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Introduction: On October 12, local time, Moderna and Merck jointly announced that Merck exercised the option to jointly develop and commercialize the personalized cancer vaccine (PCV) mRNA-4157/V940 in accordance with the terms of the existing cooperation and licensing agreement
.
Currently, mRNA-4157/V940 is being evaluated in combination with Merck's anti-PD-1 therapy KEYTRUDA as an adjunctive therapy
for high-risk melanoma patients in Moderna's ongoing Phase 2 clinical trial.
Under the agreement, Merck will pay $250 million
to Moderna.
Melanoma is the most aggressive form of skin cancer, growing rapidly and having the highest risk of death, accounting for only about 1% of all skin cancers but causing most of the deaths
associated with skin cancer.
Because melanoma grows rapidly, a delay in treatment can mean the difference
between life and death.
In recent years, the incidence of melanoma has been increasing year by year, and effective treatment options
are urgently needed.
At present, the treatment methods of melanoma mainly include melanoma surgery, lymphadenectomy, metastasectomy, targeted cancer therapy, radiation therapy, and immunotherapy
.
This time, Moderna and Merck jointly developed mRNA cancer vaccines to explore the treatment of high-risk melanoma patients, once again enriching the treatment methods of
melanoma patients.
The combination of the two pharmaceutical giants, the dawn of cancer vaccine research and development, Moderna is a famous mRNA vaccine manufacturer in the United States, its therapeutic concept is to use mRNA to make the cells in the patient's body become the "in vivo factory" of drug therapy, focusing on medical key areas including infectious diseases , immuno-oncology, personalized cancer vaccines, rare diseases, cardiovascular diseases, autoimmune diseases
.
Among them, personalized cancer vaccines are designed to activate the immune system so that patients can develop a tailored anti-tumor response to their tumor mutation characteristics to treat cancer
.
Once injected into the patient, the vaccine has the potential to direct the patient's cells to express a selected new epitope, which may help the patient's immune system more accurately recognize and destroy cancer cells
.
Moderna's investigational cancer vaccine, mRNA-4157/V940, is designed to stimulate an immune response by generating a T cell response
based on the mutant characteristics of a patient's tumor.
MERK'S KEYTRUDA IS AN ANTI-PD-1 THERAPY THAT WORKS
BY IMPROVING THE BODY'S IMMUNE SYSTEM'S ABILITY TO HELP DETECT AND FIGHT TUMOR CELLS.
KEYTRUDA IS A HUMANIZED MONOCLONAL ANTIBODY THAT BLOCKS THE INTERACTION BETWEEN PD-1 AND ITS LIGANDS, PD-L1 AND PD-L2, THEREBY ACTIVATING T LYMPHOCYTES
THAT MAY AFFECT TUMOR CELLS AND HEALTHY CELLS.
Fig.
1 Design of personalized cancer vaccine mRNA-4157 (Source: [5])
The combination therapy is currently undergoing phase II clinical trials, enrolling a total of 157 high-risk melanoma patients
。 AFTER SURGICAL RESECTION, PATIENTS WERE RANDOMIZED TO MRNA-4157/V940 (9 DOSES EVERY THREE WEEKS) AND KEYTRUDA (200 MG EVERY THREE WEEKS) VERSUS KEYTRUDA ALONE FOR APPROXIMATELY ONE YEAR UNTIL DISEASE RELAPSE OR UNACCEPTABLE TOXICITY
DEVELOPED.
KEYTRUDA WAS CHOSEN AS THE COMPARATOR IN THE TRIAL BECAUSE IT IS THE STANDARD OF
CARE FOR PATIENTS WITH HIGH-RISK MELANOMA.
The primary endpoint of the trial is relapse-free survival, and secondary endpoints include survival without distant metastases and overall survival, and the companies are expected to publish clinical data
in the fourth quarter of this year.
Under the agreement, developed in 2016 and amended in 2018, Merck will pay Moderna $250 million to exercise options for personalized cancer vaccines, including mRNA-4157/V940, and will collaborate to develop and commercialize cancer vaccines
.
This amount will be spent by Merck in the third quarter of 2022 and included in its non-GAAP results, under which Merck and Moderna will share costs and profits
equally.
Affected by this news, the share prices of Moderna and Merck have risen
.
Commenting on the collaboration, Moderna President Stephen Hoge, MD, said, "We have been working with Merck on PCV since 2016 and have made significant progress
in advancing mRNA-4157 as an investigational personalized cancer treatment for use in combination with KEYTRUDA.
With the expectation of this quarter's PCV data, we are excited about
the impact of mRNA technology as a new therapeutic paradigm for cancer management.
" Continuing our strategic alliance with Merck is an important milestone as we continue to develop our mRNA platform
in promising clinical programs across multiple therapeutic areas.
