Cancer cell therapies: the clinical trial landscape

Cancer cell therapies: the clinical trial landscape

Cell therapies constitute the largest number of agents in development in immuno-oncolog. In a recent review, American researchers provide an update on the pipeline and clinical trials of cancer cell therapies. They also compare the current landscape (with a March 2020 data cut-off point) with our previous update from March 2019). The current global cancer cell therapy pipeline includes 1,483 active agents, 472 more than last year. Among the different cell therapy types, the chimeric antigen receptor (CAR)-T cell class has the largest increase (290 agents this year versus 164 in 2019), whereas novel T cell approaches (such as CRISPR ...
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GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

Outside of vaccines, GlaxoSmithKline isn’t a major producer of biologics compared with some of its Big Pharma peers. But it has just signed a big deal to scale up manufacturing in the field. The British pharma tapped South Korean CDMO Samsung Biologics in a deal worth more than $231 million to help it make biologic products over the next eight years. The manufacturing capacity Samsung offers will be flexible depending on GSK’s future needs, the company said on May 22nd. The deal will initially cover lupus drug Benlysta, with the first commercial supply expected in 2022. The pair intends to ...
Read More
Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics, Inc , a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced on May 20th that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 ...
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AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

After a manufacturing-related delay, Novartis has won conditional approval in the EU for the one-time gene therapy to treat patients with a clinical diagnosis of SMA type 1 and others with up to three copies of the SMN2 backup gene, the company said on May 19th. Zolgensma has demonstrated significant and clinically meaningful therapeutic benefit in pre-symptomatic and symptomatic SMA, including prolonged event-free survival and achievement of motor milestones unseen in natural history of the disease and to date, sustained for 5 years post-dosing. Immediate access to Zolgensma, aligned to the label, is available in France through the ATU framework ...
Read More
Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna, Inc. , a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced on May 18th positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29) ...
Read More
Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio, Inc, a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders and the Gene Therapy Program (GTP) at the University of Pennsylvania (UPenn) announced on May 07th the expansion of their collaboration agreement to include an additional five programs and extending Passage Bio’s period to exercise new programs for an additional three years (through 2025). Additionally, Passage Bio will fund discovery research at GTP and will receive exclusive rights, subject to certain limitations, to technologies resulting from the discovery program for Passage Bio products developed with GTP, such as novel capsids, ...
Read More
Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics Holdings Inc. and Catalent, Inc. announced on May 04th a partnership to support the expected manufacture of Arcturus' COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus. LUNAR-COV19 utilizes Arcturus' self-transcribing and replicating mRNA (STARR™) technology and the Company's LUNAR® lipid-mediated delivery to produce an extraordinarily low dose, potential single shot COVID-19 vaccine. The manufacture of LUNAR-COV19 at Catalent's state-of-the-art drug substance biomanufacturing facility in Madison, Wisconsin will support human clinical studies and, if successful, commercialization of the vaccine. The COVID-19 vaccine program will take advantage of the facility's flex-suite, a cGMP manufacturing suite that can ...
Read More

Cancer cell therapies: the clinical trial landscape

Cancer cell therapies: the clinical trial landscape

Cell therapies constitute the largest number of agents in development in immuno-oncolog. In a recent review, American researchers provide an update on the pipeline and clinical trials of cancer cell therapies. They also compare the current landscape (with a March 2020 data cut-off point) with our previous update from March 2019). The current global cancer cell therapy pipeline includes 1,483 active agents, 472 more than last year. Among the different cell therapy types, the chimeric antigen receptor (CAR)-T cell class has the largest increase (290 agents this year versus 164 in 2019), whereas novel T cell approaches (such as CRISPR ...
Read More
GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

Outside of vaccines, GlaxoSmithKline isn’t a major producer of biologics compared with some of its Big Pharma peers. But it has just signed a big deal to scale up manufacturing in the field. The British pharma tapped South Korean CDMO Samsung Biologics in a deal worth more than $231 million to help it make biologic products over the next eight years. The manufacturing capacity Samsung offers will be flexible depending on GSK’s future needs, the company said on May 22nd. The deal will initially cover lupus drug Benlysta, with the first commercial supply expected in 2022. The pair intends to ...
Read More
Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics, Inc , a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced on May 20th that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 ...
Read More
AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

