Vertex to Announce First-Quarter 2021 Financial Results on April 29

On April 19, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its first-quarter 2021 financial results on Thursday, April 29, 2021 after the financial markets close (Press release, Vertex Pharmaceuticals, APR 19, 2021, View Source [SID1234578196]). The company will host a conference call and webcast at 5:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Ziopharm Oncology Announces First Patient Infused in CD19 RPM CAR-T Phase I Clinical Trial Being Conducted by Joint Venture Partner Eden BioCell

On April 19, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported that in March, the first patient was infused in the CD19-Specific Rapid Personalized Manufacturing ("RPM") CAR-T Phase I Trial, being conducted by Eden BioCell, its joint venture with TriArm Therapeutics (Press release, Ziopharm, APR 19, 2021, View Source [SID1234578181]).

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The patient was treated at National Taiwan University Hospital under the direction of lead investigator, Dr. Shang-Ju Wu.

The patient’s T cells, collected from the patient via apheresis, were genetically engineered utilizing the Company’s non-viral Sleeping Beauty transposon transposase system and infused two days after gene transfer.

"We are excited to be conducting this important trial for this experimental treatment," said Dr. Jay Zhang, Chief Executive Officer of TriArm Therapeutics.

The Company and Eden BioCell will provide updates regarding the experimental treatment and other patient data in the second half of the year at appropriate venue(s), including scientific conferences, publications and / or bespoke events that the Company may convene.

About the Trial "Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients with Advanced Lymphoid Malignancies"
This is a single center phase I, open-label dose-escalation trial, for patients with relapsed CD19+ leukemias and lymphomas. Up to 24 patients will be enrolled in this trial. The primary endpoint of the trial is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.

ONCOTELIC THERAPEUTICS, INC. ANNOUNCED SYNERGY BETWEEN OT-101 AND IL-2 (PROLEUKIN) AT AACR-2021

On April 19, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC) reported a presentation at AACR (Free AACR Whitepaper)-2021 (American Association for Cancer Research/ Annual Meeting) entitled: Combination therapy of anti-sense oligonucleotide targeting TGF-β2 (TASO) and IL-2 (Proleukin) has anti-cancer effect in solid cancer (Press release, Oncotelic, APR 19, 2021, View Source [SID1234578197]).

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TGF-β (transforming growth factor-beta) is an essential cytokine for tumor proliferation and metastasis. The expression of TGF-Β correlates with malignancy of various cancers and involves immunosuppression and angiogenesis of a tumor. IL-2 is a major cytokine to proliferate T cells and NK cells which are major players of cancer immunity. However, the toxicity of high dose IL-2 limits its use in cancer therapy. Combination treatment of TGF-β inhibitor and IL-2 would have an anti-tumor effect by immune cells through diminishing immunosuppression by TGF-β and enforcement of immune cells by IL-2. Trabedersen is an anti-sense oligonucleotide targeting human TGF-β mRNA. It is shown that Trabedersen is well tolerable in cancer patients and effective reagent to treat pancreatic cancer, melanoma, and glioblastoma. Proleukin is the only approved IL-2 reagent to treat Renal cell carcinoma and Melanoma.

Trabedersen and Proleukin activated human PBMC (Peripheral Blood Mononuclear Cell) are treated to several solid cancer cell lines, such as Breast cancer, Pancreatic cancer, Melanoma, Lung cancer, and Colon cancer to see the cytotoxicity effect of combination therapy of Trabedersen and Proleukin. NSG mouse (NOD Scid Gamma mouse, NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ) which are humanized by human PBMC engraftment and the tumor growth of Melanoma and TNBC (Triple Negative Breast Cancer cell) cell line are monitored.

The combination treatment of Trabedersen and low dose Proleukin decreased cancer cell viability in vitro experiment in solid cancer cell lines. Melanoma and TNBC tumor growth was delayed in humanized NSG mouse model by Trabedersen and low dose IL-2 combination therapy and tumor growth delay was statistically significant to Trabedersen alone or IL-2 alone group. Tumor infiltrating lymphocyte population was increased in Trabedersen treated group and FoxP3+ regulatory T cell population in blood and tumor microenvironment was decreased by treatment of Trabedersen.

TGF-β inhibitor (Trabedersen) and low dose IL-2 (Proleukin) combination treatment is expected to be an effective regimen in solid cancer treatment than individual treatment by alteration of tumor environment. Modulation of the dose of Proleukin expects to help reduce the toxicity of IL-2 and increase the anti-cancer effect by combination with Trabedersen.

