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.

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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.

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]):

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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.

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.

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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.

On June 12, 2019 MannKind Corporation (NASDAQ: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, reported that it will be featured as a presenting company at the JMP Securities Life Sciences Conference at 9:00 AM (ET) on June 19, 2019 (Press release, Mannkind, JUN 12, 2019, View Source [SID1234537039]). The conference is being held at The St. Regis in New York.

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Michael Castagna, Chief Executive Officer, of MannKind Corporation, will provide an overview of the Company’s business during the live presentation. Steven B. Binder, Chief Financial Officer, will participate in one-on-one meetings with investors who are registered to attend the conference.

The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

On June 12, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported updated data from the ongoing investigator-sponsored SPiReL Phase 2 clinical trial assessing IMV’s lead candidate, DPX-Survivac, in combination with intermittent low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda (pembrolizumab) (Press release, IMV, JUN 12, 2019, View Source [SID1234537038]). The trial is designed to evaluate the safety and efficacy of the combination immunotherapy in patients with persistent or recurrent/refractory diffuse large B-cell lymphoma (DLBCL).

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At the first "on treatment" assessment, five of the first six patients demonstrated clinical benefit, including four patients with tumor regressions. Two patients reached a complete radiological response, one a partial response, and two had stable disease while on study. In addition, the combination continued to demonstrate an acceptable safety profile.

"We are highly encouraged by the level of activity that we are observing with the combination of DPX-Survivac and Keytruda in these patients with DLBCL," said Frederic Ors, IMV’s Chief Executive Officer. "We believe that the clinical benefits the SPiReL trial has yielded thus far, and the data linking this antitumor activity with the T cell responses, support DPX-Survivac’s novel mechanism of action and our combination immunotherapy approach. We will continue working with our partners to advance this clinical study towards improving the lives of patients with difficult-to-treat cancers who need better treatment options."

Updated SPiReL Data Highlights:

At the time of data cut-off for this analysis, 11 patients were enrolled in the trial. Efficacy data from the first six evaluable patients are based on modified Cheson criteriai:

Two patients achieved a complete radiological response

These patients have shown the best survivin specific T cell responses to DPX- Survivac among the analyzed samples

One patient with a Complete Response (CR) has completed the one-year study period

One patient achieved a Partial Response (PR) at first "on treatment" scan

Two patients have reached stable disease

i Cheson, B.D.,, Pfistner, B., Juweid, M.E., Gascoyne, R.D., Specht, L., Horning, S.J., . . . and Diehl, V. (2007). Revised Response Criteria for Malignant Lymphoma. Journal of Clinical Oncology, 25(5) DOI: 10.1200/JCO.2006.09.2403

Each of these patients has remained progression free for six and eight months while on treatment

One patient with bulky disease progressed at first scan

Two subjects are not evaluable, coming off trial at day 7 and day 28

The treatment combination appears to be well-tolerated with only 2 serious adverse events related to treatment (low white blood count and low neutrophil count)

Radiological results from three additional patients are pending

The ICML abstract was published on June 12, 2019 via the 15-ICML ABSTRACT BOOK, a supplement to Hematological Oncology with first author Neil Berinstein, MD, FRCPC, ABIM Haematologist at the Odette Cancer Centre, Sunnybrook Health Sciences Centre and Affiliate Scientist at Sunnybrook Research Institute. Dr. Berinstein will be available at the ICML conference to discuss the results.

IMV will host a conference call and webcast to discuss the SPIREL results today, Wednesday, June 12, 2019, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International) using the conference ID: 9685423. Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and made available on the IMV website for 30 days following the call.

About DLBCL

Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of malignant lymphoma worldwide and accounts for approximately one third of all non-Hodgkin lymphomas. In the United States, it is estimated that nearly 25,000 new cases of DLBCL will be diagnosed in 2019. As many as 30% of all patients with DLBCL who either fail to respond to or show a relapse to initial therapies are reported to have a poor outcome and require more therapeutic options.

About the SPiReL Study

SPiReL (DPX-Survivac with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or Recurrent/refractory Diffuse Large B-Cell Lymphoma) is a Phase 2 non-randomized, multi-centre, open-label study. Primary Investigator Dr. Neil Berinstein is leading the trial, which is expected to enroll 25 evaluable participants whose recurrent DLBCL expresses survivin, a tumor antigen expressed in of the majority of DLBCL tumors. The study’s primary endpoint is to document the objective response rate. Secondary objectives include measuring tumor regression and documenting the toxicity profile and durations of response. In addition, investigators will perform analyses to assess circulating antigen specific immune responses and changes in tumor-infiltrating T cell immune responses within the tumor microenvironment. They also plan to assess potential biomarkers of immune and clinical response.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a

cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac.

The U.S. Food and Drug Administration (FDA) has provided Fast Track designation to DPX-Survivac as maintenance therapy in advanced ovarian cancer. In addition, the FDA and European Medicines Agency (EMA) have granted orphan drug designation status in the ovarian cancer indication. Investigators are currently evaluating DPX-Survivac in multiple Phase 2 clinical trials.