Signet Therapeutics Announces IND Approval by the FDA for World’s First Targeted Therapy for Diffuse Gastric Cancer
July 01 2024 - 9:05PM
Business Wire
Signet Therapeutics, a biotech company using organoid disease
models and AI to advance targeted cancer therapy, today announced
that the FDA has granted its IND application for sigx1094 as a
potential treatment for diffuse gastric cancer (DGC). This marks a
significant milestone as sigx1094 is the first targeted drug
candidate for DGC, a disease currently lacking effective
treatments. The company is poised to commence a Phase I clinical
trial to assess the safety and efficacy of sigx1094 in patients
with DGC and other advanced solid tumors.
“The FDA's IND approval for sigx1094 marks a significant step
forward in addressing the critical unmet medical needs in DGC. This
milestone fuels our optimism for a new era where AI and organoid
disease models become the catalysts for more fruitful drug
discovery efforts, propelling the transformation of biological
discoveries into innovative, life-saving treatments,” said Dr.
Haisheng Zhang, Founder and CEO of Signet Therapeutics.
Accelerating Drug Discovery with Organoid Disease Models and
AI
In leveraging its proprietary organoid disease model platform
and through a strategic collaboration with XtalPi, XtalPi
(2228.HK), a leading drug R&D platform company driven by
artificial intelligence (AI) and robotics, Signet nominated
pre-clinical candidate sigx1094 in just over six months, and
received FDA’s IND approval in under four years, significantly
accelerating the drug discovery and design process. For efficacy
evaluation, Signet used its proprietary organoid disease models
developed from real-world cancer genomics data to simulate drug
effects in 3D tissues that resemble human biology, allowing for
more accurate predictions of patient responses. Sigx1094 is the
first of a series of pipeline projects that was discovered by AI
and validated by organoid disease models. By designing and
evaluating candidate molecules using data of higher clinical
relevance, the company hopes such innovative R&D approach will
increase the likelihood of clinical trial success. The company’s
novel organoid disease model platform not only supports its own
drug pipeline but also provides external services, including drug
efficacy evaluation, target screening, and model animal
experiments, ensuring a consistent revenue stream.
Signet Therapeutics’ Origins and Vision
Before establishing the company, Dr. Haisheng Zhang was part of
a team led by Dr. Adam Bass at Dana-Farber Cancer Institute at
Harvard Medical School. Their groundbreaking research, published in
Nature, classified gastric cancer into four distinct molecular
subtypes, with diffuse gastric cancer (DGC) identified as a
genomically stable cancer. This subtype is particularly challenging
due to its high invasiveness and poor response to conventional
treatments like chemotherapy and radiotherapy and the current
targeted therapies.
Driven by these insights, Dr. Zhang established Signet
Therapeutics in late 2020 and led a team dedicated to identifying
novel targets and developing effective therapies for cancers. The
team is driven by the urgent need for new treatments for cancers
where traditional therapies have often been ineffective. They have
established unique organoid disease models using transgenic mice to
study DGC, leading to the discovery of potent targets such as FAK
and YAP.
Broad Potential of sigx1094
Apart from treating DGC, sigx1094 has shown promise in
preclinical studies for treating various cancers, including
ovarian, triple-negative breast, and pancreatic cancers. The drug
candidate also demonstrated potential in combination therapies,
particularly with chemotherapy and targeted treatments for
KRAS-mutated and EGFR-mutated cancers. As clinical studies
progress, Signet hopes to further investigate and validate
sigx1094’s potential as treatment in a broader range of therapeutic
areas.
About Signet Therapeutics
Signet Therapeutics is dedicated to developing innovative
targeted cancer drugs using novel organoid disease models and AI.
The company aims to meet the unmet medical needs of cancer
patients, particularly those unresponsive to conventional
therapies. Signet Therapeutics has successfully secured nearly $22
million in three rounds of angel funding. In 2023, the company was
recognized by Forbes Asia 100 to Watch list. Signet's first
pipeline has reached the IND, with two additional pipelines being
accelerated to clinical stages through its organoid disease model
and AI platform. By combining the power of novel organoid disease
models and AI, Signet Therapeutics is revolutionizing traditional
drug discovery and paving the way for more effective cancer
treatments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240701750486/en/
Signet Therapeutics Jiaqian Zhou jiaqian.zhou@signettx.com