On May 30, 2019 XBiotech Inc. (NASDAQ: XBIT) reported that it has commenced an underwritten public offering of common shares, subject to market and other conditions (Press release, XBiotech, MAY 30, 2019, View Source [SID1234536697]). XBiotech intends to grant the underwriter in the offering a 30-day option to purchase additional common shares.

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Piper Jaffray is acting as the sole underwriter in the offering.

Net proceeds of the offering will be used primarily to advance bermekimab Phase 2 clinical trials in Hidradenitis Suppurativa and Atopic Dermatitis and for general corporate and working capital purposes. Completion of the offering is subject to customary closing conditions.

The common shares are being offered pursuant to an effective shelf registration statement on Form S-3 previously filed with and declared effective by the Securities and Exchange Commission. The prospectus supplement and accompanying prospectus relating to the offering contain important information relating to the XBiotech common shares. The prospectus supplement will be filed with the SEC and will be available on the SEC’s website at View Source, or may be obtained, when available, by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by phone at (800) 747-3924. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This offering may only be made by means of a prospectus supplement and related base prospectus.

On May 30, 2019 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported their Chief Medical Officer, Ian McGowan MD Ph.D. FRCP, will be presenting at the ASCO (Free ASCO Whitepaper) meeting which is being held in Chicago (May 31st to June 3, 2019; View Source) (Press release, Orion Biotechnology, MAY 30, 2019, View Source [SID1234536714]). His talk will be in the Gastrointestinal (Colorectal) cancer track and will focus on the surveillance and management of anal intraepithelial neoplasia in HIV and non-HIV infected patients. In his previous position, as a Professor of Medicine at the University of Pittsburgh Medical School, his laboratory undertook research to characterize the prevalence of anal human papillomavirus (HPV) infection in men who have sex with men (MSM) and transgender women. In the MTN-017 study which was conducted in the US, Peru, Thailand, and South Africa. Dr. McGowan’s laboratory showed that approximately 93% of MSM had evidence of anal HPV infection which is linked to the development of anal dysplasia and anal cancer (Cranston et al. Int J STD AIDS 2019).

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"Despite increased availability of highly efficacious HPV vaccines, there is a large pool of individuals who have already acquired anal HPV infection and are at risk of developing epithelial dysplasia and in some cases cancer. Unfortunately, this risk is significantly increased when there is co-infection with HIV. These patients should undergo regular surveillance to recognize and treat anal dysplasia to avoid progression to anal cancer," said Dr. McGowan.

Orion Biotechnology has an active preclinical program focused on the treatment of gastrointestinal cancers with our lead compound, OB-002, and plans to submit an IND to support Phase 1 clinical trials in 2020.

On May 30, 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 that the China National Medical Products Administration (NMPA, formerly known as CFDA) has accepted a supplemental new drug application (sNDA) for tislelizumab, an investigational anti-PD-1 antibody, for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma (UC) (Press release, BeiGene, MAY 30, 2019, View Source [SID1234536731]).

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"The development program for tislelizumab is achieving its milestones swiftly with our first solid-tumor filing for patients with previously treated urothelial carcinoma following our initial filing last year for patients with relapsed/refractory classical Hodgkin’s lymphoma. We sincerely hope that this submission, if approved, can bring a meaningful treatment option for patients with UC in China," said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. "We believe that the broad development program for this anti-PD1 inhibitor, along with manufacturing capabilities that are nearing completion, and non-clinical data presented earlier this year, reinforce tislelizumab as a potentially differentiated immuno-oncology compound. We are excited by its prospects to improve the way people with cancer are treated around the world."

