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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.

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"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.

Genmab Provides Update on Ofatumumab Development in Autoimmune Indications

On March 8, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the end of 2015 (Press release, Genmab, MAR 8, 2016, View Source [SID:1234509401]). Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016.

The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis. The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica.

"We are very pleased with Novartis’ commitment to move the development of ofatumumab forward in multiple sclerosis and look forward to the initiation of the Phase III studies in the second half of this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Arzerra is also approved in the U.S. as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

The subcutaneous formulation of ofatumumab is also being investigated by Novartis in multiple sclerosis. The use of ofatumumab in multiple sclerosis is investigational and is not currently approved in any market.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

Ipsen and PeptiMimesis announce a research partnership in oncology

March 8, 2016 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical company, and PeptiMimesis, a start-up from an INSERM (French National Institute of Health and Medical Research) and Strasbourg University spin-off project, funded by SATT Conectus Alsace, reported the signature of a research partnership and a licensing option for the development and marketing of novel therapeutic peptides in oncology (Press release, Ipsen, MAR 8, 2016, View Source [SID:1234509421]).

Ipsen will combine its expertise in peptide design and development with PeptiMimesis knowledge in the identification of transmembrane peptides and intracellular signaling. The target receptor is involved in different phases of cancer development, including angiogenesis, immune tolerance and proliferation.

"PeptiMimesis is extremely proud that its innovative approach is recognized by Ipsen, a prominent partner in therapeutic peptides. We are convinced that this initial collaboration will pave the way for a series of partnerships, given the tremendous possibilities of targeting transmembrane receptors," said Pascal Neuville, Chief Executive Officer of Domain Therapeutics, co-founding company of PeptiMimesis and Chairman of PeptiMimesis. "This partnership is the result of more than 15 years of research that reached the validation stage thanks to the support of SATT Conectus. Work on the project will now continue in close cooperation between my laboratory, PeptiMimesis and Ipsen," added Dominique Bagnard, Ph.D., PeptiMimesis scientific founder.

Claude Bertrand, Executive Vice President, Research & Development and Chief Scientific Officer of Ipsen, commented: "We have been working with Dominique Bagnard’s team since 2014 to assess the potential of transmembrane targeting of a specific receptor identified as involved in cancer development. We are delighted to continue our involvement with the young start-up PeptiMimesis to combine our strengths and expertise to identify and develop new treatments for cancer patients. The project aligns perfectly with our research strategy and extends our expertise in peptides."

Under the terms of the agreement, Ipsen and PeptiMimesis will work closely together to move the project forward towards clinical development. PeptiMimesis will receive financial support from Ipsen for the research phases, as well as milestone payments associated to the program. In the event the option is exercised, Ipsen could make further potential payments to PeptiMimesis at development, regulatory and commercial milestones, as well as royalty payments on worldwide annual net sales.

8-K – Current report

On March 8, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has entered a sponsored research agreement with The University of Texas MD Anderson Cancer Center ("MD Anderson") to evaluate Bio-Path’s clinical pipeline for its ability to modulate pancreatic cancer (Filing, 8-K, Bio-Path Holdings, MAR 8, 2016, View Source [SID:1234509416]).

Included in the evaluation will be BP1001 (Liposomal Grb2 antisense), Bio-Path’s lead product candidate, which is currently in a Phase II study for blood cancers.

Jason Fleming, M.D., F.A.C.S., professor of surgical oncology within the division of surgery at MD Anderson, will serve as the study’s principal investigator. Dr. Fleming initiated and developed the first direct xenograft program in gastrointestinal cancer. These xenografts were derived from malignant pancreatic tumors that Dr. Fleming and his surgical colleagues removed from patients at MD Anderson. Dr. Fleming is also director of the tissue acquisition and biorepository core for the Pancreas Cancer Research Program at MD Anderson, and is a board certified pancreatic surgeon.

"We are honored to collaborate with Dr. Fleming," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "His experience working with pancreatic xenografts makes him uniquely qualified to lead this study. We look forward to assessing whether Bio-Path’s drug candidates work in this ex vivo model before potentially moving into animal studies."