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Associate Scientist

Our client, a global leader in the sequencing space, is seeking an Associate Scientist to join their rapidly expanding team. Summary: As an Associate Scientist, you will play an integral role in developing next generation assays for diverse research and a […]

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News

Illumina Names Gary S. Guthart, Ph.D., to its Board of Directors, Adding Decades of Leadership Experience in Healthcare

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) announced today that Gary S. Guthart will join the company’s Board of Directors on December 1, 2017. Dr. Guthart is President and Chief Executive Officer of Intuitive Surgical, a global leader in the field of robotic-assisted minimally invasive surgery. Dr. Guthart joined Intuitive Surgical in April 1996 and has served as the Chief Executive Officer since January 2010. In July 2007, he was promoted to President, having assumed the role o […]

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PR Newswire

MEI Pharma Reports First Quarter Fiscal Year 2018 Results

Quarter highlighted by dosing of first patient in pivotal Phase 3 study of pracinostat and exclusive license agreement for voruciclibMultiple key milestones lined up for year ahead

SAN DIEGO, Nov. 8, 2017 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today reported results for its first quarter ended September 30, 2017.

“In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “We are well positioned for a momentous year ahead, with a healthy cash balance and a series of key milestones in each of our clinical programs.”

Upcoming Milestones

Pracinostat

  • Expecting results from Stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.

ME-401

  • Expecting to initiate combination study with Rituxan® in indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in the fourth quarter of 2017.
  • Expecting results from proof-of-concept study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma to be presented at a scientific meeting in the first half of 2018.

Voruciclib

  • Expecting to initiate Phase1/2 single-agent study in relapsed/refractory B lymphocyte malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta™) in the second quarter of 2018.

ME-344

  • Expecting interim results from the proof-of-concept study in human epidermal growth factor receptor 2 (HER2) negative breast cancer in combination with bevacizumab (marketed as Avastin®) in the first half of 2018.

Financial Highlights

  • As of September 30, 2017, MEI Pharma had $47.0 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019.
  • Cash used in operating activities was $6.6 million for the three months ended September 30, 2017, compared to cash provided by operating activities of $8.8 million for 2016. Included in cash expenditures for the three months ended September 30, 2017 was $1.9 million cash paid for the voruciclib acquisition. Included in the cash provided by operating activities in 2016 is the $15 million upfront payment from Helsinn for pracinostat.
  • Research and development expenses, including cost of research and development revenue, were $6.7 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
  • General and administrative expenses were $2.5 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The decrease was primarily due to professional service costs incurred in 2016 related to the Helsinn license agreement.
  • Revenues were $0.3 million for the three months ended September 30, 2017, compared to $1.1 million in 2016. The decrease is related to activities performed pursuant to the Helsinn license agreement.
  • Net loss was $8.8 million, or $0.24 per share, for the three months ended September 30, 2017, compared to a net loss of $4.3 million, or $0.12 per share for the three months ended September 30, 2016.

About MEI Pharma

MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s portfolio of drug candidates includes pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine for the treatment of patients with high and very high-risk myelodysplastic syndrome (MDS). MEI Pharma’s clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a Phase Ib study in patients with relapsed/refractory CLL or follicular lymphoma, and voruciclib, an oral, selective CDK inhibitor shown to suppress MCL1, a known mechanism of resistance to BCL2 inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-sponsored study in combination with bevacizumab for the treatment of HER2-negative breast cancer. Pracinostat, ME-401, ME-344 and voruciclib are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

MEI PHARMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except per share amounts)

September 30,

June 30,

2017

2017

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$             6,958

$    8,458

Short term investments

40,065

45,107

Total cash, cash equivalents and short-term investments

47,023

53,565

Prepaid expenses and other current assets

641

1,758

Total current assets

47,664

55,323

Intangible assets, net

322

331

Property and equipment, net

45

50

Total assets

$           48,031

$  55,704

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$                751

$       585

Accrued liabilities

2,767

3,285

Deferred revenues

947

996

Total current liabilities

4,465

4,866

Commitments and contingencies 

Stockholders’ equity:

Preferred stock, $0.01 par value; 100 shares authorized; none outstanding

Common stock, $0.00000002 par value; 113,000 shares authorized; 36,950 and 36,772 shares issued and outstanding at September 30, 2017 and June 30, 2017, respectively

Additional paid-in-capital

226,685

225,169

Accumulated deficit

(183,119)

(174,331)

Total stockholders’ equity

43,566

50,838

Total liabilities and stockholders’ equity

$           48,031

$  55,704

 

