On November 9, 2018 Molecular Templates, Inc., (Nasdaq: MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported the presentation today of a poster on its PD-L1 ETB with Antigen Seeding Technology (AST) at the ongoing Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, currently taking place in Washington D.C (Press release, Molecular Templates, NOV 9, 2018, View Source [SID1234531192]).

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Antigen Seeding Technology represents a novel immune-oncology approach leveraging the novel mechanism of action of Molecular Templates’ ETB technology. ETBs engineered with Antigen Seeding Technology are capable of delivering viral antigens as a payload inside the target tumor, resulting in the antigens being presented on the cell surface of the tumor cells in complex with MHC-1. ETB therapeutics incorporating antigen seeding are designed to work through dual mechanisms of action by redirecting a high avidity, pre-existing antigen-specific cytotoxic T cell (CTL) response to the tumor while at the same inducing cell death via the enzymatic and permanent destruction of ribosomes. Coupling two distinct mechanisms of tumor cell killing into one ETB molecule provides the potential to increase target penetrance, expand a prolonged immune response, and overcome tumor resistance.

The poster, titled "Identification and Functional Profiling of PD-L1 Targeted Engineered Toxin Bodies for Antigen Seeding Technology (AST) and Redirection of T cell Response to Tumors" summarizes a series of preclinical experiments conducted by Molecular Templates to create PD-L1 targeted ETBs that have antigen seeding properties and to analyze the mechanisms by which they can kill cancer cells.

"Antigen Seeding Technology represents a novel approach to immune-oncology that may be active in patients where standard immune-oncology approaches have been exhausted," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "We are currently conducting in vivo studies with PD-L1 targeted ETBs that have AST functionality. Our plan is to file an IND and enter the clinic with our first PD-L1 ETB candidate employing AST in 2019."

Poster Presentation Details:
The poster (#P9) will be available to view in Hall E of the Walter E. Johnson Convention Center today, Friday, Nov. 9 from 8 a.m. – 8 p.m. and Saturday, Nov. 10 from 8 a.m. – 8:30 p.m. (all times are E.T.)

The poster can be found under "Clinical and Scientific Presentations" at View Source

On November 9, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, reported that the Company will present preclinical data on the potential of its proprietary ACTR technology in HER2+ solid tumors and details on the design of its planned Phase 1 clinical trial to test ACTR707 in combination with trastuzumab at the upcoming San Antonio Breast Cancer Symposium taking place December 4-8, 2018 in San Antonio, Texas (Press release, Unum Therapeutics, NOV 9, 2018, View Source [SID1234531190]).

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In preclinical testing, Unum has demonstrated robust activity of its proprietary ACTR T cells in combination with trastuzumab. Importantly, preclinical data demonstrate that, unlike certain CAR-T cells that target HER2, ACTR T cells are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. Additionally, the activity of ACTR T cell has been shown to be dose-dependent, demonstrating control of ACTR activity by modulation of trastuzumab concentration. Together these data suggest that ACTR cells in combination with trastuzumab may exhibit an improved clinical therapeutic index.

"We are encouraged by these preclinical data, which further highlight our novel ACTR technology pipeline and demonstrate our innovative approach to overcoming current challenges in the solid tumor setting," said Seth Ettenberg, Chief Scientific Officer of Unum.

"We have an active IND to evaluate ACTR707 in combination with trastuzumab as a potential treatment for HER2+ solid tumor cancers in a Phase I trial called ATTCK-34-01, and we remain on track to initiate this study before the end of 2018," said Michael Vasconcelles, Chief Medical Officer of Unum. "We look forward to continuing our work in the solid tumor setting and reporting initial data in 2019."

ATTCK-34-01 is a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further study. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics.

Details on the presentation are as follows:

Presentation Title: Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells in combination with trastuzumab for the treatment of HER2-positive malignancies
Session Title: HER2-Targeted Therapy
Date & Time: Thursday, 12/6/18; 5 – 7 PM
Location:Henry G. Gonzalez Convention Center

On November 9, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during November and invited investors to participate by webcast (Press release, Exact Sciences, NOV 9, 2018, View Source [SID1234531189]).

