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February 17, 2022/eMedClub News/--On February 14, 2022, Astellas and Seagen announced their co-developed ADC drug PADCEV® (enfortumab vedotin-ejfv), a single drug Preliminary results from the EV-103 study H cohort in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin-based chemotherapy
.
This latest abstract data (Abstract No.
435) will be included in an oral presentation at the 2022 ASCO Genitourinary Cancer Symposium (ASCO GU)
.
MIBC accounts for about 25% of bladder cancers and is marked by tumor spread to the muscularis of the bladder wall
.
Treatment of MIBC typically combines cisplatin-based chemotherapy with radical cystectomy and pelvic lymph node dissection
.
MIBC has a poor survival rate, with a five-year survival rate of only 45% regardless of treatment
.
Enfortumab vedotin is an ADC drug targeting Nectin-4, a protein located on the cell surface and highly expressed in bladder cancer
.
Preclinical data suggest that the antitumor activity of enfortumab vedotin is due to its binding to cells expressing the Nectin-4 protein, followed by internalization and release of the antitumor component monomethylauristatin E (MMAE) into cells, resulting in cellular Stops proliferation (cell cycle arrest) and programmed cell death (apoptosis)
.
EV-103 study (NCT03288545) is an open-label, multi-cohort, multi-center Phase 1b/2 clinical trial to evaluate the efficacy of enfortumab vedotin as a single agent or in combination in the treatment of MIBC, first- or second-line locally advanced or metastatic uropathic Safety, tolerability and efficacy in skin cancer (la/mUC)
.
The H cohort of the EV-103 study included patients with MIBC who were candidates for surgery but were unable to receive cisplatin-based chemotherapy
.
Patients received 3 cycles of enfortumab vedotin monotherapy neoadjuvant therapy (before surgery) on days 1 and 8 every 3 weeks
.
Results from a preliminary analysis of 22 patients in cohort H showed that 36.
4% had a pathological complete response (pCR), meeting the primary endpoint, with no evidence of cancer on microscopic examination of tissue cells removed during surgery
.
Half (50%) of patients had pathological stage reduction or tumor reduction, meeting the study's secondary endpoints
.
All patients underwent surgery, and none were delayed due to enfortumab vedotin treatment
.
The most common (≥20%) adverse events (AEs) associated with enfortumab vedotin treatment were fatigue (45.
5%), alopecia (36.
4%), dysgeusia (36.
4%), diarrhea (27.
3%), nausea (27.
3%) , peripheral sensory neuropathy (27.
3%), dry eye (22.
7%), and maculopapular rash (22.
7%), consistent with the known safety profile of enfortumab vedotin
.
"Results from the H cohort of the EV-103 study showed that when patients received enfortumab vedotin before surgery, more than a third of patients showed no signs of cancer when their bladder was removed and the residual tumor was examined under a microscope
.
Daniel Petrylak, MD, professor of medicine (medical oncology) and urology at the Yale School of Medicine, co-director of the Yale Cancer Center Cancer Signaling Network, and principal investigator of the H cohort of the EV-103 study, said, "After treatment with enfortumab vedotin, all All patients underwent surgery
.
Given that no standard neoadjuvant therapy is currently available for patients who cannot receive cisplatin, these results are important and support further research
.
"Astellas' Strong Layout As a leading Japanese pharmaceutical company and a global multinational pharmaceutical giant, Astellas has always focused on the fields of oncology, immune diseases, muscle diseases and eye diseases
.
In addition to traditional small-molecule drugs, Ansi has Tailai is also committed to the research and development
of innovative biological drugs such as macromolecular antibody drugs, second-generation vaccines, gene therapy, cell therapy, etc.
On February 10, 2022, zolbetuximab for injection declared by Astellas received a clinical trial in China The trial has implied permission, and the indication is the first-line treatment of patients with metastatic pancreatic cancer
.
According to public information, zolbetuximab is an antibody drug targeting Claudin 18.
2 (CLDN18.
2), which was approved by Astellas in 2016 for 1.
4 billion The US dollar acquisition of the company is currently in the phase 3 clinical research stage worldwide
.
On February 7, 2022, Astellas announced the positive interim data of its AAV gene replacement therapy AT845 in the phase 1/2 clinical trial.
