On December 8, 2021 City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, reported it has entered into a definitive agreement to acquire Cancer Treatment Centers of America (CTCA), a network of oncology hospitals and outpatient care centers across the United States (Press release, City of Hope, DEC 8, 2021, View Source [SID1234596622]). City of Hope’s strategic acquisition of CTCA will advance the missions of both organizations, building a national, integrated cancer research and treatment system to transform the future of cancer care.

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"This is a defining moment in the fight against cancer and a powerful opportunity to reach more cancer patients with the leading treatments, care and advanced research they critically need," said Robert Stone, president and CEO of City of Hope and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "CTCA has a strong commitment to patient-centric cancer care, and combining its network and services with City of Hope’s scientific expertise, clinical trials and patient care strengths will significantly increase the number of people who can access the latest lifesaving treatments."

City of Hope’s acquisition expands and accelerates the organization’s ability to rapidly translate research and science into lifesaving care through its unique model — connecting breakthrough discoveries and academic medicine expertise with excellent, community-based specialized cancer care to the benefit of patients and families served. This acquisition also expands the portfolio, reach and impact of City of Hope’s leading-edge cancer services and capabilities, including research and development, into more communities across the country.

"Building on more than three decades of unparalleled patient experience and quality care, we’re excited to become a part of City of Hope, and to take a step closer to reaching so many more cancer patients with our unique, patient-centered model," said Pat Basu, M.D., M.B.A., president and CEO of CTCA. "Through the shared, patient-centric values of both organizations and expanded access as a result of the collaboration, cancer patients across the nation will be the ultimate beneficiaries of this relationship."

City of Hope is a national leader in advancing cancer research and treatment protocols, conducting nearly 1,000 clinical trials annually that can enroll approximately 25% of its patients. With more than 450 patent portfolios, 95 active investigator-initiated investigational new drugs (INDs) and approximately 50 IND applications submitted to the U.S. Food & Drug Administration every year, City of Hope is among the leading innovators in cancer research. The organization is also a pioneer in bone marrow and stem cell transplants with one of the largest, most successful programs of its kind in the U.S., having performed more than 17,000 procedures.

With CTCA, City of Hope builds on and accelerates its vision to forge partnerships and find new avenues for its expertise to positively impact as many lives as possible. In addition to the ongoing, significant expansion of its clinical network in Southern California, City of Hope previously acquired Translational Genomics Research Institute (TGen), which provides breakthrough genomics research. TGen’s capabilities are fully leveraged to provide highly specialized care and precision medicine treatment to City of Hope patients across its clinical care network. And in 2019, City of Hope launched AccessHopeTM to extend the reach of its clinical and research expertise directly to partner employers, including 17 of the Fortune 500 companies, so they can provide their employees with cancer information and expert clinical decision support.

Combined, City of Hope and CTCA will include approximately 11,000 team members, comprising the collaborative expertise of 575 physicians across a network of locations in California, including a new campus in Irvine opening in summer 2022, as well as Arizona, Illinois and Georgia. Basu will remain CEO of CTCA and report to Robert Stone.

"Cancer treatment is changing rapidly. Today, through advances such as immunotherapy, precision medicine and other treatments available through clinical trials, there are better survival rates and fewer side effects than ever before. A critical part of cancer care is closing the gap to access that exists for too many patients, particularly in underserved communities," continued Stone. "By joining forces with CTCA, we’re taking a major step forward in our mission to democratize cancer care and bring today’s treatments and tomorrow’s discoveries to even more people who need them now."

The transaction is expected to close in early 2022, subject to regulatory approvals. After close, City of Hope intends to convert CTCA to a nonprofit organization.

On December 8, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day beginning at 1:00 p.m. ET, where executive leadership will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook (Press release, McKesson, DEC 8, 2021, View Source [SID1234596621]).

