Adaptimmune Announces Partial Clinical Hold of Planned Pivotal Study of NY-ESO SPEAR® T-cell Therapy in Myxoid Round Cell Liposarcoma

On August 03, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, reported that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma (MRCLS) (Press release, Adaptimmune, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192667 [SID:1234514215]). This trial is not yet active at any investigational sites, and has not recruited any patients. This notification of partial clinical hold does not apply to any other Adaptimmune study.

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The FDA notification is not based on safety concerns. In its correspondence, the FDA requested additional CMC information and answers to certain trial design questions prior to the trial start. Adaptimmune intends to provide a full response to the FDA shortly.

"Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.," said James Noble, Adaptimmune CEO. "We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report."

The company will discuss this notice of partial clinical hold during its conference call to discuss the second quarter ended June 30, 2016, scheduled for 8:00 a.m. Eastern Time (1:00 p.m. BST) on Monday August 8, 2016.

Aduro Biotech Reports Second Quarter 2016 Financial Results

On August 03, 2016 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the second quarter 2016 (Press release, Aduro BioTech, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192550 [SID:1234514210]). Net income for the three months ended June 30, 2016 was $2.3 million, or $0.04 per share, and for the six months ended June 30, 2016 net loss was $26.5 million, or $0.41 per share, compared to a net loss of $26.3 million, or $0.50 per share, and $42.9 million, or $1.61 per share respectively, for the same periods in 2015.

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Cash, cash equivalents and marketable securities totaled $396.9 million at June 30, 2016, compared to $431.0 million at December 31, 2015.

"We are uniquely positioned in the field of immunotherapy with three distinct, proprietary technology platforms, as well as a strong cash position," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "As we continue to advance our programs, we anticipate a number of upcoming milestones across our three platforms, including data from our LADD platform in multiple tumor types, initial clinical results from ADU-S100, our first STING Pathway Activator, and IND-enabling studies for multiple B-select monoclonal antibodies."

Recent Progress

Preclinical data published in Blood highlighting the potential of Aduro’s proprietary monoclonal antibody BION-1301 targeting a proliferation-inducing ligand (APRIL) for the treatment of multiple myeloma
Initiated a Phase 1 clinical trial of ADU-S100, the first STING Pathway Activator compound to enter the clinic, for the treatment of cutaneously accessible tumors
Reported results from the Phase 2b ECLIPSE trial in pancreatic cancer
Reported data from the Phase 1b clinical trial in mesothelioma at ASCO (Free ASCO Whitepaper) 2016
Second Quarter 2016 Financial Results

Revenue was $39.0 million for the second quarter of 2016 and $43.0 million for the six months ended June 30, 2016, compared to $9.9 million and $19.5 million, respectively, for the same periods in 2015. The increase was primarily due to the receipt of a $35.0 million milestone payment from Novartis in connection with the initiation of the Phase 1 ADU-S100 trial in the second quarter of 2016.

Research and development expenses were $26.9 million for the second quarter of 2016 and $47.8 million for the six months ended June 30, 2016, compared to $13.5 million and $24.2 million, respectively, for the same periods in 2015. This increase was primarily due to clinical development expenses associated with our ongoing trials in pancreatic cancer, ovarian cancer and mesothelioma, including manufacturing and personnel costs.

General and administrative expenses were $8.7 million for the second quarter of 2016 and $17.7 million for the six months ended June 30, 2016, compared to $5.9 million and $12.1 million, respectively, for the same periods in 2015. This increase was primarily due to continued growth of the company and the associated increased expenses related to personnel, facilities and professional services.

There was no loss from remeasurement of fair value of warrants for either the second quarter of 2016 or six months ended June 30, 2016, compared to $16.7 million and $26.1 million, respectively, for the same periods in 2015. In April 2015, all such warrants ceased being liability-classified as the contingency surrounding the number of shares issuable upon the warrant exercise expired. All outstanding warrants were equity-classified and not subject to future remeasurement.

Provision for income taxes was $1.5 million for the second quarter of 2016 and $4.7 million for the six months ended June 30, 2016. There was no provision for income taxes in the same periods in 2015. The income tax expense recorded for the second quarter of 2016 was primarily related to current and deferred federal income taxes.

bluebird bio Reports Second Quarter 2016 Financial Results and Recent Operational Progress

On Aug. 3, 2016 bluebird bio, Inc. (Nasdaq: BLUE) a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported business highlights and financial results for the second quarter ended June 30, 2016 (Press release, bluebird bio, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192581 [SID:1234514211]).

