On November 12, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the company will co-present with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), three posters at the 36th Annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Nov. 10 – 14, 2021 from research into diagnostic tests of treatment response of NSCLC patients to immune checkpoint inhibitor therapy (Press release, Biodesix, NOV 12, 2021, View Source [SID1234595467]).

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"Biodesix is committed to performing research with biopharma companies, while pursuing, discovering and developing applications that can help physicians and researchers address the needs of patients with lung cancer who will benefit from quick, actionable test results," said Scott Hutton, CEO, Biodesix. "We are pleased to present data on two tests that have the potential to become instrumental in the care of patients with non-small cell lung cancer (NSCLC). Additionally, our data highlights novel methods that we have developed to provide an explanation as to how our proprietary Diagnostic Cortex Artificial Intelligence (AI) platform combines molecular attributes to produce individual patient results. This data is extremely important because we expect that this will provide clarity and transparency to how our AI-based tests work and how a diagnostic test may better predict efficacy of various treatments in the most appropriate patient populations. We are proud of the data being presented at SITC (Free SITC Whitepaper) as it underscores our commitment to the lung cancer community."

The three Genentech/Biodesix-sponsored posters include the following:

Abstract #26: Validation of the Primary Immune Response (PIR) test in advanced non-small cell lung cancer (NSCLC): blinded retrospective analyses from the POPLAR and OAK trials

Findings will be presented from blinded, retrospective analyses of two Genentech multicenter, open-label RCT clinical studies comparing atezolizumab versus docetaxel in patients with previously treated NSCLC (POPLAR Phase 2 and OAK Phase 3). The Biodesix liquid-biopsy mass spectrometry-based Primary Immune Response (PIR) test stratified outcomes for patients treated with the study drug in second and third line, predicting overall survival, even when adjusted for PD-L1 expression and clinical factors. The importance of understanding who will or will not respond to immunotherapy is critical and identifying predictive biomarkers of immunotherapy response has become a growing focus of immune-oncology research. This study highlights the potential of biomarkers of immune checkpoint inhibitors, such as the PIR test, to support patient stratification.

Abstract #28: Predictions of outcomes and benefit of immune checkpoint inhibitor treatment in non-small cell lung cancer require information on both tumor and host biology

Findings from a Genentech blinded, retrospective study of second- and third-line NSCLC patients in the OAK Phase 3 clinical study comparing atezolizumab versus docetaxel in patients with previously treated NSCLC will be presented. The study demonstrated that the Biodesix Anti-PD-L1 Response Test (ART), based on mass spectrometry of pretreatment serum, stratifies outcomes in both treatment arms overall and in all PD-L1 subgroups. The Biodesix ART test was shown in independent validation to predict outcomes for NSCLC patients treated in a large Phase 3 study and was discovered and developed for Genentech as a part of a partnership between the two companies.

Abstract #831: Exact Shapley Values for explaining complex machine learning based molecular tests of checkpoint inhibitors: potential utility for patients, physicians, and translational research

Data will show how Exact Shapley Values (SVs), a technique developed by Biodesix, can explain how complex machine learning (ML)-based tests combine molecular attributes to produce individual patient results. Exact SVs can be obtained for certain ML architectures used in molecular test development, revealing the overall relative importance of attributes used in such molecular tests. Specifically, this study evaluated SVs for the Biodesix Anti-PD-L1 Response Test (ART), that was shown in independent validation to predict outcomes for NSCLC patients treated in a large Phase 3 study. By subgrouping patients according to ART results, different patterns of SVs were determined, potentially revealing different biologies that were predictive of overall survival outcomes. Exact SVs explain how complex ML-based tests combine molecular attributes to produce individual patient results.

