On June 1, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported the first data from the ongoing Phase 1 study evaluating single agent AG-881 in advanced glioma and other solid tumors (Press release, Agios Pharmaceuticals, JUN 1, 2018, View Source [SID1234527131]). The data were featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. AG-881 is an investigational, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-1 (IDH1) and IDH2 enzymes, which was designed for enhanced brain penetrance for development in IDH-mutant glioma.

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"IDH mutant glioma is a distinct disease where patients are typically diagnosed in their thirties and forties and endure a deteriorating quality of life from the side effects associated with multiple rounds of surgery, radiation and chemotherapy and ultimately die of their disease," said Ingo Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center, an investigator for the study. "The AG-881 Phase 1 dose-escalation data are encouraging, as they demonstrate a favorable safety profile at lower dose levels and show signals of clinical activity that support further evaluation of the role of inhibiting mutant IDH in low-grade glioma."

"With no curative or approved targeted therapies for low-grade glioma and a poor long-term prognosis, we are committed to exploring the novel mechanism of action of our IDH inhibitors in this indication," said Chris Bowden, M.D., chief medical officer at Agios. "Data from our ivosidenib and AG-881 Phase 1 trials and the ongoing perioperative study, combined with feedback from regulators and the neurology community, will inform our pivotal development plan."

The ongoing Phase 1 dose-escalation trial is assessing the safety and tolerability of AG-881 in IDH1/2 mutant advanced solid tumors, including glioma. As of the March 29, 2018 data cut-off, 93 patients (52 with glioma and 41 with other solid tumors) have been treated with single agent AG-881. Enrollment is complete and 17 glioma patients and 1 non-glioma solid tumor patient remain on treatment. Study design, status and baseline characteristics for the 52 glioma patients are reported below.

Forty-eight percent of patients (n=25) had World Health Organization (WHO) classified Grade 2 tumors, 42% (n=22) had Grade 3 tumors, 8% (n=4) had Grade 4 tumors and 2% (n=1) was unknown.
LOGO

Ninety-two percent of patients (n=48) had an IDH1 mutation and 6% (n=3) had an IDH2 mutation. One patient did not have a biopsy but was confirmed as IDH mutant positive due to 2-HG elevation by magnetic resonance spectroscopy (MRS).

The median age of these patients is 42.5 years (ranging from 16-73 years).

Patients received a median of two prior systemic therapies (ranging from one to six).

Seventy-three percent of patients (n=38) had previously received temozolomide and 58% percent (n=30) had previously received radiotherapy.

Patients received daily doses of AG-881 ranging from 10 mg to 300 mg.

The median treatment duration was seven months (ranging from 0-27 months) for all glioma patients, 12 months (ranging from 1-27 months) for non-enhancing glioma and 3 months (ranging from 0- 27 months) for patients with enhancing disease.
Safety Data

The safety analysis conducted for all 93 treated patients as of the data cut-off demonstrated that AG-881 has a favorable safety profile at dose levels below 100 mg.

The majority of adverse events (AEs) reported by investigators were mild to moderate, with the most common (>33%) being fatigue, nausea, increases in alanine aminotransferase (ALT) and increases in aspartate aminotransferase (AST).

Grade 3 or higher AEs were observed in 33% of all patients (n=31).

Dose limiting toxicities (DLTs) of Grade 2 or higher elevated transaminases occurred in five glioma patients at the higher dose levels (³100 mg) and resolved to Grade £1 with dose modification or discontinuation. There were no treatment-related on-treatment deaths.

A maximum tolerated dose (MTD) was not reached by Bayesian model; the doses chosen for further clinical development were based on safety, pharmacokinetics and pharmacodynamics data.
Efficacy Data

Efficacy data from the 52 glioma patients (23 with non-enhancing and 29 with enhancing disease) as of the data cut-off showed:

One patient with non-enhancing disease and a 1p19q co-deletion had a sustained minor response according to the investigator by Response Assessment in Neuro-Oncology for low grade glioma (RANO-LGG) and remains on treatment.

Seventy-five percent of patients (n=39) had a best response of stable disease, including 20 patients with non-enhancing disease.

