On June 7, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported the presentation of Phase 1 data for BDB001 in combination with pembrolizumab in advanced solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Seven and Eight Biopharmaceuticals, JUN 7, 2021, View Source [SID1234583674]).

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"It is encouraging to see that BDB001 in combination with pembrolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors"

BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors. Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 as monotherapy showed favorable tolerability and robust systemic immune activation leading to durable clinical responses.

The poster discussion session at ASCO (Free ASCO Whitepaper) for Abstract #2512 revealed new interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with pembrolizumab in advanced solid tumors (NCT03486301). The results show that BDB001 in combination with pembrolizumab was well tolerated, and induced robust immune activation leading to clinical responses. Based on these results, the recommended Phase 2 dose (RP2D) of BDB001 was determined and is currently being further evaluated in an ongoing dose expansion phase.

"It is encouraging to see that BDB001 in combination with pembrolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors," said lead author and study investigator Dr. Manish R. Patel, of Florida Cancer Specialists/Sarah Cannon Research Institute.

"These promising interim results show that BDB001 in combination with pembrolizumab represents a novel and viable treatment for advanced solid tumors. It is especially encouraging to see responses in PD-L1 negative and refractory tumors," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. "We continue to enroll subjects in the dose expansion part of this trial, to further evaluate safety, efficacy, and immune modulatory effects in the tumor microenvironment."

"We are very excited about the clinical data for BDB001 in combination with pembrolizumab, as we continue to advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation," said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

Presentation Details:

Abstract Title: BDB001, an intravenously administered toll-like receptor 7 and 8 (TLR7/8) agonist, in combination with pembrolizumab in advanced solid tumors: Phase 1 safety and efficacy results.

Abstract Authors: Manish R. Patel, Anthony W. Tolcher, Drew W. Rasco, Melissa Lynne Johnson, Angela Tatiana Alistar, Lixin Li, Alexander H. Chung, Robert H.I. Andtbacka

Session Title: Poster Discussion Session, Developmental Therapeutics—Immunotherapy

On-Demand Session Release Date and Time: 6/4/2021, 9:00 AM-10:00 AM

Abstract Number: 2512

The poster presentation will be available on the ASCO (Free ASCO Whitepaper) Meeting Library and on the Company’s website at www.7and8biopharma.com

Abstract Summary:

Seven and Eight Biopharma’s systemic delivery of the TLR 7 and 8 dual agonist BDB001 is first in class.
BDB001 was delivered safely intravenously in combination with pembrolizumab.
BDB001 in combination with pembrolizumab showed robust dose dependent immune activation without increased risk of CRS, as evidenced by minimal increase in pro-inflammatory/CRS cytokines, IL-6, IL-10, and TNF-α.
Overall, BDB001 was well tolerated and over 21% of subjects did not have any treatment related adverse events. There were few Grade 3 and no grade 4 or 5 adverse events.
At BDB001 Levels 3 and 4, 19 subjects were evaluable for efficacy. There was evidence of:
Rapid and deep clinical responses were observed in tumors with low response rate to anti-PD-1 therapy based on their PD-L1 negative, MSI-stable, and TMB-low status.
5 clinical responses including 1 Complete Response (CR)
Overall Response Rate (ORR) was 26%; Disease Control Rate (DCR) of 58%
Clinical responses were seen in subjects with cholangiocarcinoma, hepatocellular carcinoma, melanoma, ovarian carcinoma, and triple negative breast cancer.
Robust anti-tumor immune activation via IP-10 (CXCL10) upregulation, which correlated with clinical responses.
BDB001 in combination with pembrolizumab is a promising novel therapeutic option for patients with advanced solid tumors and is being evaluated in an ongoing dose expansion trial.

On June 7, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported a combined long-term overall survival (OS) analysis from three clinical studies of tabelecleucel (tab-cel) in patients with Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) after solid organ transplantation (SOT) (Press release, Atara Biotherapeutics, JUN 7, 2021, View Source [SID1234583673]). The results are featured in an oral plenary presentation at the American Transplant Congress (ATC 2021 Virtual Connect), taking place June 4-9, 2021.

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Combined objective response rate (ORR) and OS data across two SOT subgroups – patients relapsed or refractory (R/R) to rituximab monotherapy and patients R/R to rituximab + chemotherapy (CT) – showed one- and two-year OS for patients achieving either complete response (CR) or those achieving partial response (PR). Data presented at ATC 2021 confirm benefit of tab-cel in SOT PTLD and show similar one- and two-year probability of OS irrespective of patients achieving CR or PR (according to Lugano criteria). Treatment response and OS data were assessed from two completed single-arm, Phase 2 studies (95-024, NCT00002663 and 11-130, NCT01498484) and the multi-center expanded access (EAP-201) study (NCT02822495).

"Patients who have received a solid organ transplant such as a new kidney, lung, heart or liver and go on to develop EBV+ PTLD that is relapsed or refractory to rituximab monotherapy or R-chemotherapy face a poor prognosis, with median survival of only about three months," said Jakob Dupont, M.D., Head of Global Research & Development at Atara. "There is a significant unmet need in these patients for whom there are no approved therapies, let alone therapies specifically designed to treat EBV+ PTLD. Combined data from across three clinical studies in SOT recipients with relapsed or refractory disease demonstrated similar long-term survival benefit in those who had either partial or complete response to treatment. These data indicate that tab-cel may help address an urgent unmet need in these patients with high rates of mortality."