After a manufacturing-related delay, Novartis has won conditional approval in the EU for the one-time gene therapy to treat patients with a clinical diagnosis of SMA type 1 and others with up to three copies of the SMN2 backup gene, the company said on May 19th. Zolgensma has demonstrated significant and clinically meaningful therapeutic benefit in pre-symptomatic and symptomatic SMA, including prolonged event-free survival and achievement of motor milestones unseen in natural history of the disease and to date, sustained for 5 years post-dosing. Immediate access to Zolgensma, aligned to the label, is available in France through the ATU framework ...
Read More
Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna, Inc. , a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced on May 18th positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29) ...
Read More
Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio, Inc, a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders and the Gene Therapy Program (GTP) at the University of Pennsylvania (UPenn) announced on May 07th the expansion of their collaboration agreement to include an additional five programs and extending Passage Bio’s period to exercise new programs for an additional three years (through 2025). Additionally, Passage Bio will fund discovery research at GTP and will receive exclusive rights, subject to certain limitations, to technologies resulting from the discovery program for Passage Bio products developed with GTP, such as novel capsids, ...
Read More
Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics Holdings Inc. and Catalent, Inc. announced on May 04th a partnership to support the expected manufacture of Arcturus' COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus. LUNAR-COV19 utilizes Arcturus' self-transcribing and replicating mRNA (STARR™) technology and the Company's LUNAR® lipid-mediated delivery to produce an extraordinarily low dose, potential single shot COVID-19 vaccine. The manufacture of LUNAR-COV19 at Catalent's state-of-the-art drug substance biomanufacturing facility in Madison, Wisconsin will support human clinical studies and, if successful, commercialization of the vaccine. The COVID-19 vaccine program will take advantage of the facility's flex-suite, a cGMP manufacturing suite that can ...
Read More
Cancer cell therapies: the clinical trial landscape

Cancer cell therapies: the clinical trial landscape

Cell therapies constitute the largest number of agents in development in immuno-oncolog. In a recent review, American researchers provide an update on the pipeline and clinical trials of cancer cell therapies. They also compare the current landscape (with a March 2020 data cut-off point) with our previous update from March 2019). The current global cancer cell therapy pipeline includes 1,483 active agents, 472 more than last year. Among the different cell therapy types, the chimeric antigen receptor (CAR)-T cell class has the largest increase (290 agents this year versus 164 in 2019), whereas novel T cell approaches (such as CRISPR ...
Read More
GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

Outside of vaccines, GlaxoSmithKline isn’t a major producer of biologics compared with some of its Big Pharma peers. But it has just signed a big deal to scale up manufacturing in the field. The British pharma tapped South Korean CDMO Samsung Biologics in a deal worth more than $231 million to help it make biologic products over the next eight years. The manufacturing capacity Samsung offers will be flexible depending on GSK’s future needs, the company said on May 22nd. The deal will initially cover lupus drug Benlysta, with the first commercial supply expected in 2022. The pair intends to ...
Read More
Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics, Inc , a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced on May 20th that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 ...
Read More
AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

After a manufacturing-related delay, Novartis has won conditional approval in the EU for the one-time gene therapy to treat patients with a clinical diagnosis of SMA type 1 and others with up to three copies of the SMN2 backup gene, the company said on May 19th. Zolgensma has demonstrated significant and clinically meaningful therapeutic benefit in pre-symptomatic and symptomatic SMA, including prolonged event-free survival and achievement of motor milestones unseen in natural history of the disease and to date, sustained for 5 years post-dosing. Immediate access to Zolgensma, aligned to the label, is available in France through the ATU framework ...
Read More
Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Moderna, Inc. , a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced on May 18th positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29) ...
Read More
Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio Announces Expansion of Gene Therapy Collaboration with University of Pennsylvania

Passage Bio, Inc, a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders and the Gene Therapy Program (GTP) at the University of Pennsylvania (UPenn) announced on May 07th the expansion of their collaboration agreement to include an additional five programs and extending Passage Bio’s period to exercise new programs for an additional three years (through 2025). Additionally, Passage Bio will fund discovery research at GTP and will receive exclusive rights, subject to certain limitations, to technologies resulting from the discovery program for Passage Bio products developed with GTP, such as novel capsids, ...
Read More
Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine

Arcturus Therapeutics Holdings Inc. and Catalent, Inc. announced on May 04th a partnership to support the expected manufacture of Arcturus' COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus. LUNAR-COV19 utilizes Arcturus' self-transcribing and replicating mRNA (STARR™) technology and the Company's LUNAR® lipid-mediated delivery to produce an extraordinarily low dose, potential single shot COVID-19 vaccine. The manufacture of LUNAR-COV19 at Catalent's state-of-the-art drug substance biomanufacturing facility in Madison, Wisconsin will support human clinical studies and, if successful, commercialization of the vaccine. The COVID-19 vaccine program will take advantage of the facility's flex-suite, a cGMP manufacturing suite that can ...
Read More