On November 1, 2018 Clinical Genomics, a leading innovator of tests for colorectal cancer, and Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported a 5-year extension to their U.S. supply agreement for the InSure ONE fecal immunochemical test (FIT) (Press release, Clinical Genomics, NOV 1, 2018, View Source [SID1234530506]). This agreement builds upon a long standing collaboration to provide InSure FIT and the new InSure ONE FIT for colorectal cancer screening programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical Genomics manufactures FIT tests, including InSure ONE, which Quest provides to physicians and organized provider groups across the United States. These provider groups include specialized programs to improve screening adherence rates for Accountable Care Organizations (ACOs) and other organizations focused on improving quality metrics under value-based care models. Quest is also an investor in the company. Under the agreement, Quest will continue to offer broad access to both the Insure FIT and Insure ONE FIT products in the U.S.

"We are pleased to continue this important partnership with Quest Diagnostics ensuring that screening programs have broad access to InSure ONE, an easy to use FIT that may lead to improved patient compliance," says Betsy Hanna, Chief Commercial Officer, Clinical Genomics.

"Barriers to screening often delay or prevent early diagnosis," said Kristie Dolan, General Manager, Oncology, Quest Diagnostics. "Insure ONE FIT helps overcome several of these screening barriers to prompt earlier screening. Our collaboration with Clinical Genomics will ensure that patients and providers in the U.S. continue to have broad access to the innovative Insure FIT and the new InSure ONE FIT."

InSure ONE is an FDA 510(k) cleared FIT for detecting blood in stool as an aid in the detection of lower gastrointestinal bleeding. A number of medical conditions may be associated with lower gastrointestinal bleeding, including colorectal cancer, iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, and adenomas.

Unlike other FIT’s, InSure ONE is the only test that is performed using toilet water collected from a single bowel movement. InSure ONE employs a patented brush sampling method which has been preferred by many doctors and patients for more than 15 years. A water sample is collected from the toilet bowel by simply brushing the surface of the stool to release any blood into the surrounding water, rather than having to collect a stool sample or smear feces.

Annual FIT is recommended by the American Cancer Society (ACS) for screening programs to detect the early signs of adenomatous polyps, precursors to cancer, and colorectal cancer. Recently, the ACS updated its recommendations lowering the screening age from 50 to 45 years. FIT, along with colonoscopy, is also recommended as a ‘Tier 1’ preferred test for colorectal cancer screening programs by the U.S. Multi-Society Task Force (MSTF). When considering large, organized colorectal cancer screening programs, the U.S. MSTF also recognizes that given the annual nature of FIT and the performance characteristics of this assay in identifying blood in the stool, FIT is "more effective and less costly" than the use every 3 years of FIT-fecal DNA, approved by FDA specifically for use in colorectal cancer screening.1

Colorectal cancer is the second leading cause of cancer death in the United States, with more than 140,000 people per year expected to be diagnosed with the disease and an estimated 50,000 who will die from it. According to U.S. Preventative Service Task Force recommendations, screening for colorectal cancer in adults who are 50 to 75 years old and at average risk reduces colorectal cancer mortality. Many people, however, are not screened according to guidelines, and studies show aversion to colonoscopy and other methods may factor into decisions not to screen. The disease is often highly treatable when caught in early stages.

Rex DK, et.al. U.S. MSTF Consensus Guideline, Gastroenterology 2017; 153:307-323

On November 1, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported positive progress in the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, with initial results showing bioavailability of the drug in patients (Press release, Moleculin, NOV 1, 2018, View Source [SID1234530522]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Although this data is preliminary, it represents a significant milestone for the development of WP1066," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "In the first two cohorts of the Phase 1 study, we are already seeing measurable levels of the drug in the patient’s plasma resulting from oral administration. Knowing we can deliver drug this way opens the door for further development and expanded clinical activity."

