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 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 Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, reported the initiation of a Phase 1 clinical trial to investigate tegavivint as a potential treatment for acute myeloid leukemia (AML) (Press release, Iterion Therapeutics, OCT 19, 2021, View Source [SID1234591534]). This investigator-initiated trial is being led by Tapan M. Kadia, M.D., from the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

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Tegavivint is a potent and selective first-in-class inhibitor of Transducin βeta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway. Binding of TBL1 to beta-catenin in the nucleus is necessary for activation of beta-catenin-dependent gene transcription. Tegavivint’s targeting of TBL1 prevents the TBL1/beta-catenin complex from forming and specifically inhibits beta-catenin’s oncogenic activity without disrupting key cell membrane functions that have been linked to toxicity common to other drugs in this pathway.

"We are very excited about this trial to research tegavivint as a potential new treatment for AML, the most common type of leukemia in adults," stated Rahul Aras, Ph.D., CEO of Iterion Therapeutics. "Having recently established the drug’s safety and clinical activity in a proof-of-concept Phase 1 study in desmoid tumors, we are expanding our clinical footprint to address additional cancers characterized by beta-catenin overexpression such as AML, NSCLC and certain pediatric cancers. The initiation of the AML clinical trial represents an important advance in this growth strategy."

Aberrant up-regulation of beta-catenin has been documented as essential for self-renewal, growth and survival of AML stem and blast progenitor cells. In AML preclinical models, tegavivint has shown single agent and combination efficacy with chemotherapy and targeted agents, without affecting normal hematopoietic stem cells. The Phase 1 trial is designed as a two-part, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint, as a monotherapy and in combination with decitabine, in patients with relapsed and refractory AML. More information on the clinical trial is available at View Source;draw=2&rank=2.

"We welcome the opportunity to initiate this clinical trial of tegavivint, which targets TBL1, a novel therapeutic target in the Wnt-signaling pathway that has been implicated by several groups in the progression of AML," said Casey Cunningham, M.D., Chief Medical Officer of Iterion Therapeutics. "This trial builds upon prior published research from MD Anderson led by Dr. Kapil N. Bhalla that defined the importance of the TBL1/beta-catenin biology in AML and the therapeutic potential for tegavivint in this patient population."

On October 19, 2021 Varian, a Siemens Healthineers company, a leading provider of cancer care technologies and solutions, reported that it will demonstrate the power of intelligent cancer care to shape the future of oncology during the 2021 American Society for Radiation Oncology (ASTRO) taking place in Chicago, Illinois, October 24-27 (Press release, Varian Medical Systems, OCT 19, 2021, View Source [SID1234591532]). The company will showcase how its combination with Siemens Healthineers will accelerate the fight against cancer and increase the impact on healthcare.

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During this year’s show, Varian will also be highlighting the following and more:

Upcoming release of TrueBeam 3.0 radiotherapy system*, which includes image quality and workflow improvements as well as cybersecurity enhancements
Meet the Expert session with a clinical expert to share the breadth of cases being treated with Varian’s Ethos therapy Adaptive Intelligence solution, built to provide patient-centric and personalized care
Smart Services solutions designed to provide comprehensive support services and proactive maintenance for clinical systems and practices
Progress in bringing human-centered artificial intelligence (AI) to the clinic. Within Varian’s software portfolio, Eclipse TPS and AI Rad Companion Organs RT are empowering clinicians to define high-quality OAR (organs at risk) contours more efficiently with AI-based auto-contouring.
Our technology-enabled solutions and clinical partnerships with our Advanced Oncology Solutions
Within our Innovation Hub, Varian will present advancements in its FLASH therapy research, an experimental treatment modality, including an update on the FAST-01 clinical trial. Attendees will also see a preview of upcoming products including advancements in ARIA, Eclipse and Halcyon.

"After the past year and a half, our global Varian team is looking forward to the opportunity to meet in person with ASTRO 2021 attendees and highlight the strength of our combination with Siemens Healthineers," said Chris Toth, Chief Executive Officer of Varian. "Together, we will create the most comprehensive cancer care portfolio in the industry and address the entire care continuum. At this year’s show, attendees will learn more about our innovative technologies, AI-based solutions, and the many ways we are a trusted partner to help our customers deliver patient centric, personalized care."

At this year’s event, Varian will participate with a dynamic booth presence highlighting the combination with Siemens Healthineers. The company will also provide one-on-one product demonstrations as well as host hybrid Users’ Meeting events over four separate dates. Varian is also this year’s official sponsor of ARRO, ASTRO’s resident program, and will host the first annual ARRO quiz bowl. In addition, Varian will have a presence at the American Society of Radiologic Technologists (ASRT) and Society of Radiation Oncology Administrators (SROA) concurrent meetings. Attendees can register for Varian demo sessions at View Source

*Not available for sale. 510(k) to be submitted soon.

On October 19, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will webcast its Quarterly Update Conference Call for the third quarter 2021 on November 2 at 4:30 p.m. ET / 1:30 p.m. PT (Press release, Halozyme, OCT 19, 2021, View Source [SID1234591531]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the third quarter ended September 30, 2021, following the close of trading.

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To register for this conference call, please use this link:
View Source
After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 5694076.