On June 19, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Press release, BeiGene, JUN 19, 2020, View Source [SID1234561252]).

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"We are pleased to submit our second sNDA in first-line advanced NSCLC and the fourth potential indication for tislelizumab in China. We credit the continued momentum of our tislelizumab clinical program to the strong expertise of our teams and the support of clinicians and patients who participated in the trials. We have three additional Phase 3 trials for tislelizumab in lung cancer and we are looking forward to continuing to expand the label for tislelizumab in lung cancer and other indications," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "Together with the previously accepted filing in patients with squamous histology, we look forward to continuing our dialogue with the CDE and to hope to bring this innovative treatment to hundreds of thousands of Chinese patients and families impacted by this devastating disease every year."

The sNDA in non-squamous NSCLC is supported by clinical results from a Phase 3 trial of tislelizumab in combination with pemetrexed and platinum chemotherapy of investigator’s choice – either carboplatin or cisplatin – in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations (NCT03663205). A total of 334 patients were randomized 2:1 to receive tislelizumab in combination with chemotherapy or chemotherapy alone. As announced in April 2020, the trial met its primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC) in the pre-planned interim analysis. The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified. Full results of the trial will be presented at an upcoming meeting.

About Non-Small Cell Lung Cancer

In contrast to most Western countries, where lung cancer death rates are decreasing, lung cancer incidence rates are still increasing in China.1,2 There were approximately 770,000 new cases of lung cancer in China in 2018, and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths in China in 2018.3 Non-small cell lung cancer comprises the most common form of lung cancer in China.4

About Tislelizumab

Tislelizumab (BGB-A317) is a 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 from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, the Center for Drug Evaluation (CDE) of the NMPA has accepted two supplemental new drug applications (sNDAs) for tislelizumab in combination with chemotherapy, one for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) and the other for first-line treatment of patients with advanced non-squamous NSCLC.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On June 19, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company") reported the closing of its previously announced public offering of 76,923,077 shares of its common stock (or common stock equivalents in lieu thereof) at a price to the public of $0.325 per share of common stock (or common stock equivalent) (Press release, Actinium Pharmaceuticals, JUN 19, 2020, View Source [SID1234561249]). The aggregate gross proceeds from this offering are approximately $25.0 million, before deducting placement agent fees and other estimated offering expenses payable by Actinium.

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H.C. Wainwright & Co. acted as exclusive lead placement agent for the offering. Maxim Group LLC and JonesTrading Institutional Services LLC acted as co-placement agents for the offering.

Actinium intends to use the net proceeds from the offering to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, prepare and submit a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") and Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA") as well as commercialization activities for Iomab-B in the United States. Net proceeds from this offering will also be used to progress Phase 1 trials for its refocused CD33 program to the proof of concept stage, to support its AWE Technology Platform, Iomab-ACT program, research and development and for general working capital needs.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on October 12, 2017. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on June 16, 2020 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement, dated June 16, 2020, and accompanying prospectus relating to the offering was filed with the SEC on June 18, 2020 and is available on the SEC’s website at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, by telephone: (646) 975-6996 or by e-mail: [email protected].

On June 19, 2020 Perrigo Company plc ("Perrigo" or the "Company") (NYSE; TASE: PRGO) reported the closing of the previously announced registered public offering by Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), of $750.0 million aggregate principal amount of the Issuer’s 3.150% Senior Notes due 2030 (the "Notes") (Press release, Perrigo Company, JUN 19, 2020, View Source [SID1234561247]). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Perrigo.

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Perrigo estimates that the total net proceeds of the offering will be approximately $737.1 million, after deducting the underwriting discount and offering expenses payable by the Issuer.

Perrigo intends to use the net proceeds of the Notes offering to fund the redemption of the Issuer’s 3.500% Senior Notes due March 15, 2021 and 3.500% Senior Notes due December 15, 2021, with the balance, if any, for general corporate purposes, which may include the repayment or redemption of additional indebtedness.

BofA Securities, J.P. Morgan and Wells Fargo Securities acted as the joint book-running managers in the offering.

The offering is being made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. The offering will be made only by means of a prospectus supplement relating to the offering and the accompanying base prospectus, copies of which may be obtained by contacting: BofA Securities, Inc. at [email protected] or toll-free at (800) 294-1322; or by calling J.P. Morgan Securities LLC collect at (212) 834-4533; or by calling Wells Fargo Securities, LLC toll-free at (800) 645-3751 or emailing [email protected].

On June 19, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JUN 19, 2020, View Source [SID1234561246]). The ODAC will meet virtually on 14 July 2020.

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Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We believe belantamab mafodotin and the results from the DREAMM clinical trial programme have significant potential for patients with relapsed/refractory multiple myeloma who have limited treatment options. We look forward to participating in the upcoming advisory committee meeting and working with the FDA to complete its review of the BLA."

Belantamab mafodotin received Breakthrough Therapy Designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Six-month primary results from the study were published in The Lancet Oncology and follow-up data were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Belantamab mafodotin is a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen) being investigated in a robust clinical trial programme for the treatment of multiple myeloma.[1] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[2]

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.[3]

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[4] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[5]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational anti-body drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On June 19, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JUN 19, 2020, View Source [SID1234561245]). The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We believe belantamab mafodotin and the results from the DREAMM clinical trial programme have significant potential for patients with relapsed/refractory multiple myeloma who have limited treatment options. We look forward to participating in the upcoming advisory committee meeting and working with the FDA to complete its review of the BLA."

Belantamab mafodotin received Breakthrough Therapy Designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Six-month primary results from the study were published in The Lancet Oncology and follow-up data were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Belantamab mafodotin is a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen) being investigated in a robust clinical trial programme for the treatment of multiple myeloma.[i] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[ii]

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.[iii]

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[iv] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[v]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.ii

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational anti-body drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

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

                  Schedule Your 30 min Free Demo!