On November 12, 2021 CERo Therapeutics, Inc., a biopharmaceutical company pioneering the development of novel autologous engineered immune cell therapies, reported the results from preclinical in vitro studies describing the characterization of novel chimeric engulfment receptor (CER) T cells (Press release, Cero Therapeutics, NOV 12, 2021, View Source [SID1234595466]). CERs are genetically engineered proteins that bind to tumor-agnostic, inducible stress ligands on the surface of tumor cells to provoke tumor-specific cytotoxicity and innate immune functions such as engulfment and antigen presentation. The data, which are being presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2021), demonstrate that T cells engineered to express CERs exhibit multifunctional properties of both innate and adaptive immune responses and suggest the potential for CER T cells to overcome barriers associated with existing adoptive cell-based therapies.

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"These studies highlight for the first time the unique orthogonal profile of CER T cells to combine the tumor cell clearance attributes of macrophages and dendritic cells of the innate immune system with the T-cell activation of the adoptive immune system into a single engineered T cell," said Daniel Corey, MD, founder and CEO of CERo. "One of the limitations of activated T cells is their poor ability to present antigens due to inefficient antigen capture. In contrast, CER T cells facilitate antigen capture, processing and presentation, and impart target-dependent cytokine function, thereby offering a possible means of improving the therapeutic potential of engineered cell therapies."

In the studies, CER T cell constructs containing an extracellular phagocytic receptor were characterized for multiple functions, including cytotoxicity in combination with a Bruton’s tyrosine kinase inhibitor (BTKi), tumor cell fragment uptake, T-cell activation, cytokine induction, and antigen-presenting cell (APC)-like activity. Results of these in vitro studies showed that CER T cells synergized with a BTKi to enhance killing of a mantle cell lymphoma tumor cell line. Further, CER T cells exhibited abilities to capture tumor cell fragments and induce expression of T-cell activation markers and cytokines. CER T cells containing a toll-like receptor (TLR) domain also showed enhanced ability to present exogenous antigen and activate antigen-specific TCR T cells.

The poster entitled "Enhanced antigen capture, antigen-presenting cell (APC)-like function, and cytotoxic responses with chimeric engulfment receptor (CER) T cells" (Abstract #207) is now accessible virtually via the SITC (Free SITC Whitepaper) website and in person today from 7:00 a.m. – 8:30 p.m. ET in Exhibit Hall E.

About CERo’s Platform Technology

CERo’s technology aims to expand the therapeutic potential of engineered T cell-based therapies by introducing distinct and complementary tumor cell clearance pathways into a single T cell. By engineering T cells to express CERs, CERo’s platform technology enables T cells to target tumors, induce cellular damage, engulf tumor fragments, and clear tumors, effectively harnessing the anti-tumor attributes of both innate and adaptive immune responses. CER T-cell products are designed to generate a more complete and durable anti-tumor response. This novel biology amends itself to combinations with classic CAR T-cell or small molecule therapy and has potential applications in hematologic malignancies and solid tumors.

On November 12, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported the company will participate in the 2021 Jefferies London Healthcare Conference (Press release, Sierra Oncology, NOV 12, 2021, View Source [SID1234595465]). Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra, will provide an overview of the company in a presentation that will be available on demand beginning at 8:00 am GMT (3:00 am ET) on Thursday, November 18, 2021, to conference attendees.

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A replay of the presentation will be available following the conference on the Investors section of Sierra’s corporate website in the Events & Webcast tab. The replay will be available for approximately 30 days following the presentation.

On November 12, 2021 MiNA Therapeutics Limited ("MiNA" or the "Company"), the pioneer in small activating RNA (saRNA) therapeutics, reported that positive safety data from the Phase 1a/b TIMEPOINT study of MTL-CEBPA in combination with pembrolizumab in adult patients with advanced solid tumours (Press release, MiNA Therapeutics, NOV 12, 2021, View Source [SID1234595464]). The data will be initially presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place on 10-14 November 2021. Separately, MiNA also highlights the publication of positive data in the peer-reviewed journal Clinical Cancer Research, demonstrating MTL-CEBPA’s mechanism of action across different tumour models and in cancer patients.

