On February 22, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter and year-end 2021 financial results on Tuesday, March 1, after the close of the U.S. financial markets (Press release, Syndax, FEB 22, 2022, View Source [SID1234608814]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, March 1, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

On February 22, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States and a leading research center for diabetes and other life-threatening illnesses, reported that its Department of Stem Cell Biology and Regenerative Medicine received a $4.9 million grant to train the next generation of scientific leaders in basic stem cell research and its translation into novel, lifesaving treatments (Press release, City of Hope, FEB 22, 2022, View Source [SID1234608832]).

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The award from the California Institute for Regenerative Medicine (CIRM) contributes to the more than $121 million in grants that Beckman Research Institute of City of Hope has received from CIRM to date, indicating the state-funded agency’s confidence in City of Hope’s long-standing leadership in stem cell-related therapies. As a biomedical institution, City of Hope has deep expertise in developmental and stem cell biology, resulting in strong clinical programs in bone marrow transplantation, cancer immunotherapy, gene therapy to correct genetic defects, and cell replacement and tissue regeneration strategies to treat diabetes.

"Our mission is to train predoctoral and postdoctoral CIRM scholars in basic stem cell and developmental biology, and the translation of this foundational knowledge into novel and effective therapies for patients with cancers, degenerative diseases, genetically caused conditions and other maladies," said Michael Barish, Ph.D., professor in the Department of Stem Cell Biology and Regenerative Medicine and program director of the CIRM-funded educational project.

The five-year grant will be used to mentor junior scientists with the help of City of Hope’s Irell & Manella Graduate School of Biological Sciences at Beckman Research Institute. The program will leverage City of Hope’s position as one of the few cancer centers in the United States with on-campus good manufacturing practice facilities capable of creating clinical-grade biologics and small molecules. Lastly, students will benefit from the fact that their classrooms and laboratories are within walking distance from where patients receive compassionate patient care.

City of Hope has an integrated, multidisciplinary approach to translating fundamental research findings into clinical practice for patients’ benefit. In addition to laboratory research, the CIRM scholars will learn how to implement cell-based therapies, engineer and manufacture cells, obtain regulatory approval and commercialize biomedical products. Instruction will come from scientific and clinical faculty, research nurses and experts in the ethics of stem cell research and its application to medicine.

Due to the program’s proximity to patient care areas, students will also have the unique opportunity to receive mentorship from both City of Hope’s Department of Supportive Care Medicine and Division of Health Equities, where they will be exposed to experts in patient engagement and community outreach programs.

"This program originates from City of Hope’s longstanding expertise in conducting clinical trials and applying fundamental stem cell biology and gene therapy to the treatment of diseases. The program reflects City of Hope’s commitment to ensuring that future scientific leaders understand the varied needs of diverse patient populations, and the inequities that presently affect both biomedical research and the development of and access to innovative therapies," said Nadia Carlesso, M.D., Ph.D., professor and chair of the Department of Stem Cell Biology and Regenerative Medicine and co-investigator of the CIRM project.

Other leaders in this CIRM-funded stem cell and regenerative medicine training program include City of Hope’s Yanhong Shi, Ph.D., Herbert Horvitz Professor in Neuroscience, Rick Kittles, Ph.D., M.S., professor and director of the Division of Health Equities, and Keely Walker, Ph.D., director of the Office of Faculty and Institutional Support.

The new program is one element of City of Hope’s broad commitment to education, including the Irell & Manella Graduate School of Biological Sciences at Beckman Research Institute, which offers doctoral programs in biological sciences and translational medicine, as well as master’s programs in regulatory affairs and translational medicine. City of Hope also supports a portfolio of National Cancer Institute-supported training programs in cancer metabolism, DNA damage and pathways to cancer, as well as training programs for students from traditionally underrepresented backgrounds (supported by the National Institute of Diabetes and Digestive and Kidney Diseases).

On February 22, 2022 Apollo Therapeutics, a biopharmaceutical company focused on translational biology and asset-centric drug development, and King’s College London, reported the formation of a new strategic collaboration (Press release, Apollo Therapeutics, FEB 22, 2022, View Source [SID1234608363]).

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The collaboration will leverage the distinct strengths of each organization with a focus on developing novel therapeutics for patients across multiple disease areas. King’s has one of the leading scientific discovery portfolios worldwide and will contribute biological research breakthroughs with the potential to create high-impact medicines. In addition, the university’s associated hospitals and clinician scientists are ideally positioned to provide support to programs during clinical development. Apollo’s translational scientists and drug development architects will progress these research programs under Apollo’s asset-centric portfolio model to rapidly and efficiently bring those with the greatest promise through clinical investigation and ultimately to patients.

"Translating our biomedical research into effective therapies that improve health is a key priority for King’s researchers. I am delighted that this new partnership with Apollo will provide new routes for us to achieve this goal," said Professor Reza Razavi, Vice President (Research) at King’s College London. "Apollo has an excellent track record in partnering with academics to progress their discoveries into therapies. King’s researchers are looking forward to working with Apollo to progress promising therapeutic programs into their drug discovery pipeline and on to clinical impact."

