On September 3, 2020 Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, reported that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers (Press release, BioThera Solutions, SEP 3, 2020, View Source [SID1234564424]). The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 270 healthy volunteers.

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"The initiation of this clinical trial represents an important milestone for our biosimilar pipeline," said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "BAT2206 is the fifth biosimilar that Bio-Thera has advanced into clinical development. It signifies Bio-Thera’s continued commitment to developing and providing safe, effective, and affordable biological products for patients in China and around the world."

Bio-Thera Solutions is developing several additional biosimilar products, including QLETLI, a biosimilar to Humira, which is approved by the NMPA in China. Bio-Thera’s lead global biosimilar is BAT1706, a biosimilar to Avastin, has completed a global Phase III clinical trial and the BLA has been submitted and accepted by NMPA. Regulatory submissions for BAT1706 to FDA and EMA will occur in 2020Q4. Bio-Thera Solutions is also pursuing biosimilar versions of Actemra, Cosentyx and Simponi.

On September 3, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration to study investigational treatments for patients with a variety of cancer types (Press release, Xencor, SEP 3, 2020, View Source [SID1234564423]). The parties will collaborate to design and execute additional clinical studies with Xencor’s portfolio of XmAb drug candidates, including novel bispecific antibodies and engineered cytokines. Xencor is committing to funding and supporting these studies over an initial five-year term.

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"MD Anderson is a leader in clinical research for both hematological and solid tumor oncology, and we are excited to enter this broad collaboration," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "This alliance partnership will enable us to expand our ongoing efforts into additional indications, generate new clinical insights, inform key decisions and accelerate development timelines across our oncology portfolio. We look forward to working closely with MD Anderson as we advance new therapies to patients in need."

Xencor’s clinical-stage bispecific antibodies and cytokines are engineered with a heterodimer Fc domain (antibody tail), which enables their rapid design, simplified development and stable structure. Nine XmAb bispecific antibodies and one engineered cytokine are being evaluated in Phase 1 clinical studies conducted by Xencor and its partners:

CD3 bispecific antibodies contain a tumor associated antigen (TAA) binding domain and a second binding domain targeted to CD3, an activating receptor on T cells, with the goal to recruit or activate T cells against tumors with the antigen target. Xencor’s CD3 bispecific candidates in Phase 1 development include vibecotamab (CD123 x CD3) for patients with acute myeloid leukemia, plamotamab (CD20 x CD3) for patients with B cell malignancies and tidutamab (SSTR2 x CD3) for patients with neuroendocrine tumors and gastrointestinal stromal tumors.
Tumor microenvironment (TME) activator bispecific antibodies promote tumor-selective T-cell activation by targeting multiple checkpoints or co-stimulating receptors. TME bispecifics incorporate Xencor’s Xtend technology for longer half-life. XmAb20717 (PD1 x CTLA4), XmAb22841 (CTLA4 x LAG3) and XmAb23104 (PD1 x ICOS) are being evaluated in Phase 1 studies in patients with select advanced solid tumors.
Cytokines built with Xencor’s XmAb bispecific Fc domain have their potencies tuned to improve therapeutic index and also incorporate Xtend technology for longer half-life. Xencor and its co-development partner Genentech are evaluating XmAb24306, a novel IL15 cytokine-Fc fusion protein, in a Phase 1 study in patients with solid tumors.
"Xencor’s portfolio of novel antibody-based therapies offers a unique opportunity to evaluate a variety of clinical hypotheses for improved cancer treatments," said Christopher Flowers, M.D., ad interim division head of Cancer Medicine at MD Anderson. "By working collaboratively, we aim to identify potential benefits for many patients with hematologic cancers and solid tumors."

On September 3, 2020 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host its fourth annual virtual R&D Day for analysts and investors at 8:00 a.m. ET on Thursday, September 17 (Press release, Moderna Therapeutics, SEP 3, 2020, View Source [SID1234564422]).

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Moderna’s R&D Day will include presentations from Stéphane Bancel, Chief Executive Officer, Tal Zaks, M.D., Ph.D., Chief Medical Officer, Stephen Hoge, M.D., President, clinical team leaders and key opinion leaders with a focus on the Company’s clinical development pipeline.

A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

On September 3, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D., will participate in an ophthalmology panel discussion during Citi’s 15th Annual BioPharma Virtual Conference, taking place September 8-11, 2020 (Press release, Aldeyra Therapeutics, SEP 3, 2020, View Source [SID1234564421]). In addition, Aldeyra’s senior management will host one-on-one meetings at the conference.

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Panel Details

Title: Seeing 20/20 in 2020
Date: Thursday, September 10, 2020
Time: 9:50 a.m. ET

A live webcast of the panel discussion will be available on the investor relations page of the company’s corporate website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On September 3, 2020 AVEO Oncology (Nasdaq: AVEO) reported that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences (Press release, AVEO, SEP 3, 2020, View Source [SID1234564420]):

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Baird 2020 Global Healthcare Conference
Date: Thursday, September 10
Time: 8:30 AM Eastern Time

H.C. Wainwright 22nd Annual Global Investment Conference
Date: Monday, September 14
Time: 4:30 PM Eastern Time

A live webcast of the events can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.