On January 3, 2019 Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company reported that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada) to evaluate the combination of Adlai Nortye’s AN0025 (EP4 Antagonist) and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors (Press release, Merck & Co, JAN 3, 2019, View Source [SID1234553811]).

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Under the terms of the agreement, Adlai Nortye and Merck will collaborate in a clinical trial to evaluate the safety and preliminary efficacy of the combination of AN0025 (EP4 Antagonist) and KEYTRUDA in patients with solid tumors.

"We are excited to announce this collaboration with Merck, to help bring innovative cancer treatments to patients with unmet medical needs. AN0025 is an investigational, oral EP4 antagonist – potentially first-in-class – with high activity and high selectivity," said Carsten Lu, CEO of Adlai Nortye. "Based on preliminary results, it is well tolerated in patients with solid tumors. This collaboration is supported by our recent preclinical data demonstrating the potential ability of AN0025 (EP4 Antagonist) to rescue patients who do not initially respond to anti-PD-1 therapy alone or who are resistant to PD-1 inhibitors with solid tumors."

"With its proposed mechanism of action and observed preclinical results, we believe that AN0025 (EP4 Antagonist) will become a key component in furthering the development of our oncology pipeline," said Dr. Lars Birgerson, CDO and CEO of Adlai Nortye USA. "In preclinical studies, AN0025 (EP4 Antagonist) combined with radiotherapy, chemoradiotherapy and with immune checkpoint inhibitors demonstrated antitumor activity in different malignancies, we are optimistic that the combination of AN0025 (EP4 Antagonist) with KEYTRUDA may provide meaningful clinical benefit in patients with solid tumors."

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