Overall Survival (OS) by Best Overall Response (BOR)

All SOT recipients with EBV+ PTLD R/R to rituximab as monotherapy or combined with chemotherapy were treated with tabelecleucel, receiving a median (range) of 2.0 (1-9) cycles

Atara has previously shown benefit in patients with EBV+ PTLD after SOT who responded to tab-cel, including up to 100 percent two-year survival rates1,2. Data presented at EBMT 2021 demonstrated similar results in terms of overall survival in EBV+ PTLD patients who received tab-cel following hematopoietic cell transplantation (HCT).

Safety

Tab-cel was well-tolerated in this immunocompromised population with high disease burden and multiple comorbidities. Notably, there was no emerging safety concern and no instances of tumor flare reaction, infusion-related reactions, graft versus host disease (GvHD), cytokine release syndrome (CRS), neurotoxicity or organ rejection reported in these patients.

"We are excited to see the data presented at ATC 2021 reinforce the clinical benefit in patients who responded to tab-cel, including up to 100 percent two-year survival rates," said Pascal Touchon, President and Chief Executive Officer at Atara. "Atara understands the imperative to provide treatment options for these very sick, treatment-refractory and immunocompromised patients."

Atara Presentation at ATC 2021:

Title: Overall Survival by Best Overall Response with Tabelecleucel in Patients with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease after Solid Organ Transplant

Date & Time: Monday, June 7, 2021 at 10:30 a.m. ET

Oral Session & Number: Plenary Oral Abstract Session 3

On June 7, 2021 Repertoire Immune Medicines, a clinical-stage biotech company decoding the immune synapse to create novel immune therapies for cancer, immune disorders, infectious disease, and other serious diseases, reported the upcoming presentation of new data from DECODE, its epitope and T cell discovery platform (Press release, Repertoire, JUN 7, 2021, View Source [SID1234583672]). The company will present data from three accepted oral abstracts at the Federation of Clinical and Immunology Societies (FOCiS) 2021 Virtual Annual Meeting taking place from June 8-11, 2021.

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The DECODE platform deciphers antigens and their precise epitopes presented by cells and recognized by the immune system. These interactions form the basis for cellular immunity and provide an opportunity for the creation of novel immune medicines.

"Repertoire is focused on advancing science to harness the power of the immune synapse using the company’s proprietary DECODE platform, which allows us to discover novel epitopes and the phenotypes of T cells that they activate and apply these to develop novel immune medicines," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire. "Our presentations at FOCiS 2021 encompass our work across cancer, autoimmune disorders and infectious disease, and further reinforces the breadth of the platform."

Session details:

Comprehensive decoding of the immune synapse to SARS-CoV-2: Epitope discovery, HLA restriction, and the relationship to endemic coronaviruses and new emerging variants. Oral Presentation. Daniel Pregibon, Ph.D., et al.

The ability to comprehensively characterize the cellular response to SARS-CoV-2 has implications for new vaccine design, patient risk stratification and assessment, and potential prevention of the threat from emerging viral variants. Repertoire’s technologies provide new insights into the immune response to SARS-CoV-2 and can more broadly facilitate deeper quantification of cellular responses to pathogens where T cell immunity is poorly understood.
Identification of Novel Epitopes and their Associated MHC- Restricted T-cell Clonotypes in the Periphery of Patients with Type 1 Diabetes. Oral Presentation. Daniel S. Rivera et al.

Decoding the immune synapse will allow an in-depth understanding of the T-cell repertoire in type 1 diabetes, which is essential in identifying the key drivers of diabetogenesis. These insights will provide disease stratifying biomarkers and will open up new possibilities to develop novel targets for therapeutic intervention. Repertoire has discovered and validated TCR-antigen pairs across patient cohorts. The epitopes seen by multiple type 1 diabetes patients and recognized by T cells with memory or effector phenotypes enable the development of novel therapeutics to induce tolerance of autoreactive cells in patients with type 1 diabetes.
Understanding the Immune Synapse with DECODE Provides Unique Insights into the T Cell Repertoire in Cancer Patients, Defines Immunological Memory in Infectious Disease and Identifies Auto-reactive T Cells in Autoimmune Diseases. Oral Presentation. Joanna Swain, Ph.D., et al.

The development of transformative immune medicines that can harness and manipulate T cell responses has been severely limited by the inability to understand the codes that determine T cell behavior and function. To unlock these codes, it is essential to know how the entire peptidome is presented, its associated HLA allelic context, and the diversity of the reactive T cell repertoire. Repertoire has developed an extensive suite of state-of-the-art tools that enable decoding of all the components of the immune synapse with both depth and precision. Decoding all aspects of the immune synapse will shed more light on the immunological diversity, allowing development of the next generation of potential therapies in cancer, infectious disease and autoimmune disorders.