"
Dr.
Eliaf Barr, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said: "Merck's expertise in immuno-oncology combined with Moderna's pioneering mRNA technology has resulted in a new customized vaccine approach
.
We look forward to working with Moderna on joint KEYTRUDA to advance mRNA-4157/V940
.
" "
The two giants of the biopharmaceutical industry have joined forces and believe that this personalized cancer vaccine can achieve good treatment results in the future and benefit the majority of patients
.
"
Cancer vaccines have made great progress, and the dream of the anti-cancer field is expected to be realizedCancer vaccines can be mainly divided into preventive cancer vaccines, Therapeutic cancer vaccines, personalized neoantigen vaccines
.
Cervical cancer and some types of hepatocellular carcinoma are caused by viruses, and vaccines against these viruses, such as human papillomavirus and hepatitis B vaccines, can prevent these cancers, and these vaccines are preventive cancer vaccines
.
Therapeutic cancer vaccines are divided into antigen cancer vaccines, whole cell cancer vaccines, dendritic cell cancer vaccines, DNA cancer vaccines, etc.
, which mainly strengthen the patient's immune system to strengthen its attack on cancer cells, thereby destroying cancer cells
.
At present, cancer vaccines are developing towards breast cancer, lung cancer, colon cancer, skin cancer, kidney cancer, etc
.
Among the top ten indications for mRNA drugs, tumor immunotherapy ranks second
only to the new coronavirus.
In April, John Haanen, MD, of the Netherlands Cancer Institute, presented data from BioNTech's ongoing mRNA-based cancer vaccine in human trials evaluating the efficacy
of BNT211 in patients with advanced solid tumors.
BNT211 includes two drug products, an autologous CAR-T cell therapy against the carcinoembryonic antigen CLDN6 and a CAR-T cell amplification RNA vaccine encoding CLDN, which is based on BioNTech's mRNA-lipoplex technology to improve the persistence and functionality
of adoptive metastatic cells.
Indications include testicular cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, sarcoma and gastric cancer
.
The results of the trial showed that 6 of the 14 evaluable patients showed partial response, and 5 patients were stable with reduced
target lesions.
In addition to demonstrating the overall targeting efficacy, it also verifies the feasibility
of mRNA technology beyond the field of infectious diseases.
At the 2022 American Clinical Association Annual Meeting, Dr.
Vinod Balachandran of MSK Cancer Center shared BioNTech's mRNA-based personalized neoantigen-specific cancer vaccine BNT122 in combination with PD-L1 antibodies Atezolizumab and mFOLFIRINOX chemotherapy.
Safety
and tolerability results in phase I clinical trials in patients undergoing surgical resection for pancreatic cancer.
Figure 2 BNT122 is inThe results of the study-phase (Source: BioNTech website)
in various cancers showed that data read from 16 patients treated with BNT122 showed that BNT122 in combination with atezolizumab was well tolerated, and the treatment induced a new neoantigen-specific T cell response
in 50% of patients 。 Based on these data, BioNTech and Genentech are planning a randomized study to further evaluate the efficacy and safety
of BNT122 in combination with atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma.
BioNTech and Regeneron Pharmaceuticals are collaborating to develop BNT111, an mRNA vaccine for advanced melanoma, which is in phase
II.
Late last year, the FDA granted the vaccine fast-track designation
based on "available preclinical and clinical data show that BNT111 has the potential to overcome the limitations of current treatments for inoperable, drug-resistant advanced melanoma.
"
Figure 3 BNT111 is in the clinical phase II stage (Source: BioNTech official website)
In addition, for Moderna, in addition to mRNA-4157/V940, it also has KRAS vaccine (mRNA-5671), Checkpoint vaccines (mRNA-4359) and other vaccines
in the field of cancer treatment.
Figure 4 Moderna's mRNA cancer vaccine in the research and development stage (Source: Moderna official website)
believes that with the further deepening of research and development, cancer vaccines will successfully benefit the majority of cancer patients!
Written by| Muzijiu
modernatx.
com/news/news-details/2022/ Merck-and-Moderna-Announce-Exercise-of-Option-by-Merck-for-Joint-Development-and-Commercialization-of-Investigational-Personalized-Cancer-Vaccine/default.
aspx [2] style="font-size: 12px;letter-spacing: 1px;" _mstmutation="1" _istranslated="1">[3]https://investors.
biontech.
de/news-releases/news-release-details/ biontech-presents-positive-preliminary-phase-12-data-first-class/[4]https://investors.
biontech.
de/news-releases/news-release-details/ positive-phase-1-data-mrna-based-individualized-neoantigen[5]https://s29.
q4cdn.
com/435878511/files/doc_presentations/2022/09/Moderna-Final-R-D-Day-Slides_ PDF-(09.
