On June 7, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will host a virtual KOL event for analysts, investors, and the scientific community on Friday, June 11, 2021 at 8AM ET / 2PM CET (Press release, Nanobiotix, JUN 7, 2021, View Source [SID1234583676]). The event will feature several key opinion leaders, including current study investigators.

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The Nanobiotix KOL event will provide an in-depth review of the immunotherapy data presented at the 2021 Annual Meeting of American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) along with clinical perspectives on the implications of potential first-in-class radioenhancer NBTXR3 across the oncology landscape.

Registration for the event is now open on the events section of the Company’s website. A live webcast of the discussion and an archived recording will be available on the events section as well.

Nanobiotix Virtual KOL Event Program

Can NBTXR3 Turn Anti-PD-1 Non-responders into Responders and Deepen Response in Naïve Patients?

Agenda:

Opening Remarks (8:00AM ET / 2:00PM CET)
Presented by Jeffrey Bockman, PhD, EVP and Oncology Practice Head, Cello Health BioConsulting
NBTXR3 Mode of Action (8:05AM ET / 2:05PM CET)
Presented by Laurent Levy, PhD, co-founder and CEO, Nanobiotix
Overview of the Treatment Landscape: Promise and Limitations of Immunotherapy, and Rationale for Combination-based Approaches (8:10AM ET / 2:10PM CET)
Presented by Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
Nanobiotix Study 1100 Safety and Efficacy Data Update (8:20AM ET / 2:20PM CET)
Presented by Tanguy Seiwert, MD, Assistant Professor of Oncology, Director, Head and Neck Cancer Oncology Disease Group, Johns Hopkins Medicine and Colette Shen, MD, PhD, Assistant Professor, Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
NBTXR3 as a Potential Combination-agnostic Product, Rationale, and Future Opportunity (8:40AM ET / 2:20PM CET)
Presented by James Welsh, MD, Associate Professor, Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Discussion and Q&A, Implications of Study 1100 in Head and Neck Cancer and Beyond (8:50AM ET / 2:50PM CET)
Panel Discussion Moderated by Jeffrey Bockman
Summary Close (9:10AM ET / 3:10PM CET)
Presented by Jeffrey Bockman

On June 7, 2021 Osel Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, reported that City of Hope, a world-renowned independent cancer and diabetes research and treatment center, presented data from a Phase 1b trial showing that an LBP, CBM588 (Clostridium butyricum MIYAIRI 588 strain), plus nivolumab/ipilimumab improved overall response rate (ORR) and progression-free survival (PFS) compared to nivolumab/ipilimumab alone in patients with metastatic renal cell carcinoma (RCC) (Press release, Osel, JUN 7, 2021, View Source [SID1234583675]).

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Osel licensed the rights for the pharmaceutical use of CBM588 in the United States, Canada and Europe from Miyarisan Pharmaceutical Co., Ltd., and has a clinical trial agreement for the CBM588 study with City of Hope.

The data were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by City of Hope’s Luis Meza, a postdoctoral fellow, and Sumanta K. Pal, M.D., clinical professor, Department of Medical Oncology & Therapeutics Research. The presentation titled First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma (Abstract #4513) is part of the session titled Genitourinary Cancer – Kidney and Bladder.

"We are very pleased with results generated from this clinical study," said Thomas Parks, Ph.D., Head of Development at Osel. "There is considerable interest in microbiome modulation to enhance immune checkpoint inhibitor efficacy that is more consistent and scalable than fecal transplants. These data are an encouraging indicator of potential patient benefit in an initial indication of metastatic RCC."

CBM588 is a spore forming anaerobe that produces short chain fatty acids, mainly butyric acid, which is a well-known energy source of intestinal epithelium. The bacterial strain exerts several beneficial effects through multiple modes of action, including inhibition of pathogenic microorganisms, immunomodulatory activities and restorative effects on intestinal dysbiosis.

"Adjunctive treatment with CBM588 is associated with improvements in response rate and PFS in patients treated in combination with standard of care versus standard of care alone – there is also a compelling trend favoring overall survival early on," Pal said. "These results warrant further investigation in a larger multi-center trial."

CBM588 is manufactured and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYAIRI 588 strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and immunocompromised patients, as confirmed by post-marketing surveillance.

"Microbiome analysis showed a statistically significant increase in Bifidobacteria in CBM588 treated clinical responders compared to CBM588 treated non-clinical responders or standard of care patients," said Motomichi Takahashi, Ph.D., Executive Senior Director, Miyarisan Pharmaceutical. "These preliminary data support the GI microbiome being successfully modulated as a mechanism of clinical efficacy."

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.