On August 20, 2020 Moffitt Cancer Ctr reported that World-renowned tumor immunologist Patrick Hwu, M.D., has been appointed the new president and CEO of Moffitt Cancer Center (Press release, Moffitt Cancer Ctr, AUG 20, 2020, View Source [SID1234563959]). He joins Moffitt from The University of Texas MD Anderson Cancer Center, where he is the division head of Cancer Medicine. Hwu begins his new role at Moffitt on Nov. 10.

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Patrick Hwu, M.D., president and CEO, Moffitt Cancer CenterPatrick Hwu, M.D., president and CEO, Moffitt Cancer Center
"Dr. Hwu is truly a cancer visionary ready to elevate Moffitt to even greater success," said Tim Adams, chair of Moffitt’s Institute Board of Directors. "Drawing from his innovative cancer research, quality patient care and extensive leadership experience, Dr. Hwu will no doubt continue to help Moffitt in our pursuit of dynamic growth and groundbreaking work."

"It is my distinct honor and privilege to be selected as the next president and CEO of Moffitt Cancer Center, which has made unprecedented strides in its 34 years in the prevention and treatment of cancer," Hwu said. "I look forward to bringing my years of experience as a cancer physician, researcher and leader to help advance the outstanding work already underway by the teams of cancer experts at Florida’s top-ranked cancer hospital. I’m confident that our collective efforts will further elevate Moffitt’s leadership in cancer patient care, research and education."

Hwu brings 33 years of oncology experience to Moffitt. He held various leadership roles during 17 years at MD Anderson, including chair of the Department of Sarcoma Medical Oncology and co-director of the Center for Cancer Immunology Research. He was the first chair of the Department of Melanoma Medical Oncology. Known for leading transformative research into the clinic, Hwu helped pioneer the field of gene modified T cells, publishing research on the first chimeric antigen receptor directed against cancer. His work focuses on vaccines, adoptive T-cell therapies and immune resistance. He is the principal investigator on a National Institutes of Health SPORE grant for melanoma and has more than 270 peer-reviewed publications.

Hwu is vice president/president elect at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), serves on the Melanoma Research Alliance Foundation Medical Advisory Panel in Washington, D.C., and is a member of numerous scientific advisory boards throughout the U.S.

Founder H. Lee MoffittFounder H. Lee Moffitt
"Dr. Patrick Hwu is a nationally respected physician-scientist with the vision to lead Moffitt into the future," said founder H. Lee Moffitt. "Coming from the largest cancer center in the country, where he has distinguished himself and produced incredible results, we expect he will successfully guide the Moffitt team through the next generation of cancer treatments and discoveries.

"I’m confident Dr. Hwu will inspire and continue our mission to contribute to the prevention and cure of cancer. Our impact on helping cancer patients will be felt worldwide and, in the process, continue to make Florida proud," Moffitt said.

Russell Reynolds Associates, a global leadership advisory and search firm, led the extensive and competitive national search.

Hwu earned his medical degree from The Medical College of Pennsylvania. He served as a house officer in Internal Medicine at The Johns Hopkins Hospital and completed a fellowship in oncology at the National Cancer Institute.

On August 20, 2020 Merck & Co reported that Checkpoint inhibitors that unleash the immune system so it can fight cancer have proven powerful in many tumor types (Press release, Merck & Co, AUG 20, 2020, View Source [SID1234563950]). But their efficacy rests on the premise that patients’ T cells can launch an attack against tumors on their own. That’s why scientists are looking for ways to improve immuno-oncology by drawing T cells to the tumor microenvironment.

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Activating a pathway called cGAS-STING is one potential strategy that has been shown to stimulate T cell recruitment to the tumor microenvironment. Now, scientists at Merck & Co. have designed a STING agonist that can be taken by mouth.

The drug, dubbed MSA-2, cleared tumors in mice bearing colorectal cancer. In tumor models that were poorly responsive to PD-1 blockade, combining MSA-2 and inhibition of the checkpoint PD-1 outperformed monotherapy at controlling tumor growth and prolonging survival, according to results published in Science.

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A Merck spokesperson said the company doesn’t yet have a plan to advance MSA-2 into clinical testing.

Merck already has a STING agonist in development, MK-1454. But MK-1454 failed to produce any responses on its own in patients with advanced solid tumors or lymphomas in a phase 1 trial. There was a 24% response rate to a combination of MK-1454 and Keytruda, the company’s blockbuster PD-1 inhibitor.

Another problem with first-generation STING agonists like MK-1454 is that they must be dosed by directly injecting tumors, which limits their application to just a small number of cancer types. These initial molecules were designed as analogs of cyclic dinucleotide (CDN), which STING binds to, but they are unstable and can induce inflammatory cytokines when administered into the circulatory system.

The Merck researchers set out to identify a non-CDN-based STING agonist that’s suitable for systemic delivery. They used a screen to detect stimulation of interferon beta, a known effect of STING activation, and eventually landed on MSA-2.

RELATED: Aduro stung as Novartis drops work on STING drug

The researchers administered MSA-2 by intratumoral, subcutaneous or oral routes in a mouse model of colorectal cancer. The drug was well tolerated and induced complete tumor regressions in 80% to 100% of treated animals. Even after mice that had no signs of cancer were re-challenged with malignant cells, 95% of the animals remained tumor-free, suggesting long-term anticancer immunity, the team reported.