The drug provides a functional alpha-glucosidase (GAA) gene for the treatment of late-onset Pompe disease (LOPD)
.
The results showed that AT845 demonstrated an encouraging safety profile during the follow-up period of week 24 after administration
More
importantly, none of the four subjects reported serious adverse events after dosing
.
On December 1, 2021, Astellas announced that it has signed a license agreement with Dyno Therapeutics and executed an option to use Dyno's CapsidMap™ platform to develop next-generation AAV vectors for gene therapy targeting skeletal and cardiac muscle
.
Astellas will pay $18 million upfront and up to $1.
6 billion in milestones and royalties to develop AAV vectors for gene therapy
.
On July 30, 2021, Astellas announced a global strategic collaboration and licensing agreement to advance the research, development and commercialization of novel cell therapies for diseases associated with mitochondrial dysfunction
.
The two companies will jointly investigate candidate cell therapies utilizing Astellas genetically engineered induced pluripotent stem cells (iPSCs) and further improved using Minovia's proprietary mitochondrial enhancement therapy (MAT) technology platform
.
On March 26, 2020, Astellas and CytomX established a strategic partnership worth over $1.
6 billion to discover and develop novel T-cell engaging bispecific antibodies that target CD3 and tumor cell surface antigens to treat cancer
.
On January 14, 2020, Astellas and UK-based Adaptimmune Therapeutics entered into a partnership agreement worth up to US$897.
5 million to jointly develop and commercialize stem cell-derived allogeneic T cell therapies (CAR-T and TCR-T )
.
Adaptimmune has a unique SPEAR (Specific Peptide Enhanced Affinity Receptor, specific peptide enhanced affinity receptor) T cell platform (TCR-T), which can target and destroy a variety of malignant tumors including solid tumors through the transformation of T cells tumor
.
It can be seen that in recent years, Astellas has invested heavily in the fields of tumor immunity, cell and gene therapy, and rare diseases, and has achieved remarkable results
.
It is expected that this company will use the professional and technical advantages of itself and its partners to develop more and more advanced therapeutic products to benefit more patients in need
.
Reference: https:// -cancer-not-eligible-for-cisplatin-chemotherapy/
.
This latest abstract data (Abstract No.
435) will be included in an oral presentation at the 2022 ASCO Genitourinary Cancer Symposium (ASCO GU)
.
MIBC accounts for about 25% of bladder cancers and is marked by tumor spread to the muscularis of the bladder wall
.
Treatment of MIBC typically combines cisplatin-based chemotherapy with radical cystectomy and pelvic lymph node dissection
.
MIBC has a poor survival rate, with a five-year survival rate of only 45% regardless of treatment
.
Enfortumab vedotin is an ADC drug targeting Nectin-4, a protein located on the cell surface and highly expressed in bladder cancer
.
Preclinical data suggest that the antitumor activity of enfortumab vedotin is due to its binding to cells expressing the Nectin-4 protein, followed by internalization and release of the antitumor component monomethylauristatin E (MMAE) into cells, resulting in cellular Stops proliferation (cell cycle arrest) and programmed cell death (apoptosis)
.
EV-103 study (NCT03288545) is an open-label, multi-cohort, multi-center Phase 1b/2 clinical trial to evaluate the efficacy of enfortumab vedotin as a single agent or in combination in the treatment of MIBC, first- or second-line locally advanced or metastatic uropathic Safety, tolerability and efficacy in skin cancer (la/mUC)
.
The H cohort of the EV-103 study included patients with MIBC who were candidates for surgery but were unable to receive cisplatin-based chemotherapy
.
Patients received 3 cycles of enfortumab vedotin monotherapy neoadjuvant therapy (before surgery) on days 1 and 8 every 3 weeks
.
Results from a preliminary analysis of 22 patients in cohort H showed that 36.
4% had a pathological complete response (pCR), meeting the primary endpoint, with no evidence of cancer on microscopic examination of tissue cells removed during surgery
.
Half (50%) of patients had pathological stage reduction or tumor reduction, meeting the study's secondary endpoints
.
All patients underwent surgery, and none were delayed due to enfortumab vedotin treatment
.
