One step closer to listing! Innovative T cell immunotherapy releases clinical data analysis

- Recently, T cell immunotherapy company Atara Biotherapeutics, at the 47th European Society for Blood and Marrow Transplantation (EBMT 2021) 2021 Nian March 14 to 17 held online conference to announce the tab-cel for its leading product Comprehensive analysis of 3 phase 2 studies of Epstein-Barr virus (EBV)-related lymphoproliferative disease (EBV+ PTLD) after hematopoietic cell transplantation (HCT) (tabelecleucel, ATA129) , and provides the latest long-term overall survival (OS) Data .

- Recently, T cell immunotherapy company Atara Biotherapeutics, at the 47th European Society for Blood and Marrow Transplantation (EBMT 2021) 2021 Nian March 14 to 17 held online conference to announce the tab-cel for its leading product Comprehensive analysis of 3 phase 2 studies of Epstein-Barr virus (EBV)-related lymphoproliferative disease (EBV+ PTLD) after hematopoietic cell transplantation (HCT) (tabelecleucel, ATA129) , and provides the latest long-term overall survival (OS) Data .

With the traditional CAR-T cell therapy different, Atara original spot T-cell immunotherapy using the PBMCs healthy people (human peripheral blood mononuclear cells), the genetic modification technologies with precise targeting, is applicable to all types of people now Cargo-type cytotoxic T cell therapy .

With the traditional CAR-T cell therapy different, Atara original spot T-cell immunotherapy using the PBMCs healthy people (human peripheral blood mononuclear cells), the genetic modification technologies with precise targeting, is applicable to all types of people now Cargo-type cytotoxic T cell therapy .

tab-cel® is currently Atara’s fastest-growing T cell immunotherapy; besides being used for post-transplant EBV+PTLD patients who have failed rituximab therapy, it is also planned to be used for other EBV-related diseases including nasopharyngeal carcinoma Hematoma and solid tumor.

▲Atara's pipeline (picture source: atarabio.

▲Atara's pipeline (picture source: atarabio.

Data analysis resultData analysis result

This analysis evaluated 2 tab-cel® completed single-arm Phase 2 studies (NCT00002663; NCT01498484), and 1 multi-center extended drug program (EAP-201) study (NCT02822495) in treatment remission data and OS data.

This analysis evaluated 2 tab-cel® completed single-arm Phase 2 studies (NCT00002663; NCT01498484), and 1 multi-center extended drug program (EAP-201) study (NCT02822495) in treatment remission data and OS data.

A comprehensive analysis of these 3 investigator-assessed Phase 2 studies shows that tab-cel® can achieve a high overall remission rate and benefit in post-transplant EBV+PTLD patients who have failed rituximab therapy the long-term survival results ; and no theory is complete remission (C R) or partial response (PR) , the Tab-Cel® Dou can ask for a similar long-term overall survival benefit .

Jakob Dupont, MD, Head of Global Research and Development at Atara, said: “Rituximab refractory patients with EBV+ PTLD after hematopoietic cell transplantation have a poor prognosis .

All study patients caught in the course of 8, and 15 on Days of 2x10 ^ 6 cells / kg dose of tab-cel®.

Summary of the EBMT data provided on the display 2021, 50 after tab-cel® receiving transplants treated EBV + PTLD subject, objective response rate (PR + CR) 62% (31/50) 24 embodiment patients achieved CR ( n = 24), 7 patients achieved PR.

▲tab-cel® (picture source: atara bio.

▲tab-cel® (picture source: atara ▲tab-cel® (picture source: atara bio.

In addition, Atara also provides the results of multi-omics integrated analysis for the tab-cel® activation method.

Pascal Touchon, President and CEO of Atara, said: “The tab-cel® data we provide today shows that the product features are consistent and clinically relevant to unrelated T cell donors , and have a high incidence of EBV+ PTLD patients after transplantation.
Overall remission rate and favorable long-term survival results.
Atara is committed to providing services for patients with a heavy burden of diseases and unmet needs, and is expected to complete the BLA application for PTLD indications in the United States in the third quarter of 2021 , and in 2021 Submit the MAA application in Europe in the fourth quarter .
" The product features have consistency and clinical relevance with unrelated T cell donors.
Complete the BLA application for PTLD indications in the United States in the third quarter of 2021.
Submit the MAA application in Europe in the fourth quarter of 2021.

