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Unum Therapeutics to Present Preclinical Data on Applications of ACTR Proprietary Technology Platform in Solid Tumors at the San Antonio Breast Cancer Symposium

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

Exact Sciences to participate in two November investor conferences

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]).

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

Personalis Launches ImmunoID NeXT, the First Platform Providing Characterization of a Tumor and its Microenvironment from a Single Sample

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.

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).

Mirati Presents Preliminary Biomarker Data From Ongoing Phase 2 Clinical Trial Of Sitravatinib In Combination With Nivolumab At The SITC 33rd Annual Meeting

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.

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.

Asterias Biotherapeutics Reports Third Quarter Results

On November 9, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported financial and operational results for the third quarter ended September 30, 2018 (Press release, Asterias Biotherapeutics, NOV 9, 2018, View Source [SID1234531180]).

On November 7, 2018, Asterias entered into a merger agreement under which Asterias will become a wholly-owned subsidiary of BioTime, Inc. (NYSE American and TASE: BTX) and each outstanding share of common stock of Asterias not already owned by BioTime will be converted into 0.71 common shares of BioTime. The transaction is expected to close during the Company’s first quarter ending March 31, 2019, subject to the satisfaction of customary closing conditions.

Third Quarter 2018 Financial Results

Research and development expenses were $3.5 million in the third quarter. General and administrative expenses were $1.9 million in the third quarter. Total operating expenses were $5.4 million in the third quarter of 2018, compared to $8.7 million in the third quarter of 2017.

Net loss was $4.5 million, or $0.08 per share for the third quarter of 2018 compared to a net loss of $6.8 million, or $0.14 per share for the third quarter of 2017. For the quarter ended September 30, 2018, net cash used in operating activities was $2.9 million compared to $4.5 million for the quarter ended September 30, 2017.

On September 28, 2018, the Company entered into two new agreements with an affiliate of Novo Nordisk, a multinational pharmaceutical company based in Denmark, which included a $2.0 million upfront payment that was received in early October 2018. Following the receipt of such funds from the Novo transaction, on October 1, 2018 the Company had cash and cash equivalents of $8.5 million and $6.2 in marketable equity securities. The Novo transaction will also result in approximately $1.0 million of annual reduction in fixed overhead allowing Asterias to advance its development programs more cost-effectively.

Conference Call

As a result of the merger agreement with BioTime, the Company’s previously announced conference to provide an overview of the third quarter results as well as the recent corporate progress, scheduled for Monday, November 12, 2018 at 5:00pm ET have been cancelled.