United States securities and exchange commission logo
July 3, 2021
Mai-Britt Zocca, Ph.D.
Chief Executive Officer
IO Biotech, Inc.
Ole Maal es Vej 3
DK-2200 Copenhagen N
Denmark
Re: IO Biotech, Inc.
Draft Registration
Statement on Form S-1
Submitted June 3,
2021
CIK No. 0001865494
Dear Dr. Zocca:
We have reviewed your 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.
Draft Registration Statement on Form S-1 submitted June 3, 2021
Overview, page 1
1. Please balance your
discussion of the Phase 1/2 clinical trial results/observations
concerning efficacy by
explaining the purpose of the trial and any material limitations to
the reported
results/observations. In this regard, we note that it is unclear whether
clinical endpoints were
established with respect to tumor regression and durability of
antitumor response and
it is also unclear whether these results/observations are
statistically
significant. With reference to your disclosure at the bottom of page 23, also
tell us whether you
were able to evaluate and determine the contributions of IO102-IO103
as compared to those of
the combination therapy.
Mai-Britt Zocca, Ph.D.
IO Biotech, Inc.
July 3, 2021
Page 2
2. With reference to your regulatory discussion on pages 146-147, please
tell us your basis
for identifying this trial as "Phase 1/2" and your planned trial as a
potentially
"registrational Phase 3 trial." Also, revise the disclosure on page 1
to explain the term
"basket trials". Revise your regulatory discussion in the Business
section to discuss these
three terms.
3. We note your statement on page 2 that your IO102-IO103 product
candidate in
combination with nivolumab demonstrated a "manageable tolerability
profile" and your
disclosure on page 107 identifying tolerability as an advantage of
your T-win Technology
Platform. Please balance these disclosures by addressing the
occurrence of serious, high-
grade adverse events in your MM1636 trial as disclosed on pages 20 and
112. Also, tell
us why there does not appear to be any discussion concerning dosage
tolerability in your
discussions of the ongoing phase 1/2 trial or the planned phase 3
trial.
4. Revise the Summary to explain why your plan is to use pembrolizumab as
the
combination product for your next trial as opposed to nivolumab.
Our Immunotherapy Pipeline, page 2
5. We note your statement on page 99 that the you plan to move into a
Phase1/2 trial for
IO112 in combination with IO102 and IO103 and your disclosure on page
23 that "it is
expected that our product candidates, if approved, would be used in
combination with
third-party drugs or biologics." Please clearly indicate such in the
pipeline table on pages
2 and 98.
Our Strategy, page 4
6. We note your disclosure here and in the Business section that your
strategy is to
"rapidly advance" 1O102-IO103 toward approval in combination with
anti-PD-1 therapy
in first-line treatment of metastatic melanoma. We also note your risk
factor disclosure
that, "[b]reakthrough therapy designation by the FDA for any product
candidate may not
lead to a faster development or regulatory review." Please
revise/balance this disclosure to
remove the implication that you will be successful in commercializing
your product
candidates in a rapid or accelerated manner as such statements are
speculative.
Some data for product candidates comes from clinical trials conducted outside
the United
States...,
FirstName page 21
LastNameMai-Britt Zocca, Ph.D.
Comapany
7. NameIO
Please Biotech,
revise to explainInc.
whether the phase 1/2 trial you reference was
representative of the
July 3, population
2021 Page that
2 you intend to label the product candidate in the United
States.
FirstName LastName
Mai-Britt Zocca, Ph.D.
FirstName
IO Biotech,LastNameMai-Britt Zocca, Ph.D.
Inc.
Comapany
July 3, 2021NameIO Biotech, Inc.
July 3,3 2021 Page 3
Page
FirstName LastName
Use of Proceeds, page 78
8. We note your statement that the use of proceeds is to fund the
development and regulatory
activities relating to your product candidates. Please revise your
disclosure to allocate the
amount of proceeds you expect to use for each of your programs and
specify how far in
the clinical development of your product candidates you expect to
reach with the net
proceeds. If any material amounts of other funds are necessary to
accomplish the specified
purposes for which the proceeds are to be obtained, state the amounts
and sources of such
other funds needed for each such specified purpose and the sources
thereof. Refer to
Instruction 3 of Item 504 of Regulation S-K.
9. We note your disclosure on page 94 that you will be obligated to pay
Herlev a fee upon
the completion of this offering. To the extent the offering proceeds
will be used to pay this
obligation, please disclose the fee owed to Herlev here.
Dual Epitope IO102-IO103, page 107
10. Please clarify your disclosure in this section to make clear that your
planned Phase 3 trial
for IO102-IO103 is a combination trial with an anti-PD-1 monoclonal
antibody therapy,
consistent with your disclosure throughout your registration
statement.
