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United States securities and exchange commission logo
January 29, 2021
Bahija Jallal, Ph.D.
Chief Executive Officer and Director
Immunocore Holdings Limited
92 Park Drive
Milton Park
Abingdon, Oxfordshire OX14 4RY
United Kingdom
Re: Immunocore Holdings
Limited
Registration
Statement on Form F-1
Filed January 15,
2021
File No. 333-252166
Dear Dr. Jallal:
We have reviewed your 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.
Registration Statement on Form F-1 filed January 15, 2021
Prospectus Summary
Our Pipeline, page 2
1. We note your response
to prior comment 1 and the updated pipeline table. The arrows for
IMC-C103C, IMC-F106C,
GSK01 and IMC-I109V are drawn to the end of the Phase 1
column. However, your
disclosure in the Business section indicates that the Phase 1
portions of the
clinical trials for each of these product candidates are still ongoing. Please
shorten the arrows in
the pipeline chart to match the current status of each trial as
described in Business
or advise.
Bahija Jallal, Ph.D.
FirstName LastNameBahija Jallal, Ph.D.
Immunocore Holdings Limited
Comapany
January 29,NameImmunocore
2021 Holdings Limited
January
Page 2 29, 2021 Page 2
FirstName LastName
Business
Phase 3 Clinical Trial, page 146
2. Please revise your description of your Phase 3 clinical trial of
tebentafusp to provide
safety and tolerability data including a description of any adverse
events and/or serious
adverse events that were linked to treatment.
3. We note your comparison of the observed hazard ratio in your Phase 3
trial of tebentafusp
to the hazard ratios observed in several other Phase 3 trials of
treatments for uveal and
cutaneous melanoma. Given that these were not head-to-head trials and
that the treatments
in the control arms of the other trials in the table varied from the
control treatment in your
trial, please tell us why you believe it is appropriate to include
these comparisons. Include
in your response whether you expect to be able to rely on this data to
support an
application for marketing approval from the FDA or comparable
regulatory body for
commercialization of tebentafusp.
Additional ImmTAC Clinical Programs, page 148
4. We note your response to prior comment 16 and updated disclosure.
Please revise to
disclose the specific endpoints for the ongoing clinical trials
described in this section.
Financial Statements, page F-1
5. Your audited financial statements are currently older than 12 months
and this is an initial
public offering of your shares. Accordingly, please update your
financial statements
pursuant to Item 8.A.4 of Form 20-F or provide the appropriate
representations in an
exhibit. Refer to Instruction 2 to Item 8.A.4.
Exhibits
6. The date of you auditor consent is January 15, 2020. Please have your
auditor provide an
appropriately dated consent.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Bahija Jallal, Ph.D.
Immunocore Holdings Limited
January 29, 2021
Page 3
You may contact Jenn Do at 202-551-3743 or Mary Mast at 202-551-3613 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Alan Campbell at 202-551-4224 or Jeff Gabor at 202-551-2544 with any other
questions.
Sincerely,
FirstName LastNameBahija Jallal, Ph.D.
Division of
Corporation Finance
Comapany NameImmunocore Holdings Limited
Office of Life
Sciences
January 29, 2021 Page 3
cc: Courtney T. Thorne, Esq.
FirstName LastName