1stOncology™: Cancer Intelligence Service – Page 16340 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Jane Osbourn

IND filing of Medi4276, MedImmune’s first bispecific antibody-directed conjugate – a Biosuperior drug candidate with real potential to help certain types of breast cancer patients (2015) (Company Web Page, AstraZeneca, MAR 8, 2016, View Source [SID:1234509411]).

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Sanofi Pasteur and Merck (Known as MSD Outside the United States and Canada) Announce Intent to End Joint Vaccines Operations in Europe, Sanofi Pasteur MSD, to Pursue Their Own Distinct Growth Strategies

On March8, 2016 Sanofi Pasteur and Merck, known as MSD outside the United States and Canada, reported their intent to end their joint vaccines operations in Europe (Press release, Merck & Co, MAR 8, 2016, View Source [SID:1234509409]). Upon concluding their joint venture, both companies plan to integrate their respective European vaccine businesses into their operations, independently manage their product portfolios and pursue their own distinct growth strategies in Europe.

The joint venture Sanofi Pasteur MSD, owned on a 50/50 basis by Sanofi Pasteur and MSD, was created in 1994 to develop and commercialize vaccines originating from both companies’ pipelines to improve and promote public health in 19 European countries. Over the past twenty years, Sanofi Pasteur MSD has launched numerous innovative vaccines originating from Sanofi Pasteur and MSD’s development pipelines, addressing key unmet medical needs and helping to protect millions of lives.

Sanofi Pasteur and MSD jointly issued the following statement: "We are proud of Sanofi Pasteur MSD’s successful 20-year history. Our joint venture has achieved considerable success over the past two decades from a public health and commercial perspective. After carefully considering our individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the European Union, we have mutually agreed that it is in our best interests to manage our vaccine product portfolios independently. We believe that focusing our efforts on opportunities unique to our respective companies will better position us to drive growth, execute in a more efficient manner and optimize vaccine coverage. By bringing vaccines more rapidly to market, both companies would deliver greater value to all stakeholders."

Sanofi Pasteur and MSD will ensure that any impact on employees as a result of the proposed changes to the business model will be managed responsibly. We are also focused on a smooth and orderly transition while achieving our public healthcare goals and upholding our commitments to our customers and business partners.

Sanofi Pasteur and MSD expect the project to be completed by the end of 2016, subject to local labor laws and regulations and regulatory approvals.

OncoSec Announces Second Quarter and YTD Results for Fiscal Year 2016 and Calendar 2016 Milestones

On March 8, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported key corporate objectives as well as financial results for the second quarter and year to date ended January 31, 2016(Press release, OncoSec Medical, MAR 8, 2016, View Source [SID:1234509408]).

CORPORATE OBJECTIVES
"As we enter the next quarter, we are confident in our team’s mission to deliver safer and more effective intratumoral immunotherapies to provide long-term benefits for cancer patients. The fundamental goal of our technology, ImmunoPulse IL-12, is to promote a systemic, tumor-specific immune response. We believe this holds the greatest potential to provide meaningful clinical benefit to patients and investment value to OncoSec’s shareholders," said Punit Dhillon, President and CEO of OncoSec. "Our objectives over the next year are focused on establishing clinical response data to support the combination rationale for ImmunoPulse IL-12 with anti-PD-1/PD-L1 as well as identifying a new lead candidate to expand our ImmunoPulse platform and deliver multiple immune molecules in a single treatment."

OncoSec’s development milestones and value drivers over the next 12 months include:

Complete patient enrollment in the Phase II combination trial of ImmunoPulse IL-12 with anti-PD-1 in patients with metastatic melanoma
Present preliminary clinical and biomarker data from our Phase II melanoma clinical trials at upcoming scientific conferences; data to be used to finalize development strategy
Identify novel "multi-gene" combination ImmunoPulse candidate
Complete triple negative breast cancer pilot study as proof-of-concept and present interim data
Present data from our preclinical programs, including studies with our existing industry collaborators
FINANCIAL RESULTS
For the second quarter of fiscal 2016 and the six months ended January 31, 2016, OncoSec reported a net loss of $7.0 million and $14.1 million, or $0.42 per share and $0.89 per share, respectively, compared to a net loss of $4.6 million and $8.7 million, or $0.38 per share and $0.71 per share, respectively, for the same periods last year. The increase in net loss for the year ended January 31, 2016, compared with the same period in 2015, resulted primarily from (i) an increase of $3.1 million in personnel costs, inclusive of non-cash stock-based compensation (ii) an increase of $1.3 million in clinical studies costs due to the progression of patient treatments in all of our clinical programs, (iii) an increase of $0.5 million related to outside services primarily associated with discovery research and next generation electroporation device development and (iv) an increase of $0.5 million in facility costs which consists primarily of rental expense due to the relocation of our Corporate headquarters, which includes onsite laboratory space. There were no revenues for the three and six months ended January 31, 2016 or January 31, 2015.

