On March 26, 2019 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will present results of eight studies at the 2019 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting, to be held April 2 – 6, 2019 in Seattle, Wash (Press release, Quest Diagnostics, MAR 26, 2019, View Source [SID1234534666]). (Quest Diagnostics booth 929). These studies by Quest Diagnostics researchers evaluate a broad range of laboratory technologies and best practices for aiding in the evaluation of risk for cancer and other diseases.

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Among the research is a study that uses a "virtual panel" to estimate genetic disease prevalence in ethnic populations; and a study of associations between certain colorectal cancer genes and risk for breast cancer.

"With so much attention on new therapeutics for cancer and other disorders, people sometimes forget the crucial role of diagnostic insights in guiding treatments to improve outcomes. Genetics and genomics have a greater impact on the treatment and management of cancer and other disorders than ever before," said Felicitas Lacbawan, MD, FCAP, FACMG, Vice President and Executive Medical Director, Advanced Diagnostics Quest Diagnostics. "Quest is delivering diagnostic innovations that provide these insights through its advanced diagnostic services so more people can benefit from new, innovative treatments personalized for them."

A study titled "Anticipated Positive Rates for Genetic Testing in the General Population: a ‘Virtual Panel’ Approach" (Poster 736) evaluates a method for estimating the rate of positivity for multi-gene testing panels in the general population and ethnic sub-populations. The study uses hereditary cancer genes as an example. The level of disease prevalence in a population influences test design and results interpretation. The Quest team developed a method to better predict disease prevalence for inherited cancer genes in ethnic groups, many of which have been traditionally under-represented in genetic testing research.

Another study, "Lynch Syndrome Families with Breast Cancer: Majority of Observed Mutations Are in MSH6 and PMS2," (Poster 220) examined the clinical and family histories of individuals positive for a Lynch syndrome mutation. Lynch syndrome, historically known as hereditary non-polyposis colorectal cancer (HNPCC), is an inherited cancer syndrome associated with a predisposition to colorectal and other cancers. The researchers analyzed the frequency of breast cancer in this population to determine the relationship between Lynch syndrome genes and breast cancer and observed an association with the MSH6 and PMS2 genes. These data, which are in line with previous findings, may help refine breast cancer risk assessment in families with Lynch syndrome, guiding clinical surveillance and management.

Quest is a leader in advanced diagnostics, including the areas of genetic and genomics. The company offers more than 1000 genetic tests, including whole exome sequencing, germline and somatic gene sequencing, noninvasive prenatal screening, pharmacogenomics as well as cytogenetics and biochemical genetic testing. The company’s 650 MDs and PhDs and genetic counselors aid physicians in test selection and interpretation and publish hundreds of studies each year. In Advanced Diagnostics – Genetics, Genomics and R&D alone, there are at least 75 PhDs, MDs and MD/PhDs with 60 board-certified scientific and medical directors.

Abstracts can be accessed on the ACMG website at: View Source;search_type=abstracts&event_id=13

Among the Quest Diagnostics scientific and clinical work being presented at the meeting are:

Double Heterozygotes and Carriers of Biallelic Pathogenic Variants Identified During Genetic Testing for Hereditary Cancer Risk at a Diagnostic Laboratory (Poster: 211)
Lynch Syndrome Families with Breast Cancer: Majority of Observed Mutations Are in MSH6 and PMS2 (Poster 220)
Preliminary Insight from CADASIL Testing: Using Aggregate Patient Data to Correlate Position of Variants in NOTCH3 to Severity of Disease (Poster: 228)
Standards for the Classification and Reporting of Constitutional Copy Number Variants: A ClinGen/ACMG Joint Consensus Recommendation (Poster: 682)
Looming False Negatives: Reconsidering the Clinical Significance of Synonymous Variants (Poster: 705)
Anticipated Positive Rates for Genetic Testing in the General Population: A "Virtual Panel" Approach (Poster 736)
Maternal Chimerism as a Cause of Confounded Gender Reporting and Gender Discordance During cfDNA Screening (Poster: 897)
Confirmatory methods used for germline NGS Testing Teach Us About the Strengths and Weaknesses of Molecular Technologies (Poster: 8781)

On March 26, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TIBSOVO (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy (Press release, Agios Pharmaceuticals, MAR 26, 2019, View Source [SID1234534686]).

