On June 3, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported data from two Phase 1 studies evaluating TIBSOVO (ivosidenib) in adult patients with newly diagnosed acute myeloid leukemia (AML) and an isocitrate dehydrogenase-1 (IDH1) mutation who are ineligible for intensive chemotherapy (Press release, Agios Pharmaceuticals, JUN 3, 2019, View Source [SID1234536795]). The data were presented as part of the scientific program at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"Newly diagnosed AML patients who are not eligible for intensive chemotherapy are typically older or have comorbidities that can lead to a worse prognosis and poor outcomes," said Courtney DiNardo, M.D., lead investigator and associate professor, department of leukemia at the University of Texas MD Anderson Cancer Center. "With an additional six months of follow up since the last data cutoff in the Phase 1 combination study of TIBSOVO with azacitidine, it is encouraging to see a 12-month survival rate of 82% and a continued increase in CR+CRh rate to 70% and CR rate to 61%. In addition, the majority of patients with CR also had IDH1 mutation clearance, suggesting direct impact on the biology of IDH1 mutant AML."

"As the data from these frontline Phase 1 studies of TIBSOVO mature, the durability of response has continued to improve over time and demonstrates that treating these patients with an IDH1 inhibitor early in the disease has the potential to provide deep, durable responses," said Chris Bowden, M.D., chief medical officer at Agios. "The recent sNDA approval in newly diagnosed AML patients with an IDH1 mutation who are ineligible for intensive chemotherapy was the first step in our broad program to develop TIBSOVO across the frontline setting."

Phase 1 Study of TIBSOVO in Combination with Azacitidine

The ongoing Phase 1/2 study is evaluating an investigational use of TIBSOVO or IDHIFA (enasidenib) in combination with azacitidine in patients with newly diagnosed IDH mutant AML unable to receive intensive chemotherapy. As of the February 19, 2019 data cutoff, 23 patients received 500 mg of TIBSOVO daily plus azacitidine in the TIBSOVO arm of the Phase 1b portion of the study. Enrollment in the TIBSOVO arm is complete. As of the data cutoff, 10 (43%) patients remained on study, and the median number of treatment cycles was 15 (range 1-30). The median age was 76 years old, and 52% of patients were age 75 or older. Sixty-five percent of patients had de novo AML and 35% had secondary AML.

Safety Results

The most common Grade 3/4 adverse events (AEs) regardless of cause were thrombocytopenia (61%), anemia (44%), febrile neutropenia (44%) and neutropenia (30%).
Investigator reported IDH differentiation syndrome was reported in four patients, of which three were serious AEs. All four cases resolved, among whom two achieved a complete response (CR), one stable disease and one was not evaluable for response.
Mean neutrophil and platelet counts were maintained near or above thresholds for CR with partial hematologic recovery (CRh) while on study treatment with TIBSOVO and azacitidine. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts (ANC >500/microliter and platelets >50,000/microliter).
Efficacy Results

Overall, 78% (18/23) of patients had a response.
70% (16/23) of patients had a CR or CRh.
61% (14/23) of patients had a CR.
The median duration of CR (95% CI 9.3, NE) as well as CR+CRh (95% CI 12.2, NE) had not been reached.
The median time to response was 1.8 months (range 0.7-3.8 months) and the median time to CR was 3.7 months (range 0.8-15.7 months).
The 12-month survival rate was 82% (95% CI 58.8, 92.8).
The median duration of follow-up was 16.1 months (range 1.3-31.7 months).
For patients who achieved a CR, IDH1 mutation clearance was observed in 9 of 14 (64%) patients with available bone marrow mononuclear cells (BMMCs) and 11 of 14 patients (79%) with available peripheral blood mononuclear cells (PBMCs) as quantified by a digital PCR assay with lower limit of sensitivity for mutant IDH1 of 0.02-0.04% (or 10-4).
TIBSOVO is not approved in any country for the treatment of patients with newly diagnosed AML in combination with azacitidine.

Untreated AML Arm of Phase 1 Study of Single Agent TIBSOVO in IDH1 Mutant Hematologic Malignancies

As of the November 2, 2018 data cutoff, a total of 258 patients with advanced hematologic malignances and an IDH1 mutation were treated in the Phase 1 study, including 34 patients with untreated AML (nine from dose-escalation and 25 from expansion) who received 500 mg of TIBSOVO daily. Enrollment in the study is complete. The median treatment duration for the untreated AML patients was 4.3 months (0.3-40.9). The median age for these patients was 76.5 years (64-87) and 47% had received a prior hypomethylating agent. Among the untreated AML patients, 24% had de novo AML and 76% had secondary AML.