Thirty-five percent of patients (n=18, including 13 patients with non-enhancing disease) remained on treatment for ³1 year.
Efficacy data from the 41 patients with non-glioma solid tumors as of the data cut-off showed:

One patient with cholangiocarcinoma had a partial response, 37% of patients (n=15) had stable disease and 44% (n=18) had progressive disease.

The median treatment duration was 2 months (ranging from 0-18 months).
Ongoing Perioperative Study in Glioma

A perioperative ‘window’ trial with ivosidenib and AG-881 (10 mg and 50 mg) in up to 45 IDH1m non-enhancing low-grade glioma patients is ongoing. The goal of the trial is to confirm CNS penetrance and tumor 2-HG suppression of ivosidenib and AG-881 as part of the strategy to finalize pivotal development plans by year-end 2018.

About Glioma

Glioma presents in varying degrees of tumor aggressiveness, ranging from slower growing (low grade glioma) to rapidly progressing (high grade glioma-Glioblastoma Multiforme). Common symptoms include seizures, memory disturbance, sensory impairment and neurologic deficits. The long-term prognosis is poor with a five-year survival rate of 33 percent. Approximately 11,000 low-grade glioma patients are diagnosed annually in the U.S. and EU and approximately 80 percent have an IDH1 mutation.

On June 1, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conferences during June and invited investors to participate by webcast (Press release, Exact Sciences, JUN 1, 2018, View Source [SID1234527026]).

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Jefferies 2018 Global Healthcare Conference, New York Presentation on Tuesday, June 5, 2018, at 9 a.m. EDT

William Blair 38th Annual Growth Stock Conference, Chicago Presentation on Tuesday, June 12, 2018, at 4:10 p.m. CDT

Goldman Sachs 39th Annual Global Healthcare Conference, Rancho Palos Verdes, Calif. Fireside chat on Wednesday, June 13, 2018, at 8 a.m. PDT

On June 1, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported it will present data evaluating certain biomarkers as potential predictors of survival in patients with previously untreated metastatic pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which takes place June 1-5 in Chicago (Press release, Halozyme, JUN 1, 2018, View Source [SID1234527045]). In addition, Halozyme partner Janssen will present five posters of clinical studies involving subcutaneous daratumumab using Halozyme ENHANZE technology.

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"Our goal at Halozyme is to develop new therapies for cancer patients, while minimizing the burden and impact of treatment on their lives," said Helen Torley, president and chief executive officer. "The exploratory plasma biomarker data may support efforts to identify patients who benefit from our investigational drug, PEGPH20, through a simple blood draw rather than a needle biopsy.

"Our ENHANZE technology allows certain drugs to be given subcutaneously in a shorter, simpler injection than when the drug is delivered intravenously, thereby reducing the treatment burden for patients. We are delighted that Janssen will be presenting five posters on their exploration of a subcutaneous version of daratumumab that can be given in 5 minutes or less using our ENHANZE technology."

The Halozyme research of peptide biomarkers measured maturation and degradation of type III collagen, a key component of the extracellular matrix, using baseline plasma samples from patients in Halozyme’s HALO-202 Phase 2 clinical study of PEGPH20 (pegvorhyaluronidase alfa) in combination with ABRAXANE (nab-paclitaxel) and gemcitabine (PAG arm) as compared to ABRAXANE and gemcitabine only (AG arm).

Highlights from the Halozyme biomarker analysis include:

In the Discovery cohort (Stage 1), median progression-free survival (PFS) was 8.0 months in the PAG arm versus 5.3 months in the AG arm for patients whose biomarker scores were equal or above a specific cut-off value. The proportion of this patient population to all subjects tested in Stage 1 is 50 percent.
In the Validation cohort (Stage 2), patients whose biomarker scores were equal to or above the cut-off value derived from the Discovery cohort experienced a median PFS of 8.8 months in the PAG arm versus 3.4 in the AG arm, as well as overall survival of 13.8 months in the PAG arm versus 8.5 months in the AG arm. The proportion of this patient population to all subjects tested in Stage 2 is 47 percent.
PEGPH20 is a proprietary enzyme that targets and degrades hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in higher concentrations around many solid tumors, potentially constricting blood vessels, impeding the immune response and the access of other therapies.

