Verastem price target lowered to $10 from $13 at H.C. Wainwright

H.C. Wainwright analyst Swayampakula Ramakanth lowered his price target for Verastem to $10 from $13 saying that while the Copiktra launch progressing, the early ramp is slower than expected. The analyst, however, continues to believe in the long-term potential of Copiktra and reiterates a Buy rating on the shares.
https://thefly.com/landingPageNews.php?id=2879075

Biohaven initiates enrollment in Phase 3 clinical trial of troriluzole

Biohaven Pharmaceutical has enrolled the first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in Spinocerebellar Ataxia, or SCA. Hereditary Spinocerebellar Ataxias are rare, potentially fatal neurodegenerative disorders affecting the cerebellum. Currently, there are no FDA-approved treatments and there is no cure for SCA. Biohaven expects to enroll approximately 230 patients in this trial across approximately 22 sites in the United States. Researchers will evaluate the efficacy and safety of troriluzole over 48 weeks in patients with a diagnosis of SCA Types 1, 2, 3, 6, 7, 8, and 10. The primary outcome measure is the change in a patient’s score on the Modified Functional Scale for the Assessment and Rating of Ataxia.
https://thefly.com/landingPageNews.php?id=2879081

Progenics asserts ownership of PMSA-617 intellectual property

Progenics (PGNX) announced that it has asserted ownership of worldwide composition of matter patent filings related to PSMA-617, a PSMA targeted radiopharmaceutical compound under development by Novartis (NVS) for the treatment of prostate cancer. The company asserts that PSMA-617 arose from sponsored research collaborations between the University of Heidelberg and Molecular Insight Pharmaceuticals, or MIP, prior to its acquisition by Progenics. Pursuant to those collaborations, the University performed analyses of multiple PSMA targeting compounds that were proprietary to and discovered by MIP, and that MIP shared with the University pursuant to defined research agreements. MIP has the full rights to the sponsored research, including intellectual property arising from the work. Without Progenics’ knowledge or consent, the invention claimed in the worldwide patent filings was exclusively licensed to ABX GmbH, and, thereafter sub-licensed to Endocyte, which was recently acquired by Novartis. MIP filed a complaint against the University in the District Court of Mannheim in Germany. On February 27, Endocyte, a wholly owned subsidiary of Novartis, filed a motion to intervene in the German litigation. Endocyte is the exclusive licensee of the patent rights that are the subject of the German proceedings. On December 10, 2018, the European Patent Office granted MIP’s request and stayed the examination of these patent applications effective November 27, 2018. MIP’s filing with the USPTO takes the position that, in light of the collaboration and contracts between MIP and the University, MIP is the co-owner of these pending U.S. patent applications
https://thefly.com/landingPageNews.php?id=2879101

Cambrex completes expansion, manufacturing upgrades at Milan lab

Cambrex announced that it has completed the expansion of a new 150 square meter research and development laboratory at its site in Milan, Italy. In addition, Cambrex has installed a new 12,000 liter reactor into one of its cGMP manufacturing facilities at the site. The R&D laboratory includes both chemistry and analytical development capabilities, with the installation of semi-automated glass lined reactors, as well as analytical instruments including multiple high and ultra-performance liquid chromatography and gas chromatography systems, which have now been qualified and validated. To complement investments at other Cambrex sites, the new laboratory has also installed a flow chemistry system to allow for continuous manufacturing development. The installation of the 12,000 liter reactor, along with the replacement of centrifuges with new, more efficient equipment in one of the site’s seven production departments, was part of a $3M investment to upgrade and improve the efficiency of the plant which manufactures intermediates and generic APIs under GMP conditions.
https://thefly.com/landingPageNews.php?id=2879135

Myriad Genetics myPath Melanoma test receives Medicare coverage

Myriad Genetics announced that the Medicare administrative contractor Palmetto GBA MolDx has issued a final local coverage determination for the myPath Melanoma test to help physicians provide a definitive diagnosis when a suspicious skin lesion is equivocal based upon histopathology. The myPath Melanoma test analyzes 23 genes and has proven to be highly accurate in multiple studies at distinguishing melanoma from benign moles.
https://thefly.com/landingPageNews.php?id=2879171

Novel Vaccine Blocks Osteoarthritis Pain in Mice

An international team of scientists from the UK, Switzerland and Latvia has developed a virus-like particle vaccine that could be used to treat chronic pain caused by osteoarthritis, by blocking the cause of the pain — the nerve growth factor. The new vaccine was tested in mice that had signs of painful osteoarthritis, and it was shown to visibly reverse these effects.

Osteoarthritis is the most prevalent joint disease costing approximately 1-2.5% of the gross domestic product of developed countries.

Greater than 75% of patients experience pain on a daily basis. Current standard therapies for pain relief, such as non-steroidal anti-inflammatory drugs and opioids are limited by their modest efficacy and long-term safety.

In the last decade, the nerve growth factor (NGF) has emerged as a promising target for osteoarthritis pain.

“This is the first successful vaccination to target pain in osteoarthritis, one of the biggest healthcare challenges of our generation,” said co-lead author Professor Tonia Vincent, a researcher at the Kennedy Institute of Rheumatology at the University of Oxford.

