AbbVie and Tizona Therapeutics Announce Strategic Collaboration to Develop First-in-Class Immunotherapy for Cancer Targeting CD39

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Tizona Therapeutics, Inc. ("Tizona"), a privately held immunotherapy company, reported that they have entered into a global, strategic collaboration to develop and commercialize CD39-targeted therapeutics, including TTX-030, a first-in-class antibody for the treatment of cancer (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532450]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment (TME) by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway.

"Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Mo Trikha, Ph.D., Vice President, Head of Oncology Early Development, AbbVie. "Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody."

"Tumors employ various strategies to create a tolerogenic microenvironment, which reduces the immune system’s ability to detect and fight cancer," said Courtney Beers, Ph.D., Vice President, Immunology, Tizona. "Preclinical research shows that inhibiting CD39 may hold the key to restoring and bolstering immune responses against tumors. In AbbVie, we have a partner who shares our passion for science and commitment to delivering breakthrough innovation to patients with cancer. We look forward to advancing this exciting program."

Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona will lead clinical development through completion of Phase 1b studies, after which AbbVie has an exclusive option to lead global development and commercial activities. Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

An investigational new drug application for TTX-030 has been accepted by the US Food and Drug Administration.

TTX-030, the Adenosine Axis, and the Tumor Microenvironment

TTX-030 is a monoclonal antibody that inhibits the activity of CD39, a cell surface enzyme upregulated on tumors, exhausted T cells, as well as many suppressive cell types as an immune evasion strategy. It catalyzes the conversion of ATP to AMP, the first step in the generation of adenosine. By blocking the action of CD39, TTX-030 prevents the formation of immune suppressive extracellular adenosine, which would otherwise inhibit effector cells in the tumor microenvironment (TME). In addition to preventing the formation of suppressive adenosine, TTX-030 prevents the degradation of ATP, preserving its ability to stimulate dendritic and myeloid-derived cells responsible for innate immunity and immune cell priming necessary for adaptive immunity.

Lilly to Participate in J.P. Morgan Healthcare Conference

On January 3, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 (Press release, Eli Lilly, JAN 3, 2019, View Source [SID1234532392]). David A. Ricks, Lilly’s chairman and chief executive officer, will participate in a fireside chat from 6:00 p.m. to 6:25 p.m. Eastern time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

AbbVie to Host Fourth-Quarter and Full-Year 2018 Earnings Conference Call

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its fourth-quarter and full-year 2018 financial results on Friday, January 25, 2019 before the market open (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532409]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Rigel to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 3, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and CEO, is scheduled to present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 11:00am PT in San Francisco, CA (Press release, Rigel, JAN 3, 2019, View Source [SID1234532425]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

Selecta Biosciences Expands Potential for ImmTOR™ Platform and Streamlined Structure Under Leadership of New CEO, Carsten Brunn, Ph.D.

On January 3, 2019 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR (SVP-Rapamycin), reported its updates on its platform priorities and streamlined structure under the leadership of its new President and CEO, Carsten Brunn, Ph.D (Press release, Selecta Biosciences, JAN 3, 2019, View Source [SID1234532443]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe 2019 will be a transformative year for Selecta with key milestones anticipated for both our chronic refractory gout and gene therapy programs. We intend to focus on executing our strategic priorities, advancing our ImmTOR platform, and growing our strategic partnerships. With this renewed focus, we plan to deprioritize our oncology pipeline and undergo a restructuring to better align with our new priorities. The restructuring was a difficult decision and I want to personally thank all those who are affected for all their contributions to Selecta," said Dr. Brunn.

Selecta strongly committed to chronic refractory gout:
The company remains committed to the development of its lead product candidate, SEL-212, (ImmTOR+pegadricase) in chronic refractory gout. Based on interim data from the recently completed Phase 2 study, inclusive of the five outstanding patients who had not previously completed their course of therapy as of October 9th, 2018, 66% of evaluable patients (21/32), maintained serum uric acid (sUA) levels of <6mg/dL after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with 0.2mg/kg of pegadricase. Furthermore, reduced total urate burden and lowered flare rates and severity were observed in the Phase 2 clinical trial, and SEL-212 continued to be generally well tolerated.

Following a December 2018U.S. Food and Drug Administration (FDA) meeting, the company plans to initiate a head-to-head superiority trial of SEL-212, utilizing revised stopping rules, compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019. An interim six-month data readout is projected for the fourth quarter of 2019 with a full statistical superiority data analysis expected in the first quarter of 2020. The results of the planned head-to-head superiority trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.

Selecta plans to explore the potential of re-dosing AAV gene therapy:
In September 2018, Selecta announced a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome. Selecta expects CureCN to initiate preclinical toxicology studies in the first half of 2019 and for the combination product candidate to enter the clinic in the second half of the year.

In addition to this renewed focus on AAV gene therapy applications, Selecta plans to deprioritize its SEL-403 Phase 1 oncology program. The trial, which was placed on clinical hold by the FDA, was being conducted by the National Cancer Institute, part of the National Institutes of Health.

Selecta’s new CEO, Dr. Brunn, announces a streamlined structure:
Effective December 1, 2018, Carsten Brunn, Ph.D., assumed the role of President and CEO of Selecta, following his previous position as President of Pharmaceuticals for the Americas and member of the Global Pharmaceutical Executive Committee at Bayer. He has also held senior executive positions at Eli Lilly, Novartis, Basilea, and Bausch and Lomb in Europe, Asia and the United States.

The company is restructuring to reduce the current workforce by 36% as of January 3, 2019. This reduction, coupled with a reprioritization of the company’s pipeline programs, is projected to reduce the yearly cash burn by 19% going forward.