"When looking at research output, King’s College London is one of the largest and most successful centers for biomedical research and education in the UK and indeed globally. With its broad clinical presence, we have also found King’s has exceptional insight in selecting and advancing research that can translate effectively into therapeutic programs," said Dr. Richard Mason, chief executive officer of Apollo. "We are proud to initiate this partnership with our newest collaborator as we look to grow both our portfolio of programs and our relationships with the world’s leading scientists and biomedical institutions. This collaboration continues to build on recent the progress we have made in advancing our internal pipeline, building our team and establishing our US operations in Cambridge, Mass."

King’s College London joins Apollo alongside other top global research partners, Imperial College London, University College London, and the University of Cambridge.

On February 22, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported a partnership with Medidata, a Dassault Systèmes company, to evaluate the use of its Synthetic Control Arm (SCA) solution in a planned Phase 2 trial of Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM), a type of brain cancer (Press release, Cytori Therapeutics, FEB 22, 2022, View Source [SID1234608799]).

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SCAs are especially advantageous in indications such as recurrent GBM where the standard of care control treatment is considered undesirable by some patients and physicians. The SCA enables study designs that have a higher than usual probability of assignment of prospective patients to the investigational therapy. This enhances patient enrollment and retention and potentially reduces clinical trial costs while upholding the scientific integrity of the trial.

"Medidata has developed a pioneering capability and helped to validate the use of synthetic controls in clinical drug development," said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. "Although a recent advancement, the U.S. Food and Drug Administration has already agreed to recognize a Phase 3 clinical trial design incorporating a synthetic control arm in a registrational randomized control arm in recurrent GBM."

About the Synthetic Control Arm

Synthetic control arm – a type of external control – is formed by carefully selecting patients from Medidata’s extensive repository of historical clinical trials to match the baseline demographic and disease characteristics of the patients treated with the new investigational product. Case studies have shown that SCAs can effectively mimic a classic randomized control and, therefore, can be used to accurately interpret the treatment effects of an investigational product.

SCAs can help enhance the scientific validity of single-arm trials and, in certain indications, enhance randomized clinical trials to expose fewer prospective patients to control and/or ineffective or existing standard-of-care treatments that might not provide a benefit to the patient. This is done while still providing highly valid scientific evidence. These factors can influence a patient’s willingness to participate in a trial where there is a very poor prognosis and perceived inadequate standard of care.

On February 22, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution for oncology, reported that it will introduce HNSCC-SEQ, a highly sensitive Plasma-Safe-SeqS and Next Generation Sequencing (NGS) assay service for head and neck squamous cell carcinomas (HNSCC), at the annual 2022 Molecular Medicine Tri-Conference being held Monday, February 21st through Wednesday, February 23rd in San Diego, California (Press release, Sysmex Inostics, FEB 22, 2022, View Source [SID1234608815]). The assay has a turn-around-time of 7-10 days and is available to researchers and clinicians.

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Sysmex Inostics senior director of medical affairs, Dr. Fred Jones stated, "We see a huge opportunity for researchers and clinicians with our HNSCC-SEQ and HPV-SEQ assays being used in tandem to appropriately identify patients’ tumor mutational drivers." Jones added, "We know the human papillomavirus (HPV) fuels a growing percentage of head and neck cancers, but there is also an unmet need to track HNSCC tumors via circulating tumor DNA (ctDNA) that are HPV-negative – that’s where HNSCC-SEQ comes in. This HNSCC panel helps researchers and clinicians identify patients quickly and accurately for the appropriate therapy and avoiding over-treatment."

HNSCC develop from the mucosal tissue in the oral cavity, pharynx, and larynx and are the most common malignancies that arise in the head and neck regions.¹ HNSCC-SEQ was designed for HPV-negative patients and can be used to detect novel therapeutic targets and frequently occurring driver mutations for treatment response monitoring. HNSCC-SEQ delivers high-sensitivity mutation detection in HNSCC with a limit of detection of 0.05% MAF.2

HNSCC-SEQ can identify head and neck cancer mutational drivers from the genes: CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, and TP53, many of which are actively being pursued as therapeutic targets.3

Dr. Jones will discuss how Plasma-Safe-SeqS technology, including HNSCC-SEQ, can aid cancer drug development, treatment guidance and monitoring, in addition to post-treatment recurrence monitoring during the 2022 Molecular Medicine Tri- Conference’s C4B- Clinical Biomarkers & Companion Diagnostics presentation track in session room Indigo 206 on Tuesday, February 22nd at the Hilton San Diego Bayfront. More information about the presentation can be viewed here.

2022 Multidisciplinary Head and Neck Cancers Symposium
Additionally, Dr. Ari Rosenberg, Assistant Professor of Medicine at the University of Chicago will present findings from his study using Sysmex Inostics HPV-SEQ test at the 2022 Multidisciplinary Head and Neck Cancers Symposium being held February 24th through 26th in Phoenix, Arizona. The poster titled ‘Dynamic changes of cell-free HPV DNA in locoregional viral-associated oropharyngeal cancer receiving response-adaptive treatment’ will be presented Thursday, February 24th. More information can be viewed here.

HNSCC-SEQ and HPV-SEQ are available as a testing service provided by the Sysmex Inostics CLIA lab in Baltimore. MD.