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The Investor Day event will showcase how McKesson will deliver long-term growth:

Highlighting significant progress in executing against its priorities by focusing on people and culture, sustainable core growth, streamlining the portfolio, and expanding its oncology and biopharma services ecosystems. The success is evidenced by its strong financial performance and outstanding operational excellence.
Reaffirming its commitment to the growth pillars of oncology and biopharma services. The company’s differentiated set of assets and capabilities uniquely positions the company to win in these growing markets and improve the health outcomes of patients.
Providing a financial overview and long-term outlook that highlights the focus on shareholder value creation and supports a compelling investment thesis.
Increasing fiscal 2022 Adjusted Earnings per Diluted Share guidance range to $22.35 to $22.95, from the previous range of $21.95 to $22.55, to reflect an additional $0.40 related to the U.S. government’s COVID-19 vaccine distribution program.
Announcing a new $4.0 billion increase to the share repurchase program authorized by the Board of Directors.
"We are excited to share our vision and strategy with the investment community. As we focus on the next chapter of growth and innovation, McKesson will leverage the breadth and depth of its core growth to further develop and build differentiated oncology and biopharma services ecosystems," said Brian Tyler, chief executive officer. "We remain committed to delivering superior shareholder returns through sustainable earnings growth and a disciplined approach to capital deployment."

Webcast and Presentations

The video webcast will be available live from 1:00 p.m. to 4:00 p.m. ET on Wednesday, December 8, 2021 at investor.mckesson.com/events-and-presentations. After the event, the archived video webcast will be available on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.

Non-GAAP Financial Measure

This press release includes a forecast of Adjusted Earnings per Diluted Share, which is not a financial measure calculated in accordance with U.S. generally accepted accounting principles (GAAP). The company is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the equivalent forward-looking GAAP measure without unreasonable effort, because the company does not forecast GAAP earnings per share and cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially. Refer to investor.mckesson.com and the company’s slide presentation noted above for definitions and explanations of the Company’s Non-GAAP financial measures.

On December 8, 2021 H3 Biomedicine Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held in a hybrid format on December 7- 10, 2021 (Press release, H3 Biomedicine, DEC 8, 2021, View Source;positive-HER2-negative-Breast-Cancer-at-San-Antonio-Breast-Cancer-Symposium [SID1234596620]). The presentations include interim investigational data from H3’s ongoing clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.

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"At H3, we are developing a pipeline of targeted medicines with the potential to impact the future of cancer treatment," said Ping Zhu, Ph.D., President and Chief Scientific Officer of H3. "Our ongoing clinical study of H3B-6545 is evaluating its potential to address current unmet medical needs in breast cancer either as a single agent or in combination with therapies such as palbociclib. We look forward to showcasing its progress at SABCS 2021."

H3B-6545 PRESENTATIONS

Abstract Number: 976

Title: H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer – A Phase II Study
Program Number: P1-17-10
Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am – 8:30am CT
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: 1166
Title: H3B-6545 in Combination with Palbociclib in Women with Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer, Phase 1b Study
Program Number: P1-17-03
Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am – 8:30am CT
Presenter: Stephen Johnston, Royal Marsden NHS FDN Trust, London, UK

About H3B-6545

Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers,1 and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies.2,3 H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα.4 H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

On December 8, 2021 Metagenomi, a genetic medicines company with a versatile portfolio of next-generation gene editing tools, reported that the company will share data related to their novel, compact, and hypo-immune gene editing systems at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), which is taking place in Atlanta, GA and virtually, December 11–14 (Press release, Metagenomi, DEC 8, 2021, View Source [SID1234596619]).

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"The development of CAR T therapies and other genetically engineered cell therapies in recent years has resulted in significant benefits for patients, yet there remains a large unmet need for gene editing systems that can be used to develop novel immunotherapy approaches to treat blood cancers," said Brian C. Thomas, PhD, CEO and Co-Founder of Metagenomi. "At ASH (Free ASH Whitepaper), we are presenting data on our novel nucleases that display highly efficient and specific gene editing both in vivo and ex vivo and hold significant potential to drive the development of new and efficacious therapies for patients."