Walter Klemp, Moleculin’s Chairman and CEO added, "We believe WP1066 is a first-in-class compound capable of stimulating a natural immune response in animal models while directly attacking tumors by modulating transcriptional activity and repressing what we call ‘oncogenic transcription factors.’ Chief among these is STAT3, considered a master regulator of tumor progression. While activity in animal models has been very promising, one of the goals of this trial was to determine the potential for bioavailability in humans. The initial positive indications of this clinical trial increase our confidence that WP1066 has the potential to become an important drug in the treatment of certain cancers. The initial demonstration of human bioavilability is an important milestone."

On November 1, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK cells, macrophages and T cells), reported that six abstracts highlighting data from the Company’s innate immune cell and T cell-based therapeutic programs have been accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA (Press release, Affimed, NOV 1, 2018, View Source [SID1234530538]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentations related to Affimed’s CD16A innate immune cells engager programs include 6-month follow-up data from the clinical study of AFM13, Affimed’s lead CD30/CD16A bispecific ROCK antibody, in combination with Merck’s Keytruda (pembrolizumab), interim data from Columbia University on AFM13 in relapsed or refractory CD30-positive lymphoma with cutaneous manifestation including translational data, and preclinical data from The University of Texas MD Anderson Cancer Center on cord blood-derived allogeneic NK cells in combination with AFM13. Additional abstracts on CD16A engagers include updates on the Company’s research on the role of AFM13 activating CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data supporting further development of Affimed’s partnered ROCK-based development candidate AFM26 (BCMA/CD16A) as a promising treatment for patients with multiple myeloma.

Preliminary results, including clinical activity and safety, from a dose escalation trial in relapsed/refractory acute lymphoblastic leukemia for AFM11, Affimed’s CD19 targeting T cell engager, will also be presented.

Full abstracts of the presentations can be accessed on the ASH (Free ASH Whitepaper) website at View Source Details for ASH (Free ASH Whitepaper) presentations are as follows:

Oral Presentation

Abstract: Cord Blood Derived Natural Killer Cells Loaded with a Tetravalent Bispecific Antibody Construct (AFM13) As Off-the-Shelf Cell Therapy for CD30+ Malignancies

Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Immunologic approaches

Date and Time: Sunday, December 2, 2018 9:30 AM – 11:00 AM

Location: San Diego Convention Center, Room 28D

Poster Presentations

Abstract: A Phase 1b Study Investigating the Combination of the Tetravalent Bispecific NK Cell Engager AFM13 and Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster II

Date and Time: Sunday, December 2, 2018 6:00 PM – 8:00 PM

Location: San Diego Convention Center, Hall GH

Abstract: CD16A-Specific Tetravalent Bispecific Immune Cell Engagers Potently Induce Antibody-Dependent Cellular Phagocytosis (ADCP) on Macrophages

Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: Preclinical Characterization of AFM26, a Novel B Cell Maturation Antigen (BCMA)-Directed Tetravalent Bispecific Antibody for High Affinity Retargeting of NK Cells Against Myeloma

Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: A Phase 1 Study Investigating AFM11 in Patients with Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia: Preliminary Results

Session: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Poster III

Date and Time: Monday, December 3, 2018 6:00 PM – 8:00 PM

Location: San Diego Convention Center, Hall GH

On November 1, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for third-quarter 2018 and provided an update on the Company’s commercial products and development programs (Press release, TESARO, NOV 1, 2018, View Source [SID1234530565]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter, we launched several initiatives to grow the use of ZEJULA for recurrent ovarian cancer and we continued to execute on our development strategies focused on gynecologic and lung cancers as we approach a period of significant data readouts," said Lonnie Moulder, CEO of TESARO. "Following results of the Phase 3 PRIMA trial next year, we intend for ZEJULA to benefit patients throughout all stages of their ovarian cancer journey, including first-line, recurrent, and late-line treatment settings. Our immuno-oncology pipeline continues to advance, led by our anti-PD-1 antibody, TSR-042, for which we are on track to submit a BLA next year. We look forward to initial data from the Phase 1 AMBER trial of our anti-TIM-3 antibody, TSR-022, in combination with TSR-042, which will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting next week."

