On January 3, 2020 Kashiv Pharma, LLC, a pharmaceutical research and drug delivery company developing next-generation technologies, innovative medicines for patients with unmet medical needs and drug life-cycle management products, reported its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars of leading global brands in the fields of oncology and immunology (Press release, Kashiv BioSciences, JAN 3, 2019, View Source [SID1234563292]). Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey plus research and development and manufacturing facilities in Bridgewater and Piscataway, New Jersey, Chicago, Illinois and Ahmedabad, India.

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Established in 2010, Kashiv Pharma focuses on innovative drug delivery systems and specialty drug products for the treatment of various debilitating diseases. The company seeks to partner with established pharmaceutical firms to commercialize products at an appropriate stage of development by offering novel products based on the next generation of advanced drug delivery platforms. Kashiv has created several proprietary technology platforms under the leadership of Dr. Navnit Shah, a world-renowned pharmaceutical scientist, for extended and time-specific oral delivery of small molecules including a novel gastric retention system (GRANDE) and a chronobiological delivery system (KRONOTEC). These advanced drug delivery systems target the drug to its optimal absorption site and at a time when the body needs it the most for maximal therapeutic effect.

Currently based in Piscataway and Chicago, Adello Biologics has been working to develop high-quality, affordable biosimilars for patients worldwide. The company is advancing a pipeline of complex proteins and monoclonal antibodies with lead candidates in oncology and immunology.

As a result of the acquisition, Kashiv BioSciences’ broad business offering includes drug delivery platforms incorporating delayed release technology and gastric retention systems that improve the efficacy and safety of known drugs; a 505(b)(2) pipeline of seven development products targeting unmet clinical needs; biosimilars; prodrugs; and, as part of a development collaboration with Amneal Pharmaceuticals LLC, 10 approved generic products and an additional 13 generic products in advanced stages of development, including several complex generic products. Kashiv BioSciences’ medications will improve the lives of patients suffering from cancer as well as neuromuscular, movement and endocrine disorders, among other debilitating conditions, both in the U.S. and globally.

"The acquisition of Adello will create a fully integrated biosciences company with a strong platform for growth," said Chintu Patel, who will become CEO of Kashiv BioSciences. "The combined breadth of expertise in small and large molecules, peptides, proteins and monoclonal antibodies will enable us to develop products with meaningful clinical differentiation and a compelling value proposition for patients, physicians and payers."

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.

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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.

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.

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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]).

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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.

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]).

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"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.