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"Outcomes for newly diagnosed AML patients ineligible for intensive chemotherapy are still poor, and there are no approved options specifically for patients with an IDH1 mutation," said Chris Bowden, M.D., chief medical officer at Agios. "The Breakthrough Therapy designation provides further support that combining azacitidine and ivosidenib for these patients has the potential to be a compelling treatment option."

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

Results from the Phase 1/2 study of ivosidenib in combination with azacitidine were last presented at the 17th International Symposium on Acute Leukemias in Munich. In the ivosidenib arm of the Phase 1b portion of the study, 23 patients received 500 mg of ivosidenib daily plus azacitidine. The median age was 76 years old, and 52% of patients were age 75 or older. The safety profile of combination therapy remains consistent with the safety profile of ivosidenib and azacitidine alone in this patient population. As of the August 1, 2018 data cutoff, mean neutrophil and platelet counts were maintained near or above thresholds for complete response (CR) with partial hematologic recovery (CRh) while on study treatment with ivosidenib and azacitidine. Overall, 78% (18/23) of patients had a response and 57% (13/23) of patients had a CR. The median duration of CR had not been reached (95% CI 7.7, NE). In addition, the 12-month survival rate was 82%.

Ivosidenib is not approved in any country for the treatment of patients with newly diagnosed AML or approved in combination with azacitidine.

About TIBSOVO (ivosidenib)

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. For more information, visit TIBSOVO.com.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased. Of the 34 patients who experienced differentiation syndrome, 27 (79%) recovered after treatment or after dose interruption of TIBSOVO. Differentiation syndrome occurred as early as 1 day and up to 3 months after TIBSOVO initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. One patient developed ventricular fibrillation attributed to TIBSOVO. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome occurred in <1% (2/258) of patients treated with TIBSOVO in the clinical study. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) of any grade were fatigue (39%), leukocytosis (38%), arthralgia (36%), diarrhea (34%), dyspnea (33%), edema (32%), nausea (31%), mucositis (28%), electrocardiogram QT prolonged (26%), rash (26%), pyrexia (23%), cough (22%), and constipation (20%).
The most frequently reported ≥Grade 3 adverse reactions (≥5%) were electrocardiogram QT prolonged (10%), dyspnea (9%), leukocytosis (8%), tumor lysis syndrome (6%), and differentiation syndrome (5%).
Serious adverse reactions (≥5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).
DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.

Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.

Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.

QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with TIBSOVO and for at least 1 month after the last dose.

Please see full Prescribing Information, including Boxed WARNING.

About Acute Myelogenous Leukemia (AML)
AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML incidence significantly increases with age, and the median age of diagnosis is 68. The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 27 percent. IDH1 mutations are present in about 6 to 10 percent of AML cases.

On March 25, 2019 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing small molecule drug candidates to treat cancer reported that it has surpassed the 75 percent enrollment milestone in its pivotal Phase 3 trial of rigosertib for the potential treatment of high-risk myelodysplastic syndromes (HR-MDS), a study known as INSPIRE (Press release, Onconova, MAR 25, 2019, View Source [SID1234534593]).

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"We are pleased to have passed the 75 percent completion of enrollment milestone and are on track with our anticipated timeline for completion of accrual to the INSPIRE study in the second half of 2019," said Dr. Richard Woodman, Onconova’s Chief Medical Officer and Senior Vice President of Research & Development. "Rigosertib has the potential to be the first new MDS treatment in more than 15 years for a condition afflicting an estimated 59,000 patients in the United States."