Virus-specific T cell therapy

Virus Specific T Cell Therapy Virus Specific T Cell Therapy

T cells are critical to the immune system's ability to detect and kill virus-infected cells.
In healthy people, virus-specific T cells are a key component of the body's natural defense system, preventing thousands of disease-causing viruses.
However, these viruses are not suppressed in immunodeficiency patients, such as those receiving hematopoietic cell transplantation (HCT), solid organ transplantation (SOT), and cancer treatment, patients infected with HIV, and the elderly.
Normally, when a virus attacks an immunodeficiency patient, standard treatment cannot solve the underlying problem of a weak immune system.
Therefore, many patients suffer life-threatening consequences, such as multiple organ damage and failure, and even death.

T cells are critical to the immune system's ability to detect and kill virus-infected cells.
In healthy people, virus-specific T cells are a key component of the body's natural defense system, preventing thousands of disease-causing viruses.
However, these viruses are not suppressed in immunodeficiency patients, such as those receiving hematopoietic cell transplantation (HCT), solid organ transplantation (SOT), and cancer treatment, patients infected with HIV, and the elderly.
Normally, when a virus attacks an immunodeficiency patient, standard treatment cannot solve the underlying problem of a weak immune system.
Therefore, many patients suffer life-threatening consequences, such as multiple organ damage and failure, and even death.

Virus-specific T cell therapy (VST) is a type of T cell specifically produced by virus infection.
It has the ability to recognize and kill infected cells, and it can also activate the immune system of other parts of the body.
VST can recognize viral antigens located on the surface of the tumor.
After VST infusion, it migrates to the tumor site and binds to the viral antigens, thereby releasing cytotoxic particles that destroy cancer cells.
Compared with ordinary CAR-T, VST therapy has a significant therapeutic effect on solid tumors and can exert a longer-term protective effect.

Virus Specific T Cell Therapy (VST) Virus Specific T Cell Therapy (VST) Virus Specific T Cell Therapy (VST)is a type of T cell specifically produced by virus infection and has the ability to recognize and kill infected cells , And can activate the immune system of other parts of the body at the same time.
VST can recognize viral antigens located on the surface of the tumor.
After VST infusion, it migrates to the tumor site and binds to the viral antigens, thereby releasing cytotoxic particles that destroy cancer cells.
Compared with ordinary CAR-T, VST therapy has a significant therapeutic effect on solid tumors and can exert a longer-term protective effect.

Based on the anti-cancer potential of VST, specific T cell therapies for various virus-related cancers have been developed.
In addition to being a monotherapy, it can also be combined with CAR targeting and other technologies to exert greater anti-cancer effects.

Based on the anti-cancer potential of VST, specific T cell therapies for various virus-related cancers have been developed.
In addition to being a monotherapy, it can also be combined with CAR targeting and other technologies to exert greater anti-cancer effects.
Combined with CAR targeting and other technologies

▲ Picture source: atarabio.
com

▲ Picture source: atarabio.
com ▲ Picture source: atarabio.
com

➤ AlloVir

➤ AlloVir ➤ AlloVir

AlloVir is an allogeneic T cell therapy company.
The company’s main product, allogeneic, off-the-shelf, multi-virus-specific T cell therapy Viralym-M (ALVR105) , is in the late stage of clinical development and can simultaneously target up to 6 different viral infections in immunodeficiency patients , Including: BK virus (can affect kidney transplant patients), cytomegalovirus, adenovirus, Epstein-Barr virus (causing mononucleosis), human herpes virus-6, JC virus.
Viralym-M has been awarded the title of Priority Drug (PRIME) by the European Medicines Agency (EMA) and the RMAT (Regenerative Medicine Advanced Therapy) certification of the US FDA.