Safety Results

The most common AEs of any grade >25% regardless of causality were diarrhea (53%), fatigue (47%), nausea (38%), decreased appetite (35%), leukocytosis (26%), anemia (26%), edema peripheral (26%) and thrombocytopenia (26%).
Adverse events of interest were the following:
9% reported Grade ≥3 ECG QT prolongation. TIBSOVO was dose reduced in two patients and held in four patients (for any grade of ECG QT prolongation).
18% reported IDH differentiation syndrome of any grade, which was managed with corticosteroids and diuretics. Three patients had their dose temporarily held, and no patients required dose reductions.
3% reported Grade ≥3 leukocytosis.
No AEs of interest lead to any permanent treatment discontinuations or deaths.
Efficacy Results

Data from the 33 untreated AML patients with an IDH1 mutation confirmed by the Abbott RealTimeTM IDH1 assay demonstrated an overall response rate of 55% (18/33 patients).
42% (14/33) of patients had a CR or CRh.
30% (10/33) of patients had a CR.
The median duration of CR (95% CI 4.2, NE) as well as CR+CRh (95% CI 4.6, NE) had not been reached. The estimated 12-month durations of response were 78% for CR and 62% for CR+CRh.
Median overall survival was 12.6 months.
Among patients who were transfusion dependent at baseline, transfusion independence was observed across all response categories, where it was defined as an absence of transfusions for at least 56 consecutive days on treatment.
IDH1 mutation clearance, defined as a reduction in mIDH1 variant allele frequency to below the limit of detection of 0.02–0.04% (or 10-4), was observed in 64% (9/14) of patients who achieved CR+CRh, including 50% (5/10) of patients with CR and 100% (4/4) of patients with CRh.
About TIBSOVO (ivosidenib)
TIBSOVO is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Adult patients with relapsed or refractory AML.
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, 25% (7/28) of patients with newly diagnosed AML and 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 7 patients with newly diagnosed AML who experienced differentiation syndrome, 6 (86%) patients recovered. Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients 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, or 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 including laboratory abnormalities (≥20%) were hemoglobin decreased (60%), fatigue (43%), arthralgia (39%), calcium decreased (39%), sodium decreased (39%), leukocytosis (38%), diarrhea (37%), magnesium decreased (36%), edema (34%), nausea (33%), dyspnea (32%), uric acid increased (32%), potassium decreased (32%), alkaline phosphatase increased (30%), mucositis (28%), aspartate aminotransferase increased (27%), phosphatase decreased (25%), electrocardiogram QT prolonged (24%), rash (24%), creatinine increased (24%), cough (23%), decreased appetite (22%), myalgia (21%), constipation (20%), and pyrexia (20%).
In patients with newly diagnosed AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were fatigue (14%), differentiation syndrome (11%), electrocardiogram QT prolonged (11%), diarrhea (7%), nausea (7%), and leukocytosis (7%). Serious adverse reactions (≥5%) were differentiation syndrome (18%), electrocardiogram QT prolonged (7%), and fatigue (7%). There was one case of posterior reversible encephalopathy syndrome (PRES).
In patients with relapsed or refractory AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were differentiation syndrome (13%), electrocardiogram QT prolonged (10%), dyspnea (9%), leukocytosis (8%), and tumor lysis syndrome (6%). 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

Because 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 Myeloid Leukemia (AML)
AML is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases estimated in the U.S. each year. AML patients are typically older or have comorbidities that preclude the use of intensive chemotherapy. These patients typically have a worse prognosis and poor outcomes. The majority of patients with AML eventually relapse. The five-year survival rate is approximately 28%. For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia. IDH1 mutations have been associated with negative prognosis in AML.

On June 3, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that the first patient has been dosed in a Phase 1 clinical study to evaluate the safety and tolerability of XmAb22841, both as a monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors (Press release, Xencor, JUN 3, 2019, View Source [SID1234536793]). XmAb22841 is a bispecific antibody that simultaneously targets the immune checkpoint receptors CTLA-4 and LAG-3.

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"Our TME activators seek to improve the tolerability and clinical benefit of immunotherapy by activating T cells specifically in the tumor microenvironment, where many checkpoint receptors are highly expressed on immune cells. Toward that goal, XmAb22841 is designed with XmAb bispecific technology to target those cytotoxic T cells that simultaneously co-express the immune checkpoints CTLA-4 and LAG-3," said Paul Foster, M.D., senior vice president and chief medical officer at Xencor. "We intend to advance XmAb22841 in combination with anti-PD1 immunotherapy to potentially drive better responses through triple checkpoint blockade."

The Phase 1 dose-escalation and expansion study, which explores XmAb22841 as a monotherapy and in combination with pembrolizumab will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration in patients with select advanced solid tumors. For more information about the study, please visit View Source (identifier: NCT03849469).