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"We continue to advance our LentiGlobinTM, Lenti-D and bb2121 programs through clinical trials, and in recent months, we’ve been pleased to showcase some of the innovative platform work we are doing to continuously improve upon our therapies. At the ASH (Free ASH Whitepaper) Workshop on Genome Editing last month, we provided more detail on our proprietary megaTAL genome editing platform, and at the ASGCT (Free ASGCT Whitepaper) annual meeting, we highlighted our progress in developing next-generation T cell-based immunotherapies and improving manufacturing, transduction efficiency and assay development," said Nick Leschly, chief bluebird. "In the second half of 2016, we look forward to continued progress on our clinical programs, including initiation of the LentiGlobin HGB-207 Phase 3 study in non-β0/β0 transfusion-dependent thalassemia (TDT), the integration of manufacturing process improvements into our LentiGlobin clinical trials, and presenting updated LentiGlobin clinical data at ASH (Free ASH Whitepaper)."

Recent Highlights

MANUFACTURING AGREEMENT WITH LONZA – In June, bluebird and Lonza announced a strategic manufacturing agreement providing for the future commercial production of bluebird bio’s Lenti-D and LentiGlobin drug products. This agreement follows a successful multi-year clinical manufacturing relationship and provides bluebird bio with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility. Under this multi-year agreement, Lonza will complete the suite design, construction and validation along with process validation prior to anticipated commercial launch.

GENOME EDITING DATA PRESENTED AT ASH (Free ASH Whitepaper) WORKSHOP ON GENOME EDITING – In July, pre-clinical data from bluebird’s megaTAL genome editing platform was presented at the ASH (Free ASH Whitepaper) Workshop on Genome Editing in Washington, DC. The data reported at the ASH (Free ASH Whitepaper) workshop highlight recent progress bluebird has made in:
Expanding the number of megaTAL targetable sites in the genome to permit the precise placement of an editing event within a target gene

Refining the specificity of megaTALs to eliminate undesirable off-target activity
Combining megaTALs targeting different target genes to achieve the knockout of multiple genes simultaneously
ORPHAN DRUG DESIGNATION GRANTED FOR BB2121 IN MULTIPLE MYELOMA – In May, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for bb2121 in multiple myeloma. bb2121 is a chimeric antigen receptor T cell (CAR T) therapy targeting B cell maturation antigen (BCMA), and is being developed by bluebird bio in collaboration with Celgene Corporation. In February, the first patient was infused in the CRB-401 study of anti-BCMA CAR T therapy bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene exercised its option to exclusively license bb2121.

PRESENTED INTERIM DATA FROM STARBEAM STUDY AT AAN ANNUAL MEETING – In April, Dr. Florian Eichler of Massachusetts General Hospital for Children presented interim clinical data from the Starbeam study of Lenti-D in CALD at AAN. Initial Starbeam results suggest Lenti-D gene therapy may have similar efficacy to allogeneic hematopoietic stem cell transplant (HCT), the current standard of care, with a more favorable safety profile. As of March 31, 2016, three of the 17 patients enrolled in the study have reached two years of follow-up and remain free of major functional disabilities (MFDs), the primary endpoint of the study. Sixteen of the 17 patients had stabilization of their neurological function score (NFS), and 14 of 17 had a stable Loes score. The safety profile of Lenti-D treatment appeared consistent with myeloablative conditioning.

TEN ABSTRACTS PRESENTED AT ASGCT (Free ASGCT Whitepaper) 19th ANNUAL MEETING – In April, two oral presentations given by bluebird’s academic collaborators highlighted previously presented data from bluebird bio’s ongoing gene therapy clinical trials, including interim data from the Starbeam Study of Lenti-D in cerebral adrenoleukodystrophy, and interim data from the HGB-205 study of LentiGlobin in severe sickle cell disease and TDT. Eight additional presentations were featured at the meeting, highlighting progress across the company’s preclinical, research and process development activities in both HSC gene therapy and T cell immunotherapy.
Second Half 2016 Anticipated Milestones

Update on LentiGlobin process improvements
Initiation of the HGB-207 study in patients with TDT with the non-β0/β0 genotype
Presentation of updated clinical data for LentiGlobin at the ASH (Free ASH Whitepaper) annual meeting in December 2016
Second Quarter 2016 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2016 were $779.0 million, compared to $865.8 million as of December 31, 2015, a decrease of $86.8 million.

Revenues: Collaboration revenue was $1.6 million for the second quarter of 2016 compared to $4.9 million for second quarter of 2015. The decrease is a result of an amendment to our collaboration agreement with Celgene in June 2015.
R&D Expenses: Research and development expenses were $41.8 million for the second quarter of 2016 compared to $44.3 million for the second quarter of 2015. The decrease in research and development expenses was primarily attributable to decreased in-licensing milestones and fees and stock-based compensation expense partially offset by increased employee payroll and facilities costs due to increased headcount, and increased manufacturing, clinical, and information technology costs to support the advancement of our clinical and pre-clinical programs.

G&A Expenses: General and administrative expenses were $18.4 million for the second quarter of 2016 compared to $10.7 million for the second quarter of 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to increased headcount, and consulting costs to support our overall growth.
Net Loss: Net loss was $58.8 million for the second quarter of 2016 compared to $51.8 million for the second quarter of 2015.
Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $779.0 million as of June 30, 2016 will be sufficient to fund its current operations through 2018.