AlloVir is an allogeneic T cell therapy company.
The company’s main product, allogeneic, off-the-shelf, multi-virus-specific T cell therapy Viralym-M (ALVR105) , is in the late stage of clinical development and can simultaneously target up to 6 different viral infections in immunodeficiency patients , Including: BK virus (can affect kidney transplant patients), cytomegalovirus, adenovirus, Epstein-Barr virus (causing mononucleosis), human herpes virus-6, JC virus.
Viralym-M has been awarded the title of Priority Drug (PRIME) by the European Medicines Agency (EMA) and the RMAT (Regenerative Medicine Advanced Therapy) certification of the US FDA.
Multi-virus-specific T cell therapy Viralym-M (ALVR105)

▲Image source: allovir.
com

▲Image source: allovir.
com ▲Image source: allovir.
com

The company's second allogeneic, spot multivirus- specific T cell therapy is ALVR106 , which targets four acquired respiratory viruses: respiratory syncytial virus, influenza virus, parainfluenza virus and human lung interstitial virus.
The IND application for AlloVir ALVR106 has been approved in 2020.
In addition, for high-risk patients with new coronary pneumonia , AlloVir and Baylor College of Medicine (BCM) have jointly developed an allogeneic, off-the-shelf, virus-specific T cell therapy (VST) ALVR109 , which aims to eliminate infection by the new coronavirus .
Cells to prevent disease progression.
In September 2020, the US FDA has approved the IND application for ALVR109 for the treatment of patients with severe new coronary pneumonia (COVID-19) caused by SARS-CoV-2, and it is currently being evaluated in the phase 1 study ( NCT04401410 ).

The company's second allogeneic, spot multivirus- specific T cell therapy is ALVR106 , which targets four acquired respiratory viruses: respiratory syncytial virus, influenza virus, parainfluenza virus and human lung interstitial virus.
The IND application for AlloVir ALVR106 has been approved in 2020.
ALVR106 ALVR106's IND application.
In addition, for high-risk patients with new coronary pneumonia , AlloVir and Baylor College of Medicine (BCM) have jointly developed an allogeneic, off-the-shelf, virus-specific T cell therapy (VST) ALVR109 , which aims to pass Eliminate cells infected by the new coronavirus to prevent disease progression.
In September 2020, the US FDA has approved the IND application for ALVR109 for the treatment of patients with severe new coronary pneumonia (COVID-19) caused by SARS-CoV-2, and it is currently being evaluated in the phase 1 study ( NCT04401410 ).
For high-risk patients with new coronary pneumonia , ALVR109 ALVR109 NCT04401410

➤ Kite

➤ Kite ➤ Kite ➤ Kite

Kite’s autologous TCR therapy KITE-439 is used to treat HPV-16-related cancers .
It is currently being evaluated in a phase 1 clinical trial (NCT03912831) and has initially shown good safety and effectiveness.

Kite’s autologous TCR therapy KITE-439 is used to treat HPV-16-related cancers .
It is currently being evaluated in a phase 1 clinical trial (NCT03912831) and has initially shown good safety and effectiveness.
Autologous TCR therapy KITE-439 for the treatment of HPV-16 related cancers

▲Image source: kitepharma.
com

▲Image source: ▲Image source: kitepharma.
com kitepharma.
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In the early stage of the trial, among 8 patients who received KITE-439 for metastatic HPV-16-positive tumors, 90-99% of the T cells from 6 patients expressed E7 TCR on the cell surface.
The patients received KITE-439 for 6 weeks.
After treatment, these T cells can still be detected in the peripheral blood.
It is worth noting that these patients have received 3 to 7 other treatment options before receiving TCR-T treatment.

In the early stage of the trial, among 8 patients who received KITE-439 for metastatic HPV-16-positive tumors, 90-99% of the T cells from 6 patients expressed E7 TCR on the cell surface.
The patients received KITE-439 for 6 weeks.
After treatment, these T cells can still be detected in the peripheral blood.
It is worth noting that these patients have received 3 to 7 other treatment options before receiving TCR-T treatment.

In addition, of the 7 evaluable patients, 3 patients achieved PR, and 2 of them had received PD-1 antibody treatment and were in stable disease.
As of the data release, the patient had sustained remission for up to 9 months.
No dose limiting toxicity was observed in this test.
The company plans to submit an IND for KITE-439 treatment of HPV-16 E7 solid tumors before the end of the year.

