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BioInvent Publishes First Clinical Data From BI-1206 Phase l/lla Trials

On June 12, 2019 BioInvent International AB (BINV) reported the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU respectively (Press release, BioInvent, JUN 12, 2019, View Source [SID1234537044]).

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In the UK trial, 10 patients have received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients have received up to 100 mg BI-1206 in combination with rituximab. The data are published in the Abstract Book from the 15-ICML International Conference on Malignant Lymphoma, available online as of today (View Source).

Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. While target-mediated drug disposition has not yet been overcome, as the optimal dose has still not been reached, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy.

"These are exciting results that further support the development of BI-1206 as a potential first-in-class therapeutic with a unique mechanism of action. Circumventing rituximab internalization by FcγRIIB blocking means it will potentially enhance rituximab’s efficacy," says BioInvent’s CEO Martin Welschof.

Affimed to Present Data on AFM13 at the 15th International Conference on Malignant Lymphoma in Lugano, Switzerland

On June 12, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that two abstracts from the Company’s lead innate cell engager AFM13 have been accepted for oral and poster presentation at the 15th International Conference on Malignant Lymphoma (ICML) being held June 18 to 22, 2019 in Lugano, Switzerland (Press release, Affimed, JUN 12, 2019, View Source [SID1234537043]).

Presentations related to AFM13, Affimed’s lead CD30/CD16A bispecific ROCK antibody, include a data update of the completed clinical study of AFM13 in combination with Merck’s Keytruda (pembrolizumab) in patients with relapsed or refractory Hodgkin lymphoma and updated clinical and immunological data from Columbia University on AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation. Details for the ICML presentations are as follows:

Oral Presentation:

Abstract: Investigating safety and preliminary efficacy of AFM13 plus Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure
Session: 11 – New Drugs Combination
Date and Time: Saturday, June 22, 8:30 – 10:00 am (CET)
Location: Room A (main hall of Palazzo dei Congressi)

Poster Presentation:

Abstract: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)
Section: Immunotherapy
Poster sessions: Wednesday, June 19, 12:00 – 17:00 (CET), Thursday, June 20, 9:00 – 17:00 (CET) and Friday, June 21, 9:00 – 18:30 (CET)
Location: Marquee Parco Ciani

Full abstracts of the presentations are published in the supplement to "Hematological Oncology" (John Wiley and Sons, Inc.), available on the Wiley Online Library website.

BeiGene Announces Clinical Data on Zanubrutinib to Be Presented at the 15th International Conference on Malignant Lymphoma (ICML)

On June 12, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported upcoming data in three oral presentations and one poster presentation on its investigational BTK inhibitor zanubrutinib at the 15thInternational Conference on Malignant Lymphoma (ICML), taking place June 18-22, 2019 in Lugano, Switzerland (Press release, BeiGene, JUN 12, 2019, View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" rel="nofollow">View Source [SID1234537042]). The company will also host an investor conference call and webcast of mid-2019 clinical data updates on Thursday, June 20 at 8:00 a.m. EDT.

Oral Presentations:

Title: Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Session: Focus on Mantle Cell Lymphoma
Date: Wednesday, June 19
Time: 17:45 CEST
Lead Author: Yuqin Song, M.D., Ph.D.

Title: Zanubrutinib for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Session: Session 3 – CLL
Date: Thursday, June 20
Time: 14:45 CEST
Lead Author: Wei Xu, M.D.

Title: Zanubrutinib Plus Obinutuzumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
Session: Focus on Non-Clinical and Early Clinical Data with New Combinations
Date: Thursday, June 20
Time: 17:25 CEST
Lead Author: Constantine S. Tam, M.D.
Poster Presentation:

Title: Updated Safety and Efficacy Data in the Phase 1 Trial of Patients with Mantle Cell Lymphoma (MCL) Treated with Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib (BGB-3111)
Abstract Code: 191
Session: Mantle Cell Lymphomas section
Dates and Times: Wednesday, June 19 (12:00-17:00), Thursday, June 20 (9:00-17:00) and Friday, June 21 (9:00-18:30) CEST
Lead Author: Constantine S. Tam, M.D.

Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Zanubrutinib

Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a pivotal Phase 2 trial in patients with R/R marginal zone lymphoma (MZL); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

Syros to Present at JMP Securities Life Sciences Conference

On June 12, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Securities Life Sciences Conference. Details are as follows (Press release, Syros Pharmaceuticals, JUN 12, 2019, View Source [SID1234537041]):

JMP Securities Life Sciences Conference:
Date: Wednesday, June 19
Time: 1:00 p.m. ET
Location: The St. Regis New York, 2 East 55th Street, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.

Sorrento to Explore Potential Initial Public Offering of Scilex Holding Company

On June 12, 2019 Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE) reported that it is exploring the possibility of an initial public offering of its majority-owned subsidiary, Scilex Holding Company (Press release, Sorrento Therapeutics, JUN 12, 2019, View Source [SID1234537040]). No decisions have been taken at this point on the structure or timing of any initial public offering, and no assurance can be given that an initial public offering will be pursued or completed.

This press release is being made pursuant to, and in accordance with, Rule 135 under the Securities Act of 1933, as amended. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.