On January 7, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $142.5 million and $143.5 million for the fourth quarter ended Dec. 31, 2018, an increase of 64 percent from the same quarter of 2017 (Press release, Exact Sciences, JAN 7, 2019, View Source [SID1234532523]). The company completed approximately 292,000 Cologuard tests during the fourth quarter of 2018, which represents 66-percent growth from the same period of 2017.

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For full-year 2018, the company anticipates reporting total revenue between $454 million and $455 million, a year-over-year increase of 71 percent. Completed Cologuard test volume during 2018 was approximately 934,000 tests, a 64-percent increase from 2017.

Nearly 15,000 health care providers ordered Cologuard for the first time during the fourth quarter of 2018. The number of providers who have ordered Cologuard since its launch increased to nearly 147,000 during 2018.

"2018 was a landmark year for Exact Sciences," said Kevin Conroy, chairman and CEO of Exact Sciences. "We helped more than 930,000 people get screened for colorectal cancer, launched a partnership with Pfizer to help bring Cologuard to more patients, and scaled our operations to meet rising demand. Our team continues working hard to deliver life-changing innovations in early cancer detection. In 2019, we expect to open a new clinical lab, integrate Epic software into our operations, and advance our pipeline of liquid biopsy tests."

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2018. The revenue ranges presented in this news release for the fourth quarter of 2018 and for the year ended Dec. 31, 2018 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2018. We are in the process of completing our customary year-end close and review procedures as of and for the year ended Dec. 31, 2018, and there can be no assurance that our final results for this period will not differ from these estimates. During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended Dec. 31, 2018, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2018 financial results and provide guidance during its February 2019 earnings call.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On January 7, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that the Safety Review Committee (SRC) has endorsed dose escalation in the ongoing ADP-A2AFP (AFP) study in patients with hepatocellular carcinoma (liver cancer) to the second dose cohort (Press release, Adaptimmune, JAN 7, 2019, View Source;p=RssLanding&cat=news&id=2382311 [SID1234532522]). The SRC has also endorsed moving to the expansion phase of the ADP-A2M10 (MAGE-A10) lung cancer study.

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Across both studies, most adverse events have been consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies with no evidence of alloreactivity or toxicity related to off-target binding.

In the ADP-A2AFP study, two patients have received 100 million transduced SPEAR T-cells targeting AFP in the first dose cohort, and there was no evidence of hepatotoxicity. The SRC endorsed dose escalation after evaluating the first two patients and taking into consideration the benefit:risk profile observed across programs in Cohort 1.

In the ADP-A2M10 lung cancer study, ten patients have been treated in the first three cohorts (up to six billion transduced cells), and the expansion phase will allow for doses of up to ten billion transduced cells (range 1.2 to 10 billion).

"We are pleased that the SRC has endorsed moving to the expansion phase of the ADP-A2M10 lung cancer study. Additionally, our ADP-A2AFP study has progressed to the next dose level of 1 billion transduced cells. Importantly, we did not observe liver toxicity in the two patients treated at a dose of 100 million transduced cells. In our other studies, we continue to enroll in the expansion phases and, as we previously have said, we are on track to report our next clinical data by May this year," said Rafael Amado, Adaptimmune’s President of Research & Development.

Overview of ADP-A2AFP (AFP) Study Design

This is a first-in-human, open-label study utilizing a modified 3+3 design in up to 36 patients with escalating target doses of 100 million (Cohort 1), 1 billion (Cohort 2), and 1.2‑6 billion (Cohort 3) transduced SPEAR T-cells to evaluate safety, including dose limiting toxicities (DLTs) followed by an expansion phase with doses of up to 10 billion SPEAR T-cells
This trial is being conducted in patients with hepatocellular carcinoma
There was a 21-day stagger between patients in Cohort 1, with this stagger dropping to 7 days in Cohorts 2, and 3 in the absence of DLTs. There is no pre-determined stagger in the expansion phase
Cohorts 1-3 were intended to enroll 3 patients each with an expansion to 6 patients if DLTs were observed
The expansion phase can enroll up to 30 patients
The lymphodepletion regimen is fludarabine (flu) (20mg/m2/day) and cyclophosphamide (cy) (500 mg/m2/day) for 3 days
Efficacy is assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 16, month 6, and then every 3 months until confirmation of disease progression
Overview of ADP-A2M10 (MAGE-A10) Lung Cancer Study Design

