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City of Hope Opens the Most Advanced Comprehensive Cancer Center in Orange County, Calif., Delivering World-Renowned Treatment, Research and Cancer Cures to the Nation’s Sixth Largest County

On July 27, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that opens its visionary comprehensive cancer center in Orange County, California, creating a national model for delivering breakthrough research and pioneering treatments (Press release, City of Hope, JUL 27, 2022, View Source [SID1234617026]). The academic cancer center ushers in a new era of hope for people with cancer.

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Here, a team of some of the world’s most acclaimed physician-scientists — with expertise in lung, breast, gastrointestinal, gynecological, genitourinary, blood cancers and more — leads next-level cancer treatment and research.

City of Hope Orange County Lennar Foundation Cancer Center was made possible by a transformational $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation. In Orange County alone, City of Hope has more than 15,000 philanthropic supporters who fuel its mission to end cancer.

A Cancer Crisis in Orange County and Across the Nation

City of Hope officials cite several reasons for an expanded presence in the region.

Nearly 20% of residents with cancer have left the area for advanced care, with many heading to City of Hope’s main campus in Duarte, California — an up to two-hour commute each way. In addition, despite its reputation for healthy living, Orange County is not immune from the 1 in 3 national statistic for cancer incidence.

In fact, the cancer incidence rate in the county is projected to increase by 18% over the next decade. Cancer risk increases with age and Orange County has a higher percentage of seniors than the U.S. average.

City of Hope, one of only 52 National Cancer Institute-designated comprehensive cancer centers in the country, is answering the call to extend its personalized care, outstanding research and lifesaving treatments closer to home for the county’s 3.2 million residents. City of Hope was recognized as the seventh "Best Hospital" for cancer in the nation, according to U.S. News & World Report’s 2022-23 Best Hospitals: Specialty Ranking.

Distinguishing clinical services at City of Hope Orange County Lennar Foundation Cancer Center will include:

Acclaimed cancer expertise: Access to City of Hope’s 575 physicians and more than 1,000 researchers and scientists who only focus on cancer.
Lifesaving clinical trials: Access to nearly 1,000 innovative Phase 1-3 clinical trials being conducted at City of Hope each year — more cancer-focused clinical trials than anywhere in the area — to provide patients with promising new treatments long before they become the standard of care.
Breakthrough treatments: Targeted immunotherapies, including CAR T cell therapy, as well as bone marrow transplants, robotic minimally invasive surgeries and MRI-guided radiation oncology. These innovations have demonstrated improved outcomes and a better quality of life for patients in treatment.
Leading-edge technology: The latest and most comprehensive suite of market-leading radiology, interventional radiology and radiation oncology equipment, providing a powerful combination of high tech and high touch.
Integrative medicine: A trailblazing integrative medicine program combining the best of Western medicine and evidence-based complementary therapies, such as acupuncture, massage and meditation.
Cancer prevention: Programs that identify people and families with elevated cancer risk utilizing genetic risk assessments, biomarker panels and environmental surveys to help manage that risk.
Early detection: Novel blood testing and imaging techniques that find cancer early, when it is still easily curable. Patients will be among the first in the nation to have access to City of Hope’s new Center for Cancer Prevention and Early Detection.
Precision medicine: Best-in-class genomic testing to profile a patient’s tumor and determine the treatment that will be most effective for their cancer.
Screening and diagnostic services: A suite of state-of-the-art imaging equipment and procedural suites, giving patients convenient access to mammography, colonoscopy, robotic bronchoscopy and other lifesaving services.
A clinical research unit: The epicenter for clinical investigational research that speeds the development of new drugs and interventions to the bedside, allowing patients to receive the latest treatments in cancer care.
Surgical oncology: An outpatient surgery department that offers advanced perioperative care, an endoscopy suite and operating rooms with robotic-assisted surgical capabilities.
Supportive care: City of Hope is a national leader in evidence-based supportive care. The Sheri & Les Biller Patient and Family Resource Center at the comprehensive cancer center in Irvine will facilitate easy access to a wide range of programs, including care navigation, survivorship programs, psychological and spiritual counseling, pain management and more.
Built For and With the Community

City of Hope Orange County Lennar Foundation Cancer Center was designed with input from more than 500 patients, their families and community members. Every feature of the cancer center — from the design of its gathering spaces to its lighting, its wall color, even its artwork selection — was intentionally chosen to promote healing and comfort and ensure patients and their families have the best care experience. Every employee is committed to delivering compassionate care, continuing the City of Hope legacy of taking patients’ hands and never letting go.

