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January 13, 2022 / eMedClub News/--January 11, 2022, Phio Pharmaceuticals, a proprietary self-delivering RNAi (INTASYL™) therapeutic platform, a biotechnology company developing next-generation immuno-oncology therapeutics, Recently, it was announced that PH-762 was granted Clinical Trial Authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products
.
The first-in-human trial of PH-762 in melanoma will be conducted at the Gustave Roussy Institute, and the company expects to dose the first patient in the first quarter of 2022
.
The company's main product, PH-762, is a TIL therapy targeting PD-1 based on the self-delivery RNAi platform INTASYL™
.
PH-762 is designed to activate immune cells by reducing PD-1 expression to better recognize and kill cancer cells
.
Dr.
Gerrit Dispersyn, Phio's President and CEO, said: "The authorization of this clinical trial is an important milestone for Phio as it is the first clinical study of a next-generation immuno-oncology therapy based on our INTASYL self-delivering RNAi platform
.
" INTASYL ™ platform (formerly sd-rxRNA), through local administration, can alter the tumor microenvironment to improve the efficacy of adoptive cell therapy (ACT)
.
INTASYL™ are hybrid oligonucleotide compounds with single-stranded phosphorothioate regions, short double-stranded regions, and contain various nuclease-stabilizing and hydrophobic chemical modifications
.
These chemical modifications confer stability, efficient cellular uptake and reduction of inflammatory responses; at the same time, the INTASYL™ compounds require no delivery mechanism or delivery technology, i.
e.
cells can automatically take up INTASYL™ without the need for a delivery vehicle
.
▲The mechanism of action of INTASYL™ RNAi therapy (Image source: phiopharma.
com) The boom in RNAi therapy is coming.
RNAi is a gene silencing phenomenon.
silencing complex, RISC) mediates the degradation of target mRNA and inhibits its translation
.
Using this mechanism, RNAi can be used to silence specific genes associated with disease
.
There are 4 RNAi drugs that have been approved and marketed in the world, namely ONPATTRO (Patisiran) for the treatment of hereditary transthyretin amyloidosis polyneuropathy, GIVLAARI (Givosiran) for the treatment of acute hepatic porphyria, and GIVLAARI (Givosiran) for the treatment of primary hyperthyroidism.
OXLUMO (lumasiran) for oxaluria and Leqvio (Inclisiran) for treating low-density lipoprotein cholesterol, but no oncology RNAi drug has been approved yet
.
Among the major clinical-stage RNAi drugs in the field of tumor therapy, Sirnaomics' STP705 has attracted much attention
.
STP705, a dual (TGF-β1/COX-2) mimetic, showed positive efficacy in phase IIa clinical trial results in non-melanoma isSCC, with 19 of 25 subjects achieving histological clearance of lesions, STP705 The administration of TGF-β1 and COX-2 achieved knockdown of TGF-β1 and COX-2, as well as down-regulation of molecular biomarkers of tumor cell proliferation, progression and invasiveness
.
In addition, STP705 is still in clinical trials for various indications such as liver cancer, and has been granted orphan drug designation by the US FDA for the treatment of cholangiocarcinoma and primary sclerosing cholangitis
.
Recommended reading: Heavy! Sirnat Pharmaceuticals is listed on the Main Board of the Hong Kong Stock Exchange.
A variety of RNA therapies are stunning in the world.
RNAi therapies can potentially be applied to a variety of diseases with a long duration of activity in the human body.
By targeting specific disease-causing genes that were previously considered undruggable Compared with other therapies such as small molecules and antibodies, RNAi therapy has a wide range of druggable targets, enabling precise and personalized therapy, high safety and long-lasting effect, faster and higher development success rate and relatively low manufacturing cost.
lower
.
▲Principle of RNAi therapy (Image source: Alnylam official website) Although RNAi therapy in oncology is in the early stage, RNAi therapy can effectively inhibit the growth of advanced tumors in cancer treatment, with relatively low cost and high specificity, and it can also inhibit various diseases at the same time.
Multiple genes of various pathways are beneficial to reduce drug resistance
.
In the future, with the continuous breakthrough and innovation of RNAi technology, the therapeutic scope of RNAi drugs will be further expanded, and the market demand and market scale will also continue to expand
.