This is a first-in-human, open-label study utilizing a modified 3+3 design in up to 28 patients with escalating target doses of 100 million (Cohort 1), 1 billion (Cohort 2), and 1.2‑6 billion (Cohort 3) transduced SPEAR T-cells to evaluate safety, including DLTs followed by an expansion phase with doses of up to 10 billion SPEAR T-cells
This trial is being conducted in patients with non-small cell lung cancer (NSCLC)
There was a 21-day stagger between patients in Cohort 1, with this stagger dropping to 7 days in Cohorts 2, and 3 in the absence of DLTs. There is no pre-determined stagger in the expansion phase
Cohorts 1-3 were intended to enroll 3 patients each with an expansion to 6 patients if DLTs were observed
The expansion phase can enroll up to 10 patients
The lymphodepletion regimen is cyclophosphamide (1800 mg/m2/day) for 2 days in Cohort 1, fludarabine (flu) (30mg/m2/day) and cyclophosphamide (cy) (600 mg/m2/day) for 3 days in Cohort 2, and Cy (600 mg/m2/d) x 3 days + Flu (30 mg/m2/d) X 4 days in Cohort 3
Efficacy is assessed by response rate, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months (for 2 years) and then every 6 months until confirmation of disease progression

On January 7, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2018 results on Thursday, February 14, 2019, before the market opens (Press release, Quest Diagnostics, JAN 7, 2019, View Source [SID1234532521]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-424-7881 for domestic callers or 203-369-0869 for international callers, no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 14, 2019 until midnight Eastern Time on February 28, 2019.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 7, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that it is accelerating its clinical development strategy for AML and MDS and provided updates on clinical candidates CYAD-01 and CYAD-101 with key upcoming milestones for 2019 (Press release, Celyad, JAN 7, 2019, View Source [SID1234532520]).

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"We made progress in 2018 with our CAR-T clinical programs and we believe the Company is poised to achieve a number of important milestones in 2019," noted Dr. Christian Homsy, CEO of Celyad. "We continue to be encouraged by the clinical data observed with CYAD-01 for the treatment of hematological indications. As a result, we are prioritizing the clinical development program of CYAD-01 for the treatment of relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome towards Phase 2 trials."

2019 Milestones

Building upon its 2018 accomplishments, the Company intends to achieve the following key milestones over the next 12 months:

Report additional data from the Phase 1 dose-escalation THINK trial for CYAD-01 in r/r AML or MDS patients, including initial data from the schedule optimization portion of the trial;

Complete enrollment for and report initial data from the Phase 1 dose-escalation DEPLETHINK trial evaluating CYAD-01 with preconditioning chemotherapy in r/r AML or MDS patients;

Accelerate the development strategy and refine the regulatory pathway plan for CYAD-01 for the treatment of r/r AML or MDS patients, including the initiation of a Phase 2 clinical trial;

Present in vivo preclinical data for our proprietary non-gene edited allogeneic shRNA platform and progress towards an Investigational New Drug (IND) application for the program; and

Further evaluate the potential for next-generation autologous and allogeneic NKG2D-based CAR-T therapies in the treatment of solid tumors.

Press Release

07 January 2019

7:00am CET

Clinical Update for CYAD-01 in Hematological Malignancies

Celyad’s lead clinical candidate, CYAD-01, is currently being evaluated in multiple clinical trials for the treatment of patients with hematological malignancies, including r/r AML and MDS.

THINK Phase 1 Trial

In December 2018 at the 60th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, Celyad reported an encouraging objective response rate in r/r AML patients of 38% (three out of eight) from the THINK Phase 1 trial, evaluating CYAD-01 without preconditioning chemotherapy.

Preliminary data for the last two patients enrolled and treated at dose level 3 show one patient with relapsing MDS with refractory anemia with excess blasts achieved a marrow complete response after two injections of CYAD-01, while the second patient with r/r AML experienced disease stabilization after the first cycle of CYAD-01. Both patients plan to receive a second (consolidation) cycle of therapy
.
Additional results from the THINK Phase 1 trial are expected to be announced during the first half of 2019.