Janssen’s daratumumab
Janssen (Janssen Research & Development, LLC) presentations will highlight development of subcutaneous daratumumab using Halozyme ENHANZE technology. Results from the Phase 1b PAVO study of patients with relapsed or refractory multiple myeloma showed daratumumab co-formulated with ENHANZE enabled dosing in 3 to 5 minutes and was well tolerated with low infusion-related reactions.

Additional Updates and Presentations at ASCO (Free ASCO Whitepaper)
In an update on the HALO-101 Lung/Gastric Phase 1b study, Halozyme said that in light of the evolution in the standard of care in first-line non-small-cell lung cancer, it is closing enrollment in the lung cohort in the study. Investigators are being given the option to continue treatment of ongoing patients, and data will be submitted to medical forum later this year.

Halozyme’s ASCO (Free ASCO Whitepaper) abstracts include:

Extracellular matrix (ECM) circulating peptide biomarkers as potential predictors of survival in patients (pts) with untreated pancreatic ductal adenocarcinoma (mPDA) receiving pegvorhyaluronidase alfa (PEPGH20), nab-paclitaxel (A), and gemcitabine (G). Abstract 12030. Monday, June 4, 1:15 to 4:45 p.m. CT.

Tumor hyaluronan (HA) as a novel biomarker to taxane therapy in non-small cell lung cancer (NSCLC). Publication only.

A Pilot study of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma: Interim Safety and Efficacy Analysis. Publication only.

Pegvorhyaluronidase alfa (PEPGH20) enhances FOLFIRINOX efficacy in a preclinical model of human pancreatic ductal adenocarcinoma. Publication only.

Affinity histochemical evaluation of hyaluronan accumulation in solid malignancies of the digestive system. Publication only.

About PEGPH20
PEGPH20 (pegvorhyaluronidase alfa) is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies. In January, Halozyme announced the positive topline results as of December 2016 of its randomized phase 2 HALO-202 study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine chemotherapy in metastatic pancreatic cancer. In the study, PEGPH20 met key endpoints, including in the targeted HA-High patient population.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

On June 1, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that four posters will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Karyopharm, JUN 1, 2018, View Source [SID1234527027]). Among the poster presentations will be clinical results from the Phase 2 portion of the Company’s Phase 2/3 SEAL study evaluating selinexor, its lead, oral SINE compound, in patients with advanced unresectable dedifferentiated liposarcoma. The remaining posters will highlight data from ongoing investigator-sponsored trials evaluating selinexor in combination with approved anti-cancer agents in hematologic and solid tumor malignancies.

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"In the Phase 2 portion of the SEAL study, patients treated with oral selinexor achieved progression-free survival (PFS) of 5.5 months, compared to 2.7 months for placebo-treated patients, an increase of 2.8 months," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Dedifferentiated liposarcoma is particularly difficult to treat because it is resistant to both standard chemotherapy and radiation and there is a significant unmet need for therapies with a novel mechanism that can help these patients with few effective treatment options. The Phase 3 portion of the SEAL study is currently ongoing and we are anticipating top-line data by the end of 2019. Other selinexor data presented at ASCO (Free ASCO Whitepaper) from ongoing investigator-sponsored research continue to highlight early signs of clinical activity and good tolerability when selinexor is combined with approved agents in soft tissue sarcoma (STS) and acute myeloid leukemia (AML), and additional compelling evidence for selinexor’s potential combinability with checkpoint inhibitors, in this case in AML."

Phase 2 Portion of the Phase 2/3 SEAL Study Evaluating Selinexor in Patients with Liposarcoma

In the poster presentation titled, "Phase 2 results of selinexor in advanced dedifferentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study," (Abstract #11512) Mrinal Gounder, MD, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College and lead investigator of the SEAL study, presented detailed clinical data from the successful Phase 2 portion of the randomized, double-blind, placebo-controlled Phase 2/3 SEAL study evaluating oral selinexor (60mg twice weekly) in 56 patients with previously treated, advanced unresectable dedifferentiated liposarcoma (median 2 prior regimens (range 1-9)). Patients on placebo with confirmed progressive disease are permitted to cross over to the selinexor treatment arm.

