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Sandeep Singh Dhillon
NIH And 11 Pharmaceutical Companies Announce $215 Million Collaboration – Forbes
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By Ellie Kincaid , FORBES STAFF

The U.S. National Institutes of Health and 11 pharmaceutical companies today announced the launch of a five-year cancer immunotherapy research collaboration as part of the Cancer Moonshot. In total the partners will contribute $215 million to what they are calling the Partnership for Accelerating Cancer Therapies (PACT).

PACT’s fundamental question, NIH director Francis Collins told reporters in a press conference, is, “why doesn’t immunotherapy work for all patients in all types of cancer, and what can we do about that?”

Top priority in answering that question is testing immune- and cancer-related biomarkers in clinical trials to understand the mechanisms of how cancers respond to or resist immunotherapy. With standardized biomarkers to look at and harmonized assays to test them across many different trials, data from different studies will be more easily compared, Collins said.

Developing standardized biomarkers for immuno-oncology will be “extremely enabling,” like standardizing IP addresses in the early days of the web, Thomas Hudson, vice president for oncology discovery and early development at AbbVie, said at the press conference.

He expects having standard biomarkers and sharing data will help provide a scientific basis for deciding which cancer drugs to try in combination. Given the sheer number of potential combinations, that’s “one of the key reasons we got involved in PACT,” he said. “We don’t think random combinations are the way to go.”

The data for researching biomarkers will come from four National Cancer Institute-funded Cancer Immune Monitoring and Analysis Centers at Dana-Farber Cancer Institute, Stanford Cancer Institute, Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai and University of Texas MD Anderson Cancer Center. The centers will support adult and pediatric immunotherapy trials with tumor and immune profiling.

Getting access to data from clinical trials NCI supports was “very attractive,” Hudson said.

Which biomarkers the collaboration will focus on first is still to be discussed at a meeting the companies will likely have next month, said Douglas Lowy, NCI’s acting director.

The 11 pharmaceutical companies participating are AbbVie, Amgen, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb, Celgene Corporation, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research and Pfizer. Each will contribute up to $1 million per year for the five-year partnership, totaling $55 million.

The NCI will make up the rest with $160 million in funding mostly from the Cancer Moonshot, with some coming from regular appropriations, Lowy said.

Read the full article at

Sandeep Singh Dhillon
Immunotherapies might hasten tumour growth instead, suggests cancer researchers – MIMS Malaysia
Pharma Notables

At University of California in San Diego, a generally stable and strong 73-year-old patient was seeking to enter an immunotherapy trial for his slowly progressing bladder cancer.

He was then enrolled for an atezolizumab, or Tecentriq trial in June last year. But after six weeks, he stopped participating, and died two months later.

The drug has just been approved to treat bladder cancer patients.

In addition, researchers have observed a number of cases recently, whereby anti-PD-1 or anti-PD-L1 immunotherapies not only failed to stop patients’ cancer, but instead made tumours grow faster.

They published a study that looked at 155 cases in the journal Clinical Cancer Research last week. Of the total, eight patients who were fairly stable before immunotherapy treatment failed the therapy within two months.

Six saw their tumours enter a hyperactive phase, where the tumours expanded by between 53% and 258%.

Suggestive rather than conclusive findings
“There’s some phenomenon here that seems to be true, and I think we cannot just give this therapy randomly to the patient,” Shumei Kato, an oncologist at UC San Diego, and the author of the study.

Razelle Kurzock, the principal investigator of the paper, emphasises that the findings are more suggestive than conclusive, and that “further investigation is urgently needed.”

But Kato’s paper is not the first. Last year, cancer researchers at the Gustave Roussy Institute in France also published similar findings and were then considered controversial by some – since they were not widely confirmed by other oncologists.

However, these two papers are still not enough to convince other oncology experts such as Vinay Prasad, assistant professor in the Division of Haematology Oncology at Oregon Health and Science University.

“Tumour growth is not a precise measurement, and if you measure lots of people, some will have faster growth just because of the error in the test,” he said, adding that Kato’s paper does not state if growth happens “beyond the chance rate.”

Furthermore, those in Kato’s paper who experienced the hyper-progression of tumours shared specific genetic characteristics. The immunotherapies failed in six patients where amplifications were seen in the MDM2 gene family and two of ten patients with altered EGFR gene.

Two papers with similar findings cannot be ignored
But the fact that the Gustave Roussy team published similar findings – out of 131 patients, 12 patients or 9% showed hyper-progressive growth after immunotherapy treatment – cannot be ignored.