In addition, of the 7 evaluable patients, 3 patients achieved PR, and 2 of them had received PD-1 antibody treatment and were in stable disease.
As of the data release, the patient had sustained remission for up to 9 months.
No dose limiting toxicity was observed in this test.
The company plans to submit an IND for KITE-439 treatment of HPV-16 E7 solid tumors before the end of the year.

➤ Lion TCR (Lion Biology)

➤ Lion TCR (Lion Biology) ➤ Lion TCR (Lion Biology) ➤ Lion TCR (Lion Biology)

Lynn Bio, which is committed to the development of TCR-T cell therapy, published two abstracts at the 2020 Annual Meeting of the Society for Cancer Immunotherapy (SITC) held from November 9 to 14, 2020.
These summaries highlight its leading product LioCyx-M good safety and efficacy, suggesting that the hepatitis B stomatitis virus (HBV) TCR T- cells for therapeutic application prospects HBV-related hepatocellular carcinoma.

Lynn Bio, which is committed to the development of TCR-T cell therapy, published two abstracts at the 2020 Annual Meeting of the Society for Cancer Immunotherapy (SITC) held from November 9 to 14, 2020.
These summaries highlight its leading product LioCyx-M good safety and efficacy, suggesting that the hepatitis B stomatitis virus (HBV) TCR T- cells for therapeutic application prospects HBV-related hepatocellular carcinoma.
LioCyx-M hepatitis B stomatitis virus (HBV) the TCR T- hepatitis B stomatitis virus (HBV)

▲Image source: liontcr.
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▲Image source: ▲Image source: liontcr.
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LioCyx-M is a patient's autologous T cells that have been modified in vitro and express HBV-specific T cell receptors.
LioCyx-M as a monotherapy, in two separate 1 clinical study (NCT03899415; NCT02719782) are, for the treatment of unresectable of HBV -related liver small cell carcinoma, and liver transplantation HCC after relapse.
The number of data display , HB V-specific TCR-T thin cell therapy for HBV treatment-related hepatocellular carcinoma , with good good application prospect.

LioCyx-M is a patient's autologous T cells that have been modified in vitro and express HBV-specific T cell receptors.
LioCyx-M is used as a monotherapy.
Two independent LioCyx-M are modified in vitro to express HBV-specific T cell receptors from patients' autologous T cells.
A clinical study (NCT03899415; NCT02719782) are, for the treatment of unresectable of HBV -related liver small cell carcinoma, and liver transplant recurrence of hepatocellular carcinoma after.
The number of data display , HB V-specific TCR-T thin cell therapy for HBV treatment-related hepatocellular carcinoma , with good good application prospect.

➤ Tessa

➤ Tessa ➤ Tessa ➤ Tessa

Tessa's allogeneic CD30-CAR Epstein-Bar virus-specific T cell therapy (CD30-CAR EBVST) combines the unique properties of VST and CAR, and aims to develop discoverable cell therapy for the treatment of hematological malignancies and solid tumors .

Tessa's allogeneic CD30-CAR Epstein-Bar virus-specific T cell therapy (CD30-CAR EBVST) Tessa's allogeneic CD30-CAR Epstein-Bar virus-specific T cell therapy (CD30-CAR EBVST) , combined with VST The unique attributes of CAR and CAR are aimed at developing discovered cell therapy for the treatment of hematological malignancies and solid tumors.

▲Image source: tessacell.
com

▲Image source: ▲Image source: tessacell.
com tessacell.
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In early trials, allogeneic VST without any form of genetic modification has been proven to have good safety and effectiveness, and the risk of transplant rejection and other serious reactions related to current allogeneic cell therapy is low.
Currently, Tessa is cooperating with Baylor College of Medicine to conduct a phase 1 clinical trial of EBVST in the United States (NCT04288726).

In early trials, allogeneic VST without any form of genetic modification has been proven to have good safety and effectiveness, and the risk of transplant rejection and other serious reactions related to current allogeneic cell therapy is low.
Currently, Tessa is cooperating with Baylor College of Medicine to conduct a phase 1 clinical trial of EBVST in the United States (NCT04288726).
EBVST

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