CytomX Announces Second Quarter 2016 Financial Results

On August 3, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported second quarter 2016 financial results (Press release, CytomX Therapeutics, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192554 [SID:1234514238]).

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"We achieved all targeted milestones in our pipeline this quarter as we continue to execute and drive our lead, wholly-owned programs towards the clinic," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With our transformational Probody technology platform, CytomX intends to unlock the full potential of antibody therapeutics by bringing new and differentiated treatment options to cancer patients."

As of June 30, 2016, CytomX had cash and cash equivalents and investments of $195.8 million. The Company continues to expect full year net cash utilization of $20.0 to $25.0 million in 2016. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations through 2018.

Business Highlights and Recent Developments

CX-072 (PD-L1 Probody) Program

The CX-072 IND remains on track to be filed in the second half of 2016, with an initial set of study sites expected to open by year-end to support initiation of patient enrollment.
Preclinical development activities to support clinical trial initiation are complete, including pre-IND interactions with FDA, execution of GLP toxicology studies and large-scale GMP manufacturing of clinical material.
As CytomX evolves from a research-stage to a clinical-stage organization, the Company is launching a first-of-its-kind clinical trial program that enables study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella program called PROCLAIM (Probody Clinical Assessment In Man).
The first module within the PROCLAIM program is the open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf (vemurafenib) in anti-PD-(L)1 inhibitor naïve patients with certain cancers.
To realize the vision of establishing CX-072 as the PD-(L)1 combination therapy of choice, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:
Safety: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
Clinical data is expected to begin to emerge in the second half of 2017 and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate) Program

Plans remain on track for filing an IND for CX-2009, a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen, CD166, in the first half of 2017.
Completed preclinical activities include pre-IND interactions with FDA, execution of a large-scale GMP manufacturing run for clinical material and initiation of GLP toxicology studies.
Clinical data is expected to begin to emerge in the second half of 2017 and throughout 2018.
Other Pipeline Updates

The PD-pathway is one of the most important checkpoint pathways responsible for mediating tumor-induced immune suppression, and PD-(L)1 inhibitors are becoming the cornerstone of combination therapy for many types of cancer.
CX-072 targets tumor-expressed PD-L1. The Company has previously demonstrated that a Probody targeting T-cell PD-1 can also elicit potent anti-tumor activity.
To that end, CytomX expects to nominate a lead candidate for its PD-1 Probody therapeutic in 2016, and will advance the program towards the clinic.
Partnerships

CytomX’s strategy of forming collaborations with major pharmaceutical companies including AbbVie, Bristol-Myers Squibb and Pfizer, continues to validate the potential of the Probody platform to transform antibody therapeutics in cancer.
CytomX continues to make progress with its partners to advance Probody therapeutics and believes that there is robust potential for additional IND filings with partnered programs in 2017 and 2018.
Given the breadth of potential applications of the Probody platform, the Company continues to engage prospective partners regarding additional collaboration opportunities.
Second Quarter Financial Results
Cash, cash equivalents and investments totaled $195.8 million as of June 30, 2016, compared to $186.7 million as of December 31, 2015. The increase reflects a $30.0 million upfront payment received from AbbVie in connection with the collaboration agreements entered in April 2016, a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with its third target selection in January 2016, partially offset by cash used in operations.

Research and development expenses were $12.7 million for the second quarter of 2016, compared to $5.0 million for the second quarter of 2015. The increase was primarily attributable to $3.8 million in manufacturing costs for the Company’s CX-072 and CX-2009 programs in preparation for preclinical and clinical studies, $1.5 million in laboratory and professional services, $0.9 million in non-cash stock-based compensation due to higher stock valuation, $0.9 million in personnel-related expenses due to an increase in headcount and $0.5 million in royalty payments to a third party triggered by the upfront payment in connection with the AbbVie collaboration agreement. The Company expects the manufacturing costs for the two programs to decrease in the third quarter and the costs related to preparation for CX-072 clinical trials to increase.

General and administrative expenses were $4.6 million for the second quarter of 2016, compared to $2.6 million for the second quarter of 2015. The increase was predominantly due to $0.9 million in non-cash stock based compensation due to higher stock valuation, $0.8 million in personnel-related expenses due to an increase in headcount and $0.4 million in additional consulting and professional service expenses associated with operating as a public company.

First Quarter Financial Report for the Fiscal Year Ending March 31, 2017

On August 3, 2016 Eisai Co., Ltd. reported financial results for the first quarter ended June 30, 2016 (Presentation, Eisai, AUG 3, 2016, View Source [SID:1234514345]).

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Gross profit for the first quarter of 2016 was 36.9 billions of Yen in comparison to that of 139.2 billions of Yen in the first quarter of 2015 . Sales of Oncology products amounted to 28.5 billions of Yen

For Eisai’s detailed sales figures, View Source