The lead author of that study, Stephane Champiat stated that the research raised more questions than answers but added that the new study “makes me more confident.”

Champiat also suggested other factors that could be associated with the effect. In his study, patients older than 65 showed hyper-progressive growth instead – twice the rate of younger patients.

“Is it specific to older patients? I don’t think so. Do they have higher risk? Maybe,” Champiat said. “And I think it’s probably different from one tumour type to another tumour type.”

Immunotherapies not as great as promised
However, this also complicates treatment strategies for oncologists studying this phenomenon as some patients exhibit “pseudo-progression”, in which tumour scans show apparent growth then instead the cancer is being attacked by masses of immune cells.

This is what both groups initially believed, therefore keeping their patients whose cancer have hyper-progressed on the immunotherapy treatment.

This also adds on to the argument for more caution among oncologists who have witnessed exceptionally strong results from immunotherapies as most patients in fact do not respond well to immunotherapy treatments, for unknown reasons.

In a study by Prasad and Dr Nathan Gay, also of Oregon Health and Science University, of the 30% of Americans suffering from cancer who qualify for immunotherapy, only 26% actually experience tumour shrinkage.

Furthermore, the less intrusive side effects of immunotherapies can be fatal when they happen.

Approach to immunotherapy cannot be changed yet
But the latest studies are too small to justify a change in patients’ and doctors’ approach to immunotherapy.

“With these small numbers, you’re always stuck being a little unsure,” says Elad Sharon, a cancer researcher at the US National Cancer Institute in Maryland. Like Kurzock, he suggested that larger studies that make tumour images available for analysis by outside scientists are needed.

“At the end of the day, while I find this interesting, I think the main point is if you use drugs where” randomised control trials “show benefit, you will be good,” Prasad said.

However, immunotherapies are usually approved without randomised control trials so “don’t be surprised if you harm patients. True for all drugs. Even, almost surely, immunotherapy,” Prasad said.

Immunotherapy Successful Handling Hard-to-Treat Cancer
Pharma Notables

Results of several clinical trials released Sunday show the revolutionary potential of immunotherapy in treating advanced cases of hard to treat types of cancer, such as bladder and lung cancer.

One has shown that the antibody Tecentriq — a product of Genentech, a subsidiary of the Swiss pharmaceutical Roche — reduced advanced bladder tumors in a quarter of 119 patients tested, with a median survival of almost 15 months. These results compare with a nine to 10 month survival rate typical with chemotherapy, the researchers said.

The findings were presented at the annual conference of the American Society of Clinical Oncology (ASCO), the world’s largest cancer congress, held this weekend in Chicago.

Tecentriq, which allows the immune system to attack the cancer cells, was shown to be effective with patients who had advanced bladder cancer and were too weak for chemotherapy.

“Up to half of patients with advanced bladder cancer are too frail to receive the only known survival-prolonging treatment,” said lead study author Arjun Vasant Balar, a medical doctor and assistant professor of medicine at New York University.

“We are encouraged to see that atezolizumab immunotherapy may help address this major unmet need,” Balar said.

The US Food and Drug Administration (FDA) recently authorized sales of Tecentriq on an expedited basis based on preliminary results of this clinical trial.

“This and other immunotherapies have brought new momentum to bladder cancer treatment, which until recently had seen practically no treatment advances in more than a decade,” said Charles Ryan, a professor of clinical medicine and urology at the University of California at San Francisco who participated in the study.

“The fact that this treatment appears safe for elderly patients, who too often have few good options, is all the more encouraging,” Ryan said.

The researchers plan to carry out a more extensive clinical trial with Tecentriq as first treatment for advanced bladder cancer that mainly affects older people, the vast majority of whom are smokers or former smokers.

– Promising treatment –

A new immunotherapy combined with an agent that kills cancer cells has also shown to be promising in treating patients suffering from the most aggressive form of lung cancer, which amounts to 10 to 15 percent of all lung tumors, according to the results of a separate clinical trial with 74 patients that was presented at ASCO Sunday.

This treatment combines a new immunotherapy, rovalpituzumab tesirine (Rova-T), developed by the start-up Stemcentrx that was recently acquired by the US laboratory AbbVie.

This combination blocked tumor growth in 89 percent of patients with high levels of DLL3 protein, and resulted in a cancer regression in 39 percent of the group being tested, which included some who had been given only one more year to live.

