On December 3, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Robert M. Davis, chief financial offer and executive vice president, Merck Global Services, is scheduled to present at Citi’s 2018 Global Healthcare Conference in New York on Dec. 5, 2018 at 8:45 a.m. EST (Press release, Merck & Co, DEC 3, 2018, View Source [SID1234531824]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On December 3, 2018 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that its Chairman and Chief Executive Officer, Rodney Varner, will present at the 11th annual LD Micro Main Event at the Luxe Sunset Boulevard Hotel in Los Angeles, CA (Press release, Genprex, DEC 3, 2018, View Source [SID1234531841]).

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Genprex is scheduled to present on Wed., Dec. 5, 2018, at 10:30 a.m. PST. Genprex management will also attend one-on-one meetings with institutional investors throughout the day.

The LD Micro Main Event is the largest independent conference for small/micro-cap companies and will feature 250 companies presenting to an audience of over 1,200 attendees.

On December 3, 2018 Shanghai, Generon BioMed Holding Ltd (Generon), reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting the pre-clinical study results of two novel immunotherapies, A-319 (mono-valent) and A-329 (bi-valent), two CD19×CD3 bi-specific antibodies designed using Generon’s ITab platform (Press release, Generon (Shanghai), DEC 3, 2018, View Source [SID1234531890]). A series of studies were conducted to evaluate the bioactivities of A-319 and A-329 in vitro and in vivo. The in vitro data showed that the mono-valent and bi-valent CD19 binding had little effect on the CD3-associated activities including CD3 antigen binding affinity, T cell binding, and T cell activation. In contrast, the bi-valent binding format of A-329 showed better potency compared to the mono-valent format of A-319 in CD19 binding (KD 0.89 nM and 19.4 nM respectively) and in vitro human B cell killing (EC50 0.2 pM and 3.4 pM, respectively). Both A-319 and A-329 were capable of mediating tumor cell lysis with EC50 at 0.03~4.0 pM. A-329 demonstrated a greater killing activity on B cell lines with a low expression of CD19 antigen. In addition, The CD19 bi-valent format of A-329 revealed more B cell killing in monkeys. No significant differences of cytokine induction or liver injuries between A-319 and A-329 were observed. In human PBMC engrafted mouse models, in vivo efficacies of both formats on inhibiting tumor growth or improving animal survival rate were also confirmed. These results demonstrated that both A-319 and A-329 may benefit patients with B cell malignancies with less frequent dosing and lower levels of cytokine inductions than comparator therapies. A-329 especially has the potential to eliminate low CD19 expressing tumor stem cells.

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Dr. David Lacey, chairman of Generon’s scientific advisory board, commented, "The prosecution of A-319 and A-329 ITabs targeting underscores the broadening of Generon’s portfolio into the immune-oncology space. The inherent flexibility of the ITab design and the competitive attributes of its manufacture make this bi-specific platform particularly attractive for CD19 as well as future targets."

Dr. Xiao Qiang Yan, CEO and CSO of Generon, commented, "Targeting CD19 to treat patients with B cell malignancies remains a substantial unmet medical need. Generon has been focusing on developing CD3-activating bi-specific ITabs with the goal to serve patients better through more convenient dosing, improved efficacy and reduced side-effects. The preclinical data suggest that A-319 and A-329 may have unique advantages over other technologies or therapies targeting CD19".

About A-319 and A-329

A-319 and A-329 are T cell activating bi-specific antibodies (BsAb) designed to target CD19 and CD3 (anti-CD19, anti-CD3) and are under development for the treatment of patients with B cell malignancies including B cell leukemia and B cell lymphoma. Both A-319 and A-329 activate T lymphocytes in a patient to kill CD19 expressing malignant B-cells, and A-329 may also activate T lymphocytes in a patient to kill low CD19 expressing malignant B cells. A-319 was recently approved by SFDA to initiate a phase I study in patients with B cell malignancies in China.