For the primary endpoint of PFS, oral selinexor showed superiority over placebo, achieving a median PFS of 5.5 months, compared to 2.7 months for placebo with a hazard ratio (HR) of 0.67, representing a 33% reduction in the risk of progression or death. PFS was assessed by Independent Central Radiological Review based on RECIST v1.1. Additional efficacy assessments included PFS by World Health Organization (WHO) response criteria. PFS per WHO criteria achieved a HR of 1.02. Oral selinexor demonstrated an expected and manageable safety profile, primarily with nausea, fatigue, anorexia and weight loss, with low levels of Grade 3/4 cytopenias, and no new or unexpected safety signals identified. The majority of treatment-related adverse events (AEs) were low grade and reversible with dose modifications and/or standard supportive care. These data from the Phase 2 portion of the SEAL study, which is now complete, demonstrate that treatment with selinexor improves PFS (RECIST v1.1) and supports the currently ongoing Phase 3 portion of the study using RECIST v1.1 response criteria [only], and for which top-line data are expected by the end of 2019.

Dr. Gounder stated, "Extending PFS in patients with recurrent, unresectable DDLS is an important clinical goal and these data highlight that oral selinexor continues to demonstrate an expected and manageable safety profile, along with the ability to prolong PFS. We are pleased to share these data with the medical community at ASCO (Free ASCO Whitepaper) this year and look forward to further elucidating selinexor’s efficacy and safety in the already ongoing Phase 3 portion of the SEAL study."

Selinexor in Combination with Immunotherapy or Standard of Care Agents in Other Hematologic and Solid Tumor Malignancies

In the poster presentation titled, "Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)," (Abstract #11562) Eoghan Ruadh Malone, MB BCh, BAO, BA, MSc, MRCPI, Princess Margaret Cancer Centre, presented results from an investigator-sponsored Phase 1b clinical study evaluating selinexor in combination with doxorubicin in 17 patients with locally advanced or metastatic STS. Disease subtypes included leiomyosarcoma (n=6), undifferentiated pleomorphic sarcoma (n=3), liposarcoma (n=2), malignant peripheral nerve sheath tumor (n=3) and other sarcomas (n=3). Preliminary data from this study show that the combination of selinexor plus doxorubicin has a manageable tolerability profile, along with early signals of anti-tumor activity, including partial responses (n=3). Median time on treatment is 20 weeks. Enrollment in the study is ongoing.

In the poster presentation titled, "Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia," (Abstract #7048) Bhavana Bhatnagar, DO, Ohio State University Comprehensive Cancer Center, presented results from an investigator-sponsored Phase 1 clinical study evaluating selinexor in combination with mitoxantrone, etoposide and cytarabine (MEC) in patients with relapsed or refractory AML. Of the 23 evaluable patients, ten responded for an overall response rate of 44%, including six patients (26%) achieving complete remission (CR), two patients (9%) achieving CR with incomplete count recovery (CRi), and two patients (9%) achieving a morphologic leukemia-free state (MLFS). The tolerability of this combination regimen was similar to cytotoxic chemotherapy alone. The most common Grade ≥3 adverse events were febrile neutropenia (48%), catheter related infection (26%), diarrhea (26%), hyponatremia (22%), sepsis (22%), fatigue (13%), hyperglycemia (13%), and hypotension (13%). The RP2D of selinexor in in this combination regimen was established to be 60mg twice weekly. Six responders proceeded to allogeneic stem cell transplantation without evidence of AML at the time of transplant.

