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    Home > Medical News > Latest Medical News > The results of 10 popular tests such as Biogen, Merck, Gilead, etc. will be announced!

    The results of 10 popular tests such as Biogen, Merck, Gilead, etc. will be announced!

    • Last Update: 2022-08-20
    • Source: Internet
    • Author: User
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    In the first half of this year, there have been significant medical advances in the treatment of breast and lung cancer, CRISPR gene editing technology continues to show promise, and the FDA has successively approved several important new drugs, such as the first for the cause of obstructive hypertrophic cardiomyopathy hereditary heart failure Therapeutic Camzyos (mavacamten, Bristol-Myers Squibb, April 26) and the first glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist class New diabetes drug Mounjaro (tirzepatide, tiroparatide, Eli Lilly, May 13)
    .
     
    Looking at current trends, the second half of the year could see interesting results from clinical trials of drugs for Alzheimer's disease, cancer and vision loss
    .
    Recently, BiopharmaDive summarized 10 trials worth watching in the second half of the year
    .
     
    lecanemab (monoclonal antibody)
     
    Company: Eisai, Bojian
     
    Disease: Alzheimer's disease
     
    Trial name: ClarityAD
     
    Previously, lecanemab was the most inconspicuous of the Alzheimer’s disease drugs jointly developed by Eisai and Biogen, and its development “journey” was similar to the approved but controversial Aduhelm (aducanumab).

    .
    With lecanemab showing unexpectedly positive signs in trials, Eisai and Biogen appear to have an opportunity to seek FDA approval for it
    .
    A large confirmatory study, ClarityAD, is currently underway with lecanemab, enrolling nearly 2,000 patients with early-stage Alzheimer's disease and comparing lecanemab with placebo for up to 18 months
    .
    If the trial results are positive, the early data already obtained will be strengthened and further FDA decision-making on Aduhelm will be facilitated
    .
    The trial results are expected in the third quarter of this year
    .
     
      NTLA-2001 (Gene Editing)
     
      Company: Intellia Therapeutics
     
      Disease: Transthyretin amyloidosis cardiomyopathy
     
      Test name: NCT04601051
     
      Inherited heart disease has become a top target area for many drugmakers, and Intellia Therapeutics will report results from an early-stage trial testing gene-editing treatments in patients with TTR (transthyretin) cardiomyopathy by the end of the year
    .
    Previously, Intellia's therapy has shown initial success in patients characterized by nerve damage
    .
     
      If Intellia's results are positive, it will give hope to as many as half a million people in the U.
    S.
    and Europe affected by the disease
    .
    However, it will also put pressure on Alnylam, Ionis Pharmaceuticals and companies investing in the space
    .
    It is reported that the results of a study by Alnylam Pharmaceuticals also targeting the disease will be released soon
    .
     
      sotatercept (fusion protein)
     
      Company: Merck & Co.
     
      Disease: Pulmonary Arterial Hypertension
     
      Trial name: STELLAR
     
      Sotatercept, once the focal point of a collaboration between Acceleron and Celgene, appeared to hit a dead end after the study was removed from priority review status in 2016, and was later revived by testing it in pulmonary arterial hypertension
    .
     
      In 2020, its positive Phase II data and subsequent publication in the New England Journal of Medicine sent Acceleron shares soaring, and less than two years after Merck acquired Acceleron, it was also a bet on whether Sotatercept had the potential for a first-in-class therapy
    .
    By the end of this year, Merck is likely to report results from a study called STELLAR, the first of four phase III trials of the sotatercept receptor
    .
    With sotatercept, Merck hopes to justify its investment while making up for the revenue Keytruda will lose in 2028
    .
     
      KarXT (Small Molecule Drugs)
     
      Company: Karuna Therapeutics
     
      Disease : Schizophrenia
     
      Test Name: Emergent-2
     
      Brain drug developer Karuna Therapeutics has already had positive results in schizophrenia research, with a study of about 180 participants showing that people taking the drug Karuna (codenamed KarXT) had significantly less symptoms than those taking a placebo
    .
    Karuna hopes to build on the drug's evidence with two larger clinical trials, EMERGENT-2 and EMERGENT-3
    .
     