MEI PHARMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

Three Months Ended

September 30, 

2017

2016

Revenues:

 Research and development revenue 

$     283

$  1,096

Total revenues

283

1,096

Operating expenses:

Cost of research and development revenue

618

1,094

Research and development

6,064

1,646

General and administrative

2,488

2,680

Total operating expenses

9,170

5,420

Loss from operations

(8,887)

(4,324)

Other income (expense):

Interest and dividend income

100

55

Income tax expense

(1)

(1)

Net loss

$ (8,788)

$ (4,270)

Net loss per share, basic

$   (0.24)

$   (0.12)

Net loss per share, diluted

$   (0.24)

$   (0.12)

Shares used in computing net loss per share:

Basic

37,245

35,747

Diluted

37,245

35,747

 

 

View original content with multimedia:http://www.prnewswire.com/news-releases/mei-pharma-reports-first-quarter-fiscal-year-2018-results-300551614.html

SOURCE MEI Pharma, Inc.

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PR Newswire

CellSight Technologies Announces Strategic Collaboration With Boehringer Ingelheim to Develop a New Technology for Monitoring Anti-tumor T-Cell Activation

– New technology could help to accelerate development of novel immuno-oncological therapies and support physicians in optimizing treatment decisions- Positron Emission Tomography (PET) enables non-invasive determination of T-cell activation against tumors

SAN FRANCISCO, Nov. 8, 2017 /PRNewswire/ — CellSight Technologies, a US-based PET (Positron Imaging Tomography) imaging company, announced today a collaboration with Boehringer Ingelheim to evaluate CellSight’s PET imaging tracer, VisAcT, for future use in the development and monitoring of immune-oncological therapies.

VisAcT ([18F]fluoro-arabinofuranosylguanine [18F]F-AraG), is preferentially taken up by activated T cells, thus, enabling the non-invasive determination of changes in T cell activation within tumor lesion(s) as a consequence of anti-cancer immune system activation. A clinical trial to evaluate immunological response to PD-1 checkpoint inhibition in squamous cell carcinoma of the head and neck is currently ongoing (NCT03129061).  The focus of the trial is to determine if early PET scans, at 6-12 weeks after the initial anti-PD1 inhibitor therapy dose, with the VisAcT tracer are predictive of response to immunotherapy.  Within cohort 1 of the trial 20 patients will be recruited. The goal is to assess whether [18F]F-AraG accumulation  in tumor lesion(s) can be used for assessment of T cell activation and expansion in the tumor and its microenvironment. The trial is currently open for recruitment at the Stanford University Medical Center and is led by Dimitrios Colevas M.D., John Sunwoo M.D., Quynh-Thu Le M.D., Olivier Gaevert Ph.D., Chris Holsinger M.D., Nancy Fischbein M.D.and Shyam Srinivas M.D.

“CellSight is extremely pleased to be working with Boehringer Ingelheim, after connecting through the National Cancer Institute Small Business Innovations Research program,” said Aruna Gambhir, CEO of CellSight. “We believe that our PET imaging tracer, which is specific for activated T cells can help increase the success rate for immunotherapies by predicting response early in the treatment regimen thus allowing clinicians and patients to make more informed decisions.” 

Prof. Florian Gantner Head of Translational Medicine and Clinical Pharmacology at Boehringer Ingelheim: “We are very excited to  collaborate with CellSight Technologies, to provide a novel diagnostic tool for patients and doctors to non-invasively obtain the information needed to optimize treatment regimens. VisAcT has the potential to accelerate numerous research efforts in immuno-oncology and make a real difference for patients.”

About CellSight Technologies

Founded by Dr. Sanjiv Sam Gambhir, CellSight Technologies is based in San Francisco, United States.  It is a privately held, clinical-stage biotechnology company specializing in the development of PET imaging tracers for diagnostic imaging in the immunotherapy field.

For more information please visit www.cellsighttech.com

Media Contact:

Sam Quezada
650-799-1589

View original content:http://www.prnewswire.com/news-releases/cellsight-technologies-announces-strategic-collaboration-with-boehringer-ingelheim-to-develop-a-new-technology-for-monitoring-anti-tumor-t-cell-activation-300551203.html

SOURCE CellSight Technologies

[…]

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San Diego Biotech Jobs

ASSOCIATE DIRECTOR ENGINEERING AND DEVICE SECURITY – SERVICE AND SUPPORT – Global Pharmatek – San Diego, CA

At Client, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking… $155,000 – $168,000 a yearFrom Global Pharmatek – Wed, 08 Nov 2017 04:21:56 GMT – View all S… […]