“Whilst there are still safety issues that need to be considered before these types of approaches can be used in patients, we are reassured that this vaccine design allows us to control antibody levels and thus tailor treatment to individual cases according to need.”

Professor Vincent and colleagues developed and tested a virus-like particle vaccine that triggers the immune system to produce antibodies to block naturally-occurring NGF.

“I’m happy to see the vaccine platform perform so well, and look forward to seeing the vaccine enter clinical testing in companion animals,” said co-lead author Professor Martin Bachmann, from the Jenner Institute at the University of Oxford and the University of Bern.

“We know that for the 10 millions people with arthritis, persistent pain is life changing,” said Dr. Stephen Simpson, Director of research at Versus Arthritis, which funded the research.

“Too many people living with pain do not get effective relief from the treatments that are currently available, and that is why the development of more effective painkillers, with fewer side-effects, is vital for people living with arthritis.”

“Although at an early stage, this is highly innovative research and these results are very promising.”

The results appear in the Annals of Rheumatic Disease.

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Isabell S. von Loga et al. Active Immunisation Targeting Nerve Growth Factor Attenuates Chronic Pain Behaviour in Murine Osteoarthritis. Annals of Rheumatic Disease, published online March 12, 2019;

http://www.sci-news.com/medicine/vaccine-osteoarthritis-pain-06982.html

Blood Test Study Meets Goal, Validates Epic’s Prostate Cancer Target

Epic Sciences has commercialized a blood test that can predict how likely a patient with late-stage prostate cancer treated with hormones is likely to respond to an additional course of such therapy. Now, the San Diego-based company has additional data that it says supports use of its tests to determine when not to use hormone therapy.

In study results published Wednesday, the presence of the specific protein fragment that Epic (not to be confused with Verona, WI-based EHR software maker Epic Systems) tests for in circulating tumor cells predicted a shorter median length of survival for men whose disease has spread beyond the gland and isn’t responding to therapies that depress testosterone levels. According to the study, the median length of time patients who had this biomarker lived without their disease worsening was about three months compared to about six months in those who did not. More strikingly, the median length of their overall survival was about eight months, compared to more than two years for those who did not have the protein fragment.

Researchers said the results suggest that patients whose tests detect the biomarker should receive chemotherapy or join a clinical trial for an investigational therapy instead of receiving additional hormone therapy.

The Epic blood test, marketed by Genomic Health (NASDAQ: GHDX), is part of a broader effort to develop new kinds of tests to detect and monitor cancer, as well as to avoid more invasive tissue biopsies. Myriad Genetics (NASDAQ: MYGN), in Salt Lake City, offers a blood test to inform treatment for last-stage breast cancer. Some companies are aiming to advance cancer diagnostics even further, with tests intended to detect the disease before any symptoms appear. For example, Grail, a spinoff of San Diego DNA sequencing giant Illumina (NASDAQ: ILMN) based in Menlo Park, CA, has raised millions to support its efforts to develop a “liquid biopsy” that can detect cancer in blood at the disease’s earliest stages.

The results from the latest study evaluating Epic’s blood tests were published in the Journal of Clinical Oncology. Blood samples from 118 patients were tested on both the Epic assay and a similar test developed by Johns Hopkins scientists that is currently used in research. Andrew Armstrong, associate director for clinical research in the Duke Cancer Institute’s Center for Prostate & Urologic Cancers, led the group.

“We have therapies to treat recurrent, metastatic prostate cancer, but they don’t work on everyone, and cross-resistance between newer hormonal therapies is a major emerging problem in our field,” said Armstrong, in a prepared statement. “It’s important to know which men are more likely to benefit from further hormonal therapies as well as to identify those men with little chance of benefiting in order to rapidly provide alternative, more effective therapies and or to develop new therapies for these men.”

Epic estimates 50,000 men in the U.S. have advanced prostate cancer. About half, Epic says, have Medicare coverage. Medicare covers the test, called Oncotype DX AR-V7 Nucleus Detect.

This latest study could support coverage of the test by insurance companies, as well as convince more physicians of its usefulness, said Ryan Dittamore (pictured), Epic’s chief of medical innovation and head of translational research partnerships, in an interview with Xconomy. Dittamore co-authored the study, which was backed by the Prostate Cancer Foundation, the Movember Foundation, and the Department of Defense’s Prostate Cancer Clinical Trials Consortium.

Epic, which tests blood samples at its San Diego lab, is working to develop more such tests, as well as studying cancers in conjunction with academic centers and working on drug development with biopharma companies, Dittamore said.

The company raised $52 million in September in a Series E round led by New York private equity firm Blue Ox Healthcare Partners to advance Epic’s development of blood tests for other cancers.

“There’s a lot of talk about being able to use blood tests to predict patient outcomes, and now we’ve done that in prostate cancer,” Dittamore said. “While, certainly, a lot of our colleagues are working on cancer drugs, the reality is that we need to know which drug to give which patient, and it’s not one-size-fits-all.”

https://xconomy.com/san-diego/2019/03/13/blood-test-study-meets-goal-validates-epics-prostate-cancer-target/