On January 3, 2019 Mavupharma (Mavu) reported that it has selected its first immuno-oncology clinical development candidate, MAVU-104, a novel innate immune modulator (Press release, Mavupharma, JAN 3, 2019, View Source [SID1234537639]).

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MAVU-104 is a first-in-class, orally active, small molecule inhibitor of ENPP1, a phosphodiesterase that negatively regulates the STING (Stimulator of Interferon Genes) pathway. STING signaling plays a crucial role in the generation of an immune response directed at the tumor, and enhancing STING signaling has been shown to induce cures in multiple preclinical cancer models. Inhibiting ENPP1 activity with MAVU-104 allows for highly-controlled enhancement of STING signaling in all tumors and lymph nodes without any injections.

"With our approach, which focuses on blocking a key negative regulator of the STING pathway, as opposed to directly stimulating STING itself, the degree and duration of innate immune activation are tunable, which avoids both overstimulation of the pathway and high levels of cytokine release," stated Mike Gallatin, Ph.D., Mavu’s president and co-founder. "Having selected our first immuno-oncology drug candidate, we are now focused on the path to IND for MAVU-104, which we expect to file in the second half of 2019."

Mavu’s approach may have significant advantages over other developmental therapies that stimulate the STING pathway. Published studies on the direct STING agonists in clinical development show that these therapies are administered via direct injection into the tumor(s) and may induce release of pro-inflammatory cytokines into systemic circulation, which has been associated with side effects.

Previously, Mavu presented data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 meeting showing that ENPP1 inhibition leads to tumor shrinkage and can be combined with other immunotherapies to induce long-term cures and durable immunologic memory in mouse models of cancer.

On January 3, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, reported its anticipated milestones for 2019 (Press release, Unum Therapeutics, JAN 3, 2019, View Source [SID1234532383]).

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"Unum made substantial progress in 2018 as we reported early data from our programs in non-Hodgkin lymphoma and multiple myeloma, while simultaneously expanding applications of our ACTR platform into solid tumors and introducing a second novel technology platform, BOXR, designed to improve the functionality of engineered T cells," said Chuck Wilson, CEO of Unum. "We expect 2019 also to be a year of significant momentum, with data expected from all four of our ongoing clinical programs, including readouts from the ATTCK-20-03 and ATTCK-17-01 trials, as well as an initial data readout from our first study in solid tumors. Additionally, we continue to innovate in the field of cell therapy and have recently nominated our first development candidate from our BOXR technology platform to advance toward clinical development."

Anticipated 2019 Milestones

ACTR707 + rituximab in r/r NHL

Complete the dose escalation phase of ATTCK-20-03, the ongoing, multicenter Phase 1 study testing ACTR707 in combination with rituximab to treat patients with relapsed/refractory B cell non-Hodgkin lymphoma. Advance into cohort expansion to confirm the preliminary recommended Phase 2 dose.
Report results from the dose escalation phase and preliminary data from the cohort expansion phase of the ATTCK-20-03 study.
ACTR087 + SEA-BCMA in r/r multiple myeloma

Progress dose escalation of ACTR087 and SEA-BCMA in ATTCK-17-01, a Phase 1, multi-center, open-label trial designed to test the safety, tolerability and anti-myeloma activity of the combination in patients with r/r multiple myeloma.
Report clinical data from multiple cohorts of the dose escalation phase.
ACTR707 + trastuzumab in HER2+ advanced cancers

Enroll and dose patients in Unum’s first ACTR T cell study in solid tumors, ATTCK-34-01, a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab in patients with HER2+ advanced cancers.
Report initial clinical data from ongoing dose escalation.
ACTR087 + rituximab in r/r NHL

Complete enrollment in ATTCK-20-2, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with relapsed or refractory B cell NHL, and report data from the trial.
BOXR Platform

Continued progress with new Bolt-On Chimeric Receptor technology platform ("BOXR") that improves T cell functionality by countering immunosuppression in solid tumor cancers. Initiate clinical development of BOXR1030, which has been nominated as the first product candidate from this platform.

On January 3, 2019 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the 37th Annual J.P. Morgan Healthcare Conference, Tuesday, January 8, at 2:30 p.m. PT at the Westin St. Francis Hotel, San Francisco, followed by a question and answer breakout session at 3:00 p.m (Press release, bluebird bio, JAN 3, 2019, View Source [SID1234532417]).

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To access the live webcast of bluebird bio’s presentation and breakout session, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the conference.

On January 3, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that Eddie Gray, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, at 9 am PT (Press release, Dynavax Technologies, JAN 3, 2019, View Source [SID1234532433]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source

On January 3, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported it will release its financial results for the 2018 fourth quarter and full year before the market opens on Wednesday, January 30, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, JAN 3, 2019, View Source [SID1234532453]).

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During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, February 8, 2019.