- MT-303 is Myeloid's second clinical
in vivo mRNA CAR program; it incorporates proprietary
next-generation mRNA innovations -
- MT-303 programs immune
cells directly in patients; the first time an in vivo CAR has been
evaluated in HCC -
CAMBRIDGE, Mass., July 31,
2024 /PRNewswire/ -- Myeloid Therapeutics, Inc.
("Myeloid"), a clinical-stage immunology company advancing RNA
therapeutics to conquer cancer, has dosed the first patient with
MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC).
MT-303 is Myeloid's second in vivo mRNA CAR program to enter
the clinic from its pipeline of in vivo immune cell
programming therapies. Dosing with MT-303 represents a
significant milestone to bring advanced novel therapies to people
with liver cancer.
Dr. Matthew Maurer, Chief Medical
Officer of Myeloid, commented, "We are thrilled to have swiftly
advanced MT-303 into the clinic as the first in vivo CAR
therapy applicable to the majority of liver cancers, and other
cancers expressing GPC3. MT-303 can be administered like any other
off-the-shelf intravenous therapy, without the need for
pretreatment conditioning, and offers the potential to trigger a
coordinated immune response against the cancer, reinforced and
maintained with ongoing repeat dosing."
GPC3 is a target of significant global interest given its high
expression in HCC and limited expression in normal tissues. Unlike
autologous cell therapies, Myeloid's approach focuses on in
vivo programming of immune cells with off-the-shelf
mRNA-encoded CAR technology that expresses selectively within
myeloid cells. MT-303 arms myeloid cells with a proprietary
chimeric antigen receptor that enables these cells to kill
hepatocellular carcinoma and to engage an adaptive immune response
against the tumor. This coordinated immune response is essential to
foster a sustained immune surveillance and defense against tumor
recurrence.
Dr. Timothy Humphries, Linear
Clinical Research, lead principal investigator on the MT-303 trial
added, "Hepatocellular carcinoma is a highly lethal cancer with
limited effective therapies. I am elated to bring the option
and potential of MT-303, the first in vivo CAR therapy for
this disease, to my patients with the hope of providing tolerable
and durable clinical benefit."
"The Myeloid team continues to push forward and revolutionize
cancer treatment with the world's first clinical-stage in
vivo mRNA CAR therapies," said Daniel
Getts, Ph.D., CEO of Myeloid. "With multiple clinical trials
ongoing that evaluate our therapeutic candidates, including MT-302,
our novel TROP2-targeting mRNA CAR in dose escalation studies, and
adding MT-303, we have a proven ability to translate cutting-edge
mRNA CAR technology into clinical candidates. We are excited by the
transformative potential of our in vivo immune cell
programming for liver cancer patients."
Dr. Getts continued, "Strategically, these clinical programs
provide insights as we continue to expand our development portfolio
to other targets, to other immune cell types, and to novel receptor
combinations for our in vivo CAR approaches."
Myeloid's in vivo programming candidates are designed
with proprietary insights to deliver personalized therapy,
providing benefits to patients while reducing time and costs
through the elimination of ex vivo handling of patient cells
and complex neoantigen sequencing. The Myeloid platform integrates
validated antibody/antigen binding with novel combinations of
myeloid signaling domains, coded within a simple mRNA that can be
delivered repeatedly using lipid nanoparticles (LNPs). The
platform's versatility provides a range of signaling domains and
immune cell types useful for combination approaches.
About Liver Cancer
With limited treatment options, and over 850,000 new cases
diagnosed globally each year, liver cancer has become the third
leading cause of cancer death. After initial treatment success with
small molecule therapies, the development of new treatment
approaches in the field of liver cancer has been limited.
Today, patients with liver cancer who are refractory to first line
treatment are left with few treatment options, creating a
substantial unmet medical need. Myeloid sees an opportunity
to make a significant contribution to address this need, by
providing a new CAR for these patients who are living with liver
cancer. The CARs are capable of providing a coordinated and
durable immune response to counter advanced disease. The CARs
are combinable and will expand the treatment options for
physicians.
About the Phase 1 Study of MT-303
The MT-303 Phase 1 study (NCT06478693) is an open-label dose
escalation study to investigate the safety, pharmacokinetics,
pharmacodynamics, and preliminary efficacy of MT-303 in adults with
advanced or metastatic hepatocellular carcinoma that overexpresses
GPC3. This study will also define the recommended Phase 2 dose
(RP2D) of MT-303.
About MT-303
MT-303 represents the first candidate in a new therapeutic
modality targeting hepatocellular carcinoma (HCC). This clinical
candidate is a first-in-class, GPC3-FcA-LNP, with a strong
preclinical profile supporting its advance into this first-in-human
trial. GPC3 is overexpressed in most human hepatocellular
carcinomas, with limited expression in corresponding normal
tissues. Increased GPC3 expression has been linked to tumor
growth.
Treatment with MT-303 as a monotherapy demonstrates activity in
a GPC3/HCC preclinical model, confirming the tumor-fighting potency
of programmed myeloid cells even in the model's absence of T cells.
MT-303 has demonstrated strong expression in myeloid cells and a
favorable safety profile in rodents and non-human primates. Unlike
other therapies, MT-303 brings the potential advantages of
eliciting a full immune response by also presenting tumor
neoantigen to stimulate T cells.
MT-303 represents Myeloid's second in vivo CAR clinical
program, building on the company's innovative approach to cancer
treatment through immune cell programming.
About Myeloid Therapeutics
Myeloid Therapeutics is a clinical stage immunology
company, engineering cutting-edge RNA technology to program
immune cells to combat cancer and other deadly diseases. Myeloid is
headquartered in Cambridge,
MA.
For additional information, please
visit, https://www.myeloidtx.com/ and follow us
on LinkedIn and X/Twitter. For collaborative
interests, write to partnering@myeloidtx.com.
Investor Contact
Amy Conrad
Juniper Point
Amy@juniper-point.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/myeloid-therapeutics-initiates-patient-dosing-with-mt-303-a-novel-gpc3-targeting-rna-car-in-phase-1-study-for-advanced-hepatocellular-carcinoma-hcc-302210394.html
SOURCE Myeloid Therapeutics, Inc.