On January 7, 2019 McKesson Corporation (NYSE:MCK) reported that it will release financial results for its third fiscal quarter ended December 31, 2018 on Thursday, January 31, 2019, following the market close at approximately 4:00 PM Eastern Time (1:00 PM Pacific Time) (Press release, McKesson, JAN 7, 2019, View Source [SID1234532546]). The company has scheduled a conference call for 5:00 PM Eastern Time (2:00 PM Pacific Time), during which John Hammergren, chairman and chief executive officer, Brian Tyler, president and chief operating officer, and Britt Vitalone, executive vice president and chief financial officer, will review these results.

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The dial-in number for individuals wishing to participate on the call is 323-794-2588. Craig Mercer, senior vice president, Investor Relations is the leader of the call and the password is ‘McKesson’. The conference call will also be available live and archived on the company’s Investor Relations website at View Source

On January 7, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease and cancer, reported it will regain rights to develop and commercialize XmAb13676, a CD20 x CD3 bispecific antibody, from Novartis effective June 20, 2019, due to strategic pipeline reprioritization by Novartis (Press release, Xencor, JAN 7, 2019, View Source [SID1234532562]). Xencor granted Novartis co-development and ex-U.S. commercial rights in June 2016 through a collaboration and license agreement to develop and commercialize novel bispecific antibodies, including XmAb13676 and XmAb14045, and to access Xencor’s XmAb bispecific Fc and other Fc technologies. Currently XmAb13676 is being evaluated in an open-label Phase 1, multiple-dose, dose-escalation study to assess its safety, tolerability and preliminary anti-tumor activity in patients with B-cell malignancies, and initial data are expected in 2019.

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"We continue to work closely with Novartis across multiple programs in the collaboration, and both companies are eager to advance XmAb14045 in clinical development. Recently we presented encouraging early data from our Phase 1 study in patients with relapsed/refractory AML, observing multiple complete remissions on a weekly dosing schedule, and we continue to optimize dose in that study. Novartis also has internal XmAb preclinical bispecific programs progressing," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Xencor will continue to develop XmAb13676 as planned, and we believe its tuned potency holds potential for the treatment of patients with B-cell malignancies."

Under the terms of the collaboration agreement, Xencor and Novartis continue to share costs for the worldwide development of XmAb14045 with Xencor maintaining U.S. commercialization rights and Novartis having commercialization rights in the rest of the world, and worldwide development costs for XmAb13676 will be shared until June 2020. Novartis received worldwide rights to Xencor’s bispecific technology to develop and commercialize four additional targets selected by Novartis. Xencor is eligible to receive clinical, regulatory and sales milestone payments for successful programs, as well as tiered, low double-digit royalties for sales of XmAb14045 outside of the U.S. and mid single-digit tiered royalties for worldwide sales of the four proprietary Novartis bispecific molecules.

About XmAb13676

XmAb13676 is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1 clinical trial for the treatment of B-cell malignancies. An XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on XmAb13676. CD20 is highly expressed on B-cell tumors, including in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Engagement of CD3 by XmAb13676 activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

About XmAb14045

XmAb14045 is a tumor-targeted antibody that contains both a CD123 binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and other CD123-expressing hematologic malignancies. An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on XmAb14045. CD123 is highly expressed on AML cells and leukemic stem cells, and it is associated with poorer prognosis in AML patients. Engagement of CD3 by XmAb14045 activates T cells for highly potent and targeted killing of CD123-expressing tumor cells.

On January 7, 2019 Adagene, Inc., an innovative antibody discovery and engineering company, reported a collaboration with Dr. Richard Childs, Chief of the Laboratory of Transplantation Immunotherapy at the National, Heart, Lung, and Blood Institute, part of the National Institutes of Health, to discover antibodies targeting a novel antigen expressed on the surface of tumor cells (Press release, US NIH, JAN 7, 2019, View Source [SID1234553809]). Dr. Childs’s laboratory will convert these antibodies into a CAR-T, as they work to develop a non-major histocompatibility complex (MHC) restricted immunotherapy approach to targeting an endogenous retrovirus with tumor-restricted expression.

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"We are very pleased to be collaborating with such an expert in the field of clinical cancer biology," said Peter Luo, CEO of Adagene. "At Adagene, our goal is to translate innovation and scientific research into life-saving medications. It is incredibly rewarding to have the opportunity to leverage our proprietary Dynamic Precision Library to develop antibodies against a disease with such highly unmet medical need."

"Adagene has gone to great lengths to develop our leading antigen display technology," said Felix Du, Head of Technology Development at Adagene. "With our unique combination of antigen presentation technologies and having a very large, diverse and fully human antibody discovery library we were able to find the first antibodies targeting non-MHC restricted surface-expressed antigens against this class of challenging cancer targets."

On January 7, 2019 Aduro Biotech, Inc presented the corporate presentation (Presentation, Aduro Biotech, JAN 7, 2019, View Source [SID1234532498]).

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On January 7, 2019, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX) a clinical-stage targeted oncology company, reported a clinical collaboration with Bristol-Myers Squibb Company to evaluate the combination of sitravatinib and nivolumab (OPDIVO), in Mirati’s planned Phase 3 trial in second line non-small cell lung cancer (NSCLC) patients who have progressed following treatment with a platinum-based regimen and a checkpoint inhibitor (Press release, Mirati, JAN 7, 2019, View Source [SID1234532531]).

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The Phase 3 pivotal trial is expected to start in the first half of 2019 and will randomize patients to either the combination of sitravatinib with nivolumab or single-agent docetaxel. The trial will include an interim analysis of overall response rate (ORR) as the basis for potential accelerated approval. This interim analysis and the use of a docetaxel control arm follows guidance from Mirati’s FDA end of phase 2 meeting. The primary endpoint of the final analysis for the Phase 3 clinical trial will be overall survival.

"Our Phase 2 clinical trial of sitravatinib plus nivolumab in patients with checkpoint refractory NSCLC has shown promising activity and a well-tolerated safety profile," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "The trial is expected to result in a new drug application (NDA) for sitravatinib for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum containing regimen and a checkpoint inhibitor. This collaboration further validates the potential of sitravatinib and allows Mirati to invest in and expand the development of our clinical and pre-clinical programs."

Under the terms of the collaboration, Mirati will sponsor and fund the clinical trial and Bristol-Myers Squibb will provide nivolumab at no cost. Mirati maintains global development and commercial rights to sitravatinib outside of certain Asian territories, where it is partnered with BeiGene, and is free to develop the program in combination with other agents.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations