On August 6, 2015 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, provided a corporate update and reported financial results for the second quarter ended June 30, 2015 (Press release, Acceleron Pharma, AUG 6, 2015, View Source [SID:1234507052]).

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"In the second quarter, we presented promising new longer-term treatment data from our luspatercept programs. These results further reinforce our excitement about the potential of luspatercept to help patients with myelodysplastic syndromes and beta-thalassemia. We and our collaboration partner, Celgene, look forward to starting pivotal trials in both of these indications by the end of this year," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "At Acceleron, we remain focused on bringing innovative therapies to patients, and we are continuing to advance and expand our earlier stage pipeline as well. We have scheduled our first Research and Development Day for investors on October 23, 2015. At that meeting, we will review our clinical and preclinical programs, including a first look at top-line data from the phase 1 trial with our candidate muscle agent, ACE-083."

Recent Highlights and Current Updates

Development Programs

Hematology

Completed enrollment and treatment in the luspatercept phase 2 dose escalation study in myelodysplastic syndromes (MDS) – Enrollment and treatment ongoing in the phase 2 dose escalation beta-thalassemia study.

Long-term phase 2 extension studies ongoing with luspatercept in both MDS and beta-thalassemia – Patients who completed their 3-month treatment in the MDS or beta-thalassemia dose escalation studies were eligible to enroll in the 12-month MDS or beta-thalassemia extension study. Enrollment in the MDS extension study is complete and enrollment in the beta-thalassemia extension study is ongoing.

Presented luspatercept phase 2 data supporting the advancement to phase 3 clinical trials at the European Hematology Association (EHA) (Free EHA Whitepaper)’s annual meeting – In lower risk MDS patients, which represent a large majority of patients affected by the disease, longer-term treatment with luspatercept led to sustained increases in hemoglobin levels and transfusion independence. In both transfusion and non-transfusion dependent beta-thalassemia patients, luspatercept generated durable increases in hemoglobin levels, reductions in transfusion burden and improvements in iron overload. Based on these promising data, Acceleron and Celgene are advancing luspatercept to phase 3 clinical trials in MDS and beta-thalassemia.

Luspatercept granted Fast Track designations for beta-thalassemia – The United States Food and Drug Administration (FDA) has granted Fast Track Designations to luspatercept for two separate indications—the use of luspatercept for the treatment of patients with transfusion dependent beta-thalassemia and the use of luspatercept for the treatment of patients with non-transfusion dependent beta-thalassemia.

Oncology

Presented preliminary renal cell carcinoma (RCC) phase 2 data showing that the combination of dalantercept and axitinib generated encouraging, progression-free survival – In 2nd through 4th line RCC patients, the aggregate median progression-free survival (PFS) rate for the combination of dalantercept and axitinib across all three dose levels of dalantercept tested was 8.3 months. The median PFS has not yet been reached for the 0.9 mg/kg dose group, which has been chosen as the dose level for the randomized Part 2 stage of this study.

Muscle Diseases

Completed enrollment and treatment in ACE-083 phase 1 clinical trial – The phase 1 study of ACE-083, a therapeutic candidate designed to selectively increase muscle mass and strength in the muscle into which it is administered, has completed enrollment and treatment in healthy volunteers.
Advanced and expanded pipeline – Acceleron is advancing several promising preclinical programs, particularly those designed to increase muscle mass and strength. Our goal is to advance a fifth, internally discovered therapeutic candidate into clinical trials by the end of 2016.

Upcoming Milestones and Events

Phase 3 clinical trials with luspatercept in MDS and beta-thalassemia expected to start by year-end – Acceleron and Celgene plan to initiate pivotal programs for luspatercept in beta-thalassemia and MDS by year-end.

Acceleron Research and Development (R&D) Day scheduled for Friday October 23, 2015 – Acceleron will hold its first R&D Day on Friday morning, October 23, 2015 in New York City.

ACE-083 phase 1 clinical data – Preliminary, top-line data from the ACE-083 phase 1 clinical trial will be presented at the Acceleron R&D Day on October 23.

Data from a new preclinical muscle program expected to be presented at the World Muscle Society annual meeting – Acceleron plans to present data from a new preclinical program, ACE-2494, at the World Muscle Society’s 20th International Congress in Brighton, UK, which runs from September 30 to October 4, 2015.

Financial Results

Cash Position – Cash, cash equivalents and investments as of June 30, 2015 were $156.6 million. As of December 31, 2014 the company had cash and cash equivalents of $176.5 million. Acceleron expects that its cash, cash equivalents and investments as of June 30, 2015 will be sufficient to fund the Company’s operations into the second half of 2017.

On August 6, 2015 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported financial results for the second quarter ended June 30, 2015 and provided an update on the Company’s corporate and clinical development activities (Press release, ChemoCentryx, AUG 6, 2015, View Source [SID:1234507084]).

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"We continued to execute on all of our planned initiatives during the quarter and remain on track to deliver on several key milestones during 2015. We are particularly excited about the progress in our orphan and rare diseases program with our lead drug candidate, CCX168," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Both the CLEAR and CLASSIC Phase II trials of CCX168 in patients with ANCA-associated vasculitis reached significant enrollment milestones, and we also initiated an important proof-of-concept trial in patients with atypical Hemolytic Uremic Syndrome. Further, in the immuno-oncology area, we have completed the first part of a two-part clinical trial of CCX872 in patients with advanced pancreatic cancer and we look forward to reporting early results from this trial by year-end."

Recent Pipeline Developments Across Key Therapeutic Areas

Orphan and Rare Diseases: CCX168 is one of the Company’s lead drug candidates. It is an orally-administered inhibitor of the complement C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical Hemolytic Uremic Syndrome (aHUS). These are severe and often fatal autoimmune diseases that are characterized by inflammation that can negatively affect many different areas of the body.

Patient enrollment was completed in the European Phase II CLEAR clinical trial of CCX168 in AAV;
Additionally, patient enrollment in the Phase II CLASSIC trial in North America of CCX168 in AAV reached the halfway mark, per plan;

A Phase II proof-of-concept clinical trial was initiated for the treatment of aHUS in patients with end stage renal disease with CCX168;

Data demonstrating the anti-thrombogenic effect of CCX168 in serum from patients with aHUS were presented at the 52nd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress in London; and
ChemoCentryx collaborators presented data supporting the biological mechanism of C5a inhibition and the resultant anti-thrombotic effect in aHUS by showing that, in serum, CCX168 blocks aHUS induced up-regulation of Von Willebrand factor (VWF) on human microvascular endothelial cells at the 15th European Meeting on Complement in Human Disease in Uppsala, Sweden.
Chronic Kidney Disease: CCX140, an inhibitor of the chemokine receptor known as CCR2 and one of the Company’s lead drug candidates, is being developed as an orally administered therapy for the treatment of diabetic nephropathy, a form of chronic kidney disease.

Positive clinical results from the Phase II trial in patients with diabetic nephropathy treated with CCX140 were presented at the 52nd ERA-EDTA Congress in London in a late breaking oral presentation.

Immuno-Oncology: CCX872, a potent and selective inhibitor of the chemokine receptor known as CCR2, is being evaluated in patients with non-resectable pancreatic cancer.

Patient enrollment advanced in the clinical trial of non-resectable pancreatic cancer treated with CCX872; Part A of the trial has completed and enrollment in Part B has commenced. The two-part trial is evaluating if the combination of CCX872 and FOLFIRINOX, one of the current standard of care treatments for advanced pancreatic cancer, can promote a more effective anti-tumor response in these patients than standard care treatment alone.

Anticipated Milestones

Orphan and Rare Diseases:

Report top-line data by the end of 2015 from the Phase II CLEAR trial in patients with AAV treated with CCX168, which is being conducted in Europe;
Continue enrollment in the Phase II CLASSIC trial in AAV in North America, and report top-line data in the first half of 2016;
Plan for an End of Phase II meeting in 2016 and, with positive CLEAR and CLASSIC Phase II results, initiate Phase III trial in patients with AAV by the end of 2016; and
Report initial results from the CCX168 Phase II proof-of-concept trial in patients with aHUS by the end of 2015.

Chronic Kidney Disease:

Present additional study results from the CCX140 Phase II trial in diabetic nephropathy at subsequent medical meetings and in peer-reviewed publications during the year;
Continue design of Phase III trials and preparation for Phase III development; and
Prepare for an End of Phase II meeting with the FDA.
Immuno-Oncology:

Continue to advance the pancreatic cancer trial of CCX872 in combination with FOLFIRINOX and report early results by the end of 2015; and
Present preclinical results from the combination therapy of chemokine receptor and check point inhibitors in the fourth quarter of 2015.

Second Quarter 2015 Financial Results

Research and development expenses were $8.6 million for the three months ended June 30, 2015 compared to $9.0 million reported for the same period in 2014. The decrease in research and development expenses from 2014 to 2015 were primarily attributable to lower expenses associated with CCX140, the Company’s CCR2 inhibitor, due to the completion of the Phase II clinical trial in patients with diabetic nephropathy in the fourth quarter of 2014 and CCX507, the Company’s second generation CCR9 inhibitor, due to the completion of Phase I clinical development in the third quarter of 2014. These decreases were partially offset by higher expenses associated with CCX168, the Company’s C5aR inhibitor, due to continuing patient enrollment in the third and final step of the CLEAR Phase II clinical trial in Europe and the CLASSIC Phase II clinical trial in North America for the treatment of AAV. Further, the commencement of enrollment in Phase II proof of concept clinical trials in patients with Immunoglobulin A nephropathy, or IgAN and aHUS and costs associated with initiating a Phase Ib clinical trial with CCX872, the Company’s second generation CCR2 inhibitor, in patients with pancreatic cancer in the second quarter of 2015 contributed to the increase.

General and administrative expenses were $3.6 million for the three months ended June 30, 2015 compared to $3.4 million for the comparable period in 2014. The increase in general and administrative expenses from 2014 to 2015 was primarily due to increases in stock based compensation expense for stock option grants and restricted stock unit awards and professional service expenses.

Net loss was $12.1 million for the second quarter ended June 30, 2015 compared to $12.3 million in the same period in 2014.

Total shares outstanding at June 30, 2015 were approximately 44.1 million shares.

Cash, cash equivalents and investments totaled $94.2 million at June 30, 2015.

(Filing, 10-Q, GlycoMimetics, AUG 6, 2015, View Source [SID:1234507092])

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On August 6, 2015 Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported business highlights and financial results for the second quarter ended June 30, 2015 (Press release, Agios Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076543 [SID:1234507053]).

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"In the first half of 2015, we continued to drive rapid and meaningful progress across our development programs, as well as selecting our fourth molecule for development, AG-881, and advancing it into two Phase 1 studies," said David Schenkein, M.D., chief executive officer of Agios. "Additionally, we recently initiated DRIVE PK, a Phase 2 study of AG-348 in PK deficiency patients, and are on track to initiate two global, registration-enabling Phase 3 studies of AG-221 and AG-120 in patients with acute myeloid leukemia in the next six to 12 months. These efforts bring us closer to our goal of being a late-stage biopharmaceutical company capable of changing the treatment paradigm for people with cancer and rare genetic disorders."

KEY UPCOMING MILESTONES

Agios anticipates the following milestones from its IDH clinical development programs in collaboration with Celgene:

AG-221: a first-in-class, oral, selective, potent inhibitor of the mutated IDH2 protein

Initiate a global Phase 3 registration-enabling study in relapsed/refractory acute myeloid leukemia (AML) patients who harbor an IDH2 mutation by the end of 2015.

Initiate combination trials to evaluate AG-221 as a potential frontline treatment for patients with AML who harbor an IDH2 mutation by the end of 2015.

AG-120: a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein

Begin combination trials to evaluate AG-120 as a potential frontline treatment for AML patients who harbor an IDH1 mutation by the end of 2015.

Initiate a global registration-enabling Phase 3 study in AML patients who harbor an IDH1 mutation in the first half of 2016.
Present data on the ongoing Phase 1 study of AG-120 in IDH1 mutant-positive advanced solid tumors at a medical meeting in the fourth quarter of 2015.

RECENT DEVELOPMENT UPDATES IN CANCER METABOLISM

Agios has provided the following updates on its clinical development programs in collaboration with Celgene:

AG-221

New data from the dose-escalation phase and expansion cohorts from the ongoing Phase 1 study evaluating single agent AG-221 were presented in June at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Read the full AG-221 data here.
As of July, Agios completed the dose-escalation portion of the Phase 1 study of AG-221 in IDH2 mutant-positive hematologic malignances. The expansion cohorts are on track, including the fifth expansion cohort of 125 patients with IDH2 mutant-positive AML who are in second or later relapse, refractory to second-line induction or re-induction treatment, or have relapsed after allogeneic transplantation.

Dose escalation continues in the Phase 1/2 trial in patients with advanced solid tumors and angioimmunoblastic T-cell lymphoma (AITL) who carry an IDH2 mutation.

AG-120

New data from the dose-escalation phase of the ongoing Phase 1 study evaluating single agent AG-120 in advanced hematologic malignancies were presented in June at EHA (Free EHA Whitepaper). Read the full AG-120 data here.

Also announced in June, the U.S. Food and Drug Administration (FDA) granted Agios orphan drug designation for AG-120 for the treatment of patients with IDH1 mutant-positive AML.

In May, Agios announced that the FDA granted Fast Track designation to AG-120 for the treatment of patients with IDH1 mutant-positive AML.

As of July, Agios completed the dose-escalation portion of the Phase 1 study of AG-120 in IDH1 mutant-positive hematologic malignances. The three expansion cohorts to evaluate AG-120 in 175 patients with IDH1-mutated advanced hematologic malignancies, including one cohort with 125 patients with relapsed and/or refractory AML, are on track.
AG-881: a brain-penetrant, first-in-class, oral, potent pan-inhibitor of the mutated IDH1 and IDH2 proteins

In June, Agios announced that the first patient was dosed in a Phase 1, open-label, dose-escalation and expansion study of single agent AG-881 in patients with IDH mutant-positive advanced solid tumors, including gliomas.
In August, the first patient was dosed in a second dose-escalating and expansion trial for patients with IDH mutant-positive advanced hematologic malignancies, whose cancer has progressed on a prior IDH inhibitor therapy.

RECENT DEVELOPMENT UPDATES IN RARE GENETIC METABOLIC DISORDERS

AG-348: a novel, first-in-class, oral activator of pyruvate kinase-R (PKR) for the treatment of pyruvate kinase (PK) deficiency

In June, final data from the Phase 1 multiple-ascending dose (MAD) study in healthy volunteers were presented at EHA (Free EHA Whitepaper), establishing clear proof-of-mechanism for AG-348. Read the full AG-348 data, as well as data from Boston Children’s natural history study, here.

Also in June, Agios initiated DRIVE PK, a global Phase 2, open-label safety and efficacy trial in adult, transfusion-independent patients with PK deficiency. The first patient was dosed in July.

CORPORATE UPDATE

Agios plans to host and webcast an investor event in October 2015 in an effort to provide background and education on the novel programs it is targeting and the diseases the company aims to treat. Additional details will be provided in the coming weeks.

SECOND QUARTER 2015 FINANCIAL RESULTS

Cash, cash equivalents and marketable securities as of June 30, 2015 were $434.0 million, compared to $467.4 million as of December 31, 2014. The decrease was driven by cash expenditures for operating activities of approximately $64.9 million, which was offset by cash received from Celgene of approximately $43.3 million during the six months ended June 30, 2015 related to our collaboration agreements.

Collaboration revenue was $13.2 million for the second quarter of 2015, compared to $8.4 million for the comparable period in 2014. The increase reflects revenues recognized under the company’s collaboration agreements with Celgene, including $8.8 million related to the delivery of the U.S. and ex-U.S. licenses for AG-881.

Research and development (R&D) expense was $36.4 million, including $4.6 million of stock- based compensation expense in the second quarter of 2015, compared to $22.6 million, including $1.4 million in stock-based compensation expense for the comparable period in 2014. The increase in R&D expense was primarily due to increased costs to support advancement of the company’s lead investigational medicines toward later-stage development.

General and administrative (G&A) expense was $8.9 million, including $3.6 million of stock-based compensation expense, in the second quarter of 2015, compared to $4.2 million, including $1.0 million of stock-based compensation expense, for the comparable period in 2014. The increase in G&A expense was largely due to increased headcount and other professional expenses to support growing operations.

Net loss for the second quarter of 2015 was $31.9 million, compared to net loss of $18.3 million for the comparable period in 2014.

ADJUSTED FINANCIAL GUIDANCE FOR THE FULL YEAR 2015

Today Agios raised its previous year end cash guidance and now expects to end 2015 with more than $350.0 million of cash, cash equivalents and marketable securities. The anticipated year end 2015 cash position does not include any additional program-specific milestone payments. Agios expects that its cash, cash equivalents and marketable securities would be sufficient to fund its operating expenses and capital expenditure requirements until late 2017.

On August 6, 2015 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter ended June 30, 2015, and provided an update on the Company’s clinical development programs for 2015 (Press release, Clovis Oncology, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076802 [SID:1234507085]).

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"This is a very exciting time for our company," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We have completed our first rociletinib NDA and MAA submissions, we are building out our commercial organizations in both the U.S. and E.U., and we are preparing for a potential U.S. launch as early as the end of this year. We are quickly accelerating toward becoming a global commercial biopharmaceutical organization."

Second Quarter 2015 Financial Results

The Company reported no revenues for the second quarter and first half of 2015, compared to $13.6 million for the first quarter and first half of 2014 which consisted of a milestone payment pursuant to its collaboration and license agreement for lucitanib with Les Laboratoires Servier (Servier).

Research and development expenses totaled $60.4 million for the second quarter of 2015 and $117.1 million for the first half of 2015, compared to $28.4 million and $52.6 million for the comparable periods in 2014. The increase in expenses for both the three- and six-month periods is due to the significantly expanded clinical development activities for rociletinib and rucaparib, increased launch planning activities for rociletinib and increased personnel-related expenses associated with the hiring of additional staff to support the Company’s expanded activities.

General and administrative expenses totaled $7.2 million for the second quarter of 2015 and $14.0 million for the first half of 2015, compared to $5.3 million and $10.6 million for the comparable periods in 2014. The year over year increase is primarily due to higher share-based compensation and personnel expense for employees engaged in general and administrative activities, increased facility costs and higher professional service fees.

Net loss attributable to common shareholders was $71.5 million ($2.10 per share) for the second quarter of 2015 and $134.7 million ($3.96 per share) for the first half of 2015, compared to a net loss of $34.8 million ($1.03 per share) and $65.5 million ($1.93 per share) for the comparable periods of 2014. Share-based compensation expense totaled $8.4 million for the second quarter of 2015 and $17.1 million for the first half of 2015.

Clovis had $377.6 million in cash, cash equivalents and available-for-sale securities and approximately 34.1 million outstanding shares of common stock as of June 30, 2015. In July 2015, the Company raised net proceeds of $298.0 million through an offering of 4.1 million shares of common stock.

2015 Key Milestones and Objectives

Highlights of planned or completed objectives for each product follows:

Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M. The T790M mutation develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors.

On July 30, 2015, the Company submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014. Clovis also submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the same indication. There is a validation period before both applications are formally accepted, after which the review commences.

The U.S. and E.U. regulatory submissions include data from two single-arm studies, TIGER-X and TIGER-2. During the second quarter, updated findings from the TIGER-X study, evaluating the safety and activity of rociletinib in a very advanced EGFR-mutant NSCLC patient population were presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Highlights of the data presented included the following:

60% overall response rate (ORR) and 90% disease control rate (DCR) in heavily pretreated centrally confirmed tissue T790M-positive patients at the 500mg BID dose

Median progression free survival (PFS) of 10.3 months observed in patients without a history of CNS metastases; median PFS of 8 months observed in an overall population of 270 heavily pretreated centrally confirmed tissue T790M-positive patients, including 40% of patients with a history of CNS metastases

37% ORR in centrally confirmed tissue T790M-negative patients

57% ORR and 80% DCR in centrally confirmed plasma-genotyped T790M-positive patients – may allow for broader testing for mutations in patients ineligible for tissue biopsy

Well-tolerated; the most frequent adverse reactions or lab abnormalities reported were diarrhea, nausea, fatigue, QTc prolongation and hyperglycemia; the only Grade 3 adverse reaction or lab abnormality reported in greater than 5% of patients was hyperglycemia

Rucaparib

Rucaparib is an oral, potent small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as "BRCA-like."

In April 2015, Clovis was granted its second Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA), in this case for rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

Also during the second quarter, updated findings from ARIEL2 and Study 10, two ongoing studies evaluating the safety and activity of rucaparib in advanced ovarian cancer patients, were presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data from these studies demonstrated encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with gBRCA and sBRCA mutations. In addition, these data demonstrated that the application of Clovis’ proprietary BRCA-like tumor DNA signature to Foundation Medicine’s companion diagnostic assay successfully predicts the population of BRCA-like patients that are not gBRCA or sBRCA that respond to rucaparib therapy. Highlights of the data presented included the following (all RECIST response rates):

Data from ARIEL2 in BRCA-mutant patients demonstrated an ORR of 69%, a DCR of 94% and a median PFS of 9.4 months
Complete responses (CRs) observed in 10% of patients
Data from ARIEL2 in patients with the BRCA-like signature demonstrated an ORR of 30%, a DCR of 73% and a median PFS of 7.1 months

Approximately 60% of the 204 patients treated in the initial ARIEL2 study had either BRCA-mutant or BRCA-like tumors
61% ORR and median duration of response greater than 11 months observed in 23 BRCA-mutant patients treated with at least three prior lines of chemotherapy from ARIEL2 and Study 10 combined
CRs observed in 13% of patients in this group

Rucaparib is well-tolerated with a manageable safety profile. The grade 3/4 treatment-related adverse events (AEs) observed in >15% of patients treated with the recommended 600mg BID dose were anemia/decreased hemoglobin (16%) in ARIEL2, and fatigue/asthenia (18%), and anemia (25%) in Study 10

Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFRα-β). Clovis, which holds exclusive U.S. and Japanese rights, is collaborating with its development partner Les Laboratoires Servier (Servier) on the global clinical development of lucitanib outside of China, initially targeting solid tumors with FGFR pathway activation, including breast and lung cancers.

A Phase 2 program is underway to explore lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced lung cancer with FGFR1 amplification, both of which are currently enrolling patients. In parallel with these Clovis-sponsored studies, a Servier-sponsored Phase 2 study of lucitanib in patients with advanced breast cancer is underway to identify the population of patients most likely to benefit from lucitanib therapy. The Company anticipates initial data from its breast cancer study by year-end 2015.