United States securities and exchange commission logo
January 4, 2021
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive
Suite 400
Cambridge, MA 02140
Re: Vor Biopharma Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted December
18, 2020
CIK No. 0001817229
Dear Dr. Ang:
We have reviewed your amended 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our
December 3, 2020 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1, Submitted
December 18, 2020
Summary, page 1
1. We note your response
to our prior comment number 1. Please revise your disclosure in
the Overview section to
clearly state that your lead candidate, VOR33 is preclinical. To
explain the novelty and
uniqueness of your approach and to highlight the associated
challenges, please also
revise the Overview to disclose that (i) engineered hematopoietic
stem cells have never
undergone clinical trials and (ii) the removal of CD33 from
hematopoietic stem
cells has never been studied in clinical trials.
Robert Ang, M.B.B.S.
FirstName LastNameRobert Ang, M.B.B.S.
Vor Biopharma Inc.
Comapany
January NameVor Biopharma Inc.
4, 2021
January
Page 2 4, 2021 Page 2
FirstName LastName
2. We note your response to our prior comment number 4. On page 18 you
state that you
have not yet filed an IND application for VOR33. Please revise pages 2
or 4 to state when
you plan to submit an IND for VOR33 for AML.
Our Proprietary Vor Platform, page 2
3. We note that your disclosure on page 3 highlights that you have a
highly efficient
manufacturing process. Please revise page 3 to clarify the meaning of
this statement in
light of your risk factor disclosure on page 39, where you state that
you "have not
demonstrated that eHSCs or VCAR33 can be frozen and thawed in large
quantities
without damage, in a cost-efficient manner and without degradation"
and, further, that you
"may not be able to commercialize eHSCs, VCAR33 or other cell-based
companion
therapeutics we may develop on a large scale or in a cost-effective
manner."
Risk Factors
Development of a product candidate such as VOR33, which is intended for use in
combination or
in sequence with an already approved therapy.., page 27
4. We note your response to prior comment 6. With reference to your
disclosure on page 28,
please revise to clarify whether you will need to work with Pfizer to
satisfy the
requirement that you reference in this risk factor. In this regard, it
should be clear whether
you will need to negotiate a license and/or supply agreement so that
Mylotarg can be used
in combination or in sequence with VOR33.
Business, page 121
5. We note your response to our prior comment number 11. Please revise
pages 103 and 127
to expressly state that your companion therapeutic VCAR33, which is
intended to be used
in conjunction with VOR33, employs viral vectors.
You may contact Eric Atallah at 202-551-3663 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Richard Segal, Esq.