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.

On January 3, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it, through its subsidiary, has entered into a licensing and partnership agreement with Chongqing Jingdong Junzhuo Pharmaceutical Co., Ltd. ("Chongqing Jingdong Pharmaceutical") on December 30, 2018 to exclusively develop and commercialize KX2-391 for the treatment of actinic keratosis and oncology indications in humans in China (Press release, Athenex, JAN 3, 2019, View Source [SID1234534523]).

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KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor. KX2-391 ointment is a topical medicinal product for the treatment of actinic keratosis that is in late stage Phase III development. Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly, or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. Other drug candidates with KX2-391 as the compound are also being developed for oncology indications.

Pursuant to the terms and conditions of the arrangement, Athenex will grant to Chongqing Jingdong Pharmaceutical an exclusive license under Athenex’s intellectual property to commercialize topical and oral products containing KX2-391 in mainland China, excluding Hong Kong, Macau and Taiwan. Athenex is expected to receive an upfront payment of an aggregate amount of US$14.5 million. Athenex will also be eligible to receive other development milestone payments of up to US$15 million. In addition, the agreement provides for tiered royalties based on annual net sales starting at 15%, and with incremental increases of royalties with increases in sales.

Athenex will be responsible for conducting all preclinical and clinical studies, as well as regulatory submissions, required for approval in China. Chongqing Jingdong Pharmaceutical will employ its expertise to plan and prepare for the commercialization of the products in China. Athenex announced on July 26, 2018 that statistical significance (p < 0.001) was achieved in two Phase III studies conducted in the United States to support the registration of KX2-391 ointment for the treatment of actinic keratosis. Athenex has submitted an abstract to the American Academy of Dermatology for potential presentation of top-line data from Phase III studies at the AAD meeting in March 2019.

Bin Li, Chief Executive Officer, Chongqing Jingdong Pharmaceutical, commented, "We are pleased to enter into this strategic collaboration with Athenex. We are excited with the very encouraging results generated from the two Phase III studies of KX2-391 ointment, and are impressed by the Athenex team in their innovation and execution of drug development efforts. KX2-391 ointment has the potential to change the standard of care for treatment of actinic keratosis and there is a large unmet medical need in China. We look forward to bringing this promising product to market in China, as well as other potential drug candidates. Our strength and capabilities in drug commercialization and our relationships with key stakeholders in both the pharmaceutical industry and healthcare system in China will complement Athenex’s drug development expertise."

Johnson Lau, Chief Executive Officer, Athenex, added, "Athenex is excited to partner with Chongqing Jingdong Pharmaceutical to develop and commercialize KX2-391. Chongqing Jingdong Pharmaceutical is a pioneer in pharmaceutical drug sales and distribution in China. We are impressed by the management team of Chongqing Jingdong Pharmaceutical and are confident that this partnership will create strong synergies and a platform for growth for both companies in China. Chongqing Jingdong Pharmaceutical’s experience and execution in the Chinese market will be critical to bringing our product to market in the country."

Athenex has a license agreement with Almirall, S.A. on the rights to KX2-391 ointment in the following territories: USA, European Union, Russia and Turkey. Details of this arrangement were disclosed in December 2017.

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 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported its participation at the 37th Annual J.P. Morgan Healthcare Conference (Press release, Kura Oncology, JAN 3, 2019, View Source [SID1234532393]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Thursday, January 10, 2019 at 9:30 a.m. PT / 12:30 p.m. ET, followed by a Q&A session at 10:00 a.m. PT / 1:00 p.m. ET. The conference will be held from January 7-10, 2019 in San Francisco.

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Live audio webcasts of the presentation and Q&A session will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.