inc., or Akoya, pursuant to a companion
diagnostic agreement."
We also note your disclosure here that you have begun enrolling
patients in your Phase 2
clinical trial. Please update your disclosure to clarify if the
OncoSignature tests to be used
in the study will be procured and manufactured by Akoya or otherwise
advise.
Summary of adverse events from published reports on clinical trials with
ACR-368 monotherapy
dosed at RP2D, page 125
6. We note your response to comment 17 and reissue in part. Please update
your narrative
disclosure here and your risk factor disclosure on page 24 to clarify
that adverse events
greater than or equal to Grade 3 are considered "serious adverse
events" or otherwise
advise.
Patent License Agreement, page 141
7. Please update your disclosure to clarify which product(s) or product
candidates(s) are
covered by the patent license agreement.
Peter Blume-Jensen, M.D., Ph.D.
Acrivon Therapeutics, Inc.
October 5, 2022
Page 3
General
8. We note your response to comment 25 and reissue in part. We note there is
still illegible
text in Figure 20 on page 131. To the extent that the illegible text is
not necessary to
understand the graphic, consider removing the text. Otherwise, revise as
appropriate so the
text is legible. In addition, please include a legend or otherwise
provide additional
narrative disclosure explaining what this figure represents.
You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Daniel Crawford at 202-551-7767 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
FirstName LastNamePeter Blume-Jensen, M.D., Ph.D.
Division of
Corporation Finance
Comapany NameAcrivon Therapeutics, Inc.
Office of Life
Sciences
October 5, 2022 Page 3
cc: Ryan Sansom
FirstName LastName