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.

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.

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.

On April 19, 2021 Stand Up To Cancer (SU2C) and Mirati Therapeutics Inc. (NASDAQ: MRTX) – a late-stage targeted oncology company – reported that Mirati will contribute a $4 million grant to SU2C to develop new approaches to treat patients with KRAS mutant cancers, as a part of the SU2C Catalyst program (Press release, Stand Up To Cancer, APR 19, 2021, View Source;to-Support-Research-on-KRAS-Mutant-Cancers/default.aspx [SID1234578195]).

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The research will focus on cancer types with unmet medical needs, and the application of tumor-agnostic strategies and molecular testing to address those needs. Certain cancers can sometimes have mutations in the KRAS gene, which makes a protein involved in cellular growth and death. In KRAS mutant cancers, that protein can cause cancers to grow and spread. KRAS proteins were once considered undruggable, but recent research advances have resulted in the identification and development of investigational drugs against cancers that have specific KRAS mutations. Preliminary data from these investigational drugs have demonstrated early signs of clinical activity and studies are ongoing.

The grant from Mirati will leverage the SU2C Catalyst innovative research process, which uses funding and materials from the pharmaceutical, biotechnology, diagnostic and medical devices industries to accelerate research on cancer prevention, detection and treatment. The research will explore new treatment strategies with a KRASG12C inhibitor currently being developed by Mirati.

"The SU2C Catalyst program encourages a collaborative yet nimble and transparent process that accelerates the pace of research and identifies new or unexpected uses for cancer drugs and technologies," said Nobel laureate Phillip A. Sharp, PhD, chair of Stand Up To Cancer’s Scientific Advisory Committee and an institute professor at the David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. "Combined with our rigorous review and milestone-driven process, the program provides a unique framework with the objective to get treatments to patients as quickly and safely as possible."

SU2C’s Catalyst program began in 2016, with contributions from industry supporters Merck, Bristol Myers Squibb and Genentech, a member of the Roche Group. Through the program, companies donate funds to collaborative research studies, in which use of the companies’ products and materials is strongly encouraged. Those materials might include new pharmaceutical compounds that companies are developing or approved agents that can be investigated for other uses. A primary goal of SU2C Catalyst is to encourage collaborative research between academics and companies and shorten the time it takes to get new treatments to patients.

"We are excited to collaborate with Mirati Therapeutics and are thankful for their contribution to the SU2C Catalyst program," said Sung Poblete, PhD, RN, CEO of Stand Up To Cancer. "The opportunity to test the utility of KRAS inhibitors in several different cancer types is a great example of SU2C’s cancer-agnostic approach to research."

"We are proud to support the SU2C Catalyst program and the innovative research it makes possible," said Joseph Leveque, M.D., executive vice president and chief medical officer, Mirati Therapeutics, Inc. "So much progress has been made in understanding and treating cancers through collaborative research. Industry and academic scientists, working together, offer the best chance to move ideas forward that can make a real difference for patients."

As a part of the collaboration with Mirati, SU2C will convene a day-long innovation summit to bring together experts in KRAS signaling, clinical trial design, tumor agnostic approaches to cancer therapy development and other disciplines. The summit will be headed by members of SU2C’s scientific leadership team as well as Mirati representatives. These experts will consider the most pressing research needs in the field and define a grants process that provides a pathway for applicants, and the eventual grantees, to address those issues. Attention will be given to the current state of KRAS genetic testing in different cancer types and approaches that may be considered to appropriately expand testing both across tumor types and among traditionally underserved and minority populations.

On April 19, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) (Press release, Agenus, APR 19, 2021, View Source [SID1234578194]). The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and includes data from its pivotal Phase 2 single-arm clinical trial, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. These clinical data, along with preclinical data, suggest that balstilimab demonstrates differentiated features from other anti-PD-1 antibodies.

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"Women with recurrent or metastatic cervical cancer have a very poor prognosis and limited treatment options. Data suggest balstilimab may bring benefit to patients beyond what is available in this disease setting today," said Jennifer Buell, PhD, President and Chief Operating Officer at Agenus. "This submission also marks a significant step in our transition to a commercial company and the advancement of our oncology combination strategy."

The balstilimab BLA submission is based on an update to data presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 and published in an Oncogene editorial, which demonstrate that balstilimab shows potential differentiation from other anti-PD-1 antibodies. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months.

"We expect that the potential approval of balstilimab will enable us to better pursue our oncology combination strategy for our own extensive pipeline of agents as well as for existing and future partner products," said Steven O’Day, MD, Chief Medical Officer at Agenus. "In particular, we hope to use this potential approval to allow us to rapidly proceed with our anti-CTLA-4 combination strategy, which we believe can add significantly to the benefit provided by our anti-PD-1 agent. There are currently limited treatment options available for recurrent or metastatic cervical cancer patients, and our vision is to bring effective treatments to these patients."

In April 2020, the FDA granted Fast Track designation for balstilimab in recurrent or metastatic cervical cancer based on its potential to provide benefit to patients with a serious condition and unmet medical need.

A global, randomized, Phase 3 confirmatory clinical trial designed to support global registration is planned.

About Cervical Cancer
Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die. Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.1 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.