The most common (≥20%) adverse events (AEs) associated with enfortumab vedotin treatment were fatigue (45.
5%), alopecia (36.
4%), dysgeusia (36.
4%), diarrhea (27.
3%), nausea (27.
3%) , peripheral sensory neuropathy (27.
3%), dry eye (22.
7%), and maculopapular rash (22.
7%), consistent with the known safety profile of enfortumab vedotin
.
"Results from the H cohort of the EV-103 study showed that when patients received enfortumab vedotin before surgery, more than a third of patients showed no signs of cancer when their bladder was removed and the residual tumor was examined under a microscope
.
Daniel Petrylak, MD, professor of medicine (medical oncology) and urology at the Yale School of Medicine, co-director of the Yale Cancer Center Cancer Signaling Network, and principal investigator of the H cohort of the EV-103 study, said, "After treatment with enfortumab vedotin, all All patients underwent surgery
.
Given that no standard neoadjuvant therapy is currently available for patients who cannot receive cisplatin, these results are important and support further research
.
"Astellas' Strong Layout As a leading Japanese pharmaceutical company and a global multinational pharmaceutical giant, Astellas has always focused on the fields of oncology, immune diseases, muscle diseases and eye diseases
.
In addition to traditional small-molecule drugs, Ansi has Tailai is also committed to the research and development
of innovative biological drugs such as macromolecular antibody drugs, second-generation vaccines, gene therapy, cell therapy, etc.
On February 10, 2022, zolbetuximab for injection declared by Astellas received a clinical trial in China The trial has implied permission, and the indication is the first-line treatment of patients with metastatic pancreatic cancer
.
According to public information, zolbetuximab is an antibody drug targeting Claudin 18.
2 (CLDN18.
2), which was approved by Astellas in 2016 for 1.
4 billion The US dollar acquisition of the company is currently in the phase 3 clinical research stage worldwide
.
On February 7, 2022, Astellas announced the positive interim data of its AAV gene replacement therapy AT845 in the phase 1/2 clinical trial.
The drug provides a functional alpha-glucosidase (GAA) gene for the treatment of late-onset Pompe disease (LOPD)
.
The results showed that AT845 demonstrated an encouraging safety profile during the follow-up period of week 24 after administration
More
importantly, none of the four subjects reported serious adverse events after dosing
.
On December 1, 2021, Astellas announced that it has signed a license agreement with Dyno Therapeutics and executed an option to use Dyno's CapsidMap™ platform to develop next-generation AAV vectors for gene therapy targeting skeletal and cardiac muscle
.
Astellas will pay $18 million upfront and up to $1.
6 billion in milestones and royalties to develop AAV vectors for gene therapy
.
On July 30, 2021, Astellas announced a global strategic collaboration and licensing agreement to advance the research, development and commercialization of novel cell therapies for diseases associated with mitochondrial dysfunction
.
The two companies will jointly investigate candidate cell therapies utilizing Astellas genetically engineered induced pluripotent stem cells (iPSCs) and further improved using Minovia's proprietary mitochondrial enhancement therapy (MAT) technology platform
.
On March 26, 2020, Astellas and CytomX established a strategic partnership worth over $1.
6 billion to discover and develop novel T-cell engaging bispecific antibodies that target CD3 and tumor cell surface antigens to treat cancer
.
On January 14, 2020, Astellas and UK-based Adaptimmune Therapeutics entered into a partnership agreement worth up to US$897.
5 million to jointly develop and commercialize stem cell-derived allogeneic T cell therapies (CAR-T and TCR-T )
.
Adaptimmune has a unique SPEAR (Specific Peptide Enhanced Affinity Receptor, specific peptide enhanced affinity receptor) T cell platform (TCR-T), which can target and destroy a variety of malignant tumors including solid tumors through the transformation of T cells tumor
.
It can be seen that in recent years, Astellas has invested heavily in the fields of tumor immunity, cell and gene therapy, and rare diseases, and has achieved remarkable results
.
It is expected that this company will use the professional and technical advantages of itself and its partners to develop more and more advanced therapeutic products to benefit more patients in need
.
Reference: https:// -cancer-not-eligible-for-cisplatin-chemotherapy/