On December 3, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported preclinical data in two abstracts for its first-in-class anti-APRIL antibody BION-1301 supporting its potential use as a treatment for multiple myeloma (MM) at the 60TH American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, CA (Press release, Aduro Biotech, DEC 3, 2018, View Source;p=RssLanding&cat=news&id=2379030 [SID1234531808]). Data from the studies demonstrated that therapies blocking a proliferation inducing ligand (APRIL) from binding to B cell maturation antigen (BCMA) and transmembrane activator and cyclophilin ligand interactor (TACI) may simultaneously target MM cells and APRIL-induced immunosuppression.

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"Our newest findings from the data presented at ASH (Free ASH Whitepaper) indicate that combining an anti-APRIL antibody such as BION-1301, which inhibits APRIL binding to TACI and BCMA, with a BCMA-targeted therapy may have the potential to augment anti-myeloma activity," commented Dr. Kenneth C. Anderson, director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center at Dana-Farber Cancer Institute. "These studies support the rationale for use of the investigational agent, BION-1301, in the treatment of multiple myeloma."

Moreover, studies showed patient serum levels of APRIL were elevated at all stages of MM investigated, suggesting a role for APRIL in early development and pathogenesis. In addition, APRIL was found to induce production of key chemokines with osteolytic capacity. Blocking APRIL could modulate the tumor microenvironment more broadly, illustrating the potential of BION-1301 as a therapeutic agent for MM, particularly in combination therapies.

"We are encouraged by the data we presented at ASH (Free ASH Whitepaper), which support our ongoing clinical evaluation of BION-1301," said Andrea van Elsas, Ph.D., chief scientific officer of Aduro. "We believe BION-1301 could represent a first-in-class therapy for the treatment of multiple myeloma and that its differentiated approach to blocking APRIL may have further potential in combination strategies."

Aduro is currently 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.

The abstract, "APRIL Is Significantly Elevated at All Stages of Multiple Myeloma (MM) and Interferes with Anti-BCMA Monoclonal Antibody-Mediated Cytolysis, Supporting the Clinical Evaluation of BION-1301 As a Novel Therapeutic Approach in MM," was presented in a poster session titled "652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II" and is available online at the ASH (Free ASH Whitepaper) Annual Meeting Website.

The abstract, "BION-1301 Blocks APRIL-Induced Anti-Apoptotic Signaling, Immune Suppressive Phenotype, and Chemokine Production Associated with Multiple Myeloma," was presented in a poster session titled "651. Myeloma: Biology and Pathophysiology, excluding Therapy: Poster I" and is available online at the ASH (Free ASH Whitepaper) Annual Meeting Website.

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 MM 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
BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM. Aduro also plans to explore BION-1301 as a potential treatment for IgA nephropathy (IgAN). Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In prior preclinical studies, Aduro established 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

On December 3, 2018 Amphivena Therapeutics, Inc., reported a privately held biotechnology company developing AMV564, a CD33/CD3 T cell engager for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), presented Saturday night in a poster presentation at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) first-in-human Phase 1 clinical data that demonstrate that in patients with relapsed/refractory AML, AMV564 is well-tolerated and has anti-leukemic activity through T-cell engagement (Press release, Amphivena Therapeutics, DEC 3, 2018, View Source [SID1234531842]). The data from this ongoing dose escalation trial further show that AMV564 has a unique PK profile with a gradual increase in drug exposures that mitigates cytokine release syndrome (CRS).

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"The ASH (Free ASH Whitepaper) data reports continued evidence of single-agent clinical activity in heavily pre-treated patients with refractory/relapsed AML. AMV564 has been well-tolerated and has the potential to be safely combined with other agents. Importantly, its 2-day half-life supports intermittent dosing which differentiates AMV564 from other T cell engagers in development for myeloid malignancies," said Eric J. Feldman, M.D., Amphivena’s Chief Medical Officer.

The poster highlights the safety and efficacy data on 26 evaluable patients, as follows:

Complete and partial responses (CRi, PR) observed in patients dosed at 100 mcg with a 14-day dosing regimen
No dose-limiting toxicity through the 150 mcg cohort, with a 0% 30-day mortality rate
No Grade 2+ CRS with a lead-in dose and no Grade 3+ CRS
Novel pharmacokinetic profile with a 2-day terminal half-life
A seamless Phase 1/2 study is ongoing at six centers in the U.S.