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Exelixis to Release Third Quarter 2021 Financial Results on Tuesday, November 2, 2021

On October 19, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021 after the markets close (Press release, Exelixis, OCT 19, 2021, View Source [SID1234591520]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 9563879 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 4, 2021. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9563879. A webcast replay will also be archived on www.exelixis.com for one year.

HUYABIO International Launches Hiyasta as Monotherapy for Adult T-cell Leukemia/Lymphoma in Japan

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]).

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.

SHINE receives $35-million award from DOE/NNSA

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]).

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.

Amgen Successfully Completes Acquisition Of Teneobio, Inc.

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.

"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.

Sana Biotechnology Obtains a Non-Exclusive License to CRISPR Cas12b Gene Editing Technology from Beam Therapeutics to Enable Engineered Cell Programs

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]).

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.