NantHealth and NantOmics Announce GPS Cancer® Platform May Improve Clinical Trial Design of Combination Strategies by Identifying Previously Unrecognized Cancer Type Specific Associations between Immunoregulatory Molecules and Genomic Mutations

On February 19, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company and NantOmics, LLC, the leader in molecular analysis, reported Real-world data for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs during an oral presentation at the Real World Evidence in Immunotherapy Session at the Clinical Immuno-Oncology Symposium, sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) (Press release, NantHealth, FEB 19, 2020, View Source [SID1234554509]).

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The Symposium, held at Rosen Shingle Creek in Orlando, FL from February 6-8, 2020 provides cutting-edge translational science and relevant clinical results to a diverse audience of leaders in oncology education, doctors and care teams.

"Our analysis shows that commonly evaluated mutations are associated with therapeutic targets for immunotherapy," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "For example we saw high IDO expression in in patient samples with FBXW7 mutations. IDO has failed in clinical trials in the past but perhaps the wrong patient population was assessed. This data may help design better clinical trials which match the molecular phenotype with the best possible combination of therapies."

IDO1 (i.e. IDO) is the molecular target for several immunotherapy drugs (e.g. Epacadostat) that have failed in trials that selected patients based on tissue-type. FBXW7 mutants are significantly higher in IDO1 expression regardless of which tissue they show up in, and FXBW7 mutations are found in many tissue types. Agnostic-driven clinical trial designs using strategies to identify FBXW7 tumors that have higher expression of IDO1 may be a good strategy for these types of drugs.

In the study, authors utilized TCGA data and data collected from NantHealth’s GPS Cancer database on whole exome (WES) DNA tumor and paired normal and matched deep whole transcriptomic sequencing (RNA-Seq) to identify novel associations between oncogenic mutations and immune checkpoint therapeutic targets.

"CDKN2A mutation status was identified as associated with increased PD1 and CTLA4 expression while KRAS and APC mutations were assessed as associated with decreased PDL1/2 expression," said Christopher Szeto, Director of Machine Learning. "These mutation associations remained significant after accounting for tissue-specific expression patterns."

Title: "Real-world data validation for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs," Abstract #10
Authors: Jacob J. Adashek, Christopher Szeto, Sandeep K. Reddy, Philippe E. Spiess
Poster Session and Number:
Who: NantHealth, Inc. and NantOmics, LLC
What: Real World Evidence in Immunotherapy Session
When: February 6-8, 2020
Location: Rosen Shingle Creek

Memorial Sloan Kettering’s Cycle for Survival Exceeds $250 Million for Rare Cancer Research

On February 19, 2020 Cycle for Survival, the movement to beat rare cancers, made history by topping $250 million raised since it was founded in 2007 (Press release, Memorial Sloan-Kettering Cancer Center, FEB 19, 2020, View Source [SID1234554526]). The grassroots fundraising effort includes donations from more than one million individuals across all 50 states. This milestone reflects the determination and generosity of a passionate community uniting to fight rare cancers. Every dollar raised goes to clinical trials, research studies and groundbreaking technologies pioneered by Memorial Sloan Kettering (MSK).

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MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
Maximizing their success with the peer-to-peer fundraising model, Cycle for Survival has grown consistently over the past 14 years, with significant growth in the previous few years. More than half of the $250 million total was raised in the past three years.

Equinox, Cycle for Survival’s founding partner and host, has been essential to the fundraising achievements since the beginning. In celebration of the $250 million raised, Equinox provided a $500,000 donation match yesterday to help drive Cycle for Survival over the extraordinary quarter of a billion dollars mark.

In honor of this milestone, and to celebrate the 11th year of Cycle for Survival events in Chicago, Willis Tower lit its iconic antennas orange on February 8 during the local rides.

Starting as a single indoor cycling ride in New York City with just 230 people on 50 bikes, Cycle for Survival now has more than 37,000 participants on 9,000 bikes, and 250,000 donors annually. Participating teams include more than 1,100 corporate teams from 610 companies rallying colleagues to ride together. Cycle for Survival’s signature stationary cycling events, led by instructors from Equinox, take place in 17 cities across the country this January, February and March.

The $250 million raised by Cycle for Survival has allowed hundreds of MSK physicians, scientists and research teams to pursue bold ideas to change the way cancer is diagnosed and treated. Their investigations have made a direct impact on patient care, including FDA-approved drugs and effective experimental therapies. Cycle for Survival donations often provide vital seed funding for new research endeavors.

All of the money raised is allocated within the six months following the close of fundraising annually. The funds go directly to research and clinical trials for rare cancers, which affect about half of all cancer patients and include thyroid, brain, ovarian, pancreatic, all pediatric cancers and many others. As doctors and researchers pursue new treatments, Cycle for Survival provides urgently needed resources. Visit www.CycleforSurvival.org to learn more.

Cellectis and Servier Expand Collaboration on UCART19 Products

On February 18, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), and Servier, an international pharmaceutical company, reported the execution of a binding term sheet to enter into an amendment to the agreement initially signed between the two companies in 2014 (Press release, Cellectis, FEB 18, 2020, View Source [SID1234554424]).

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Under the term sheet, Cellectis shall grant to Servier, through an amendment to the agreement, an expanded exclusive worldwide license to develop and commercialize all next generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to ALLO-501A, an anti-CD19 candidate in which the rituximab recognition domains have been removed, either directly or through its US sublicensee Allogene Therapeutics.

In this amendment, financial terms will be improved to include an additional USD 27.6 million (EUR 25 million) upfront payment, as well as up to USD 410 million (EUR 370 million) in clinical and commercial milestones. The royalty rate will be increased from tiered high single-digit royalties to flat low double-digit royalties based on net sales of products.

In addition, pursuant to the amendment, Cellectis shall regain exclusive control over the five undisclosed allogeneic CAR T-cell targets previously covered by the initial agreement.

The amendment will be effective upon its execution.

"This amendment to our license agreement with Servier provides to Cellectis an attractive economic upside to product candidates targeting CD19 and enriches our proprietary portfolio of targets," said Dr. André Choulika, Chairman and CEO, Cellectis. "We are committed to positioning Servier and Allogene for streamlined success, so the CD19-directed products have the potential to reach patients faster, while also providing Cellectis the means to expand our proprietary product pipeline."

About UCART19/ALLO-501 and ALLO-501A

UCART19/ALLO-501 and ALLO-501A are two anti-CD19 allogeneic CAR-T product candidates being jointly developed under a clinical development collaboration between Servier and Allogene Therapeutics based on an exclusive license granted by Cellectis to Servier.

Such products utilize Cellectis’ technologies, including TALEN gene editing technology pioneered and controlled by Cellectis. Servier grants to Allogene exclusive rights to UCART19 in the US while Servier retains exclusive rights for all other countries.

FibroGen to Report Fourth Quarter and Full Year 2019 Financial Results

On February 18, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its fourth quarter and full year 2019 financial results after market close on Monday, March 2, 2020 (Press release, FibroGen, FEB 18, 2020, View Source [SID1234554440]). FibroGen will also conduct a conference call on that day at 5:00 p.m. (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the FibroGen website at View Source It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information
Live (U.S./Canada): (877) 658-9081
Live (International): (602) 563-8732
Confirmation number: 8058848

A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (800) 585-8367 (domestic) or (404) 537-3406 (international), and use passcode 8058848#.

Boundless Bio Announces Presentations at Additional Conferences in February

On February 18, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences this month (Press release, Boundless Bio, FEB 18, 2020, View Source [SID1234554456]):

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16th UC San Diego Moores Cancer Center Industry/Academia "Next Generation Precision Oncology" Symposium: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will speak during a session devoted to solid tumors. The presentation will take place at 9:15 a.m. PST on Thursday, February 20, 2020 in La Jolla, California.
9th Annual SVB Leerink Global Healthcare Conference: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will provide a company overview at 2:00 p.m. EST on Tuesday, February 25, 2020 in New York, New York.
Biocom’s Annual Global Life Sciences Partnering Conference: Scott Moorefield, Ph.D., Chief Business Officer of Boundless Bio, will present a company overview at 11:45 a.m. PST on Wednesday, February 26, 2020 in La Jolla, California.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.