Dr. Steven M. Fruchtman, President and CEO of Onconova, stated, "Clinical execution including completing our INSPIRE study remains our top priority. In addition to near-term milestones for the INSPIRE study, we are advancing business development discussions and remain on track to reach other important clinical milestones throughout 2019 and into 2020. This includes advancing our oral rigosertib program in MDS. We are grateful to patients and to our valued partners for their participation in the important INSPIRE study, and look forward to completing patient enrollment later this year."

The INSPIRE study is a Phase 3, open label, randomized, controlled, international study designed to determine the efficacy, safety and tolerability of single agent intravenous (IV) rigosertib to treat second-line higher-risk MDS patients. The trial includes patients under the age of 82 who have progressed on, relapsed, or failed to respond to previous treatment with hypomethylating agent (HMA) therapy within nine cycles over the course of one year after initiation of HMA therapy. Patients are randomized to receive either rigosertib with best supportive care, or the physician’s choice of therapy with best supportive care. The primary endpoint of the study is the sequential analysis of overall survival of all randomized patients in the intent-to-treat population, and the International Prognostic Scoring System – Revised (IPSS-R) Very High-Risk subgroup. Based on the promising survival signal observed by the Independent Data Monitoring Committee at interim analysis in early 2018, the Committee recommended that the trial continue with an expansion in enrollment to 360 patients based on a pre-planned sample size re-estimation.

Persons interested in participating in the INSPIRE study can obtain more information by visiting View Source

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, leading to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

On March 25, 2019 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel tetravalent bispecific antibodies that target the immune system to fight cancer, reported that new preclinical data on three immuno-oncology programmes will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, US, held from 29 March – 03 April 2019 (Press release, f-star, MAR 25, 2019, View Source [SID1234534609]).

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Neil Brewis, CSO of F-star said "We are excited about this new preclinical data, as it demonstrates the full potential of our tetravalent molecules to leverage a superior anti-tumour response compared to other checkpoint monotherapies, alone or in combination. In addition, our drugs harness a potentially safer mode of action, independent of FcγR-binding, which has been reported to drive systemic cytotoxicity."

FS120 and FS222 are two proprietary F-star assets targeting members of the Tumour Necrosis Factor Receptor Super Family (TNFRSF). FS120 is a first-in-class dual agonist mAb² simultaneously targeting OX40 (CD134, TNFRSF4) and CD137 (4-1BB) while FS222 is an agonist/antagonist mAb² against CD137/PD-L1 (Programmed Death-Ligand 1). Both are on track for IND filings this year.

The preclinical presentations illustrate the synergistic benefit of F-star’s tetravalent mAb² and how both FS120 and FS222 individually outperform combinations of single agents in multiple assays. Furthermore, and in contrast to broader CD3-mediated immune stimulation, F-star programmes promote a more controlled activation of immune effectors. The mAb² also benefit from a safer FcγR-independent profile, especially regarding dose-limiting hepatotoxicity, as supported by data to be presented on FS222.

Finally, F-star will also share preclinical data on a third programme, FS118, a potentially first-in-class bispecific antagonist of LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1. The poster describes FS118’s potential to increase response rates by overcoming the LAG-3-mediated tumour evasion mechanism that often takes place following single agent checkpoint blockade. FS118 is currently investigated in a Phase 1 study in patients who have progressed on or after prior PD-1/PD-L1 containing therapy.

Eliot Forster, CEO of F-star said "We are creating a paradigm shift in the future of cancer treatment and believe our drugs will offer meaningful benefits to patients who are currently poorly responding or non-eligible to other immuno-oncology therapies. In addition, the mAb² format is poised to become a game changer in the industrial landscape, as it maintains the well-established and favourable manufacturing properties of IgG antibodies."

FS118 is under an exclusive option to Merck KGaA, Darmstadt, Germany.