08.
22).
pdf
.
Currently, mRNA-4157/V940 is being evaluated in combination with Merck's anti-PD-1 therapy KEYTRUDA as an adjunctive therapy
for high-risk melanoma patients in Moderna's ongoing Phase 2 clinical trial.
Under the agreement, Merck will pay $250 million
to Moderna.
Melanoma is the most aggressive form of skin cancer, growing rapidly and having the highest risk of death, accounting for only about 1% of all skin cancers but causing most of the deaths
associated with skin cancer.
Because melanoma grows rapidly, a delay in treatment can mean the difference
between life and death.
In recent years, the incidence of melanoma has been increasing year by year, and effective treatment options
are urgently needed.
At present, the treatment methods of melanoma mainly include melanoma surgery, lymphadenectomy, metastasectomy, targeted cancer therapy, radiation therapy, and immunotherapy
.
This time, Moderna and Merck jointly developed mRNA cancer vaccines to explore the treatment of high-risk melanoma patients, once again enriching the treatment methods of
melanoma patients.
The combination of the two pharmaceutical giants, the dawn of cancer vaccine research and development, Moderna is a famous mRNA vaccine manufacturer in the United States, its therapeutic concept is to use mRNA to make the cells in the patient's body become the "in vivo factory" of drug therapy, focusing on medical key areas including infectious diseases , immuno-oncology, personalized cancer vaccines, rare diseases, cardiovascular diseases, autoimmune diseases
.
Among them, personalized cancer vaccines are designed to activate the immune system so that patients can develop a tailored anti-tumor response to their tumor mutation characteristics to treat cancer
.
Once injected into the patient, the vaccine has the potential to direct the patient's cells to express a selected new epitope, which may help the patient's immune system more accurately recognize and destroy cancer cells
.
Moderna's investigational cancer vaccine, mRNA-4157/V940, is designed to stimulate an immune response by generating a T cell response
based on the mutant characteristics of a patient's tumor.
MERK'S KEYTRUDA IS AN ANTI-PD-1 THERAPY THAT WORKS
BY IMPROVING THE BODY'S IMMUNE SYSTEM'S ABILITY TO HELP DETECT AND FIGHT TUMOR CELLS.
KEYTRUDA IS A HUMANIZED MONOCLONAL ANTIBODY THAT BLOCKS THE INTERACTION BETWEEN PD-1 AND ITS LIGANDS, PD-L1 AND PD-L2, THEREBY ACTIVATING T LYMPHOCYTES
THAT MAY AFFECT TUMOR CELLS AND HEALTHY CELLS.
Fig.
1 Design of personalized cancer vaccine mRNA-4157 (Source: [5])
The combination therapy is currently undergoing phase II clinical trials, enrolling a total of 157 high-risk melanoma patients
。 AFTER SURGICAL RESECTION, PATIENTS WERE RANDOMIZED TO MRNA-4157/V940 (9 DOSES EVERY THREE WEEKS) AND KEYTRUDA (200 MG EVERY THREE WEEKS) VERSUS KEYTRUDA ALONE FOR APPROXIMATELY ONE YEAR UNTIL DISEASE RELAPSE OR UNACCEPTABLE TOXICITY
DEVELOPED.
KEYTRUDA WAS CHOSEN AS THE COMPARATOR IN THE TRIAL BECAUSE IT IS THE STANDARD OF
CARE FOR PATIENTS WITH HIGH-RISK MELANOMA.
The primary endpoint of the trial is relapse-free survival, and secondary endpoints include survival without distant metastases and overall survival, and the companies are expected to publish clinical data
in the fourth quarter of this year.
Under the agreement, developed in 2016 and amended in 2018, Merck will pay Moderna $250 million to exercise options for personalized cancer vaccines, including mRNA-4157/V940, and will collaborate to develop and commercialize cancer vaccines
.
This amount will be spent by Merck in the third quarter of 2022 and included in its non-GAAP results, under which Merck and Moderna will share costs and profits
equally.
Affected by this news, the share prices of Moderna and Merck have risen
.
Commenting on the collaboration, Moderna President Stephen Hoge, MD, said, "We have been working with Merck on PCV since 2016 and have made significant progress
in advancing mRNA-4157 as an investigational personalized cancer treatment for use in combination with KEYTRUDA.
With the expectation of this quarter's PCV data, we are excited about
the impact of mRNA technology as a new therapeutic paradigm for cancer management.
" Continuing our strategic alliance with Merck is an important milestone as we continue to develop our mRNA platform
in promising clinical programs across multiple therapeutic areas.
"
Dr.
Eliaf Barr, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said: "Merck's expertise in immuno-oncology combined with Moderna's pioneering mRNA technology has resulted in a new customized vaccine approach
.
