On January 4, 2019 Synaffix B.V. reported it has entered into a license agreement with Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need (Press release, Synaffix, JAN 4, 2019, View Source [SID1234532485]). This agreement provides Mersana access to Synaffix’s industry-leading site-specific GlycoConnect ADC technology that has consistently demonstrated an ability to improve both the safety and the efficacy profiles of ADC product candidates. Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a projected total deal value of $295 million, plus royalties­­.

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Under the terms of the agreement, Mersana has been granted a non-exclusive license to incorporate GlycoConnect into one of its ADC development candidates, as well as an option to expand to additional programs. This agreement follows a research collaboration between the two companies that was centered around multiple product candidates.

"After evaluating several site-specific conjugation platforms, we have chosen Synaffix’s GlycoConnect technology for use in future ADC candidates," said Anna Protopapas, President and Chief Executive Officer of Mersana. "We are excited about the potential of this technology as it is designed not to require additional antibody engineering or cell-line modifications, which would offer us the potential to create site-specific antibodies for use in our ADCs when required."

"We are particularly excited to enter into this agreement with a leading company in the field of ADCs such as Mersana," said Peter van de Sande, CEO of Synaffix, who added "This collaboration is another testimony of the additional value that GlycoConnect is able to provide to already cutting-edge ADC technologies, thereby enabling novel medicines that are uniquely positioned to address areas of unmet medical need."

Per the agreement, Mersana is responsible for the research, development, manufacturing and commercialization of any resulting ADC product while Synaffix will supply components that are specifically related to its proprietary GlycoConnect technology.

About GlycoConnect

The proprietary GlycoConnect technology of Synaffix is a platform ADC technology that utilizes proprietary enzymes and metal-free click conjugation to stably attach ADC payloads specifically to the native glycan of any antibody, a privileged site for ADC applications. This approach can be applied directly to an existing antibody without any DNA and or protein engineering and is compatible with all ADC payload classes. The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

On January 4, 2019 Adaptive Biotechnologies, an immune-driven medicine company, reported that it will enter into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers (Press release, Adaptive Biotechnologies, JAN 4, 2019, View Source [SID1234532469]). The collaboration will combine Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery and immune profiling platform (TruTCR) to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.

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"We are thrilled that Genentech has selected Adaptive as a partner to develop neoantigen directed T-cell therapies, a personalized approach to cellular therapy," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Genentech brings an industry-leading team of scientists and drug development experts who could potentially enable our patented TCR discovery and immune profiling platform to help as many patients as possible."

Adaptive offers a pioneering technology platform to rapidly identify T-cell receptors (TCRs) that can most effectively recognize and directly target specific neoantigens, which are proteins generated by tumor-specific mutations not present in normal tissues. Through this partnership, Adaptive will utilize the investigational TCR discovery platform to identify the optimal TCRs to most effectively target each patient’s neoantigens for treatment. Genentech will engineer and manufacture a personalized cellular medicine to deliver to each patient. The goal is to harness the vast majority of therapeutically relevant, patient-specific neoantigens and advance the next generation of cellular therapies in oncology.

"We believe targeting neoantigens could be the most effective approach for harnessing a person’s immune system to fight cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptive’s pioneering platform for identifying T-cell receptors with Genentech’s cancer immunology expertise, has the potential to change the way cancer is treated and bring us one step closer to truly personalized healthcare."

"Cellular therapy approaches in cancer have been limited by the inability to effectively screen and translate the immune response to patient-specific neoantigens. Accurate recognition of such neoantigens is a major driver in the activity of novel immunotherapies," added Harlan Robins, Ph.D., head of innovation and co-founder of Adaptive Biotechnologies. "Given Adaptive’s unique ability to read and access the immune system at unprecedented scale and precision, Adaptive and Genentech can potentially jointly develop a patient-specific approach to treating cancer."

Under the terms of the agreement, Adaptive will receive $300 million in an initial upfront payment and may be eligible to receive more than $2 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. Genentech will have responsibility for clinical, regulatory, and commercialization efforts, and Adaptive will be responsible for patient-specific screening on a global basis.

Adaptive will continue to use its TCR discovery and immune profiling platform to collaborate in the development of cellular therapies in other disease areas, including autoimmune conditions and infectious diseases.

The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to occur in the first quarter of 2019.

Chad Robins, Adaptive CEO, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 8 at 11:30 am PT/2:30 pm ET. Robins will also participate in a panel presentation, Reinventing the Disease Continuum Through Precision Health, on January 7, 2019 at 5:00 pm PT/8:00 pm ET to discuss the impact of immune profiling on the future of immune-driven medicine.

About the TruTCR Screening Platform in this Collaboration

Adaptive’s TruTCR screening platform enables the discovery of TCRs against any type of clinically relevant antigen at high throughput. The platform can be used to identify antigens that are shared among patients as well as those that are specific to individual patients. In this collaboration, TruTCR will be used to identify and characterize clinical-grade superior TCRs for attractive antigen binding and tumor cell killing activity plus safety properties by querying hundreds of antigens simultaneously with high sensitivity. To initiate clinical development, the collaboration will first leverage Adaptive’s growing library of well-characterized antigen-specific TCRs that have been screened against thousands of known cancer antigens in patients. The ultimate goal, however, is to screen and select a patient’s own potent TCRs targeting their own most relevant neoantigens as a personalized therapy. This individual patient screening process will be implemented as part of the manufacturing process for each treated patient to custom tailor a cell therapy medicine for that specific patient’s 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