Dr. Frédéric Lehmann, Vice President of Clinical Development and Medical Affairs at Celyad, commented, "Current clinical data for the last two patients treated at dose level 3 of the THINK trial provide additional support for the further development of CYAD-01 as a potential treatment of r/r AML and MDS and our decision to rapidly identify the best clinical path forward for the investigational therapy."

DEPLETHINK Phase 1 Trial

In December 2018, Celyad reported initial data from Cohort 1 of the trial, in which the administration of CYAD-01 following the preconditioning regimen of cyclophosphamide and fludarabine was well-tolerated, with no dose-limiting toxicity or treatment-related grade 3 or above adverse events observed. Based on these preliminary safety data from Cohort 1, enrollment has been initiated in Cohort 2 of the trial. Preliminary data from the DEPLETHINK Phase 1 trial are expected in mid-2019.

EPITHINK Phase 1 Trial

Based on the data generated to date for CYAD-01 from the THINK trial and the recent update in the treatment landscape for newly diagnosed AML patients, the Company has put the EPITHINK trial on hold to focus its efforts on the development of CYAD-01 for the treatment of r/r AML patients. Celyad plans to reassess the opportunity for CYAD-01 in newly diagnosed AML patients after the optimal treatment design for the therapy is determined. The EPITHINK Phase 1 dose-escalation trial planned to assess the administration of CYAD-01 concurrently with 5-azacytidine in treatment-naïve and/or elderly AML patients ineligible for intensive treatment.

Press Release

07 January 2019

7:00am CET

Solid Tumor Clinical Program Update

In November 2018 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, the Company reported an interim analysis from the Phase 1 dose-escalation SHRINK trial evaluating the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy (a combination of 5-fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC). Follow-up assessment of patients based on response evaluation criteria in solid tumors (RECIST) from dose level 1 of the trial confirmed one patient achieved a partial response and two patients experienced disease stabilization. Full data from the SHRINK Phase 1 trial are expected in 2019.

In December 2018, Celyad initiated the alloSHRINK trial evaluating the non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable mCRC. To date, no relevant treatment related toxicity has been observed in the first subject enrolled in the trial. Topline data from alloSHRINK trial are expected in the second half of 2019.

About CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signaling of the TCR complex, which is responsible for Graft versus Host Disease (GvHD) and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.

On January 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and Biologics License Application (BLA) submissions to the U.S. Food and Drug Administration (FDA) (Press release, Checkpoint Therapeutics, JAN 7, 2019, View Source [SID1234532508]). These cohorts include:

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• Microsatellite instability-high (MSI-H) endometrial cancer that has progressed following one or two prior anti-cancer therapies;

• Microsatellite stable (MSS) endometrial cancer that has progressed following one or two prior anti-cancer therapies; and

• MSI-H or mismatch repair deficient (dMMR) colorectal cancer that has progressed on or after, or been intolerant of, previous treatments, including a fluoropyrimidine-and oxaliplatin-and irinotecan-based chemotherapy.

Each cohort is evaluating a fixed dose of 800 mg CK-301 every two weeks (Q2W). The primary endpoint for each cohort is objective response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma.

"We are excited to advance our first immuno-oncology drug candidate, CK-301, into these potentially registration-enabling cohorts, representing a significant milestone in the execution of our strategy to obtain multiple accelerated approvals for our anti-PD-L1 antibody," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to presenting interim safety and efficacy data from the ongoing clinical trial in the coming months."

The Phase 1, open-label, multi-center trial is evaluating the safety and tolerability of ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Following completion of dose escalation in 2018, multiple dose expansion cohorts were initiated. Preliminary data from the ongoing trial suggest that CK-301 is safe and well-tolerated across dose levels ranging from 200 mg to 800 mg administered every two weeks and 1200 mg administered every three weeks, with treatment-related adverse events consistent with marketed anti-PD-1/PD-L1 antibodies.

About CK-301
CK-301 is a fully-human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death Ligand-1 (PD-L1) and blocks the PD-L1 interaction with the Programmed Death Receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. CK-301’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response