Details of the posters are below:

FS120 communication: Dual agonist bispecific antibody targeting OX40 and CD137 mediates anti-tumour immunity and synergises with PD-1/PD-L1 blockade to improve survival in a syngeneic mouse model

Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: 01 Apr from 13:00 – 17:00
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
Poster Board Number: 22
Abstract Number: 2398

FS222 communication: FS222 mAb2, a bispecific conditional agonist antibody targeting CD137 and PD-L1, induces potent lymphocyte activation and has a favourable safety profile

Session Category: Immunology
Session Title: Therapeutic Antibodies 2
Session Date and Time: 01 Apr from 08:00 – 12:00
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
Poster Board Number: 09
Abstract Number: 1540

FS118 communication: LAG-3/PD-L1 mAb2 can overcome PD-L1-mediated compensatory upregulation of LAG-3 induced by single-agent checkpoint blockade

Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: 01 Apr from 13:00 – 17:00
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
Poster Board Number: 23
Abstract Number: 2399

On March 25, 2019 BioXcel Therapeutics, Inc. ("BTI") (BTAI) reported that it has filed a Clinical Trial Application (CTA) with the U.K. health authorities for its lead immuno-oncology asset, BXCL701, an orally-available small molecule immune-modulator with dual mechanisms of action, in combination with pembrolizumab (Keytruda), a checkpoint inhibitor, in tNEPC (Press release, BioXcel Therapeutics, MAR 25, 2019, View Source [SID1234534627]). BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

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Following approval of the CTA, BTI plans to expand the Phase 1b/2 US study of BXCL701 and pembrolizumab in tNEPC to the U.K. Professor Johann de Bono, M.D., Ph.D., of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, will serve as Principal Investigator for the European study of BXCL701 in tNEPC. Data from the open-label trial will support the ongoing global clinical development of BXCL701.

Additionally, BioXcel Therapeutics is preparing to file an Investigational New Drug (IND) application with the FDA for a clinical trial evaluating the triple combination of BXCL701, NKTR-214 and avelumab in the treatment of advanced pancreatic cancer.

Dr. Chetan D. Lathia, SVP & Head of Translational Medicine, Clinical Pharmacology and Regulatory Affairs of BTI said, "The filing of the CTA in the U.K., for the BXCL701 combination trial is an important regulatory milestone for BTI. It marks the beginning of our plans for the global development of our lead programs."

Dr. Vimal Mehta, Chief Executive Officer of BTI added, "We remain committed to translating the potential of BXCL701’s novel mechanism of action into therapies that can fundamentally change the lives of cancer patients. The filing of this CTA is the first milestone in the expansion of our footprint into major markets outside the US. We believe that our pancreatic cancer clinical development partnership with Nektar, Pfizer and Merck KGaA, Darmstadt, Germany will also benefit the broader BXCL701 program."

The Company also announced that Professor de Bono has joined its Immuno-oncology Clinical Advisory Board. Professor De Bono is the Regius Professor of Cancer Research and a Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust. He is also the Director of the Drug Development Unit, overseeing the Phase I trials, with a particular interest in innovative trial designs, circulating biomarkers and prostate cancer. Additionally, he leads the Prostate Cancer Targeted Therapy Group and the Cancer Biomarkers laboratory team. He has served as chief investigator on trials for multiple approved drugs, including ZYTIGA, JEVTANA and XTANDI.

Professor de Bono is a clinical investigator in the KEYNOTE- 199 trial, a study evaluating Pembrolizumab in docetaxel pre-treated castrate-resistant metastatic prostate cancer patients. He graduated with a medical degree and a postdoctoral degree from University of Glasgow. He also trained in medical oncology and was awarded a master’s degree in cancer sciences from the University of Glasgow. Professor de Bono has received multiple awards including one of the "World’s Most Influential Scientific Minds," the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) award and the Royal Society of Chemistry award.

About BXCL701

BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.