Features include:

67 spacious exam and treatment rooms.
15 consultation rooms equipped with the latest technology, allowing patients and family members to meet comfortably with their care team.
An infusion center designed around patient preferences with 43 infusion bays and 10 private infusion treatment rooms. The infusion bays feature repositionable furnishings, flexible privacy options, and panoramic views of the Saddleback mountains.
Hope Boutique, a full-service salon and specialty shopping experience with oncology-trained cosmetologists who help patients with customized cosmetology services, breast prostheses and more.
A retail and specialty pharmacy that dispenses traditional, specialty, and over-the-counter medications, alleviating the travel burden on patients for their medication needs. In addition, a compounding pharmacy provides a full evaluation of patients’ needs and prepares personalized chemotherapeutic and non-chemotherapeutic medications. Specialty-trained clinical pharmacists assist patients with medication management.
A full range of state-of-the-art laboratory services in one location, making it convenient for patients to get routine blood draws.
Feng Shui design, art galleries, a healing garden, dedicated space for family members to gather or work, and programs to care for the whole patient — mind, body, and spirit.
City of Hope Orange County’s cancer care network currently includes four regional clinics — two in Newport Beach, one in Huntington Beach and one in Irvine. The cancer center, the regional clinics and the planned hospital will create Orange County’s largest network dedicated exclusively to cancer treatment and cures.

Supporting quotes

Robert Stone, president, CEO, and Helen and Morgan Chu Chief Executive Officer Distinguished Chair, City of Hope
"City of Hope’s vision is to make leading-edge research, treatment and care accessible to more patients, families and communities across the country. Our new Orange County campus does just that, embedding an academic cancer center in the heart of a community to deliver cancer breakthroughs and innovation for generations of patients in need of our advanced care. Thank you to the teams, partners, and philanthropists who brought us to this historic day."

Annette M. Walker, president, City of Hope Orange County
"With the opening of City of Hope Orange County Lennar Foundation Cancer Center, we are delivering on our promise to the people of Orange County and changing cancer care for our family, friends and neighbors. Four years ago, we pledged to bring the most advanced cancer care to Orange County, home to 3.2 million people. As we open our cancer center’s doors, our highly committed teams join the community in celebrating the delivery of tomorrow’s lifesaving treatments to those who need them today. Hope is truly here in Orange County."

Edward S. Kim, M.D., M.B.A., physician-in-chief, City of Hope Orange County, and vice physician-in-chief, City of Hope National Medical Center
"This extraordinary cadre of preeminent cancer physician-scientists changes the Orange County landscape. Our physician roster comprises many of the best minds in the world for preventing, treating, and curing cancer. With their highly specialized expertise, distinguished history of research breakthroughs and compassionate approach, this team will transform our ability to address cancer for generations."

Marshall H. Ames, chairman, Lennar Foundation
"Giving back to the communities in which we build and developing healthier communities are core values at Lennar. The Lennar Foundation could not be prouder to have supported this new cancer center. It is gratifying to know that our gift will make a positive impact by expanding access to care, advancing research and supporting the incredible science that will one day eliminate cancer. We hope others in the philanthropic community will see the results of our efforts and join us in supporting City of Hope."

Farrah N. Khan, mayor of Irvine
"City of Hope Orange County is well-matched for Irvine, heightening our city’s reputation for pioneering innovation. This is an outstanding health care resource for the community and brings great promise to many. The center has already attracted exceptional health care professionals eager to save lives and offer our friends and neighbors a tremendous source of hope."

Leslie Bruce Amin, grateful patient
"I’ve been waiting for this day ever since City of Hope announced its plans for an Orange County campus. Whenever I connect with people navigating a cancer diagnosis, my first piece of advice is to always find a cancer-specific research center for the most advanced care. Now, right here in our community, people with cancer have the highly specialized and compassionate care they need — all in one place."

For more information or to become a volunteer or philanthropic partner of City of Hope Orange County, go to CityofHope.org/OC

BIO 300 Pharmacokinetics Studies Published

On July 27, 2022 Humanetics Corporation reported that paper in Radiation Research, the official journal of the Radiation Research Society, details the results from a series of pharmacokinetics (PK) studies conducted with it’s (Humanetics) new radioprotective drug, BIO 300 (Press release, Humanetics, JUL 27, 2022, View Source [SID1234617025]). The studies, which were conducted by researchers at the University of Maryland Schools of Medicine and Pharmacy (UMB), compared the PK of BIO 300 using oral, subcutaneous, and intramuscular dosing. These nonclinical studies also examined the effect of radiation exposure on the PK of BIO 300. The researchers concluded that the effect of irradiation on the PK of BIO 300 is minimal, an important finding for use of the drug during radiation emergencies or during cancer radiotherapy treatments.