We look forward to working with Moderna on joint KEYTRUDA to advance mRNA-4157/V940
.
" "
The two giants of the biopharmaceutical industry have joined forces and believe that this personalized cancer vaccine can achieve good treatment results in the future and benefit the majority of patients
.
"
Cancer vaccines have made great progress, and the dream of the anti-cancer field is expected to be realizedCancer vaccines can be mainly divided into preventive cancer vaccines, Therapeutic cancer vaccines, personalized neoantigen vaccines
.
Cervical cancer and some types of hepatocellular carcinoma are caused by viruses, and vaccines against these viruses, such as human papillomavirus and hepatitis B vaccines, can prevent these cancers, and these vaccines are preventive cancer vaccines
.
Therapeutic cancer vaccines are divided into antigen cancer vaccines, whole cell cancer vaccines, dendritic cell cancer vaccines, DNA cancer vaccines, etc.
, which mainly strengthen the patient's immune system to strengthen its attack on cancer cells, thereby destroying cancer cells
.
At present, cancer vaccines are developing towards breast cancer, lung cancer, colon cancer, skin cancer, kidney cancer, etc
.
Among the top ten indications for mRNA drugs, tumor immunotherapy ranks second
only to the new coronavirus.
In April, John Haanen, MD, of the Netherlands Cancer Institute, presented data from BioNTech's ongoing mRNA-based cancer vaccine in human trials evaluating the efficacy
of BNT211 in patients with advanced solid tumors.
BNT211 includes two drug products, an autologous CAR-T cell therapy against the carcinoembryonic antigen CLDN6 and a CAR-T cell amplification RNA vaccine encoding CLDN, which is based on BioNTech's mRNA-lipoplex technology to improve the persistence and functionality
of adoptive metastatic cells.
Indications include testicular cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, sarcoma and gastric cancer
.
The results of the trial showed that 6 of the 14 evaluable patients showed partial response, and 5 patients were stable with reduced
target lesions.
In addition to demonstrating the overall targeting efficacy, it also verifies the feasibility
of mRNA technology beyond the field of infectious diseases.
At the 2022 American Clinical Association Annual Meeting, Dr.
Vinod Balachandran of MSK Cancer Center shared BioNTech's mRNA-based personalized neoantigen-specific cancer vaccine BNT122 in combination with PD-L1 antibodies Atezolizumab and mFOLFIRINOX chemotherapy.
Safety
and tolerability results in phase I clinical trials in patients undergoing surgical resection for pancreatic cancer.
Figure 2 BNT122 is inThe results of the study-phase (Source: BioNTech website)
in various cancers showed that data read from 16 patients treated with BNT122 showed that BNT122 in combination with atezolizumab was well tolerated, and the treatment induced a new neoantigen-specific T cell response
in 50% of patients 。 Based on these data, BioNTech and Genentech are planning a randomized study to further evaluate the efficacy and safety
of BNT122 in combination with atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma.
BioNTech and Regeneron Pharmaceuticals are collaborating to develop BNT111, an mRNA vaccine for advanced melanoma, which is in phase
II.
Late last year, the FDA granted the vaccine fast-track designation
based on "available preclinical and clinical data show that BNT111 has the potential to overcome the limitations of current treatments for inoperable, drug-resistant advanced melanoma.
"
Figure 3 BNT111 is in the clinical phase II stage (Source: BioNTech official website)
In addition, for Moderna, in addition to mRNA-4157/V940, it also has KRAS vaccine (mRNA-5671), Checkpoint vaccines (mRNA-4359) and other vaccines
in the field of cancer treatment.
Figure 4 Moderna's mRNA cancer vaccine in the research and development stage (Source: Moderna official website)
believes that with the further deepening of research and development, cancer vaccines will successfully benefit the majority of cancer patients!
Written by| Muzijiu
Typesetting | Essay competition
End
Resources:
[1]https://investors.modernatx.
com/news/news-details/2022/ Merck-and-Moderna-Announce-Exercise-of-Option-by-Merck-for-Joint-Development-and-Commercialization-of-Investigational-Personalized-Cancer-Vaccine/default.
aspx [2] style="font-size: 12px;letter-spacing: 1px;" _mstmutation="1" _istranslated="1">[3]https://investors.
biontech.
de/news-releases/news-release-details/ biontech-presents-positive-preliminary-phase-12-data-first-class/[4]https://investors.
biontech.
de/news-releases/news-release-details/ positive-phase-1-data-mrna-based-individualized-neoantigen[5]https://s29.
q4cdn.
com/435878511/files/doc_presentations/2022/09/Moderna-Final-R-D-Day-Slides_ PDF-(09.
08.
22).