Oncotelic has previously announced the regulatory approval from the Ministry of Food and Drug Safety of Korea for the phase 1b clinical trial of a patented OT-101/IL-2 combination. This phase 1b clinical trial will confirm the safety and effectiveness of OT-101/IL-2 in solid cancer patients in cooperation with the UK global pharmaceutical company Clinigen Group. The study will be conducted together with Autotelic BIO- a partner of Mateon on OT-101/IL-2 combination.

OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.

Perrigo Announces Quarterly Dividend

On April 19, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.24 per share, payable on June 22, 2021 to shareholders of record on June 4, 2021 (Press release, Perrigo Company, APR 19, 2021, View Source [SID1234578182]).

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NorthShore and Sema4 Launch System-Wide Genomics Program to Improve Primary and Specialty Care with Data-Driven Insights

On April 19, 2021 NorthShore University HealthSystem (NorthShore) and Sema4, a patient-centered health intelligence company, reported the availability of a system-wide data-driven genomics program that utilizes predictive analytics to help clinicians and patients prevent, detect, and treat diseases at an early stage, when they are most treatable (Press release, NorthShore University HealthSystem, APR 19, 2021, View Source [SID1234578198]). As part of the program, NorthShore clinicians and patients will have access to Sema4’s industry-leading, information-rich genomic solutions for hereditary cancer, cardiovascular diseases, pharmacogenomics, and rare diseases.

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"Unlocking the power of genomics in patient care requires us to make information available in a way that clinicians and patients can easily act upon over time," said Peter Hulick, MD, director of the Mark R. Neaman Center for Personalized Medicine at NorthShore. "The partnership between NorthShore and Sema4 will allow us to get even better at delivering on the promise of genomic insights to prevent, detect, and manage diseases through one of the largest and most comprehensive personalized medicine programs in the country."

Advanced Clinical Offerings

By combining clinical information with genomic analysis, Sema4’s technology platform structures and evaluates data sets to draw insights on how genetic variants will impact patients’ chances of developing disease and to determine the most appropriate treatment options, helping their doctors administer more personalized, holistic care plans. NorthShore will have the opportunity to benefit from disease network models developed by Sema4. For example, disease models for cancers will provide more comprehensive views of cancer patients, their tumor progression, and how best to diagnose or treat them.

Amidst the pandemic, as evidence reflects people are delaying preventative care, these more personalized genomic insights are particularly relevant in helping patients and physicians make informed decisions about prioritizing care.

"By narrowing the significant gap between available biomedical data and health and disease information, we are enabling NorthShore clinicians to make real-time use of the latest insights that allow for highly informed decisions at the point-of-care and improved health outcomes," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "NorthShore has done what few health systems in the country have – brought the potential of genomics from the research labs to the front lines of care. Through the implementation of Sema4’s innovative health intelligence platform in a clinical-care setting, we are together advancing industry standards."

Improved Patient and Clinician Experiences

In addition to guiding clinicians, the program makes it easier for NorthShore patients to understand the implications of genomic findings. Novel digital tools and resources will uncover personalized insights that shape the care of multiple conditions throughout the lifetimes of patients. Patients also have an opportunity to consent to share de-identified data to improve research programs focused on expanding the understanding of genomic-guided care.

The strategic alliance between NorthShore and Sema4 will significantly expand on NorthShore’s existing clinical genomics offerings, which were already the largest in routine primary care in the U.S. More than 1,000 physicians and approximately 300,000 NorthShore patients will have access to Sema4’s offerings.

"Precision medicine represents the next major transformation in health care, allowing us to predict and prevent disease, to identify the right treatment at the right time, and to empower patients and clinicians to make better choices about health," said J.P. Gallagher, President and Chief Executive Officer of NorthShore. "This advanced genomics and health intelligence initiative with Sema4 builds on our long history of pioneering technology and genomic advancements to improve patient care – and aligns with our strong commitment to improving the accessibility of our best-in-class care to address documented disparities in health care services, disease prevalence, and outcomes."

Addressing Disparities in Care

Due to NorthShore’s intentional focus on increasing access to advanced clinical programs, the program is launching in conjunction with an investment to engage culturally diverse communities. In addition to understanding and addressing barriers to access, NorthShore, via a gift from the Swedish Hospital Foundation, will subsidize genetic testing costs for patients who do not have the financial resources to pay for testing.

Earlier this month, NorthShore began offering the program to patients of Swedish Hospital, a State of Illinois Safety Net Hospital located in a federally designated Medically Underserved Area and a member of the NorthShore family. Through the program, the system expects to gain insights about the views of diverse patient populations towards personalized medicine and barriers to receiving genetic information and testing.