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Wednesday, June 6, 2018

Cancer Research, Medical Records Targeted by Amazon Mystery Initiative


The secret group within Amazon working on a series of bold projects is starting to become a little less secret. Several news reports in recent days have speculated on the purpose and structure of the new group within the company traditionally known for e-commerce, consumer devices and web services.
On Tuesday, MSNBC cracked the story by reporting that the group, known as Grand Challenge, was being led by Google Glass creator Babak Parviz. According to an internal chart, Grand Challenge is part of Amazon Web Services (AWS) and Parviz reports directly to AWS CEO Andy Jassy.
“Similar to Alphabet’s experimental research lab, X (formerly Google X), Grand Challenge is a research team set up to explore ambitious new ventures that can eventually expand Amazon’s already wide footprint,’ MSNBC reported.
BioSpace readers will be particularly interested to know about two possible areas of focus — cancer research and medical records.
Cancer research to be supported by AI application
According to those familiar with the project, Parviz and his team are working with Fred Hutchinson Cancer Research Center in Seattle to apply machine learning in ways that can help prevent and cure cancers.
Machine learning is an application of artificial intelligence (AI) that provides systems the ability to automatically learn and improve from experience without being explicitly programmed. Machine learning focuses on the development of computer programs that can access data and use it to learn for themselves.
The story has also been covered by GeekWire. “We have several projects underway with a few of our tech neighbors including Microsoft, Amazon and Tableau,” said a Fred Hutchinson spokesperson. “Given the early stages, we don’t have any specific Amazon Web Services projects to preview but hopefully later this year,” GeekWire reported.
Patient data analysis to improve accuracy of medical records
In January, a press release on BioSpace seemed to foreshadow Amazon’s entry into the medical records field. At the time, they were looking for a professional who can “own and operate” the security and compliance aspects of a new initiative. The job posting also required the candidate to ensure that the new initiative meets HIPAA business associate agreement requirements, meaning Amazon intends to work with outside partners that manage personal health information.
That initiative has been internally dubbed Hera, MSNBC reported. In development for at least three years, Hera involves taking unstructured data from electronic medical records to identify an incorrect code or the misdiagnosis of a patient. The technology captures patient data that a physician may miss. This can help remove inaccuracies for insurers, resulting in greater efficiencies and more accurate assessment of a population’s risk.
According to two people familiar with the effort, Grand Challenge is already starting to pitch Hera to commercial health insurance companies.

Axovant Licenses Gene Therapy for Parkinson’s from Oxford BioMedica


Axovant Sciences, one of Vivek Ramaswamy’s biotech startups best known for its spectacular flameout over its Alzheimer’s drug in September 2017, is taking another shot, this time at Parkinson’s disease.
The company announced it has licensed exclusive worldwide rights to OXB-102, now dubbed AXO-Lenti-PD, from Oxford BioMedica The compound is an investigational gene therapy for Parkinson’s disease. It is designed to deliver three genes that encode a set of enzymes required for dopamine synthesis in the brain.
Oxford BioMedica focuses on lentiviral vector product development and manufacturing. It will continue as the clinical and commercial manufacturer of AXO-Lenti-PD.
Axovant says it plans to launch a Phase I/II dose-escalation trial of AXO-Lenti-PD in patients with advanced Parkinson’s disease by the end of 2018.
Part of Ramaswamy’s business strategy, aside from convincing investors to heavily invest in his companies, is to acquire cast-off drugs from other companies for bargain-bin prices. The key example is intepirdine, which is the Alzheimer’s drug that failed in a Phase III trial. Ramaswamy and Axovant bought the drug from GlaxoSmithKline for $5 million. It had shown a favorable safety and tolerability profile, and in a Phase IIb trial, showed immediate and sustained efficacy over placebo. But it had been abandoned by GSK after four clinical trials.
This appears to be something of a strategic pivot—although a very risky one—for the company. Axovant is paying an upfront payment of $30 million in cash, $5 million which will be applied as a credit towards the process development work and clinical supply. Oxford BioMedia will be eligible for various milestone payments that could exceed $812 million, as well as tiered royalties on net sales of the product if approved.
In addition, Roivant, Ramswamy’s parent company, will buy $25 million of Axovant common shares, which will support the clinical development of AXO-Lenti-PD.
The company is also shaking up its executive team, which has been undergoing a shakeup since September anyway. Last summer David Hung, former founder and chief executive officer of Medivation had taken on the chief executive role. But he left the company shortly after the Alzheimer’s failure. Pavan Cheruvu took over in February 2018.
Part of today’s announcement included that Fraser Wright will join the company as chief technology officer. He is the co-founder and former chief technology officer of Spark Therapeutics.
Cheruvu said in a statement, “Axovant remains committed to developing innovative treatments for serious neurodegenerative conditions such as Parkinson’s disease, and we are excited to partner with Oxford BioMedica, a recognized global leader in cell and gene therapy. We are also pleased to welcome Fraser to our leadership team.”
It’s anyone’s guess as to whether this shift will be successful. Parkinson’s is a slightly less volatile arena than Alzheimer’s, but it’s no picnic, either. As STAT points out, “If you bet $100 on Axovant Sciences nine months ago, you’re down 93 bucks.”
STAT further points out, “In biotech circles, the Axovant debacle became a referendum on Ramaswamy, who left a career as a hedge fund manager to build a constellation of biotech companies at work on drugs licensed from other firms.”
On the one hand, you have to admire someone who swings for the fences. But as any baseball fan knows, you’ve got to hit a homerun periodically if you do, and so far Ramswamy’s companies are striking out. That doesn’t mean all of them will—it seems likely that some of them, which are taking less risky approaches than Axovant, will get a break and become profitable. But gene therapy and Parkinson’s disease is still a tricky and difficult area to be taking big chances in. Maybe it’s good someone is willing to.

Zymeworks cut to neutral by Citi


Zymeworks downgraded to Neutral from Buy at Citi. Citi analyst Yigal Nochomovitz downgraded Zymeworks to Neutral while raising his price target for the shares to $20 from $18. The analyst believes the good ZW25 data at ASCO are now reflected in the valuation. Further, he sees a lack of near-term share catalysts

Perrigo cut to neutral by Barclays


Perrigo downgraded to Equal Weight from Overweight at Barclays. Barclays analyst Douglas Tsao downgraded Perrigo to Equal Weight and lowered his price target for the shares to $80 from $93. The company’s inability to win approval for its generic version of ProAir reduces near-term earnings momentum, Tsao tells investors in a research note. The analyst feels it will be hard for investors to get comfortable with Perrigo’s long-term outlook given secular changes in over-the-counter space.

CymaBay target hiked by Wainwright


CymaBay price target raised to $23 from $21 at H.C. Wainwright. H.C. Wainwright analyst Ed Arce raised his price target for CymaBay Therapeutics to $23 saying the company is well positioned to successfully execute its strategy with seladelpar. The analyst reiterates a Buy rating on the shares

Kitov target upped by Wainwright


Kitov Pharmaceuticals price target raised to $12.50 from $10 at H.C. Wainwright. H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Kitov Pharmaceuticals to $12.50 after the FDA approved Consensi “on schedule.” The analyst reiterates a Buy rating on the shares.

Sage started at buy by Ladenburg


Sage Therapeutics initiated with a Buy at Ladenburg. Ladenburg Thalmann analyst Michael Higgins started Sage Therapeutics with a Buy rating and $230 price target.