In a poster titled "A Novel Type V CRISPR System with Potential for Genome Editing in the Liver," it is shown that Metagenomi’s novel Type V CRISPR-associated nuclease was highly active in the liver of mice when systemically administered via lipid nanoparticles (LNP). The nuclease was derived from a unique natural environment and is phylogenetically distinct from previously identified Type V systems. Moreover, no antibodies to the nuclease were detected in serum from 50 healthy human donors, while between one third and half of the same serum samples contained antibodies that bind to spCas9, which is derived from a Streptococcus bacteria that commonly infects humans. In summary, this novel Type V CRISPR-associated nuclease is a promising new gene editing system for in vivo editing of the liver.

In a separate poster titled "Novel CRISPR-Associated Gene Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genomic Engineering for Cell Therapy Development," three novel gene editing systems were used to make reproducible and efficient edits to human immune cells, demonstrating utility for the next generation of cell therapy development for blood cancers. Metagenomi’s novel gene editing systems were used to disrupt the T cell receptor alpha-chain constant region and the T cell receptor beta-chain constant region in approximately 90 percent of cells. Beta-2 microglobulin was edited in 95 percent of T cells. A chimeric antigen receptor (CAR) construct was also shown to be integrated in up to 60 percent of T cells. Novel gene editing systems were deployed in NK cells to disrupt CD38 — a cell surface immune modulator that can be targeted in the development of cancer immunotherapy — and to integrate a CAR construct that led to robust CAR-directed cellular cytotoxicity. B cell editing occurred in approximately 80% of target cells with successful transgene integration. What’s more, as these gene editing systems are taken from environmental samples as opposed to human pathogens, pre-existing immunity is expected to be rare. In summary, these novel systems were shown to result in highly efficient and specific gene edits in human immune cells and display the potential for use in cell therapy development.

Details of the presentations are below:

Presentation Title: A Novel Type V CRISPR System with Potential for Genome Editing in the Liver
Session Title: 801. Gene Therapies: Poster I
Presenting Author: Morayma Temoche-Diaz, PhD
Publication Number: 1862
Session Time: Saturday, December 11, 5:30 p.m. ET

Presentation Title: Novel CRISPR-Associated Gene-Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genome Engineering for Cell Therapy Development
Session Title: 801. Gene Therapies: Poster III
Presenting Author: Gregory Cost, PhD, Vice President of Biology, Metagenomi
Publication Number: 3984
Session Time: Monday, December 13, 6:00 – 8:00 p.m. ET

On December 8, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported that it has been awarded a second ‘Direct to Phase 2’ Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, Shasqi, DEC 8, 2021, View Source [SID1234596618]). The $1.9 million grant will support a Phase 1b dose-expansion cohort in the company’s ongoing development program for its click-activated prodrug therapy, SQ3370. The safety and efficacy data from this cohort will support dose selection for the planned Phase 2 study of SQ3370 in patients with advanced soft tissue sarcoma.

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"The NCI has made two investments in our Phase 1 clinical studies of SQ3370, which will enable us to accelerate the development of SQ3370 and gather additional efficacy and safety data to inform our Phase 2 clinical trial design. We are grateful for the vision of the NCI and their support of SQ3370 and our click chemistry platform," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "The early data from our Phase 1 study of SQ3370 provides initial validation for our platform in humans, with an encouraging safety profile and initial hints of clinical activity. We believe we can improve the efficacy, safety, and biological effects of many existing cancer therapies and various modalities which are currently either too toxic to be used widely, have significant safety burden, or have limited efficacy due to a limited therapeutic window."

About CAPAC and SQ3370:

SQ3370 is the first click chemistry-based treatment to be tested in humans, and utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the site of the tumor. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing drugs and various modalities that have a limited therapeutic window.