Recent Business Highlights

ZEJULA net revenue increased 61% year-over-year to $63.2 million for the third quarter of 2018. In the U.S. and Europe, approximately 10,000 patients have been treated with ZEJULA since its launch in April 2017. ZEJULA is now approved in 33 countries and is reimbursed and launched in Germany, the U.K., Italy and several other European countries.
Safety data were presented from the Phase 3 PRIMA trial of ZEJULA monotherapy in first-line ovarian cancer during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in October. Data demonstrated a favorable tolerability profile for niraparib when dosed according to a patient’s weight and platelet count compared to a fixed starting dose. The PRIMA Phase 3 trial is fully enrolled and top-line results are expected in late 2019.
Based upon the responses observed in the first stage of the study, the second stage of the Phase 2 JASPER study was initiated, which evaluates ZEJULA in combination with TSR-042 as a first-line treatment for patients with non-small cell lung cancer and high levels of PD-L1 expression.
Data were presented from the GARNET trial of TSR-042 monotherapy at ESMO (Free ESMO Whitepaper) and demonstrated TSR-042 is well tolerated and has robust clinical activity in patients with MSI-H endometrial cancer.
Zai Lab Limited announced ZEJULA approval in Hong Kong on October 22, 2018. ZEJULA is the first and only PARP inhibitor approved in Hong Kong for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA mutation status.
In October, TESARO and actress Cobie Smulders launched Not on My Watch, a national movement to empower the ovarian cancer community, especially women with recurrent ovarian cancer, to take informed and proactive steps against the threat of disease recurrence.
Development milestones were achieved in October related to Janssen’s ongoing GALAHAD trial of niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. The achievement of these milestones triggered an $18 million payment from Janssen to TESARO.
Third Quarter 2018 Financial Results

TESARO reported net product revenue of $63.6 million for the third quarter of 2018, compared to a total of $41.8 million for the third quarter of 2017. ZEJULA net revenue increased 61% to $63.2 million for the third quarter of 2018, compared to $39.4 million for the third quarter of 2017. Cost of goods sold increased to $14.2 million for the third quarter of 2018, compared to $6.2 million for the same period in 2017, primarily related to increased volume and new supplier set-up expenses.

Research and development expenses increased to $94.2 million for the third quarter of 2018, compared to $73.4 million for the third quarter of 2017, driven primarily by higher manufacturing and clinical development costs associated with TSR-042, TSR-022, and ZEJULA, and research collaborations.

Selling, general and administrative expenses increased to $93.5 million for the third quarter of 2018, compared to $84.0 million for the third quarter of 2017, primarily due to increased headcount and activities in support of the launches of ZEJULA in the U.S. and Europe.

Operating expenses as described above include total non-cash, stock-based compensation expense of $24.8 million for the third quarter of 2018, compared to $25.0 million for the third quarter of 2017.

Net loss totaled $137.1 million, or ($2.49) per share, for the third quarter of 2018, compared to a net loss of $25.3 million, or ($0.47) per share, for the third quarter of 2017. The increase in net loss was primarily due to the $100.0 million up-front payment received and recorded as revenue in the third quarter of 2017 as part of the license agreement with Takeda, partially offset by a $17.6 million gain in the third quarter of 2018 associated with the divestiture of VARUBI in the U.S., for which TESARO received an up-front payment of $35 million.

(in thousands, except per share amounts) Three Months Ended
September 30,
2018
2017

Product revenue, net
ZEJULA $ 63,226 $ 39,375
VARUBI/VARUBY $ 386 $ 2,380
Total product revenue, net $ 63,612 $ 41,755
License, collaboration, and other revenue $ 787 $ 101,011
Total revenues $ 64,399 $ 142,766

Net loss $ (137,088 ) $ (25,277 )

Net loss per share, basic and diluted $ (2.49 ) $ (0.47 )

(in thousands) Three Months Ended
September 30,
2018 2017
Cost of sales – product $ 14,225 $ 6,216
Cost of sales – intangible asset amortization $ 728 $ 1,254
Research and development (R&D) $ 94,188 $ 73,388
Selling, general and administrative (SG&A) $ 93,497 $ 83,998
Acquired in-process R&D $ - $ -
Cash and Cash Equivalents

As of September 30, 2018, TESARO had approximately $476.8 million in cash and cash equivalents and approximately 55.0 million outstanding shares of common stock.

