Amylin Pharmaceuticals has bought a $10 million stake in BioSeek, and the firms have penned a joint research collaboration to discover and develop treatments for inflammatory conditions, according to BioSeek.
Encouraged by the success of its previous collaboration with BioSeek, Amylin would like to help the company evolve from a fee-for-service shop into a drug discovery firm, according to Michael Hanley, vice president of discovery research for Amylin.
Terms of the alliance call for privately held BioSeek to use its BioMAP screening system to evaluate the potential of Amylin’s polypeptide hormone library Phormol to yield peptide therapeutics for inflammatory conditions.
BioSeek’s screening platform consists of in vitro cell-based models of various diseases with a primary focus on inflammatory and autoimmune processes. The platform database contains profiles of many known compounds and their behavior in cells.
BioSeek will pay Amylin royalties and milestones in exchange for the right to select and exclusively license two resultant peptides that it would then optimize and develop for therapeutic indications outside of Amylin’s core focus.
The company is also eligible to receive royalties from Amylin if the drug maker develops or licenses an additional limited set of peptides for uses identified in the collaboration.
The agreement builds on a screening collaboration the companies formed last year. According to Hanley, the company entered into the 2006 deal because it wanted to see whether BioSeek’s technology would determine if its peptide library contained potential anti-inflammatory agents. And the answer was a resounding yes, he says.
BioSeek CEO Peter Staple said that although his company has signed similar agreements in the past, the Amylin alliance is the first that has included a capital investment.
He says the company will likely use the $10 million to identify and develop new product development programs, and would probably seek to raise additional financing when it identifies such programs.
— Charlotte LoBuono
FDA’s IVDMIA Draft May Inspire Rx/Dx Co-development
It’s no secret that the divergent development timelines for therapeutics and diagnostics are a major roadblock to Rx/Dx co-development deals. However, drug and diagnostics developers have had difficulty formulating strategies to align their divergent timeframes in a way that is mutually beneficial. It can take as much as 15 years to bring a drug to market, while it takes only a few years for a diagnostic company to launch a new test.
But some industry players believe that the FDA’s draft guidance on in vitro diagnostic multivariate index assays may help meet those goals because it would require certain tests to be approved by the FDA, therefore reducing some of the added risk that would ordinarily discourage pharmas from working hand in hand with diagnostic shops.
Caroline Popper, regulatory affairs senior advisor at Exagen, says that while the guidance doesn’t have provisions for aligning timelines, FDA oversight of IVDMIAs may spur Rx/Dx co-development by giving pharmaceutical companies more confidence in the diagnostics they use to narrow their clinical trial population.
“Essentially [the IVDMIA draft guidance] aligns diagnostic and drug development, but I don’t believe it aligns timelines,” Popper says. “My interpretation is what is happening is IVDMIAs are useful in segmenting the patient population for clinical trials because they define patients with specific attributes in the drug development process.”
Exagen recently submitted its breast cancer recurrence test, eXagenBC, to the FDA for clearance. If approved, it will be the second FDA-cleared test for breast cancer recurrence after Agendia’s MammaPrint test.
Others in the industry agree. “When you look at it from a co-development perspective, it is really out of sync with diagnostics development,” says Scott Fogerty, manager of clinical market development at Affymetrix. “I will say that [with] the recent revelations from the IVDMIA emerging guidance, there may be a way to put this back on track.”
— Turna Ray
Qiagen plans to buy molecular diagnostics firm Digene in a cash and stock deal valued at around $1.6 billion. Digene’s core platform is a human papillomavirus test that screens for high-risk strains of HPV that have been linked to cervical cancer. The test has been approved by the US Food and Drug Administration and has received European CE-mark approval.
As part of its strategy to broaden patient access, Genomic Health hired Medical Solutions to exclusively distribute its Oncotype DX breast cancer assay in the UK. The test predicts the likelihood of breast cancer recurrence in women with newly diagnosed, early stage invasive breast cancer, as well as whether chemotherapy will be beneficial.
The Helmholtz Association of German Research Centers launched an initiative to study how genomics, proteomics, and other fields can help identify the causes of complex diseases and disorders. The group will spend around €24 million on the initiative through 2011, and will seek funding from a network of partners as well.
OncoMethylome Sciences and Exact Sciences plan to advance the sale of stool-based colorectal cancer-screening technologies through service labs in Europe and North America. The agreement calls for Exact to grant OncoMethylome non-exclusive rights to its DNA stabilization, isolation, and extraction technology for stool-based CRC-screening tests in Europe.
Almac Diagnostics, previously known as ArraDx, plans to meet with the US FDA about starting clinical trials of an array-based colorectal recurrence test it hopes to launch next year. The UK-based company, which has to date offered arrays for research purposes, intends to launch the assays as an in vitro diagnostic if the FDA clears its 510(k) application.
LabCorp licensed a gene-methylation technology developed by Veridex in order develop a qPCR assay for prostate cancer. The tool is designed to detect the methylated GST-Pi gene.
A pan-European project called Colon and Breast Cancer Diagnostics, or COBRED, has received a €2.9 million grant from the European Union. The nine-member project, which was created to discover biomarkers for monitoring and following patients with breast and colon cancer, is coordinated by Paris-based Biosystems International.
Abbott extended a research partnership with Caprion Proteomics to identify and use cancer antibody targets. The agreement grants Abbott exclusive rights for up to two years to 10 lung cancer targets that Caprion found.
AdvanDx will buy peptide nucleic acid probes from Panagene for use in its PNA FISH in vitro diagnostics. AdvanDx's molecular-based tests identify bacteria species associated with bloodstream infections from blood cultures.
Vocabulary Lesson: Sorting Out Clinical Trials
Phase I. Testing generally involves anywhere from 10 to 100 healthy volunteers, and the goal is to determine the drug candidate’s safety profile and safe dosing levels.
Phase II. Effectiveness of the drug is tested in this phase, which usually involves 100 to 500 volunteer patients who have the disease or condition the drug is designed to target.
Phase III. Here, the drug candidate is broadened out to clinics and hospitals, which will typically enroll 1,000 to 5,000 patients who have the disease. Doctors monitor drug use for efficacy and adverse events.
Source: PhRMA (Pharmaceutical Research and Manufacturers of America)
Pairs of chromosomes in the human genome, and basis for the name of biotech startup 23andMe, a personal genomics company that received $3.9 million from Google as part of a Series A round of private-equity financing. Other investors included Genentech, New Enterprise Associates, and Mohr Davidow Ventures.
NeoClone Biotechnology has received a $750,000 Phase II SBIR grant from the NIH to continue development of an antibody microarray for ovarian cancer. The array will use NeoClone’s proprietary method for generating monoclonal antibodies to certain ovarian cancer-related targets.
US Patent 7,217,807. Bioinformatically detectable group of novel HIV regulatory genes and uses thereof. Inventor: Itzhak Bentwich. Assignee: Rosetta Genomics. Issued: May 15, 2007.
The patent covers “a group of novel viral RNA regulatory genes [which may] be useful in diagnosing, preventing, and treating viral disease,” according to the patent abstract. Details include nucleic acid molecules, vectors, and probes, as well as systems for detecting and counteracting these particular genes.
US Patent 7,217,699. Compositions comprising genome segments and methods of using the same. Inventor: Leonid Yakubov. Assignee: Panagenic International. Issued: May 15, 2007.
This invention covers “methods of treating an individual who has a disease or disorder associated with one or more genetic mutations or undesirable alleles in genomic DNA … by replacing a segment of genomic DNA that has a mutated sequence or undesirable allele with a corresponding segment of DNA that has a non-mutated sequence or desirable allele.”