About XmAb22841

XmAb22841 is a bispecific antibody that simultaneously targets immune checkpoint receptors CTLA-4 and LAG-3 and is designed to promote tumor-selective T-cell activation. Xencor’s XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture. XmAb bispecific Fc domains have been engineered to eliminate Fc gamma receptor (FcγR) binding, with the intent to prevent activation and/or depletion of T cells via engagement by FcγR-expressing cells. XmAb22841 is being evaluated in a Phase 1 study for the treatment of advanced solid tumors, as a monotherapy and in combination with pembrolizumab.

On June 3, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported compelling new interim results from its ongoing Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo) (Press release, Heat Biologics, JUN 3, 2019, View Source [SID1234536792]). The updated results were obtained from Cohort B patients whose data has matured an additional 3 months since last reported at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in February of this year. This data may represent the first Phase 2 data showing clinical activity in non-small cell lung cancer (NSCLC) patients whose disease has progressed after prior treatment with a checkpoint inhibitor (CPI). The Cohort B results were presented yesterday at the2019American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting poster session.

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COL(ret) George E Peoples, MD, FACS, Heat’s Chief Medical Advisor, noted, "These latest Cohort B data provides us even greater confidence that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after treatment with a CPI. Of particular note, 4 out of 5 evaluable patients in Cohort B with PD-L1 negative tumors achieved disease stabilization and 4 out of 7 evaluable patients with low CD8+ TIL levels in their tumors achieved disease stabilization. We are encouraged by these positive results and look forward to reporting additional data later this year."

Jeff Hutchins, Ph.D., Heat’s Chief Scientific and Operating Officer said, "The fact that we saw tumor shrinkage in 35% of patients and disease control in 55% of patients whose disease has progressed after treatment with a CPI supports our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may improve clinical outcomes for patients who have lost the benefit of treatment with a checkpoint inhibitor. It is also important to note that the occurrence of dermal injection site reactions is associated with statistically significant improved progression free survival and overall survival, providing further support for the mechanism of action of HS-110."

Highlights for Cohort B patients arepresented below:

HS-110 in combination with nivolumab demonstrates clinical activity i’difficult to treat’ low CD8+ TIL (≤10%) and PD-L1 negative (<1%) tumors:
4 out of 5 evaluable patients with PD-L1 negative tumors achieved disease stabilization, 1 of which was a RECIST partial response.
4 out of 7 evaluable patients with low CD8+ TIL tumors achieved disease stabilization, 2 of which were RECIST partial responses.
The addition of HS-110 to nivolumab may restore clinical benefit to patients whose disease has progressed after CPI treatment failure:
Tumor shrinkage observed in 35% of patients
Disease control rate of 55%
Median Progression-Free Survival (mPFS) of 2.7 months
Median Overall Survival (mOS) not yet reached
The occurrence of any grade dermal Injection Site Reaction during treatment (Y/N) is associated with improved Progression-Free Survival and Overall Survival:
mPFS: NR vs 1.8 months; HR 0.17 (95% CI, 0.03-0.84); p=0.013
mOS: NR vs 5 months; HR 0.13 (95% CI, 0.02-0.71); p=0.002
Treatment with HS-110 in combination with nivolumab was well tolerated, with no additional toxicities beyond those observed with single agent CPI therapy.

Trial results are summarized in the official 2019 ASCO (Free ASCO Whitepaper)Annual Meeting poster.

Trial Design

The Phase 2 trial is designed to evaluate the safety and efficacy of HS-110 combined with an immune checkpoint inhibitor for the treatment of advanced non-small cell lung cancer. Cohort B consists of patients who received a minimum of 4 months of treatment with a checkpoint inhibitor (CPI) as part of their prior therapy, but subsequently had documented progressive disease. Patients receive weekly HS-110 (1 x 107 cells) administered as 5 intradermal 0.1 mL injections for 18 weeks in combination with bi-weekly nivolumab 240 mg IV administered until confirmed disease progression or unacceptable toxicity, whichever occurs first. The primary endpoint is objective response rate (ORR); secondary endpoints include overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and duration of response (DOR). Exploratory endpoints include correlation of clinical outcomes to baseline CD8+ TILs, PD-L1 expression, peripheral blood tumor mutation burden and ELISPOT analysis.

On June 3, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that data from its recently completed Phase II trial in patients with hepatocellular cancer (HCC), the most common form of liver cancer, was presented at the late-breaking abstract session of the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the world’s largest clinical cancer research meeting (Press release, Can-Fite BioPharma, JUN 3, 2019, View Source [SID1234536791]).

