On October 19, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that the company entered into an agreement with Beam Therapeutics Inc. (NASDAQ: BEAM) for non-exclusive commercial rights to Beam’s CRISPR Cas12b nuclease system for certain ex vivo engineered cell therapy programs (Press release, Sana Biotechnology, OCT 19, 2021, View Source [SID1234591516]).

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Cas12b is a CRISPR-based nuclease with a high degree of specificity and efficiency that can be used to knock out and/or knock in genes in certain cell types. Under the agreement, Beam granted Sana non-exclusive rights to utilize its Cas12b system with certain allogeneic T cell and stem cell-derived programs, including the ability to make gene edits for Sana’s hypoimmune platform. The license does not include any rights to base editing using Cas12b, which remain at Beam.

"Gene editing technology is a key component in developing engineered cells as medicines, and we are pleased to have the ability to use the Cas12b system as part of a number of our ex vivo engineered cell programs," said Steve Harr, Sana’s President and CEO. "The specificity and efficiency of Cas12b make it appealing for Sana’s allogeneic T cell as well as gene-edited pluripotent stem cell programs. We intend to incorporate this platform into multiple product candidates, with the first IND filed as early as next year."

Under the terms of the agreement, Sana agreed to pay Beam an upfront payment of $50 million. Beam is also eligible to receive certain target option exercise fees, certain milestone payments upon the achievement of certain development and sales milestones, and certain royalties on net sales of royalty-bearing products by Sana, its affiliates, its sublicensees and affiliates of its sublicensees.

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 Amgen (NASDAQ: AMGN) reported that it has successfully completed its previously announced acquisition of Teneobio, Inc. (Teneobio) (Press release, Amgen, OCT 19, 2021, View Source [SID1234591517]). Effective as of Oct. 19, 2021, Amgen has acquired all outstanding equity of Teneobio in exchange for a $900 million upfront cash payment, as well as future contingent milestone payments, to former Teneobio equity holders potentially worth up to an additional $1.6 billion in cash.

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"Amgen is pioneering the application of T cell engagers and a broad array of bi- and multispecific biologics to treat a range of human diseases across our therapeutic areas of focus," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Teneobio’s expertise and technologies will further expand our repertoire of multispecific architectures and advance our overarching mission to develop transformative innovation to bring to market best-in-class products to serve our patients."

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which complement Amgen’s existing antibody capabilities and BiTE platform and will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. The acquisition will also add TNB-585, a Phase 1 bispecific T cell engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term Investigational New Drug (IND) filings. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in Phase 1. Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed.

Prior to the consummation of the acquisition, Teneobio distributed to its equity holders all equity held by Teneobio in (i) TeneoTwo, Inc., which develops TNB-486, a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells, (ii) TeneoFour, Inc., which develops anti-CD38 heavy chain antibodies that block the enzyme functions of CD38, and (iii) TeneoTen, Inc., which develops bispecific antibodies directed against the hepatitis B surface antigen (HBsAg) and CD3.

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 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.