On June 19, 2020 DiscoveryBioMed, Inc. (DBM, www.discoverybiomed.com) reported a new unit of its contract research organization (CRO) services business called TumorCube that is formed based upon our growing expertise in 3D Biogel-driven bioassays on diseased and normal human cell platform technologies (Press release, DiscoveryBioMed, JUN 19, 2020, View Source [SID1234561256]). A trademark application has been filed.

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"DBM has a growing CRO services business in 3D Biogel-driven bioassays of diseased and normal human kidney cells. It is showcased prominently on our website, and we are proud to have many biotechnology companies and BioPharmaceutical organizations globally as our clients," explained Dr. Erik Schwiebert, Ph.D., CEO of DBM. "We have now extended those offerings to include the assay of human urological cancers and endocrine-driven cancers such as ovarian cancers and breast cancers." DBM is also assessing the feasibility of our 3D platforms for the assay of neurological and other cancers at present. DBM is utilizing existing human cancer cell lines in our initial technology optimization.

"Interestingly, diseased human kidney cells and existing human cancer cell lines respond differently to specific lead therapeutic drugs or industry standard anti-cancer drugs when grown in 3D versus the traditional 2D tissue culture plastic-based assays," explained Dr. Deborah Mai, DBM’s Chief Biological Officer. "DBM focuses on more physiological 3D growth formats as its preferred assay platforms and methods."

Not only does DBM wish to offer higher-throughput 3D assay platforms for hit-to-lead and lead oncology therapeutic profiling, DBM is optioning and licensing 3D bioreactor technology from the University of Alabama at Birmingham (UAB) that was invented by Dr. Joel Berry, Ph.D. in the Department of Biomedical Engineering to be a future platform for our TumorCube unit. "It has been exciting to collaborate with DBM on this commercial-academic partnership, and we are also excited to see TumorCube realized," declared Dr. Berry. "We and DBM are also collaborating with investigators within the O’Neal Comprehensive Cancer Center at UAB on this platform development, which is an additional value add."

DBM is also pleased about continuing its local collaboration with UAB. "DBM has several current and past UAB-derived scientists that have contributed to the establishment and growth of our life sciences and biotechnology company, myself included," explained Dr. Grace Salzer, a Senior Scientist and Business Development specialist. "DBM is fortunate to be collaborating with UAB scientists and technology transfer on this venture."

On June 19, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that BYVASDA (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China (Press release, Innovent Biologics, JUN 19, 2020, View Source [SID1234561254]). BYVASDA is Innovent’s second monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection, officially approved for treatment of patients with Hodgkin’s lymphoma in December 2018).

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In recent years, the cancer burden in China has been continuously increasing. According to the report of Cancer Today from the WHO’s International Agency for Cancer Research, there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China in 2018. Among the malignant tumors in China, lung cancer ranks first both in incidence rate (0.774 million newly diagnosed patients) and mortality rate (0.691 million deaths). Colorectal cancer ranks second in incidence rate (0.517 million newly diagnosed patients) and fifth in mortality rate (0.245 million deaths). Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, and in China it was approved for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide. Currently there still remains huge unmet clinical demand for bevacizumab treatment in China, as many ordinary Chinese patients cannot afford for it. BYVASDA is an anti-VEGF humanized monoclonal antibody and a bevacizumab biosimilar independently developed by Innovent. The launch of BYVASDA will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "BYVASDA is another example of our success with the National Major New Drug Innovation and Development Projects and the second monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection). We hope to bring this high-quality and cost-saving drugs to more patients in need in China as soon as possible. In January 2020, Innovent out-licensed the commercial rights of BYVASDA in the United States and Canada to Coherus BioSciences, a leading biosimilar company, demonstrated an international recognition of the quality of BYVASDA. We are looking forward to working together to make BYVASDA benefit more patients globally."

About BYVASDA

BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

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].