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Prof. Salomon M. Stemmer, Principal Investigator of Can-Fite’s Phase II trial, delivered the presentation on Sunday June 2, 2019 at the Developmental Immunotherapy and Tumor Immunobiology session. The presentation is entitled: "A phase II, randomized, double-blind, placebo-controlled trial evaluating efficacy and safety of namodenoson (CF102), an a3 adenosine receptor agonist (A3AR), as a second-line treatment in patients with Child-Pugh B (CPB) advanced hepatocellular carcinoma (HCC)." While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78), superiority in overall survival was found in the largest study subpopulation of patients who were classified Child Pugh B7 (n=56) based on severity of disease compared to the placebo treated group. Median survival in the Namodenoson group (n = 34) was 6.8 months, versus 4.3 months for the placebo group (n = 18) (Hazard Ratio = 0.77, p = 0.40). (See Figure 1 )

The most impressive finding was that 44% of the patients with Child Pugh B7 treated with Namodenoson were alive at one year compared to 18% in the placebo group. In the overall patient population, among patients who had at least one assessment post baseline, disease control was significant in the Namodenoson group, 26% versus 10% in the control group after four months of treatment, P value 0.013. Among the other positive findings that were presented is the 9% partial response in the Namodenoson treated group vs. 0% in the placebo group. An example of a patient demonstrating an excellent tumor shrinkage was presented. (See Figure 2)

A3AR expression level at baseline was 1.98±0.36 in comparison to 1 unit in healthy subjects and was not changed substantially during the treatment period, demonstrating that continuous treatment with Namodenoson does not result in de-sensitization or loss of the target. Consistent with its previously demonstrated favorable safety profile, Namodenoson showed an adverse event profile that was comparable to that of placebo.

"No systemic therapies have shown clinical benefit in Child Pugh B patients with advanced HCC, underscoring the importance of developing an effective drug to serve this unmet medical need," stated Can-Fite CEO Pnina Fishman. "We believe evidence of Namodenoson’s efficacy to prolong life in Child Pugh B7 liver cancer patients, without any deterioration in quality of life due to the drug’s strong safety data, make it a promising anti cancer agent to be moved into Phase III. We were pleased that ASCO (Free ASCO Whitepaper) selected Prof. Stemmer’s presentation so he could share these important findings at ASCO (Free ASCO Whitepaper) with the world’s leading clinical cancer researchers and physicians."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On June 3, 2019 HiFiBiO Therapeutics, a pioneer in innovative biotherapeutics with a unique single-cell analytics platform for extensive immune profiling, reported results from a breakthrough translational study in collaboration with scientists at world-leading academic institutions. A manuscript, "High-Throughput Single-Cell ChIP-seq Identifies Heterogeneity of Chromatin States in Breast Cancer," was released online ahead of publication in Nature Genetics.

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In this study, scientists from HiFiBiO Therapeutics, ESPCI Paris and the Institut Curie applied HiFiBiO Therapeutics’ proprietary single-cell CelliGO platform and unique Drug Intelligent Science (DIS) capabilities to probe why certain disease cells are resistant to available therapeutics. The team demonstrated a novel high-throughput single-cell ChIP-seq (scChIP-seq) approach that overcomes the current limitations of chromatin immunoprecipitation followed by sequencing (ChIP-seq) technologies to better understand the role chromatin heterogeneity plays in cellular differentiation and development. The team used the scChIP-seq approach to discover new biomarkers for triple negative breast cancer, which led to several patent applications.

"This publication is a major milestone for HiFiBiO Therapeutics and another example of how we are applying our proprietary single-cell technology platform to develop new solutions that can address unmet medical needs and transform patient care," said Liang Schweizer, PhD, CEO and President of HiFiBiO Therapeutics. "The new HiFiBiO scChIP-seq approach enables us and our collaborators to target more precise patient subsets and generate higher and longer lasting responses to the innovative therapeutics under development."

The new scChIP-seq approach profiles chromatin landscapes of thousands of cells in tumors and other complex biological systems with high accuracy at single-cell resolution. Using patient-derived xenograft models of acquired resistance to chemotherapy and targeted therapy for triple negative breast cancer patients, the team identified a subset of cells within the untreated drug-sensitive tumors that share a common chromatin signature with resistant cells, undetectable by using bulk approaches. This signature has the potential to lead to the discovery of new drug targets and biomarkers for patient stratification.

"We are committed to partnering with leading academic institutions, as well as pharmaceutical and biotechnology companies. We strongly believe that our proprietary CelliGO platform and unique DIS capabilities can accelerate the development of high-quality antibody drugs and enable novel biomarker discovery for better patient stratification and clinical success," said Annabelle Gérard, PhD, Senior author of the publication and Head of External Innovation at HiFiBiO Therapeutics. "Together with scientists at ESPCI Paris and the Institut Curie, we have demonstrated a new approach that enables the scientific community to decipher novel biology, understand mechanisms of action, develop more effective therapeutics, and design targeted clinical trials for patients with cancer and other complex diseases."

To read the full manuscript, please visit View Source