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Jefferies 2018 London Healthcare Conference, London
Presentation and Q&A session on Thursday, Nov. 15 at 2:40 p.m. GMT, 9:40 a.m. EST
Evercore ISI HealthconX, Boston
Fireside chat on Tuesday, Nov. 27 at 12:30 p.m. EST

On November 9, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported the launch of its universal cancer immunogenomics platform, ImmunoID NeXT (Press release, Personalis, NOV 9, 2018, View Source [SID1234531186]). This is the first platform to enable comprehensive analysis of both a tumor and its microenvironment from a single sample.

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Personalis CEO, John West, said, "While the success of checkpoint blockade has been hugely promising, it’s increasingly apparent that predicting response to immunotherapies and developing new ones requires a more comprehensive approach to tumor immunogenomics. With ImmunoID NeXT, it’s now possible to characterize the complex interactions between the tumor cells and immune cells of the microenvironment using a single platform. This means researchers no longer have to make the difficult choice of which biomarkers to analyze due to sample limitations, particularly when dealing with FFPE specimens."

The unique design of the ImmunoID NeXT Platform facilitates the delivery of therapeutic and diagnostic biomarker information across ~20,000 genes from DNA and RNA, including:

Neoantigen identification and characterization
Human leukocyte antigens (HLA) typing
Tumor infiltrating adaptive immune cells
T-cell receptor (TCR) repertoire (α, β, γ, and δ chains)
B-cell receptor (BCR) repertoire (heavy and light chains)
Tumor infiltrating innate immune cells
Immune response and tumor escape mechanisms
Neoantigen load and tumor mutational burden (TMB)
Microsatellite instability (MSI) status
Oncoviral detection
Germline genomic variation
Personalis is offering pharmaceutical customers the opportunity to participate in an Early Access Program beginning in January, 2019. The company also anticipates the release of a clinical diagnostic test based on this platform in 2019.

Personalis will be presenting new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C., November 8-11, 2018. Personalis representatives will also be available to discuss the ImmunoID NeXT Platform at the company’s exhibit (Booth #617).

On November 9, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported preliminary biomarker data from the ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab (OPDIVO) in non-small cell lung cancer (NSCLC) patients at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C (Press release, Mirati, NOV 9, 2018, View Source [SID1234531183]). The data will be presented today in a poster and also in an oral presentation on Saturday, November 10th.

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The ongoing Phase 2 clinical trial is evaluating the safety and efficacy of sitravatinib in combination with an anti-PD-1 immune checkpoint inhibitor, in patients who have experienced documented disease progression following prior checkpoint inhibitor therapy. Efficacy data were recently presented at the October 2018European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The data demonstrated a higher rate of durable responses than would be expected from treatment with docetaxel, the standard of care. Today’s presentation, "Preliminary Biomarker Analysis of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor", highlighted an initial assessment of correlative biomarkers for the 56 evaluable patients from the on-going clinical trial. Exploratory baseline and dynamic biomarker endpoints were evaluated for correlation with clinical outcomes.

The analysis demonstrated a CD8+ T effector cell response in patients who achieved a clinical benefit, suggesting a therapy-driven restoration of the anti-tumor immune response in patients who had become refractory to prior checkpoint inhibitor treatment. The data suggest that patients with high PD-L1 at baseline may be more likely to benefit from treatment with the combination although the difference was not statistically significant. There was no difference in treatment outcomes for patients based on their baseline tumor mutational burden or other baseline biomarkers.

"We are encouraged that we observed clear evidence of an adaptive immune response in our Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab. This suggests that the mechanism of sitravatinib is mediated, at least in part, by its effect on immune cell populations and that an anti-tumor immune response can be restored by sitravatinib administered with checkpoint therapy," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "We will continue to evaluate correlative endpoints as clinical trial data mature and determine whether biomarkers can be utilized to select patients who are most likely to benefit."

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.