AbClon, HER2 Affibody Switchable CAR-T" U.S. Patent granted……
AbClon is
making a move to dominate the untapped solid tumor CAR-T market, having
completed its global patent portfolio, including in the U.S.
On the
17th, antibody drug development company AbClon announced that it has received a
patent grant decision from the U.S. Patent and Trademark Office (USPTO) for its
'HER2 Affibody-based Switchable CAR-T Technology.'
With
this, AbClon has secured exclusive technological rights in the world's largest
pharmaceutical market, the U.S., following Korea, Canada, China, Japan, and
Australia, with final registration also pending in Europe.
The newly
patented technology is a 'Switchable' CAR-T, designed to activate immune cells
targeting HER2-expressing cancer cells only when needed. This next-generation
platform addresses the fundamental limitations of existing CAR-T therapies.
Currently,
all seven FDA-approved CAR-T products are limited to blood cancers. Their
T-cell receptors, which recognize cancer cells, are permanently bound,
resulting in an 'always-on' state once injected into the body, where they are
continuously active.
This can
lead to severe side effects such as Cytokine Release Syndrome (CRS) and Immune
effector Cell-Associated Neurotoxicity Syndrome (ICANS), and even attacks on
healthy cells. Furthermore, because they only target a single antigen, their
therapeutic effect diminishes if cancer cells develop resistance.
AbClon 's
proprietary switchable CAR-T platform, 'zCAR-T,' is designed to require an
intermediary 'switch molecule' instead of the CAR-T cells directly recognizing
cancer cells. Much like an electrical switch, it allows the CAR-T cells to be
turned on and off as needed.
AbClon
has utilized the zCAR-T platform to develop its HER2 affibody-based switchable
CAR-T technology, which is the core technology for its first zCAR-T candidate,
'AT501,' currently in preclinical development as a treatment for ovarian
cancer.
AT501's
switch molecule consists of two parts. One side, 'cotinine' (a metabolite of
nicotine), binds to the CAR-T cell, while the other side, an 'affibody' (a
small protein about 1/25th the size of a regular antibody), binds to cancer
cells that express HER2.
This acts
like a bridge between the cancer cell and the CAR-T cell. The switch molecule
can be used to control the activation and proliferation of CAR-T cells and to
change and regulate their targets. Additionally, if side effects occur,
administration of the switch molecule can be stopped to immediately halt the
CAR-T cell activity.
The HER2
targeted therapy market was valued at $8.9 billion in 2021 and is growing at an
annual rate of 12%. Blockbuster drugs like Herceptin, Perjeta, and Enhertu form
a market worth over $12 billion annually. However, most of these are based on
monoclonal antibodies or ADCs, and a CAR-T approach is still in its early
stages.
While
several pharmaceutical companies like CARsgen and Adaptimmune Therapeutics are
developing solid tumor CAR-T therapies, few possess a specialized switchable
platform for HER2, which is drawing market attention to AbClon's differentiated
technology.
An AbClon
official stated, "The U.S. patent registration for our 'HER2
Affibody-based Switchable CAR-T Technology' will be a major catalyst for us to
lead the charge in the untapped solid tumor CAR-T market. We have confirmed the
potential for our switchable CAR-T platform, 'zCAR-T,' to expand beyond a
single therapeutic agent into a platform-based business model, so we will be
accelerating licensing agreements and joint development collaborations with
multinational pharmaceutical companies."
Furthermore,
while conventional CAR-T therapies are developed to directly target specific
proteins on the surface of cancer cells, requiring a separate CAR-T for each
cancer type, AbClon's zCAR-T platform allows for a single 'switchable CAR-T' to
be created, with different switch molecules developed for each cancer type.
For
example, a HER2-targeting switch can be used for HER2-positive breast cancer,
and a different target switch can be used for ovarian cancer. Moreover, using
multiple switch molecules simultaneously allows for multi-target attacks, which
can overcome issues of immune evasion and resistance due to antigen loss in
cancer cells.