In the poster presentation titled, "Profiling the immune checkpoint pathway in acute myeloid leukemia," (Abstract #7015) Paola Dama, PhD, University of Chicago, presented results from an investigator-sponsored study assessing the expression of immune checkpoint biomarkers in AML patients treated with the combination of selinexor, high-dose cytarabine (HiDAC) and mitoxantrone. Data from this study demonstrated high level expression of Gal9 in CD34- cells at diagnosis in patients who failed induction chemotherapy, compared to those in complete remission. There was no difference in PD-L1 expression between the two patient groups. Increased expression of Tim 3 on CD4 and CD8 T cells and high PD-1 in peripheral CD4+ T cell were observed at disease remission suggesting an exhausted immune status at the time of disease remission on the selinexor + HiDAC + mitoxantrone combination, which the researchers believe could be targeted with the addition of checkpoint inhibitors.

Details for the ASCO (Free ASCO Whitepaper) 2018 selinexor presentations are as follows:

Company-sponsored Trials

Title:Phase 2 results of selinexor in advanced de-differentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study
Lead author:Mrinal Gounder, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Poster Board #: 257
Abstract #: 11512
Poster Discussion Session: Sarcoma
Poster Discussion Presenter:Mark Andrew Dickson
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT; Discussion from 3:18 – 3:30PM CT
Location: Hall A

Investigator-sponsored Trials

Title:Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia
Lead author:Bhavana Bhatnagar, Ohio State University Comprehensive Cancer Center
Poster Board #: 108
Abstract: 7048
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title:Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)
Lead author: Eoghan Ruadh Malone, Princess Margaret Cancer Centre
Poster Board #: 307
Abstract: 11562
Poster Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title:Profiling the immune checkpoint pathway in acute myeloid leukemia
Lead author:Paola Dama, University of Chicago
Poster Board #: 75
Abstract: 7015
Poster Discussion Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT; Discussion from 11:30 AM – 12:45 PM CT
Location: Hall A

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On June 1, 2018 LabCorp (NYSE: LH), a leading global life sciences company, and Unilabs, a leading European provider of clinical laboratory testing and medical diagnostic imaging services, reported a strategic collaboration to provide expanded global development and delivery of companion diagnostics (Press release, LabCorp, JUN 1, 2018, View Source;p=RssLanding&cat=news&id=2352738 [SID1234527046]). This collaboration broadens the network of laboratories used by biopharmaceutical companies to support companion diagnostic development and commercialization. The purpose of the collaboration is to expand access to commercialization channels for companion diagnostics in North America and Europe, and accelerate the adoption of companion diagnostics. The companies will use globally harmonized processes to simplify the technical, regulatory and clinical complexities associated with these critical assays. The companies expect the first application of these processes will be in oncology, particularly immuno-oncology.

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This press release features multimedia. View the full release here: View Source

LabCorp, an established leader in the development and commercialization of companion diagnostics, processes more than 2.5 million patient specimens per week, collected from clinician offices and hospitals and via its own network of nearly 2,000 patient service centers, more than 5,000 in-office phlebotomists and a growing retail presence. Unilabs, a European leader, has more than 230 laboratories in 15 countries and 350 customer service locations, and processes more than 188 million diagnostic tests each year.

The collaboration will initially focus on the commercial availability of assays that have been developed and validated both analytically and clinically by LabCorp and Covance, LabCorp’s drug development business. Terms of the agreement have not been disclosed.

"Companion diagnostics are an essential component of precision medicine, enabling physicians to identify the patients who are most likely to benefit from targeted and novel therapies," said David P. King, LabCorp chairman and CEO. "With this collaboration, we are capitalizing on the scientific and operational strengths of two leaders in companion diagnostics to benefit biopharmaceutical clients who need global solutions for precision medicine, with the ultimate goal of improving health and improving lives for patients around the world."

"Our collaboration with LabCorp addresses the need for global harmonization and combined capabilities, including scientific expertise, operational excellence and timely availability of high-quality companion diagnostic services," said Unilabs CEO, Jos Lamers. "With our extensive laboratory network and geographical footprint, we enable clients to accelerate their precision medicine development and commercialization efforts. Our combined ability to bridge the time gaps between development phase and drug approval, and to national reimbursement, by offering a centralized laboratory testing facility, gives our respective customers the advantage of early adoption of their drug. The intimate knowledge of local testing standards, regulatory and quality requirements and navigating logistical challenges will ensure instant access to high-quality testing. This facilitates embracing of a new test in the clinic thereby removing critical barriers for a new treatment."