References: 1.
Pharmaceutical Times "Global RNAi Drug Clinical Progress Collection | What wonderful things are worth looking forward to? 2.
https://
.
The first-in-human trial of PH-762 in melanoma will be conducted at the Gustave Roussy Institute, and the company expects to dose the first patient in the first quarter of 2022
.
The company's main product, PH-762, is a TIL therapy targeting PD-1 based on the self-delivery RNAi platform INTASYL™
.
PH-762 is designed to activate immune cells by reducing PD-1 expression to better recognize and kill cancer cells
.
Dr.
Gerrit Dispersyn, Phio's President and CEO, said: "The authorization of this clinical trial is an important milestone for Phio as it is the first clinical study of a next-generation immuno-oncology therapy based on our INTASYL self-delivering RNAi platform
.
" INTASYL ™ platform (formerly sd-rxRNA), through local administration, can alter the tumor microenvironment to improve the efficacy of adoptive cell therapy (ACT)
.
INTASYL™ are hybrid oligonucleotide compounds with single-stranded phosphorothioate regions, short double-stranded regions, and contain various nuclease-stabilizing and hydrophobic chemical modifications
.
These chemical modifications confer stability, efficient cellular uptake and reduction of inflammatory responses; at the same time, the INTASYL™ compounds require no delivery mechanism or delivery technology, i.
e.
cells can automatically take up INTASYL™ without the need for a delivery vehicle
.
▲The mechanism of action of INTASYL™ RNAi therapy (Image source: phiopharma.
com) The boom in RNAi therapy is coming.
RNAi is a gene silencing phenomenon.
silencing complex, RISC) mediates the degradation of target mRNA and inhibits its translation
.
Using this mechanism, RNAi can be used to silence specific genes associated with disease
.
There are 4 RNAi drugs that have been approved and marketed in the world, namely ONPATTRO (Patisiran) for the treatment of hereditary transthyretin amyloidosis polyneuropathy, GIVLAARI (Givosiran) for the treatment of acute hepatic porphyria, and GIVLAARI (Givosiran) for the treatment of primary hyperthyroidism.
OXLUMO (lumasiran) for oxaluria and Leqvio (Inclisiran) for treating low-density lipoprotein cholesterol, but no oncology RNAi drug has been approved yet
.
Among the major clinical-stage RNAi drugs in the field of tumor therapy, Sirnaomics' STP705 has attracted much attention
.
STP705, a dual (TGF-β1/COX-2) mimetic, showed positive efficacy in phase IIa clinical trial results in non-melanoma isSCC, with 19 of 25 subjects achieving histological clearance of lesions, STP705 The administration of TGF-β1 and COX-2 achieved knockdown of TGF-β1 and COX-2, as well as down-regulation of molecular biomarkers of tumor cell proliferation, progression and invasiveness
.
In addition, STP705 is still in clinical trials for various indications such as liver cancer, and has been granted orphan drug designation by the US FDA for the treatment of cholangiocarcinoma and primary sclerosing cholangitis
.
Recommended reading: Heavy! Sirnat Pharmaceuticals is listed on the Main Board of the Hong Kong Stock Exchange.
A variety of RNA therapies are stunning in the world.
RNAi therapies can potentially be applied to a variety of diseases with a long duration of activity in the human body.
By targeting specific disease-causing genes that were previously considered undruggable Compared with other therapies such as small molecules and antibodies, RNAi therapy has a wide range of druggable targets, enabling precise and personalized therapy, high safety and long-lasting effect, faster and higher development success rate and relatively low manufacturing cost.
lower
.
▲Principle of RNAi therapy (Image source: Alnylam official website) Although RNAi therapy in oncology is in the early stage, RNAi therapy can effectively inhibit the growth of advanced tumors in cancer treatment, with relatively low cost and high specificity, and it can also inhibit various diseases at the same time.
Multiple genes of various pathways are beneficial to reduce drug resistance
.
In the future, with the continuous breakthrough and innovation of RNAi technology, the therapeutic scope of RNAi drugs will be further expanded, and the market demand and market scale will also continue to expand
.
References: 1.
Pharmaceutical Times "Global RNAi Drug Clinical Progress Collection | What wonderful things are worth looking forward to? 2.
https://
