On September 4, 2018 BioInvent International AB (OMXS: BINV) reported that it has started dosing of the first patient in a dose escalation, consecutive-cohort, open-label phase I/IIa study of BI-1206 after recently obtaining approval from the Swedish Medical Product Agency and the U.S. Food and Drug Administration to initiate patient inclusion (Press release, BioInvent, SEP 4, 2018, http://www.bioinvent.com/media/press-releases/releases?id=69B6C3003DD16AD1 [SID1234529257]). The study will recruit approximately 30 patients across sites in the EU and the U.S. The trial will evaluate BioInvent’s proprietary antibody BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma. The targeted sub-indications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The study will explore BI-1206’s safety and tolerability, and seek to determine a recommended phase ll dose when given in combination with rituximab.

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Andres McAllister, Chief Medical Officer of BioInvent, said: "With its unique ability to recover and enhance the activity and efficacy of rituximab – a major component of the current standard treatment of NHL and clinically one of the best validated antibodies in cancer therapy, BI-1206 has the potential to become a mainstay in the cancer drug arsenal, and substantially improve outcomes."

About BI-1206 in combination with rituximab
BI-1206 is a monoclonal antibody that recognizes with high affinity and selectivity FcγRIIB (CD32B), the only inhibitory member of the FcγR family. CD32B is highly overexpressed by a number of NHL tumors, and overexpression has been shown to be associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma or follicular lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies. The combination of the two drugs could provide a new and important option for patients suffering from NHL.

On September 4, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported the publication of a peer reviewed paper in Leukemia authored by scientists from the Dana Farber Cancer Institute and Aduro as part of their ongoing collaboration to study the role of APRIL (A PRoliferation Inducing Ligand) in multiple myeloma (MM) (Press release, Aduro Biotech, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2366001 [SID1234529283]). The authors profile the impact that APRIL, acting through its receptor TACI (transmembrane activator and cyclophilin ligand interactor), has on immune regulatory T cells (Tregs) in MM. The paper further reports that APRIL binding to TACI contributes to the immunosuppressive and treatment resistant MM bone marrow microenvironment, an effect that could potentially be mitigated by anti-APRIL antibody, BION-1301. Aduro is currently advancing BION-1301 in a Phase 1/2 dose escalation trial for the treatment of MM.

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Key findings from the study include the observation that TACI expression is significantly higher in Tregs than conventional T cells from the same patient. APRIL significantly stimulates proliferation and survival of these Tregs, whereas a neutralizing anti-APRIL antibody (BION-1301) may inhibit these effects. Furthermore, the paper explained how APRIL specifically augments Tregs to enhance MM cell survival.

"It is now well-known that APRIL acts through its two receptors TACI and BCMA (B cell maturation antigen), the most specific MM antigen expressed at high levels in malignant plasma cells/B cells of all MM patients. Our newest findings from this study indicate that an anti-APRIL antibody such as BION-1301 may have the potential to treat MM through a differentiated mechanism of action, not only by inhibiting APRIL binding to BCMA, but also stimulating immunity to cancer by blocking APRIL binding to TACI," commented Dr. Yu-Tzu Tai, lead author and Principal Scientist in Medical Oncology at the Dana-Farber Cancer Institute.

The paper entitled "APRIL signaling via TACI mediates immunosuppression by T regulatory cells in multiple myeloma: therapeutic implications," can be accessed at View Source

About APRIL
APRIL is a member of the tumor necrosis factor superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA and TACI to stimulate a wide variety of responses that promote MM growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for MM. Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that APRIL plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through BCMA, was shown to be critically involved in the survival, proliferation and chemoresistance of MM, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in MM blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM.

On September 4, 2018 BeiGene, Ltd. (NASDAQ: BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the company will present at the Morgan Stanley 16th Annual Global Healthcare Conference in New York, NY (Press release, BeiGene, SEP 4, 2018, View Source;p=irol-newsArticle&ID=2365780 [SID1234529258]). The presentation is scheduled for 11:40 AM ET on Wednesday, September 12, 2018.

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On September 4, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that preclinical data for its first-in-class anti-APRIL antibody BION-1301 was presented at the 5TH European Congress of Immunology in Amsterdam, The Netherlands. Data from the preclinical studies demonstrated that BION-1301 was well-tolerated (Press release, Aduro Biotech, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365988 [SID1234529284]). In addition, pharmacological activity of BION-1301 binding to APRIL (A Proliferation-Inducing Ligand), a ligand for the receptors BCMA (B cell maturation antigen) and TACI (transmembrane activator and cyclophilin ligand interactor), was established in a dose-dependent fashion. The pharmacokinetics (PK) and target engagement biomarkers were used to predict the first-in-human dose. APRIL mediates important B-cell functions including activation, survival and maturation. Serum levels of APRIL are enhanced in patients diagnosed with multiple myeloma (MM) and correlate with a poor prognosis. APRIL in the bone marrow triggers a cascade of events to support human MM to proliferate, survive, induce resistance to standard-of-care drugs in MM cells and provide an immune protective environment.

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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

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"The pioneering work on the mechanism of action, PK and pharmacodynamics presented today has paved the way for the first clinical evaluation of BION-1301, an ongoing Phase 1/2 trial in patients with multiple myeloma," commented Hans van Eenennaam, Ph.D., executive vice president antibody research and site head, Aduro Biotech Europe.

Aduro is conducting a Phase 1/2 multi-center, open-label study (see www.clinicaltrials.gov, identifier NCT03340883) designed to evaluate the safety and activity of BION-1301 in patients with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies, including immunomodulatory drugs, proteasome inhibitors, chemotherapies, or monoclonal antibodies.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for MM. Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that APRIL plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through BCMA, was shown to be critically involved in the survival, proliferation and chemoresistance of MM, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in MM blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM.

On September 4, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the Morgan Stanley 16th Annual Global Healthcare Conference on Friday, September 14, 2018, in New York City (Press release, Medtronic, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365882 [SID1234529342]).

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Karen Parkhill, executive vice president and chief financial officer of Medtronic, will answer questions about the company beginning at 10:30 a.m. EDT (9:30 a.m. CDT).

A live audio webcast of the session will be available on September 14, 2018, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.