      Results of the EMERGENT-2 trial, which evaluated nearly 250 adult patients with schizophrenia over 5 weeks, showed that patients taking the drug "KarXT" showed significant improvement in symptoms compared to those taking a placebo
    .
    Compared with the placebo group, the KarXT group saw an average drop of 9.
    6 points in the medical scorecard, which measures the severity of schizophrenia symptoms, meeting the study's primary goal
    .
    Karuna said the trial was also successful on a secondary objective and was generally well tolerated
    .
    EMERGENT-3 results are expected in early 2023
    .
    The company plans to submit an application for approval by the middle of next year
    .
    In addition, Karuna intends to initiate a late-stage program this year to evaluate KarXT's efficacy in Alzheimer's disease
    .
     
      Padcev (antibody-drug conjugate)
     
      Company: Seagen
     
      Disease: Bladder Cancer
     
      Trial name: EV103, CohortK
     
      Seagen, which has been tumultuous over the past few months, is awaiting interim results from a major clinical trial testing Padcev (enfortumab vedotin) along with Merck's immunotherapy Keytruda in patients with newly diagnosed advanced bladder tumors
    .
     
      Analysts believe the trial will have an important impact on Seagen, as positive results and an application for accelerated approval will unlock a market opportunity worth about $7 billion and accelerate Seagen's path to profitability
    .
     
      Zimura (oligonucleotide)
     
      Company: IvericBio
     
      Disease: Geographic Atrophy (macular degeneration)
     
      Zimura, Iveric's valuable asset inherited from the Ophthotech days, is undergoing clinical trials for geographic atrophy, a type of blindness disease for which there is no effective treatment
    .
    The results of its third phase are expected in the third quarter of this year
    .
     
      Zimura has previously been successful in a phase III trial, the results of which will be published in the Journal of the American Academy of Ophthalmology in 2020
    .
     
      Lumakras (Small Molecule Drugs)
     
      Company: Amgen
     
      Disease: Lung cancer
     
      The KRAS gene targeted by Lumakras (sotorasib) is commonly mutated in lung, colon and pancreatic cancers
    .
    Earlier research found that Lumakras shrank tumors and slowed disease progression in trials of lung cancer patients, an early hope that earned it accelerated approval from the FDA
    .
    But the toughest test for Lumakras is now in an ongoing large-scale study, in which Lumakras goes head-to-head with standard chemotherapy for KRAS-mutated lung cancer
    .
     
      Results are expected in the third quarter of this year, and if the results are positive, Amgen may convert its conditional license to full approval
    .
    Strong data will also help it stay ahead of its competitors
    .
     
      resmetirom (small molecule drug)
     
      Company: Madrigal Pharmaceuticals
     
      Disease: nonalcoholic steatohepatitis
     
      Trial name: MAESTRO-NASH
     
      Non-alcoholic steatohepatitis (NASH) affects millions of people and is a long-standing area for pharmaceutical companies
    .
    Previously, a series of high-profile experimental drugs have failed key clinical trials
    .
    The only drug Ocaliva (obeticholic acid, OCA) from Intercept Pharmaceuticals, which has been successful in phase III studies, has not yet been approved by the US FDA
    .
    These setbacks also preserve NASH's huge R&D prospects, of which Madrigal's resmetirom is a competitive player
    .
     
      Resmetirom is a drug that helps regulate liver function and promote thyroid hormone activity.
    It has a positive effect on certain liver health -related biomarkers, and has not shown serious side effects in clinical trials
    .
    But it's unclear whether resmetirom can alter the course of NASH
    .
    The answer will be revealed in the fourth quarter of this year, when Madrigal will report top-line results from its Phase 3 study
    .
     
      domvanalimab (monoclonal antibody)
     
      Companies: Arcus Bioscience, Gilead
     
      Disease: Lung cancer
     
      Test name: ARC-7
     
      In recent years, a group of drugs targeting the cellular target TIGIT (the most popular immune checkpoint after PD-1) has attracted the attention of the industry
    .
    Pharmaceutical companies hope to build on the success of cancer immunotherapy with the TIGIT drug to build on the latest treatments
    .
    However, the outlook does not seem so bright
    .
    Since March, Roche's tilagorumab failed phase III trials in both types of lung cancer, sparking widespread skepticism of the TIGIT class and sending shares of several developers lower
    .
     
      Arcus Biosciences and Gilead have been collaborating in this area since 2020
    .
    Results from a phase II study of its TIGIT drug domvanalimab in patients with non-small cell lung cancer may be available by the end of this year
    .
    If the results are positive, it may boost the morale of other companies working on TIGIT drugs, such as Bristol-Myers Squibb and Compugen, but it should not be blindly optimistic.
    After all, Roche's drugs have also been successful in the second phase
    .
     
      FT596 (Cell Therapy)
     
      Disease: B-cell lymphoma
     
      Test name: NCT04245722
     
      To replace the personalized CAR-T treatments from Novartis, Gilead and Bristol-Myers Squibb, some drugmakers are working to develop more convenient cell therapies, and have proposed one that involves genetically modifying "natural killer" or NK cells.
    strategy, these cells have characteristics that T cells involved in CAR-T therapy do not have and are safer
    .
     
      An NK cell therapy from Fate, Nkarta and co-developed by MD Anderson Cancer Center and biotech company Affimed has shown promise in treating blood cancers without the potentially lethal side effects associated with CAR-T
    .
    However, these studies are still in the early stages, and it is not yet possible to prove how long the effects of NK cell therapy will last
    .
    Other approaches involving T cells are difficult to compare with the durability of CAR-T, and some investors are also skeptical of NK cell therapy because of their inherently short life cycle
    .
    Fate is expected to report results this year on an experimental lymphoma treatment, code-named FT596, with the antibody drug rituximab, and it remains to be seen whether it will be a glimmer of hope for NK cell therapy in the fog
    .
      In the first half of this year, there have been significant medical advances in the treatment of breast and lung cancer, CRISPR gene editing technology continues to show promise, and the FDA has successively approved several important new drugs, such as the first for the cause of obstructive hypertrophic cardiomyopathy hereditary heart failure Therapeutic Camzyos (mavacamten, Bristol-Myers Squibb, April 26) and the first glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist class New diabetes drug Mounjaro (tirzepatide, tiroparatide, Eli Lilly, May 13)
    .
     
      Looking at current trends, the second half of the year could see interesting results from clinical trials of drugs for Alzheimer's disease, cancer and vision loss
    .
    Recently, BiopharmaDive summarized 10 trials worth watching in the second half of the year
    .
     
      lecanemab (monoclonal antibody)
    lecanemab (monoclonal antibody)
     
      Company: Eisai, Bojian
    Company: Eisai, Bojian
     
      Disease: Alzheimer's disease
    Disease: Alzheimer's disease
     
      Trial name: ClarityAD
    Trial name: ClarityAD
     
      Previously, lecanemab was the most inconspicuous of the Alzheimer’s disease drugs jointly developed by Eisai and Biogen, and its development “journey” was similar to the approved but controversial Aduhelm (aducanumab).

    .
    With lecanemab showing unexpectedly positive signs in trials, Eisai and Biogen appear to have an opportunity to seek FDA approval for it
    .
    A large confirmatory study, ClarityAD, is currently underway with lecanemab, enrolling nearly 2,000 patients with early-stage Alzheimer's disease and comparing lecanemab with placebo for up to 18 months
    .
    If the trial results are positive, the early data already obtained will be strengthened and further FDA decision-making on Aduhelm will be facilitated
    .
    The trial results are expected in the third quarter of this year
    .
     
      NTLA-2001 (Gene Editing)
    NTLA-2001 (Gene Editing)
     
      Company: Intellia Therapeutics
    Company: Intellia Therapeutics
     
      Disease: Transthyretin amyloidosis cardiomyopathy
    Disease: Transthyretin amyloidosis cardiomyopathy
     
      Test name: NCT04601051
    Test name: NCT04601051
     
      Inherited heart disease has become a top target area for many drugmakers, and Intellia Therapeutics will report results from an early-stage trial testing gene-editing treatments in patients with TTR (transthyretin) cardiomyopathy by the end of the year
    .
    Previously, Intellia's therapy has shown initial success in patients characterized by nerve damage
    .
    heart heart
     
      If Intellia's results are positive, it will give hope to as many as half a million people in the U.
    S.
    and Europe affected by the disease
    .
    However, it will also put pressure on Alnylam, Ionis Pharmaceuticals and companies investing in the space
    .
    It is reported that the results of a study by Alnylam Pharmaceuticals also targeting the disease will be released soon
    .
     
      sotatercept (fusion protein)
    sotatercept (fusion protein)
     
      Company: Merck & Co.
    Company: Merck & Co.
     
