- Merck details PhII TIGIT/PD-1 fail in lung cancer Endpoints News
- Merck stock falls as cancer trial for Keytruda combo fails Seeking Alpha
- Merck’s lung cancer drug combo fails trial in setback for new therapy class Reuters
- Merck & Co. digs into TIGIT fail, sharing survival data from phase 2 lung cancer trial FierceBiotech
- Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Business Wire
Tag Archives: Merck
Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading – CNBC
- Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading CNBC
- Cancer vaccines poised to unlock ‘new treatment paradigm’ with Merck/Moderna data Yahoo News
- Cancer vaccines poised to unlock ‘new treatment paradigm’ with Merck/Moderna data Reuters
- Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Yahoo Finance
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Moderna, Merck say their cancer vaccine reduces metastases by 65% in PhII study of high-risk melanoma: #ASCO23 – Endpoints News
- Moderna, Merck say their cancer vaccine reduces metastases by 65% in PhII study of high-risk melanoma: #ASCO23 Endpoints News
- Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading CNBC
- Cancer vaccines poised to unlock ‘new treatment paradigm’ with Merck/Moderna data KSL.com
- Moderna and Merck reveal new data on individualized cancer treatment MarketWatch
- Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Yahoo Finance
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Moderna and Merck Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination with KEYTRUDA(R) (Pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Patients with High-Risk Stage III/IV Melano – Moderna Investor Relations
- Moderna and Merck Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination with KEYTRUDA(R) (Pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Patients with High-Risk Stage III/IV Melano Moderna Investor Relations
- AACR 2023 – more hope for Moderna’s neoantigen immunotherapy Evaluate Pharma
- Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial The Lancet
- Phase 2 Data of Personalized Cancer Vaccine With Adjuvant Pembrolizumab for Resected High-Risk Melanoma Dermatology Times
- Merck clashes with AstraZeneca in biliary tract cancer FiercePharma
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Moderna and Merck Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination with KEYTRUDA(R) (Pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Patients with High-Risk Stage III/IV Melano – news.modernatx.com
- Moderna and Merck Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination with KEYTRUDA(R) (Pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Patients with High-Risk Stage III/IV Melano news.modernatx.com
- Including Anti-PD-1 in First-Line Ups Survival in Biliary Tract Cancer Medpage Today
- AACR 2023 – more hope for Moderna’s neoantigen immunotherapy evaluate.com
- Phase 2 Data of Personalized Cancer Vaccine With Adjuvant Pembrolizumab for Resected High-Risk Melanoma Dermatology Times
- Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial The Lancet
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Merck Announces Phase 3 KEYNOTE-671 Trial Met Primary Endpoint of Event-Free Survival (EFS) in Patients With Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer – Merck
- Merck Announces Phase 3 KEYNOTE-671 Trial Met Primary Endpoint of Event-Free Survival (EFS) in Patients With Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer Merck
- Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer FiercePharma
- Merck Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789 businesswire.com
- Pembrolizumab Plus Standard Therapy Falls Short in mCRPC, EGFR-Mutant NSCLC Trials OncLive
- Merck scraps third prostate cancer study as Keytruda therapy disappoints Reuters
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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination With KEYTRUDA(R) (pembrolizumab), was Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients – Moderna Investor Relations
- Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination With KEYTRUDA(R) (pembrolizumab), was Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients Moderna Investor Relations
- Moderna Pops On An FDA Boon For Its Merck-Tied Cancer Vaccine Investor’s Business Daily
- Moderna expands CRISPR gene editing research with ElevateBio partnership The Boston Globe
- Moderna’s combination skin cancer therapy receives FDA’s breakthrough tag Reuters
- Moderna taps Life Edit to develop next-gen gene therapies FierceBiotech
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J&J and Merck Ebola vaccines produce lasting antibodies in children and adults
Ebola vaccines developed by Johnson & Johnson and Merck & Co produced virus-fighting antibodies and appear to be safe in children and adults, according to data from two studies published on Wednesday.
Both companies’ vaccines produced antibodies 14 days after the first of two shots and were detectable at varying levels in both children and adults for one year, data from the studies conducted in Western Africa showed.
The vaccines are designed to target the Zaire strain of the virus, not the Sudan strain of Ebola that recently caused an outbreak and at least 56 deaths in Uganda.
The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid (Reuters Photos)
One regimen tested a dose of J&J’s vaccine, followed by a booster shot of a vaccine from Danish drugmaker Bavarian Nordic, while another tested two doses of Merck’s vaccine with eight weeks in between. A third option followed the first Merck dose with a placebo.
MODERNA AND MERCK TEAM-UP TO FIGHT MELANOMA
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| JNJ | JOHNSON & JOHNSON | 179.79 | +0.35 | +0.20% |
| MRK | MERCK & CO. INC. | 111.55 | +1.37 | +1.24% |
“I think the study shows that both the vaccines elicit good antibody responses,” said Dr. H. Clifford Lane, one of the researchers and a clinical director at the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
Only Merck’s shot can potentially be given as a single dose while J&J’s vaccine may need to continue as a two-dose regimen, Lane added.
