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 Integral Molecular, the industry leader in the discovery of monoclonal antibodies (MAbs) against multipass membrane proteins, and Ono Pharmaceutical Co., Ltd. reported that they have entered into a new collaboration for antibody discovery following a previously successful collaboration (Press release, Integral Molecular, JAN 3, 2019, View Source [SID1234533986]). This second collaboration involves the discovery of candidate MAbs against an undisclosed target and leverages the power of Integral Molecular’s MPS Antibody Discovery platform.

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Integral Molecular has used the MPS platform to discover antibody assets targeting a number of other multipass membrane proteins, including GPCRs (CB1) and transporters (GLUT4). Many of these MAbs are the first of their kind to be isolated, as complex membrane proteins have historically been extremely difficult targets for antibody discovery.

"We have a proven track record discovering large panels of high-affinity antibodies against difficult membrane proteins. This has been driven by our innovative MPS platform and over 15 years of experience working with multipass membrane proteins, so we are confident in the success of this collaboration," said Dr. Ross Chambers, VP of Antibody Discovery at Integral Molecular. "We are pleased that Ono, a global leader in innovative medicines, considers us to be a trusted partner in antibody discovery."

"We have been impressed by Integral Molecular’s membrane protein expertise and their proven record in discovering antibodies against them," said Hideaki Tada, Executive Director, Center of Oncology Research of Ono. "This is our second collaboration with Integral Molecular, and we are very pleased to deepen our engagement with them."

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.

On January 3, 2019 Aadi Bioscience, Inc. (Aadi), a clinical stage biopharmaceutical company focused on treating diseases driven by mTOR activation, reported that its drug TARZIFYX (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received Breakthrough Therapy Designation status from the FDA for the indication of Advanced (metastatic or locally advanced) Malignant PEComa (perivascular epithelioid cell tumor) (Press release, Aadi, JAN 3, 2019, View Source [SID1234532410]). The designation was granted based on data provided to the FDA from Aadi’s ongoing phase 2 registration trial (NCT02494570) in Advanced Malignant PEComa. In October 2018, Aadi also received Fast Track Designation from the FDA for TARZIFYX for the same indication. Aadi received orphan drug designation for TARZIFYX for the treatment of PEComa in December 2017.

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Aadi’s Phase 2 registration trial for Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT), a rare form of sarcoma, has completed enrollment. Aadi previously received agreement from the FDA that this open label study in 30 efficacy evaluable patients with a primary endpoint of overall response rate could support the submission of an NDA for approval to treat this rare disease.

"We are extremely pleased with the progress of the AMPECT study and recognition of the high unmet need in this patient population via the Breakthrough Designation. Our small, but dedicated team is gearing up for NDA filing in 2019," said Neil Desai, Ph.D., Founder and Chief Executive Officer of Aadi. "There has been no prior clinical trial in this rare disease and standard chemotherapies used in sarcoma treatment have very limited activity in this patient population."

mTOR inhibition is relevant in a number of disease states and has not been fully exploited in oncology, cardiovascular disease, CNS diseases, mitochondrial disease, diseases of ageing, etc. Due to the unique properties of Aadi’s drug including effective CNS penetration, it is being tested in nine ongoing clinical studies across these indications with encouraging results even outside of oncology in early studies in pulmonary hypertension and surgically refractory epilepsy. Aadi’s ongoing and planned clinical trials include Oncology (pediatric tumors, advanced sarcoma, first-line treatment of advanced colorectal cancer, newly diagnosed and recurrent glioblastoma, advanced neuroendocrine tumors), Cardiovascular indications (pulmonary arterial hypertension), CNS indications (surgically refractory epilepsy) and Mitochondrial disease (Leigh Syndrome).