On June 7, 2021 IASO Biotherapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases, reported that its clinical trial application for the in-house developed CD19xCD22 fully human dual-targeted CAR T-cell therapy (CT120) for treatment of its second indication for relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), has been accepted by the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2101088, CXSL2101089) (Press release, IASO BioMed, JUN 7, 2021, View Source [SID1234583671]). This acceptance came just one day after the acceptance of the drug’s first indication for treatment of CD19xCD22 positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). These successful clinical trial applications highlight the company’s speed and strength in developing innovative novel CAR-T therapies.

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CT120 is developed on IASO Bio’s fully human antibody platform IMARS and high throughput CAR-T drug selection platform. IMARS is one of the industry’s top antibody discovery platforms in terms of database capacity. With over 240 billion candidate antibodies, the platform has powerful capacity and provides speedy antibody screening. The company’s high-throughput CAR-T drug selection platform, which uses cutting-edge single-cell analysis and next-generation sequencing (NGS) technology, can implement cost effective, high efficiency functional CAR-T candidate screening. CT120 is prepared at IASO Bio’s integrated good manufacturing practice (GMP) compliant manufacturing facility in Nanjing, which is fully equipped to produce high quality plasmids, viral vectors and gene edited cellular products cost-efficiently.

B-cell non-Hodgkin’s lymphoma (B-NHL) is a group of hematologic malignancies of B-lymphocytes origin. Current standard of care (SOC) include chemotherapy, radiotherapy, hematopoietic stem cell transplant, molecular targeted drug, and more. While most patients can achieve short-term remission following standard care, relapsed or refractory disease is common. For such patients, conventional therapies are limited, and CAR-T therapy is considered to be a promising alternative. And while CD19-targeted single-targeted CAR-T therapy has shown good efficacy in clinical studies, some patients still experience progression or recurrence a short time after such therapy (Nature). It is thought that CD19 antigen escape on the surface of tumor cells is one of the possible reasons.

Studies have shown that both CD22 and CD19 are generally expressed on the surface of multiple B-cell tumors, including B-NHL. Similar to CD19, CD22 is also expressed on tumors with certain specificity, which makes it another ideal therapeutic target. In light of this, CD19xCD22 dual-targeted CAR-T therapy theoretically can reduce the risk of treatment evasion due to missing a single target. As a result, it shows good potential for further reducing disease recurrence and thus, yielding long-term survival benefits for patients.

"Investigator initiated trials (IITs) underway at Tongji Hospital – which is affiliated with Tongji Medical College of Huazhong University of Science & Technology and the First Affiliated Hospital, College of Medicine, Zhejiang University – show that fully human dual-targeted CT120 not only benefits CAR-T naïve relapsed/refractory B-ALL patients but also those whose disease progressed during or after murine single-targeted CD19 CAR-T. Therefore, the therapy shows promise in terms of both market landscape and patient benefits," said Dr. Wang Wen, CEO, IASO Biotherapeutics. "Importantly, our IND submission for this product marks the maturation of the company’s phage antibody library-based antibody discovery platform. We expect that fully human antibody products based on this antibody library will continuously contribute to the company’s cell therapy and antibody therapy pipelines. At IASO Biotherapeutics, we will continue to expand and exploit new product pipelines to benefit more patients in the future."

About CT120：

CT120 is an autologous dual-target CAR-T therapy. Its extra cellular domain contains two fully-human scFv sequences that can specifically recognize CD19 and CD22. Dual-antigen specific CAR-T cells, which have the potential to persistent in vivo longer than mono-specific CAR-T cells, enhance therapeutic effects by reducing relapse resulting from antigen escape.

CT120 proves to be significantly effective in an ongoing IIT trial in China. Results show that CT120 not only has a durable response on CAR-T treatment-naive relapsed/refractory B-ALL patients, but also has a curative effect on relapsed patients who have previously received mono-specific CAR-T treatment. CT120 can reduce the risk of antigen escape and tumor relapse as a result of lower/loss of CD19 or CD22 expression following mono-specific CAR-T treatment, resulting in better therapeutic outcomes and longer survival benefits for patients.

About Non-Hodgkin Lymphoma (NHL):

Lymphomas of immune system cells origin may cause damage to any organ in the body and give rise to a variety of accompanying complicated pathologic processes. Lymphomas are divided into two categories: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Approximately 85% of non-Hodgkin’s lymphomas are of B-cell origin. Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL. DLBCL accounts for 31% of NHLs in European and American countries and more than 40% of NHLs in Asian countries. The incidence of the disease increases with age. According to statistics from 2006 to 2016, the standardized morbidity and mortality rates of NHLs in China were 4.29/100,000 and 2.45/100,000, respectively (Biomed Central).

On June 7, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that Derek Maetzold, president and chief executive officer, is scheduled to present a company overview at the Baird 2021 Healthcare ESG Symposium on June 17, 2021, at 11:20 a.m. Eastern time (Press release, Castle Biosciences, JUN 7, 2021, View Source [SID1234583669]).

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A live audio webcast of the company’s presentation will be available by visiting Castle Biosciences’ website at View Source A replay of the webcast will be available for two weeks following the conclusion of the live broadcast.