Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
September 12 2022 - 07:01AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
September 12, 2022
Commission File Number: 001-39363
IMMATICS N.V.
Paul-Ehrlich-Straße 15
72076 Tübingen, Federal Republic of Germany
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(1):
☐
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(7):
☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On September 10, 2022, Immatics N.V. (the “Company” or “Immatics”)
announced a comprehensive preclinical data set for its T cell
engaging receptor (TCER®) product candidate IMA402 at
the European Society for Medical Oncology (ESMO) Congress 2022 held
in Paris, France, from September 9 to 13, 2022. Data highlights
include:
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· |
The IMA402 TCER® utilizes a high-affinity TCR
designed to specifically bind to an HLA-A*02:01-presented peptide
derived from PRAME on tumor cells |
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· |
The T cell recruiter domain is a proprietary low-affinity T
cell recruiter against the TCR/CD3 complex that demonstrates
superior in vivo tumor control compared to analogous
TCER® molecules designed with higher-affinity variants
of a widely used antibody recruiter |
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· |
The IMA402 TCER® is optimized to reduce T cell
engager-associated toxicities in patients, which is demonstrated by
reduced recruiter-mediated cytokine release in vitro |
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· |
IMA402 showed potent and selective activity against
PRAME-positive tumor cell lines in vitro |
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· |
In vivo studies in mice demonstrated dose-dependent
anti-tumor activity of IMA402. Sufficiently high drug doses were
key to achieving the desired anti-tumor effects over a prolonged
period |
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· |
In vitro safety assessment including toxicity screening
against 20 normal tissue types, whole blood cytokine release
assessment and alloreactivity evaluation confirmed favorable safety
profile for IMA402 |
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· |
The half-life extended format of IMA402 confers a serum
half-life of >1 week in mice suggesting a favorable dosing
regimen and prolonged drug exposure at therapeutic levels when
compared to TCR Bispecifics lacking half-life extension
strategies |
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· |
IMA402 is designed to allow high dosing not limited by
toxicities with the goal of reaching relevant therapeutic doses in
tumor tissue and achieve a meaningful clinical benefit in
patients |
A clinical trial evaluating IMA402 in patients with solid tumors is
expected to start in 2023. The Phase 1 part of the trial will start
with a minimal anticipated biological effect level (MABEL) dose of
IMA402 and will have an adaptive design aimed at accelerating dose
escalation to determine the recommended Phase 2 dose (RP2D).
HLA-A*02:01-positive patients with different solid tumors
expressing PRAME will initially receive weekly infusions of IMA402.
Pharmacokinetics data will be assessed throughout the trial and
might provide an opportunity to adapt the treatment interval. The
Phase 2a dose expansion part of the trial will be designed to
comprise several cohorts to further evaluate IMA402 in specific
indications and combination therapies. Submission of the IND
application is planned for Q2 2023.
In connection with the foregoing, the Company issued a press
release, a copy of which is attached hereto as Exhibit 99.1.
INCORPORATION BY REFERENCE
This Report on Form 6-K (other than Exhibit 99.1) shall be deemed
to be incorporated by reference into the registration statements on
Form F-3 (Registration Nos. 333-258351 and 333-240260) of Immatics
N.V. and to be a part thereof from the date on which this report is
filed, to the extent not superseded by documents or reports
subsequently filed or furnished.
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 |
Press release dated September 10,
2022 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
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IMMATICS N.V. |
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Date: September 12, 2022 |
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By: |
/s/ Harpreet Singh |
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Name: |
Harpreet Singh |
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Title: |
Chief Executive Officer |
Immatics NV (NASDAQ:IMTX)
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