2018 Financial Guidance

TESARO is updating its 2018 financial guidance for ZEJULA:

Total Revenue, net, worldwide (FY) $258 to $265 million
(previously $250 to $265 million)
ZEJULA (FY) $233 to $238 million
(previously $225 to $235 million)
ZEJULA (Q4) $67 to $72 million
Other revenue, including licensing and
VARUBY oral (FY) $25 to $27 million
(previously $25 to $30 million)
Interest expense (FY) Approximately $60 million,
including non-cash interest expense of $14 million
In the third quarter, TESARO’s cash and cash equivalents balance declined by approximately $98 million. TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million.

Key Development Milestones

Gynecologic Cancers:

Submit QUADRA sNDA for treatment of late-line ovarian cancer beyond BRCAmut near year-end
Results of the AVANOVA Phase 2 study of ZEJULA in combination with bevacizumab for treatment of recurrent ovarian cancer to be submitted for presentation at a medical meeting in 1H 2019
Report Phase 2 OVARIO results of ZEJULA in combination with bevacizumab in first-line ovarian cancer maintenance in late 2019
Report Phase 3 PRIMA results of ZEJULA in first-line ovarian cancer maintenance in late 2019
Lung Cancer:

Report initial data for the AMBER trial of TSR-022 in combination with TSR-042 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting on November 9
Report additional data from the NSCLC cohort of the GARNET trial of TSR-042 at SITC (Free SITC Whitepaper)
Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019
Report additional data from the Phase 2 JASPER study of ZEJULA in combination with anti-PD-1 at a medical meeting in 1H 2019
Breast Cancer:

Submit BRAVO data for ZEJULA in germline BRCAmut breast cancer patients for publication in Q4 2018
Complete protocol development for registration study of ZEJULA in combination with TSR-042 and other agents in breast cancer
Prostate Cancer:

Janssen to advance GALAHAD trial of ZEJULA in mCRPC and DNA-repair anomalies to support global regulatory filings in 2019
Planning underway by Janssen for a future Phase 3 trial that will assess the clinical benefit of niraparib in combination with abiraterone acetate + prednisone in mCRPC patients
Immuno-oncology Pipeline:

Continue dose-escalation in the CITRINO trial (combination of TSR-033 plus TSR-042) and report Phase 1 monotherapy dose-escalation data for TSR-033 at SITC (Free SITC Whitepaper)
Advance IND-enabling studies of PD-1/LAG-3 bi-specific antibody (TSR-075)
Today’s Conference Call and Webcast

TESARO will host a conference call to discuss the Company’s third quarter operating results and provide an update on the Company’s commercial products and development programs today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

About ZEJULA (niraparib)

ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

On November 1, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that an abstract describing data from the expansion of the MARIO-1 Phase 1b Study of IPI-549 in combination with nivolumab in advanced solid tumors has been selected as a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington D.C., November 7 – 11. Details of the presentation are as follows (Press release, Infinity Pharmaceuticals, NOV 1, 2018, View Source [SID1234530631]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: The first clinical/translational data from the expansion cohorts of a Ph1/1b Study of IPI-549, a tumor macrophage-reprogramming small molecule, in combination with nivolumab in advanced solid tumors
Poster Number: P716; Abstract Number: 10767
Poster Presentation Hours: Saturday, November 10, 2018 at 12:20-1:50 p.m. and 7:00-8:30 p.m.
Poster Hall Location: Hall E
Presenting Author: Ryan J. Sullivan, M.D., Massachusetts General Hospital, PI for the MARIO-1 Study

Infinity will also host a reception for investors and analysts on Saturday, November 10, 2018, from 6:30 a.m. to 7:30 a.m. ET to discuss these results. The event will feature David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. There will also be a panel discussion with David Hong, M.D., and, from Infinity Pharmaceuticals, Sam Agresta, M.D., M.P.H., CMO, and Jeffery Kutok, M.D., Ph.D., CSO.

About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.i ii As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with nivolumab (Opdivo) in approximately 200 patients with advanced solid tumors.iii The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.