FILE- This May 1, 2018, file photo shows Merck corporate headquarters in Kenilworth, N.J. Shares of Merck and Moderna jumped early Tuesday, Dec. 13, 2022, after the drugmakers said a potential skin cancer vaccine they are developing using the same te (AP Photo/Seth Wenig, File / AP Newsroom)
The NIH researchers noted that they were unable to assess the actual level of protection against the disease from the vaccines as no participants contracted Ebola during the trial, which began enrollment in 2017. But they said the vaccines were found to be safe for children and adults.
GSK VACCINE FOR OLDER ADULTS GRANTED FDA PRIORITY REVIEW
“Long-term follow up of the participants in this trial is taking place to determine if and when booster doses might be needed,” said Brian Greenwood, a study co-author from the London School of Hygiene & Tropical Medicine.
A total of 1,400 adults and 1,401 children aged 1 to 17 years old participated in the trials conducted in collaboration with Liberia Ministry of Health and with the University Clinical Research Center and the Center for Vaccine Development-Mali.
The results were published in The New England Journal of Medicine.
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Merck’s vaccine Ervebo was approved by the European regulator and prequalified by the World Health Organization in 2019. J&J’s Zabdeno got European and WHO clearances in 2020 and 2021, respectively. Bavarian Nordic’s Mvabea, used in the J&J regimen, also received European approval in 2020 and WHO prequalification in 2021.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| BVNRY | BAVARIAN NORDIC | 10.43 | +0.00 | +0.00% |
J&J and Merck Ebola vaccines produce lasting antibodies in children and adults
Ebola vaccines developed by Johnson & Johnson and Merck & Co produced virus-fighting antibodies and appear to be safe in children and adults, according to data from two studies published on Wednesday.
Both companies’ vaccines produced antibodies 14 days after the first of two shots and were detectable at varying levels in both children and adults for one year, data from the studies conducted in Western Africa showed.
The vaccines are designed to target the Zaire strain of the virus, not the Sudan strain of Ebola that recently caused an outbreak and at least 56 deaths in Uganda.
The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid (Reuters Photos)
One regimen tested a dose of J&J’s vaccine, followed by a booster shot of a vaccine from Danish drugmaker Bavarian Nordic, while another tested two doses of Merck’s vaccine with eight weeks in between. A third option followed the first Merck dose with a placebo.
MODERNA AND MERCK TEAM-UP TO FIGHT MELANOMA
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| JNJ | JOHNSON & JOHNSON | 179.79 | +0.35 | +0.20% |
| MRK | MERCK & CO. INC. | 111.55 | +1.37 | +1.24% |
“I think the study shows that both the vaccines elicit good antibody responses,” said Dr. H. Clifford Lane, one of the researchers and a clinical director at the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
Only Merck’s shot can potentially be given as a single dose while J&J’s vaccine may need to continue as a two-dose regimen, Lane added.
FILE- This May 1, 2018, file photo shows Merck corporate headquarters in Kenilworth, N.J. Shares of Merck and Moderna jumped early Tuesday, Dec. 13, 2022, after the drugmakers said a potential skin cancer vaccine they are developing using the same te (AP Photo/Seth Wenig, File / AP Newsroom)
The NIH researchers noted that they were unable to assess the actual level of protection against the disease from the vaccines as no participants contracted Ebola during the trial, which began enrollment in 2017. But they said the vaccines were found to be safe for children and adults.
GSK VACCINE FOR OLDER ADULTS GRANTED FDA PRIORITY REVIEW
“Long-term follow up of the participants in this trial is taking place to determine if and when booster doses might be needed,” said Brian Greenwood, a study co-author from the London School of Hygiene & Tropical Medicine.
A total of 1,400 adults and 1,401 children aged 1 to 17 years old participated in the trials conducted in collaboration with Liberia Ministry of Health and with the University Clinical Research Center and the Center for Vaccine Development-Mali.
The results were published in The New England Journal of Medicine.
CLICK HERE TO GET THE FOX BUSINESS APP
Merck’s vaccine Ervebo was approved by the European regulator and prequalified by the World Health Organization in 2019. J&J’s Zabdeno got European and WHO clearances in 2020 and 2021, respectively. Bavarian Nordic’s Mvabea, used in the J&J regimen, also received European approval in 2020 and WHO prequalification in 2021.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| BVNRY | BAVARIAN NORDIC | 10.43 | +0.00 | +0.00% |
Positive Moderna, Merck cancer vaccine data advances mRNA promise, shares rise
CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.
A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.
The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.
Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.
The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.
“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.
Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”
The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.
The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.
A PROMISING FIELD
In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.
The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.
To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.
When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.
Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.
Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.
Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.
Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.
Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.
“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.
Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.
Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.