      Disease: Pulmonary Arterial Hypertension
    Diseases: pulmonary arterial hypertension , hypertension , hypertension
     
      Trial name: STELLAR
    Trial name: STELLAR
     
      Sotatercept, once the focal point of a collaboration between Acceleron and Celgene, appeared to hit a dead end after the study was removed from priority review status in 2016, and was later revived by testing it in pulmonary arterial hypertension
    .
     
      In 2020, its positive Phase II data and subsequent publication in the New England Journal of Medicine sent Acceleron shares soaring, and less than two years after Merck acquired Acceleron, it was also a bet on whether Sotatercept had the potential for a first-in-class therapy
    .
    By the end of this year, Merck is likely to report results from a study called STELLAR, the first of four phase III trials of the sotatercept receptor
    .
    With sotatercept, Merck hopes to justify its investment while making up for the revenue Keytruda will lose in 2028
    .
     
      KarXT (Small Molecule Drugs)
    KarXT (Small Molecule Drugs)
     
      Company: Karuna Therapeutics
    Company: Karuna Therapeutics
     
      Disease : Schizophrenia
    disease disease disease : schizophrenia
     
      Test Name: Emergent-2
    Test Name: Emergent-2
     
      Brain drug developer Karuna Therapeutics has already had positive results in schizophrenia research, with a study of about 180 participants showing that people taking the drug Karuna (codenamed KarXT) had significantly less symptoms than those taking a placebo
    .
    Karuna hopes to build on the drug's evidence with two larger clinical trials, EMERGENT-2 and EMERGENT-3
    .
     
      Results of the EMERGENT-2 trial, which evaluated nearly 250 adult patients with schizophrenia over 5 weeks, showed that patients taking the drug "KarXT" showed significant improvement in symptoms compared to those taking a placebo
    .
    Compared with the placebo group, the KarXT group saw an average drop of 9.
    6 points in the medical scorecard, which measures the severity of schizophrenia symptoms, meeting the study's primary goal
    .
    Karuna said the trial was also successful on a secondary objective and was generally well tolerated
    .
    EMERGENT-3 results are expected in early 2023
    .
    The company plans to submit an application for approval by the middle of next year
    .
    In addition, Karuna intends to initiate a late-stage program this year to evaluate KarXT's efficacy in Alzheimer's disease
    .
     
      Padcev (antibody-drug conjugate)
    Padcev (antibody-drug conjugate)
     
      Company: Seagen
    Company: Seagen
     
      Disease: Bladder Cancer
    Disease: Bladder Cancer
     
      Trial name: EV103, CohortK
     
      Seagen, which has been tumultuous over the past few months, is awaiting interim results from a major clinical trial testing Padcev (enfortumab vedotin) along with Merck's immunotherapy Keytruda in patients with newly diagnosed advanced bladder tumors
    .
     
      Analysts believe the trial will have an important impact on Seagen, as positive results and an application for accelerated approval will unlock a market opportunity worth about $7 billion and accelerate Seagen's path to profitability
    .
     
      Zimura (oligonucleotide)
    Zimura (oligonucleotide)
     
      Company: IvericBio
    Company: IvericBio
     
      Disease: Geographic Atrophy (macular degeneration)
     
      Zimura, Iveric's valuable asset inherited from the Ophthotech days, is undergoing clinical trials for geographic atrophy, a type of blindness disease for which there is no effective treatment
    .
    The results of its third phase are expected in the third quarter of this year
    .
     
      Zimura has previously been successful in a phase III trial, the results of which will be published in the Journal of the American Academy of Ophthalmology in 2020
    .
     