Research and development expenses were $4.1 million and $7.8 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, respectively, compared to $2.9 million and $5.4 million for the same periods in 2015. General and administrative expenses were $2.9 million and $6.3 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, compared to $1.7 million and $3.3 million for the same period in 2015.

At January 31, 2016, OncoSec had $28.8 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at July 31, 2015. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

Myriad Advances Proprietary myVision® Variant Classification Tools to a Broader Range of Cancer Risk Genes

On March 08, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported it will present new data on its proprietary variant classification program that is used to classify variants in cancer risk genes (Press release, Myriad Genetics, MAR 8, 2016, View Source [SID:1234509407]). The study will be highlighted at the American College of Medical Genetics (ACMG) and Genomics annual clinical genetics meeting in Tampa, Fla.

"As the world leader in multi-gene panel testing for hereditary cancer, we have a long track record and commitment to advancing the science of variant classification," said Johnathan Lancaster, chief medical officer, Myriad Genetic Laboratories. "Our goal is to provide physicians with the highest quality results possible for every test we perform."

Myriad’s myVision variant classification program is comprised of proprietary techniques that allow for the most accurate classification for hereditary cancer variants including: Pheno, M-Co, InSite and LitView. The Pheno technique is a history weighting algorithm that could only be developed by Myriad after sequencing the DNA of more than 400,000 patients.

In this study, the Pheno algorithm was used to analyze variants of unknown significance associated with high cancer risk genes including BRCA1, BRCA2, MLH1, MSH2 and MSH6. Additionally, the algorithm was updated to analyze variants of unknown significance in moderate cancer risk genes including ATM, CHEK2 and PALB2. The results of this study showed that Pheno was >99.5 percent accurate for upgrading and downgrading variants of uncertain significance to more definitive clinical classifications.

"As the myRisk Hereditary Cancer 25-gene panel test becomes more integrated into clinical practice, there will be a need to classify a greater number of variants," said Lancaster. "Variants of uncertain significance are particularly problematic for physicians because they leave questions as to whether variations in a patient’s DNA are of concern. This study demonstrates the ability of Pheno to accurately classify variants from a broader range of genes, which should help reduce anxiety for more patients and their families."

Details about the featured Myriad presentations at ACMG are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date with the meeting by using the hashtag #ACMGMtg16.

Myriad Presentations

Title: Reclassification of uncertain variants identified in high and moderate cancer risk genes using history weighting analysis.
Date: Friday, March 11, 2016: 10:30 a.m. to 12:00 p.m. ET.
Location: Poster 110.
Presenter: Karla Bowles, Myriad Genetic Laboratories.

Title: Detailed review of four patients affected with cancer that were previously unaffected at the time of single syndrome testing and subsequently had pathogenic variants identified by a 25-gene panel.
Date: Thursday, March 10, 2016: 10:30 a.m. to 12:00 p.m. ET.
Location: Poster 109.
Presenter: Allison Anguiano, Myriad Genetic Laboratories.
About Pheno and myVision Variant Classification Program

Pheno is a family history-weighting tool that compares the severity of personal and family histories of patients who carry a specific variant to that of individuals who carry known deleterious mutations and to individuals in whom no mutation was detected. Pheno is a proprietary component of the myVision Variant Classifcation Program, which is the most advanced informatics program in the industry, overseeing the classification and reclassification of genetic variants, and is part of Myriad’s commitment to patients and their families that lasts a lifetime. For more information about Myriad’s variant classification program visit: View Source

About Myriad myRisk Hereditary Cancer Testing

The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

Dynavax Reports Fourth Quarter and Year End 2015 Financial Results

On March 8, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Dynavax Technologies, MAR 8, 2016, View Source [SID:1234509405]).

The Company had $196.1 million in cash, cash equivalents and marketable securities as of December 31, 2015.

Total revenues for the year ended December 31, 2015, decreased by $7.0 million or 63 percent compared to the same period in 2014, primarily due to a $5.2 million decrease in collaboration revenue due to winding down of work performed for the AZD1419 program and expiration of our collaboration agreement with GSK in 2014.

Operating expenses increased by $6.8 million or seven percent during 2015 compared to 2014, primarily due to costs related to HBV-23, the Phase 3 clinical study of HEPLISAV-B completed in October 2015, preparation for the commercial launch of HEPLISAV-B in the United States and clinical trial expense for SD-101, Dynavax’s cancer immunotherapeutic product candidate.

The net loss allocable to common stockholders for the year ended December 31, 2015 was $106.8 million, or $3.25 per share, compared to $90.7 million, or $3.45 per share for the year ended December 31, 2014.

"During 2015, we completed HBV-23 and significantly strengthened the Company’s cash position. Earlier this year we reported that this third pivotal study had met both co-primary endpoints. We plan to resubmit the HEPLISAV-B BLA (Biologics License Application) to the FDA by the end of this month. Based on our expectation of a six-month review, if our application is approved we expect to launch this product in the fourth quarter of this year," said Eddie Gray, chief executive officer of Dynavax.