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Robert Habib, CEO of MiNA Therapeutics, commented:

"The data presented at SITC (Free SITC Whitepaper) and published in Clinical Cancer Research further adds to the strong foundation of clinical evidence we have established for MTL‑CEBPA. Multiple studies across different tumour models and in cancer patients have demonstrated the unique immunological effects of MTL-CEBPA and its role as a potential combination treatment in cancer. We are excited to progress into Phase 1b the development of MTL-CEBPA in patients with solid tumour malignancies."

Data presented at SITC (Free SITC Whitepaper) from the ongoing Phase 1a/b, first-in-human, open-label, multicenter TIMEPOINT study demonstrates the safety and tolerability of MiNA’s lead candidate, MTL-CEBPA in combination with pembrolizumab, an approved anti-PD-1 (programmed death receptor-1) checkpoint inhibitor. The study is enrolling patients with advanced solid tumour treatment settings in which anti-PD-1 checkpoint inhibitors are not approved therapies.

At the three dose levels tested, the combination was generally well tolerated, with no dose-limiting toxicity and no serious adverse events observed. Encouragingly, anti-tumour activity was also observed in three patients. These included two confirmed partial responses in patients with advanced ovarian cancer and malignant pleural mesothelioma. The data package to date supports the continuation of this programme and MiNA is currently enrolling patients into a Phase 1b dose expansion cohort, which will additionally assess immunological changes as well as clinical activity of the combination treatment. Analysis of approximately 40 patients in the Phase 1b dose expansion cohort is expected to complete in the second half of 2023.

Additionally, translational proof-of-concept data further establishing MTL-CEBPA’s mechanism of action was recently published in the peer-reviewed journal Clinical Cancer Research. The data demonstrated that therapeutic up-regulation of C/EBP-α by MTL-CEBPA caused inactivation of immune-suppressive myeloid cells, potentiating anti-tumour responses in patients with advanced primary liver cancer (hepatocellular carcinoma (HCC)), as well as in several pre-clinical tumor models, including liver cancer, lung carcinoma, and colon adenocarcinoma.

This data provides evidence to support the role of MTL-CEBPA to counteract a key cancer immune evasion pathway by inhibiting immune suppression by myeloid cells, and for the potential of MTL‑CEBPA in combination treatment with immunotherapies across multiple tumour types. This data also supports MiNA’s strategy in liver cancer, where the Company is investigating MTL-CEBPA in patients with advanced HCC in combination with sorafenib (standard-of-care multi-kinase inhibitor), with a randomised Phase 2 clinical trial (OUTREACH-2) expected to initiate around the end of 2021.

Both the poster presented at SITC (Free SITC Whitepaper) and paper published in Clinical Cancer Research will be made available on the Company’s website in the Publications section under "RNA Activation".

About the TIMEPOINT study

TIMEPOINT is a global Phase 1a/1b clinical study in patients with solid tumour malignancies that will assess the safety and tolerability of MTL‑CEBPA in combination with pembrolizumab in patients who are ineligible or resistant to standard therapies. The study has received clearance from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). To learn more about the TIMEPOINT clinical study, please visit our listing at clinicaltrials.gov.

About MTL-CEBPA

MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and in solid tumour cancers have been identified as a critical barrier for many therapies to induce clinical responses. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing their suppressive effect in the tumour micro-environment. MTL-CEBPA is currently in clinical development as a combination therapy for the treatment of advanced liver cancer and advanced solid tumour malignancies.

On November 12, 2021 MiNA Therapeutics Limited ("MiNA" or the "Company"), the pioneer in small activating RNA (saRNA) therapeutics, reported that its Chief Executive Officer, Robert Habib, will present and host one-on-one meetings at the Jefferies 2021 London Healthcare Conference, taking place from 16-19 November 2021 in-person and virtually (Press release, MiNA Therapeutics, NOV 12, 2021, View Source [SID1234595463]).

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MiNA’s presentation will take place at 3:40pm GMT on Tuesday, 16 November 2021, with a live webcast available via the following link: View Source

Mr Habib will introduce MiNA and its saRNA technology platform, as well as provide an update on the Company’s clinical progress and strategy.