      Lumakras (Small Molecule Drugs)
    Lumakras (Small Molecule Drugs)
     
      Company: Amgen
    Company: Amgen
     
      Disease: Lung cancer
    Disease: Lung cancer
     
      The KRAS gene targeted by Lumakras (sotorasib) is commonly mutated in lung, colon and pancreatic cancers
    .
    Earlier research found that Lumakras shrank tumors and slowed disease progression in trials of lung cancer patients, an early hope that earned it accelerated approval from the FDA
    .
    But the toughest test for Lumakras is now in an ongoing large-scale study, in which Lumakras goes head-to-head with standard chemotherapy for KRAS-mutated lung cancer
    .
    standard standard
     
      Results are expected in the third quarter of this year, and if the results are positive, Amgen may convert its conditional license to full approval
    .
    Strong data will also help it stay ahead of its competitors
    .
     
      resmetirom (small molecule drug)
    resmetirom (small molecule drug)
     
      Company: Madrigal Pharmaceuticals
    Company: Madrigal Pharmaceuticals
     
      Disease: nonalcoholic steatohepatitis
    Disease: nonalcoholic steatohepatitis
     
      Trial name: MAESTRO-NASH
    Trial name: MAESTRO-NASH
     
      Non-alcoholic steatohepatitis (NASH) affects millions of people and is a long-standing area for pharmaceutical companies
    .
    Previously, a series of high-profile experimental drugs have failed key clinical trials
    .
    The only drug Ocaliva (obeticholic acid, OCA) from Intercept Pharmaceuticals, which has been successful in phase III studies, has not yet been approved by the US FDA
    .
    These setbacks also preserve NASH's huge R&D prospects, of which Madrigal's resmetirom is a competitive player
    .
     
      Resmetirom is a drug that helps regulate liver function and promote thyroid hormone activity.
    It has a positive effect on certain liver health -related biomarkers, and has not shown serious side effects in clinical trials
    .
    But it's unclear whether resmetirom can alter the course of NASH
    .
    The answer will be revealed in the fourth quarter of this year, when Madrigal will report top-line results from its Phase 3 study
    .
    healthy and healthy
     
      domvanalimab (monoclonal antibody)
    domvanalimab (monoclonal antibody)
     
      Companies: Arcus Bioscience, Gilead
    Companies: Arcus Bioscience, Gilead
     
      Disease: Lung cancer
    Disease: Lung cancer
     
      Test name: ARC-7
    Test name: ARC-7
     
      In recent years, a group of drugs targeting the cellular target TIGIT (the most popular immune checkpoint after PD-1) has attracted the attention of the industry
    .
    Pharmaceutical companies hope to build on the success of cancer immunotherapy with the TIGIT drug to build on the latest treatments
    .
    However, the outlook does not seem so bright
    .
    Since March, Roche's tilagorumab failed phase III trials in both types of lung cancer, sparking widespread skepticism of the TIGIT class and sending shares of several developers lower
    .
     
      Arcus Biosciences and Gilead have been collaborating in this area since 2020
    .
    Results from a phase II study of its TIGIT drug domvanalimab in patients with non-small cell lung cancer may be available by the end of this year
    .
    If the results are positive, it may boost the morale of other companies working on TIGIT drugs, such as Bristol-Myers Squibb and Compugen, but it should not be blindly optimistic.
    After all, Roche's drugs have also been successful in the second phase
    .
     
      FT596 (Cell Therapy)
    FT596 (Cell Therapy)
     
      Disease: B-cell lymphoma
    Disease: B-cell lymphoma
     
      Test name: NCT04245722
    Test name: NCT04245722
     
      To replace the personalized CAR-T treatments from Novartis, Gilead and Bristol-Myers Squibb, some drugmakers are working to develop more convenient cell therapies, and have proposed one that involves genetically modifying "natural killer" or NK cells.
    strategy, these cells have characteristics that T cells involved in CAR-T therapy do not have and are safer
    .
     
      An NK cell therapy from Fate, Nkarta and co-developed by MD Anderson Cancer Center and biotech company Affimed has shown promise in treating blood cancers without the potentially lethal side effects associated with CAR-T
    .
    However, these studies are still in the early stages, and it is not yet possible to prove how long the effects of NK cell therapy will last
    .
    Other approaches involving T cells are difficult to compare with the durability of CAR-T, and some investors are also skeptical of NK cell therapy because of their inherently short life cycle
    .
    Fate is expected to report results this year on an experimental lymphoma treatment, code-named FT596, with the antibody drug rituximab, and it remains to be seen whether it will be a glimmer of hope for NK cell therapy in the fog
    .
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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