The sNDA is supported by a clinical, non-clinical, and CMC data package, including the results from a pivotal Phase 2 study of tislelizumab in 113 Chinese and South Korean patients with previously treated PD-L1+ locally advanced or metastatic urothelial carcinoma (chinadrugtrials.org registration number: CTR20170071). A recent independent review of data showed that, with a median follow-up time of 8 months at the data cutoff, overall response rate (ORR) in 104 efficacy-evaluable patients was 23.1 percent, including eight (7.7 percent) confirmed complete responses (CRs) and 16 (15.4 percent) confirmed partial responses (PRs). Frequency and severity of adverse events were generally consistent with the previously reported Phase 1/2 safety and tolerability data for tislelizumab, or, in the case of certain immune-related adverse events, consistent with previous reports of other PD-1 antibodies. Full results of the study are planned to be presented at an upcoming medical conference.

About Urothelial Carcinoma
Urothelial carcinoma (UC), also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer.i In 2018, there was an estimated 82,270 incidences of bladder cancer in China, accounting for 27.3 percent of all incidences worldwide.ii Although UC is most common in the bladder, it can occur in other parts of the urinary system.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

In addition to the pivotal Phase 2 trial of tislelizumab in locally advanced or metastatic urothelial cancer mentioned in this release, BeiGene has also completed a pivotal Phase 2 clinical trial in patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL). Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; a Phase 3 trial in patients with Stage III NSCLC; a Phase 2 clinical trial in second- or third-line patients with HCC; and a Phase 1 clinical trial in patients with relapsed/refractory (R/R) NK/T-cell lymphomas. The aforementioned studies are enrolling patients in multiple countries, including the U.S., Europe, and China.

Additionally, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); and a pivotal Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies are enrolling patients in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and the R/R cHL filing has been granted priority review. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On May 30, 2019 ImaginAb, Inc., a clinical stage immuno-oncology imaging company, reported that it is scheduled to present at the following investor and scientific conferences in May and June 2019 (Press release, ImaginAb, MAY 30, 2019, View Source [SID1234536679]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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US-China Bio-Partnering Forum

May 30-31 2019, Chicago, Illinois

Ian Wilson CEO will update investors on current progress of ImaginAb programs and pharmaceutical collaborations.

2019 ASCO (Free ASCO Whitepaper) Annual Meeting

May 31-June 4, 2019, McCormick Place, Chicago, Illinois

Ian Wilson, CEO, Ivan Plavec, CBO, and Ron Korn CMO, will be attending and hosting meetings.

2019 BIO International Convention

June 3-6, 2019, Pennsylvania Convention Center, Philadelphia, Pennsylvania

Ivan Plavec, CBO, will be attending and hosting meetings.

Cavendish Global Conference

June 18-19, 2019, Chicago, Illinois

Ian Wilson CEO will update the conference on current progress of ImaginAb programs and pharmaceutical collaborations.

SNMMI 2019 Annual Meeting

June 22-25, 2019, Anaheim Convention Center, Anaheim, California

ImaginAb will have a booth at the SNMMI conference, where ImaginAb team will be hosting meetings, with clinical investigators, pharmaceutical companies, and partner organizations.

Ian Wilson CEO will update the conference on ImaginAb’s lead program 89ZrCD8PET on Sunday, June 23 in 6.23 CMIT in the Emerging Technologies session.

Inquiries or to schedule a meeting:

ImaginAb

Ian Wilson, Salli Walker
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144

On May 30 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (U.S. FDA) granted a Priority Review for the supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant (ASCT) (Press release, Genmab, MAY 30, 2019, View Source [SID1234536715]). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a U.S. FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The U.S. FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of September 26, 2019 to take a decision on daratumumab in this indication. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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The sBLA submission is based on data from the Phase III CASSIOPEIA study of daratumumab in combination with VTd as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen. Genmab announced topline results from the trial in October 2018 and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted an abstract containing more complete data, submitted by Janssen, for oral presentation at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting in June 2019.

"Thanks to the strong collaborative effort of IFM, HOVON and Janssen, should the U.S. FDA approve this sBLA, patients in the United States newly diagnosed with multiple myeloma who are eligible candidates for ASCT may one day also be able to include DARZALEX in combination with VTd in their treatment regimen," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the CASSIOPEIA (MMY3006) study
This Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen, including 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations