On July 22, 2021 The Cancer Research Institute (CRI), a U.S. nonprofit organization dedicated to saving more lives through the discovery and development of powerful immunotherapies for all cancers, reported that it has awarded more than $28.5 million in research grants and fellowships during the 2021 fiscal year ending June 30, 2021 (Press release, Cancer Research Institute, JUL 22, 2021, View Source [SID1234585078]). In total, CRI gave 79 awards that will support immunology and cancer immunotherapy research at 43 institutions in 8 countries.

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"Advances in immunology and cancer immunotherapy are being made at an accelerating pace thanks in part to new technologies and techniques that are opening up exciting new ways to explore the complex relationship between cancer and the immune system," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute. "However, it is the brilliant scientists who apply these new tools and techniques to test their bold hypotheses that make possible true progress in the fight against cancer. CRI is proud to support their promising ideas to advance research and improve cancer patient care."

The awards, which are made possible through generous donations from individuals, foundations, and corporate sponsors who support CRI’s lifesaving mission, include:

12 Anna-Maria Kellen Clinical Accelerator Grants

These grants total $10.7 million for the launch, expansion, or ongoing support of platform studies including the AMADEUS biomarker study as well as the IPROC (ovarian cancer), PORTER (prostate cancer), and REVOLUTION (pancreatic cancer) studies testing novel immunotherapy combinations in these hard-to-treat cancers.

6 Lloyd J. Old STAR Awards

Each award provides a grant of $1.25 million over 5 years to future "stars" in the field of cancer immunology to support exploration of unconventional, high-risk/high-reward research directions that have significant potential to advance cancer immunotherapeutics. The 2021 Cancer Research Institute Lloyd J. Old STARs, or "Scientists Taking Risks" include:

Guoliang Cui, Ph.D., of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ), who is studying the immunological functions of skeletal muscles and their link to T cell exhaustion in the context of cancer and chronic viral infection
Peter Edward Fecci, M.D., Ph.D., of Duke University Medical Center, who is working to understand and remove barriers to T cell function within the skull
Malay Haldar, M.D., Ph.D., of the University of Pennsylvania, who is characterizing diverse subsets of mononuclear phagocytes found within tumors and identifying pathways through which they might be targeted therapeutically
Ning Jiang, Ph.D., of the University of Pennsylvania, who is applying a systems immunology approach to characterize the T cell repertoire in cancer
Enrico Lugli, Ph.D., of the Fondazione Humanitas per la Ricerca, who is studying T cell stemness and exhaustion in immunosuppression and adoptive cell transfer immunotherapy
Ivan Zanoni, Ph.D., of Boston Children’s Hospital, who is exploring the role of the innate immune system in the development and control of colorectal cancer
31 CRI Irvington Postdoctoral Fellowships

Each fellowship provides up to $175,500 over three years to support laboratory research, training, and career development for promising young scientists working under the mentorship of leading immunologists.

3 CRI Irvington Postdoctoral Fellowships to Promote Racial Diversity

As part of CRI’s new health equity initiatives launched this year, this program is designed to address opportunity disparities in immunology and tumor immunology faced by U.S. Black, Hispanic, and Latino scientists. Each fellowship provides up to $175,500 over three years to support laboratory research, training, and career development and mentoring.

Together, the 34 fellows awarded in 2021 are working to improve our understanding of fundamental cancer and immune biology by developing new technologies like single cell-sequencing, liquid biopsies, and a personalized CAR T-on-a-chip screening platform, and by exploring topics such as antiviral immune memory, abnormal genomic elements known as retrotransposons, and natural killer cell exhaustion and re-programmability, among other promising research areas.

13 Clinic and Laboratory Integration Program (CLIP) Grants

Each grant provides $200,000 in support for the translation of basic laboratory discoveries into novel therapies that can be tested in patients. The 2021 CLIP grantees are investigating how diverse cell types like macrophages and gamma-delta T cells influence the tumor microenvironment, how the innate immune system senses and responds to threats, and how epigenetic reprogramming could boost checkpoint immunotherapy’s effectiveness.

This year, CRI is proud to announce that 5 of the 13 CLIP grantees are co-funded in partnership with the V Foundation for Cancer Research: Tullia Carmela Bruno, Ph.D., at the University of Pittsburgh; Silvio J. Gutkind, Ph.D., at the University of California, San Diego; Adilia Hormigo, M.D., Ph.D., at the Icahn School of Medicine at Mount Sinai; Justin Paul Kline, M.D., at the University of Chicago; and Tannishtha Reya, Ph.D., at the University of California, San Diego.

Additionally, Jean-Paul Wolinsky, M.D., at Northwestern University, has been named the new CRI-Chordoma Foundation CLIP Investigator, and is working to identify and target immune suppression in malignant chordoma, a rare cancer of bones of the skull base and spine.

5 Technology Impact Awards

Each award supplies seed funding of up to $200,000 to be used over 24 months to address the gap between technology development and clinical application of cancer immunotherapies. 2021 awardees are exploring research areas including T cell generation to re-establish T cell immunity, an inducible molecular memory system to overcome immunotherapy resistance, and a gene therapy platform to improve safety of drug delivery at the tumor site.

9 Impact Grants

These grants total $905,000 and include support for a glioblastoma immunotherapy consortium intended to facilitate development of novel targets for cellular therapy and a research technician pipeline program at Memorial Sloan Kettering Cancer Center aimed at attracting underrepresented minority graduate students to pursue careers in academic scientific research.

To view our full roster of 2021 grant and fellowship award recipients, visit cancerresearch.org/funding. More information about CRI’s grants, fellowships, and other programs is available at cancerresearch.org/grants.

On July 22, 2021 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will provide a corporate and financial update for the second quarter 2021, on Thursday, August 5, 2021, before the market opens (Press release, Athenex, JUL 22, 2021, View Source [SID1234585094]). Athenex’s management team will host a conference call and live audio webcast at 8:00am Eastern Time.

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To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast under "Events and Presentations" at the Investor Relations section of the Company’s website, located at View Source

On July 22, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the National Comprehensive Cancer Network (NCCN) added Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients (Press release, Jazz Pharmaceuticals, JUL 22, 2021, View Source [SID1234585111]).

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The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric ALL now include asparaginase erwinia chrysanthemi (recombinant)-rywn as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen to complete the full treatment course.

"Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from E. coli are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence. We are pleased by the NCCN’s decision to quickly incorporate Rylaze into the Clinical Practice Guidelines for ALL."

Rylaze was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 for use as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.1 The approval followed review of a Biologics Licensing Application under the FDA’s Real-Time Oncology Review program, and it was based on clinical data from a pivotal Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group.

The NCCN Guidelines play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options that may increase the chances of favorable outcomes for patients.

The NCCN is a not-for-profit alliance of 30 leading U.S. cancer centers devoted to patient care, research and education that aims to facilitate quality, effective, efficient and accessible care so that patients can live better lives.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

About ALL
ALL is a cancer of the blood and bone marrow that can progress quickly if not treated.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4,5 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.6 The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the United States in 2021.6 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.7 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.8

About Lymphoblastic Lymphoma
LBL is a rare, fast-growing, aggressive subtype of Non-Hodgkin’s lymphoma, most often seen in teenagers and young adults.7 LBL is a very aggressive lymphoma – also called high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.9,10

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On June 22, 2021 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2021 (Press release, Abbott, JUL 22, 2021, View Source [SID1234585059]).

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Second-quarter sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis, which excludes the impact of foreign exchange.
Second-quarter GAAP diluted EPS was $0.66 and adjusted diluted EPS, which excludes specified items, was $1.17, reflecting 105.3 percent growth versus the prior year.1
Abbott continues to project full-year 2021 diluted EPS from continuing operations on a GAAP basis of $2.75 to $2.95 and full-year adjusted diluted EPS from continuing operations of $4.30 to $4.50, reflecting strong, double-digit growth versus the prior year.
Diagnostics sales increased 62.8 percent on a reported basis and 57.2 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $1.3 billion in the second quarter.
Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in Adult Nutrition globally.
Established Pharmaceuticals sales increased 16.4 percent on a reported basis and 14.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in several countries, including India, China, Russia, and several countries across Latin America.
Medical Devices sales increased 51.3 percent on a reported basis and 45.1 percent on an organic basis in the second quarter. Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.2
"We’re achieving very strong growth across our portfolio," said Robert B. Ford, president and chief executive officer, Abbott. "Perhaps most impressively, excluding COVID testing-related sales, our sales grew more than 11 percent on an organic basis compared to pre-pandemic levels in the second quarter of 2019, which demonstrates the fundamental strength of our performance."

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the second quarter 2021:

* Total 1H 2021 Abbott sales from continuing operations include Other Sales of approximately $38 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2021 worldwide sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis.

Compared to pre-pandemic sales in 2019, worldwide sales increased 12.3 percent on a reported basis and 11.3 percent on an organic basis in the second quarter, excluding COVID-19 testing-related sales.3

Worldwide Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.2 percent on a reported basis and 15.6 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.7 percent on a reported basis and 4.4 percent on an organic basis. Strong performance of Abbott’s market-leading toddler brands, Pedialyte and PediaSure, and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 8.9 percent.

Worldwide Diagnostics sales increased 62.8 percent on a reported basis in the second quarter and increased 57.2 percent on an organic basis. Global COVID-19 testing-related sales were $1.3 billion in the second quarter, led by combined sales of $1.0 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms. Excluding COVID-19 testing-related sales, worldwide diagnostics sales increased 42.5 percent on a reported basis in the second quarter and 37.2 percent on an organic basis.4 Compared to 2019, sales in Core Laboratory and Molecular Diagnostics, excluding COVID-19 testing-related sales, grew 6.8 percent and 8.3 percent, respectively, on a reported basis in the second quarter and grew 4.2 percent and 6.5 percent, respectively, on an organic basis.5

Established Pharmaceuticals sales increased 16.4 percent on a reported basis in the second quarter and increased 14.5 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 19.7 percent on a reported basis in the quarter and increased 18.4 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including India, China, Russia, and several countries across Latin America.

Other sales increased 6.5 percent on a reported basis in the quarter and increased 2.6 percent on an organic basis.

Worldwide Medical Devices sales increased 51.3 percent on a reported basis in the second quarter and increased 45.1 percent on an organic basis. Strong growth in the quarter was driven by continued strong recovery from the COVID-19 pandemic.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.2

In Structural Heart, MitraClip sales increased 88.0 percent on a reported basis and 82.1 percent on an organic basis in the second quarter compared to the prior year, driven by the highest-ever number of MitraClip procedures in the second quarter.

In Diabetes Care, sales of FreeStyle Libre and Libre Sense were $904 million in the quarter, which represents 52.5 percent reported sales growth and 42.9 percent organic sales growth compared to the prior year.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under GAAP of $2.75 to $2.95. Abbott forecasts specified items for the full-year 2021 of $1.55 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, including expenses to align its COVID-19 testing-related business with current and projected demand, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for full-year 2021.

ABBOTT DECLARES 390TH CONSECUTIVE QUARTERLY DIVIDEND
On June 11, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s cash dividend is payable Aug. 16, 2021 to shareholders of record at the close of business on July 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.