Exposure to radiation can lead to acute radiation syndrome (ARS), which consists of numerous serious and life-threatening injuries. Survivors of ARS are at risk of developing delayed effects of acute radiation exposure (DEARE), which include a multitude of chronic injuries, notably to the lungs. There are currently no FDA-approved drugs that prevent ARS or DEARE. Humanetics is developing BIO 300 as a medical countermeasure (MCM) for use by the military, first responders, and in civilian populations that have been exposed, or may become exposed, to radiation to prevent or mitigate both ARS and DEARE.

"Our ongoing collaboration with colleagues at UMB has been instrumental in the development of BIO 300 for use as a MCM," said Ronald Zenk, CEO of Humanetics. "Current events in Ukraine and global threats of nuclear incidents point to the urgent need for drugs like BIO 300."

BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799). In addition, a phase 2b trial is currently in progress evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

AKSO Announces Publication of Preclinical Data Demonstrating Engineered Soluble BCMA Decoy Receptor AB001 Effectively Inhibits Multiple Myeloma and Diffuse Large B Cell Lymphoma

On July 27, 2022 AKSO Biopharmaceutical, Inc. ("AKSO"), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, reported the publication in the Journal of Experimental Medicine of preclinical data demonstrating that AKSO’s late preclinical stage molecule AB001 effectively inhibits growth of Multiple Myeloma ("MM") and Diffuse Large B Cell Lymphoma ("DLBCL") in mice (Press release, AKSO Biopharmaceutical, JUL 27, 2022, View Source [SID1234617024]). Importantly, AB001 was also found to be nontoxic in non-human primates.

"AB001 is a first-in-class and potentially best-in-class ligand trap targeting APRIL and BAFF, which are known to be difficult to sequester due to high native binding affinities to their receptors, but also critical regulators of B cell development and survival," said Professor Amato Giaccia, AKSO’s Chairman and Senior Scientific Strategist. "Our study demonstrated the novel mechanism of APRIL and BAFF in modulating protein translation; and suggest that engineered soluble BCMA could be a superior alternative to therapeutics either approved or in development for MM and DLBCL."

"Safe and effective targeted therapies are urgently needed for MM and DLBCL patients who exhaust currently available treatment options," said Dr. Rebecca Miao, AKSO’s Chief Scientific Officer. "Collectively, our data support AB001 as a clinically viable candidate for the treatment of MM and DLBCL. Furthermore, the biological functions of BAFF and APRIL are not limited to B cell malignancies but extend to autoimmune disorders and other diseases triggered by pathological B cells, indicating a broad clinical application of AB001."

Key findings from the study performed under the guidance of Professor Giaccia and Dr. Miao, reported in the publication titled "Developing High-Affinity Decoy Receptor Optimized for Multiple Myeloma and Diffuse Large B Cell Lymphoma Treatment", include:

APRIL and BAFF mediated signalling is required for MM progression;
When compared to the wild-type soluble BCMA receptor, AB001 shows 500-fold stronger binding toward BAFF and 4-fold stronger binding toward APRIL;
AB001 is capable of neutralizing APRIL and BAFF and their receptor activities, impacting protein translation and production in MM and DLBCL cells;
Treatment with AB001 led to enhanced antitumor activity in a number of MM and DLBCL mouse models;
AB001 also demonstrated an adequate toxicity profile and on-target mechanism of action in nonhuman primate studies.
ABOUT AB001

AB001 is a late preclinical stage first-in-class and best-in-class engineered soluble BCMA decoy receptor. AB001 traps APRIL and BAFF with ultra-high binding affinities thereby inhibiting ligand mediated activation of receptors BCMA, BAFF Receptor and TACI.

Agenus to Provide Corporate Update and Second Quarter 2022 Financial Report

On July 27, 2022 Agenus (NASDAQ: AGEN) an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported it will release its second quarter 2022 financial results before the market opens on Tuesday, August 9, 2022 (Press release, Agenus, JUL 27, 2022, View Source [SID1234617023]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET that morning to discuss the results and to provide a corporate update.

Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

vTv Therapeutics Announces Paul Sekhri as new President and Chief Executive Officer

On July 27, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), reported that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022 (Press release, vTv Therapeutics, JUL 27, 2022, View Source [SID1234617022]). Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors.

Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D.

Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia.

Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399.

"While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his."

Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera.

"During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials."

On July 26, 2022, Mr. Sekhri was granted stock options (the "Options") to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the "Inducement Award Agreement"). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4).