What’s more, in four mouse tumor models of advanced colorectal cancer, melanoma and lung tumors that were not responsive to PD-1 blockade, combinations of PD-1 blockade and MSA-2 led to better inhibition of tumor growth and extended lives of the rodents compared with either drug alone.

STING is a hot yet challenging target in immuno-oncology. MK-1454, after its initial disappointment, is now being evaluated alongside Keytruda in a phase 2 trial in head and neck squamous cell carcinoma. Aduro Biotech, which is on track to merge with Chinook Therapeutics, also has an intratumoral candidate, ADU-S100. Novartis previously licensed that drug in a $200 million upfront deal only to return it after lackluster clinical data.

GlaxoSmithKline is developing GSK3745417, which can be administered intravenously. Bristol Myers Squibb, through its 2017 acquisition of IFM Therapeutics, has BMS-986301, which is being paired with Opvido and Yervoy in solid tumors. Other STING players include Nimbus Therapeutics as well as Takeda, which is working with Curadev on a candidate.

In a separate Science study, researchers at Scripps Research and the California Institute for Biomedical Research also described a non-CDN STING agonist, dubbed SR-717. The drug demonstrated robust anti-tumor activities in a mouse model of melanoma with a level of efficacy in terms of tumor burden and overall survival that was superior than that for PD-1/L1 therapy.

"Non-nucleotide small-molecule STING agonists that can be administered systemically may represent an attractive approach for targeting this path­way and have the potential to transform the therapeutic landscape once optimized," wrote two University of Chicago scientists in a related Perspective in Science.

On August 20, 2020 Junshi Biosciences, a Shanghai biopharma, reported a JV with Nanjing’s Impact Therapeutics to develop Impact’s PARP inhibitor (Press release, ChinaBio, AUG 20, 2020, View Source [SID1234563932]). Junshi will contribute $43 million for 50% of the JV while Impact will add Greater China rights to IMP4297, the company’s clinical-stage PARP inhibitor. The two companies will collaborate on conducting clinical trials of the candidate in multiple indications, starting with ovarian cancer, plus preparing for manufacturing and commercialization.

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On August 20, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported it has engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization ("CRO") for its upcoming Berubicin clinical trials (Press release, CNS Pharmaceuticals, AUG 20, 2020, View Source [SID1234563917]).

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Worldwide is a a full-service, midsize, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. Worldwide specializes in therapeutic areas where there remain unmet medical needs, including CNS disorders and oncology. Worldwide provides proactive insight and operational support and has successfully managed clinical trials across more than 60 countries.

"Designing and operating trials in areas of high unmet medical need, such as glioblastoma, is a challenging and complex task for any company. We are excited to bring on a high caliber partner such as Worldwide, which has extensive expertise in CNS and oncology, as our CRO for the upcoming Berubicin clinical trials," commented John Climaco, CEO of CNS Pharmaceuticals. "Engaging Worldwide is one of the key pieces of our preparations. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Berubicin’s clinical development. We believe that with Worldwide’s deep clinical CNS and oncology experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase II Berubicin trials in adults in the US and Poland as well as our Phase I pediatric trial."

"The relationship between CNS Pharmaceuticals and Worldwide exemplifies state-of-the-art strategic program development – innovative program design coupled to exceptional clinical and operational acumen for a compound that offers considerable promise to both adults as well as children with such devastating illnesses," commented Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer at Worldwide. "Speaking on behalf of our organization, it is a privilege to express our personal and professional commitment to its success."

The Company’s decision to engage Worldwide as its CRO for the upcoming Berubicin clinical trials is the latest milestone in a series of recent preparation achievements. The Company has been active in implementing its strategic plan and engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) for the production of Berubicin drug product. The decision to add both Pii and BSP as manufacturers of Berubicin was part of the Company’s strategy to implement a dual-track drug product manufacturing strategy. The Company believes this dual-track strategy will help mitigate COVID-19 related risks, diversify its supply chain, and provide for localized availability of Berubicin. Furthermore, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

On August 20, 2020 CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, reported that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for the first-in-class drug candidate CT041, autologous chimeric antigen receptor (CAR) T cells for the treatment of claudin18.2-positive solid tumors (Press release, Carsgen Therapeutics, AUG 20, 2020, View Source [SID1234563916]).

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CT041, a humanized CAR-claudin18.2 T-cell therapy developed by CARsgen Therapeutics for patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, previously received IND clearance from the United States Food and Drug Administration (FDA) in May 2020. CT041 is the first claudin18.2-targeted CAR T-cell therapy IND cleared for clinical trials in China.

"Annual incidence of gastric cancer in China has already exceeded 600,000 cases. Pancreatic cancer is also one of the malignancies with highest unmet medical needs. Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable, and new treatment options are urgently needed," said Professor Lin Shen, principal investigator from Beijing Cancer Hospital, Peking University in China. "Claudin18.2 is abundant in a variety of human malignancies including gastric, pancreatic, esophageal cancer, and biliary tract tumor, which indicates that claudin18.2 is a highly attractive target for cancer immunotherapies. We will continue to advance the clinical trial and facilitate its translation into robust clinical benefits."

"The IND clearance by the NMPA is an important regulatory milestone in the clinical development and commercialization of CT041 anti-claudin18.2 CAR T cells," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year[1] . Gastric and pancreatic cancer are among the malignancies with the highest unmet medical needs. Our goal is to develop novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."