On October 19, 2021 SHINE Technologies LLC, a nuclear technology company, reported that it has received a $35-million award from the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) (Press release, Shine Medical Technologies, OCT 19, 2021, View Source [SID1234591518]).

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The award is part of DOE/NNSA efforts to establish a reliable, U.S.-produced supply of molybdenum-99, or Mo-99, without using highly enriched uranium. Mo-99 is the most commonly used medical isotope, relied on for approximately 40 million patient procedures around the world every year to diagnose conditions such as heart disease and cancer.

"We are really excited to continue and expand our strong partnership with DOE/NNSA," said Greg Piefer, Chairman and CEO of SHINE. "The agency’s support of our Mo-99 project continues to be an accelerant in our efforts to create a large domestic supply of Mo-99, which will both improve the lives of millions of patients and make the world safer through the elimination of highly enriched uranium anywhere in the supply chain."

SHINE-Production-Facility-Construction-10.2021
SHINE plans to use its fusion-based technology to produce medical isotopes at its first-of-a-kind facility in Janesville, Wis.

Construction of SHINE’s medical isotope production facility in Janesville, continues to progress after achieving weathertight status earlier this year. Reaching weathertight status marked the beginning of installation of the plant’s process equipment. Crews most recently began prepping the concrete bays where the neutron generators will be installed. The first two generators are completed and undergoing commissioning. The facility will be the first of its kind and will use SHINE’s patented fusion-based technology to produce Mo-99.

SHINE-Production-Facility-Interior-Construction-10.2021
Progress continues at SHINE’s Moly-99 plant in Janesville, Wis., where equipment is being installed that will produce medical isotopes.

The award was made under a cooperative agreement between DOE/NNSA and SHINE that requires SHINE to provide $35 million to receive the same amount in a matching award from DOE/NNSA.

On October 19, 2021 ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) reported the initiation of a Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell Lymphoma in the U.S (Press release, Ono, OCT 19, 2021, View Source [SID1234591535]).

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This study is a multicenter, open label, dose escalation Phase 1 study to evaluate ONO-4685 in patients with relapsed or refractory T-cell lymphoma (ONO-4685-03). For more information, please visit the following website at View Source (NCT05079282).

"We are excited to initiate the Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody with a novel mechanism of action, and hope that ONO-4685 will provide benefit to the patients with relapsed or refractory T-cell lymphoma in the U.S. one day," said Masahiro Katayama, Executive Vice President, US/EU Head of Clinical Development, ONO PHARMA USA, INC.

About T-cell Lymphoma

T-cell lymphomas are rare types of cancer, which are categorized as tumors of mature T-cell or natural killer (NK)-cell origin and comprise approximately 10 to 15% of non-Hodgkin’s lymphoma (NHL). T-cell lymphoma can develop in lymphoid tissues and/or outside of lymphoid tissues such as liver, skin, blood and others. The main subtypes of T-cell lymphoma are peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) which have a poorer prognosis than that seen in most B-cell NHL subtypes. Therefore, new treatment options are needed to improve patient outcomes for patients with T-cell lymphoma.

About ONO-4685

ONO-4685 is an investigational anti-PD-1/CD3 bispecific antibody, which binds specifically to human PD-1 and CD3 being developed as a potential treatment of both autoimmune diseases and hematologic malignancies. PD-1 is an inhibitory receptor specifically expressed and increased on activated T and B cells. In addition, PD-1 is expressed on malignant T-cells in some subtypes of Tcell lymphomas. CD3 is a component protein of the T-cell receptor. CD3-bispecific antibody therapy is one of cancer immunotherapy approaches and engages T-cells with malignant cells, consequently inducing anti-tumor activity. Based upon the non-clinical study data, ONO-4685 has the potential to be active against T-cell lymphomas.

On October 19, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the product launch in Japan for Hiyasta tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL) (Press release, HUYA Bioscience, OCT 19, 2021, View Source [SID1234591519]).

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Japanese patients with relapsed and/or refractory R/R ATLL have very poor prognosis. The effectiveness of available treatments, such as chemotherapy, diminishes with each relapse. Results from the HBI-8000 study in these patients have demonstrated clinically meaningful tumor response despite the advanced stage of disease. The treatment was safe and side effects could be managed with routine care. "In my opinion, this treatment is expected to address an important unmet medical need," said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of the HBI-8000 Phase 2 study.

HUYABIO recently announced the approval of Hiyasta by the Japanese Minister of Health, Labor and Welfare based on the results of a clinical trial conducted in Japan in patients with R/R ATLL. Meiji Seika Pharmaceuticals, HUYABIO’s partner, will market the product in Japan. HUYABIO retains worldwide rights to the drug ex-Asia. Development of HBI-8000 is ongoing globally.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first product launch for our lead oncology drug, HBI-8000, is a major milestone for HUYABIO as we transition into a revenue generating Company. It demonstrates our global reach and ability to develop and commercialize products licensed from China for debilitating diseases and make a major public health contribution."

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.

On October 19, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it intends to offer (the "Offering") USD-denominated senior notes (the "Notes") (Press release, Thermo Fisher Scientific, OCT 19, 2021, View Source [SID1234591536]).

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Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the cash consideration payable for the proposed acquisition of PPD, Inc., a Delaware corporation (the "PPD Acquisition"). Thermo Fisher may also determine to use a portion of the net proceeds of the Offering for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, working capital and capital expenditures or the repurchase of its outstanding equity securities or it may temporarily invest the net proceeds in short-term, liquid investments until they are used for their ultimate purpose.

The joint book-running managers for the Offering are Barclays Capital Inc., Morgan Stanley & Co. LLC, BofA Securities, Inc., Citigroup Global Markets Inc. and Mizuho Securities USA LLC.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and the Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in the Offering will arrange to send you the prospectus if you request it by calling Barclays Capital Inc. toll-free at 1-888-603-5847; Morgan Stanley & Co. LLC toll-free at 1-866-718-1649; BofA Securities, Inc. toll-free at 1-800-294-1322; Citigroup Global Markets Inc. toll-free at 1-800-831-9146; or Mizuho Securities USA LLC toll-free at 1-866-271-7403.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any offer, solicitation or sale of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On October 19, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, November 5, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the third quarter of 2021 (Press release, Oncolytics Biotech, OCT 19, 2021, https://ir.oncolyticsbiotech.com/news/detail/548/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights [SID1234591503]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 859-440#.