Preclinical Development, page 108
11. We note your disclosure that, "[t]here have been no health impairments
in the two non-
clinical toxicity studies performed with IO102 and IO103." Please
clarify here if the
studies performed evaluated your combination product IO102-IO103 or if
the studies
evaluated each product candidate individually.
Development of Dual Epitope IO102-IO103 in the First-line Setting, page 111
12. We note your disclosure that the results from the MM1636 trial have a
cut-off date of
February 22, 2021 and that the prior cut-off date was in January 2021.
With a view to
disclosure, please tell us whether you are receiving updated data from
this cohort and
whether a more recent cut-off date will be used in future amendments.
Additional Trials in Other First-Line Indications and Neo-Adjuvant and Adjuvant
Settings, page
120
13. We note that Table 5 on page 121 depicts a summary of adverse events
of various
investigator completed trials with IO101, IO102 and IO103 and Table 6
and Table 7
depict ongoing and planned trials. Please provide narrative disclosure
to accompany Table
5 to specifically discuss any material serious adverse events
occurring in your trials. In
addition, include narrative disclosure for Table 6 and Table 7 to
clarify the specific trials
designs and their status, including planned or actual initiation dates
and planned
completion dates.
Mai-Britt Zocca, Ph.D.
FirstName
IO Biotech,LastNameMai-Britt Zocca, Ph.D.
Inc.
Comapany
July 3, 2021NameIO Biotech, Inc.
July 3,4 2021 Page 4
Page
FirstName LastName
Collaborations
Agreements with Herlev Hospital, page 139
14. We note your disclosure that the Company entered into a Framework
Assignment
Agreement and an Assignment Agreement in January 2017 and December
2018 with
Herlev, for certain rights related to your lead product candidates.
Please file such
agreements as an exhibit pursuant to Item 601(b)(10) of Regulation S-K
or tell us why you
believe such filing is not required. In addition, we note your
disclosure that you obtained
assignments and licenses related to each of your lead product
candidates, IO102, IO103
and IO112. However, you appear to only discuss two Assignment
Agreements
that cover (i) the PD-L1 technology and (ii) the Arginase technology.
Please describe or
otherwise advise if a separate agreement covers your IDO target
(IDO102).
15. We note your disclosure here that your agreement with Herlev covers
"cancer vaccines"
and your Merck Collaboration Agreement disclosure also references a
"peptide vaccine."
Please update your disclosure in your business section or otherwise
advise if you are
currently developing cancer vaccines or peptide vaccines referenced
here.
Patents, page 144
16. We note your disclosure that the, "[g]rant is imminent in China" for
your patents related to
IO103 and that your TDO patent family is also "(grant imminent)" for
the EPO. Given
that the grant of a patent in these jurisdictions appear to be outside
of your control, please
provide your basis that the patents will be imminently granted in
these jurisdictions or
otherwise advise.
17. We note that you have multiple types of patents (composition of matter
and methods of
use) granted in multiple jurisdictions for your product candidates.
Please revise
and expand your disclosure to clearly state the patent expiration date
for each material
jurisdiction. In addition, please disaggregate and clarify the patent
expiration dates for
your different types of patents (composition of matter and methods of
use).
General
18. Please provide us with copies of all written communications, as
defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they
retain copies of the communications.
19. We note several graphics where the text is not legible. For example
only, we note figure 2
and 3 on page 105, figure 4 on page 106 and figure 13 and 14 on page
119, where the text
is not clear or legible. Please modify your graphics throughout your
filing as necessary to
ensure that all text is legible.
20. At first use, please define abbreviations. For example only, we note
that "CI" on page 109
and "LDH" and "DMSO" on page 111 are not defined at first use.
Mai-Britt Zocca, Ph.D.
IO Biotech, Inc.
July 3, 2021
Page 5
21. We note your disclosure here to various sources where the description is
not clear. For
example only, we note references to Ascierto (2019), Robert (2019),
Larkin (2019), Maio
(2015) and Garbe (2011). If you funded or were otherwise affiliated with
any of the
studies or reports you cite, please disclose such information. In
addition, please confirm
that these sources are widely available to the public and update your
disclosure
accordingly to provide additional details regarding the studies you
appear to reference so
the disclosure clearly identifies the specific sources.
You may contact David Burton at (202) 551-3626 or Al Pavot at (202)
551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at (202) 551-8342 or Joe McCann at (202) 551-6262 with any
other
questions.
Sincerely,
FirstName LastNameMai-Britt Zocca, Ph.D.
Division of
Corporation Finance
Comapany NameIO Biotech, Inc.
Office of Life
Sciences
July 3, 2021 Page 5
cc: Frank Rahmani, Esq.
FirstName LastName