“We’ve seen too few successes in recent years for small cell lung cancer, which makes these early signs of efficacy all the more encouraging,” said lead study author Charles Rudin, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York.

A European study also presented at the ASCO conference showed encouraging results for an immunotherapy that targets the protein claudine18.2 in cases of advanced gastric cancer.

That immunotherapy, IMAB362 of Germany’s Ganymed Pharmaceuticals, is also combined with chemotherapy.

The clinical study with 161 patients who suffered from aggressive gastric tumors showed that this antibody significantly prolonged their survival when combined with chemotherapy, with 13.2 months or 16.7 months against 8.4 or nine months in patients treated with chemotherapy alone.

Drug Companies to Try a Unified Front Against Cancer – Courtesy of NYTimes
Pharma News

SAN FRANCISCO — Some leading pharmaceutical companies are joining forces in an effort to speed the testing of new types of cancer drugs that harness the body’s immune system to battle tumors.

The cooperative effort, announced on Monday, will include Amgen,Celgene and some smaller companies. The effort, known as the National Immunotherapy Coalition, will try to rapidly test various combinations of such drugs.

Perhaps the most exciting development in oncology now is the sudden success, after decades of failure, of efforts to unleash the immune system to control cancer. Three drugs that have been approved in the last few years — Keytruda from Merck and Opdivo and Yervoy from Bristol-Myers Squibb — have produced significant and long-lasting improvements in some patients.

But many other patients do not benefit at all from the drugs. Researchers believe that combinations of two or more drugs that engage different parts of the immune system might be effective for more patients than a single drug.

The drugs from Merck and Bristol-Myers are “looking at only one tiny aspect,” said Dr. Patrick Soon-Shiong, a billionaire pharmaceutical entrepreneur who is the driving force behind the new coalition. “What we wanted to do is capture all these different molecules in the immunotherapy system.”

Merck and Bristol-Myers are already testing their drugs in combinations with dozens of other drugs, many from other companies. Those companies and two others considered leaders in this field, Roche and AstraZeneca, are not in the new coalition.

But there are a dizzying number of possible combinations and arranging such trials one by one can be time-consuming. The coalition said it would have access to 60 drugs and would seek to enroll 20,000 patients by 2020. It will run early-stage trials of various combinations of drugs for up to 20 types of cancer, including breast, lung and prostate.

Some other companies, including GlaxoSmithKline, Pfizer and Merck of Germany, have been considering joining the coalition but have not done so yet.

Academic medical centers and community oncologists will be involved.

Dr. Soon-Shiong, who is based in Los Angeles and is a part owner of the Los Angeles Lakers, is best known for developing the cancer drug Abraxane. He sold the company that owned that drug to Celgene for $2.9 billion in 2010. Forbes estimates his wealth at $12.4 billion, making him the richest American pharmaceutical executive.

He is now involved in various companies and projects aimed at conquering cancer, including one called NantWorks. Some critics, however, have accused him of making exaggerated claims.

The coalition is the basis for what Dr. Soon-Shiong calls Cancer MoonShot 2020. Vice President Joseph R. Biden Jr., whose son Beau died of cancer last year, has also talked about devoting the rest of his term in office and his years after that to a “moonshot” against cancer. Mr. Biden has met with Dr. Soon-Shiong, but has not decided what his program would entail.

The announcement of the coalition came on the first day of the huge J.P. Morgan Healthcare Conference in San Francisco, when numerous companies make announcements.

Correction: January 11, 2016
An earlier version of this article, using information from a press release issued in advance under embargo by NantWorks, one of Dr. Patrick Soon-Shiong’s companies, and by two public relations companies he was working with — Sitrick and Company and W2O Group — erroneously included some companies among those forming the new cancer drug-testing coalition. Amgen and Celgene will be part of the effort; GlaxoSmithKline, Pfizer and Merck of Germany are not part of the coalition at this time.
India & Europe join hands for cancer and neurodegenerative disease remedies
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Heavy Hydrogen (Deuterium) in Living Organisms May Provide Clues to Prevent and Treat Cancer
Pharma News
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BUDAPEST, HUNGARY: Sub-molecular cellular events, driven by hydrogen’s replacements with deuterium, explain medical and economical failures of targeted molecular cancer drugs, which are the main conclusions of the 3 rd International Congress on Deuterium Depletion held in Budapest, Hungary, in May 2015.  Read more …